49 CFR 192.245 - Repair or removal of defects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Welding of Steel in Pipelines § 192... be preheated if conditions exist which would adversely affect the quality of the weld repair. After... minimum mechanical properties specified for the welding procedure used to make the original weld are met...

76 FR 43534 - Alternative to Minimum Days Off Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

... fatigue does not adversely affect public health and safety and the common defense and security. Among... health and safety and the common defense and security by establishing clear and enforceable requirements... public health and safety and common defense and security. B. Alternative to the Minimum Days Off...

Adverse Climatic Conditions and Impact on Construction Scheduling and Cost

DTIC Science & Technology

1988-01-01

ABBREVIATIONS ABS MAX MAX TEMP ...... Absolute maximum maximum temperature ABS MIN MIN TEMP ...... Absolute minimum minimum temperature BTU...o Degrees Farenheit MEAN MAX TEMP o.................... Mean maximum temperature MEAN MIN TEMP...temperatures available, a determination had to be made as to whether forecasts were based on absolute , mean, or statistically derived temperatures

An analysis of data related to the minimum temperatures for valid testing in cryogenic wind tunnels using nitrogen as the test gas

NASA Technical Reports Server (NTRS)

Hall, R. M.

1976-01-01

The minimum operating temperature which avoids adverse low temperature effects, such as condensation, has been determined at a free stream Mach number of 0.85 for flow over a 0.137 meter airfoil mounted at zero incidence in the Langley 1/3 meter transonic cryogenic tunnel. The onset of low temperature effects is established by comparing the pressure coefficient measured at a given orifice for a particular temperature with those measured at temperatures sufficiently above where low temperature effects might be expected to occur. The pressure distributions over the airfoil are presented in tabular form. In addition, the comparisons of the pressure coefficient as a function of total temperature are presented graphically for chord locations of 0, 25, 50, and 75 percent. Over the 1.2 to 4.5 atmosphere total pressure range investigated, low temperature effects are not detected until total temperatures are 2 K, or more, below free stream saturation temperatures.

Wage theft as a neglected public health problem: an overview and case study from San Francisco's Chinatown District.

PubMed

Minkler, Meredith; Salvatore, Alicia L; Chang, Charlotte; Gaydos, Megan; Liu, Shaw San; Lee, Pam Tau; Tom, Alex; Bhatia, Rajiv; Krause, Niklas

2014-06-01

Wage theft, or nonpayment of wages to which workers are legally entitled, is a major contributor to low income, which in turn has adverse health effects. We describe a participatory research study of wage theft among immigrant Chinatown restaurant workers. We conducted surveys of 433 workers, and developed and used a health department observational tool in 106 restaurants. Close to 60% of workers reported 1 or more forms of wage theft (e.g., receiving less than minimum wage [50%], no overtime pay [> 65%], and pay deductions when sick [42%]). Almost two thirds of restaurants lacked required minimum wage law signage. We discuss the dissemination and use of findings to help secure and enforce a wage theft ordinance, along with implications for practice.

Effects of extended work shifts and shift work on patient safety, productivity, and employee health.

PubMed

Keller, Simone M

2009-12-01

It is estimated 1.3 million health care errors occur each year and of those errors 48,000 to 98,000 result in the deaths of patients (Barger et al., 2006). Errors occur for a variety of reasons, including the effects of extended work hours and shift work. The need for around-the-clock staff coverage has resulted in creative ways to maintain quality patient care, keep health care errors or adverse events to a minimum, and still meet the needs of the organization. One way organizations have attempted to alleviate staff shortages is to create extended work shifts. Instead of the standard 8-hour shift, workers are now working 10, 12, 16, or more hours to provide continuous patient care. Although literature does support these staffing patterns, it cannot be denied that shifts beyond the traditional 8 hours increase staff fatigue, health care errors, and adverse events and outcomes and decrease alertness and productivity. This article includes a review of current literature on shift work, the definition of shift work, error rates and adverse outcomes related to shift work, health effects on shift workers, shift work effects on older workers, recommended optimal shift length, positive and negative effects of shift work on the shift worker, hazards associated with driving after extended shifts, and implications for occupational health nurses. Copyright 2009, SLACK Incorporated.

Focal treatment of spasticity using botulinum toxin A in cerebral palsy cases of GMFCS level V: evaluation of adverse effects☆☆☆

PubMed Central

Tedesco, Ana Paula; Martins, Juliana Saccol; Nicolini-Panisson, Renata D’Agostini

2014-01-01

Objective To report on the experience of injections of botulinum toxin A (BTA) in a series of patients with cerebral palsy of Gross Motor Function Classification System (GMFCS) level V. Methods This was a retrospective case series study on 33 patients with cerebral palsy of GMFCS level V who received 89 sessions of BTA application (of which 84 were Botox® and five were other presentations), in which the basic aim was to look for adverse effects. Results The mean number of application sessions per patient was three, and the mean age at the time of each injection was 4 + 6 years (range: 1.6–13 years). The muscles that most frequently received injections were the gastrocnemius, hamstrings, hip adductors, biceps brachii and finger flexors. The mean total dose was 193 U and the mean dose per weight was 12.5 U/kg. Only one patient received anesthesia for the injections and no sedation was used in any case. No local or systemic adverse effects were observed within the minimum follow-up of one month. Conclusion The absence of adverse effects in our series was probably related to the use of low doses and absence of sedation or anesthesia. According to our data, BTA can be safely used for patients with cerebral palsy of GMFCS level V, using low doses and preferably without sedation or anesthesia. PMID:26229827

Wage Theft as a Neglected Public Health Problem: An Overview and Case Study From San Francisco’s Chinatown District

PubMed Central

Salvatore, Alicia L.; Chang, Charlotte; Gaydos, Megan; Liu, Shaw San; Lee, Pam Tau; Tom, Alex; Bhatia, Rajiv; Krause, Niklas

2014-01-01

Wage theft, or nonpayment of wages to which workers are legally entitled, is a major contributor to low income, which in turn has adverse health effects. We describe a participatory research study of wage theft among immigrant Chinatown restaurant workers. We conducted surveys of 433 workers, and developed and used a health department observational tool in 106 restaurants. Close to 60% of workers reported 1 or more forms of wage theft (e.g., receiving less than minimum wage [50%], no overtime pay [> 65%], and pay deductions when sick [42%]). Almost two thirds of restaurants lacked required minimum wage law signage. We discuss the dissemination and use of findings to help secure and enforce a wage theft ordinance, along with implications for practice. PMID:24825200

Adverse Space Weather at the Solar Cycle Minimum

NASA Astrophysics Data System (ADS)

Baker, D. N.; Kanekal, S. G.; McCollough, J. P.; Singer, H. J.; Chappell, S. P.; Allen, J. H.

2008-05-01

It is commonly understood that many types of adverse space weather (solar flares, coronal mass ejections, geomagnetic storms) occur most commonly around the maximum of the 11-year sunspot activity cycle. Other types of well-known space weather such as relativistic electron events in the Earth's outer magnetosphere (that produce deep dielectric charging in spacecraft systems) are usually associated with the period just after sunspot maximum. At the present time, we are in the very lowest activity phase of the sunspot cycle (solar minimum). As such we would not expect much in the way of adverse space weather events. However, in early to mid-February of 2008 quite prominent solar coronal holes produced two high-speed streams that in turn stimulated very large, long-duration relativistic electron enhancements in Earth's magnetosphere. These seem to have been associated with several spacecraft operational anomalies at various spacecraft orbital locations. We describe these recent space weather events and assess their operational significance in this presentation. These results show that substantial space weather events can and do occur even during the quietest parts of the solar cycle.

The contribution of different information sources for adverse effects data.

PubMed

Golder, Su; Loke, Yoon K

2012-04-01

The aim of this study is to determine the relative value and contribution of searching different sources to identify adverse effects data. The process of updating a systematic review and meta-analysis of thiazolidinedione-related fractures in patients with type 2 diabetes mellitus was used as a case study. For each source searched, a record was made for each relevant reference included in the review noting whether it was retrieved with the search strategy used and whether it was available but not retrieved. The sensitivity, precision, and number needed to read from searching each source and from different combinations of sources were also calculated. There were 58 relevant references which presented sufficient numerical data to be included in a meta-analysis of fractures and bone mineral density. The highest number of relevant references were retrieved from Science Citation Index (SCI) (35), followed by BIOSIS Previews (27) and EMBASE (24). The precision of the searches varied from 0.88% (Scirus) to 41.67% (CENTRAL). With the search strategies used, the minimum combination of sources required to retrieve all the relevant references was; the GlaxoSmithKline (GSK) website, Science Citation Index (SCI), EMBASE, BIOSIS Previews, British Library Direct, Medscape DrugInfo, handsearching and reference checking, AHFS First, and Thomson Reuters Integrity or Conference Papers Index (CPI). In order to identify all the relevant references for this case study a number of different sources needed to be searched. The minimum combination of sources required to identify all the relevant references did not include MEDLINE.

30 CFR 780.22 - Geologic information.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Geologic information shall include, at a minimum the following: (1) A description of the geology of the... adversely impacted by mining. The description shall include the areal and structural geology of the permit...

30 CFR 780.22 - Geologic information.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) Geologic information shall include, at a minimum the following: (1) A description of the geology of the... adversely impacted by mining. The description shall include the areal and structural geology of the permit...

Oral Finasteride Presents With Sexual-Unrelated Withdrawal in Long-Term Treated Androgenic Alopecia in Men.

PubMed

Perez-Mora, Nicolas; Velasco, Carlos; Bermüdez, Fernando

2015-01-01

Side effects associated with oral finasteride (FT) (1 mg/d) and topical 5% minoxidil (M5) have been previously described. The authors have evaluated long-term adverse effects and causes of long-term therapy withdrawal in patients with androgenic alopecia (AGA) treated with M5+FT vs M5 without FT. A total of 130 AGA patients with a minimum 2-year follow-up volunteered to complete a questionnaire on side effects. Patients' responses were classified as "never," "rarely," "sometimes," "often," and "all the time." An adverse effect was considered in the presence of an "often" or "all the time" response. A total of 100 patients received combined M5+FT and were compared with 30 patients receiving single-therapy M5 according to the physician's clinical criteria. Erectile dysfunction (3%), diminished libido (4%), and reduced ejaculation (7%) were present in patients taking M5+FT but were absent in patients taking M5. Only 1 of 100 patients taking M5+FT quit long-term therapy due to sexual adverse effects (diminished libido). The main causes for therapy withdrawal in the FT group were lack of positive results in 11% and in the M5 group side effects in 4% (P < .02). Increased body hair was different between groups: with 6.6% in the M5 group and 4% in the M5+FT group (P < .03). FT demonstrates sexual-unrelated reasons as the main cause of therapy withdrawal in long-term treated AGA patients.

Robust inference from multiple test statistics via permutations: a better alternative to the single test statistic approach for randomized trials.

PubMed

Ganju, Jitendra; Yu, Xinxin; Ma, Guoguang Julie

2013-01-01

Formal inference in randomized clinical trials is based on controlling the type I error rate associated with a single pre-specified statistic. The deficiency of using just one method of analysis is that it depends on assumptions that may not be met. For robust inference, we propose pre-specifying multiple test statistics and relying on the minimum p-value for testing the null hypothesis of no treatment effect. The null hypothesis associated with the various test statistics is that the treatment groups are indistinguishable. The critical value for hypothesis testing comes from permutation distributions. Rejection of the null hypothesis when the smallest p-value is less than the critical value controls the type I error rate at its designated value. Even if one of the candidate test statistics has low power, the adverse effect on the power of the minimum p-value statistic is not much. Its use is illustrated with examples. We conclude that it is better to rely on the minimum p-value rather than a single statistic particularly when that single statistic is the logrank test, because of the cost and complexity of many survival trials. Copyright © 2013 John Wiley & Sons, Ltd.

Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation.

PubMed

Duffy, Jmn; Hirsch, M; Pealing, L; Showell, M; Khan, K S; Ziebland, S; McManus, R J

2018-06-01

Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. To assess safety reporting in pre-eclampsia trials. Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC. © 2017 Royal College of Obstetricians and Gynaecologists.

14 CFR 135.4 - Applicability of rules for eligible on-demand operations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... minimum of 500 hours. (ii) For multi-engine turbine-powered fixed-wing and powered-lift aircraft, the... runway to be used has water, snow, slush, ice, or similar contamination that may adversely affect...

Ondansetron versus granisetron in the prevention of chemotherapy induced nausea and vomiting in children with acute lymphoblastic leukemia.

PubMed

Siddique, R; Hafiz, M G; Rokeya, B; Jamal, C Y; Islam, A

2011-10-01

Effect of ondansetron and granisetron were evaluated in sixty (60) children (age 4-11 years) irrespective of sex, diagnosed case of acute lymphoblastic leukemia (ALL) who received high dose methotrexate and did not receive any antiemetic 24 hours prior to HDMTX. This was a prospective, randomized, double-blind, single center study. Of 60 children, 30 received oral ondansetron (4mg) and rest 30 granisetron (1mg) half an hour before therapy. Drugs were randomly allocated with appropriate code. The patients were followed up from day 1 to day 5 of therapy. Episodes of nausea and vomiting were recorded and scorings was done every 24 hours following chemotherapy. No significant difference was found between two groups according to acute emesis (Day-1) (p=0.053). In day two and day three it was significant (p<0.05). In day four it was significant (p=0.002). Early chemotherapy induced nausea and vomiting (CINV) were controlled 90% in children who received granisetron and 70% in children who received ondansetron. Delayed (Day 2-4) CINV were controlled in 80% of children who received granisetron and 43.4% who received ondansetron (p<0.05). Granisetron group required additional doses only 3.3% cases and ondanseton group 30% cases on the second day (p<0.05). Result was significant between two groups. About 36.7% patients had episodes of nausea on day four of chemotherapy in ondansetron group and it was only 3.3% in granisetron group due to adverse effects of antiemetic drug itself (p=0.001). Maximum episodes of vomiting were found on the second day in ondansetron group 33.3% and in granisetron group 3.3% (p=0.003). Though adverse effects like headache, constipation, abdominal pain and loose motion were common in both group of children but their number was much less in children who received granisetron. On second day of therapy score of nausea and vomiting was maximum in ondansetron and minimum in granisetron treated on day 4 and the result was significant. So, to prevent acute and delayed CINV in children with ALL, oral graniseteron can be considered as more effective and well tolerated with minimum adverse effects compared with ondansetrons.

Efficacy and Safety of 3 Different Anesthesia Techniques Used in Total Hip Arthroplasty

PubMed Central

Liang, Chengwei; Wei, Jionglin; Cai, Xiaoxi; Lin, Weilong; Fan, Yongqian; Yang, Fengjian

2017-01-01

Background This study compared the efficacy and safety of 3 different anesthesia techniques used in total hip arthroplasty (THA). Material/Methods We allocated 198 patients preparing to undertake THA into 3 groups: general anesthesia group (GA group, n=66), caudal epidural anesthesia group (CEA group, n=66), and spinal-epidural anesthesia group (SEA group, n=66). We compared postoperative adverse effects occurring in patients of the 3 anesthesia groups. The Visual Analog Scale (VAS) score, Minimum Mental State Examination (MMSE) score, and β-amyloid (Aβ) expression were calculated to determine the effects of different anesthesia on the postoperative pain and cognitive dysfunction of patients. Results The CEA and SEA groups had lower rates of perioperative adverse effects than in the GA group. Patients in the GA group required significantly higher administration of analgesics after the surgery than those in CEA and SEA groups. Higher Aβ expression levels and VAS scores, as well as lower MMSE scores, were also seen in the GA group compared with the other 2 groups. Conclusions CEA and SEA were more effective than GA in THA, and CEA seemed to be a better anesthesia technique than SEA. PMID:28767640

Radiation production and absorption in human spacecraft shielding systems under high charge and energy Galactic Cosmic Rays: Material medium, shielding depth, and byproduct aspects

NASA Astrophysics Data System (ADS)

Barthel, Joseph; Sarigul-Klijn, Nesrin

2018-03-01

Deep space missions such as the planned 2025 mission to asteroids require spacecraft shields to protect electronics and humans from adverse effects caused by the space radiation environment, primarily Galactic Cosmic Rays. This paper first reviews the theory on how these rays of charged particles interact with matter, and then presents a simulation for a 500 day Mars flyby mission using a deterministic based computer code. High density polyethylene and aluminum shielding materials at a solar minimum are considered. Plots of effective dose with varying shield depth, charged particle flux, and dose in silicon and human tissue behind shielding are presented.

Imidacloprid treatment of marsupials for fleas (Pygiopsylla hoplia).

PubMed

Baker, R T; Beveridge, I

2001-09-01

Two eastern barred bandicoots (Perameles gunnii), two eastern quells (Dasyunrus viverrinus), four fat-tailed dunnarts (Sminthopsis crassicaudata), a Leadbeater's possum (Gymnobelideus leadbeateri), a yellow-bellied glider (Petaurus australis), and a ring-tailed possum (Pseudocheirus peregrinus) were treated with imidacloprid (10.7 +/- 0.6 mg/kg topically, minimum dose 0.5 mg) after observation of fleas (Pygiopsylla hoplia) on animals and in their nest boxes. No live fleas or adverse reactions to imidacloprid were observed for 27 days following treatment. The ease of application, absence of toxicity, and long residual effect makes imidacloprid a useful drug for treating flea infestations in these marsupials.

Pirbenicillin: Comparison with Carbenicillin and BL-P1654, Alone and with Gentamicin, Against Pseudomonas aeruginosa

PubMed Central

Lopez, Carlos E.; Standiford, Harold C.; Tatem, Beverly A.; Calia, Frank M.; Schimpff, Stephen C.; Snyder, Merrill J.; Hornick, Richard B.

1977-01-01

Minimum inhibitory concentrations (MIC) of pirbenicillin against 135 clinical isolates of Pseudomonas aeruginosa were one-fourth of those required for carbenicillin but two times higher than those for BL-P1654. Increasing the inoculum size produced an adverse effect on the bactericidal activity for all three antibiotics. This was more apparent for pirbenicillin than for carbenicillin, but less than the effect on BL-P1654. When concentrations of antibiotics likely to be achieved clinically were used, gentamicin increased the inhibitory and bactericidal effects of all three semisynthetic penicillins for the majority of isolates. Strains highly resistant to the aminoglycoside antibiotic, however, were inhibited no more by the penicillin-gentamicin combinations than by the most effective of the antibiotics alone. PMID:404963

42 CFR 84.177 - Inhalation and exhalation valves; minimum requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... air from adversely affecting filters, except where filters are specifically designed to resist... DEVICES Non-Powered Air-Purifying Particulate Respirators § 84.177 Inhalation and exhalation valves... external influence; and (3) Designed and constructed to prevent inward leakage of contaminated air. ...

42 CFR 84.177 - Inhalation and exhalation valves; minimum requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... air from adversely affecting filters, except where filters are specifically designed to resist... DEVICES Non-Powered Air-Purifying Particulate Respirators § 84.177 Inhalation and exhalation valves... external influence; and (3) Designed and constructed to prevent inward leakage of contaminated air. ...

Indian Herbal Medicines: Possible Potent Therapeutic Agents for Rheumatoid Arthritis

PubMed Central

Rathore, Brijesh; Ali Mahdi, Abbas; Nath Paul, Bhola; Narayan Saxena, Prabhu; Kumar Das, Siddharth

2007-01-01

Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology and is mainly characterized by the progressive erosion of cartilage leading to chronic polyarthritis and joint distortion. Although the exact pathogenesis of the disease has yet not been elucidated, however, studies suggest that cellular proliferation of synoviocytes result in pannus formation which damages the cartilage and bone. Recent reports also support the role of free radicals in its pathogenesis. Apart from the conventional treatment strategies using nonsteroidal anti-inflammatory drugs, disease modifying antirheumatic drugs and glucocorticoids, newer and safer drugs are continuously being searched, as long term usage of these drugs have resulted in adverse effects. Alternative medicine provides another approach for treatment of RA and currently a number of medicinal plants are under scientific evaluation to develop a novel drug. There is a dire need to investigate the complete therapeutic potential and adverse effects, if any, of these herbals for providing newer and safer treatment options with minimum side effects. In this review we have tried to explore various Indian ancient Ayurvedic, Unani and Tibbi, as also some Chinese and Korean, herbals for their potential to treat RA. PMID:18392103

Strategies for combating bacterial biofilms: A focus on anti-biofilm agents and their mechanisms of action

PubMed Central

Roy, Ranita; Tiwari, Monalisa; Donelli, Gianfranco; Tiwari, Vishvanath

2018-01-01

ABSTRACT Biofilm refers to the complex, sessile communities of microbes found either attached to a surface or buried firmly in an extracellular matrix as aggregates. The biofilm matrix surrounding bacteria makes them tolerant to harsh conditions and resistant to antibacterial treatments. Moreover, the biofilms are responsible for causing a broad range of chronic diseases and due to the emergence of antibiotic resistance in bacteria it has really become difficult to treat them with efficacy. Furthermore, the antibiotics available till date are ineffective for treating these biofilm related infections due to their higher values of minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC), which may result in in-vivo toxicity. Hence, it is critically important to design or screen anti-biofilm molecules that can effectively minimize and eradicate biofilm related infections. In the present article, we have highlighted the mechanism of biofilm formation with reference to different models and various methods used for biofilm detection. A major focus has been put on various anti-biofilm molecules discovered or tested till date which may include herbal active compounds, chelating agents, peptide antibiotics, lantibiotics and synthetic chemical compounds along with their structures, mechanism of action and their respective MICs, MBCs, minimum biofilm inhibitory concentrations (MBICs) as well as the half maximal inhibitory concentration (IC50) values available in the literature so far. Different mode of action of anti biofilm molecules addressed here are inhibition via interference in the quorum sensing pathways, adhesion mechanism, disruption of extracellular DNA, protein, lipopolysaccharides, exopolysaccharides and secondary messengers involved in various signaling pathways. From this study, we conclude that the molecules considered here might be used to treat biofilm-associated infections after significant structural modifications, thereby investigating its effective delivery in the host. It should also be ensured that minimum effective concentration of these molecules must be capable of eradicating biofilm infections with maximum potency without posing any adverse side effects on the host. PMID:28362216

The Effect of Sex and Anthropometry on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention for Complex Coronary Lesions.

PubMed

Lee, Seung Yul; Shin, Dong Ho; Kim, Jung Sun; Kim, Byeong Keuk; Ko, Young Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong Ki

2017-03-01

To evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI). From three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions. For 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423-0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160-35.206, p=0.033). Sex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height.

Circadian misalignment affects sleep and medication use before and during spaceflight

PubMed Central

Flynn-Evans, Erin E; Barger, Laura K; Kubey, Alan A; Sullivan, Jason P; Czeisler, Charles A

2016-01-01

Sleep deficiency and the use of sleep-promoting medication are prevalent during spaceflight. Operations frequently dictate work during the biological night and sleep during the biological day, which contribute to circadian misalignment. We investigated whether circadian misalignment was associated with adverse sleep outcomes before (preflight) and during spaceflight missions aboard the International Space Station (ISS). Actigraphy and photometry data for 21 astronauts were collected over 3,248 days of long-duration spaceflight on the ISS and 11 days prior to launch (n=231 days). Sleep logs, collected one out of every 3 weeks in flight and daily on Earth, were used to determine medication use and subjective ratings of sleep quality. Actigraphy and photometry data were processed using Circadian Performance Simulation Software to calculate the estimated endogenous circadian temperature minimum. Sleep episodes were classified as aligned or misaligned relative to the estimated endogenous circadian temperature minimum. Mixed-effects regression models accounting for repeated measures were computed by data collection interval (preflight, flight) and circadian alignment status. The estimated endogenous circadian temperature minimum occurred outside sleep episodes on 13% of sleep episodes during preflight and on 19% of sleep episodes during spaceflight. The mean sleep duration in low-Earth orbit on the ISS was 6.4±1.2 h during aligned and 5.4±1.4 h (P<0.01) during misaligned sleep episodes. During aligned sleep episodes, astronauts rated their sleep quality as significantly better than during misaligned sleep episodes (66.8±17.7 vs. 60.2±21.0, P<0.01). Sleep-promoting medication use was significantly higher during misaligned (24%) compared with aligned (11%) sleep episodes (P<0.01). Use of any medication was significantly higher on days when sleep episodes were misaligned (63%) compared with when sleep episodes were aligned (49%; P<0.01). Circadian misalignment is associated with sleep deficiency and increased medication use during spaceflight. These findings suggest that there is an immediate need to deploy and assess effective countermeasures to minimize circadian misalignment and consequent adverse sleep outcomes both before and during spaceflight. PMID:28725719

Circadian misalignment affects sleep and medication use before and during spaceflight.

PubMed

Flynn-Evans, Erin E; Barger, Laura K; Kubey, Alan A; Sullivan, Jason P; Czeisler, Charles A

2016-01-01

Sleep deficiency and the use of sleep-promoting medication are prevalent during spaceflight. Operations frequently dictate work during the biological night and sleep during the biological day, which contribute to circadian misalignment. We investigated whether circadian misalignment was associated with adverse sleep outcomes before (preflight) and during spaceflight missions aboard the International Space Station (ISS). Actigraphy and photometry data for 21 astronauts were collected over 3,248 days of long-duration spaceflight on the ISS and 11 days prior to launch ( n =231 days). Sleep logs, collected one out of every 3 weeks in flight and daily on Earth, were used to determine medication use and subjective ratings of sleep quality. Actigraphy and photometry data were processed using Circadian Performance Simulation Software to calculate the estimated endogenous circadian temperature minimum. Sleep episodes were classified as aligned or misaligned relative to the estimated endogenous circadian temperature minimum. Mixed-effects regression models accounting for repeated measures were computed by data collection interval (preflight, flight) and circadian alignment status. The estimated endogenous circadian temperature minimum occurred outside sleep episodes on 13% of sleep episodes during preflight and on 19% of sleep episodes during spaceflight. The mean sleep duration in low-Earth orbit on the ISS was 6.4±1.2 h during aligned and 5.4±1.4 h ( P <0.01) during misaligned sleep episodes. During aligned sleep episodes, astronauts rated their sleep quality as significantly better than during misaligned sleep episodes (66.8±17.7 vs. 60.2±21.0, P <0.01). Sleep-promoting medication use was significantly higher during misaligned (24%) compared with aligned (11%) sleep episodes ( P <0.01). Use of any medication was significantly higher on days when sleep episodes were misaligned (63%) compared with when sleep episodes were aligned (49%; P <0.01). Circadian misalignment is associated with sleep deficiency and increased medication use during spaceflight. These findings suggest that there is an immediate need to deploy and assess effective countermeasures to minimize circadian misalignment and consequent adverse sleep outcomes both before and during spaceflight.

5 CFR 890.1008 - Mandatory debarment for longer than the minimum length.

Code of Federal Regulations, 2010 CFR

2010-01-01

... that were not adjudicated, adversely affected the physical, mental, or financial well-being of one or... (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM Administrative Sanctions Imposed Against Health Care Providers Mandatory Debarments § 890.1008 Mandatory debarment for...

The Anti-Staphylococcus aureus Effect of Combined Echinophora platyloba Essential Oil and Liquid Smoke in Beef

PubMed Central

Pilevar, Zahra; Hajimehdipoor, Homa; Shahraz, Farzaneh; Alizadeh, Leyla; Mahmoudzadeh, Maryam

2017-01-01

Summary In the current study, the antibacterial effect of Echinophora platyloba essential oil and common liquid smoke (individually and in combination) against Staphylococcus aureus in beef meat samples is investigated. Using an automated microbiological growth analyser and the turbidimetric technique, the minimum inhibitory concentrations (MIC) and the minimum bactericidal concentrations (MBC) of the essential oil and liquid smoke were determined. Anti-S. aureus activity of essential oil and liquid smoke (individually and in combination) was defined by disk diffusion assay, generation time and cell constituent release. Apart from that, the interactions between these two compounds were measured by the checkerboard assay and by calculating the fractional inhibitory concentration (FIC) indices. Related MIC values of essential oil and smoke were found to be 7200 and 5500 mg/L, and MBC values were 8500 and 8000 mg/L, respectively. The conducted organoleptic assay showed that the addition of 0.05 g of essential oil and 0.6 g of liquid smoke to 100 g of meat samples did not have adverse effect on the overall acceptance. Weaker antibacterial effect against Staphylococcus aureus was observed when only Echinophora platyloba essential oil was used than when it was used in combination with liquid smoke. PMID:28559740

Pharmaceutical Price Controls and Minimum Efficacy Regulation: Evidence from the United States and Italy

PubMed Central

Atella, Vincenzo; Bhattacharya, Jay; Carbonari, Lorenzo

2012-01-01

Objective This article examines the relationship between drug price and drug quality and how it varies across two of the most common regulatory regimes in the pharmaceutical market: minimum efficacy standards (MES) and a mix of MES and price control mechanisms (MES + PC). Data Sources Our primary data source is the Tufts-New England Medical Center-Cost Effectiveness Analysis Registry which have been merged with price data taken from MEPS (for the United States) and AIFA (for Italy). Study Design Through a simple model of adverse selection we model the interaction between firms, heterogeneous buyers, and the regulator. Principal Findings The theoretical analysis provides two results. First, an MES regime provides greater incentives to produce high-quality drugs. Second, an MES + PC mix reduces the difference in price between the highest and lowest quality drugs on the market. Conclusion The empirical analysis based on United States and Italian data corroborates these results. PMID:22091623

Full-scale Wind-tunnel and Flight Tests of a Fairchild 22 Airplane Equipped with a Fowler Flap

NASA Technical Reports Server (NTRS)

Dearborn, C H; Soule, H A

1936-01-01

Full-scale wind-tunnel and flight tests were made of a Fairchild 22 airplane equipped with a Fowler flap to determine the effect of the flap on the performance and control characteristics of the airplane. In the wind-tunnel tests of the airplane with the horizontal tail surfaces removed, the flap was found to increase the maximum lift coefficient from 1.27 to 2.41. In the flight test, the flap was found to decrease the minimum speed from 58.8 to 44.4 miles per hour. The required take-off run to attain an altitude of 50 feet was reduced from 935 feet to 700 feet by the use of the flap, the minimum distance being obtained with five-sixths full deflection. The landing run from a height of 50 feet was reduced one-third. The longitudinal and directional control was adversely affected by the flap, indicating that the design of the tail surfaces is more critical with a flapped than a plain wing.

Acute toxicity in five dogs after ingestion of a commercial snail and slug bait containing iron EDTA.

PubMed

Haldane, S L; Davis, R M

2009-07-01

This case series of five dogs describes the effects of ingesting large amounts of an iron EDTA snail-bait product. In all cases signs of toxicity occurred between 6 and 24 h after ingestion and included abdominal pain and haemorrhagic gastroenteritis. Two of the dogs had pretreatment serum iron levels measured and in both cases the levels were above normal limits. All of the dogs were treated with iron chelation therapy and supportive care including intravenous fluids, analgesics, gastric protectants and antibiotics. Chelation therapy with desferrioxamine mesylate did not cause adverse effects in any of the dogs and all survived to discharge. The effects of iron EDTA snail bait in dogs requires further study and minimum toxic doses need to be established.

Global Association of Cold Spells and Adverse Health Effects: A Systematic Review and Meta-Analysis

PubMed Central

Ryti, Niilo R.I.; Guo, Yuming; Jaakkola, Jouni J.K.

2015-01-01

Background There is substantial evidence that mortality increases in low temperatures. Less is known about the role of prolonged cold periods denoted as cold spells. Objective We conducted the first systematic review and meta-analysis to summarize the evidence on the adverse health effects of cold spells in varying climates. Data sources and extraction Four databases (Ovid Medline, PubMed, Scopus, Web of Science) were searched for all years and languages available. “Cold spell” was defined as an event below a temperature threshold lasting for a minimum duration of 2 days. Of 1,527 identified articles, 26 satisfied our eligibility criteria for the systematic review, and 9 were eligible for meta-analyses. The articles were grouped by the three main study questions into Overall-effect Group, Added-effect Group, and Temperature-change-effect Group. Data synthesis Based on random-effects models in the meta-analyses, cold spells were associated with increased mortality from all or all nonaccidental causes (summary rate ratio = 1.10; 95% CI: 1.04, 1.17 based on 9 estimates from five studies), cardiovascular diseases (1.11; 95% CI: 1.03, 1.19; 12 estimates from eight studies), and respiratory diseases (1.21; 95% CI: 0.97, 1.51; 8 estimates from four studies). Estimated associations were stronger for people ≥ 65 years of age (1.06; 95% CI: 1.00, 1.12) than for people 0–64 years of age (1.01; 95% CI: 1.00, 1.03). Study-specific effect estimates from a limited number of studies suggested an increased morbidity related to cold spells, but it was not possible to quantitatively summarize the evidence. Conclusions Cold spells are associated with increased mortality rates in populations around the world. The body of evidence suggests that cold spells also have other adverse health effects. There was substantial heterogeneity among the studies, which should be taken into account in the interpretation of the results. Citation Ryti NR, Guo Y, Jaakkola JJ. 2016. Global association of cold spells and adverse health effects: a systematic review and meta-analysis. Environ Health Perspect 124:12–22; http://dx.doi.org/10.1289/ehp.1408104 PMID:25978526

Global Association of Cold Spells and Adverse Health Effects: A Systematic Review and Meta-Analysis.

PubMed

Ryti, Niilo R I; Guo, Yuming; Jaakkola, Jouni J K

2016-01-01

There is substantial evidence that mortality increases in low temperatures. Less is known about the role of prolonged cold periods denoted as cold spells. We conducted the first systematic review and meta-analysis to summarize the evidence on the adverse health effects of cold spells in varying climates. Four databases (Ovid Medline, PubMed, Scopus, Web of Science) were searched for all years and languages available. "Cold spell" was defined as an event below a temperature threshold lasting for a minimum duration of 2 days. Of 1,527 identified articles, 26 satisfied our eligibility criteria for the systematic review, and 9 were eligible for meta-analyses. The articles were grouped by the three main study questions into Overall-effect Group, Added-effect Group, and Temperature-change-effect Group. Based on random-effects models in the meta-analyses, cold spells were associated with increased mortality from all or all nonaccidental causes (summary rate ratio = 1.10; 95% CI: 1.04, 1.17 based on 9 estimates from five studies), cardiovascular diseases (1.11; 95% CI: 1.03, 1.19; 12 estimates from eight studies), and respiratory diseases (1.21; 95% CI: 0.97, 1.51; 8 estimates from four studies). Estimated associations were stronger for people ≥ 65 years of age (1.06; 95% CI: 1.00, 1.12) than for people 0-64 years of age (1.01; 95% CI: 1.00, 1.03). Study-specific effect estimates from a limited number of studies suggested an increased morbidity related to cold spells, but it was not possible to quantitatively summarize the evidence. Cold spells are associated with increased mortality rates in populations around the world. The body of evidence suggests that cold spells also have other adverse health effects. There was substantial heterogeneity among the studies, which should be taken into account in the interpretation of the results. Ryti NR, Guo Y, Jaakkola JJ. 2016. Global association of cold spells and adverse health effects: a systematic review and meta-analysis. Environ Health Perspect 124:12-22; http://dx.doi.org/10.1289/ehp.1408104.

20 CFR 655.0 - Scope and purpose of part.

Code of Federal Regulations, 2013 CFR

2013-04-01

... affect the wages or working conditions of similarly employed U.S. workers. These factual determinations... job opportunity will not adversely affect the wages or working conditions of similarly employed U.S... employment under conditions below the established minimum levels. Florida Sugar Cane League, Inc. v. Usery...

20 CFR 655.0 - Scope and purpose of part.

Code of Federal Regulations, 2011 CFR

2011-04-01

... affect the wages or working conditions of similarly employed U.S. workers. These factual determinations... job opportunity will not adversely affect the wages or working conditions of similarly employed U.S... employment under conditions below the established minimum levels. Florida Sugar Cane League, Inc. v. Usery...

20 CFR 655.0 - Scope and purpose of part.

Code of Federal Regulations, 2012 CFR

2012-04-01

... affect the wages or working conditions of similarly employed U.S. workers. These factual determinations... job opportunity will not adversely affect the wages or working conditions of similarly employed U.S... employment under conditions below the established minimum levels. Florida Sugar Cane League, Inc. v. Usery...

20 CFR 655.0 - Scope and purpose of part.

Code of Federal Regulations, 2014 CFR

2014-04-01

... affect the wages or working conditions of similarly employed U.S. workers. These factual determinations... job opportunity will not adversely affect the wages or working conditions of similarly employed U.S... employment under conditions below the established minimum levels. Florida Sugar Cane League, Inc. v. Usery...

Minimum airflow reset of single-duct VAV terminal boxes

NASA Astrophysics Data System (ADS)

Cho, Young-Hum

Single duct Variable Air Volume (VAV) systems are currently the most widely used type of HVAC system in the United States. When installing such a system, it is critical to determine the minimum airflow set point of the terminal box, as an optimally selected set point will improve the level of thermal comfort and indoor air quality (IAQ) while at the same time lower overall energy costs. In principle, this minimum rate should be calculated according to the minimum ventilation requirement based on ASHRAE standard 62.1 and maximum heating load of the zone. Several factors must be carefully considered when calculating this minimum rate. Terminal boxes with conventional control sequences may result in occupant discomfort and energy waste. If the minimum rate of airflow is set too high, the AHUs will consume excess fan power, and the terminal boxes may cause significant simultaneous room heating and cooling. At the same time, a rate that is too low will result in poor air circulation and indoor air quality in the air-conditioned space. Currently, many scholars are investigating how to change the algorithm of the advanced VAV terminal box controller without retrofitting. Some of these controllers have been found to effectively improve thermal comfort, indoor air quality, and energy efficiency. However, minimum airflow set points have not yet been identified, nor has controller performance been verified in confirmed studies. In this study, control algorithms were developed that automatically identify and reset terminal box minimum airflow set points, thereby improving indoor air quality and thermal comfort levels, and reducing the overall rate of energy consumption. A theoretical analysis of the optimal minimum airflow and discharge air temperature was performed to identify the potential energy benefits of resetting the terminal box minimum airflow set points. Applicable control algorithms for calculating the ideal values for the minimum airflow reset were developed and applied to actual systems for performance validation. The results of the theoretical analysis, numeric simulations, and experiments show that the optimal control algorithms can automatically identify the minimum rate of heating airflow under actual working conditions. Improved control helps to stabilize room air temperatures. The vertical difference in the room air temperature was lower than the comfort value. Measurements of room CO2 levels indicate that when the minimum airflow set point was reduced it did not adversely affect the indoor air quality. According to the measured energy results, optimal control algorithms give a lower rate of reheating energy consumption than conventional controls.

Design and in vivo evaluation of solid lipid nanoparticulate systems of Olanzapine for acute phase schizophrenia treatment: Investigations on antipsychotic potential and adverse effects.

PubMed

Joseph, Emil; Reddi, Satish; Rinwa, Vibhu; Balwani, Garima; Saha, Ranendra

2017-06-15

The present paper discusses the design, characterization and in vivo evaluation of glyceryl monostearate nanoparticles of Olanzapine, an atypical antipsychotic drug for acute schizophrenia treatment, during which hospitalization is mandatory and adverse effects are at its peak. The solid lipid nanoparticulate system was obtained by emulsification-ultra sonication technique wherein three factors such as solid lipid content, concentration of surfactant and drug: solid lipid ratio were selected at three different levels in order to study their influence on significant characteristic responses such as particle size, encapsulation efficiency and drug content. A Box Behnken design with 17 runs involving whole factors at three levels was employed for the study. The optimized formulation was further coated with Polysorbate 80 in order to enhance its brain targeting potential through endocytosis transport process via blood brain barrier. The designed formulations were pre-clinically tested successfully in Wistar rat model for in vivo antipsychotic efficacy (apomorphine induced psychosis) and adverse effects (weight gain study for 28days). The results obtained indicated that solid lipid nanoparticles had very narrow size distribution (151.29±3.36nm) with very high encapsulation efficiency (74.51±1.75%). Morphological studies by SEM have shown that solid lipid nanoparticles were spherical in shape with smooth surface. Olanzapine-loaded nanoparticles prepared from solid lipid, extended the release of drug for 48h, as found by the in vitro release studies. The formulations also exhibited high redispersibility after freeze-drying and stability study results demonstrated good stability, with no significant change for a period of 6months. In vivo evaluation and adverse effects studies of Olanzapine-loaded nanoparticulate systems in animal model have demonstrated an improved therapeutic efficacy than pure Olanzapine. The antipsychotic effect of drug loaded nanoparticulate systems was maintained for 48h as compared to 8h antipsychotic action of pure Olanzapine solution. The weight gain studies for 28days demonstrated a significant inhibition in weight gain for Olanzapine-loaded nanoparticulate systems as compared to the pure Olanzapine. The present research findings indicate that OLN-loaded nanoparticulate systems may be highly promising for effective delivery of Olanzapine with better efficacy and minimum adverse effects. Copyright © 2017 Elsevier B.V. All rights reserved.

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial.

PubMed

Walker, Bruce F; Losco, Barrett; Clarke, Brenton R; Hebert, Jeff; French, Simon; Stomski, Norman J

2011-10-31

Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998.

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998 PMID:22040597

76 FR 70516 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

... Budget for extension and approval. Rule 17Ad-6 requires every registered transfer agent to make and keep... taken to perform transfer agent activities (to ensure compliance with the minimum performance standards... appointment or termination of the transfer agent; (4) stop orders or notices of adverse claims to the...

[Determination of sensitivity of biofilm-positive forms of microorganisms to antibiotics].

PubMed

Holá, Veronika; Růzicka, Filip; Tejkalová, Renata; Votava, Miroslav

2004-10-01

Nosocomial infections caused by biofilm-positive microorganisms are a serious therapeutic problem. In the biofilm, microorganisms are protected against adverse effects of the external environment, including the action of antibiotics. It is well known that the values of minimum inhibitory concentrations (MIC) determined for planktonic forms do not correspond to the actual concentrations of antibiotics necessary for the eradication of bacteria in a biofilm. The purpose of the study was to propose a method of determining minimum biofilm inhibitory concentrations (MBIC) and minimum biofilm eradication concentrations (MBEC) and to compare these values with MIC values. Biofilm-positive strains of Staphylococcus epidermidis were cultured so as to form a biofilm layer on polystyrene pegs. The biofilm on the pegs was then exposed to the action of antibiotics and after 18 hours we determined the minimum biofilm inhibitory concentration (MBIC). The evaluation of minimum biofilm eradication concentrations was done colorimetrically from the metabolic activity of surviving cells. MBIC and MBEC values were many times higher than MIC values. We selected such a duration of the biofilms cultivation on the pegs of the plate, which ensured that the number of bacterial cells corresponded to standard MIC assessment. The MBEC values established in our study indicate that the currently used concentrations of tested antibiotics cannot be used in monotherapy for an efficacious eradication of a biofilm. The MBEC determination is a far more laborious and time-consuming method than the determination of MIC, but the use of plates with pegs facilitates the handling of biofilms. The advantage of our method is the possibility of standardization of the size of the inoculum and thus of the whole MBEC assessment.

The management of acute adverse effects of breast cancer treatment in general practice: a video-vignette study.

PubMed

Jiwa, Moyez; Long, Anne; Shaw, Tim; Pagey, Georgina; Halkett, Georgia; Pillai, Vinita; Meng, Xingqiong

2014-09-03

There has been a focus recently on the use of the Internet and email to deliver education interventions to general practitioners (GPs). The treatment of breast cancer may include surgery, radiotherapy, chemotherapy, and/or hormone treatment. These treatments may have acute adverse effects. GPs need more information on the diagnosis and management of specific adverse effects encountered immediately after cancer treatment. The goal was to evaluate an Internet-based educational program developed for GPs to advise patients with acute adverse effects following breast cancer treatment. During phase 1, participants viewed 6 video vignettes of actor-patients reporting 1 of 6 acute symptoms following surgery and chemotherapy and/or radiotherapy treatment. GPs indicated their diagnosis and proposed management through an online survey program. They received feedback about each scenario in the form of a specialist clinic letter, as if the patient had been seen at a specialist clinic after they had attended the GP. This letter incorporated extracts from local guidelines on the management of the symptoms presented. This feedback was sent to the GPs electronically on the same survey platform. In phase 2, all GPs were invited to manage similar cases as phase 1. Their proposed management was compared to the guidelines. McNemar test was used to compare data from phases 1 and 2, and logistic regression was used to explore the GP characteristics that were associated with inappropriate case management. A total of 50 GPs participated. Participants were younger and more likely to be female than other GPs in Australia. For 5 of 6 vignettes in phase 1, management was consistent with expert opinion in the minority of cases (6%-46%). Participant demographic characteristics had a variable effect on different management decisions in phase 1. The variables modeled explained 15%-28% of the differences observed. Diagnosis and management improved significantly in phase 2, especially for diarrhea, neutropenia, and seroma sample cases. The proportion of incorrect management responses was reduced to a minimum (25.3%-49.3%) in phase 2. There was evidence that providing feedback by experts on specific cases had an impact on GPs' knowledge about how to appropriately manage acute treatment adverse effects. This educational intervention could be targeted to support the implementation of shared care during cancer treatment.

The Management of Acute Adverse Effects of Breast Cancer Treatment in General Practice: A Video-Vignette Study

PubMed Central

Pagey, Georgina; Halkett, Georgia; Pillai, Vinita; Meng, Xingqiong

2014-01-01

Background There has been a focus recently on the use of the Internet and email to deliver education interventions to general practitioners (GPs). The treatment of breast cancer may include surgery, radiotherapy, chemotherapy, and/or hormone treatment. These treatments may have acute adverse effects. GPs need more information on the diagnosis and management of specific adverse effects encountered immediately after cancer treatment. Objective The goal was to evaluate an Internet-based educational program developed for GPs to advise patients with acute adverse effects following breast cancer treatment. Methods During phase 1, participants viewed 6 video vignettes of actor-patients reporting 1 of 6 acute symptoms following surgery and chemotherapy and/or radiotherapy treatment. GPs indicated their diagnosis and proposed management through an online survey program. They received feedback about each scenario in the form of a specialist clinic letter, as if the patient had been seen at a specialist clinic after they had attended the GP. This letter incorporated extracts from local guidelines on the management of the symptoms presented. This feedback was sent to the GPs electronically on the same survey platform. In phase 2, all GPs were invited to manage similar cases as phase 1. Their proposed management was compared to the guidelines. McNemar test was used to compare data from phases 1 and 2, and logistic regression was used to explore the GP characteristics that were associated with inappropriate case management. Results A total of 50 GPs participated. Participants were younger and more likely to be female than other GPs in Australia. For 5 of 6 vignettes in phase 1, management was consistent with expert opinion in the minority of cases (6%-46%). Participant demographic characteristics had a variable effect on different management decisions in phase 1. The variables modeled explained 15%-28% of the differences observed. Diagnosis and management improved significantly in phase 2, especially for diarrhea, neutropenia, and seroma sample cases. The proportion of incorrect management responses was reduced to a minimum (25.3%-49.3%) in phase 2. Conclusions There was evidence that providing feedback by experts on specific cases had an impact on GPs’ knowledge about how to appropriately manage acute treatment adverse effects. This educational intervention could be targeted to support the implementation of shared care during cancer treatment. PMID:25274131

On the Minimum Induced Drag of Wings

NASA Technical Reports Server (NTRS)

Bowers, Albion H.

2010-01-01

Of all the types of drag, induced drag is associated with the creation and generation of lift over wings. Induced drag is directly driven by the span load that the aircraft is flying at. The tools by which to calculate and predict induced drag we use were created by Ludwig Prandtl in 1903. Within a decade after Prandtl created a tool for calculating induced drag, Prandtl and his students had optimized the problem to solve the minimum induced drag for a wing of a given span, formalized and written about in 1920. This solution is quoted in textbooks extensively today. Prandtl did not stop with this first solution, and came to a dramatically different solution in 1932. Subsequent development of this 1932 solution solves several aeronautics design difficulties simultaneously, including maximum performance, minimum structure, minimum drag loss due to control input, and solution to adverse yaw without a vertical tail. This presentation lists that solution by Prandtl, and the refinements by Horten, Jones, Kline, Viswanathan, and Whitcomb

On the Minimum Induced Drag of Wings -or- Thinking Outside the Box

NASA Technical Reports Server (NTRS)

Bowers, Albion H.

2011-01-01

Of all the types of drag, induced drag is associated with the creation and generation of lift over wings. Induced drag is directly driven by the span load that the aircraft is flying at. The tools by which to calculate and predict induced drag we use were created by Ludwig Prandtl in 1903. Within a decade after Prandtl created a tool for calculating induced drag, Prandtl and his students had optimized the problem to solve the minimum induced drag for a wing of a given span, formalized and written about in 1920. This solution is quoted in textbooks extensively today. Prandtl did not stop with this first solution, and came to a dramatically different solution in 1932. Subsequent development of this 1932 solution solves several aeronautics design difficulties simultaneously, including maximum performance, minimum structure, minimum drag loss due to control input, and solution to adverse yaw without a vertical tail. This presentation lists that solution by Prandtl, and the refinements by Horten, Jones, Kline, Viswanathan, and Whitcomb.

On the Minimum Induced Drag of Wings

NASA Technical Reports Server (NTRS)

Bowers, Albion H.

2011-01-01

Of all the types of drag, induced drag is associated with the creation and generation of lift over wings. Induced drag is directly driven by the span load that the aircraft is flying at. The tools by which to calculate and predict induced drag we use were created by Ludwig Prandtl in 1903. Within a decade after Prandtl created a tool for calculating induced drag, Prandtl and his students had optimized the problem to solve the minimum induced drag for a wing of a given span, formalized and written about in 1920. This solution is quoted in textbooks extensively today. Prandtl did not stop with this first solution, and came to a dramatically different solution in 1932. Subsequent development of this 1932 solution solves several aeronautics design difficulties simultaneously, including maximum performance, minimum structure, minimum drag loss due to control input, and solution to adverse yaw without a vertical tail. This presentation lists that solution by Prandtl, and the refinements by Horten, Jones, Kline, Viswanathan, and Whitcomb.

The Effect of Sex and Anthropometry on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention for Complex Coronary Lesions

PubMed Central

Lee, Seung-Yul; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

2017-01-01

Purpose To evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI). Materials and Methods From three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions. Results For 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion–related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423–0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160–35.206, p=0.033). Conclusion Sex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height. PMID:28120559

78 FR 65145 - Federal Agricultural Mortgage Corporation Funding and Fiscal Affairs; Farmer Mac Capital Planning

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... capital base and promote best practices for capital adequacy planning and stress testing. We view high... minimum supervisory standards for the capital planning process, including stress testing, (ii) describes... stress tests to ensure they are able to sustain financial soundness under adverse market conditions. In...

76 FR 23208 - Alternative to Minimum Days Off Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-26

... specified in Sec. 26.4(a)(1) through (a)(4) (i.e., certain operations, chemistry, health physics, fire... nuclear power plant licensees to ensure that worker fatigue does not adversely affect public health and... licensees will manage cumulative fatigue in a manner that contributes to the protection of public health and...

Exploration of the association rules mining technique for the signal detection of adverse drug events in spontaneous reporting systems.

PubMed

Wang, Chao; Guo, Xiao-Jing; Xu, Jin-Fang; Wu, Cheng; Sun, Ya-Lin; Ye, Xiao-Fei; Qian, Wei; Ma, Xiu-Qiang; Du, Wen-Min; He, Jia

2012-01-01

The detection of signals of adverse drug events (ADEs) has increased because of the use of data mining algorithms in spontaneous reporting systems (SRSs). However, different data mining algorithms have different traits and conditions for application. The objective of our study was to explore the application of association rule (AR) mining in ADE signal detection and to compare its performance with that of other algorithms. Monte Carlo simulation was applied to generate drug-ADE reports randomly according to the characteristics of SRS datasets. Thousand simulated datasets were mined by AR and other algorithms. On average, 108,337 reports were generated by the Monte Carlo simulation. Based on the predefined criterion that 10% of the drug-ADE combinations were true signals, with RR equaling to 10, 4.9, 1.5, and 1.2, AR detected, on average, 284 suspected associations with a minimum support of 3 and a minimum lift of 1.2. The area under the receiver operating characteristic (ROC) curve of the AR was 0.788, which was equivalent to that shown for other algorithms. Additionally, AR was applied to reports submitted to the Shanghai SRS in 2009. Five hundred seventy combinations were detected using AR from 24,297 SRS reports, and they were compared with recognized ADEs identified by clinical experts and various other sources. AR appears to be an effective method for ADE signal detection, both in simulated and real SRS datasets. The limitations of this method exposed in our study, i.e., a non-uniform thresholds setting and redundant rules, require further research.

Electroencephalography for children with autistic spectrum disorder: a sedation protocol.

PubMed

Keidan, Ilan; Ben-Menachem, Erez; Tzadok, Michal; Ben-Zeev, Bruria; Berkenstadt, Haim

2015-02-01

To report the effectiveness and efficiency of a predetermined sedation protocol for providing sedation for electroencephalograph (EEG) studies in children with autism. Sleep EEG has been advocated for the majority of children with autism spectrum disorder. In most cases, sedation is required to allow adequate studies. Most sedation drugs have negative effects on the EEG pattern. The sedation protocol we adopted included chloral hydrate, dexmedetomidine, and ketamine and was evaluated prospectively for 2 years. One hundred and eighty-three children with autistic spectrum disorder were sedated with the described drug protocol that was efficient, provided adequate EEG readings, and was not associated with serious adverse events. Our protocol kept costs to a minimum but provided appropriate escalation in care when required. © 2014 John Wiley & Sons Ltd.

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

Reynolds, Adam F.; Steinfeldt, Bradley Alexander; Lafleur, Jarret Marshall

The U.S. nuclear stockpile hedge is an inventory of non-deployed nuclear warheads and a force structure capable of deploying those warheads. Current guidance is to retain this hedge to mitigate the risk associated with the technical failure of any single warhead type or adverse geopolitical developments that could require augmentation of the force. The necessary size of the hedge depends on the composition of the nuclear stockpile and assumed constraints. Knowing the theoretical minimum hedge given certain constraints is useful when considering future weapons policy. HedgeHOGS, an Excel-based tool, was developed to enable rapid calculation of the minimum hedge sizemore » associated with varying active stockpile composition and hedging strategies.« less

Does patella lowering improve crouch gait in cerebral palsy? Comparative retrospective study.

PubMed

Desailly, E; Thévenin-Lemoine, C; Khouri, N

2017-09-01

Patella lowering aims to improve quadriceps function as a means of correcting crouch gait in patients with cerebral palsy. Few studies have assessed the effects of patella lowering as a component of multilevel surgery. Including patella lowering into the components of multilevel surgery is beneficial in patients with crouch gait and patella alta. In 12 lower limbs with patella alta (Caton-Deschamps index>1.4) in 41 children with cerebral palsy, patella lowering was performed, without distal femoral extension osteotomy or hamstring release. Among limbs with similar surgical procedures (e.g., hamstring lengthening, rectus femoris transfer) except for patella lowering, controls were selected retrospectively by matching on a propensity score for patella lowering. The propensity score was computed based on preoperative knee flexion contracture, knee extension lag, and minimum knee flexion at mid-stance. Clinical and 3D kinematic data were compared between the two groups. The improvement in minimum knee flexion at mid-stance was significantly greater in the group with patellar lowering (-24°±12°vs. -12°±7°). The Gait Deviation Index improved similarly in the two groups. Knee flexion contracture improved only in the group with patellar lowering. Extension lag did not improve in either group. Peak knee flexion during the swing phase remained unchanged in both groups. Patellar lowering is effective in diminishing minimum knee flexion at mid-stance in patients with patella alta and crouch gait due to cerebral palsy. Patellar lowering has not adverse effects on gait. These findings cannot be assumed to apply to patients with normal patellar height. IV (retrospective study). Copyright © 2017. Published by Elsevier Masson SAS.

Impact of HIPAA’s Minimum Necessary Standard on Genomic Data Sharing

PubMed Central

Evans, Barbara J.; Jarvik, Gail P.

2017-01-01

Purpose This article provides a brief introduction to the HIPAA Privacy Rule’s minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions. Methods This research used the Thomson Reuters Westlaw™ database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data-sharing. We considered relevant example cases of genomic data-sharing needs. Results In a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized—whether for research, public health, or clinical interpretation and medical practice support—affects how the minimum necessary standard applies and its overall impact on data access and use. Conclusion There is no clear regulatory guidance on how to apply HIPAA’s minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy-makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows. PMID:28914268

Impact of HIPAA's minimum necessary standard on genomic data sharing.

PubMed

Evans, Barbara J; Jarvik, Gail P

2018-04-01

This article provides a brief introduction to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions. This research used the Thomson Reuters Westlaw database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data sharing. We considered relevant example cases of genomic data-sharing needs. In a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized-whether for research, public health, or clinical interpretation and medical practice support-affects how the minimum necessary standard applies and its overall impact on data access and use. There is no clear regulatory guidance on how to apply HIPAA's minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows.

Multi-Center Pilot Study to Evaluate the Safety Pro le of High Energy Fractionated Radiofrequency With Insulated Microneedles to Multiple Levels of the Dermis.

PubMed

Cohen, Joel L; Weiner, Steven F; Pozner, Jason N; Ibrahimi, Omar A; Vasily, David B; Ross, E Victor; Gabriel, Zena

2016-11-01

In this multi-center pilot study, the safety pro le of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for safety in the treatment of the aging neck and face. A newly designed insulated microneedle system delivers a signi cant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty- ve healthy subjects from seven aesthetic practices were evaluated, and data from each were incorporated in this case report. The subjects received a single treatment using settings that delivered the highest RF energies suggested from the new recommended protocols. The depth of thermal delivery was adjusted before each pass and all subjects received a minimum of two to three passes to the treated areas. Before and after photographs along with adverse effects were recorded. This case report demonstrates the ability to deliver significant RF thermal injury to several layers of the dermis with insulated microneedles safely with little injury to the epidermis and minimum downtime. J Drugs Dermatol. 2016;15(11):1308-1312..

Association of acute adverse effects with high local SAR induced in the brain from prolonged RF head and neck hyperthermia

NASA Astrophysics Data System (ADS)

Adibzadeh, F.; Verhaart, R. F.; Verduijn, G. M.; Fortunati, V.; Rijnen, Z.; Franckena, M.; van Rhoon, G. C.; Paulides, M. M.

2015-02-01

To provide an adequate level of protection for humans from exposure to radio-frequency (RF) electromagnetic fields (EMF) and to assure that any adverse health effects are avoided. The basic restrictions in terms of the specific energy absorption rate (SAR) were prescribed by IEEE and ICNIRP. An example of a therapeutic application of non-ionizing EMF is hyperthermia (HT), in which intense RF energy is focused at a target region. Deep HT in the head and neck (H&N) region involves inducing energy at 434 MHz for 60 min on target. Still, stray exposure of the brain is considerable, but to date only very limited side-effects were observed. The objective of this study is to investigate the stringency of the current basic restrictions by relating the induced EM dose in the brain of patients treated with deep head and neck (H&N) HT to the scored acute health effects. We performed a simulation study to calculate the induced peak 10 g spatial-averaged SAR (psSAR10g) in the brains of 16 selected H&N patients who received the highest SAR exposure in the brain, i.e. who had the minimum brain-target distance and received high forwarded power during treatment. The results show that the maximum induced SAR in the brain of the patients can exceed the current basic restrictions (IEEE and ICNIRP) on psSAR10g for occupational environments by 14 times. Even considering the high local SAR in the brain, evaluation of acute effects by the common toxicity criteria (CTC) scores revealed no indication of a serious acute neurological effect. In addition, this study provides pioneering quantitative human data on the association between maximum brain SAR level and acute adverse effects when brains are exposed to prolonged RF EMF.

Full-scale Wind-tunnel and Flight Tests of a Fairchild 22 Airplane Equipped with External-airfoil Flaps

NASA Technical Reports Server (NTRS)

Reed, Warren D; Clay, William C

1937-01-01

Wind-tunnel and flight tests have been made of a Fairchild 22 airplane equipped with a wing having external-airfoil flaps that also perform the function of ailerons. Lift, drag, and pitching-moment coefficients of the airplane with several flap settings, and the rolling- and yawing-moment coefficients with the flaps deflected as ailerons were measured in the full-scale tunnel with the horizontal tail surfaces and propeller removed. The effect of the flaps on the low speed and on the take-off and landing characteristics, the effectiveness of flaps when used as ailerons, and the forces required to operate them as ailerons were determined in flight. The wind-tunnel tests showed that the flaps increased the maximum lift coefficient of the airplane from 1.51 with the flap in the minimum drag position to 2.12 with the flap in the minimum drag position to 2.12 with the flap deflected 30 degrees. In the flight tests the minimum speed decreased from 46.8 miles per hour with the flaps up to 41.3 miles per hour with the flaps deflected. The required take-off run to attain a height of 50 feet was reduced from 820 to 750 feet and the landing run from a height of 50 feet was reduced from 930 to 480 feet. The flaps for this installation gave lateral control that was not entirely satisfactory. Their rolling action was good but the adverse yaw resulting from their use was greater than is considerable, and the stick forces required to operate them increased too rapidly with speed.

Chronic exposure to low levels of dibromoacetic acid, a water disinfection by-product, adversely affects reproductive function in male rabbits

EPA Science Inventory

Four groups (minimum of 10/dose group) of male Dutch-Belted rabbits were treated daily to dibromoacetic acid (DBA) via drinking water beginning in utero from gestation day 15 throughout life; target dosages were 1, 5, and 50 mg DBA /kg body weight. Developmental, prepubertal as ...

Minimum pricing of alcohol versus volumetric taxation: which policy will reduce heavy consumption without adversely affecting light and moderate consumers?

PubMed

Sharma, Anurag; Vandenberg, Brian; Hollingsworth, Bruce

2014-01-01

We estimate the effect on light, moderate and heavy consumers of alcohol from implementing a minimum unit price for alcohol (MUP) compared with a uniform volumetric tax. We analyse scanner data from a panel survey of demographically representative households (n = 885) collected over a one-year period (24 Jan 2010-22 Jan 2011) in the state of Victoria, Australia, which includes detailed records of each household's off-trade alcohol purchasing. The heaviest consumers (3% of the sample) currently purchase 20% of the total litres of alcohol (LALs), are more likely to purchase cask wine and full strength beer, and pay significantly less on average per standard drink compared to the lightest consumers (A$1.31 [95% CI 1.20-1.41] compared to $2.21 [95% CI 2.10-2.31]). Applying a MUP of A$1 per standard drink has a greater effect on reducing the mean annual volume of alcohol purchased by the heaviest consumers of wine (15.78 LALs [95% CI 14.86-16.69]) and beer (1.85 LALs [95% CI 1.64-2.05]) compared to a uniform volumetric tax (9.56 LALs [95% CI 9.10-10.01] and 0.49 LALs [95% CI 0.46-0.41], respectively). A MUP results in smaller increases in the annual cost for the heaviest consumers of wine ($393.60 [95% CI 374.19-413.00]) and beer ($108.26 [95% CI 94.76-121.75]), compared to a uniform volumetric tax ($552.46 [95% CI 530.55-574.36] and $163.92 [95% CI 152.79-175.03], respectively). Both a MUP and uniform volumetric tax have little effect on changing the annual cost of wine and beer for light and moderate consumers, and likewise little effect upon their purchasing. While both a MUP and a uniform volumetric tax have potential to reduce heavy consumption of wine and beer without adversely affecting light and moderate consumers, a MUP offers the potential to achieve greater reductions in heavy consumption at a lower overall annual cost to consumers.

Comparison of synovial fluid, urine, and serum ion levels in metal-on-metal total hip arthroplasty at a minimum follow-up of 18 years.

PubMed

Lass, Richard; Grübl, Alexander; Kolb, Alexander; Stelzeneder, David; Pilger, Alexander; Kubista, Bernd; Giurea, Alexander; Windhager, Reinhard

2014-09-01

Diagnosis of adverse reactions to metal debris in metal-on-metal hip arthroplasty is a multifactorial process. Systemic ion levels are just one factor in the evaluation and should not be relied upon solely to determine the need for revision surgery. Furthermore, the correlation between cobalt or chromium serum, urine, or synovial fluid levels and adverse local tissue reactions is still incompletely understood. The hypothesis was that elevated serum and urine metal-ion concentrations are associated with elevated local metal-ion concentrations in primary total hip arthroplasties (THA) and with failure of metal-on-metal articulations in the long-term. In our present study, we evaluated these concentrations in 105 cementless THA with metal-on-metal articulating surfaces with small head diameter at a minimum of 18 years postoperatively. Spearman correlation showed a high correlation between the joint fluid aspirate concentration of cobalt and chromium with the serum cobalt (r = 0.81) and chromium level (r = 0.77) in patients with the THA as the only source of metal-ions. In these patients serum metal-ion analysis is a valuable method for screening. In patients with more than one source of metal or renal insufficiency additional investigations, like joint aspirations are an important tool for evaluation of wear and adverse tissue reactions in metal-on-metal THA. © 2014 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

Effects of forebody geometry on subsonic boundary-layer stability

NASA Technical Reports Server (NTRS)

Dodbele, Simha S.

1990-01-01

As part of an effort to develop computational techniques for design of natural laminar flow fuselages, a computational study was made of the effect of forebody geometry on laminar boundary layer stability on axisymmetric body shapes. The effects of nose radius on the stability of the incompressible laminar boundary layer was computationally investigated using linear stability theory for body length Reynolds numbers representative of small and medium-sized airplanes. The steepness of the pressure gradient and the value of the minimum pressure (both functions of fineness ratio) govern the stability of laminar flow possible on an axisymmetric body at a given Reynolds number. It was found that to keep the laminar boundary layer stable for extended lengths, it is important to have a small nose radius. However, nose shapes with extremely small nose radii produce large pressure peaks at off-design angles of attack and can produce vortices which would adversely affect transition.

Effects of two eye drop products on computer users with subjective ocular discomfort.

PubMed

Skilling, Francis C; Weaver, Tony A; Kato, Kenneth P; Ford, Jerry G; Dussia, Elyse M

2005-01-01

An increasing number of people seek medical attention for symptoms of visual discomfort due to computer vision syndrome (CVS). We compared the efficacy and adverse event rates of a new eye lubricant, OptiZen (InnoZen, Inc., polysorbate 80 0.5%) and Visine Original (Pfizer Consumer Healthcare, tetrahydrozoline HCl 0.05%). In this double-blind parallel arm trial, 50 healthy men and women, ages 18 to 65 years, with symptoms of CVS who use a video display terminal for a minimum of 4 hours per day were randomized to OptiZen (n = 25) or Visine Original (n= 25), 1 to 2 drops b.i.d. for 5 days. The primary end-points were ocular discomfort and adverse events. OptiZen and Visine Original had similar efficacy in alleviating symptoms of ocular discomfort (odds ratio of 1.23 [95% confidence interval, 0.63 to 2.42], P= 0.55). OptiZen and Visine Original were very similar with respect to odds ratios and 95% confidence interval (CI) for each of the measurement times (P= 0.72). Visine Original users reported a significantly higher incidence of temporary ocular stinging/burning immediately after drug instillation (28%, 7/25) than did OptiZen users (4%, 1/24) (P= 0.05). Patients using OptiZen were 89% less likely to have stinging/burning effects than those patients using Visine Original (95% CI: 0.01 to 0.95). OptiZen and Visine Original are effective at alleviating ocular discomfort associated with prolonged computer use. Adverse event findings suggest that OptiZen causes less ocular discomfort on instillation, potentially attributable to its milder ingredient profile.

Antibiotic-loaded bone void filler accelerates healing in a femoral condylar rat model.

PubMed

Shiels, S M; Cobb, R R; Bedigrew, K M; Ritter, G; Kirk, J F; Kimbler, A; Finger Baker, I; Wenke, J C

2016-08-01

Demineralised bone matrix (DBM) is rarely used for the local delivery of prophylactic antibiotics. Our aim, in this study, was to show that a graft with a bioactive glass and DBM combination, which is currently available for clinical use, can be loaded with tobramycin and release levels of antibiotic greater than the minimum inhibitory concentration for Staphylococcus aureus without interfering with the bone healing properties of the graft, thus protecting the graft and surrounding tissues from infection. Antibiotic was loaded into a graft and subsequently evaluated for drug elution kinetics and the inhibition of bacterial growth. A rat femoral condylar plug model was used to determine the effect of the graft, loaded with antibiotic, on bone healing. We found that tobramycin loaded into a graft composed of bioglass and DBM eluted antibiotic above the minimum inhibitory concentration for three days in vitro. It was also found that the antibiotic loaded into the graft produced no adverse effects on the bone healing properties of the DBM at a lower level of antibiotic. This antibiotic-loaded bone void filler may represent a promising option for the delivery of local antibiotics in orthopaedic surgery. Cite this article: Bone Joint J 2016;98-B:1126-31. ©2016 The British Editorial Society of Bone & Joint Surgery.

Effect of whole-body vibration therapy on health-related physical fitness in children and adolescents with disabilities: a systematic review.

PubMed

Matute-Llorente, Angel; González-Agüero, Alejandro; Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Casajús Mallén, José Antonio

2014-04-01

To summarize the current literature regarding the effects of whole-body vibration (WBV) therapy on the health-related physical fitness of children and adolescents with disabilities. A literature search using MEDLINE-PubMed, SPORT DISCUS, and EMBASE databases was conducted up to August 2013. A total of 22 articles were included in this review (eight randomized controlled trials, four non-randomized controlled trials, three case reports, and seven reviews). Most of the studies showed positive effects of WBV on health-related physical fitness in children and adolescents with disabilities. Overall, 10-20 minutes at least three times per week, for a minimum of 26 weeks, with high frequency (between 15 and 35 Hz) and low amplitude (no more than 4 mm of peak-to-peak displacement) might be an appropriate protocol to achieve improvement in body composition and muscular strength. Because no serious adverse events have been observed, WBV might be defined as a safe treatment to be applied in children and adolescents with disabling conditions. Further research is recommended to explore the minimum dose of exposure to WBV required to elicit an optimal response in children and adolescents for improving health-related physical fitness. These may be translated into a more specific WBV protocol. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Prescribing psychotropic drugs to adults with an intellectual disability

PubMed Central

Trollor, Julian N; Salomon, Carmela; Franklin, Catherine

2016-01-01

SUMMARY Mental illness is common in people with intellectual disability. They may also have physical health problems which can affect their mental state. Difficulties in communication can contribute to mental health problems being overlooked. These may present with changes in behaviour. Psychological management is usually preferable to prescribing psychotropic drugs. Behavioural approaches are the most appropriate way to manage challenging behaviour. If a drug is considered, prescribers should complete a thorough diagnostic assessment, exclude physical and environmental contributions to symptoms, and consider medical comorbidities before prescribing. Where possible avoid psychotropics with the highest cardiometabolic burden. Prescribe the minimum effective dose and treatment length, and regularly monitor drug efficacy and adverse effects. There is insufficient evidence to support the use of psychotropics for challenging behaviour. They should be avoided unless the behaviour is severe and non-responsive to other treatments. PMID:27756975

In vitro interactions of Peucedanum officinale essential oil with antibiotics.

PubMed

Miladinović, Dragoljub L; Ilić, Budimir S; Kocić, Branislava D; Miladinović, Ljiljana C; Marković, Marija S

2015-01-01

The chemical composition and antibacterial activity of Peucedanum officinale L. (Apiaceae) essential oil were examined, as well as the association between it and antibiotics: tetracycline, streptomycin and chloramphenicol. The interactions of the essential oil with antibiotics were evaluated using the microdilution checkerboard assay. Monoterpene hydrocarbons, with α-phellandrene as the dominant constituent, were the most abundant compound class of the essential oil of P. officinale. The researched essential oil exhibited slight antibacterial activity against the tested bacterial strains in vitro. On the contrary, essential oil of P. officinale possesses a great synergistic potential with chloramphenicol and tetracycline. Their combinations reduced the minimum effective dose of the antibiotic and, consequently, minimised its adverse side effects. In addition, investigated interactions are especially successful against Gram-negative bacteria, the pharmacological treatment of which is very difficult nowadays.

Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background Hot flushes and night sweats (vasomotor symptoms) are common menopausal symptoms, often causing distress, sleep deprivation and reduced quality of life. Although hormone replacement therapy is an effective treatment, there are concerns about serious adverse events. Non-hormonal pharmacological therapies are less effective and can also cause adverse effects. Complementary therapies, including acupuncture, are commonly used for menopausal vasomotor symptoms. While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive, acupuncture has a low risk of adverse effects, and two small studies suggest it may be more effective than non-insertive sham acupuncture. Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women. Our current study design is informed by methods tested in a pilot study. Methods/design This is a stratified, parallel, randomised sham-controlled trial with equal allocation of participants to two trial groups. We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency. Exclusion criteria include breast cancer, surgical menopause, and current hormone replacement therapy use. Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive (blunt) needles for ten treatments over eight weeks. Participants are blinded to treatment allocation. Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures. The primary outcome measure is hot flush score, assessed using the validated Hot Flush Diary. Secondary outcome measures include health-related quality of life, anxiety and depression symptoms, credibility of the sham treatment, expectancy and beliefs about acupuncture, and adverse events. Participants will be analysed in the groups in which they were randomised using an intention-to-treat analysis strategy. Discussion Results from this trial will significantly add to the current body of evidence on the role of acupuncture for vasomotor symptoms. If found to be effective and safe, acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611000393954 11/02/2009. PMID:24925094

Benefit-risk analysis : a brief review and proposed quantitative approaches.

PubMed

Holden, William L

2003-01-01

Given the current status of benefit-risk analysis as a largely qualitative method, two techniques for a quantitative synthesis of a drug's benefit and risk are proposed to allow a more objective approach. The recommended methods, relative-value adjusted number-needed-to-treat (RV-NNT) and its extension, minimum clinical efficacy (MCE) analysis, rely upon efficacy or effectiveness data, adverse event data and utility data from patients, describing their preferences for an outcome given potential risks. These methods, using hypothetical data for rheumatoid arthritis drugs, demonstrate that quantitative distinctions can be made between drugs which would better inform clinicians, drug regulators and patients about a drug's benefit-risk profile. If the number of patients needed to treat is less than the relative-value adjusted number-needed-to-harm in an RV-NNT analysis, patients are willing to undergo treatment with the experimental drug to derive a certain benefit knowing that they may be at risk for any of a series of potential adverse events. Similarly, the results of an MCE analysis allow for determining the worth of a new treatment relative to an older one, given not only the potential risks of adverse events and benefits that may be gained, but also by taking into account the risk of disease without any treatment. Quantitative methods of benefit-risk analysis have a place in the evaluative armamentarium of pharmacovigilance, especially those that incorporate patients' perspectives.

Qualification of an Acceptable Alternative to Halon 1211 DOD Flightline Extinguishers

DTIC Science & Technology

2008-09-01

Minimum Performance Standard MSDS Material Safety Data Sheet NATO North Atlantic Treaty Organization NAWCAD Naval Air Warfare Center Aircraft...included chronic and acute occupational exposure limits and cardiotoxicity. Alternatives that were carcinogens or that had any adverse developmental...gear to fight the fires Does not exceed pain threshold for exposed skin Each unit tested met this performance objective 2. Firefighting

Human antitransforming growth factor beta(2) monoclonal antibody--a new modulator of wound healing in trabeculectomy: a randomized placebo controlled clinical study.

PubMed

Siriwardena, Dilani; Khaw, Peng T; King, Anthony J; Donaldson, Mark L; Overton, Barry M; Migdal, Clive; Cordeiro, M Francesca

2002-03-01

The human monoclonal antibody that neutralizes the growth factor TGFbeta(2) (CAT-152) safely and effectively inhibits in vitro and in vivo models of conjunctival scarring. This phase I/IIa clinical trial was designed to assess the safety and tolerability of CAT-152 in patients undergoing trabeculectomy. Prospective randomized placebo-controlled clinical trial. Twenty-four patients who were due to undergo primary trabeculectomy at Moorfields or Western Eye Hospitals in London, England, were recruited for this study and randomly assigned to treatment with either CAT-152 (100 microg in 100 microl) (n = 16) or placebo (n = 8). The treatment regimen was a series of four 100-microl subconjunctival injections, given immediately before and after surgery, and at 1 day and 1 week postoperatively. Assessment consisted of a full ophthalmic examination with recordings of the logarithm of the minimum angle of resolution visual acuities performed at baseline and at set intervals after surgery. Any adverse events were recorded. Logarithm of the minimum angle of resolution visual acuity, intraocular pressure, complications, and adverse events. The results of 12 month's follow-up on all patients are documented. There were no statistically significant differences in the incidence of complications between the two groups, and no serious adverse events related to the study drug occurred. Blebs after CAT-152 antibody treatment were diffuse, noncystic, and nonavascular, unlike blebs associated with antimetabolites. The fall in intraocular pressure was greater in the CAT-152 group at 3 and 6 months (P < 0.05) and approached statistical significance at 12 months. There was a trend toward less intervention in those patients treated with CAT-152. The small number of patients included limited the power of the study (34%) to detect a difference between groups. Sixteen patients in each arm of the study would be required to obtain a power of 90% with a 5% significance level. This is the first clinical study of CAT-152 in patients undergoing glaucoma filtration surgery. CAT-152 seems to be well tolerated, and based on these results further multicenter trials are underway.

Minimum financial outlays for purchasing alcohol brands in the U.S.

PubMed

Albers, Alison Burke; DeJong, William; Naimi, Timothy S; Siegel, Michael; Shoaff, Jessica Ruhlman; Jernigan, David H

2013-01-01

Low alcohol prices are a potent risk factor for excessive drinking, underage drinking, and adverse alcohol-attributable outcomes. Presently, there is little reported information on alcohol prices in the U.S., in particular as it relates to the costs of potentially beneficial amounts of alcohol. To determine the minimum financial outlay necessary to purchase individual brands of alcohol using online alcohol price data from January through March 2012. The smallest container size and the minimum price at which that size beverage could be purchased in the U.S. in 2012 were determined for 898 brands of alcohol, across 17 different alcoholic beverage types. The analyses were conducted in March 2012. The majority of alcoholic beverage categories contain brands that can be purchased in the U.S. for very low minimum financial outlays. In the U.S., a wide variety of alcohol brands, across many types of alcohol, are available at very low prices. Given that both alcohol use and abuse are responsive to price, particularly among adolescents, the prevalence of low alcohol prices is concerning. Surveillance of alcohol prices and minimum pricing policies should be considered in the U.S. as part of a public health strategy to reduce excessive alcohol consumption and related harms. Copyright © 2013 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Minimum Financial Outlays for Purchasing Alcohol Brands in the U.S

PubMed Central

Albers, Alison Burke; DeJong, William; Naimi, Timothy S.; Siegel, Michael; Shoaff, Jessica Ruhlman; Jernigan, David H.

2012-01-01

Background Low alcohol prices are a potent risk factor for excessive drinking, underage drinking, and adverse alcohol-attributable outcomes. Presently, there is little reported information on alcohol prices in the U.S., in particular as it relates to the costs of potentially beneficial amounts of alcohol. Purpose To determine the minimum financial outlay necessary to purchase individual brands of alcohol using online alcohol price data from January through March 2012. Methods The smallest container size and the minimum price at which that size beverage could be purchased in the U.S. in 2012 were determined for 898 brands of alcohol, across 17 different alcoholic beverage types. The analyses were conducted in March 2012. Results The majority of alcoholic beverage categories contain brands that can be purchased in the U.S. for very low minimum financial outlays. Conclusions In the U.S., a wide variety of alcohol brands, across many types of alcohol, are available at very low prices. Given that both alcohol use and abuse are responsive to price, particularly among adolescents, the prevalence of low alcohol prices is concerning. Surveillance of alcohol prices and minimum pricing policies should be considered in the U.S. as part of a public health strategy to reduce excessive alcohol consumption and related harms. PMID:23253652

Western Australian Public Opinions of a Minimum Pricing Policy for Alcohol: Study Protocol

PubMed Central

Keatley, David A; Daube, Mike; Hardcastle, Sarah J

2015-01-01

Background Excessive alcohol consumption has significant adverse economic, social, and health outcomes. Recent estimates suggest that the annual economic costs of alcohol in Australia are up to AUD $36 billion. Policies influencing price have been demonstrated to be very effective in reducing alcohol consumption and alcohol-related harms. Interest in minimum pricing has gained traction in recent years. However, there has been little research investigating the level of support for the public interest case of minimum pricing in Australia. Objective This article describes protocol for a study exploring Western Australian (WA) public knowledge, understanding, and reaction to a proposed minimum price policy per standard drink. Methods The study will employ a qualitative methodological design. Participants will be recruited from a wide variety of backgrounds, including ethnic minorities, blue and white collar workers, unemployed, students, and elderly/retired populations to participate in focus groups. Focus group participants will be asked about their knowledge of, and initial reactions to, the proposed policy and encouraged to discuss how such a proposal may affect their own alcohol use and alcohol consumption at the population level. Participants will also be asked to discuss potential avenues for increasing acceptability of the policy. The focus groups will adopt a semi-structured, open-ended approach guided by a question schedule. The schedule will be based on feedback from pilot samples, previous research, and a steering group comprising experts in alcohol policy and pricing. Results The study is expected to take approximately 14 months to complete. Conclusions The findings will be of considerable interest and relevance to government officials, policy makers, researchers, advocacy groups, alcohol retail and licensed establishments and organizations, city and town planners, police, and other stakeholder organizations. PMID:26582408

Western Australian Public Opinions of a Minimum Pricing Policy for Alcohol: Study Protocol.

PubMed

Keatley, David A; Carragher, Natacha; Chikritzhs, Tanya; Daube, Mike; Hardcastle, Sarah J; Hagger, Martin S

2015-11-18

Excessive alcohol consumption has significant adverse economic, social, and health outcomes. Recent estimates suggest that the annual economic costs of alcohol in Australia are up to AUD $36 billion. Policies influencing price have been demonstrated to be very effective in reducing alcohol consumption and alcohol-related harms. Interest in minimum pricing has gained traction in recent years. However, there has been little research investigating the level of support for the public interest case of minimum pricing in Australia. This article describes protocol for a study exploring Western Australian (WA) public knowledge, understanding, and reaction to a proposed minimum price policy per standard drink. The study will employ a qualitative methodological design. Participants will be recruited from a wide variety of backgrounds, including ethnic minorities, blue and white collar workers, unemployed, students, and elderly/retired populations to participate in focus groups. Focus group participants will be asked about their knowledge of, and initial reactions to, the proposed policy and encouraged to discuss how such a proposal may affect their own alcohol use and alcohol consumption at the population level. Participants will also be asked to discuss potential avenues for increasing acceptability of the policy. The focus groups will adopt a semi-structured, open-ended approach guided by a question schedule. The schedule will be based on feedback from pilot samples, previous research, and a steering group comprising experts in alcohol policy and pricing. The study is expected to take approximately 14 months to complete. The findings will be of considerable interest and relevance to government officials, policy makers, researchers, advocacy groups, alcohol retail and licensed establishments and organizations, city and town planners, police, and other stakeholder organizations.

Family perceptions of insulin pump adverse events in children and adolescents.

PubMed

Wheeler, Benjamin J; Donaghue, Kim C; Heels, Kristine; Ambler, Geoffrey R

2014-04-01

Insulin pumps (for continuous subcutaneous insulin infusion [CSII]) are used widely in type 1 diabetes mellitus. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events and no data on family perceptions of adverse events and their confidence in dealing with them. We approached all families of children and adolescents ≤ 19 years of age on CSII attending the diabetes clinic over a 16-week clinic cycle. Participants completed a retrospective questionnaire examining issues over the previous 12 months. Data on pump adverse events as well as answers to questions pertaining to education and confidence were collected. Our survey received a response rate of 99%, with 235 of the 238 families approached participating. In the preceding 12 months, 104 of 230 (45%) had reported at least one pump-related adverse event (either mechanical or set-related), with an associated 52 of 229 (23%) resulting in pump replacement. This equated to a minimum incidence density of 53 adverse events/100 person-years. Additionally, 18 of 230 (8%) reported a hospital admission or emergency department attendance as a consequence. Pump malfunction and infusion set/site failures were the most common events reported, with one or more events in 58 of 104 (56%) and 47 of 104 (45%), respectively. Adverse events, excluding set/site failures, were associated with older age (13.1 ± 3.4 years vs. 11.9 ± 4 years; P = 0.02). This is the first study to look at family perceptions of adverse events while using modern CSII. It highlights a high self-reported rate of CSII-related adverse events, pump replacement, and subsequent presentation to the hospital. Potential areas for additional targeted education are identified. Further prospective study examining pump adverse event characteristics and incidence is warranted.

Medicare payment changes and nursing home quality: effects on long-stay residents.

PubMed

Konetzka, R Tamara; Norton, Edward C; Stearns, Sally C

2006-09-01

The Balanced Budget Act of 1997 dramatically changed the way that Medicare pays skilled nursing facilities, providing a natural experiment in nursing home behavior. Medicare payment policy (directed at short-stay residents) may have affected outcomes for long-stay, chronic-care residents if services for these residents were subsidized through cost-shifting prior to implementation of Medicare prospective payment for nursing homes. We link changes in both the form and level of Medicare payment at the facility level with changes in resident-level quality, as represented by pressure sores and urinary tract infections in Minimum Data Set (MDS) assessments. Results show that long-stay residents experienced increased adverse outcomes with the elimination of Medicare cost reimbursement.

The relation between treatment outcome and efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial of treatment-naïve HIV-1 infected patients.

PubMed

Josephson, Filip; Andersson, Maria C H; Flamholc, Leo; Gisslén, Magnus; Hagberg, Lars; Ormaasen, Vidar; Sönnerborg, Anders; Vesterbacka, Jan; Böttiger, Ylva

2010-04-01

The relation between treatment outcome and trough plasma concentrations of efavirenz (EFV), atazanavir (ATV) and lopinavir (LPV) was studied in a pharmacokinetic/pharmacodynamic substudy of the NORTHIV trial-a randomised phase IV efficacy trial comparing antiretroviral-naïve human immunodeficiency virus-1-infected patients treated with (1) EFV + 2 nucleoside reverse transcriptase inhibitors (2NRTI) once daily, (2) ritonavir-boosted ATV + 2NRTI once daily or (3) ritonavir-boosted LPV + 2NRTI twice daily. The findings were related to the generally cited minimum effective concentration levels for the respective drugs (EFV 1,000 ng/ml, ATV 150 ng/ml, LPV 1,000 ng/ml). The relation between atazanavir-induced hyperbilirubinemia and virological efficacy was also studied. Drug concentrations were sampled at weeks 4 and 48 and optionally at week 12 and analysed by high-performance liquid chromatography with UV detector. When necessary, trough values were imputed by assuming the reported average half-lives for the respective drugs. Outcomes up to week 48 are reported. No relation between plasma concentrations of EFV, ATV or LPV and virological failure, treatment withdrawal due to adverse effects or antiviral potency (viral load decline from baseline to week 4) was demonstrated. Very few samples were below the suggested minimum efficacy cut-offs, and their predictive value for treatment failure could not be validated. There was a trend toward an increased risk of virological failure in patients on ATV who had an average increase of serum bilirubin from baseline of <25 micromol/l. The great majority of treatment-naïve and adherent patients on standard doses of EFV, ritonavir-boosted ATV and ritonavir-boosted LPV have drug concentrations above that considered to deliver the maximum effect for the respective drug. The results do not support the use of routine therapeutic drug monitoring (TDM) for efficacy optimisation in treatment-naïve patients on these drugs, although TDM may still be of value in some cases of altered pharmacokinetics, adverse events or drug interactions. Serum bilirubin may be a useful marker of adherence to ATV therapy.

Efficacy and safety of lacosamide in infants and young children with refractory focal epilepsy.

PubMed

Grosso, Salvatore; Parisi, Pasquale; Spalice, Alberto; Verrotti, Alberto; Balestri, Paolo

2014-01-01

Lacosamide is effective and well-tolerated antiepileptic drug (AED) in both children and adults. This multicentric, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in children aged less than four years presenting with refractory focal seizures. Lacosamide was added to the baseline therapy at a starting dose of 1-2 mg/kg/day and titrated to the final dose, ranging from 7 to 15.5 mg/kg/day. Efficacy was evaluated after a three-month period of therapy. When possible, we compared the initial efficacy and the retention after a minimum of 12 months of lacosamide, with regard to loss of efficacy (defined as the return to the baseline seizure frequency). Twenty-four children were enrolled in the study. Mean age was 2.7 years. After a minimum three-month period of lacosamide add-on therapy, ten (42%) patients were responders (more than a 50% decrease in seizure frequency), of whom 4 (17%) became seizure free. Retention rate, after a minimum of 12 months of lacosamide, was evaluated in a group of 18 patients. In the latter group, eight patients (44%) were initial responders (three of whom seizure free). After 12 months of follow-up, four of them (22%) maintained the improvement, 2 (11%) of whom remained seizure free. A loss of efficacy was observed in 4 of the initial responders (50%). Adverse events were seen in 8 (33%) patients. We conclude that lacosamide is an effective and a well-tolerated antiepileptic drug in an etiologically wide range of focal seizures. Therefore, lacosamide might represent a possible therapeutic option in infants and young children affected by uncontrolled focal epilepsy. Copyright © 2013 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Inclusion of the fitness sharing technique in an evolutionary algorithm to analyze the fitness landscape of the genetic code adaptability.

PubMed

Santos, José; Monteagudo, Ángel

2017-03-27

The canonical code, although prevailing in complex genomes, is not universal. It was shown the canonical genetic code superior robustness compared to random codes, but it is not clearly determined how it evolved towards its current form. The error minimization theory considers the minimization of point mutation adverse effect as the main selection factor in the evolution of the code. We have used simulated evolution in a computer to search for optimized codes, which helps to obtain information about the optimization level of the canonical code in its evolution. A genetic algorithm searches for efficient codes in a fitness landscape that corresponds with the adaptability of possible hypothetical genetic codes. The lower the effects of errors or mutations in the codon bases of a hypothetical code, the more efficient or optimal is that code. The inclusion of the fitness sharing technique in the evolutionary algorithm allows the extent to which the canonical genetic code is in an area corresponding to a deep local minimum to be easily determined, even in the high dimensional spaces considered. The analyses show that the canonical code is not in a deep local minimum and that the fitness landscape is not a multimodal fitness landscape with deep and separated peaks. Moreover, the canonical code is clearly far away from the areas of higher fitness in the landscape. Given the non-presence of deep local minima in the landscape, although the code could evolve and different forces could shape its structure, the fitness landscape nature considered in the error minimization theory does not explain why the canonical code ended its evolution in a location which is not an area of a localized deep minimum of the huge fitness landscape.

Cytoprotective doses of erythropoietin or carbamylated erythropoietin have markedly different procoagulant and vasoactive activities.

PubMed

Coleman, Thomas R; Westenfelder, Christof; Tögel, Florian E; Yang, Ying; Hu, Zhuma; Swenson, Leanne; Leuvenink, Henri G D; Ploeg, Rutger J; d'Uscio, Livius V; Katusic, Zvonimir S; Ghezzi, Pietro; Zanetti, Adriana; Kaushansky, Kenneth; Fox, Norma E; Cerami, Anthony; Brines, Michael

2006-04-11

Recombinant human erythropoietin (rhEPO) is receiving increasing attention as a potential therapy for prevention of injury and restoration of function in nonhematopoietic tissues. However, the minimum effective dose required to mimic and augment these normal paracrine functions of erythropoietin (EPO) in some organs (e.g., the brain) is higher than for treatment of anemia. Notably, a dose-dependent risk of adverse effects has been associated with rhEPO administration, especially in high-risk groups, including polycythemia-hyperviscosity syndrome, hypertension, and vascular thrombosis. Of note, several clinical trials employing relatively high dosages of rhEPO in oncology patients were recently halted after an increase in mortality and morbidity, primarily because of thrombotic events. We recently identified a heteromeric EPO receptor complex that mediates tissue protection and is distinct from the homodimeric receptor responsible for the support of erythropoiesis. Moreover, we developed receptor-selective ligands that provide tools to assess which receptor isoform mediates which biological consequence of rhEPO therapy. Here, we demonstrate that rhEPO administration in the rat increases systemic blood pressure, reduces regional renal blood flow, and increases platelet counts and procoagulant activities. In contrast, carbamylated rhEPO, a heteromeric receptor-specific ligand that is fully tissue protective, increases renal blood flow, promotes sodium excretion, reduces injury-induced elevation in procoagulant activity, and does not effect platelet production. These preclinical findings suggest that nonerythropoietic tissue-protective ligands, which appear to elicit fewer adverse effects, may be especially useful in clinical settings for tissue protection.

Cytoprotective doses of erythropoietin or carbamylated erythropoietin have markedly different procoagulant and vasoactive activities

PubMed Central

Coleman, Thomas R.; Westenfelder, Christof; Tögel, Florian E.; Yang, Ying; Hu, Zhuma; Swenson, LeAnne; Leuvenink, Henri G. D.; Ploeg, Rutger J.; d’Uscio, Livius V.; Katusic, Zvonimir S.; Ghezzi, Pietro; Zanetti, Adriana; Kaushansky, Kenneth; Fox, Norma E.; Cerami, Anthony; Brines, Michael

2006-01-01

Recombinant human erythropoietin (rhEPO) is receiving increasing attention as a potential therapy for prevention of injury and restoration of function in nonhematopoietic tissues. However, the minimum effective dose required to mimic and augment these normal paracrine functions of erythropoietin (EPO) in some organs (e.g., the brain) is higher than for treatment of anemia. Notably, a dose-dependent risk of adverse effects has been associated with rhEPO administration, especially in high-risk groups, including polycythemia–hyperviscosity syndrome, hypertension, and vascular thrombosis. Of note, several clinical trials employing relatively high dosages of rhEPO in oncology patients were recently halted after an increase in mortality and morbidity, primarily because of thrombotic events. We recently identified a heteromeric EPO receptor complex that mediates tissue protection and is distinct from the homodimeric receptor responsible for the support of erythropoiesis. Moreover, we developed receptor-selective ligands that provide tools to assess which receptor isoform mediates which biological consequence of rhEPO therapy. Here, we demonstrate that rhEPO administration in the rat increases systemic blood pressure, reduces regional renal blood flow, and increases platelet counts and procoagulant activities. In contrast, carbamylated rhEPO, a heteromeric receptor-specific ligand that is fully tissue protective, increases renal blood flow, promotes sodium excretion, reduces injury-induced elevation in procoagulant activity, and does not effect platelet production. These preclinical findings suggest that nonerythropoietic tissue-protective ligands, which appear to elicit fewer adverse effects, may be especially useful in clinical settings for tissue protection. PMID:16585502

Case closed: research evidence on the positive public health impact of the age 21 minimum legal drinking age in the United States.

PubMed

DeJong, William; Blanchette, Jason

2014-01-01

In 2006, the nonprofit organization Choose Responsibility called for repealing the 1984 National Minimum Drinking Age Act, which had led all 50 states to establish a minimum legal drinking age (MLDA) of 21 years, and allowing the states to lower their MLDA to 18 years. Two years later, the organization assembled a small group of college and university presidents (the Amethyst Initiative) to call publicly for a critical reexamination of the law. Public health and traffic safety experts responded to these efforts by generating new research on the age 21 MLDA, thus warranting an updated review of the literature. This review focuses primarily on research published since 2006, when Choose Responsibility began its public relations campaign to lower the MLDA. Recent research on the age 21 MLDA has reinforced the position that the current law has served the nation well by reducing alcohol-related traffic crashes and alcohol consumption among youths, while also protecting drinkers from long-term negative outcomes they might experience in adulthood, including alcohol and other drug dependence, adverse birth outcomes, and suicide and homicide. The age 21 law saves lives and is unlikely to be overturned. College and university leaders need to put into effect workable policies, stricter enforcement, and other evidence-based prevention efforts that have been demonstrated to reduce underage drinking and alcohol-related problems on campus and are being applied successfully at prominent academic institutions.

An injectable acoustic transmitter for juvenile salmon

DOE PAGES

Deng, Zhiqun; Carlson, Thomas J.; Li, Huidong; ...

2015-01-29

Salmon recovery, and the potential detrimental effects of dams on fish, has been attracting national attention in due to great environmental and economic implications. Acoustic Telemetry has been the primary method for studying salmon passage. However, the size of the existing transmitters limits the minimum size of fish that can be studied, introducing bias to the study results. We developed the first acoustic fish transmitter that can be implanted by injection instead of surgery. The new injectable transmitter offers improved performance and 30% weight reduction. Because the new transmitter costs significantly less to use, substantially reduces adverse effects of implantation,more » and provides additional biological benefits for tagged fish, it will become the enabling technology for studying migration behavior and survival of species and sizes of fish that have never been studied before. This will lead to critical information for salmon recovery and the development of fish-friendly hydroelectric systems.« less

An injectable acoustic transmitter for juvenile salmon

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

Deng, Zhiqun; Carlson, Thomas J.; Li, Huidong

Salmon recovery, and the potential detrimental effects of dams on fish, has been attracting national attention in due to great environmental and economic implications. Acoustic Telemetry has been the primary method for studying salmon passage. However, the size of the existing transmitters limits the minimum size of fish that can be studied, introducing bias to the study results. We developed the first acoustic fish transmitter that can be implanted by injection instead of surgery. The new injectable transmitter offers improved performance and 30% weight reduction. Because the new transmitter costs significantly less to use, substantially reduces adverse effects of implantation,more » and provides additional biological benefits for tagged fish, it will become the enabling technology for studying migration behavior and survival of species and sizes of fish that have never been studied before. This will lead to critical information for salmon recovery and the development of fish-friendly hydroelectric systems.« less

An injectable acoustic transmitter for juvenile salmon

NASA Astrophysics Data System (ADS)

Deng, Z. D.; Carlson, T. J.; Li, H.; Xiao, J.; Myjak, M. J.; Lu, J.; Martinez, J. J.; Woodley, C. M.; Weiland, M. A.; Eppard, M. B.

2015-01-01

Salmon recovery and the potential detrimental effects of dams on fish have been attracting national attention due to the environmental and economic implications. In recent years acoustic telemetry has been the primary method for studying salmon passage. However, the size of the existing transmitters limits the minimum size of fish that can be studied, introducing a bias to the study results. We developed the first acoustic fish transmitter that can be implanted by injection instead of surgery. The new injectable transmitter lasts four times longer and weighs 30% less than other transmitters. Because the new transmitter costs significantly less to use and may substantially reduce adverse effects of implantation and tag burden, it will allow for study of migration behavior and survival of species and sizes of fish that have never been studied before. The new technology will lead to critical information needed for salmon recovery and the development of fish-friendly hydroelectric systems.

An injectable acoustic transmitter for juvenile salmon

PubMed Central

Deng, Z. D.; Carlson, T. J.; Li, H.; Xiao, J.; Myjak, M. J.; Lu, J.; Martinez, J. J.; Woodley, C. M.; Weiland, M. A.; Eppard, M. B.

2015-01-01

Salmon recovery and the potential detrimental effects of dams on fish have been attracting national attention due to the environmental and economic implications. In recent years acoustic telemetry has been the primary method for studying salmon passage. However, the size of the existing transmitters limits the minimum size of fish that can be studied, introducing a bias to the study results. We developed the first acoustic fish transmitter that can be implanted by injection instead of surgery. The new injectable transmitter lasts four times longer and weighs 30% less than other transmitters. Because the new transmitter costs significantly less to use and may substantially reduce adverse effects of implantation and tag burden, it will allow for study of migration behavior and survival of species and sizes of fish that have never been studied before. The new technology will lead to critical information needed for salmon recovery and the development of fish-friendly hydroelectric systems. PMID:25630763

Micronucleus as biomarkers of cancer risk in anabolic androgenic steroids users.

PubMed

Souza, L da Cunha Menezes; da Cruz, L A; Cerqueira, E de Moraes Marcílio; Meireles, Jrc

2017-03-01

The use of anabolic androgenic steroids (AAS) has grown among practitioners of recreational bodybuilding, with significant contributions of designer steroids, aiming muscle hypertrophy in healthy subjects. The abusive use of AAS in general is associated with adverse effects; one of the most worrisome is cancer development. The aim of this study was to evaluate the effectiveness of the cytokinesis block micronucleus (CBMN) test in human lymphocytes in identifying risk groups for cancer development in users of AAS. Blood was collected from 15 AAS users bodybuilders (G1), 20 non-users bodybuilders (G2) and 20 non-users sedentary (G3). MN analysis was performed on a minimum of 1000 binucleated lymphocytes. The occurrence of MN was significantly higher ( p < 0.05) in individuals of G1 compared to G2 and G3. The results indicate the sensitivity of CBMN in human lymphocytes in the identification of chromosomal damage in consequence of AAS.

A randomized trial to determine the optimal dosage of multivitamin supplements to reduce adverse pregnancy outcomes among HIV-infected women in Tanzania.

PubMed

Kawai, Kosuke; Kupka, Roland; Mugusi, Ferdinand; Aboud, Said; Okuma, James; Villamor, Eduardo; Spiegelman, Donna; Fawzi, Wafaie W

2010-02-01

We previously reported that supplementation with multivitamins (vitamin B complex, vitamin C, and vitamin E) at multiples of the Recommended Dietary Allowance (RDA) significantly decreased the risk of adverse pregnancy outcomes among HIV-infected women. The minimum dosage of multivitamins necessary for optimal benefits is unknown. We investigated the efficacy of multivitamin supplements at single compared with multiple RDAs on decreasing the risk of adverse pregnancy outcomes among HIV-infected women. We conducted a double-blind, randomized controlled trial among 1129 HIV-infected pregnant women in Tanzania. Eligible women between 12 and 27 gestational weeks were randomly assigned to receive daily oral supplements of either single or multiple RDA multivitamins from enrollment until 6 wk after delivery. Multivitamins at multiple and single doses of the RDA had similar effects on the risk of low birth weight (11.6% and 10.2%, respectively; P = 0.75). We found no difference between the 2 groups in the risk of preterm birth (19.3% and 18.4%, respectively; P = 0.73) or small-for-gestational-age (14.8% and 12.0%, respectively; P = 0.18). The mean birth weights were similar in the multiple RDA (3045 + or - 549 g) and single RDA multivitamins group (3052 + or - 534 g; P = 0.83). There were no significant differences between the 2 groups in the risk of fetal death (P = 0.99) or early infant death (P = 0.19). Multivitamin supplements at a single dose of the RDA may be as efficacious as multiple doses of the RDA in decreasing the risk of adverse pregnancy outcomes among HIV-infected women. This trial was registered at clinicaltrials.gov as NCT00197678.

Comparison of discriminant analysis methods: Application to occupational exposure to particulate matter

NASA Astrophysics Data System (ADS)

Ramos, M. Rosário; Carolino, E.; Viegas, Carla; Viegas, Sandra

2016-06-01

Health effects associated with occupational exposure to particulate matter have been studied by several authors. In this study were selected six industries of five different areas: Cork company 1, Cork company 2, poultry, slaughterhouse for cattle, riding arena and production of animal feed. The measurements tool was a portable device for direct reading. This tool provides information on the particle number concentration for six different diameters, namely 0.3 µm, 0.5 µm, 1 µm, 2.5 µm, 5 µm and 10 µm. The focus on these features is because they might be more closely related with adverse health effects. The aim is to identify the particles that better discriminate the industries, with the ultimate goal of classifying industries regarding potential negative effects on workers' health. Several methods of discriminant analysis were applied to data of occupational exposure to particulate matter and compared with respect to classification accuracy. The selected methods were linear discriminant analyses (LDA); linear quadratic discriminant analysis (QDA), robust linear discriminant analysis with selected estimators (MLE (Maximum Likelihood Estimators), MVE (Minimum Volume Elipsoid), "t", MCD (Minimum Covariance Determinant), MCD-A, MCD-B), multinomial logistic regression and artificial neural networks (ANN). The predictive accuracy of the methods was accessed through a simulation study. ANN yielded the highest rate of classification accuracy in the data set under study. Results indicate that the particle number concentration of diameter size 0.5 µm is the parameter that better discriminates industries.

Factors Determining the Clinical Complications of Radiosurgery for AVM.

PubMed

Machnowska, Matylda; Taeshineetanakul, Patamintita; Geibprasert, Sasikhan; Menezes, Ravi; Agid, Ronit; Terbrugge, Karel G; Andrade-Souza, Yuri; Schwartz, Michael L; Krings, Timo

2013-11-01

To identify the predictors of symptomatic post-radiation T2 signal change in patients with arteriovenous malformations (AVM) treated with radiosurgery. The charts of 211 consecutive patients with arteriovenous malformations treated with either gamma knife radisurgery or linear accelerator radiosurgery between 2000-2009 were retrospectively reviewed. 168 patients had a minimum of 12 months of clinical and radiologic follow-up following the procedure and complete dosage data. Pretreatment characteristics and dosimetric variables were analyzed to identify predictors of adverse radiation effects. 141 patients had no clinical symptomatic complications. 21 patients had global or focal neurological deficits attributed to symptomatic edema. Variables associated with development of symptomatic edema included a non-hemorrhagic symptomatic presentation compared to presentation with hemorrhage, p=0.001; OR (95%CI) = 6.26 (1.99, 19.69); the presence of venous rerouting compared to the lack of venous rerouting, p=0.031; OR (95% CI) = 3.25 (1.20, 8.80); radiosurgery with GKS compared to linear accelerator radiosurgery p = 0.012; OR (95% CI) = 4.58 (1.28, 16.32); and the presence of more than one draining vein compared to a single draining vein p = 0.032; OR (95% CI) = 2.82 (1.06, 7.50). We postulated that the higher maximal doses used with gamma knife radiosurgery may be responsible for the greater number of adverse radiation effects with this modality compared to linear accelerator radiosurgery. We found that AVMs with greater venous complexity and therefore instability resulted in more adverse treatment outcomes, suggesting that AVM angioarchitecture should be considered when making treatment decisions. Facteurs en cause dans les complications cliniques de la radiochirurgie pour une malformation artérioveineuse.

Once-daily dosing vs. conventional dosing schedule of mesalamine and relapse of quiescent ulcerative colitis: systematic review and meta-analysis.

PubMed

Ford, Alexander C; Khan, Khurram J; Sandborn, William J; Kane, Sunanda V; Moayyedi, Paul

2011-12-01

Maintenance therapy with 5-aminosalicylates (5-ASAs) is recommended in patients with quiescent ulcerative colitis (UC), but compliance rates are low. Once-daily dosing may improve adherence, but impact on the relapse of disease activity is unclear as no previous meta-analysis has studied this issue. MEDLINE, EMBASE, and the Cochrane central register of controlled trials were searched (through April 2011). Eligible randomized controlled trials (RCTs) recruited adults with quiescent UC, and compared once-daily dosing of 5-ASAs with a more frequent dosing schedule of an identical total daily dose of the same 5-ASA drug. Minimum treatment duration was 6 months. Trials reported a dichotomous assessment of relapse of disease activity at last point of follow-up. Data concerning non-compliance and adverse events were extracted, where reported. Effect of once-daily vs. more frequent dosing schedule was reported as relative risk (RR) of relapse with a 95% confidence interval (CI). The search identified 3,061 citations, and seven RCTs containing 2,745 patients were eligible. All RCTs used mesalamine. Relapse rates were not significantly different between once-daily and conventional dosing schedules for mesalamine (RR of relapse=0.94; 95% CI: 0.82-1.08). Non-compliance (RR=0.87; 95% CI: 0.46-1.66) and adverse events were no more likely with once-daily dosing (RR=1.08; 95% CI: 0.97-1.20). Once-daily dosing with mesalamine is as effective as conventional dosing schedules for the prevention of relapse of quiescent UC, although there is no definitive evidence that compliance with once-daily dosing is better. Adverse events occur at a similar frequency.

Effects of ketamine and lidocaine in combination on the sevoflurane minimum alveolar concentration in alpacas

PubMed Central

Queiroz-Williams, Patricia; Doherty, Thomas J.; da Cunha, Anderson F.; Leonardi, Claudia

2016-01-01

This study investigated the effects of ketamine and lidocaine in combination on the minimum alveolar concentration of sevoflurane (MACSEVO) in alpacas. Eight healthy, intact male, adult alpacas were studied on 2 separate occasions. Anesthesia was induced with SEVO, and baseline MAC (MACB) determination began 45 min after induction. After MACB determination, alpacas were randomly given either an intravenous (IV) loading dose (LD) and infusion of saline or a loading dose [ketamine = 0.5 mg/kg body weight (BW); lidocaine = 2 mg/kg BW] and an infusion of ketamine (25 μg/kg BW per minute) in combination with lidocaine (50 μg/kg BW per minute), and MACSEVO was re-determined (MACT). Quality of recovery, time-to-extubation, and time-to-standing, were also evaluated. Mean MACB was 1.88% ± 0.13% and 1.89% ± 0.14% for the saline and ketamine + lidocaine groups, respectively. Ketamine and lidocaine administration decreased (P < 0.05) MACB by 57% and mean MACT was 0.83% ± 0.10%. Saline administration did not change MACB. Time to determine MACB and MACT was not significantly different between the treatments. The quality of recovery, time-to-extubation, and time-to-standing, were not different between groups. The infusion of ketamine combined with lidocaine significantly decreased MACSEVO by 57% and did not adversely affect time-to-standing or quality of recovery. PMID:27127341

Effects of ketamine and lidocaine in combination on the sevoflurane minimum alveolar concentration in alpacas.

PubMed

Queiroz-Williams, Patricia; Doherty, Thomas J; da Cunha, Anderson F; Leonardi, Claudia

2016-04-01

This study investigated the effects of ketamine and lidocaine in combination on the minimum alveolar concentration of sevoflurane (MACSEVO) in alpacas. Eight healthy, intact male, adult alpacas were studied on 2 separate occasions. Anesthesia was induced with SEVO, and baseline MAC (MACB) determination began 45 min after induction. After MACB determination, alpacas were randomly given either an intravenous (IV) loading dose (LD) and infusion of saline or a loading dose [ketamine = 0.5 mg/kg body weight (BW); lidocaine = 2 mg/kg BW] and an infusion of ketamine (25 μg/kg BW per minute) in combination with lidocaine (50 μg/kg BW per minute), and MACSEVO was re-determined (MACT). Quality of recovery, time-to-extubation, and time-to-standing, were also evaluated. Mean MACB was 1.88% ± 0.13% and 1.89% ± 0.14% for the saline and ketamine + lidocaine groups, respectively. Ketamine and lidocaine administration decreased (P < 0.05) MACB by 57% and mean MACT was 0.83% ± 0.10%. Saline administration did not change MACB. Time to determine MACB and MACT was not significantly different between the treatments. The quality of recovery, time-to-extubation, and time-to-standing, were not different between groups. The infusion of ketamine combined with lidocaine significantly decreased MACSEVO by 57% and did not adversely affect time-to-standing or quality of recovery.

Safety and Tolerability of Essential Oil from Cinnamomum zeylanicum Blume Leaves with Action on Oral Candidosis and Its Effect on the Physical Properties of the Acrylic Resin

PubMed Central

Oliveira, Julyana de Araújo; da Silva, Ingrid Carla Guedes; Trindade, Leonardo Antunes; Lima, Edeltrudes Oliveira; Carlo, Hugo Lemes; Cavalcanti, Alessandro Leite; de Castro, Ricardo Dias

2014-01-01

The anti-Candida activity of essential oil from Cinnamomum zeylanicum Blume, as well as its effect on the roughness and hardness of the acrylic resin used in dental prostheses, was assessed. The safety and tolerability of the test product were assessed through a phase I clinical trial involving users of removable dentures. Minimum inhibitory concentration (MIC) and minimum fungicidal concentrations (MFC) were determined against twelve Candida strains. Acrylic resin specimens were exposed to artificial saliva (GI), C. zeylanicum (GII), and nystatin (GIII) for 15 days. Data were submitted to ANOVA and Tukey posttest (α = 5%). For the phase I clinical trial, 15 healthy patients used solution of C. zeylanicum at MIC (15 days, 3 times a day) and were submitted to clinical and mycological examinations. C. zeylanicum showed anti-Candida activity, with MIC = 625.0 µg/mL being equivalent to MFC. Nystatin caused greater increase in roughness and decreased the hardness of the material (P < 0.0001), with no significant differences between GI and GII. As regards the clinical trial, no adverse clinical signs were observed after intervention. The substance tested had a satisfactory level of safety and tolerability, supporting new advances involving the clinical use of essential oil from C. zeylanicum. PMID:25574178

Determining minimum staffing levels during snowstorms using an integrated simulation, regression, and reliability model.

PubMed

Kunkel, Amber; McLay, Laura A

2013-03-01

Emergency medical services (EMS) provide life-saving care and hospital transport to patients with severe trauma or medical conditions. Severe weather events, such as snow events, may lead to adverse patient outcomes by increasing call volumes and service times. Adequate staffing levels during such weather events are critical for ensuring that patients receive timely care. To determine staffing levels that depend on weather, we propose a model that uses a discrete event simulation of a reliability model to identify minimum staffing levels that provide timely patient care, with regression used to provide the input parameters. The system is said to be reliable if there is a high degree of confidence that ambulances can immediately respond to a given proportion of patients (e.g., 99 %). Four weather scenarios capture varying levels of snow falling and snow on the ground. An innovative feature of our approach is that we evaluate the mitigating effects of different extrinsic response policies and intrinsic system adaptation. The models use data from Hanover County, Virginia to quantify how snow reduces EMS system reliability and necessitates increasing staffing levels. The model and its analysis can assist in EMS preparedness by providing a methodology to adjust staffing levels during weather events. A key observation is that when it is snowing, intrinsic system adaptation has similar effects on system reliability as one additional ambulance.

Effectiveness and safety of nitrofurantoin in outpatient male veterans.

PubMed

Ingalsbe, Michelle L; Wojciechowski, Amy L; Smith, Kelly A; Mergenhagen, Kari A

2015-08-01

The aim of the study was to assess both the safety and the effectiveness of nitrofurantoin in male veterans treated for urinary tract infections (UTIs) with varying degrees of renal impairment in the outpatient setting. Nitrofurantoin is an important oral option for treating UTIs given increasing resistance to commonly used agents. Nitrofurantoin is currently contraindicated in patients with a creatinine clearance (CrCl) of < 60 ml/min, but the reason for this threshold has not been well documented. Data were collected through a retrospective chart review from January 2004 to July 2013 of men who had received nitrofurantoin. Bivariate analyses followed by multivariate analyses were performed between patients experiencing clinical cure and those who did not, to determine factors significantly impacting effectiveness. The Gram stain of the organism causing the UTI and CrCl were significant factors impacting effectiveness. For every 1 ml/min increase in CrCl, the odds of clinical cure increased by 1.3%. Patients with Gram-negative UTIs predictably had 80% cure rates with CrCl around 60 ml/min. Patients with Gram-positive UTIs required higher CrCl, nearing 100 ml/min, to establish an 80% cure rate. Adverse effects did not vary with CrCl. The odds of clinical cure varied with CrCl and with the type of organism causing the UTI, while adverse events did not differ based on renal function. A minimum CrCl of 60 ml/min is suggested for men to achieve an 80% cure rate for UTIs with the most common urinary pathogens.

Sub-Saharan Africa Report, No. 2817.

DTIC Science & Technology

1983-07-06

between the two countries. During his visit to Montevideo, he will deliver a personal message from the head of state, El Hadj Omar Bongo , to his...inception. The spokesman said that unless (Khaketla) could manage to attract the minimum affection from the people of Lesotho he would never have the...socialist countries would affect religion adversely. [Text] [MB180718 Maseru Domestic Service in English 0500 GMT 18 Jun 83] JONATHAN TOUR—The

Minimum Pricing of Alcohol versus Volumetric Taxation: Which Policy Will Reduce Heavy Consumption without Adversely Affecting Light and Moderate Consumers?

PubMed Central

Sharma, Anurag; Vandenberg, Brian; Hollingsworth, Bruce

2014-01-01

Background We estimate the effect on light, moderate and heavy consumers of alcohol from implementing a minimum unit price for alcohol (MUP) compared with a uniform volumetric tax. Methods We analyse scanner data from a panel survey of demographically representative households (n = 885) collected over a one-year period (24 Jan 2010–22 Jan 2011) in the state of Victoria, Australia, which includes detailed records of each household's off-trade alcohol purchasing. Findings The heaviest consumers (3% of the sample) currently purchase 20% of the total litres of alcohol (LALs), are more likely to purchase cask wine and full strength beer, and pay significantly less on average per standard drink compared to the lightest consumers (A$1.31 [95% CI 1.20–1.41] compared to $2.21 [95% CI 2.10–2.31]). Applying a MUP of A$1 per standard drink has a greater effect on reducing the mean annual volume of alcohol purchased by the heaviest consumers of wine (15.78 LALs [95% CI 14.86–16.69]) and beer (1.85 LALs [95% CI 1.64–2.05]) compared to a uniform volumetric tax (9.56 LALs [95% CI 9.10–10.01] and 0.49 LALs [95% CI 0.46–0.41], respectively). A MUP results in smaller increases in the annual cost for the heaviest consumers of wine ($393.60 [95% CI 374.19–413.00]) and beer ($108.26 [95% CI 94.76–121.75]), compared to a uniform volumetric tax ($552.46 [95% CI 530.55–574.36] and $163.92 [95% CI 152.79–175.03], respectively). Both a MUP and uniform volumetric tax have little effect on changing the annual cost of wine and beer for light and moderate consumers, and likewise little effect upon their purchasing. Conclusions While both a MUP and a uniform volumetric tax have potential to reduce heavy consumption of wine and beer without adversely affecting light and moderate consumers, a MUP offers the potential to achieve greater reductions in heavy consumption at a lower overall annual cost to consumers. PMID:24465368

Genotoxicity, acute and subchronic toxicity studies in rats of a rooster comb extract rich in sodium hyaluronate.

PubMed

Canut, Lourdes; Zapatero, Jorge; López, Sílvia; Torrent, Anna; Ruhí, Ramon; Vicente, Laura

2012-04-01

The toxicity of a rooster comb extract (IB0004) that contains mainly sodium hyaluronate was assessed in acute and subchronic studies and in a bacterial reverse mutation assay. In a single dose acute study, male and female rats were administered 2000 mg/kg body weight (bw) of the product and observed for 14 days. No mortality was recorded, thus it was considered that the minimum lethal dose for rats by oral route was greater than 2000 mg/kg bw. A 90-day subchronic study (5, 55 and 600 mg/kg bw/day, oral gavage) with 50 male and 50 female Wistar-Hannover rats produced no significant adverse effects on food consumption, body weight, mortality, clinical biochemistry, hematology, gross pathology, and histopathology. Although some differences were observed between the treated and control animals in body weight gain (%) and some hematological parameters, these changes were generally minor in nature and, are considered to be of no toxicological significance. The no-observable-adverse-effects level was established at 600 mg/kg bw/day. There was no evidence of mutagenic activity in Salmonella typhimurium TA98, TA100, TA1535 and TA1537 or in Escherichia coli WP2 uvra pkM101. In conclusion, the results from these safety studies support the safety of rooster comb extract IB0004 in food. Copyright © 2011 Elsevier Inc. All rights reserved.

Gaining competence in needle-knife fistulotomy – can I begin on my own?

PubMed Central

Lopes, Luís; Dinis-Ribeiro, Mário; Rolanda, Carla

2016-01-01

Background: While there are guidelines for appropriate training in ERCP, these are non-existent for needle-knife precut. The aim of this study was: (1) evaluate the experience curve of three endoscopists in needle-knife fistulotomy (NKF); (2) propose a minimum number of NKF procedures to attest proficiency. Methods: Between November 1997 and March 2011, the first 120 consecutive NKF performed by three endoscopists (A, B, and C) were selected (360 patients) from three centers. Each group of 120 patients was chronologically ordered into three subgroups of 40. The main outcomes were: NKF use, NKF success, and post-ERCP adverse events. Results: The need for NKF did not decrease over time. The NKF success rate in the first attempt for endoscopist A and C in each of the three subgroups was 85 %/85 %, 87.5 %/87.5 %, and 87.5 %/90 %, respectively. Furthermore, both demonstrated a high NKF success in their initial 20 NKFs (85 % and 80 %, respectively). Endoscopist B however presented a different pattern as the success rate initiated at 60 %, then rose to 82.5 % and 85 % for the last group (P = 0.03). Adverse events were mild (28 of the 32 occurrences) with no clear reduction with increased experience. Conclusions: A skillful endoscopist may expect to master NKF easily with few adverse events. While some endoscopists could begin on their own because of their innate skills, a minimal training is needed for all, as we cannot predict skills in advance. We propose a minimum of 20 NKF precuts to attest a trainee’s competence in this procedure. PMID:27092315

Cardiovascular effects of pimobendan in healthy mature horses.

PubMed

Afonso, T; Giguère, S; Rapoport, G; Barton, M H; Coleman, A E

2016-05-01

Pimobendan is an inodilator used in dogs for the management of heart failure due to myxomatous valve disease or dilated cardiomyopathy. The lack of data regarding the effects of pimobendan in horses prevents the rational use of this drug. To determine the cardiovascular effects of pimobendan in healthy mature horses. Randomised experimental study. Five horses were fasted overnight prior to receiving i.v. pimobendan (0.25 mg/kg bwt), intragastric (i.g.) pimobendan (0.25 mg/kg bwt) or i.g. placebo with a washout period of one week between each administration. Horses were instrumented for the measurement of right ventricular (RV) minimum pressure, RV maximum pressure, RV end diastolic pressure, and maximum rate of increase and decrease in RV pressure before and 0.5, 1, 2, 4, and 8 h after drug administration. Arterial blood pressure, central venous pressure, cardiac output and heart rate were measured at the same time points. Data were expressed as a maximum percentage of change over baseline values. There were no adverse effects associated with administration of pimobendan. The percentage increase in heart rate was significantly greater for horses given pimobendan i.g. (33 ± 4%) and i.v. (36 ± 14%) than for those given a placebo (-2 ± 7%). The percentage increase in maximum rate of increase in RV pressure (35 ± 36%) and the percentage decrease in minimum pressure (47 ± 24%) and end diastolic pressure (34 ± 13%) were significantly greater in horses given pimobendan i.v. than in those given placebo. Other variables measured were not significantly different between treatment groups. Pimobendan administered i.v. has positive chronotropic and inotropic effects in healthy mature horses and warrants further investigation for the treatment of heart failure in horses. © 2015 EVJ Ltd.

29 CFR 520.409 - When will authority to pay apprentices special minimum wages become effective and what is the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... wages become effective and what is the special minimum wage rate? 520.409 Section 520.409 Labor... apprentices special minimum wages become effective and what is the special minimum wage rate? (a) An... Division. (b) The wage rate specified by the apprenticeship program becomes the special minimum wage rate...

Predicting Occurrence of Spine Surgery Complications Using "Big Data" Modeling of an Administrative Claims Database.

PubMed

Ratliff, John K; Balise, Ray; Veeravagu, Anand; Cole, Tyler S; Cheng, Ivan; Olshen, Richard A; Tian, Lu

2016-05-18

Postoperative metrics are increasingly important in determining standards of quality for physicians and hospitals. Although complications following spinal surgery have been described, procedural and patient variables have yet to be incorporated into a predictive model of adverse-event occurrence. We sought to develop a predictive model of complication occurrence after spine surgery. We used longitudinal prospective data from a national claims database and developed a predictive model incorporating complication type and frequency of occurrence following spine surgery procedures. We structured our model to assess the impact of features such as preoperative diagnosis, patient comorbidities, location in the spine, anterior versus posterior approach, whether fusion had been performed, whether instrumentation had been used, number of levels, and use of bone morphogenetic protein (BMP). We assessed a variety of adverse events. Prediction models were built using logistic regression with additive main effects and logistic regression with main effects as well as all 2 and 3-factor interactions. Least absolute shrinkage and selection operator (LASSO) regularization was used to select features. Competing approaches included boosted additive trees and the classification and regression trees (CART) algorithm. The final prediction performance was evaluated by estimating the area under a receiver operating characteristic curve (AUC) as predictions were applied to independent validation data and compared with the Charlson comorbidity score. The model was developed from 279,135 records of patients with a minimum duration of follow-up of 30 days. Preliminary assessment showed an adverse-event rate of 13.95%, well within norms reported in the literature. We used the first 80% of the records for training (to predict adverse events) and the remaining 20% of the records for validation. There was remarkable similarity among methods, with an AUC of 0.70 for predicting the occurrence of adverse events. The AUC using the Charlson comorbidity score was 0.61. The described model was more accurate than Charlson scoring (p < 0.01). We present a modeling effort based on administrative claims data that predicts the occurrence of complications after spine surgery. We believe that the development of a predictive modeling tool illustrating the risk of complication occurrence after spine surgery will aid in patient counseling and improve the accuracy of risk modeling strategies. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

A new chapter in the bisphenol A story: bisphenol S and bisphenol F are not safe alternatives to this compound.

PubMed

Eladak, Soria; Grisin, Tiphany; Moison, Delphine; Guerquin, Marie-Justine; N'Tumba-Byn, Thierry; Pozzi-Gaudin, Stéphanie; Benachi, Alexandra; Livera, Gabriel; Rouiller-Fabre, Virginie; Habert, René

2015-01-01

Bisphenol A (BPA) is a widely studied typical endocrine-disrupting chemical, and one of the major new issues is the safe replacement of this commonly used compound. Bisphenol S (BPS) and bisphenol F (BPF) are already or are planned to be used as BPA alternatives. With the use of a culture system that we developed (fetal testis assay [FeTA]), we previously showed that 10 nmol/L BPA reduces basal testosterone secretion of human fetal testis explants and that the susceptibility to BPA is at least 100-fold lower in rat and mouse fetal testes. Here, we show that addition of LH in the FeTA system considerably enhances BPA minimum effective concentration in mouse and human but not in rat fetal testes. Then, using the FeTA system without LH (the experimental conditions in which mouse and human fetal testes are most sensitive to BPA), we found that, as for BPA, 10 nmol/L BPS or BPF is sufficient to decrease basal testosterone secretion by human fetal testes with often nonmonotonic dose-response curves. In fetal mouse testes, the dose-response curves were mostly monotonic and the minimum effective concentrations were 1,000 nmol/L for BPA and BPF and 100 nmol/L for BPS. Finally, 10,000 nmol/L BPA, BPS, or BPF reduced Insl3 expression in cultured mouse fetal testes. This is the first report describing BPS and BPF adverse effects on a physiologic function in humans and rodents. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Microinvasive Glaucoma Stent (MIGS) Surgery With Concomitant Phakoemulsification Cataract Extraction: Outcomes and the Learning Curve.

PubMed

Al-Mugheiry, Toby S; Cate, Heidi; Clark, Allan; Broadway, David C

2017-07-01

To evaluate learning effects with respect to outcomes of a microinvasive glaucoma stent (MIGS) inserted during cataract surgery in glaucoma patients. Single surgeon, observational cohort study of 25 consecutive Ivantis Hydrus microstent insertions, with a minimum follow-up of 12 months. A learning curve analysis was performed by assessing hypotensive effect, adverse effects, and surgical procedure duration, with respect to consecutive case number. Success was defined with respect to various intraocular pressure (IOP) targets (21, 18, 15 mm Hg) and reduction in required antiglaucoma medications. Complete success was defined as achieving target IOP without antiglaucoma therapy. No clinically significant adverse events or learning effects were identified, although surgical time reduced with consecutive case number. Mean follow-up was 16.8 months. At final follow-up the mean IOP for all eyes was reduced from 18.1 (±3.6) mm Hg [and a simulated untreated value of 25.9 (±5.2) mm Hg] to 15.3 (±2.2) mm Hg (P=0.007; <0.0001) and the mean number of topical antiglaucoma medications was reduced from 1.96 (±0.96) to 0.04 (±0.20) (P<0.0001). Complete success (IOP<21 mm Hg, no medications) was 96% at final follow-up. Complete success (IOP<18 mm Hg, no medications) was 80% at final follow-up, but only 32% with a target IOP of <15 mm Hg (no medications). No significant learning curve effects were observed for a trained surgeon with respect to MIGS microstent insertion performed at the time of cataract surgery. Adjunctive MIGS surgery was successful in lowering IOP to <18 mm Hg and reducing/abolishing the requirement for antiglaucoma medication in eyes with open-angle glaucoma, but less successful at achieving low IOP levels (<15 mm Hg).

Temporal variation of VOC emission from solvent and water based wood stains

NASA Astrophysics Data System (ADS)

de Gennaro, Gianluigi; Loiotile, Annamaria Demarinis; Fracchiolla, Roberta; Palmisani, Jolanda; Saracino, Maria Rosaria; Tutino, Maria

2015-08-01

Solvent- and water-based wood stains were monitored using a small test emission chamber in order to characterize their emission profiles in terms of Total and individual VOCs. The study of concentration-time profiles of individual VOCs enabled to identify the compounds emitted at higher concentration for each type of stain, to examine their decay curve and finally to estimate the concentration in a reference room. The solvent-based wood stain was characterized by the highest Total VOCs emission level (5.7 mg/m3) that decreased over time more slowly than those related to water-based ones. The same finding was observed for the main detected compounds: Benzene, Toluene, Ethylbenzene, Xylenes, Styrene, alpha-Pinene and Camphene. On the other hand, the highest level of Limonene was emitted by a water-based wood stain. However, the concentration-time profile showed that water-based product was characterized by a remarkable reduction of the time of maximum and minimum emission: Limonene concentration reached the minimum concentration in about half the time compared to the solvent-based product. According to AgBB evaluation scheme, only one of the investigated water-based wood stains can be classified as a low-emitting product whose use may not determine any potential adverse effect on human health.

Minimum Wages and Skill Acquisition: Another Look at Schooling Effects.

ERIC Educational Resources Information Center

Neumark, David; Wascher, William

2003-01-01

Examines the effects of minimum wage on schooling, seeking to reconcile some of the contradictory results in recent research using Current Population Survey data from the late 1970s through the 1980s. Findings point to negative effects of minimum wages on school enrollment, bolstering the findings of negative effects of minimum wages on enrollment…

MAOIs and transdermal delivery.

PubMed

Vandenberg, Chad M

2012-09-01

Although not currently considered a first-line treatment for depression due to safety and tolerability concerns, MAOIs are effective antidepressants, particularly for atypical or treatment-resistant depression. FDA-approved oral MAOIs inhibit both MAO-A and MAO-B; inhibition of MAO-A in the brain is required for an antidepressant effect, but inhibition in the intestinal tract can allow excessive absorption of tyramine, which can lead to hypertensive crisis. A transdermal formulation of selegiline delivers the medication directly into the circulatory system, bypassing the first-pass metabolism of the GI system and substantially reducing the risk for tyramine-related adverse events. The skin patch allows for a lower dose of the drug to achieve an antidepressant effect, maintains a steady dose of the medication over 24 hours, and avoids the need for dietary restrictions at the minimum effective dose of 6 mg/24 hours. MAOIs are useful treatment options for patients who have not responded to first-line treatments, and understanding their mechanism of action can help clinicians to accurately and safely prescribe these medications. © Copyright 2012 Physicians Postgraduate Press, Inc.

Impact of air pollution and temperature on adverse birth outcomes: Madrid, 2001-2009.

PubMed

Arroyo, Virginia; Díaz, Julio; Carmona, Rocío; Ortiz, Cristina; Linares, Cristina

2016-11-01

Low birth weight (<2500 g) (LBW), premature birth (<37 weeks of gestation) (PB), and late foetal death (<24 h of life) (LFD) are causes of perinatal morbi-mortality, with short- and long-term social and economic health impacts. This study sought to identify gestational windows of susceptibility during pregnancy and to analyse and quantify the impact of different air pollutants, noise and temperature on the adverse birth outcomes. Time-series study to assess the impact of mean daily PM 2.5 , NO 2 and O 3 (μg/m 3 ), mean daily diurnal (Leqd) and nocturnal (Leqn) noise levels (dB(A)), maximum and minimum daily temperatures (°C) on the number of births with LBW, PB or LFD in Madrid across the period 2001-2009. We controlled for linear trend, seasonality and autoregression. Poisson regression models were fitted for quantification of the results. The final models were expressed as relative risk (RR) and population attributable risk (PAR). Leqd was observed to have the following impacts in LBW: at onset of gestation, in the second trimester and in the week of birth itself. NO 2 had an impact in the second trimester. In the case of PB, the following: Leqd in the second trimester, Leqn in the week before birth and PM 2.5 in the second trimester. In the case of LFD, impacts were observed for both PM 2.5 in the third trimester, and minimum temperature. O 3 proved significant in the first trimester for LBW and PB, and in the second trimester for LFD. Pollutants concentrations, noise and temperature influenced the weekly average of new-borns with LBW, PB and LFD in Madrid. Special note should be taken of the effect of diurnal noise on LBW across the entire pregnancy. The exposure of pregnant population to the environmental factors analysed should therefore be controlled with a view to reducing perinatal morbi-mortality. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of 300 mesh Soy Bean Crusher for Tofu Material Processing

NASA Astrophysics Data System (ADS)

Lee, E. S.; Pratama, P. S.; Supeno, D.; Jeong, S. W.; Byun, J. Y.; Woo, J. H.; Park, C. S.; Choi, W. S.

2018-03-01

A machine such as bean crusher machine is subjected to different loads and vibration. Due to this vibration there will be certain deformations which affect the performance of the machine in adverse manner. This paper proposed a vibration analysis of bean crusher machine using ANSYS. The effect of vibration on the structure was studied in order to ensure the safety using finite element analysis. This research supports the machine designer to create a better product with lower cost and faster development time. To do this, firstly, using Inventor, a CAD model is prepared. Secondly, the analysis is to be carried out using ANSYS 15. The modal analysis and random vibration analysis of the structure was conducted. The analysis shows that the proposed design was successfully shows the minimum deformation when the vibration was applied in normal condition.

Modelling of 10 Gbps Free Space Optics Communication Link Using Array of Receivers in Moderate and Harsh Weather Conditions

NASA Astrophysics Data System (ADS)

Gupta, Amit; Shaina, Nagpal

2017-08-01

Intersymbol interference and attenuation of signal are two major parameters affecting the quality of transmission in Free Space Optical (FSO) Communication link. In this paper, the impact of these parameters on FSO communication link is analysed for delivering high-quality data transmission. The performance of the link is investigated under the influence of amplifier in the link. The performance parameters of the link like minimum bit error rate, received signal power and Quality factor are examined by employing erbium-doped fibre amplifier in the link. The effects of amplifier are visualized with the amount of received power. Further, the link is simulated for moderate weather conditions at various attenuation levels on transmitted signal. Finally, the designed link is analysed in adverse weather conditions by using high-power laser source for optimum performance.

Minimum Wage Laws and the Distribution of Employment.

ERIC Educational Resources Information Center

Lang, Kevin

The desirability of raising the minimum wage long revolved around just one question: the effect of higher minimum wages on the overall level of employment. An even more critical effect of the minimum wage rests on the composition of employment--who gets the minimum wage job. An examination of employment in eating and drinking establishments…

Anesthetic induction with guaifenesin and propofol in adult horses.

PubMed

Brosnan, Robert J; Steffey, Eugene P; Escobar, André; Palazoglu, Mine; Fiehn, Oliver

2011-12-01

To evaluate whether guaifenesin can prevent adverse anesthetic induction events caused by propofol and whether a guaifenesin-propofol induction combination has brief cardiovascular effects commensurate with rapid drug washout. 8 healthy adult horses. Guaifenesin was administered IV for 3 minutes followed by IV injection of a bolus of propofol (2 mg/kg). Additional propofol was administered if purposeful movement was detected. Anesthesia was maintained for 2 hours with isoflurane or sevoflurane at 1.2 times the minimum alveolar concentration with controlled normocapnic ventilation. Normotension was maintained via a dobutamine infusion. Plasma concentrations of propofol and guaifenesin were measured every 30 minutes. Mean ± SD guaifenesin and propofol doses inducing anesthesia in half of the horses were 73 ± 18 mg/kg and 2.2 ± 0.3 mg/kg, respectively. No adverse anesthetic induction events were observed. By 70 minutes, there was no significant temporal change in the dobutamine infusion rate required to maintain normotension for horses anesthetized with isoflurane or sevoflurane. Mean plasma guaifenesin concentrations were 122 ± 30 μM, 101 ± 33 μM, 93 ± 28 μM, and 80 ± 24 μM at 30, 60, 90, and 120 minutes after anesthetic induction, respectively. All plasma propofol concentrations were below the limit of quantitation. Guaifenesin prevented adverse anesthetic induction events caused by propofol. Guaifenesin (90 mg/kg) followed by propofol (3 mg/kg) should be sufficient to immobilize > 99% of calm healthy adult horses. Anesthetic drug washout was rapid, and there was no change in inotrope requirements after anesthesia for 70 minutes.

Results of the combined U.S. Multicenter Pivotal Study and the Continuing Access Study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus.

PubMed

Moore, John W; Greene, Jessica; Palomares, Salvadore; Javois, Alexander; Owada, Carl Y; Cheatham, John P; Hoyer, Mark H; Jones, Thomas K; Levi, Daniel S

2014-12-01

This study aimed to compare the efficacy and safety of the Nit-Occlud PDA device (PFM Medical, Cologne, Germany) to benchmarks designed as objective performance criteria (OPC). The Nit-Occlud PDA is a nitinol coil-type patent ductus arteriosus (PDA) occluder with a reverse cone configuration, which is implanted using a controlled delivery system. Patients with <4-mm minimum diameter PDA were prospectively enrolled in the Pivotal and the Continuing Access Studies from 15 sites in the United States and were followed up for 12 months post-procedure. Investigator-reported outcomes were compared to OPC including a composite success criterion, efficacy criteria of successful closure (clinical and echocardiographic), and safety criteria incidence of adverse events (serious and of total). The Pivotal Study enrolled patients between November 1, 2002 and October 31, 2005, and the Continuing Access Study enrolled additional patients between September 1, 2006 and October 31, 2007. A total of 357 patients were enrolled, and 347 had successful device implantations. After 12 months, 96.8% had complete echocardiographic closure (OPC = 85%) and 98.1% had clinical closure (OPC = 95%). There were no deaths or serious adverse events (OPC = 1%). The total adverse event rate was 4.7% (OPC = 6%). Composite success was 95.1% in the study patients (OPC = 80%). Closure of small- and medium-sized PDA with the Nit-Occlud PDA is effective and safe when compared with OPC. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Dietary phosphorus restriction to half the minimum required amount slightly reduces weight gain and length of tibia, but sustains femur mineralization and prevents nephrocalcinosis in female kittens.

PubMed

Pastoor, F J; Opitz, R; Van 't Klooster, A T; Beynen, A C

1995-07-01

The effects of dietary P restriction to half the recommended minimum level on growth, bone and renal mineralization and urinary composition were studied in female kittens. In two separate experiments, 8-week-old weanling kittens were fed on purified diets containing either 4.6 or 9.2 mmol P/MJ (2.8 or 5.6 g P/kg diet). In the second experiment there was an additional low-P diet in which the Ca concentration was reduced from 9.5 to 4.8 mmol/MJ (7.5 v. 3.8 g Ca/kg diet). P restriction slightly but systematically reduced weight gain (to a maximum of 16%) and growth of the tibia (by 1-4%); the former effect was statistically significant (P < 0.05) between the ages of 15 and 20 weeks in Expt 1 only, and the latter did not reach statistical significance at any time point (P > or = 0.13). No adverse effect of P restriction was found on mineralization of femur at the age of 39 weeks. Kidney Ca concentrations were significantly lowered (Expt 1, 6 v. 20 mumol/g dry weight, P < 0.001; Expt 2, 7 v. 16 mumol/g dry weight, P < 0.01) in cats fed on the low-P diets, this effect not being affected by the dietary Ca:P ratio. Urinary P concentration was significantly depressed (by 50-96%) after feeding the low-P diets (P < 0.001). P intake did not influence P, Ca and Mg retention during the period of 15 to 39 weeks of age.

Failure or success of search strategies to identify adverse effects of medical devices: a feasibility study using a systematic review.

PubMed

Golder, Su; Wright, Kath; Rodgers, Mark

2014-10-13

Research has indicated that adverse effects terms are increasingly prevalent in the title, abstract or indexing terms of articles that contain adverse drug effects data in MEDLINE and Embase. However, it is unknown whether adverse effects terms are present in the database records of articles that contain adverse effects data of medical devices, and thus, to what extent the development of an adverse effects search filter for medical devices may be feasible. A case study systematic review of a medical device was selected. The included studies from a systematic review of the safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion were used in the analysis. For each included study, the corresponding database record on MEDLINE and Embase was assessed to measure the presence or absence of adverse effects terms in the title, abstract or indexing. The performance of each potential adverse effects search term was also measured and compared. There were 82 publications (49 studies) included in the systematic review with 51 of these indexed on MEDLINE and 55 on Embase. Ninety-four percent (48/51) of the records on MEDLINE and 95% (52/55) of the records on Embase contained at least one adverse effects related search term. The wide variety of adverse effects terms included in the title, abstract or indexing of bibliographic records, and the lack of any individual high-performing search terms suggests that a combination of terms in different fields is required to identify adverse effects of medical devices. In addition, the most successful search terms differed from the most successful terms for identifying adverse drug effects. The search filters currently available for adverse drug effects are not necessarily useful for searching adverse effects data of medical devices. The presence of adverse effects terms in the bibliographic records of articles on medical devices, however, indicates that combinations of adverse effects search terms may be useful in search strategies in MEDLINE and Embase. The results, therefore, suggest that not only a search filter for the adverse effects of medical devices is feasible, but also that it should be a research priority.

Are adverse effects incorporated in economic models? An initial review of current practice.

PubMed

Craig, D; McDaid, C; Fonseca, T; Stock, C; Duffy, S; Woolacott, N

2009-12-01

To identify methodological research on the incorporation of adverse effects in economic models and to review current practice. Major electronic databases (Cochrane Methodology Register, Health Economic Evaluations Database, NHS Economic Evaluation Database, EconLit, EMBASE, Health Management Information Consortium, IDEAS, MEDLINE and Science Citation Index) were searched from inception to September 2007. Health technology assessment (HTA) reports commissioned by the National Institute for Health Research (NIHR) HTA programme and published between 2004 and 2007 were also reviewed. The reviews of methodological research on the inclusion of adverse effects in decision models and of current practice were carried out according to standard methods. Data were summarised in a narrative synthesis. Of the 719 potentially relevant references in the methodological research review, five met the inclusion criteria; however, they contained little information of direct relevance to the incorporation of adverse effects in models. Of the 194 HTA monographs published from 2004 to 2007, 80 were reviewed, covering a range of research and therapeutic areas. In total, 85% of the reports included adverse effects in the clinical effectiveness review and 54% of the decision models included adverse effects in the model; 49% included adverse effects in the clinical review and model. The link between adverse effects in the clinical review and model was generally weak; only 3/80 (< 4%) used the results of a meta-analysis from the systematic review of clinical effectiveness and none used only data from the review without further manipulation. Of the models including adverse effects, 67% used a clinical adverse effects parameter, 79% used a cost of adverse effects parameter, 86% used one of these and 60% used both. Most models (83%) used utilities, but only two (2.5%) used solely utilities to incorporate adverse effects and were explicit that the utility captured relevant adverse effects; 53% of those models that included utilities derived them from patients on treatment and could therefore be interpreted as capturing adverse effects. In total, 30% of the models that included adverse effects used withdrawals related to drug toxicity and therefore might be interpreted as using withdrawals to capture adverse effects, but this was explicitly stated in only three reports. Of the 37 models that did not include adverse effects, 18 provided justification for this omission, most commonly lack of data; 19 appeared to make no explicit consideration of adverse effects in the model. There is an implicit assumption within modelling guidance that adverse effects are very important but there is a lack of clarity regarding how they should be dealt with and considered in modelling. In many cases a lack of clear reporting in the HTAs made it extremely difficult to ascertain what had actually been carried out in consideration of adverse effects. The main recommendation is for much clearer and explicit reporting of adverse effects, or their exclusion, in decision models and for explicit recognition in future guidelines that 'all relevant outcomes' should include some consideration of adverse events.

[Leaf water potential of spring wheat and field pea under different tillage patterns and its relationships with environmental factors].

PubMed

Zhang, Ming; Zhang, Ren-Zhi; Cai, Li-Qun

2008-07-01

Based on a long-term experiment, the leaf water potential of spring wheat and field pea, its relationships with environmental factors, and the diurnal variations of leaf relative water content and water saturation deficient under different tillage patterns were studied. The results showed that during whole growth period, field pea had an obviously higher leaf water potential than spring wheat, but the two crops had similar diurnal variation trend of their leaf water potential, i.e., the highest in early morning, followed by a descent, and a gradual ascent after the descent. For spring wheat, the maximum leaf water potential appeared at its jointing and heading stages, followed by at booting and flowering stages, and the minimum appeared at filling stage. For field pea, the maximum leaf water potential achieved at squaring stage, followed by at branching and flowering stages, and the minimum was at podding stage. The leaf relative water content of spring wheat was the highest at heading stage, followed by at jointing and flowering stages, and achieved the minimum at filling stage; while the water saturation deficient was just in adverse. With the growth of field pea, its leaf relative water content decreased, but leaf water saturation deficient increased. The leaf water potential of both spring wheat and field pea had significant correlations with environmental factors, including soil water content, air temperature, solar radiation, relative air humidity, and air water potential. Path analysis showed that the meteorological factor which had the strongest effect on the diurnal variation of spring wheat' s and field pea' s leaf water potential was air water potential and air temperature, respectively. Compared with conventional tillage, the protective tillage patterns no-till, no-till plus straw mulching, and conventional tillage plus straw returning increased the leaf water potential and relative water content of test crops, and the effect of no-till plus straw mulching was most significant.

Ginger (Zingiber officinale) as an Analgesic and Ergogenic Aid in Sport: A Systemic Review.

PubMed

Wilson, Patrick B

2015-10-01

Ginger is a popular spice used to treat a variety of maladies, including pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently used by athletes to manage and prevent pain; unfortunately, NSAIDs contribute to substantial adverse effects, including gastrointestinal (GI) dysfunction, exercise-induced bronchoconstriction, hyponatremia, impairment of connective tissue remodeling, endurance competition withdrawal, and cardiovascular disease. Ginger, however, may act as a promoter of GI integrity and as a bronchodilator. Given these potentially positive effects of ginger, a systematic review of randomized trials was performed to assess the evidence for ginger as an analgesic and ergogenic aid for exercise training and sport. Among 7 studies examining ginger as an analgesic, the evidence indicates that roughly 2 g·d(-1) of ginger may modestly reduce muscle pain stemming from eccentric resistance exercise and prolonged running, particularly if taken for a minimum of 5 days. Among 9 studies examining ginger as an ergogenic aid, no discernable effects on body composition, metabolic rate, oxygen consumption, isometric force generation, or perceived exertion were observed. Limited data suggest that ginger may accelerate recovery of maximal strength after eccentric resistance exercise and reduce the inflammatory response to cardiorespiratory exercise. Major limitations to the research include the use of untrained individuals, insufficient reporting on adverse events, and no direct comparisons with NSAID ingestion. While ginger taken over 1-2 weeks may reduce pain from eccentric resistance exercise and prolonged running, more research is needed to evaluate its safety and efficacy as an analgesic for a wide range of athletic endeavors.

Adverse effects of aromatherapy: a systematic review of case reports and case series.

PubMed

Posadzki, Paul; Alotaibi, Amani; Ernst, Edzard

2012-01-01

This systematic review was aimed at critically evaluating the evidence regarding the adverse effects associated with aromatherapy. Five electronic databases were searched to identify all relevant case reports and case series. Forty two primary reports met our inclusion criteria. In total, 71 patients experienced adverse effects of aromatherapy. Adverse effects ranged from mild to severe and included one fatality. The most common adverse effect was dermatitis. Lavender, peppermint, tea tree oil and ylang-ylang were the most common essential oils responsible for adverse effects. Aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.

Evaluating Use of Environmental Flows to Aerate Streams by Modelling the Counterfactual Case.

PubMed

Stewardson, Michael J; Skinner, Dominic

2018-03-01

This paper evaluates an experimental environmental flow manipulation by modeling the counterfactual case that no environmental flow was applied. This is an alternate approach to evaluating the effect of an environmental flow intervention when a before-after or control-impact comparison is not possible. In this case, the flow manipulation is a minimum flow designed to prevent hypoxia in a weir on the low-gradient Broken Creek in south-eastern Australia. At low flows, low reaeration rates and high respiration rates associated with elevated organic matter loading in the weir pool can lead to a decline in dissolved oxygen concentrations with adverse consequences both for water chemistry and aquatic biota. Using a one dimensional oxygen balance model fitted to field measurements, this paper demonstrates that increased flow leads to increases in reaeration rates, presumably because of enhanced turbulence and hence mixing in the surface layers. By comparing the observed dissolved oxygen levels with the modeled counterfactual case, we show that the environmental flow was effective in preventing hypoxia.

The effect of Sequoyah Nuclear Plant on dissolved oxygen in Chickamauga Reservoir

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

Butkus, S.R.; Shiao, M.C.; Yeager, B.L.

1990-09-01

During the summer of 1985, the Tennessee Division of Water Pollution Control and the Tennessee Wildlife Resources Agency measured dissolved oxygen (DO) concentrations downstream from the Sequoyah Nuclear Plant (SQN) discharge mixing zone that were below the state criterion for DO. The Tennessee General Water Quality Criteria'' specifies that DO should be a minimum of 5.0 mg/l measured at a depth of 5 feet for the protection of fish and aquatic life. The Tennessee Valley Authority developed the present study to answer general concerns about reservoir conditions and potential for adverse effects on aquatic biota. Four objectives were defined formore » this study: (1) to better define the extent and duration of the redistribution of DO in the reservoir, (2) to better understand DO dynamics within the mixing zone, (3) to determine whether DO is being lost (or added) as the condenser cooling water passes through the plant, and (4) to evaluate the potential for impact on aquatic life in the reservoir.« less

Evaluating Use of Environmental Flows to Aerate Streams by Modelling the Counterfactual Case

NASA Astrophysics Data System (ADS)

Stewardson, Michael J.; Skinner, Dominic

2018-03-01

This paper evaluates an experimental environmental flow manipulation by modeling the counterfactual case that no environmental flow was applied. This is an alternate approach to evaluating the effect of an environmental flow intervention when a before-after or control-impact comparison is not possible. In this case, the flow manipulation is a minimum flow designed to prevent hypoxia in a weir on the low-gradient Broken Creek in south-eastern Australia. At low flows, low reaeration rates and high respiration rates associated with elevated organic matter loading in the weir pool can lead to a decline in dissolved oxygen concentrations with adverse consequences both for water chemistry and aquatic biota. Using a one dimensional oxygen balance model fitted to field measurements, this paper demonstrates that increased flow leads to increases in reaeration rates, presumably because of enhanced turbulence and hence mixing in the surface layers. By comparing the observed dissolved oxygen levels with the modeled counterfactual case, we show that the environmental flow was effective in preventing hypoxia.

The Incidence and Short Term Functional Effect of Partial PCL Release in Fixed and Mobile Bearing PCL Retaining TKA.

PubMed

Schwarzkopf, Ran; Woolwine, Spencer; Josephs, Lee; Scott, Richard D

2015-12-01

Posterior cruciate ligament (PCL) release may be required to balance the flexion gap in PCL retaining TKA. This study examines the incidence and functional consequences of PCL release in both fixed and mobile bearing TKA. A consecutive series of 1388 TKAs with 1014 fixed bearing, and 374 mobile bearing implants were reviewed for prevalence of partial PCL release, restoration of potential flexion and objective knee stability at minimum one-year follow-up. Patients receiving mobile bearing inserts were more likely to need partial PCL release (42% versus 17.5%). The occurrence of partial PCL release did not have a significant impact on knee range of motion and subjective knee stability. The need for a partial PCL release appears to be greater in mobile than in fixed bearing. Knees that required a release in both groups demonstrated no difference in restoration of flexion compared with unreleased knees and no adverse effects on flexion stability. Copyright © 2015 Elsevier Inc. All rights reserved.

Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

PubMed

Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

2017-06-01

The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with minimum safety concerns in the actual clinical practice. The observed treatment persistence suggests that tafluprost can be used long term owing to its benefit-risk profile. Santen Pharmaceutical Co., Ltd., Osaka, Japan.

Efficacy and tolerability of brivaracetam compared to lacosamide, eslicarbazepine acetate, and perampanel as adjunctive treatments in uncontrolled focal epilepsy: Results of an indirect comparison meta-analysis of RCTs.

PubMed

Brigo, Francesco; Bragazzi, Nicola Luigi; Nardone, Raffaele; Trinka, Eugen

2016-11-01

Brivaracetam (BRV), eslicarbazepine acetate (ESL), lacosamide (LCM), and perampanel (PER) have been recently marketed as adjunctive treatments for focal onset seizures. To date, no randomized controlled trial (RCT) has directly compared BRV with ESL, LCM, or PER. To compare BRV with the other add-on AEDs in patients with uncontrolled focal epilepsy, estimating their efficacy and tolerability through an adjusted, common-reference based indirect comparison meta-analysis. We systematically searched RCTs in which add-on treatment with ESL or LCM in patients with focal onset seizures have been compared with placebo. Efficacy and tolerability outcomes were considered. Random-effects Mantel-Haenszel meta-analyses were performed to obtain odds ratios (ORs) for the efficacy of BRV, LCM, ESL, or PER versus placebo. Adjusted indirect comparisons were then made between BRV and the other three AEDs using the obtained results, comparing the minimum and the highest effective recommended daily dose of each drug. Seventeen RCTs, with a total of 4971 patients were included. After adjusting for dose-effects, indirect comparisons showed no difference between BRV and LCM, ESL, or PER for responder rate and seizure freedom. Lower adverse events were observed with high dose BRV compared to high dose ESL or PER, but no difference was found in withdrawing because of adverse events. Indirect comparisons do not demonstrate a significant difference in efficacy between add-on BRV and LCM, ESL, or PER in focal epilepsy, and might suggest a better tolerability of BRV than ESL, and possibly also PER, at the highest effective recommended dose. Copyright © 2016 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Long-Term Outcomes of Attention-Deficit/Hyperactivity Disorder and Conduct Disorder: A Systematic Review and Meta-Analysis.

PubMed

Erskine, Holly E; Norman, Rosana E; Ferrari, Alize J; Chan, Gary C K; Copeland, William E; Whiteford, Harvey A; Scott, James G

2016-10-01

Attention-deficit/hyperactivity disorder (ADHD) and conduct disorder (CD) are common externalizing disorders. Despite previous research demonstrating that both are longitudinally associated with adverse outcomes, there have been no systematic reviews examining all of the available evidence linking ADHD and CD with a range of health and psychosocial outcomes. Electronic databases (EMBASE, Medline, and PsycINFO) were searched for studies published from 1980 up to March 2015. Published cohort and case-control studies were included if they reported a longitudinal association between ADHD or CD and adverse outcomes with a minimum follow-up of 2 years. Outcomes with sufficient data were pooled in a random effects meta-analysis to give overall odds ratios (ORs) with corresponding 95% CIs. Of the 278 studies assessed, 114 met inclusion criteria and 98 were used in subsequent meta-analyses. ADHD was associated with adverse outcomes including academic achievement (e.g. failure to complete high school; odds ratio [OR] = 3.7, 95% CIs 2.0-7.0), other mental and substance use disorders (e.g. depression; OR = 2.3, 1.5-3.7), criminality (e.g. arrest; OR = 2.4, 1.5-3.8), and employment (e.g., unemployment; OR = 2.0, 1.0-3.9). CD was associated with outcomes relating to academic achievement (e.g. failure to complete high school; OR = 2.7, 1.5-4.7), other mental and substance use disorders (e.g., illicit drug use; OR = 2.1, 1.7-2.6), and criminality (e.g. violence; OR = 3.5, 2.3-5.3). This study demonstrated that ADHD and CD are associated with disability beyond immediate health loss. Although the analyses could not determine the mechanisms behind these longitudinal associations, they demonstrate the importance of addressing ADHD and CD early in life so as to potentially avert a wide range of future adverse outcomes. Copyright © 2016 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

PreSERVE-AMI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Intracoronary Administration of Autologous CD34+ Cells in Patients With Left Ventricular Dysfunction Post STEMI.

PubMed

Quyyumi, Arshed A; Vasquez, Alejandro; Kereiakes, Dean J; Klapholz, Marc; Schaer, Gary L; Abdel-Latif, Ahmed; Frohwein, Stephen; Henry, Timothy D; Schatz, Richard A; Dib, Nabil; Toma, Catalin; Davidson, Charles J; Barsness, Gregory W; Shavelle, David M; Cohen, Martin; Poole, Joseph; Moss, Thomas; Hyde, Pamela; Kanakaraj, Anna Maria; Druker, Vitaly; Chung, Amy; Junge, Candice; Preti, Robert A; Smith, Robin L; Mazzo, David J; Pecora, Andrew; Losordo, Douglas W

2017-01-20

Despite direct immediate intervention and therapy, ST-segment-elevation myocardial infarction (STEMI) victims remain at risk for infarct expansion, heart failure, reinfarction, repeat revascularization, and death. To evaluate the safety and bioactivity of autologous CD34+ cell (CLBS10) intracoronary infusion in patients with left ventricular dysfunction post STEMI. Patients who underwent successful stenting for STEMI and had left ventricular dysfunction (ejection fraction≤48%) ≥4 days poststent were eligible for enrollment. Subjects (N=161) underwent mini bone marrow harvest and were randomized 1:1 to receive (1) autologous CD34+ cells (minimum 10 mol/L±20% cells; N=78) or (2) diluent alone (N=83), via intracoronary infusion. The primary safety end point was adverse events, serious adverse events, and major adverse cardiac event. The primary efficacy end point was change in resting myocardial perfusion over 6 months. No differences in myocardial perfusion or adverse events were observed between the control and treatment groups, although increased perfusion was observed within each group from baseline to 6 months (P<0.001). In secondary analyses, when adjusted for time of ischemia, a consistently favorable cell dose-dependent effect was observed in the change in left ventricular ejection fraction and infarct size, and the duration of time subjects was alive and out of hospital (P=0.05). At 1 year, 3.6% (N=3) and 0% deaths were observed in the control and treatment group, respectively. This PreSERVE-AMI (Phase 2, randomized, double-blind, placebo-controlled trial) represents the largest study of cell-based therapy for STEMI completed in the United States and provides evidence supporting safety and potential efficacy in patients with left ventricular dysfunction post STEMI who are at risk for death and major morbidity. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01495364. © 2016 American Heart Association, Inc.

Minimizing AED adverse effects: improving quality of life in the interictal state in epilepsy care.

PubMed

St Louis, Erik K; Louis, Erik K

2009-06-01

The goals of epilepsy therapy are to achieve seizure freedom while minimizing adverse effects of treatment. However, producing seizure-freedom is often overemphasized, at the expense of inducing adverse effects of treatment. All antiepileptic drugs (AEDs) have the potential to cause dose-related, "neurotoxic" adverse effects (i.e., drowsiness, fatigue, dizziness, blurry vision, and incoordination). Such adverse effects are common, especially when initiating AED therapy and with polytherapy. Dose-related adverse effects may be obviated in most patients by dose reduction of monotherapy, reduction or elimination of polytherapy, or substituting for a better tolerated AED. Additionally, all older and several newer AEDs have idiosyncratic adverse effects which usually require withdrawal in an affected patient, including serious rash (i.e., Stevens-Johnson Syndrome, toxic epidermal necrolysis), hematologic dyscrasias, hepatotoxicity, teratogenesis in women of child bearing potential, bone density loss, neuropathy, and severe gingival hyperplasia. Unfortunately, occurrence of idiosyncratic AED adverse effects cannot be predicted or, in most cases, prevented in susceptible patients. This article reviews a practical approach for the definition and identification of adverse effects of epilepsy therapies, and reviews the literature demonstrating that adverse effects result in detrimental quality of life in epilepsy patients. Strategies for minimizing AED adverse effects by reduction or elimination of AED polytherapy, appropriately employing drug-sparing therapies, and optimally administering AEDs are outlined, including tenets of AED selection, titration, therapeutic AED laboratory monitoring, and avoidance of chronic idiosyncratic adverse effects.

Tolerability of High-dose Baclofen in the Treatment of Patients with Alcohol Disorders: A Retrospective Study.

PubMed

Rigal, Laurent; Legay Hoang, Léa; Alexandre-Dubroeucq, Constance; Pinot, Juliette; Le Jeunne, Claire; Jaury, Philippe

2015-09-01

The aim of this study was to describe the tolerability of high-dose baclofen taken by patients with alcohol disorders during their first year of treatment. The medical records of all patients prescribed baclofen by one general practitioner were examined and all patients who could be contacted were retrospectively interviewed about adverse effects. Of the 146 eligible patients, 116 (79%) could be interviewed. Ninety (78%) reported at least one adverse effect (mean number per patient: 2.8 ± 2.7). The mean dosage of baclofen at the onset of the first adverse effect was 83 ± 57 mg/day. The most frequent group of adverse effects involved disruption of the wake-sleep cycle and affected 73 patients (63%). Persistent adverse effects occurred in 62 patients (53%). Eight patients (7%) had adverse effects that led them to stop taking baclofen. Their dosages were <90 mg/day at that time. Alertness disorders and depression were the adverse effects that most frequently led to stopping baclofen. Bouts of somnolence and hypomanic episodes were the most potentially dangerous adverse effects. Women reported significantly more adverse effects than men. High-dose baclofen exposes patients with alcohol disorders to many adverse effects. Generally persistent, some adverse effects appear at low doses and may be dangerous. © The Author 2015. Medical Council on Alcohol and Oxford University Press. All rights reserved.

Teaching the Minimum Wage in Econ 101 in Light of the New Economics of the Minimum Wage.

ERIC Educational Resources Information Center

Krueger, Alan B.

2001-01-01

Argues that the recent controversy over the effect of the minimum wage on employment offers an opportunity for teaching introductory economics. Examines eight textbooks to determine topic coverage but finds little consensus. Describes how minimum wage effects should be taught. (RLH)

The Effect of Minimum Wages on Adolescent Fertility: A Nationwide Analysis.

PubMed

Bullinger, Lindsey Rose

2017-03-01

To investigate the effect of minimum wage laws on adolescent birth rates in the United States. I used a difference-in-differences approach and vital statistics data measured quarterly at the state level from 2003 to 2014. All models included state covariates, state and quarter-year fixed effects, and state-specific quarter-year nonlinear time trends, which provided plausibly causal estimates of the effect of minimum wage on adolescent birth rates. A $1 increase in minimum wage reduces adolescent birth rates by about 2%. The effects are driven by non-Hispanic White and Hispanic adolescents. Nationwide, increasing minimum wages by $1 would likely result in roughly 5000 fewer adolescent births annually.

Validity and reliability of a novel immunosuppressive adverse effects scoring system in renal transplant recipients.

PubMed

Meaney, Calvin J; Arabi, Ziad; Venuto, Rocco C; Consiglio, Joseph D; Wilding, Gregory E; Tornatore, Kathleen M

2014-06-12

After renal transplantation, many patients experience adverse effects from maintenance immunosuppressive drugs. When these adverse effects occur, patient adherence with immunosuppression may be reduced and impact allograft survival. If these adverse effects could be prospectively monitored in an objective manner and possibly prevented, adherence to immunosuppressive regimens could be optimized and allograft survival improved. Prospective, standardized clinical approaches to assess immunosuppressive adverse effects by health care providers are limited. Therefore, we developed and evaluated the application, reliability and validity of a novel adverse effects scoring system in renal transplant recipients receiving calcineurin inhibitor (cyclosporine or tacrolimus) and mycophenolic acid based immunosuppressive therapy. The scoring system included 18 non-renal adverse effects organized into gastrointestinal, central nervous system and aesthetic domains developed by a multidisciplinary physician group. Nephrologists employed this standardized adverse effect evaluation in stable renal transplant patients using physical exam, review of systems, recent laboratory results, and medication adherence assessment during a clinic visit. Stable renal transplant recipients in two clinical studies were evaluated and received immunosuppressive regimens comprised of either cyclosporine or tacrolimus with mycophenolic acid. Face, content, and construct validity were assessed to document these adverse effect evaluations. Inter-rater reliability was determined using the Kappa statistic and intra-class correlation. A total of 58 renal transplant recipients were assessed using the adverse effects scoring system confirming face validity. Nephrologists (subject matter experts) rated the 18 adverse effects as: 3.1 ± 0.75 out of 4 (maximum) regarding clinical importance to verify content validity. The adverse effects scoring system distinguished 1.75-fold increased gastrointestinal adverse effects (p=0.008) in renal transplant recipients receiving tacrolimus and mycophenolic acid compared to the cyclosporine regimen. This finding demonstrated construct validity. Intra-class correlation was 0.81 (95% confidence interval: 0.65-0.90) and Kappa statistic of 0.68 ± 0.25 for all 18 adverse effects and verified substantial inter-rater reliability. This immunosuppressive adverse effects scoring system in stable renal transplant recipients was evaluated and substantiated face, content and construct validity with inter-rater reliability. The scoring system may facilitate prospective, standardized clinical monitoring of immunosuppressive adverse drug effects in stable renal transplant recipients and improve medication adherence.

UREA/ammonium ion removal system for the orbiting frog otolith experiment. [ion exchange resins for water treatment during space missions

NASA Technical Reports Server (NTRS)

Schulz, J. R.; Anselmi, R. T.

1976-01-01

The feasibility of using free urease enzyme and ANGC-101 ion exchange resin to remove urea and ammonium ion for space system waste water applications was studied. Specifically examined is the prevention of urea and ammonia toxicity in a 30-day Orbiting Frog Otolith (OFO) flight experiment. It is shown that free urease enzyme used in conjunction with ANGC-101 ion-exchange resin and pH control can control urea and amonium ion concentration in unbuffered recirculating water. In addition, the resin does not adversely effect the bullfrogs by lowering the concentration of cations below critical minimum levels. Further investigations on bioburden control, frog waste excretion on an OFO diet, a trade-off analysis of methods of automating the urea/ammonium ion removal system and fabrication and test of a semiautomated breadboard were recommended as continuing efforts. Photographs of test equipment and test animals are shown.

A randomized, double-blind, controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy volunteers.

PubMed

Jang, Hee-Chang; Kim, Choong Jong; Kim, Kye Hyoung; Lee, Kwang-Hee; Byun, Young-Ho; Seong, Baik-Lin; Saletti, Giulietta; Czerkinsky, Cecil; Park, Wan Beom; Park, Sang-Won; Kim, Hong-Bin; Kim, Nam Joong; Oh, Myoung-don

2010-08-16

A randomized, double-blind, controlled clinical trial was conducted to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, and to determine its minimum effective dose. The overall rates of cutaneous "take" reaction and humoral and cellular immunogenicity in CJ-50300 vaccinees were 100% (123/123), 99.2% (122/123), and 90.8% (109/120), respectively, and these rates did not differ significantly between the conventional-dose and the low-dose CJ-50300 (1.0x10(8) and 1.0x10(7) plaque-forming units/mL, respectively) (P>0.05 for each). No serious adverse reaction was observed. However, one case of possible generalized vaccinia occurred in the conventionally dosed group [ClinicalTrials.gov Identifier: NCT00607243].

How to avoid a swift kick in the chameleons

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

Padilla, Antonio; Stefanyszyn, David; Wilson, Toby

2016-03-01

Recently, it was argued that the conformal coupling of the chameleon to matter fields created an issue for early universe cosmology. As standard model degrees of freedom become non-relativistic in the early universe, the chameleon is attracted towards a ''surfing'' solution, so that it arrives at the potential minimum with too large a velocity. This leads to rapid variations in the chameleon's mass and excitation of high energy modes, casting doubts on the classical treatment at Big Bang Nucleosynthesis. Here we present the DBI chameleon, a consistent high energy modification of the chameleon theory that dynamically renders it weakly coupledmore » to matter during the early universe thereby eliminating the adverse effects of the 'kicks'. This is done without any fine tuning of the coupling between the chameleon and matter fields, and retains its screening ability in the solar system. We demonstrate this explicitly with a combination of analytic and numerical results.« less

New Minimum Wage Research: A Symposium.

ERIC Educational Resources Information Center

Ehrenberg, Ronald G.; And Others

1992-01-01

Includes "Introduction" (Ehrenberg); "Effect of the Minimum Wage [MW] on the Fast-Food Industry" (Katz, Krueger); "Using Regional Variation in Wages to Measure Effects of the Federal MW" (Card); "Do MWs Reduce Employment?" (Card); "Employment Effects of Minimum and Subminimum Wages" (Neumark,…

"PowerUp"!: A Tool for Calculating Minimum Detectable Effect Sizes and Minimum Required Sample Sizes for Experimental and Quasi-Experimental Design Studies

ERIC Educational Resources Information Center

Dong, Nianbo; Maynard, Rebecca

2013-01-01

This paper and the accompanying tool are intended to complement existing supports for conducting power analysis tools by offering a tool based on the framework of Minimum Detectable Effect Sizes (MDES) formulae that can be used in determining sample size requirements and in estimating minimum detectable effect sizes for a range of individual- and…

Chinese herbal medicine for diabetic peripheral neuropathy.

PubMed

Chen, Wei; Zhang, Yin; Li, Xinxue; Yang, Guoyan; Liu, Jian Ping

2013-10-06

Chinese herbal medicine is frequently used for treating diabetic peripheral neuropathy in China. Many controlled trials have been undertaken to investigate its efficacy.This is an update of a Cochrane review that was first published in the year 2011. To assess the beneficial effects and harms of Chinese herbal medicine for people with diabetic peripheral neuropathy. On 14 May 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register CENTRAL (2012, Issue 4 in The Cochrane Library), MEDLINE (January 1966 to May 2012), EMBASE (January 1980 to May 2012), AMED (January 1985 to May 2012) and in October 2012, the Chinese Biomedical Database (CBM) (1979 to October 2012), Chinese National Knowledge Infrastructure Database (CNKI) (1979 to October 2012), and VIP Chinese Science and Technique Journals Database (1989 to October 2012). We searched for unpublished literature in the Chinese Conference Papers Database, and Chinese Dissertation Database (from inception to October 2012). There were no language or publication restrictions. We included randomised controlled trials of Chinese herbal medicine (with a minimum of four weeks treatment duration) for people with diabetic peripheral neuropathy compared with placebo, no intervention, or conventional interventions. Trials of herbal medicine plus a conventional drug versus the drug alone were also included. Two authors independently extracted data and evaluated trial quality. We contacted study authors for additional information. Forty-nine randomised trials involving 3639 participants were included. All trials were conducted and published in China. Thirty-eight different herbal medicines were tested in these trials, including four single herbs (extracts from a single herb), eight traditional Chinese patent medicines, and 26 self concocted Chinese herbal compound prescriptions. The trials reported on global symptom improvement (including improvement in numbness or pain) and changes in nerve conduction velocity. The positive results described from the 49 studies of low quality are of questionable significance. There was inadequate reporting on adverse events in the included trials. Eighteen trials found no adverse events. Two trials reported adverse events: adverse events occurred in the control group in one trial, and in the other it was unclear in which group the adverse events occurred. 29 trials did not mention whether they monitored adverse events. Conclusions cannot be drawn from this review about the safety of herbal medicines, due to inadequate reporting. Most of the trials were of very low methodological quality and therefore the interpretation of any positive findings for the efficacy of the included Chinese herbal medicines for treating diabetic peripheral neuropathy should be made with caution. Based on this systematic review, there is no evidence to support the objective effectiveness and safety of Chinese herbal medicines for diabetic peripheral neuropathy. No well-designed, randomised, placebo controlled trial with objective outcome measures has been conducted.

Antidepressants for the treatment of abdominal pain-related functional gastrointestinal disorders in children and adolescents.

PubMed

Kaminski, Angela; Kamper, Adrian; Thaler, Kylie; Chapman, Andrea; Gartlehner, Gerald

2011-07-06

Abdominal pain-related functional gastrointestinal disorders (FGIDs) are among the most common medical problems in paediatric medicine. Frequently, physicians prescribe antidepressants as a second-line treatment for children and adolescents with FGIDs. To date, the evidence on the benefits and harms of antidepressants for the treatment of abdominal pain-related FGIDs has not been assessed systematically. The primary objectives were to conduct a systematic review to evaluate the efficacy and safety of antidepressants for the treatment of abdominal pain-related FGIDs in children and adolescents. We searched The Cochrane Library, PubMed, EMBASE, IPA, CINAHL, PsycINFO, ISI Web of Science, Biosis Previews and the International Clinical Trials Registry Platform of the World Health Organization with appropriate filters (from inception to January 31, 2011). For efficacy we included double-blind, randomised controlled trials (RCTs) of antidepressants for treatment of abdominal pain-related FGIDs in children and adolescents 18 years or younger. Open-label and uncontrolled experimental studies, as well as observational studies were eligible for the assessment of harms. The minimum study duration was 4 weeks. The minimum study size was 30 participants. Two authors independently assessed all abstracts and full text articles, and rated the risk of bias for included studies. Data were extracted independently by one author and checked for accuracy by another author. Data were analysed using RevMan 5. Two RCTs (123 participants), both using amitriptyline, met the pre-specified inclusion criteria. These studies provided mixed findings on the efficacy of amitriptyline for the treatment of abdominal pain-related FGIDs. The larger, publicly-funded study reported no statistically significant difference in efficacy between amitriptyline and placebo in 90 children and adolescents with FGIDs after 4 weeks of treatment. On intention-to-treat (ITT)- analysis, 59% of the children reported feeling better in the amitriptyline group compared with 53% in the placebo group (RR 1.12; 95% CI: 0.77 to 1.63; P = 0.54). The risk of bias for this study was rated as low.The second RCT enrolled 33 adolescents with irritable bowel syndrome. Patients receiving amitriptyline experienced greater improvements in the primary outcome, overall quality of life, at weeks 6, 10, and 13 compared with those on placebo (P= 0.019, 0.004, and 0.013, respectively). No effect estimates were calculated for the quality of life outcome because mean quality of life scores and standard deviations were not reported. For most secondary outcomes no statistically significant differences between amitriptyline and placebo could be detected. The risk of bias for this study was rated as unclear for most items. However, it was rated as high for other bias due to multiple testing. The results of this study should be interpreted with caution due to the small number of patients and multiple testing.The larger study reported mild adverse events including fatigue, rash and headache and dizziness. On ITT analysis, 4% of the amitriptyline group experienced at least one adverse event compared to 2% of the placebo group. There was no statistically significant difference in the proportion of patients who experienced at least one adverse event (RR 1.91; 95% CI 0.18 to 20.35; P = 0.59). The smaller study reported no adverse events. The methods of adverse effects assessment was poorly reported in both studies and no clear conclusions on the risks of harms of amitriptyline can be drawn. Clinicians must be aware that for the majority of antidepressant medications no evidence exists that supports their use for the treatment of abdominal pain-related FGIDs in children and adolescents. The existing randomised controlled evidence is limited to studies on amitriptyline and revealed no statistically significant differences between amitriptyline and placebo for most efficacy outcomes. Amitriptyline does not appear to provide any benefit for the treatment of FGIDs in children and adolescents. Studies in children with depressive disorders have shown that antidepressants can lead to substantial, sometimes life-threatening adverse effects. Until better evidence evolves, clinicians should weigh the potential benefits of antidepressant treatment against known risks of antidepressants in paediatric patients.

The two sides of adversity: the effect of distant versus recent adversity on updating emotional content in working memory.

PubMed

Levens, Sara M; Armstrong, Laura Marie; Orejuela-Dávila, Ana I; Alverio, Tabitha

2017-09-01

Previous research suggests that adversity can have both adaptive and maladaptive effects, yet the emotional and working memory processes that contribute to more or less adaptive outcomes are unclear. The present study sought to investigate how updating emotional content differs in adolescents who have experienced past, recent, or no adversity. Participants who had experienced distant adversity (N = 53), no adversity (N = 58), or recent adversity only (N = 20) performed an emotion n-back task with emotional facial expressions. Results revealed that the distant adversity group exhibited significantly faster reaction times (RTs) than the no adversity and recent adversity only groups. In contrast, the recent adversity only group exhibited significantly slower RTs and more errors than the distant adversity and no adversity groups. These results suggest an emotion and executive control pathway by which both the benefits and negative effects of adversity may be conferred. Results also highlight the importance of time in assessing the impact of adversity.

Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials

PubMed Central

Derry, Sheena; Kong Loke, Yoon; Aronson, Jeffrey K

2001-01-01

Background We would expect information on adverse drug reactions in randomised clinical trials to be easily retrievable from specific searches of electronic databases. However, complete retrieval of such information may not be straightforward, for two reasons. First, not all clinical drug trials provide data on the frequency of adverse effects. Secondly, not all electronic records of trials include terms in the abstract or indexing fields that enable us to select those with adverse effects data. We have determined how often automated search methods, using indexing terms and/or textwords in the title or abstract, would fail to retrieve trials with adverse effects data. Methods We used a sample set of 107 trials known to report frequencies of adverse drug effects, and measured the proportion that (i) were not assigned the appropriate adverse effects indexing terms in the electronic databases, and (ii) did not contain identifiable adverse effects textwords in the title or abstract. Results Of the 81 trials with records on both MEDLINE and EMBASE, 25 were not indexed for adverse effects in either database. Twenty-six trials were indexed in one database but not the other. Only 66 of the 107 trials reporting adverse effects data mentioned this in the abstract or title of the paper. Simultaneous use of textword and indexing terms retrieved only 82/107 (77%) papers. Conclusions Specific search strategies based on adverse effects textwords and indexing terms will fail to identify nearly a quarter of trials that report on the rate of drug adverse effects. PMID:11591220

The vagal nerve stimulation outcome, and laryngeal effect: Otolaryngologists roles and perspective.

PubMed

Al Omari, Ahmad I; Alzoubi, Firas Q; Alsalem, Mohammad M; Aburahma, Samah K; Mardini, Diala T; Castellanos, Paul F

Epilepsy is one of the most common neurologic disorders. Vagus nerve stimulation (VNS), first investigated in 1938 and subsequently studied as a potential therapy for epilepsy. The FDA approved the use of VNS in 1997 as an adjunctive non-pharmacologic symptomatic treatment option for refractory epilepsy for adults and adolescents over 12years. VNS can cause laryngeal and voice side effects that can be managed by otolaryngologists safely and effectively. This study is to review the outcomes of vagal nerve stimulator (VNS) implantation in terms of the surgical procedures, complications, seizure frequency, and the clinical effect on larynx and vocal folds motion. Series of thirty consecutive patients who had VNS implantation between 2007 and 2014 were recruited. Seizure-frequency outcome, surgical complications and device adverse effects of VNS were retrospectively reviewed. Additional evaluation included use of the Voice Handicap Index and Maximum Phonation Time (MPT) were conducted before and after the implantation. Videolaryngoscopy was used to evaluate the vocal fold mobility before and after the VNS implantation. Seizure frequency reduction over a minimum of 2years of follow up demonstrated: 100% in seizure frequency reduction in 1 patient, drastic reduction in seizure frequency (70-90%) in 9 patients, a good reduction in terms of seizure frequency (50%) in 8 patients, a 30% reduction in 5 patients, no response in 6 patients, and 1 patient had increased frequency. The most commonly reported adverse effects after VNS activation were coughing and voice changes with pitch breaks, as well as mild intermittent shortness of breath in 33% of patients. For those patients secondary supraglottic muscle tension and hyper function with reduced left vocal fold mobility were noticed on videolaryngoscopy, though none had aspiration problems. Surgical complications included a wound dehiscence in one patient (3%) which was surgically managed, minor intra-operative bleeding 3%; a superficial wound infection in one patient (3%) which was treated conservatively, none of the complications necessitated VNS removal. VNS appears to be an effective non-pharmacologic adjuvant therapy in patients with medically refractory seizures. With the favorable adverse-effect profile previously described, VNS is generally well tolerated and of a great benefit to such patients. Laryngeal side effects, of which hoarseness being of the greatest repetition, are the most common after the VNS implantation. VNS can affect the voice and reduced vocal cord motion on the implantation side with secondary supraglottic muscle tension. Otolaryngologists are not only capable of performing VNS implantation, but can also manage surgical complications, assess laryngeal side effects and treat them as needed. Copyright © 2017 Elsevier Inc. All rights reserved.

Purification and Thermal Dependence of Glutathione Reductase from Two Forage Legume Species 1

PubMed Central

Kidambi, Saranga P.; Mahan, James R.; Matches, Arthur G.

1990-01-01

Alfalfa (Medicago sativa L.) and sainfoin (Onobrychis viciifolia Scop.) are forage legumes that differ in their responses to high and low temperature stresses. Thermal limitations on the function of glutathione reductase (EC 1.6.4.2) could adversely affect the ability of the plant to cope with adverse temperatures. Our objectives were to (a) purify glutathione reductase from `Cimarron' alfalfa and `PI 212241' sainfoin and (b) investigate the intraspecies variation in the thermal dependency of glutathione reductase from each of three cultivars of alfalfa and two cultivars and an introduction of sainfoin. Glutathione reductase was purified 1222-and 1948-fold to a specific activity of 281 and 273 units per milligram of protein, from one species each of alfalfa and sainfoin, respectively. The relative molecular mass of the protein was approximately 140 kilodaltons with subunits of 57 and 37 kilodaltons under denaturing conditions. The activation energies were approximately 50 kilojoules per mole for both species. Over a 5 to 45°C temperature gradient, large variation among species and genotypes within species was found for: (a) the minimum apparent Michaelis constant (0.6-2.1 micromoles of NADPH), (b) the temperature at which the minimum apparent Michaelis constant was observed (10-25°C), and (c) the thermal kinetic windows (6-19°C width). Future studies will focus on relating the thermal dependence of the Michaelis constant of the glutathione reductases and plant growth rates and forage quality of these species throughout the growing season. PMID:16667283

Comparative Study Using 100-300 Versus 300-500 μm Microspheres for Symptomatic Patients Due to Enlarged-BPH Prostates.

PubMed

Gonçalves, Octavio Meneghelli; Carnevale, Francisco Cesar; Moreira, Airton Mota; Antunes, Alberto Azoubel; Rodrigues, Vanessa Cristina; Srougi, Miguel

2016-10-01

The purpose of the study was to compare safety and efficacy outcomes following prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with 100-300 versus 300-500 μm tris-acryl gelatin microspheres. Patients were prospectively treated between August 2011 and June 2013 to receive PAE with 100-300 μm (group A) or 300-500 μm (group B) tris-acryl gelatin microspheres. Patients were followed for a minimum of 12 months and were assessed for changes in International Prostate Symptom Score (IPSS), quality of life (QoL) index, prostate volume determined by magnetic resonance imaging, serum prostate specific antigen (PSA), and maximum urine flow rate (Qmax), as well as any treatment-related adverse events. Fifteen patients were included in each group, and PAE was technically successful in all cases. Both groups experienced significant improvement in mean IPSS, QoL, prostate volume, PSA, and Qmax (p < 0.05 for all). The differences observed between the two groups included a marginally insignificant more adverse events (p = 0.066) and greater mean serum PSA reduction at 3 months of follow-up (p = 0.056) in group A. Both 100-300 and 300-500 μm microspheres are safe and effective embolic agents for PAE to treat LUTS-related to BPH. Although functional and imaging outcomes did not differ significantly following use of the two embolic sizes, the greater incidence of adverse events with 100-300 μm microspheres suggests that 300-500 μm embolic materials may be more appropriate.

Noise pollution levels in the pediatric intensive care unit.

PubMed

Kramer, Bree; Joshi, Prashant; Heard, Christopher

2016-12-01

Patients and staff may experience adverse effects from exposure to noise. This study assessed noise levels in the pediatric intensive care unit and evaluated family and staff opinion of noise. Noise levels were recorded using a NoisePro DLX. The microphone was 1 m from the patient's head. The noise level was averaged each minute and levels above 70 and 80 dBA were recorded. The maximum, minimum, and average decibel levels were calculated and peak noise level great than 100 dBA was also recorded. A parent questionnaire concerning their evaluation of noisiness of the bedside was completed. The bedside nurse also completed a questionnaire. The average maximum dB for all patients was 82.2. The average minimum dB was 50.9. The average daily bedside noise level was 62.9 dBA. The average % time where the noise level was higher than 70 dBA was 2.2%. The average percent of time that the noise level was higher than 80 dBA was 0.1%. Patients experienced an average of 115 min/d where peak noise was greater than 100 dBA. The parents and staff identified the monitors as the major contribution to noise. Patients experienced levels of noise greater than 80 dBA. Patients experience peak noise levels in excess of 100 dB during their pediatric intensive care unit stay. Copyright © 2016 Elsevier Inc. All rights reserved.

Activity of virgin coconut oil, lauric acid or monolaurin in combination with lactic acid against Staphylococcus aureus.

PubMed

Tangwatcharin, Pussadee; Khopaibool, Prapaporn

2012-07-01

The objective of this study was to investigate the in vitro activities of virgin coconut oil, lauric acid and monolaurin in combination with lactic acid against two strains of Staphylococcus aureus, ATCC 25923 and an isolate from a pig carcass, by determination of Fractional Bactericidal Concentration Index (FBCI), time-kill method, as well as scanning and transmission electron microscopy. Minimum bactericidal concentrations (MBC) of lauric acid, monolaurin and lactic acid were 3.2 mg/ml, 0.1 mg/ml and 0.4% (v/v), respectively. The effects of lauric acid + lactic acid and monolaurin + lactic acid combinations were synergistic against both strains, exhibiting FBCIs of 0.25 and 0.63, respectively. In time-kill studies, lauric acid and monolaurin + lactic acid combinations added at their minimum inhibitory concentrations produced a bactericidal effect. The induction of stress in non-stressed cells was dependent on the type and concentration of antimicrobial. This resulted in a loss and change of the cytoplasm and membrane in cells of the bacterium. In contrast, virgin coconut oil (10%) was not active against S. aureus. The bacterial counts found in pork loin treated with lauric acid and monolaurin alone were significantly higher (p <0.05) than those treated with both lipids in combination with lactic acid at sub-inhibitory concentrations. The color, odor and overall acceptability of the pork loins were adversely affected by treatment with the three lipids and lactic acid alone but when combinations of the agents were used the sensory quality was acceptable.

Adverse Reactions to Zolpidem: Case Reports and a Review of the Literature

PubMed Central

Miyaoka, Tsuyoshi; Tsuji, Seiichi; Inami, Yasushi; Nishida, Akira; Horiguchi, Jun

2010-01-01

Objective: Zolpidem, a nonbenzodiazepine hypnotic, is very effective and widely prescribed in clinical practice for the treatment of insomnia and is thought to have few adverse effects. However, zolpidem-induced adverse effects have begun to be reported in the literature, but few systemic descriptions of the adverse effects (especially for psychotic reactions) of zolpidem have been undertaken. In light of the accumulating reports of adverse reactions to zolpidem, we present 2 case reports of zolpidem-induced adverse effects and review the literature on this subject. Data Sources: Articles were selected by the authors on the basis of our experience and by a PubMed search using the terms zolpidem or side effects or adverse effects or adverse reactions. Study Selection and Data Extraction: Publications relevant to the objective of this article were obtained (1992–2010), and some adverse neuropsychiatric reactions were summarized. Data Synthesis: Zolpidem has been associated with the development of adverse neuropsychiatric reactions, such as hallucinations/sensory distortion, amnesia, sleepwalking/somnambulism, and nocturnal eating. The following 4 variables should be considered when prescribing zolpidem: (1) gender: women have been found to have a significantly higher serum zolpidem concentration than men; (2) zolpidem dose: the adverse reactions that develop are dose dependent; (3) protein binding affinity: a high proportion of zolpidem is protein bound; therefore, low serum albumin results in a higher level of free zolpidem leading to adverse psychiatric reactions; and (4) cytochrome P450 (CYP) isoenzyme inhibition: concomitant administration of zolpidem and other drugs may cause interactions that lead to increased concentrations of zolpidem. Conclusions: Zolpidem is clinically very effective in treating insomnia. However, while rare, zolpidem-induced unusual complex behavior may develop. Primary care physicians should be alert to the possible unusual complex adverse effects of zolpidem. PMID:21494350

Effect of ginger (Zingiber officinale) on heavy menstrual bleeding: a placebo-controlled, randomized clinical trial.

PubMed

Kashefi, Farzaneh; Khajehei, Marjan; Alavinia, Mohammad; Golmakani, Ebrahim; Asili, Javad

2015-01-01

A wide range of herbal plants have been reported to treat various gynecological problems of women. This study was set out to investigate the effect of ginger (Zingiber officinale) on heavy menstrual bleeding (HMB) in high school girls. Ninety-two young women who experienced HMB and met the inclusion criteria were recruited in this study. Participants were evaluated for six consecutive menstrual cycles. During 3 assessment cycles, their HMB was confirmed by Pictorial Blood Assessment Chart. They were then randomly allocated to two study groups to receive either ginger or placebo capsules. The participants filled in the same chart during three intervention cycles. The level of menstrual blood loss dramatically declined during the three intervention cycles in ginger-receiving group. The decrease of blood loss in ginger-receiving group was significantly more remarkable than that of participants receiving placebo (p<0.001). Minimum number of participants reported adverse effects. HMB is highly prevalent among young women. Considering the significance of appropriate and timely treatment and also the importance of prevention of unwanted consequences, ginger may be considered as an effective therapeutic option for HMB. Copyright © 2014 John Wiley & Sons, Ltd.

Essure Permanent Birth Control, Effectiveness and Safety: An Italian 11-Year Survey.

PubMed

Franchini, Mario; Zizolfi, Brunella; Coppola, Carmela; Bergamini, Valentino; Bonin, Cecilia; Borsellino, Giovanni; Busato, Enrico; Calabrese, Stefania; Calzolari, Stefano; Fantin, Gian Piero; Giarrè, Giovanna; Litta, Piero; Luerti, Massimo; Mangino, Francesco Paolo; Marchino, Gian Luigi; Molinari, Maria Antonietta; Scatena, Elisa; Scrimin, Federica; Telloli, Paolo; Di Spiezio Sardo, Attilio

To describe safety, tolerability, and effectiveness results through a minimum 2-year follow-up of patients who underwent permanent sterilization with the Essure insert. A retrospective multicenter study (Canadian Task Force classification II2). Seven general hospitals and 4 clinical teaching centers in Italy. A total of 1968 women, mean age 39.5 years (range, 23-48 years) who underwent office hysteroscopic sterilization using the Essure insert between April 1, 2003, and December 30, 2014. The women underwent office hysteroscopic bilateral Essure insert placement, with satisfactory device location and tube occlusion based on hysterosalpingography or hysterosalpingo-contrast sonography (HyCoSy). Placement rate, successful bilateral tubal occlusion, perioperative adverse events, early postoperative (during the first 3 months of follow-up), and late complications were evaluated. Satisfactory insertion was accomplished in 97.2% of women and, in 4, perforation and 1 expulsion were detected during hysterosalpingography. Three unintended pregnancies occurred before the 3-month confirmation test. Two pregnancies were reported among women relying on the Essure inserts. Postprocedure pain was minimal and brief; in 9 women, pelvic pain became intractable, necessitating removal of the devices via laparoscopy. On telephone interviews, overall satisfaction was rated as "very satisfied" by the majority of women (97.6%), and no long-term adverse events were reported. The findings from this extended Italian survey further support the effectiveness, tolerability, and satisfaction of Essure hysteroscopic sterilization when motivated women are selected and well informed of the potential risks of the device. Moreover, the results do not demonstrate an increased incidence of complications and pregnancies associated with long-term Essure use. Patients with a known hypersensitivity to nickel may be less suitable candidates for the Essure insert. Copyright © 2017 AAGL. Published by Elsevier Inc. All rights reserved.

Air traffic controllers' long-term speech-in-noise training effects: A control group study.

PubMed

Zaballos, Maria T P; Plasencia, Daniel P; González, María L Z; de Miguel, Angel R; Macías, Ángel R

2016-01-01

Speech perception in noise relies on the capacity of the auditory system to process complex sounds using sensory and cognitive skills. The possibility that these can be trained during adulthood is of special interest in auditory disorders, where speech in noise perception becomes compromised. Air traffic controllers (ATC) are constantly exposed to radio communication, a situation that seems to produce auditory learning. The objective of this study has been to quantify this effect. 19 ATC and 19 normal hearing individuals underwent a speech in noise test with three signal to noise ratios: 5, 0 and -5 dB. Noise and speech were presented through two different loudspeakers in azimuth position. Speech tokes were presented at 65 dB SPL, while white noise files were at 60, 65 and 70 dB respectively. Air traffic controllers outperform the control group in all conditions [P<0.05 in ANOVA and Mann-Whitney U tests]. Group differences were largest in the most difficult condition, SNR=-5 dB. However, no correlation between experience and performance were found for any of the conditions tested. The reason might be that ceiling performance is achieved much faster than the minimum experience time recorded, 5 years, although intrinsic cognitive abilities cannot be disregarded. ATC demonstrated enhanced ability to hear speech in challenging listening environments. This study provides evidence that long-term auditory training is indeed useful in achieving better speech-in-noise understanding even in adverse conditions, although good cognitive qualities are likely to be a basic requirement for this training to be effective. Our results show that ATC outperform the control group in all conditions. Thus, this study provides evidence that long-term auditory training is indeed useful in achieving better speech-in-noise understanding even in adverse conditions.

Clinical outcomes of extended versus intermittent administration of piperacillin/tazobactam for the treatment of hospital-acquired pneumonia: a randomized controlled trial.

PubMed

Bao, H; Lv, Y; Wang, D; Xue, J; Yan, Z

2017-03-01

The purpose of this study was to assess the pharmacokinetic (PK) characteristics, clinical efficiency, and pharmacoeconomic parameters of piperacillin/tazobactam administered by extended infusion (EI) or intermittent infusion (II) in the treatment of hospital-acquired pneumonia (HAP) in critically ill patients with low illness severity in China. Fifty patients completed the study, with 25 patients receiving 4/0.5 g piperacillin/tazobactam over 30 min as the II group and 25 patients receiving 4/0.5 g piperacillin/tazobactam over 3 h every 6 h as the EI group. Drug assay was performed using high-performance liquid chromatography (HPLC). The percentage of the dosing interval for which the free piperacillin concentration (%fT) exceeds the minimum inhibitory concentration (MIC) was calculated. The patients' therapy cost, clinical efficiency, and adverse effects were also recorded. %fT>MIC was about 100, 98.73, and 93.04 % in the EI arm versus 81.48, 53.29, and 42.15 % in the II arm, respectively, when the microorganism responsible for HAP had an MIC of 4, 8, and 16 mg/L. The therapy cost in the EI group was lower than that of the II group ($1351.72 ± 120.39 vs. $1782.04 ± 164.51, p = 0.001). However, the clinical success rate, clinical failure rate, and drug-related adverse events did not significantly differ between groups. EI treatment with piperacillin/tazobactam was a cost-effective approach to the management of HAP, being equally clinically effective to conventional II.

Risk of wound infection and safety profile of amoxicillin in healthy patients which required third molar surgery: a systematic review and meta-analysis.

PubMed

Isiordia-Espinoza, M A; Aragon-Martinez, O H; Martínez-Morales, J F; Zapata-Morales, J R

2015-11-01

The aim of this systematic review and meta-analysis was to assess the risk of surgical wound infection and the adverse effects of amoxicillin in healthy patients who required excision of third molars. We identified eligible reports from searches of PubMed, Medline®, the Cochrane Library, Imbiomed, LILACS, and Google Scholar. Studies that met our minimum requirements were evaluated using inclusion and exclusion criteria and the Oxford Quality Scale. Those with a score of 3 or more on this Scale were included and their data were extracted and analysed. For evaluation of the risk of infection the absolute risk reduction, number needed to treat, and 95% CI were calculated. For evaluation of the risk of an adverse effect the absolute risk increase, number needed to harm, and 95% CI were calculated using the Risk Reduction Calculator. Each meta-analysis was made with the help of the Mantel-Haenszel random effects model, and estimates of risk (OR) and 95% CI were calculated using the Review Manager 5.3, from the Cochrane Library. A significant risk was assumed when the lower limit of the 95% CI was greater than 1. Probabilities of less than 0.05 were accepted as significant. The results showed that there was no reduction in the risk of infection when amoxicillin was given before or after operation compared with an untreated group or placebo. In conclusion, this study suggests that amoxicillin given prophylactically or postoperatively does not reduce the risk of infection in healthy patients having their third molars extracted. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

36 CFR 800.6 - Resolution of adverse effects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Resolution of adverse effects... PROTECTION OF HISTORIC PROPERTIES The section 106 Process § 800.6 Resolution of adverse effects. (a) Continue... the undertaking that could avoid, minimize, or mitigate adverse effects on historic properties. (1...

The effect of early in-hospital medication review on health outcomes: a systematic review.

PubMed

Hohl, Corinne M; Wickham, Maeve E; Sobolev, Boris; Perry, Jeff J; Sivilotti, Marco L A; Garrison, Scott; Lang, Eddy; Brasher, Penny; Doyle-Waters, Mary M; Brar, Baljeet; Rowe, Brian H; Lexchin, Joel; Holland, Richard

2015-07-01

Adverse drug events are an important cause of emergency department visits, unplanned admissions and prolonged hospital stays. Our objective was to synthesize the evidence on the effect of early in-hospital pharmacist-led medication review on patient-oriented outcomes based on observed data. We systematically searched eight bibliographic reference databases, electronic grey literature, medical journals, conference proceedings, trial registries and bibliographies of relevant papers. We included studies that employed random or quasi-random methods to allocate subjects to pharmacist-led medication review or control. Medication review had to include, at a minimum, obtaining a best possible medication history and reviewing medications for appropriateness and adverse drug events. The intervention had to be initiated within 24 h of emergency department presentation or 72 h of admission. We extracted data in duplicate and pooled outcomes from clinically homogeneous studies of the same design using random effects meta-analysis. We retrieved 4549 titles of which seven were included, reporting the outcomes of 3292 patients. We pooled data from studies of the same design, and found no significant differences in length of hospital admission (weighted mean difference [WMD] -0.04 days, 95% confidence interval [CI] -1.63, 1.55), mortality (odds ratio [OR] 1.09, 95% CI 0.69, 1.72), readmissions (OR 1.15, 95% CI 0.81, 1.63) or emergency department revisits at 3 months (OR 0.60, 95% CI 0.27, 1.32). Two large studies reporting reductions in readmissions could not be included in our pooled estimates due to differences in study design. Wide confidence intervals suggest that additional research is likely to influence the effect size estimates and clarify the effect of medication review on patient-oriented outcomes. This systematic review failed to identify an effect of pharmacist-led medication review on health outcomes. © 2015 The British Pharmacological Society.

[Which hip articulation bearing for which patient? : Tribology of the future].

PubMed

Morlock, M M; Bishop, N; Kaddick, C

2011-12-01

Replacement of the hip joint has become an exceptionally successful procedure since the inauguration of the low friction principle by Charnley. Aseptic osteolysis and joint dislocation have been addressed by the development of wear-optimized materials and the introduction of larger heads. As an increase in head diameter against polyethylene causes wear increase, larger hard-on-hard bearings were introduced, which exhibit reduced wear and reduced dislocation risk with increasing head diameter. These findings were derived from standard simulator testing, not sufficiently considering the risk of fluid film breakdown under adverse conditions, which can cause a dramatic increase in wear and friction proportional to the head diameter. Such adverse conditions can occur clinically in patients due to several factors and have caused the presently observed unexpected problems with these new designs. Standardized preclinical testing has to be viewed as a minimum requirement but certainly not as a guarantee for the clinical success of new materials and designs even if the testing is adapted to the current patient requirements, which is presently not the case. The future of tribology lies in the prevention of adverse conditions in patients, the improvement and optimized use of proven existing materials and not in the use of new materials.

Blood pressure lowering efficacy of renin inhibitors for primary hypertension.

PubMed

Musini, Vijaya M; Lawrence, Kendra Ak; Fortin, Patricia M; Bassett, Ken; Wright, James M

2017-04-05

Hypertension is a chronic condition associated with an increased risk of mortality and morbidity. Renin is the enzyme responsible for converting angiotensinogen to angiotensin I, which is then converted to angiotensin II. Renin inhibitors are a new class of drugs that decrease blood pressure (BP) by preventing the formation of both angiotensin I and angiotensin II. To quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension.To determine the change in BP variability, pulse pressure, and heart rate and to evaluate adverse events (mortality, non-fatal serious adverse events, total adverse events, withdrawal due to adverse effects and specific adverse events such as dry cough, diarrhoea and angioedema). The Cochrane Hypertension Information Specialist searched the following databases for randomized controlled trials (RCTs) up to February 2017: the Cochrane Hypertension Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 2), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. There was no restriction by language or publication status. We also searched the European Medicines Agency (EMA) for clinical study reports, the Novartis Clinical Study Results Database, bibliographic citations from retrieved references, and contacted authors of relevant papers regarding further published and unpublished work. We included randomized, double-blinded, placebo-controlled studies evaluating BP lowering efficacy of fixed-dose monotherapy with renin inhibitor compared with placebo for a minimum duration of three to 12 weeks in adult patients with primary hypertension. This systematic review is a comprehensive update which includes four additional studies and extensive detail from nine clinical study reports (CSRs) of previously included studies obtained from EMA. The remaining three CSRs are not available.Two review authors independently assessed study eligibility and extracted data. In all cases where there was a difference between the CSR and the published report, data from the CSR was used. Dichotomous outcomes were reported as risk ratio (RR) with 95% confidence intervals (CIs) and continuous outcomes as mean difference (MD) with 95% CIs. 12 studies (mean duration of eight weeks) in 7439 mostly Caucasian patients (mean age 54 years) with mild-to-moderate uncomplicated hypertension were eligible for inclusion in the review. Aliskiren was the only renin inhibitor evaluated. All included studies were assessed to have high likelihood of attrition, reporting and funding bias.Aliskiren has a dose-related systolic/diastolic blood pressure (SBP/DBP) lowering effect as compared with placebo MD with 95% CI: aliskiren 75 mg (MD -2.97, 95% CI -4.76 to -1.18)/(MD -2.05, 95% CI -3.13 to -0.96) mm Hg (moderate-quality evidence), aliskiren 150 mg (MD -5.95, 95% CI -6.85 to -5.06)/ (MD -3.16, 95% CI -3.74 to -2.58) mm Hg (moderate-quality evidence), aliskiren 300 mg (MD -7.88, 95% CI -8.94 to -6.82)/ (MD -4.49, 95% CI -5.17 to -3.82) mm Hg (moderate-quality evidence), aliskiren 600 mg (MD -11.35, 95% CI -14.43 to -8.27)/ (MD -5.86, 95% CI -7.73 to -3.99) mm Hg (low-quality evidence). There was a dose-dependent decrease in blood pressure for aliskiren 75 mg, 150 mg and 300 mg. The blood pressure lowering effect of aliskiren 600 mg was not different from 300 mg (MD -0.61, 95% CI -2.78 to 1.56)/(MD -0.68, 95% CI -2.03 to 0.67). Aliskiren had no effect on blood pressure variability. Due to very limited information available regarding change in heart rate and pulse pressure, it was not possible to meta-analyze these outcomes.Mortality and non-fatal serious adverse events were not increased. This review found that in studies of eight week duration aliskiren may not increase withdrawal due to adverse events (low-quality evidence). Diarrhoea was increased in a dose-dependent manner (RR 7.00, 95% CI 2.48 to 19.72) with aliskiren 600 mg (low-quality evidence). The most frequent adverse events reported were headache, nasopharyngitis, diarrhoea, dizziness and fatigue. Compared to placebo, aliskiren lowered BP and this effect is dose-dependent. This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). There is no difference in mortality, nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy. Diarrhoea was considerably increased with aliskiren 600 mg.

A rare adverse effect of metronidazole: nervous system symptoms.

PubMed

Kafadar, Ihsan; Moustafa, Fatma; Yalçın, Koray; Klç, Betül Aydn

2013-06-01

Metronidazole, as a 5-nitroimidazole compound, is effective on anaerobic bacteria and protozoon diseases. Mostly, metronidazole is a tolerable drug but rarely presents serious adverse effects on the nervous system. In case of these adverse effects, treatment must be stopped.In this report, a 3-year-old child hospitalized because of diarrhea is presented. During the metronidazole treatment, loss of sight, vertigo, ataxia, and headache occurred as the adverse effects. By this report, we want to express the rare adverse effects of drugs in the differential diagnoses of nervous system diseases.

Preventability of adverse effects of analgesics: analysis of spontaneous reports.

PubMed

Cazacu, Irina; Miremont-Salamé, Ghada; Mogosan, Cristina; Fourrier-Réglat, Annie; Loghin, Felicia; Haramburu, Françoise

2015-05-01

The aims of this study were to determine the patterns of analgesic adverse drug reactions (ADRs) and to assess their preventability and contributing factors. This is a retrospective, descriptive study conducted on ADRs of analgesics and other drugs indicated as analgesics, spontaneously reported to the Bordeaux pharmacovigilance center from January 2011 to June 2012. The 141 cases selected for the analysis included 16 cases of medication errors (11.3%) and 15 addiction cases (10.6%). In total, 214 ADRs were registered, for which 173 analgesic medicines were suspected. The most frequent ADRs reported were nervous system disorders (26.6%), psychiatric disorders (15.0%), and skin and subcutaneous tissue disorders (12.1%). Tramadol alone or in combination (17.3%), followed by morphine (15%), fentanyl (9.8%), and paracetamol (8.7%) were the most frequently involved analgesics. More than half of the cases (54.6%) were serious and led to hospitalization or prolonged hospitalization. Preventability was determined for 134 cases (95%): 51.5% were considered as preventable, 26.1% not preventable, and 22.4% not assessable. The main contributing factors for the preventable cases included negligence of recommendations for analgesic use and failure to consider patients' risk factors when prescribing. A significant number of analgesic ADRs could be prevented, and being aware of their contributing factors promotes efficient analgesia with minimum risks to the patients.

Adverse Effects of UV-B Radiation on Plants Growing at Schirmacher Oasis, East Antarctica.

PubMed

Singh, Jaswant; Singh, Rudra P

2014-01-01

This study aimed to assess the impacts of ultraviolet-B (UV-B) radiation over a 28-day period on the levels of pigments of Umbilicaria aprina and Bryum argenteum growing in field. The depletion of stratospheric ozone is most prominent over Antarctica, which receives more UV-B radiation than most other parts of the planet. Although UV-B radiation adversely affects all flora, Antarctic plants are better equipped to survive the damaging effects of UV-B owing to defenses provided by UV-B absorbing compounds and other screening pigments. The UV-B radiations and daily average ozone values were measured by sun photometer and the photosynthetic pigments were analyzed by the standard spectrophotometric methods of exposed and unexposed selected plants. The daily average atmospheric ozone values were recorded from 5 January to 2 February 2008. The maximum daily average for ozone (310.7 Dobson Units (DU)) was recorded on 10 January 2008. On that day, average UV-B spectral irradiances were 0.016, 0.071, and 0.186 W m(-2) at wavelengths of 305, 312, and 320 nm, respectively. The minimum daily average ozone value (278.6 DU) was recorded on 31 January 2008. On that day, average UV-B spectral irradiances were 0.018, 0.085, and 0.210 W m(-2) at wavelengths of 305, 312, and 320 nm, respectively. Our results concludes that following prolonged UV-B exposure, total chlorophyll levels decreased gradually in both species, whereas levels of UV-B absorbing compounds, phenolics, and carotenoids gradually increased.

Adverse Effects of UV-B Radiation on Plants Growing at Schirmacher Oasis, East Antarctica

PubMed Central

Singh, Jaswant; Singh, Rudra P.

2014-01-01

This study aimed to assess the impacts of ultraviolet-B (UV-B) radiation over a 28-day period on the levels of pigments of Umbilicaria aprina and Bryum argenteum growing in field. The depletion of stratospheric ozone is most prominent over Antarctica, which receives more UV-B radiation than most other parts of the planet. Although UV-B radiation adversely affects all flora, Antarctic plants are better equipped to survive the damaging effects of UV-B owing to defenses provided by UV-B absorbing compounds and other screening pigments. The UV-B radiations and daily average ozone values were measured by sun photometer and the photosynthetic pigments were analyzed by the standard spectrophotometric methods of exposed and unexposed selected plants. The daily average atmospheric ozone values were recorded from 5 January to 2 February 2008. The maximum daily average for ozone (310.7 Dobson Units (DU)) was recorded on 10 January 2008. On that day, average UV-B spectral irradiances were 0.016, 0.071, and 0.186 W m-2 at wavelengths of 305, 312, and 320 nm, respectively. The minimum daily average ozone value (278.6 DU) was recorded on 31 January 2008. On that day, average UV-B spectral irradiances were 0.018, 0.085, and 0.210 W m-2 at wavelengths of 305, 312, and 320 nm, respectively. Our results concludes that following prolonged UV-B exposure, total chlorophyll levels decreased gradually in both species, whereas levels of UV-B absorbing compounds, phenolics, and carotenoids gradually increased. PMID:24748743

CO and NO pulmonary diffusing capacity during pregnancy: Safety and diagnostic potential

PubMed Central

Zavorsky, Gerald S.; Blood, Arlin B.; Power, Gordon G.; Longo, Lawrence D.; Artal, Raul; Vlastos, Emanuel J.

2013-01-01

This paper reviews the scientific evidence for the safety of carbon monoxide (CO) and nitric oxide (NO) inhalation to measure pulmonary diffusing capacity (DLCO and DLNO) in pregnant women and their fetuses. In eight earlier studies, 650 pregnant women had DLCO measurements performed at various times during pregnancy, with a minimum of two to four tests per session. Both pregnant subjects that were healthy and those with medical complications were tested. No study reported adverse maternal, fetal, or neonatal outcomes from the CO inhalation in association with measuring DLCO. Eleven pregnant women, chiefly with pulmonary hypertension, and 1105 pre-term neonates, mostly with respiratory failure, were administered various dosages of NO (5–80 ppm for 4 weeks continuously in pregnant women, and 1–20 ppm for 15 min to 3 weeks for the neonates). NO treatment was found to be an effective therapy for pregnant women with pulmonary hypertension. In neonates with respiratory failure and pulmonary hypertension, NO therapy improved oxygenation and survival and has been associated with only minor, transient adverse effects. In conclusion, maternal carboxyhemoglobin ([HbCO]) levels can safely increase to 5% per testing session when the dose-exposure limit is 0.3% CO inhalation for ≤3 min, and for NO, 80 ppm for ≤ 3 min. The risk of late fetal or neonatal death from increased HbCO from diffusion testing is considerably less than the risk of death from all causes reported by the Centers for Disease Control, and is therefore considered “minimal risk”. PMID:20149901

Fluid overload and survival in critically ill patients with acute kidney injury receiving continuous renal replacement therapy

PubMed Central

Kim, Il Young; Kim, Joo Hui; Lee, Dong Won; Lee, Soo Bong; Rhee, Harin; Seong, Eun Young; Kwak, Ihm Soo

2017-01-01

Background Fluid overload is known to be associated with increased mortality in patients with acute kidney injury (AKI) who are critically ill. In this study, we intended to uncover whether the adverse effect of fluid overload on survival could be applied to all of the patients with AKI who received continuous renal replacement therapy (CRRT). Methods We analyzed 341 patients with AKI who received CRRT in our intensive care units. The presence of fluid overload was defined as a minimum 10% increase in body weight from the baseline. Demographics, comorbid diseases, clinical data, severity of illness [the sequential organ failure assessment (SOFA) score, number of vasopressors, diagnosis of sepsis, use of ventilator] upon ICU admission, fluid overload status, and time elapsed from AKI diagnosis until CRRT initiation were reviewed from the medical charts. Results Patients with total fluid overload from 3 days before CRRT initiation to ICU discharge had a significantly lower survival rate after ICU admission, as compared to patients with no fluid overload (P < 0.001). Among patients with sepsis (P < 0.001) or with high SOFA scores (P < 0.001), there was a significant difference in survival of the patients with and without fluid overload. In patients without sepsis or with low SOFA score, there was no significant difference in survival of patients irrespective of fluid overload. Conclusion Our study demonstrates that the adverse effect of fluid overload on survival is more evident in patients with sepsis or with more severe illness, and that it might not apply to patients without sepsis or with less severe illness. PMID:28196107

36 CFR 800.5 - Assessment of adverse effects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Assessment of adverse effects... PROTECTION OF HISTORIC PROPERTIES The section 106 Process § 800.5 Assessment of adverse effects. (a) Apply criteria of adverse effect. In consultation with the SHPO/THPO and any Indian tribe or Native Hawaiian...

Comparison of search strategies in systematic reviews of adverse effects to other systematic reviews.

PubMed

Golder, Su; Loke, Yoon K; Zorzela, Liliane

2014-06-01

Research indicates that the methods used to identify data for systematic reviews of adverse effects may need to differ from other systematic reviews. To compare search methods in systematic reviews of adverse effects with other reviews. The search methodologies in 849 systematic reviews of adverse effects were compared with other reviews. Poor reporting of search strategies is apparent in both systematic reviews of adverse effects and other types of systematic reviews. Systematic reviews of adverse effects are less likely to restrict their searches to MEDLINE or include only randomised controlled trials (RCTs). The use of other databases is largely dependent on the topic area and the year the review was conducted, with more databases searched in more recent reviews. Adverse effects search terms are used by 72% of reviews and despite recommendations only two reviews report using floating subheadings. The poor reporting of search strategies in systematic reviews is universal, as is the dominance of searching MEDLINE. However, reviews of adverse effects are more likely to include a range of study designs (not just RCTs) and search beyond MEDLINE. © 2014 Crown Copyright.

Radon detection system, design, test and performance

NASA Astrophysics Data System (ADS)

Balcázar, M.; Chávez, A.; Piña-Villalpando, G.; Navarrete, M.

1999-02-01

A portable radon detection system (α-Inin) has been designed and constructed for using it in adverse environmental conditions where humidity, temperature and chemical vaporous are present. The minimum integration time is in periods of 15 min during 41 days. A 12 V battery and a photovoltaic module allow the α-Inin autonomy in field measurements. Data is collected by means of a laptop computer where data processing and α-Inin programming are carried out. α-Inin performance was simultaneously tested in a controlled radon chamber, together with a commercial α-Meter.

The Effect of Minimum Wages on Youth Employment in Canada: A Panel Study.

ERIC Educational Resources Information Center

Yuen, Terence

2003-01-01

Canadian panel data 1988-90 were used to compare estimates of minimum-wage effects based on a low-wage/high-worker sample and a low-wage-only sample. Minimum-wage effect for the latter is nearly zero. Different results for low-wage subgroups suggest a significant effect for those with longer low-wage histories. (Contains 26 references.) (SK)

The adverse health effects of chronic cannabis use.

PubMed

Hall, Wayne; Degenhardt, Louisa

2014-01-01

This paper summarizes the most probable of the adverse health effects of regular cannabis use sustained over years, as indicated by epidemiological studies that have established an association between cannabis use and adverse outcomes; ruled out reverse causation; and controlled for plausible alternative explanations. We have also focused on adverse outcomes for which there is good evidence of biological plausibility. The focus is on those adverse health effects of greatest potential public health significance--those that are most likely to occur and to affect a substantial proportion of regular cannabis users. These most probable adverse effects of regular use include a dependence syndrome, impaired respiratory function, cardiovascular disease, adverse effects on adolescent psychosocial development and mental health, and residual cognitive impairment. Copyright © 2013 John Wiley & Sons, Ltd.

Identification and Characterization of Adverse Effects in 21st Century Toxicology

EPA Science Inventory

The ILSI Health and Environmental Sciences Institute Project Committee on Distinguishing Adverse from Non-Adverse / Adaptive Effects held a workshop in May 2011 to discuss approaches to identifying adverse effects in the context of the 2007 NRC committee report titled “Toxicity T...

State cigarette minimum price laws - United States, 2009.

PubMed

2010-04-09

Cigarette price increases reduce the demand for cigarettes and thereby reduce smoking prevalence, cigarette consumption, and youth initiation of smoking. Excise tax increases are the most effective government intervention to increase the price of cigarettes, but cigarette manufacturers use trade discounts, coupons, and other promotions to counteract the effects of these tax increases and appeal to price-sensitive smokers. State cigarette minimum price laws, initiated by states in the 1940s and 1950s to protect tobacco retailers from predatory business practices, typically require a minimum percentage markup to be added to the wholesale and/or retail price. If a statute prohibits trade discounts from the minimum price calculation, these laws have the potential to counteract discounting by cigarette manufacturers. To assess the status of cigarette minimum price laws in the United States, CDC surveyed state statutes and identified those states with minimum price laws in effect as of December 31, 2009. This report summarizes the results of that survey, which determined that 25 states had minimum price laws for cigarettes (median wholesale markup: 4.00%; median retail markup: 8.00%), and seven of those states also expressly prohibited the use of trade discounts in the minimum retail price calculation. Minimum price laws can help prevent trade discounting from eroding the positive effects of state excise tax increases and higher cigarette prices on public health.

Adverse Effects of Electronic Cigarette Use: A Concept Mapping Approach

PubMed Central

Nasim, Aashir; Rosas, Scott

2016-01-01

Abstract Introduction: Electronic cigarette (ECIG) use has grown rapidly in popularity within a short period of time. As ECIG products continue to evolve and more individuals begin using ECIGs, it is important to understand the potential adverse effects that are associated with ECIG use. The purpose of this study was to examine and describe the acute adverse effects associated with ECIG use. Methods: This study used an integrated, mixed-method participatory approach called concept mapping (CM). Experienced ECIG users ( n = 85) provided statements that answered the focus prompt “A specific negative or unpleasant effect (ie, physical or psychological) that I have experienced either during or immediately after using an electronic cigarette device is…” in an online program. Participants sorted these statements into piles of common themes and rated each statement. Using multidimensional scaling and hierarchical cluster analysis, a concept map of the adverse effects statements was created. Results: Participants generated 79 statements that completed the focus prompt and were retained by researchers. Analysis generated a map containing five clusters that characterized perceived adverse effects of ECIG use: Stigma, Worry/Guilt, Addiction Signs, Physical Effects, and Device/Vapor Problems. Conclusions: ECIG use is associated with adverse effects that should be monitored as ECIGs continue to grow in popularity. If ECIGs are to be regulated, policies should be created that minimize the likelihood of user identified adverse effects. Implications: This article provides a list of adverse effects reported by experienced ECIG users. This article organizes these effects into a conceptual model that may be useful for better understanding the adverse outcomes associated with ECIG use. These identified adverse effects may be useful for health professionals and policy makers. Health professionals should be aware of potential negative health effects that may be associated with ECIG use and policy makers could design ECIG regulations that minimize the risk of the adverse effects reported by ECIG users in this study. PMID:26563262

A new strategy of CyberKnife treatment system based radiosurgery followed by early use of adjuvant bevacizumab treatment for brain metastasis with extensive cerebral edema.

PubMed

Wang, Yang; Wang, Enmin; Pan, Li; Dai, Jiazhong; Zhang, Nan; Wang, Xin; Liu, Xiaoxia; Mei, Guanghai; Sheng, Xiaofang

2014-09-01

Bevacizumab blocks the effects of vascular endothelial growth factor in leakage-prone capillaries and has been suggested as a new treatment for cerebral radiation edema and necrosis. CyberKnife is a new, frameless stereotactic radiosurgery system. This work investigated the safety and efficacy of CyberKnife followed by early bevacizumab treatment for brain metastasis with extensive cerebral edema. The eligibility criteria of the patients selected for radiosurgery followed by early use of adjuvant bevacizumab treatment were: (1) brain tumors from metastasis with one solitary brain lesion and symptomatic extensive cerebral edema; (2) >18 years of age; (3) the patient refused surgery due to the physical conditions and the risk of surgery; (4) no contraindications for bevacizumab. (5) bevacizumab was applied for a minimum of 2 injections and a maximum of 6 injections with a 2-week interval between treatments, beginning within 2 weeks of the CyberKnife therapy; (6) Karnofsky performance status (KPS) ≥30. Tumor size and edema were monitored by magnetic resonance imaging (MRI). Dexamethasone dosage, KPS, adverse event occurrence and associated clinical outcomes were also recorded. Eight patients were accrued for this new treatment. Radiation dose ranged from 20 to 33 Gy in one to five sessions, prescribed to the 61-71 % isodose line. Bevacizumab therapy was administered 3-10 days after completion of CyberKnife treatment for a minimum of two cycles (5 mg/kg, at 2-week intervals). MRI revealed average reductions of 55.8 % (post-gadolinium) and 63.4 % (T2/FLAIR). Seven patients showed significant clinical neurological improvements. Dexamethasone was reduced in all patients, with five successfully discontinuing dexamethasone treatment 4 weeks after bevacizumab initiation. Hypertension, a bevacizumab-related adverse event, occurred in one patient. After 3-8 months, all patients studied were alive and primary brain metastases were under control, 2 developed new brain metastases and underwent salvage CyberKnife treatment. Recurrent edema and emerging radiation necrosis were not observed. CyberKnife radiosurgery followed by early use of bevacizumab is promising and appears safe for treatment of brain metastases with extensive cerebral edema.

Labor market outcomes and the transition to adulthood.

PubMed

Danziger, Sheldon; Ratner, David

2010-01-01

According to Sheldon Danziger and David Ratner, changes in the labor market over the past thirty-five years, such as labor-saving technological changes, increased globalization, declining unionization, and the failure of the minimum wage to keep up with inflation, have made it more difficult for young adults to attain the economic stability and self-sufficiency that are important markers of the transition to adulthood. Young men with no more than a high school degree have difficulty earning enough to support a family. Even though young women have achieved gains in earnings, employment, and schooling relative to men in recent decades, those without a college degree also struggle to achieve economic stability and self-sufficiency. The authors begin by describing trends in labor market outcomes for young adults-median annual earnings, the extent of low-wage work, employment rates, job instability, and the returns to education. Then they examine how these outcomes may contribute to delays in other markers of the transition to adulthood-completing an education, establishing independent living arrangements, and marrying and having children. They conclude that adverse changes in labor market outcomes are related to those delays but have not been shown to be the primary cause. Danziger and Ratner next consider several public policy reforms that might improve the economic outlook for young adults. They recommend policies that would increase the returns to work, especially for less-educated workers. They propose raising the federal minimum wage and adjusting it annually to maintain its value relative to the median wage. Expanding the Earned Income Tax Credit for childless low-wage workers, the authors say, could also raise the take-home pay of many young adult workers, with minimal adverse employment effects. New policies should also provide work opportunities for young adults who cannot find steady employment either because of poor economic conditions or because of physical and mental disabilities or criminal records that make it hard for them to work steadily even when the economy is strong. Finally, the authors recommend increasing federal Pell grants for college and improving access to credit for would-be college students to raise the educational attainment of young adults from low-income families.

Posterior segment nucleotomy for dislocated sclerotic cataractous lens using chandelier endoilluminator and sharp tipped chopper

PubMed Central

Takkar, Brijesh; Azad, Rajvardhan; Azad, Shorya; Rathi, Anubha

2015-01-01

AIM To describe a new surgical technique for managing dislocated sclerotic cataractous lens. METHODS Six patients with advanced posteriorly dislocated cataracts were operated at a tertiary care centre and analyzed retrospectively. After standard 3 port 23 G pars plana vitrectomy and perfluorocarbon liquid (PFCL) injection, the dislocated white cataract was held with occlusion using phaco fragmatome and then chopped into smaller pieces with a sharp tipped chopper using 25 G chandelier endoilluminator. Each piece was emulsified individually. Following aspiration of PFCL, Fluid Air Exchange was done in all the cases and surgery completed uneventfully. RESULTS Best corrected visual acuity (BCVA) in all the patients was better than 6/12 after one month of follow up. No serious complications were noted till minimum 6mo of follow up. CONCLUSION Four port posterior segment nucleotomy with a chandelier endoilluminator, fragmatome and a chopper appears to be a safe, easy and effective procedure for managing dislocated sclerotic cataractous nuclei. Ultrasonic energy used and adverse thermal effects of the fragmatome on the sclera may be lesser. PMID:26309887

Engineering of electronic properties of single layer graphene by swift heavy ion irradiation

NASA Astrophysics Data System (ADS)

Kumar, Sunil; Kumar, Ashish; Tripathi, Ambuj; Tyagi, Chetna; Avasthi, D. K.

2018-04-01

In this work, swift heavy ion irradiation induced effects on the electrical properties of single layer graphene are reported. The modulation in minimum conductivity point in graphene with in-situ electrical measurement during ion irradiation was studied. It is found that the resistance of graphene layer decreases at lower fluences up to 3 × 1011 ions/cm2, which is accompanied by the five-fold increase in electron and hole mobilities. The ion irradiation induced increase in electron and hole mobilities at lower fluence up to 1 × 1011 ions/cm2 is verified by separate Hall measurements on another irradiated graphene sample at the selected fluence. In contrast to the adverse effects of irradiation on the electrical properties of materials, we have found improvement in electrical mobility after irradiation. The increment in mobility is explained by considering the defect annealing in graphene after irradiation at a lower fluence regime. The modification in carrier density after irradiation is also observed. Based on findings of the present work, we suggest ion beam irradiation as a useful tool for tuning of the electrical properties of graphene.

Evaluation of ceftiofur–PHBV microparticles in rats

PubMed Central

Vilos, Cristian; Constandil, Luis; Rodas, Paula I; Cantin, Mario; Zepeda, Katherine; Herrera, Natalia; Velasquez, Luis A

2014-01-01

Despite the high number of antibiotics used for the treatment of infectious disease in animals, the development of slow release formulations presents a significant challenge, particularly in using novel biomaterials with low cost. In this report, we studied the pharmacokinetics, toxicity, and therapeutic activity of ceftiofur–PHBV (ceftiofur–poly(3-hydroxybutyrate-co-3-hydroxyvalerate)) in rats. The pharmacokinetic study demonstrated a sustained release of ceftiofur into the bloodstream, with detectable levels over the minimum inhibitory concentration for at least 17 days after a single intramuscular injection of ceftiofur–PHBV (10 mg/kg weight). In addition, the toxicological evaluation of biochemical, hematological, and coagulation blood parameters at the therapeutic dose demonstrated the safety of ceftiofur–PHBV, with no adverse effects. In addition, ceftiofur–PHBV exhibited a therapeutic effect for a longer time period than the nonencapsulated ceftiofur in rats challenged with Salmonella Typhimurium. The slow release of ceftiofur from the ceftiofur–PHBV, its low toxicity in the blood parameters evaluated, and the efficacy in the rats infected with Salmonella Typhimurium make ceftiofur–PHBV a strong candidate for biotechnological applications in the veterinary industry. PMID:24936127

Recent Immigrants as Labor Market Arbitrageurs: Evidence from the Minimum Wage.

PubMed

Cadena, Brian C

2014-03-01

This paper investigates the local labor supply effects of changes to the minimum wage by examining the response of low-skilled immigrants' location decisions. Canonical models emphasize the importance of labor mobility when evaluating the employment effects of the minimum wage; yet few studies address this outcome directly. Low-skilled immigrant populations shift toward labor markets with stagnant minimum wages, and this result is robust to a number of alternative interpretations. This mobility provides behavior-based evidence in favor of a non-trivial negative employment effect of the minimum wage. Further, it reduces the estimated demand elasticity using teens; employment losses among native teens are substantially larger in states that have historically attracted few immigrant residents.

FEMALE SEX AND DISCONTINUATION OF ISONIAZID DUE TO ADVERSE EFFECTS DURING THE TREATMENT OF LATENT TUBERCULOSIS

PubMed Central

Pettit, April C.; Bethel, James; Hirsch-Moverman, Yael; Colson, Paul W.; Sterling, Timothy R.

2013-01-01

SUMMARY Objectives To determine the rate of and risk factors for discontinuation of isoniazid due to adverse effects during the treatment of latent tuberculosis infection in a large, multi-site study. Methods The Tuberculosis Epidemiologic Studies Consortium (TBESC) conducted a prospective study from March 2007–September 2008 among adults initiating isoniazid for treatment of LTBI at 12 sites in the US and Canada. The relative risk for isoniazid discontinuation due to adverse effects was determined using negative binomial regression. Adjusted models were constructed using forward stepwise regression. Results Of 1,306 persons initiating isoniazid, 617 (47.2%, 95% CI 44.5–50.0%) completed treatment and 196 (15.0%, 95% CI 13.1–17.1%) discontinued due to adverse effects. In multivariable analysis, female sex (RR 1.67, 95% CI 1.32–2.10, p<0.001) and current alcohol use (RR 1.41, 95% CI 1.13–1.77, p=0.003) were independently associated with isoniazid discontinuation due to adverse effects. Conclusions The rate of discontinuation of isoniazid due to adverse effects was substantially higher than reported earlier. Women were at increased risk of discontinuing isoniazid due to adverse effects; close monitoring of women for adverse effects may be warranted. Current alcohol use was also associated with isoniazid discontinuation; counseling patients to abstain from alcohol could decrease discontinuation due to adverse effects. PMID:23845828

Cumulative high doses of inhaled formoterol have less systemic effects in asthmatic children 6–11 years-old than cumulative high doses of inhaled terbutaline

PubMed Central

Kaae, Rikke; Agertoft, Lone; Pedersen, Sören; Nordvall, S Lennart; Pedroletti, Christophe; Bengtsson, Thomas; Johannes-Hellberg, Ingegerd; Rosenborg, Johan

2004-01-01

Objectives To evaluate high dose tolerability and relative systemic dose potency between inhaled clinically equipotent dose increments of formoterol and terbutaline in children. Methods Twenty boys and girls (6–11 years-old) with asthma and normal ECGs were studied. Ten doses of formoterol (Oxis®) 4.5 µg (F4.5) or terbutaline (Bricanyl®) 500 µg (T500) were inhaled cumulatively via a dry powder inhaler (Turbuhaler®) over 1 h (three patients) or 2.5 h (17 patients) and compared to a day of no treatment, in a randomised, double-blind (active treatments only), crossover trial. Blood pressure (BP), ECG, plasma potassium, glucose, lactate, and adverse events were monitored up to 10 h to assess tolerability and relative systemic dose potency. Results Formoterol and terbutaline had significant β2-adrenergic effects on most outcomes. Apart from the effect on systolic BP, QRS duration and PR interval, the systemic effects were significantly more pronounced with terbutaline than with formoterol. Thus, mean minimum plasma potassium, was suppressed from 3.56 (95% confidence interval, CI: 3.48–3.65) mmol l−1 on the day of no treatment to 2.98 (CI: 2.90–3.08) after 10 × F4.5 and 2.70 (CI: 2.61–2.78) mmol l−1 after 10 × T500, and maximum Q-Tc (heart rate corrected Q-T interval [Bazett's formula]) was prolonged from 429 (CI: 422–435) ms on the day of no treatment, to 455 (CI: 448–462) ms after 10 × F4.5 and 470 (CI: 463–476) ms after 10 × T500. Estimates of relative dose potency indicated that F4.5 µg had the same systemic activity as the clinically less effective dose of 250 µg terbutaline. The duration of systemic effects differed marginally between treatments. Spontaneously reported adverse events (most frequently tremor) were fewer with formoterol (78% of the children) than with terbutaline (95%). A serious adverse event occurred after inhalation of 45 µg formoterol over the 1 h dosing time, that prompted the extension of dosing time to 2.5 h. Conclusions Multiple inhalations over 2.5 h of formoterol (4.5 µg) via Turbuhaler® are at least as safe as and associated with less systemic effects than multiple inhalations of the clinically equipotent dose of terbutaline (500 µg) in children with asthma. PMID:15373934

Cumulative high doses of inhaled formoterol have less systemic effects in asthmatic children 6-11 years-old than cumulative high doses of inhaled terbutaline.

PubMed

Kaae, Rikke; Agertoft, Lone; Pedersen, Sören; Nordvall, S Lennart; Pedroletti, Christophe; Bengtsson, Thomas; Johannes-Hellberg, Ingegerd; Rosenborg, Johan

2004-10-01

To evaluate high dose tolerability and relative systemic dose potency between inhaled clinically equipotent dose increments of formoterol and terbutaline in children. Twenty boys and girls (6-11 years-old) with asthma and normal ECGs were studied. Ten doses of formoterol (Oxis) 4.5 microg (F4.5) or terbutaline (Bricanyl) 500 microg (T500) were inhaled cumulatively via a dry powder inhaler (Turbuhaler) over 1 h (three patients) or 2.5 h (17 patients) and compared to a day of no treatment, in a randomised, double-blind (active treatments only), crossover trial. Blood pressure (BP), ECG, plasma potassium, glucose, lactate, and adverse events were monitored up to 10 h to assess tolerability and relative systemic dose potency. Formoterol and terbutaline had significant beta2-adrenergic effects on most outcomes. Apart from the effect on systolic BP, QRS duration and PR interval, the systemic effects were significantly more pronounced with terbutaline than with formoterol. Thus, mean minimum plasma potassium, was suppressed from 3.56 (95% confidence interval, CI: 3.48-3.65) mmol l(-1) on the day of no treatment to 2.98 (CI: 2.90-3.08) after 10 x F4.5 and 2.70 (CI: 2.61-2.78) mmol l(-1) after 10 x T500, and maximum Q-Tc (heart rate corrected Q-T interval [Bazett's formula]) was prolonged from 429 (CI: 422-435) ms on the day of no treatment, to 455 (CI: 448-462) ms after 10 x F4.5 and 470 (CI: 463-476) ms after 10 x T500. Estimates of relative dose potency indicated that F4.5 microg had the same systemic activity as the clinically less effective dose of 250 microg terbutaline. The duration of systemic effects differed marginally between treatments. Spontaneously reported adverse events (most frequently tremor) were fewer with formoterol (78% of the children) than with terbutaline (95%). A serious adverse event occurred after inhalation of 45 microg formoterol over the 1 h dosing time, that prompted the extension of dosing time to 2.5 h. Multiple inhalations over 2.5 h of formoterol (4.5 microg) via Turbuhaler) are at least as safe as and associated with less systemic effects than multiple inhalations of the clinically equipotent dose of terbutaline (500 microg) in children with asthma. Copyright 2004 Blackwell Publishing Ltd

18 CFR 292.211 - Petition for initial determination on whether a project has a substantial adverse effect on the...

Code of Federal Regulations, 2013 CFR

2013-04-01

... determination on whether a project has a substantial adverse effect on the environment (AEE petition). 292.211... for initial determination on whether a project has a substantial adverse effect on the environment... that it has no substantial adverse effect on the environment as specified in § 292.208(b)(1). (b) The...

18 CFR 292.211 - Petition for initial determination on whether a project has a substantial adverse effect on the...

Code of Federal Regulations, 2012 CFR

2012-04-01

... determination on whether a project has a substantial adverse effect on the environment (AEE petition). 292.211... for initial determination on whether a project has a substantial adverse effect on the environment... that it has no substantial adverse effect on the environment as specified in § 292.208(b)(1). (b) The...

18 CFR 292.211 - Petition for initial determination on whether a project has a substantial adverse effect on the...

Code of Federal Regulations, 2011 CFR

2011-04-01

... determination on whether a project has a substantial adverse effect on the environment (AEE petition). 292.211... for initial determination on whether a project has a substantial adverse effect on the environment... that it has no substantial adverse effect on the environment as specified in § 292.208(b)(1). (b) The...

18 CFR 292.211 - Petition for initial determination on whether a project has a substantial adverse effect on the...

Code of Federal Regulations, 2014 CFR

2014-04-01

... determination on whether a project has a substantial adverse effect on the environment (AEE petition). 292.211... for initial determination on whether a project has a substantial adverse effect on the environment... that it has no substantial adverse effect on the environment as specified in § 292.208(b)(1). (b) The...

18 CFR 292.211 - Petition for initial determination on whether a project has a substantial adverse effect on the...

Code of Federal Regulations, 2010 CFR

2010-04-01

... determination on whether a project has a substantial adverse effect on the environment (AEE petition). 292.211... for initial determination on whether a project has a substantial adverse effect on the environment... that it has no substantial adverse effect on the environment as specified in § 292.208(b)(1). (b) The...

Understanding the Minimum Wage: Issues and Answers.

ERIC Educational Resources Information Center

Employment Policies Inst. Foundation, Washington, DC.

This booklet, which is designed to clarify facts regarding the minimum wage's impact on marketplace economics, contains a total of 31 questions and answers pertaining to the following topics: relationship between minimum wages and poverty; impacts of changes in the minimum wage on welfare reform; and possible effects of changes in the minimum wage…

A review of solifenacin in the treatment of urinary incontinence

PubMed Central

Basra, Ramandeep; Kelleher, Con

2008-01-01

Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was launched in 2005, and has been shown in both short and long term clinical trials to fulfill these requirements. Solifenacin is a competitive M3 receptor antagonist with a long half-life (45–68 hours). It is available in two dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open label 40 week continuation study. PMID:18728701

Low force cementation.

PubMed

Wilson, P R

1996-07-01

The marginal adaptation of full coverage restorations is adversely affected by the introduction of luting agents of various minimum film thicknesses during the cementation process. The increase in the marginal opening may have long-term detrimental effects on the health of both pulpal and periodontal tissues. The purpose of this study was to determine the effects of varying seating forces (2.5, 12.5, 25 N), venting, and cement types on post-cementation marginal elevation in cast crowns. A standardized cement space of 40 microns was provided between a machined gold crown and a stainless steel die. An occlusal vent was placed that could be opened or closed. The post-cementation crown elevation was measured, following the use of two commercially available capsulated dental cements (Phosphacap, and Ketac-cem Applicap). The results indicate that only the combination of Ketac-Cem Applicap and crown venting produced post-cementation crown elevation of less than 20 microns when 12.5 N seating force was used. Higher forces (25 N) and venting were required for comparable seating when using Phosphacap (19 microns). The amount of force required to allow maximum seating of cast crowns appears to be cement specific, and is reduced by effective venting procedures.

Mortality, Transmitter Retention, Growth, and Wound Healing in Juvenile Salmon Injected with Micro Acoustic Transmitters

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

Liss, Stephanie A.; Brown, Richard S.; Deters, Katherine A.

A cylindrical acoustic transmitter (AT; 0.2 g) has been developed for injection into the peritoneum of fish. Laboratory studies can provide tagging guidelines to minimize the effect of implantation techniques and transmitter burden (relative weight of the transmitter to the weight of the fish) in fish before a transmitter is used in field studies. The goal of this study was to examine response variables (mortality, transmitter expulsion, growth, wound area) of juvenile Chinook Salmon (Oncorhynchus tschawytscha; 65–104 mm fork length [FL]) injected with an AT along a wide range of sizes that could lead to a guideline for minimizing taggingmore » effects. The overarching goal was to determine a minimum size threshold for fish that can be injected, while minimizing adverse transmitter effects. Juveniles (n = 700) were separated into four treatments: (1) acoustic transmitter injection (AT), (2) AT and a passive integrated transponder tag injection (AT+PIT), (3) visual implant elastomer injection (Marked control), and (4) unmarked (Unmarked control). Fish were evaluated weekly for four weeks, and again at the end of the study (60 d post-tagging). Fish injected with an AT or an AT+PIT experienced greater mortality than Marked controls. By 60 d post-tagging, transmitter expulsion was 44% for AT fish and 20% for AT+PIT fish. Fish injected with an AT or an AT+PIT grew (FL and weight gain) significantly less than Marked controls, and no minimum size thresholds were detected. Finally, initial size (FL) significantly affected wound area in AT and AT+PIT fish. A size threshold was only identified on Day 7 (85.1 mm) for AT+PIT fish, indicating that wound areas in fish < 85.1 mm were larger than wound areas of fish > 85.1 mm. This research suggests that injecting juveniles with an AT or an AT+PIT had a greater effect on smaller fish than larger fish.« less

The legacy of minimum legal drinking age law changes: Long-term effects on suicide and homicide deaths among women

PubMed Central

Grucza, Richard A; Hipp, Pamela R.; Norberg, Karen E.; Rundell, Laura; Evanoff, Anastasia; Cavazos-Rehg, Patricia; Bierut, Laura J.

2013-01-01

Background Prior to the establishment of the uniform drinking age of 21 in the United States, many states permitted legal purchase of alcohol at younger ages. Lower drinking ages were associated with several adverse outcomes, including elevated rates of suicide and homicide among youth. The objective of this study is to examine whether individuals who were legally permitted to drink prior to age 21 remained at elevated risk in adulthood. Methods Analysis of data from the U.S. Multiple Cause of Death files, 1990–2004, combined with data on the living population from the U.S. Census and American Community Survey. The assembled data contained records on over 200,000 suicides and 130,000 homicides for individuals born between 1949 and 1972, the years during which the drinking age was in flux. Logistic regression models were used to evaluate whether adults who were legally permitted to drink prior to age 21 were at elevated risk for death by these causes. A quasi-experimental analytical approach was employed which incorporated state and birth year fixed effects to account for unobserved covariates associated with policy exposure. Results In the population as a whole, we found no association between minimum drinking age and homicide or suicide. However, significant policy-by-sex interactions were observed for both outcomes, such that women exposed to permissive drinking age laws were at higher risk for both suicide (OR=1.12; 95% CI 1.05, 1.18, p=0.0003) and homicide (OR=1.15; 95% CI 1.04, 1.25; p=0.0028). Effect sizes were stronger for the portion of the cohort born after 1960, whereas no significant effects were observed for women born prior to 1960. Conclusions Lower drinking ages may result in persistent elevated risk for suicide and homicide among women born after 1960. The national drinking age of 21 may be preventing about 600 suicides and 600 homicides annually. PMID:22085045

Responses to social and environmental stress are attenuated by strong male bonds in wild macaques

PubMed Central

Young, Christopher; Majolo, Bonaventura; Heistermann, Michael; Schülke, Oliver; Ostner, Julia

2014-01-01

In humans and obligatory social animals, individuals with weak social ties experience negative health and fitness consequences. The social buffering hypothesis conceptualizes one possible mediating mechanism: During stressful situations the presence of close social partners buffers against the adverse effects of increased physiological stress levels. We tested this hypothesis using data on social (rate of aggression received) and environmental (low temperatures) stressors in wild male Barbary macaques (Macaca sylvanus) in Morocco. These males form strong, enduring, and equitable affiliative relationships similar to human friendships. We tested the effect of the strength of a male’s top three social bonds on his fecal glucocorticoid metabolite (fGCM) levels as a function of the stressors’ intensity. The attenuating effect of stronger social bonds on physiological stress increased both with increasing rates of aggression received and with decreasing minimum daily temperature. Ruling out thermoregulatory and immediate effects of social interactions on fGCM levels, our results indicate that male Barbary macaques employ a tend-and-befriend coping strategy in the face of increased environmental as well as social day-to-day stressors. This evidence of a stress-ameliorating effect of social bonding among males under natural conditions and beyond the mother–offspring, kin or pair bond broadens the generality of the social buffering hypothesis. PMID:25489097

Rare and very rare adverse effects of clozapine

PubMed Central

De Fazio, Pasquale; Gaetano, Raffaele; Caroleo, Mariarita; Cerminara, Gregorio; Maida, Francesca; Bruno, Antonio; Muscatello, Maria Rosaria; Moreno, Maria Jose Jaén; Russo, Emilio; Segura-García, Cristina

2015-01-01

Clozapine (CLZ) is the drug of choice for the treatment of resistant schizophrenia; however, its suitable use is limited by the complex adverse effects’ profile. The best-described adverse effects in the literature are represented by agranulocytosis, myocarditis, sedation, weight gain, hypotension, and drooling; nevertheless, there are other known adverse effects that psychiatrists should readily recognize and manage. This review covers the “rare” and “very rare” known adverse effects of CLZ, which have been accurately described in literature. An extensive search on the basis of predefined criteria was made using CLZ and its combination with adverse effects as keywords in electronic databases. Data show the association between the use of CLZ and uncommon adverse effects, including ischemic colitis, paralytic ileus, hematemesis, gastroesophageal reflux disease, priapism, urinary incontinence, pityriasis rosea, intertriginous erythema, pulmonary thromboembolism, pseudo-pheochromocytoma, periorbital edema, and parotitis, which are influenced by other variables including age, early diagnosis, and previous/current pharmacological therapies. Some of these adverse effects, although unpredictable, are often manageable if promptly recognized and treated. Others are serious and potentially life-threatening. However, an adequate knowledge of the drug, clinical vigilance, and rapid intervention can drastically reduce the morbidity and mortality related to CLZ treatment. PMID:26273202

Recent Immigrants as Labor Market Arbitrageurs: Evidence from the Minimum Wage*

PubMed Central

Cadena, Brian C.

2014-01-01

This paper investigates the local labor supply effects of changes to the minimum wage by examining the response of low-skilled immigrants’ location decisions. Canonical models emphasize the importance of labor mobility when evaluating the employment effects of the minimum wage; yet few studies address this outcome directly. Low-skilled immigrant populations shift toward labor markets with stagnant minimum wages, and this result is robust to a number of alternative interpretations. This mobility provides behavior-based evidence in favor of a non-trivial negative employment effect of the minimum wage. Further, it reduces the estimated demand elasticity using teens; employment losses among native teens are substantially larger in states that have historically attracted few immigrant residents. PMID:24999288

A Retrospective Analysis of Apheresis Donor Deferral and Adverse Reactions at a Tertiary Care Centre in India.

PubMed

Arora, Disha; Garg, Ketan; Kaushik, Ankit; Sharma, Richa; Rawat, D S; Mandal, A K

2016-11-01

With increasing demand of platelet component each day, blood bank plays a pivotal role in ensuring supply of safe blood as and when required. Plateletpheresis procedure is a relatively simple, safe and important adjunct to blood bank inventory. However, recruitment of healthy blood donors is a challenge that the health industry is facing today. To determine the reasons and rates of apheresis donor deferral along with investigation of adverse reactions encountered during the procedure. Records of single donor apheresis were retrospectively analysed from 1 st January 2010 to 31 st December 2014. The study was carried out at Blood Bank, Safdarjung Hospital, New Delhi, India. The donor details that were studied included - age, sex, type of donation (voluntary/replacement/ repeat), reason for donor deferral and type of adverse reaction, if encountered during the procedure. Among the 478 donors screened for plateletpheresis procedure during a study period of 5 years, 134 (28.03%) were deferred. Temporary deferrals accounted for majority (93.28%) of the deferrals. Low platelet count (50.75%) was the main reason of donor deferral followed by low haemoglobin (20.89%). Amongst the 344 selected donors, 15 (4.36%) had some type of adverse reaction associated with the procedure. We suggest that the selection criteria for plateletpheresis donors should be revised to deal with shortage of apheresis donors. The criteria regarding minimum pre-procedure platelet count (above1.5 lac/μl) and haemoglobin (above 12.5 g/dl) need to be lowered so as to suit the Indian scenario. The lower adverse reaction rates, 14/344 (4.06%) associated with this procedure encourages safety of donors and is important in recruitment of new donors.

Adverse Effects Associated With Newer Diabetes Therapies.

PubMed

Akiyode, Oluwaranti F; Adesoye, Adebola A

2017-04-01

The increasing number of newer type 2 diabetes therapies has allowed providers an increased armamentarium for the optimal management of patients with diabetes. In fact, these newer agents have unique benefits in the management of type 2 diabetes. However, they are also associated with certain adverse effects. This review article aims to describe the notable adverse effects of these newer antidiabetic therapies including the glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and the sodium-glucose cotransporter 2 inhibitors. The adverse effects reviewed herein include pancreatitis, medullary thyroid carcinoma, heart failure, gastrointestinal disturbances, renal impairment, and genitourinary infections. More clinical data are necessary to solidify the association of some of these adverse effects with the newer diabetes agents. However, it is important for health care practitioners to be well informed and prepared to properly monitor patients for these adverse effects.

Elevated Patient Body Mass Index Does Not Negatively Affect Self-Reported Outcomes of Thoracolumbar Surgery: Results of a Comparative Observational Study with Minimum 1-Year Follow-Up

PubMed Central

Manson, Neil A.; Green, Alana J.; Abraham, Edward P.

2015-01-01

Study Design Retrospective study. Objective Quantify the effect of obesity on elective thoracolumbar spine surgery patients. Methods Five hundred consecutive adult patients undergoing thoracolumbar spine surgery to treat degenerative pathologies with minimum follow-up of at least 1 year were included. Primary outcome measures included Numerical Rating Scales for back and leg pain, the Short Form 36 Physical Component Summary and Mental Component Summary, the modified Oswestry Disability Index, and patient satisfaction scores collected preoperatively and at 3, 6, 12, and 24 months postoperatively. Secondary outcome measures included perioperative and postoperative adverse events, postoperative emergency department presentation, hospital readmission, and revision surgeries. Patients were grouped according to World Health Organization body mass index (BMI) guidelines to isolate the effect of obesity on primary and secondary outcome measures. Results Mean BMI was 30 kg/m2, reflecting a significantly overweight population. Each BMI group reported statistically significant improvement on all self-reported outcome measures. Contrary to our hypothesis, however, there was no association between BMI group and primary outcome measures. Patients with BMI of 35 to 39.99 visited the emergency department with complaints of pain significantly more often than the other groups. Otherwise, we did not detect any differences in the secondary outcome measures between BMI groups. Conclusions Patients of all levels of obesity experienced significant improvement following elective thoracolumbar spine surgery. These outcomes were achieved without increased risk of postoperative complications such as infection and reoperation. A risk–benefit algorithm to assist with surgical decision making for obese patients would be valuable to surgeons and patients alike. PMID:26933611

How Low Can You Go? Determining a Size Threshold for Implantation of a New Acoustic Transmitter in Age-0 White Sturgeon

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

Ashton, Neil K.; Liss, Stephanie A.; Walker, Ricardo W.

Telemetry studies are often used to investigate sturgeon habitat use and movement patterns; however, existing acoustic transmitters are generally too large to implant into age-0 sturgeon without harming the fish. Recent development of a miniaturized acoustic transmitter (cylindrical, 0.7 g in air, 24.2 mm long, 5.0 mm diameter) with up to 365 d battery life has the potential to advance our understanding of age-0 sturgeon ecology in rivers and lakes. Prior to use in field studies, it is essential to conduct experiments evaluating potential adverse transmitter effects on fish. We tested transmitter retention, fish survival, and growth of a broadmore » size range of age-0 white sturgeon (Acipenser transmontanus; 158–277 mm fork length; 26–126 g; 0.6–2.6% transmitter burden) in an 84 d laboratory study, with an ultimate goal of determining a minimum size threshold of sturgeon that can be implanted with this acoustic transmitter. At 84 d post-implantation, transmitter retention and fish survival were 100%. Specific growth rates were reduced at 7 and 14 d post-implantation, resulting in minimum fork length thresholds of 250 and 171 mm, respectively. Juveniles implanted with transmitters regained their growth potential by 28 d post-implantation and no size differences were detected in comparisons with unmarked control fish. This study demonstrates the ability to implant small age-0 sturgeon with high transmitter retention and fish survival, and only minor growth effects. Use of new miniaturized acoustic transmitters may give researchers a means to address questions about young-of-the-year fish recruitment, ecological patterns, and potentially advance conservation management of sturgeon populations.« less

Adverse effects of ketoconazole in dogs--a retrospective study.

PubMed

Mayer, Ursula K; Glos, Katharina; Schmid, Matthias; Power, Helen T; Bettenay, Sonya V; Mueller, Ralf S

2008-08-01

Although ketoconazole has been used extensively in dogs for the treatment of various fungal infections, information about adverse effects is mainly anecdotal. Common adverse effects in humans include dose-dependant anorexia, nausea and vomiting, allergic rashes and pruritus. Drug-induced hepatitis is very rare, but potentially fatal. The aim of this study was to evaluate the type and frequency of adverse effects associated with ketoconazole therapy in dogs treated for skin diseases and any possible influence of dosage, duration of therapy, signalment or concurrent medication. The medical records of 632 dogs treated with ketoconazole (2.6-33.4 mg/kg) were reviewed. Adverse effects occurred in 14.6% (92 dogs) and included vomiting (7.1%), anorexia (4.9%), lethargy (1.9%), diarrhea (1.1%), pruritus (0.6%), erythema (0.3%) and other adverse effects (2.5%). Of the dogs with other adverse effects, four of 16 (25%) were ataxic and three of these received concurrent ivermectin. Adverse effects were significantly more often recorded in dogs concurrently treated with ciclosporin (P = 0.034) or ivermectin (P = 0.007). Increased liver enzyme levels were reported rarely, and icterus was not seen in any of the dogs. However, monitoring liver enzymes during therapy is recommended, although this might not necessarily prevent severe idiosyncratic hepatotoxicity.

Adverse health effects of non-medical cannabis use.

PubMed

Hall, Wayne; Degenhardt, Louisa

2009-10-17

For over two decades, cannabis, commonly known as marijuana, has been the most widely used illicit drug by young people in high-income countries, and has recently become popular on a global scale. Epidemiological research during the past 10 years suggests that regular use of cannabis during adolescence and into adulthood can have adverse effects. Epidemiological, clinical, and laboratory studies have established an association between cannabis use and adverse outcomes. We focus on adverse health effects of greatest potential public health interest-that is, those that are most likely to occur and to affect a large number of cannabis users. The most probable adverse effects include a dependence syndrome, increased risk of motor vehicle crashes, impaired respiratory function, cardiovascular disease, and adverse effects of regular use on adolescent psychosocial development and mental health.

Maternal adverse effects of different antenatal magnesium sulphate regimens for improving maternal and infant outcomes: a systematic review

PubMed Central

2013-01-01

Background Antenatal magnesium sulphate, widely used in obstetrics to improve maternal and infant outcomes, may be associated with adverse effects for the mother sufficient for treatment cessation. This systematic review aimed to quantify maternal adverse effects attributed to treatment, assess how adverse effects vary according to different regimens, and explore women’s experiences with this treatment. Methods Bibliographic databases were searched from their inceptions to July 2012 for studies of any design that reported on maternal adverse effects associated with antenatal magnesium sulphate given to improve maternal or infant outcomes. Primary outcomes were life-threatening adverse effects of treatment (death, cardiac arrest, respiratory arrest). For randomised controlled trials, data were meta-analysed, and risk ratios (RR) pooled using fixed-effects or random-effects models. For non-randomised studies, data were tabulated by design, and presented as RR, odds ratios or percentages, and summarised narratively. Results A total of 143 publications were included (21 randomised trials, 15 non-randomised comparative studies, 32 case series and 75 reports of individual cases), of mixed methodological quality. Compared with placebo or no treatment, magnesium sulphate was not associated with an increased risk of maternal death, cardiac arrest or respiratory arrest. Magnesium sulphate significantly increased the risk of 'any adverse effects’ overall (RR 4.62, 95% CI 2.42-8.83; 4 trials, 13,322 women), and treatment cessation due to adverse effects (RR 2.77; 95% CI 2.32-3.30; 5 trials, 13,666 women). Few subgroup differences were observed (between indications for use and treatment regimens). In one trial, a lower dose regimen (2 g/3 hours) compared with a higher dose regimen (5 g/4 hours) significantly reduced treatment cessation (RR 0.05; 95% CI 0.01-0.39, 126 women). Adverse effect estimates from studies of other designs largely supported data from randomised trials. Case reports supported an association between iatrogenic overdose of magnesium sulphate and life-threatening consequences. Conclusions Appropriate administration of antenatal magnesium sulphate was not shown to be associated with serious maternal adverse effects, though an increase in 'minor’ adverse effects and treatment cessation was shown. Larger trials are needed to determine optimal regimens, achieving maximal effectiveness with minimal adverse effects, for each antenatal indication for use. Vigilance in the use of magnesium sulphate is essential for women’s safety. PMID:24139447

Agricultural losses related to frost events: use of the 850 hPa level temperature as an explanatory variable of the damage cost

NASA Astrophysics Data System (ADS)

Papagiannaki, K.; Lagouvardos, K.; Kotroni, V.; Papagiannakis, G.

2014-01-01

The objective of this study is to analyze frost damaging events in agriculture, by examining the relationship between the daily minimum temperature at the lower atmosphere (at the pressure level of 850 hPa) and crop production losses. Furthermore, the study suggests a methodological approach for estimating agriculture risk due to frost events, with the aim to estimate the short-term probability and magnitude of frost-related financial losses for different levels of 850 hPa temperature. Compared with near surface temperature forecasts, temperature forecast at the level of 850 hPa is less influenced by varying weather conditions, as well as by local topographical features, thus it constitutes a more consistent indicator of the forthcoming weather conditions. The analysis of the daily monetary compensations for insured crop losses caused by weather events in Greece, during the period 1999-2011, shows that frost is the major meteorological phenomenon with adverse effects on crop productivity in the largest part of the country. Two regions of different geographical latitude are further examined, to account for the differences in the temperature ranges developed within their ecological environment. Using a series of linear and logistic regressions, we found that minimum temperature (at 850 hPa level), grouped in three categories according to its magnitude, and seasonality are significant variables when trying to explain crop damage costs, as well as to predict and quantify the likelihood and magnitude of frost damaging events.

Adverse Childhood Experiences, Commitment Offense, and Race/Ethnicity: Are the Effects Crime-, Race-, and Ethnicity-Specific?

PubMed

DeLisi, Matt; Alcala, Justin; Kusow, Abdi; Hochstetler, Andy; Heirigs, Mark H; Caudill, Jonathan W; Trulson, Chad R; Baglivio, Michael T

2017-03-22

Adverse childhood experiences are associated with an array of health, psychiatric, and behavioral problems including antisocial behavior. Criminologists have recently utilized adverse childhood experiences as an organizing research framework and shown that adverse childhood experiences are associated with delinquency, violence, and more chronic/severe criminal careers. However, much less is known about adverse childhood experiences vis-à-vis specific forms of crime and whether the effects vary across race and ethnicity. Using a sample of 2520 male confined juvenile delinquents, the current study used epidemiological tables of odds (both unadjusted and adjusted for onset, total adjudications, and total out of home placements) to evaluate the significance of the number of adverse childhood experiences on commitment for homicide, sexual assault, and serious persons/property offending. The effects of adverse childhood experiences vary considerably across racial and ethnic groups and across offense types. Adverse childhood experiences are strongly and positively associated with sexual offending, but negatively associated with homicide and serious person/property offending. Differential effects of adverse childhood experiences were also seen among African Americans, Hispanics, and whites. Suggestions for future research to clarify the mechanisms by which adverse childhood experiences manifest in specific forms of criminal behavior are offered.

Abundance of adverse environmental conditions during critical stages of crop production in Northern Germany.

PubMed

Strer, Maximilian; Svoboda, Nikolai; Herrmann, Antje

2018-01-01

Understanding the abundance of adverse environmental conditions e.g. frost, drought, and heat during critical crop growth stages, which are assumed to be altered by climate change, is crucial for an accurate risk assessment for cropping systems. While a lengthening of the vegetation period may be beneficial, higher frequencies of heat or frost events and drought spells are generally regarded as harmful. The objective of the present study was to quantify shifts in maize and wheat phenology and the occurrence of adverse environmental conditions during critical growth stages for four regions located in the North German Plain. First, a statistical analysis of phenological development was conducted based on recent data (1981-2010). Next, these data were used to calibrate the DSSAT-CERES wheat and maize models, which were then used to run three climate projections representing the maximum, intermediate and minimum courses of climate development within the RCP 8.5 continuum during the years 2021-2050. By means of model simulation runs and statistical analysis, the climate data were evaluated for the abundance of adverse environmental conditions during critical development stages, i.e. the stages of early crop development, anthesis, sowing and harvest. Proxies for adverse environmental conditions included thresholds of low and high temperatures as well as soil moisture. The comparison of the baseline climate and future climate projections showed a significant increase in the abundance of adverse environmental conditions during critical growth stages in the future. The lengthening of the vegetation period in spring did not compensate for the increased abundance of high temperatures, e.g. during anthesis. The results of this study indicate the need to develop adaptation strategies, such as implementing changes in cropping calendars. An increase in frost risk during early development, however, reveals the limited feasibility of early sowing as a mitigation strategy. In addition, the abundance of low soil water contents that hamper important production processes such as sowing and harvest were found to increase locally.

The struggle against perceived negligence. A qualitative study of patients' experiences of adverse events in Norwegian hospitals.

PubMed

Hågensen, Gunn; Nilsen, Gudrun; Mehus, Grete; Henriksen, Nils

2018-04-25

Every year, 14 % of patients in Norwegian hospitals experience adverse events, which often have health-damaging consequences. The government, hospital management and health personnel attempt to minimize such events. Limited research on the first-hand experience of the patients affected is available. The aim of this study is to present patients' perspectives of the occurrence of, disclosure of, and healthcare organizations' responses to adverse events. Findings are discussed within a social constructivist framework and with reference to principles of open disclosure policy. This qualitative study with an explorative descriptive design included fifteen in-depth interviews with former patients recruited by the Health and Social Services ombudsmen in the two northernmost counties of Norway. Inclusion criteria were as follows: 1) experience of adverse events in connection with surgical, orthopedic or medical treatment in general hospitals; 2) men and women; 3) aged 20-70; and 4) a minimum of one year since the event occurred. Transcribed audio-recorded interviews were analyzed through qualitative content analysis. The analysis revealed three main topics regarding patients' experiences of adverse events: 1) ignored concerns or signs of complications; 2) lack of responsibility and error correction; and 3) lack of support, loyalty and learning opportunities. Patients had to struggle to demonstrate the error that had occurred and to receive the necessary treatment and monitoring in the aftermath of the events. Patient narratives reveal a lack of openness, care and responsibility in connection with adverse events. Conflicting power structures, attitudes and established procedures may inhibit prevention, learning and patient safety work in spite of major efforts and good intentions. Attitudes in day-to-day patient care and organizational procedures should be challenged to invite patients into open disclosure processes and include them in health and safety work to a greater extent. The study's small sample of self-selected participants limits the generalizability of the findings, and future studies should include a larger number of patients as well as professional perspectives.

Pathways towards risk: syndemic conditions mediate the effect of adversity on HIV risk behaviors among young men who have sex with men (YMSM).

PubMed

Herrick, Amy; Stall, Ron; Egan, James; Schrager, Sheree; Kipke, Michele

2014-10-01

Research shows that young men who have sex with men (YMSM) engage in higher rates of health risk behaviors and experience higher rates of negative health outcomes than their peers. The purpose of this study is to determine if the effects of adversity on HIV risk are mediated by syndemics (co-occurring health problems). Participants were 470 ethnically diverse YMSM ages 18 to 24 recruited between 2005 and 2006 and surveyed every 6 months for 24 months. Regression analyses examined the impact of adversity on syndemics (emotional distress, substance use, and problematic alcohol use) and the effects of both adversity and syndemics on HIV risk behaviors over time. Gay-related discrimination and victimization-among other adversity variables-were significantly associated with syndemics and condomless sex (CS). Syndemics mediated the effects of adversity on CS in all models. Adverse events impact HIV risk taking among YMSM through syndemics. These findings suggest that prevention programs aimed at reducing adversity may reduce both the synergistic effect of multiple psychosocial health problems and HIV risk taking.

A cooperative reduction model for regional air pollution control in China that considers adverse health effects and pollutant reduction costs.

PubMed

Xie, Yujing; Zhao, Laijun; Xue, Jian; Hu, Qingmi; Xu, Xiang; Wang, Hongbo

2016-12-15

How to effectively control severe regional air pollution has become a focus of global concern recently. The non-cooperative reduction model (NCRM) is still the main air pollution control pattern in China, but it is both ineffective and costly, because each province must independently fight air pollution. Thus, we proposed a cooperative reduction model (CRM), with the goal of maximizing the reduction in adverse health effects (AHEs) at the lowest cost by encouraging neighboring areas to jointly control air pollution. CRM has two parts: a model of optimal pollutant removal rates using two optimization objectives (maximizing the reduction in AHEs and minimizing pollutant reduction cost) while meeting the regional pollution control targets set by the central government, and a model that allocates the cooperation benefits (i.e., health improvement and cost reduction) among the participants according to their contributions using the Shapley value method. We applied CRM to the case of sulfur dioxide (SO 2 ) reduction in Yangtze River Delta region. Based on data from 2003 to 2013, and using mortality due to respiratory and cardiovascular diseases as the health endpoints, CRM saves 437 more lives than NCRM, amounting to 12.1% of the reduction under NCRM. CRM also reduced costs by US $65.8×10 6 compared with NCRM, which is 5.2% of the total cost of NCRM. Thus, CRM performs significantly better than NCRM. Each province obtains significant benefits from cooperation, which can motivate them to actively cooperate in the long term. A sensitivity analysis was performed to quantify the effects of parameter values on the cooperation benefits. Results shown that the CRM is not sensitive to the changes in each province's pollutant carrying capacity and the minimum pollutant removal capacity, but sensitive to the maximum pollutant reduction capacity. Moreover, higher cooperation benefits will be generated when a province's maximum pollutant reduction capacity increases. Copyright © 2016 Elsevier B.V. All rights reserved.

The Effect of an Increased Minimum Wage on Infant Mortality and Birth Weight

PubMed Central

Livingston, Melvin D.; Markowitz, Sara; Wagenaar, Alexander C.

2016-01-01

Objectives. To investigate the effects of state minimum wage laws on low birth weight and infant mortality in the United States. Methods. We estimated the effects of state-level minimum wage laws using a difference-in-differences approach on rates of low birth weight (< 2500 g) and postneonatal mortality (28–364 days) by state and month from 1980 through 2011. All models included state and year fixed effects as well as state-specific covariates. Results. Across all models, a dollar increase in the minimum wage above the federal level was associated with a 1% to 2% decrease in low birth weight births and a 4% decrease in postneonatal mortality. Conclusions. If all states in 2014 had increased their minimum wages by 1 dollar, there would likely have been 2790 fewer low birth weight births and 518 fewer postneonatal deaths for the year. PMID:27310355

The Effect of an Increased Minimum Wage on Infant Mortality and Birth Weight.

PubMed

Komro, Kelli A; Livingston, Melvin D; Markowitz, Sara; Wagenaar, Alexander C

2016-08-01

To investigate the effects of state minimum wage laws on low birth weight and infant mortality in the United States. We estimated the effects of state-level minimum wage laws using a difference-in-differences approach on rates of low birth weight (< 2500 g) and postneonatal mortality (28-364 days) by state and month from 1980 through 2011. All models included state and year fixed effects as well as state-specific covariates. Across all models, a dollar increase in the minimum wage above the federal level was associated with a 1% to 2% decrease in low birth weight births and a 4% decrease in postneonatal mortality. If all states in 2014 had increased their minimum wages by 1 dollar, there would likely have been 2790 fewer low birth weight births and 518 fewer postneonatal deaths for the year.

A Cross-Cultural Longitudinal Examination of the Effect of Cumulative Adversity on the Mental and Physical Health of Older Adults

PubMed Central

Palgi, Yuval; Shrira, Amit

2015-01-01

Self-oriented adversity refers to traumatic events that primarily inflict the self, whereas other-oriented adversity refers to events that affect the self by primarily targeting others. The present study aimed to examine whether cultural background moderates the effects of self-oriented and other-oriented adversity on mental and physical health of older adults. Using longitudinal data from the Israeli component of the Survey of Health and Retirement, we focused on 370 Jews and 239 Arabs who reported their exposure to various adversities across the lifespan, and completed questionnaires regarding mental and physical health. Results showed that the effect of self-oriented adversity on health did not differ among Jews and Arabs. However, other-oriented adversity showed a stronger effect on Arabs’ mental and physical health than on Jews’ health. Our findings suggest that the accumulation of adverse events that affect the self by primarily targeting others may have a stronger impact in collectivist cultures than in individualist cultures. PMID:25961862

Daily nursing care on patients undergoing venous-venous extracorporeal membrane oxygenation: a challenging procedure!

PubMed

Redaelli, Sara; Zanella, Alberto; Milan, Manuela; Isgrò, Stefano; Lucchini, Alberto; Pesenti, Antonio; Patroniti, Nicolò

2016-12-01

Daily nursing in critical care patients may alter vital parameters, especially in the most critically ill patients. The aim of our study was to evaluate feasibility and safety of daily nursing on patients undergoing venous-venous extracorporeal membrane oxygenation (vv-ECMO) for severe respiratory failure. Daily nursing was performed following defined phases (sponge bath, elevation with scooping stretcher, change position of endotracheal tube, dressing replacement). We recorded physiological and ECMO parameters before and during daily nursing in 5 patients for several days (total: 25 daily nursing) and adverse events: desaturation, hypertension, reduction of mixed venous oxygen saturation, arterial oxygen saturation or ECMO blood flow and elevation in minute ventilation. Sedative drug dosage and additional bolus were recorded. Daily nursing was performed in 92 % of cases (23/25), with a minimum of two adverse events per daily nursing. Hypertension and tachycardia were mostly recorded at the beginning, while desaturation, reduction in mixed venous oxygen saturation and blood flow were recorded during elevation with scooping stretcher. Increase in minute ventilation was frequent in spontaneous breathing patients. Additional bolus of sedation was required before and/or during nursing. Daily nursing significantly alters physiologic parameters; thus, it should be performed only when physicians are readily available to treat adverse events.

Emphasis on the early diagnosis of antithyroid drug-induced agranulocytosis: retrospective analysis over 16 years at one Chinese center.

PubMed

He, Y; Li, J; Zheng, J; Khan, Z; Qiang, W; Gao, F; Zhao, Y; Shi, B

2017-07-01

Antithyroid drug (ATD)-induced agranulocytosis is a rare but life-threatening adverse drug reaction that occurs in patients during the treatment of Graves' disease. We aimed to comprehensively examine data for patients with this rare complication and to improve the clinical safety of ATDs. We retrospectively reviewed the medical records of 64 hospitalized patients diagnosed with ATD-induced agranulocytosis between 2000 and 2015. Agranulocytosis occurred in 52 (81.3%) patients within the first 3 months after initiation of ATD therapy. Fever (84.4%) and sore throat (82.8%) were the most common symptoms. Although they experienced symptoms, 30 (46.9%) patients did not seek treatment immediately and delayed their diagnosis of agranulocytosis. The minimum granulocyte count was lower in the patients diagnosed after the appearance of symptoms than in those diagnosed before the appearance of symptoms (0.01 × 10 9 /L (0 × 10 9 /L - 0.06 × 10 9 /L) versus 0.26 × 10 9 /L (0.05 × 10 9 /L - 0.40 × 10 9 /L), P < 0.001). The interval days from the appearance of symptoms to the diagnosis of agranulocytosis were negatively correlated with the minimum granulocyte count (r = -0.348, P = 0.005). In addition, a lower minimum granulocyte count was associated with a longer recovery time (β = -11.899, 95% CI -15.304 to -8.496). Our findings have demonstrated that delayed diagnosis of ATD-induced agranulocytosis is common in our population. Delayed diagnosis is associated with severe agranulocytosis and may prolong the recovery time from agranulocytosis. Monitoring of the white blood cell and granulocyte counts may be an effective way to establish an early diagnosis and prevent progression to severe agranulocytosis.

Efficacy and Safety of Leucine Supplementation in the Elderly.

PubMed

Borack, Michael S; Volpi, Elena

2016-12-01

Leucine supplementation has grown in popularity due to the discovery of its anabolic effects on cell signaling and protein synthesis in muscle. The current recommendation is a minimum intake of 55 mg ⋅ kg -1 . d -1 Leucine acutely stimulates skeletal muscle anabolism and can overcome the anabolic resistance of aging. The value of chronic leucine ingestion for muscle growth is still unclear. Most of the research into leucine consumption has focused on efficacy. To our knowledge, very few studies have sought to determine the maximum safe level of intake. Limited evidence suggests that intakes of ≤1250 mg ⋅ kg -1 . d -1 do not appear to have any health consequences other than short-term elevated plasma ammonia concentrations. Similarly, no adverse events have been reported for the leucine metabolite β-hydroxy-β-methylbutyrate (HMB), although no studies have tested HMB toxicity in humans. Therefore, future research is needed to evaluate leucine and HMB toxicity in the elderly and in specific health conditions. © 2016 American Society for Nutrition.

Toxicity of copper on the growth of marine microalgae Pavlova sp. and its chlorophyll-a

NASA Astrophysics Data System (ADS)

Purbonegoro, T.; Suratno; Puspitasari, R.; Husna, N. A.

2018-02-01

Marine microalgae is the primary producer at the base of the marine food chain. Their sensitivity to metal contamination provides important information for predicting the environmental impact of pollution. Toxicity testing using marine microalgae Pavlova sp. was carried out to assess the toxicity of copper on the growth and chlorophyll-a content. Results of this study show that adverse effects were observed by the increase of copper concentration. Cell number began to decrease at the lowest concentration (13 μg/L) and reduced drastically at 98 μg/L. Minimum cell number was observed at the highest concentration (890 μg/L). The inhibition concentration (IC50) value of copper for Pavlova sp. was 51.46 μg/L and at concentrations >29 μgL-1 the chlorophyll-a content decreased dramatically compared to the control. A variation in cell size and morphology was also observed at the higher concentration by the increase in the cell size and loss of setae compared to normal cells.

Automated parameter tuning applied to sea ice in a global climate model

NASA Astrophysics Data System (ADS)

Roach, Lettie A.; Tett, Simon F. B.; Mineter, Michael J.; Yamazaki, Kuniko; Rae, Cameron D.

2018-01-01

This study investigates the hypothesis that a significant portion of spread in climate model projections of sea ice is due to poorly-constrained model parameters. New automated methods for optimization are applied to historical sea ice in a global coupled climate model (HadCM3) in order to calculate the combination of parameters required to reduce the difference between simulation and observations to within the range of model noise. The optimized parameters result in a simulated sea-ice time series which is more consistent with Arctic observations throughout the satellite record (1980-present), particularly in the September minimum, than the standard configuration of HadCM3. Divergence from observed Antarctic trends and mean regional sea ice distribution reflects broader structural uncertainty in the climate model. We also find that the optimized parameters do not cause adverse effects on the model climatology. This simple approach provides evidence for the contribution of parameter uncertainty to spread in sea ice extent trends and could be customized to investigate uncertainties in other climate variables.

Active vibration control of a single-stage spur gearbox

NASA Astrophysics Data System (ADS)

Dogruer, C. U.; Pirsoltan, Abbas K.

2017-02-01

The dynamic transmission error between driving and driven gears of a gear mechanism with torsional mode is induced by periodic time-varying mesh stiffness. In this study, to minimize the adverse effect of this time-varying mesh stiffness, a nonlinear controller which adjusts the torque acting on the driving gear is proposed. The basic approach is to modulate the input torque such that it compensates the periodic change in mesh stiffness. It is assumed that gears are assembled with high precision and gearbox is analyzed by a finite element software to calculate the mesh stiffness curve. Thus, change in the mesh stiffness, which is inherently nonlinear, can be predicted and canceled by a feed-forward loop. Then, remaining linear dynamics is controlled by pole placement techniques. Under these premises, it is claimed that any acceleration and velocity profile of the input shaft can be tracked accurately. Thereby, dynamic transmission error is kept to a minimum possible value and a spur gearbox, which does not emit much noise and vibration, is designed.

Adverse effects of methotrexate in three psoriatic arthritis patients.

PubMed

Maejima, Hideki; Watarai, Akira; Nakano, Toshiaki; Katayama, Chieko; Nishiyama, Hiromi; Katsuoka, Kensei

2014-04-01

Methotrexate, a folic acid analogue with anti-proliferative and anti-inflammatory effects, is commonly used to treat patients with severe destructive psoriatic arthritis and has considerable efficacy. Combined anti-tumor necrosis factor and MTX therapy result in less treatment discontinuation due to adverse events. Despite its efficacy, MTX may result in adverse effects including hepatic, pulmonary, and renal toxicity as well as lymphoproliferative disorders and predisposition to infection. We herein report rare adverse effects of MTX treatment, specifically asymptomatic pulmonary tuberculosis, renal cell carcinoma, and lateral uveitis, in three psoriatic arthritis patients treated with MTX. MTX is an important drug for the treatment for psoriatic arthritis patient, but an awareness of the possible adverse effects is needed.

Assessment of patients' preferences regarding the characteristics associated with the treatment of chronic obstructive pulmonary disease.

PubMed

Bulcun, Emel; Ekici, Mehmet; Ekici, Aydanur

2014-01-01

Patient preferences regarding characteristics associated with the treatment of chronic obstructive pulmonary disease (COPD) must be determined to increase the compatibility between the patients and the treatments, but as yet no studies have been performed regarding these characteristics. Here, we evaluate the preferred characteristics associated with the treatment of patients with COPD. The expectations of patients receiving copd therapy were assessed in six categories: time allocated by the physician to listen to patients' complaints, treatment to be applied, estimated adverse effect frequency concerning the therapy, ability of patients to visit the same physician each time, integral approach of the physician to the treatment of the patient, and therapy cost. These groups were divided into categories of therapy indicating 25 alternative treatment methods, using conjoint analysis. Patients were sorted to the 25 types of treatment with regard to their preferences. The major expectation of conjoint analysis associated with the treatment of COPD patients is for the therapy to allow the patients to completely recover from their complaints. The order preferred by patients of other treatment expectations is from sufficient time to be allowed by the physician to listen to the patient, to no cost for the treatment, to minimum adverse effects resulting from the treatment, to each follow-up to be performed by the same physician, and to the physician performing an assessment of the patient's well-being, rather than examining only the areas of complaint. The major expectation of COPD patients regarding treatment was to completely recover with the help of the therapy. Considering the expectations of the patient may help improve the compatibility of the patient with the treatment.

Safety and tolerability of varenicline tartrate (Champix(®)/Chantix(®)) for smoking cessation in HIV-infected subjects: a pilot open-label study.

PubMed

Cui, Qu; Robinson, Linda; Elston, Dawn; Smaill, Fiona; Cohen, Jeffrey; Quan, Corinna; McFarland, Nancy; Thabane, Lehana; McIvor, Andrew; Zeidler, Johannes; Smieja, Marek

2012-01-01

The prevalence of smoking in HIV-infected subjects is high. As a smoking cessation aid, varenicline (Champix(®), Pfizer, Saint-Laurent, QC, Canada or Chantix(®), Pfizer, Mission, KS) has not been previously evaluated in HIV-infected smokers. In this multicenter pilot open label study, varenicline 1.0 mg was used twice daily for 12 weeks with dose titration in the first week. Adverse events (AEs) during the treatment period were recorded. Changes from baseline in laboratory tests, vital signs, daily cigarette consumption, nicotine dependence, and withdrawal were measured through week 24. Self-reported abstinence was validated by serum cotinine at week 12. We enrolled 36 subjects with a mean of 29 pack-years of smoking and a minimum of 4 cigarettes per day. All but 1 were male, 33 (92%) were white. The most frequently reported AEs were nausea (33%), abnormal dreams (31%), affect lability (19%), and insomnia (19%). Six (17%) subjects discontinued varenicline due to AEs. No grade 3/4 laboratory abnormalities or serious AEs occurred during the study. There was no significant change in HIV viral load. CD4 counts increased by 69 cells/mm3 (p = 0.001) at week 24. Serum cotinine-verified 4-week continuous abstinence rate through weeks 9-12 was 42% (95% confidence interval [CI]: 26-58%). AEs and abstinence rates were comparable to those in published randomized controlled trials conducted in generally healthy HIV-negative smokers. Varenicline was safe and appears effective among HIV-infected smokers in this exploratory study, although AEs were common. The most common AE was nausea, with no adverse effect on HIV treatment outcome. Close monitoring of liver enzymes and blood pressure is recommended for HIV-positive smokers taking varenicline.

Transcranial magnetic stimulation of the brain: guidelines for pain treatment research

PubMed Central

Klein, Max M.; Treister, Roi; Raij, Tommi; Pascual-Leone, Alvaro; Park, Lawrence; Nurmikko, Turo; Lenz, Fred; Lefaucheur, Jean-Pascal; Lang, Magdalena; Hallett, Mark; Fox, Michael; Cudkowicz, Merit; Costello, Ann; Carr, Daniel B.; Ayache, Samar S.; Oaklander, Anne Louise

2015-01-01

Abstract Recognizing that electrically stimulating the motor cortex could relieve chronic pain sparked development of noninvasive technologies. In transcranial magnetic stimulation (TMS), electromagnetic coils held against the scalp influence underlying cortical firing. Multiday repetitive transcranial magnetic stimulation (rTMS) can induce long-lasting, potentially therapeutic brain plasticity. Nearby ferromagnetic or electronic implants are contraindications. Adverse effects are minimal, primarily headaches. Single provoked seizures are very rare. Transcranial magnetic stimulation devices are marketed for depression and migraine in the United States and for various indications elsewhere. Although multiple studies report that high-frequency rTMS of the motor cortex reduces neuropathic pain, their quality has been insufficient to support Food and Drug Administration application. Harvard's Radcliffe Institute therefore sponsored a workshop to solicit advice from experts in TMS, pain research, and clinical trials. They recommended that researchers standardize and document all TMS parameters and improve strategies for sham and double blinding. Subjects should have common well-characterized pain conditions amenable to motor cortex rTMS and studies should be adequately powered. They recommended standardized assessment tools (eg, NIH's PROMIS) plus validated condition-specific instruments and consensus-recommended metrics (eg, IMMPACT). Outcomes should include pain intensity and qualities, patient and clinician impression of change, and proportions achieving 30% and 50% pain relief. Secondary outcomes could include function, mood, sleep, and/or quality of life. Minimum required elements include sample sources, sizes, and demographics, recruitment methods, inclusion and exclusion criteria, baseline and posttreatment means and SD, adverse effects, safety concerns, discontinuations, and medication-usage records. Outcomes should be monitored for at least 3 months after initiation with prespecified statistical analyses. Multigroup collaborations or registry studies may be needed for pivotal trials. PMID:25919472

An improved method for determining the distribution of swift fox in Kansas

USGS Publications Warehouse

Roy, Christiane C.; Sovada, Marsha A.; Sargeant, Glen A.; Roy, Christiane C.

1999-01-01

During 1997 and 1998 we tested a new method for determining the distribution of swift foxes (Vulpes velox) in Kansas. From a sampling frame of 30 counties in western Kansas, we selected a systematic sample of alternate townships in a checkerboard pattern. During September and October 1997 and August 1998, experienced observers delineated suitable swift fox habitat within each sample township and searched it for evidence of occupancy (tracks, dens, and the animals themselves) by swift fox and other furbearers. Each township was searched for a minimum of 30 minutes, with searches continuing until swift foxes were either detected or for 120 minutes. Of the 288 townships selected in 1997, 271 (94.1%) were searched effectively with swift fox detected in 40.5% of the townships. Adverse weather conditions prevented surveys in two northwestern counties of our sample frame. In 1998, 245 township were searched effectively. Swift fox were detected in 27 counties searched to date. We did not detect swift fox in Seward, Meade and Ford counties, where the species is thought to be uncommon or absent. Tracks were difficult to discern in areas with hard or sandy soils and were sometimes obliterated by adverse weather, vehicle traffic, and agricultural activities. To determine how frequently we failed to detect swift foxes that were present, we plan to repeat searches in 1999 in townships where swift foxes were not detected previously. Nevertheless, preliminary results suggest our method to be a practical means for conducting landscape-scale presence/absence surveys of swift fox. Restricting searches to habitat judged best for swift foxes and most favorable for track detection helped control costs and achieve high detection rates.

Safety and Tolerability of Varenicline Tartrate (Champix®/Chantix®) for Smoking Cessation in HIV-Infected Subjects: A Pilot Open-Label Study

PubMed Central

Robinson, Linda; Elston, Dawn; Smaill, Fiona; Cohen, Jeffrey; Quan, Corinna; McFarland, Nancy; Thabane, Lehana; McIvor, Andrew; Zeidler, Johannes; Smieja, Marek

2012-01-01

Abstract The prevalence of smoking in HIV-infected subjects is high. As a smoking cessation aid, varenicline (Champix®, Pfizer, Saint-Laurent, QC, Canada or Chantix®, Pfizer, Mission, KS) has not been previously evaluated in HIV-infected smokers. In this multicenter pilot open label study, varenicline 1.0 mg was used twice daily for 12 weeks with dose titration in the first week. Adverse events (AEs) during the treatment period were recorded. Changes from baseline in laboratory tests, vital signs, daily cigarette consumption, nicotine dependence, and withdrawal were measured through week 24. Self-reported abstinence was validated by serum cotinine at week 12. We enrolled 36 subjects with a mean of 29 pack-years of smoking and a minimum of 4 cigarettes per day. All but 1 were male, 33 (92%) were white. The most frequently reported AEs were nausea (33%), abnormal dreams (31%), affect lability (19%), and insomnia (19%). Six (17%) subjects discontinued varenicline due to AEs. No grade 3/4 laboratory abnormalities or serious AEs occurred during the study. There was no significant change in HIV viral load. CD4 counts increased by 69 cells/mm3 (p=0.001) at week 24. Serum cotinine-verified 4-week continuous abstinence rate through weeks 9–12 was 42% (95% confidence interval [CI]: 26–58%). AEs and abstinence rates were comparable to those in published randomized controlled trials conducted in generally healthy HIV-negative smokers. Varenicline was safe and appears effective among HIV-infected smokers in this exploratory study, although AEs were common. The most common AE was nausea, with no adverse effect on HIV treatment outcome. Close monitoring of liver enzymes and blood pressure is recommended for HIV-positive smokers taking varenicline. PMID:22007690

Predictors of local adverse effects caused by topical tretinoin cream 0·1% in the Veterans Affairs Topical Tretinoin Chemoprevention trial.

PubMed

Pomerantz, H; Weinstock, M A

2014-09-01

Topical tretinoin is commonly prescribed, but its frequent adverse effects are barriers to use. Predictors of resistance or susceptibility to retinoid irritation are not known. To identify baseline patient characteristics associated with adverse effects of topical tretinoin. This cohort study used data collected from 324 participants in the Veterans Affairs Topical Tretinoin Chemoprevention trial who were randomized to apply tretinoin cream on the face and ears. Univariate and multivariate logistic regression models were used to examine the associations between baseline characteristics and local adverse effects. One hundred and ninety-seven patients (61% of those randomized to tretinoin) reported local adverse effects within 6 months. Clinical signs of severe photodamage at baseline [odds ratio (OR) 0·15, 95% confidence interval (CI) 0·04-0·54] and history of acne (OR 0·46, 95% CI 0·27-0·77) were associated with a decreased risk of adverse effects to tretinoin. The use of other topical medications at enrolment (OR 1·88, 95% CI 1·15-3·08) predicted an increase in adverse effects. In this study population, the common indications of topical tretinoin treatment were associated with lower risks of adverse effects. The concurrent use of other topical medications may worsen irritation caused by tretinoin. © 2014 British Association of Dermatologists.

Long-term mucocutaneous adverse effects of imatinib in Indian chronic myeloid leukemia patients.

PubMed

Vinay, Keshavamurthy; Yanamandra, Uday; Dogra, Sunil; Handa, Sanjeev; Suri, Vikas; Kumari, Savita; Khadwal, Alka; Prakash, Gaurav; Lad, Deepesh; Varma, Subhash; Malhotra, Pankaj

2018-03-01

Short-term mucocutaneous adverse effects are well documented with imatinib. However, studies on long-term adverse effects and in the ethnic population are lacking. To study the long-term mucocutaneous adverse effects of imatinib and factors predicting these adverse effects. In this cross-sectional study, consenting adult chronic myeloid leukemia patients on imatinib for more than 250 days were recruited. The details of imatinib treatment were retrieved from hematology clinic records. Four hundred and thirty-eight patients who were on imatinib for a mean duration of 1820 days were recruited. A mean number of 1.42 ± 0.98 cutaneous adverse effects were seen per patient. Melasma-like pigmentation, periorbital edema, oral lichenoid reaction, cutaneous hypopigmentation, and vesicobullous eruptions were seen in 236 (53.9%), 81 (18.5%), 70 (16%), 42 (9.6%), and 12 (2.7%) patients, respectively. Drug-induced cutaneous eruptions (9.1%) and cutaneous hypopigmentation (9.6%) were seen less frequently. Cutaneous hyperpigmentation was more likely seen in younger patients (P = 0.001) and females (P < 0.001). On multivariate analysis, female gender was a significant risk factor for developing cutaneous hyperpigmentation and periorbital edema. Cutaneous hyperpigmentation and periorbital edema are common long-term adverse effects of imatinib in Indian patients. Female gender is a significant risk factor for the development of both these adverse effects. © 2017 The International Society of Dermatology.

Prevalence and detection of neuropsychiatric adverse effects during hepatitis C treatment.

PubMed

Masip, Montserrat; Tuneu, Laura; Pagès, Neus; Torras, Xavier; Gallego, Adolfo; Guardiola, Josep Maria; Faus, María José; Mangues, Maria Antònia

2015-12-01

Current treatment combinations for chronic hepatitis C virus infection still include pegylated interferon and ribavirin despite the new therapeutic options available. Interferon-based treatments are associated with a high incidence of adverse effects. Central nervous system events are among the most frequent adverse drug reactions and their influence on treatment adherence and effectiveness is controversial. The aim of the study was to evaluate neuropsychiatric adverse effects of interferon-based treatment for chronic hepatitis C in standard multidisciplinary clinical practice. Risk factors for these adverse effects and their impact on adherence and sustained viral response were also evaluated. Setting Ambulatory care pharmacy in coordination with the liver unit and the infectious diseases unit at a 650-bed tertiary university hospital. We included all consecutive patients with chronic hepatitis C who completed treatment with pegylated interferon and ribavirin between 2005 and 2013. All patients underwent a multidisciplinary follow-up during treatment. Neuropsychiatric adverse effects were evaluated in relation to severity, management and outcome. The presence of anxiety and depression was evaluated by means of specific tests. A total of 717 treatments in 679 patients were included. During treatment, we detected 1679 neuropsychiatric adverse effects in 618 patients (86.2 %), generating 1737 clinical interventions. Fifty-seven (3.3 %) neuropsychiatric adverse effects were severe and 2 (0.1 %) were life-threatening (suicidal attempts). Most neuropsychiatric adverse effects (1555 events, 92.6 %) resolved without sequelae. Psychiatric medication was required in 289 patients (40.3 %). Sustained viral response was achieved in 400 cases (55.8 %) and was associated with adherence (OR = 1.942, 95 % CI = 1.235-3.052, p = 0.004). A multivariate analysis did not show any relationship between neuropsychiatric adverse effects and treatment adherence or sustained viral response. A psychiatric history was a strong risk factor for depression, anxiety and other psychiatric disorders during treatment. Neuropsychiatric adverse effects during interferon-based treatments in patients with chronic hepatitis C were common but mostly mild or moderate. Early detection and accurate multidisciplinary management avoided treatment discontinuation, ensuring adherence and attaining sustained viral response. The identified risk factors could be used to determine patients eligible for interferon-free combinations, thus optimizing health system economics.

Endocrine and Metabolic Adverse Effects of Psychotropic Medications in Children and Adolescents

ERIC Educational Resources Information Center

Correll, Christoph U.; Carlson, Harold E.

2006-01-01

Objective: Despite increasing use of psychotropic medications in children and adolescents, data regarding their efficacy and safety are limited. Endocrine and metabolic adverse effects are among the most concerning adverse effects of commonly used psychotropic medications. Method: Selective review of endocrine and metabolic effects of psychotropic…

Adverse Childhood Experiences, Commitment Offense, and Race/Ethnicity: Are the Effects Crime-, Race-, and Ethnicity-Specific?

PubMed Central

DeLisi, Matt; Alcala, Justin; Kusow, Abdi; Hochstetler, Andy; Heirigs, Mark H.; Caudill, Jonathan W.; Trulson, Chad R.; Baglivio, Michael T.

2017-01-01

Adverse childhood experiences are associated with an array of health, psychiatric, and behavioral problems including antisocial behavior. Criminologists have recently utilized adverse childhood experiences as an organizing research framework and shown that adverse childhood experiences are associated with delinquency, violence, and more chronic/severe criminal careers. However, much less is known about adverse childhood experiences vis-à-vis specific forms of crime and whether the effects vary across race and ethnicity. Using a sample of 2520 male confined juvenile delinquents, the current study used epidemiological tables of odds (both unadjusted and adjusted for onset, total adjudications, and total out of home placements) to evaluate the significance of the number of adverse childhood experiences on commitment for homicide, sexual assault, and serious persons/property offending. The effects of adverse childhood experiences vary considerably across racial and ethnic groups and across offense types. Adverse childhood experiences are strongly and positively associated with sexual offending, but negatively associated with homicide and serious person/property offending. Differential effects of adverse childhood experiences were also seen among African Americans, Hispanics, and whites. Suggestions for future research to clarify the mechanisms by which adverse childhood experiences manifest in specific forms of criminal behavior are offered. PMID:28327508

Minimum Wages and School Enrollment of Teenagers: A Look at the 1990's.

ERIC Educational Resources Information Center

Chaplin, Duncan D.; Turner, Mark D.; Pape, Andreas, D.

2003-01-01

Estimates the effects of higher minimum wages on school enrollment using the Common Core of Data. Controlling for local labor market conditions and state and year fixed effects, finds some evidence that higher minimum wages reduce teen school enrollment in states where students drop out before age 18. (23 references) (Author/PKP)

Energy drink usage among university students in a Caribbean country: Patterns of use and adverse effects.

PubMed

Reid, Sandra D; Ramsarran, Jonathan; Brathwaite, Rachel; Lyman, Sarika; Baker, Ariane; Cornish, D'Andra C; Ganga, Stefan; Mohammed, Zahrid; Sookdeo, Avinash T; Thapelo, Cathrine K

2015-06-01

There has been little inquiry addressing whether or not concerns about adverse effects of energy drink usage are relevant in the Caribbean. This survey investigated energy drink usage and adverse consequences among tertiary level students in Trinidad and Tobago. A cross-sectional survey of 1994 students from eight institutions was conducted using a de novo questionnaire based on findings from a focus group of students. Chi-squared analyses and logistic regression were used to assess relationships between energy drink usage, adverse effects and other factors affecting energy drink use, and to verify predictors of energy drink use. Prevalence of use was 86%; 38% were current users. Males were more likely to use, used more frequently and at an earlier age. Energy drinks were used most commonly to increase energy (50%), combat sleepiness (45%) and enhance academic performance (40%), and occurred during sports (23%) and mixed with alcohol (22.2%). The majority (79.6%) consumed one energy drink per sitting; 62.2% experienced adverse effects, most commonly restlessness (22%), jolt and crash (17.1%) and tachycardia (16.6%). Awareness of adverse effects was associated with no use (p=0.004), but adverse effects were not a deterrent to continued use. Energy drink usage is prevalent among students. The use is not excessive, but associated with high rates of adverse effects and occurs in potentially dangerous situations like during exercise and with alcohol. There is a need to educate students about the potential adverse effects of energy drinks. Copyright © 2014 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd. All rights reserved.

Adverse effects of homeopathy, what do we know? A systematic review and meta-analysis of randomized controlled trials.

PubMed

Stub, Trine; Musial, Frauke; Kristoffersen, Agnete A; Alræk, Terje; Liu, Jianping

2016-06-01

Homeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients' symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed. Sixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis. A total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86-1.14, I(2)=54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high. Adverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine. Copyright © 2016 Elsevier Ltd. All rights reserved.

Routing Algorithm based on Minimum Spanning Tree and Minimum Cost Flow for Hybrid Wireless-optical Broadband Access Network

NASA Astrophysics Data System (ADS)

Le, Zichun; Suo, Kaihua; Fu, Minglei; Jiang, Ling; Dong, Wen

2012-03-01

In order to minimize the average end to end delay for data transporting in hybrid wireless optical broadband access network, a novel routing algorithm named MSTMCF (minimum spanning tree and minimum cost flow) is devised. The routing problem is described as a minimum spanning tree and minimum cost flow model and corresponding algorithm procedures are given. To verify the effectiveness of MSTMCF algorithm, extensively simulations based on OWNS have been done under different types of traffic source.

21 CFR 812.46 - Monitoring investigations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) Unanticipated adverse device effects. (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. (2) A sponsor who determines that an unanticipated adverse device effect presents...

Evidence for a neural dual-process account for adverse effects of cognitive control.

PubMed

Zink, Nicolas; Stock, Ann-Kathrin; Colzato, Lorenza; Beste, Christian

2018-06-09

Advantageous effects of cognitive control are well-known, but cognitive control may also have adverse effects, for example when it suppresses the implicit processing of stimulus-response (S-R) bindings that could benefit task performance. Yet, the neurophysiological and functional neuroanatomical structures associated with adverse effects of cognitive control are poorly understood. We used an extreme group approach to compare individuals who exhibit adverse effects of cognitive control to individuals who do not by combining event-related potentials (ERPs), source localization, time-frequency analysis and network analysis methods. While neurophysiological correlates of cognitive control (i.e. N2, N450, theta power and theta-mediated neuronal network efficiency) and task-set updating (P3) both reflect control demands and implicit information processing, differences in the degree of adverse cognitive control effects are associated with two independent neural mechanisms: Individuals, who show adverse behavioral effects of cognitive control, show reduced small-world properties and thus reduced efficiency in theta-modulated networks when they fail to effectively process implicit information. In contrast to this, individuals who do not display adverse control effects show enhanced task-set updating mechanism when effectively processing implicit information, which is reflected by the P3 ERP component and associated with the temporo-parietal junction (TPJ, BA 40) and medial frontal gyrus (MFG; BA 8). These findings suggest that implicit S-R contingencies, which benefit response selection without cognitive control, are always 'picked up', but may fail to be integrated with task representations to guide response selection. This provides evidence for a neurophysiological and functional neuroanatomical "dual-process" account of adverse cognitive control effects.

A cross-cultural longitudinal examination of the effect of cumulative adversity on the mental and physical health of older adults.

PubMed

Palgi, Yuval; Shrira, Amit

2016-03-01

Self-oriented adversity refers to traumatic events that primarily inflict the self, whereas other-oriented adversity refers to events that affect the self by primarily targeting others. The present study aimed to examine whether cultural background moderates the effects of self-oriented and other-oriented adversity on mental and physical health of older adults. Using longitudinal data from the Israeli component of the Survey of Health and Retirement, we focused on 370 Jews and 239 Arabs who reported their exposure to various adversities across the life span, and completed questionnaires regarding mental and physical health. Results showed that the effect of self-oriented adversity on health did not differ among Jews and Arabs. However, other-oriented adversity showed a stronger effect on Arabs' mental and physical health than on Jews' health. Our findings suggest that the accumulation of adverse events that affect the self by primarily targeting others may have a stronger impact in collectivist cultures than in individualist cultures. (c) 2016 APA, all rights reserved).

[Changes of menstruation patterns and adverse effects during the treatment of LNG-IUS for symptomatic adenomyosis].

PubMed

Li, L; Leng, J H; Zhang, J J; Jia, S Z; Li, X Y; Shi, J H; Dai, Y; Zhang, J R; Li, T; Xu, X X; Liu, Z Z; You, S S; Chang, X Y; Lang, J H

2016-09-25

Objective: To investigate the changes of mestruation patterns and adverse effects during the treatment of levonorgestrel-releasing intrauterine system(LNG-IUS)for symptomatic adenomyosis in a prospective cohort study. Methods: From December, 2006 to December, 2014, patients of symptomatic adenomyosis diagnosed by transvaginal ultrasound in Peking Union Medical College Hospital were given LNG-IUS. Before and after placement of IUS, all patients' parameters were recorded, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects. Risk factors for changes of menstruation patterns and adverse effects, and their impact on treatment effects were analyzed. Results: Totally 1 100 cases met inclusion criteria, with median age 36 years(range 20-44 years), median follow-up 35 months(range 1 -108 months). During follow-up changes of menstruation patterns increased significantly with amenorrhea and shortened-menstruation being the most common manifestations. On 3, 6, 12, 24, 36, 48 and 60 months after the placement of LNG-IUS, 0, 5.8%(43/744), 6.9%(47/682), 10.1%(60/595), 17.3%(87/502), 27.2%(104/383)and 29.6%(82/277)patients achieved amenorrhea respectively( P <0.01). Total and subclassification of adverse effects decreased significantly( P <0.01). Within 12 months and >12 months after placement, abdominal pain and body weight increasing ≥5 kg/year were the most common adverse effects. Changes of menstruation patterns, total and subclassifications of adverse effects were neither dependent on patient parameters, treatment modes and treatment effects, nor could predict future LNG-IUS carrying status(all P > 0.05). After taking out of LNG-IUS, most changes of menstruation and adverse effects disappeared. Conclusions: During the treatment of LNG-IUS for symptomatic adenomyosis, changes of menstruation patterns increase gradually with amenorrhea and shortened-menstruation being the most common manifestations, while adverse effects decrease significantly. Changes of menstruation patterns or adverse effects neither have any risk factor nor have impact on treatment effects.

Safety of American Heart Association-recommended minimum exercise for desmosomal mutation carriers.

PubMed

Sawant, Abhishek C; Te Riele, Anneline S J M; Tichnell, Crystal; Murray, Brittney; Bhonsale, Aditya; Tandri, Harikrishna; Judge, Daniel P; Calkins, Hugh; James, Cynthia A

2016-01-01

Endurance exercise is associated with adverse outcomes in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C). Exercise recommendations for family members remain undetermined. The purposes of this study were to determine if (1) endurance exercise (Bethesda class C) and exercise intensity (metabolic equivalent hours per year [MET-Hr/year]) increase the likelihood of fulfilling 2010 Task Force Criteria and ventricular arrhythmias/implantable cardioverter-defibrillator shock (ventricular tachycardia/ventricular fibrillation [VT/VF]), and (2) exercise restriction to the American Heart Association (AHA)-recommended minimum for healthy adults is associated with favorable outcomes of at-risk family members. Twenty-eight family members of 10 probands inheriting a PKP2 mutation were interviewed about exercise from age 10. Exercise threshold to maintain overall health was based on the 2007 AHA guidelines of a minimum 390 to 650 MET-Hr/year. After adjustment for age, sex, and family membership, both participation in endurance athletics (odds ratio [OR] 7.4, P = .03) and higher-intensity exercise (OR = 4.2, P = .004) were associated with diagnosis (n = 13). Endurance athletes were also significantly more likely to develop VT/VF (n = 6, P = .02). Family members who restricted exercise at or below the upper bound of the AHA goal (≤650 MET-Hr/year) were significantly less likely to be diagnosed (OR = 0.07, P = .002) and had no VT/VF. At diagnosis and first VT/VF, family members had accumulated 2.8-fold (P = .002) and 3.5-fold (P = .03), respectively, greater MET-Hr exercise than the AHA-recommended minimum. Those who developed VT/VF had performed particularly high-intensity exercise in adolescence compared to unaffected family members (age 10-14: P = .04; age 14-19: P = .02). The results of this study suggest restricting unaffected desmosomal mutation carriers from endurance and high-intensity athletics but potentially not from AHA-recommended minimum levels of exercise for healthy adults. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Influence of oxcarbazepine on the antinociceptive action of morphine and metamizole in mice.

PubMed

Pakulska, Wanda; Czarnecka, Elzbieta

2009-01-01

Numerous methods of management applied in order to obtain higher therapeutic efficacy of drugs with minimum adverse effects include taking advantage of interactions taking place between individual agents. Analgesics are combined with drugs belonging to other therapeutic groups, including, more and more frequently, antiepileptic agents. The influence of oxcarbazepine (10 mg/kg) on the antinociceptive effect of morphine (10 mg/kg) and metamizole (500 mg/kg) was investigated in mice using the hot-plate and tail-flick tests. All drugs were injected intraperitoneally (i.p.). Oxcarbazepine was administered 30 min prior to the injection of analgesic drugs. The reactions to noxious stimuli were measured 30, 60 and 90 min after the administration of an analgesic. The study was further conducted for 10 days with repeated drug doses. Single administration of oxcarbazepine enhanced the antinociceptive effect of a single dose of morphine, and 10-day administration led to a decrease of morphine tolerance in the hot-plate test. Oxcarbazepine administered in a single dose did not affect significantly the antinociceptive effect of metamizole in either of the tests. Multiple administration of oxcarbazepine enhanced the antinociceptive effect of metamizole in the hot-plate test. Oxcarbazepine alone, administered in a single and repeated doses, demonstrated an antinociceptive effect, but only for the hot-plate test, which indicates involvement of supraspinal structures in antinociception.

40 CFR 174.71 - Submission of information regarding adverse effects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... any information regarding adverse effects on human health or the environment alleged to have been... information. (b) Adverse effects on human health or the environment for purposes of plant-incorporated... (CONTINUED) PESTICIDE PROGRAMS PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS Monitoring and...

40 CFR 174.71 - Submission of information regarding adverse effects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... any information regarding adverse effects on human health or the environment alleged to have been... information. (b) Adverse effects on human health or the environment for purposes of plant-incorporated... (CONTINUED) PESTICIDE PROGRAMS PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS Monitoring and...

40 CFR 174.71 - Submission of information regarding adverse effects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... any information regarding adverse effects on human health or the environment alleged to have been... information. (b) Adverse effects on human health or the environment for purposes of plant-incorporated... (CONTINUED) PESTICIDE PROGRAMS PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS Monitoring and...

40 CFR 174.71 - Submission of information regarding adverse effects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... any information regarding adverse effects on human health or the environment alleged to have been... information. (b) Adverse effects on human health or the environment for purposes of plant-incorporated... (CONTINUED) PESTICIDE PROGRAMS PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS Monitoring and...

40 CFR 174.71 - Submission of information regarding adverse effects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... any information regarding adverse effects on human health or the environment alleged to have been... information. (b) Adverse effects on human health or the environment for purposes of plant-incorporated... (CONTINUED) PESTICIDE PROGRAMS PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS Monitoring and...

Investigations of kanuka and manuka essential oils for in vitro treatment of disease and cellular inflammation caused by infectious microorganisms.

PubMed

Chen, Chien-Chia; Yan, Sui-Hing; Yen, Muh-Yong; Wu, Pei-Fang; Liao, Wei-Ting; Huang, Tsi-Shu; Wen, Zhi-Hong; David Wang, Hui-Min

2016-02-01

Diseases caused by infectious and inflammatory microorganisms are among the most common and most severe nosocomial diseases worldwide. Therefore, developing effective agents for treating these illnesses is critical. In this study, essential oils from two tea tree species, kanuka (Kunzea ericoides) and manuka (Leptospermum scoparium), were evaluated for use in treating diseases and inflammation caused by microorganism infection. Isolates of clinically common bacteria and fungi were obtained from American Type Culture Collection and from Kaohsiung Veterans General Hospital. Minimum inhibitory concentrations for Trichosporon mucoides, Malassezia furfur, Candida albicans, and Candida tropicalis were determined by the broth microdilution method with Sabouraud dextrose broth. The antibacterial susceptibility of Staphylococcus aureus, Streptococcus sobrinus, Streptococcus mutans, and Escherichia coli were determined by the broth microdilution method. A human acute monocytic leukemia cell line (THP-1) was cultured to test the effects of the essential oils on the release of the two inflammatory cytokines, tumor necrosis factor-α and interleukin-4. Multiple analyses of microorganism growth confirmed that both essential oils significantly inhibited four fungi and the four bacteria. The potent fungicidal properties of the oils were confirmed by minimum inhibitory concentrations ranging from 0.78% to 3.13%. The oils also showed excellent bactericidal qualities with 100% inhibition of the examined bacteria. In THP-1 cells, both oils lowered tumor necrosis factor-α released after lipopolysaccharide stimulation. Finally, the antimicrobial and anti-inflammatory effects of the oils were obtained without adversely affecting the immune system. These results indicate that the potent antimicroorganism and anti-inflammation properties of kanuka and manuka essential oils make them strong candidates for use in treating infections and immune-related disease. The data confirm the potential use of kanuka and manuka extracts as pharmaceutical antibiotics, medical cosmetology agents, and food supplements. Copyright © 2014. Published by Elsevier B.V.

Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).

PubMed

Tricarico, Pierfrancesco; Tardivo, Stefano; Sotgiu, Giovanni; Moretti, Francesca; Poletti, Piera; Fiore, Alberto; Monturano, Massimo; Mura, Ida; Privitera, Gaetano; Brusaferro, Silvio

2016-08-08

Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries.

The no-observed-adverse-effect-level in drug safety evaluations: use, issues, and definition(s).

PubMed

Dorato, Michael A; Engelhardt, Jeffery A

2005-08-01

The no-observed-adverse-effect-level (NOAEL) is an important part of the non-clinical risk assessment. It is a professional opinion based on the design of the study, indication of the drug, expected pharmacology, and spectrum of off-target effects. There is no consistent standard definition of NOAEL. This is based, in part, on the varied definitions of what constitutes an adverse effect. Toxicologists, either investigating or reviewing, have not been consistent in defining an effect as either adverse or acceptable. The common definition of NOAEL, "the highest experimental point that is without adverse effect," serves us well in general discussions. It does not, however, address the interpretation of risk based on toxicologically relevant effects, nor does it consider the progression of effect with respect to duration and/or dose. This paper will discuss the issues and application of a functional definition of the NOAEL in toxicology evaluations.

Adverse mood effects of combined oral contraceptives in relation to personality traits.

PubMed

Borgström, Anna; Odlind, Viveca; Ekselius, Lisa; Sundström-Poromaa, Inger

2008-12-01

Mood symptoms, such as depressed mood, anxiety and increased irritability, remain one of the major reasons for discontinuation of combined oral contraceptive (COC) pills. The aim of this study was to compare personality traits in women with ongoing or previous use of COCs and different experiences from these compounds with respect to adverse mood symptoms. Thirty women currently on COCs with no reports of adverse mood symptoms, 28 women currently on COCs and experiencing mood-related side effects, 27 women who had discontinued COC use for reasons other than adverse mood symptoms and 33 women who had discontinued COC use due to adverse mood effects were included. All participants were asked to fill out the Swedish universities Scales of Personality (SSP) to assess different personality traits. The women who were experiencing mood-related side effects on their current COC use exhibited higher scores on the somatic anxiety and stress susceptibility traits as compared to the women who did not experience any mood-related side effects from their current COCs. Women who had discontinued COC treatment because of adverse mood effects had higher scores of detachment and mistrust compared to women who had discontinued COC for reasons unrelated to mood effects. Higher scores on specific personality traits such as somatic anxiety and stress susceptibility are found in women with ongoing experience of adverse mood symptoms from COC. Higher scores of mistrust and detachment are more common among women who have discontinued COC treatment due to adverse mood effects.

Communicating minimum impact behavior with trailside bulletin boards: Visitor characteristics associated with effectiveness

Treesearch

Stephen F. McCool; David N. Cole

2000-01-01

Bulletin boards are a frequently used method of communicating minimum impact behaviors to wilderness visitors. But how effective are they? What types of visitors are most likely to pay attention to the messages posted there? This study used a field experiment to identify visitor characteristics associated with attention to minimum impact messages posted on a bulletin...

How Will Higher Minimum Wages Affect Family Life and Children's Well-Being?

PubMed

Hill, Heather D; Romich, Jennifer

2018-06-01

In recent years, new national and regional minimum wage laws have been passed in the United States and other countries. The laws assume that benefits flow not only to workers but also to their children. Adolescent workers will most likely be affected directly given their concentration in low-paying jobs, but younger children may be affected indirectly by changes in parents' work conditions, family income, and the quality of nonparental child care. Research on minimum wages suggests modest and mixed economic effects: Decreases in employment can offset, partly or fully, wage increases, and modest reductions in poverty rates may fade over time. Few studies have examined the effects of minimum wage increases on the well-being of families, adults, and children. In this article, we use theoretical frameworks and empirical evidence concerning the effects on children of parental work and family income to suggest hypotheses about the effects of minimum wage increases on family life and children's well-being.

Right Atrial Deformation in Predicting Outcomes in Pediatric Pulmonary Hypertension.

PubMed

Jone, Pei-Ni; Schäfer, Michal; Li, Ling; Craft, Mary; Ivy, D Dunbar; Kutty, Shelby

2017-12-01

Elevated right atrial (RA) pressure is a risk factor for mortality, and RA size is prognostic of adverse outcomes in pulmonary hypertension (PH). There is limited data on phasic RA function (reservoir, conduit, and pump) in pediatric PH. We sought to evaluate (1) the RA function in pediatric PH patients compared with controls, (2) compare the RA deformation indices with Doppler indices of diastolic dysfunction, functional capacity, biomarkers, invasive hemodynamics, and right ventricular functional indices, and (3) evaluate the potential of RA deformation indices to predict clinical outcomes. Sixty-six PH patients (mean age 7.9±4.7 years) were compared with 36 controls (7.7±4.4 years). RA and right ventricular deformation indices were obtained using 2-dimensional speckle tracking (2DCPA; TomTec, Germany). RA strain, strain rates, emptying fraction, and right ventricular longitudinal strain were measured. RA function was impaired in PH patients versus controls ( P <0.001). There were significant associations between RA function with invasive hemodynamics ( P <0.01). RA reservoir, pump function, the rate of RA filling, and atrial minimum volume predicted adverse clinical outcomes (hazard ratio [HR], 0.15; confidence interval [CI], 0.03-0.73; P <0.01; HR, 0.05; CI, 0.003-0.43; P <0.004; HR, 0.04; CI, 0.006-0.56; P <0.01; and HR, 8.6; CI, 1.6-37.2; P <0.01, respectively). RA deformation properties are significantly altered in pediatric PH patients. Progressive worsening of RA reservoir and conduit functions is related to changes in right ventricular diastolic dysfunction. RA reservoir function, pump function, the rate of atrial filling, and atrial minimum volume emerged as outcome predictors in pediatric PH. © 2017 American Heart Association, Inc.

40 CFR 350.21 - Adverse health effects.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 29 2012-07-01 2012-07-01 false Adverse health effects. 350.21 Section... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims § 350.21 Adverse health effects. The Governor or State emergency response commission shall identify the...

40 CFR 350.21 - Adverse health effects.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 29 2013-07-01 2013-07-01 false Adverse health effects. 350.21 Section... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims § 350.21 Adverse health effects. The Governor or State emergency response commission shall identify the...

40 CFR 350.21 - Adverse health effects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 28 2011-07-01 2011-07-01 false Adverse health effects. 350.21 Section... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims § 350.21 Adverse health effects. The Governor or State emergency response commission shall identify the...

40 CFR 350.21 - Adverse health effects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 27 2010-07-01 2010-07-01 false Adverse health effects. 350.21 Section... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims § 350.21 Adverse health effects. The Governor or State emergency response commission shall identify the...

40 CFR 350.21 - Adverse health effects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 28 2014-07-01 2014-07-01 false Adverse health effects. 350.21 Section... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims § 350.21 Adverse health effects. The Governor or State emergency response commission shall identify the...

30 CFR 875.15 - Reclamation priorities for noncoal program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... from the extreme danger of adverse effects of mineral mining and processing practices; (2) The protection of public health, safety, and general welfare from the adverse effects of mineral mining and... degraded by the adverse effects of mineral mining and processing practices. (c) Enhancement of facilities...

30 CFR 875.15 - Reclamation priorities for noncoal program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... from the extreme danger of adverse effects of mineral mining and processing practices; (2) The protection of public health, safety, and general welfare from the adverse effects of mineral mining and... degraded by the adverse effects of mineral mining and processing practices. (c) Enhancement of facilities...

30 CFR 875.15 - Reclamation priorities for noncoal program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... from the extreme danger of adverse effects of mineral mining and processing practices; (2) The protection of public health, safety, and general welfare from the adverse effects of mineral mining and... degraded by the adverse effects of mineral mining and processing practices. (c) Enhancement of facilities...

30 CFR 875.15 - Reclamation priorities for noncoal program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... from the extreme danger of adverse effects of mineral mining and processing practices; (2) The protection of public health, safety, and general welfare from the adverse effects of mineral mining and... degraded by the adverse effects of mineral mining and processing practices. (c) Enhancement of facilities...

75 FR 38521 - Registration Review; Biopesticide Dockets Opened for Review and Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-02

... adverse human health impacts or environmental effects from exposure to the pesticides discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... perform its intended function without unreasonable adverse effects on human health or the environment...

75 FR 60117 - Registration Review; Biopesticides Dockets Opened for Review and Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... adverse human health impacts or environmental effects from exposure to the pesticides discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... its intended function without unreasonable adverse effects on human health or the environment...

77 FR 74479 - Registration Review; Pesticide Dockets Opened for Review and Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-14

... adverse human health impacts or environmental effects from exposure to the pesticides discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... function without unreasonable adverse effects on human health or the environment. Registration review...

77 FR 59188 - Registration Review; Pesticide Dockets Opened for Review and Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-26

... adverse human health impacts or environmental effects from exposure to the pesticide(s) discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... without unreasonable adverse effects on human health or the environment. Registration review dockets...

An integrated epidemiological and neural net model of the warfarin effect in managed care patients.

PubMed

Jacobs, David M; Stefanovic, Filip; Wilton, Greg; Gomez-Caminero, Andres; Schentag, Jerome J

2017-01-01

Risk assessment tools are utilized to estimate the risk for stroke and need of anticoagulation therapy for patients with atrial fibrillation (AF). These risk stratification scores are limited by the information inputted into them and a reliance on time-independent variables. The objective of this study was to develop a time-dependent neural net model to identify AF populations at high risk of poor clinical outcomes and evaluate the discriminatory ability of the model in a managed care population. We performed a longitudinal, cohort study within a health-maintenance organization from 1997 to 2008. Participants were identified with incident AF irrespective of warfarin status and followed through their duration within the database. Three clinical outcome measures were evaluated including stroke, myocardial infarction, and hemorrhage. A neural net model was developed to identify patients at high risk of clinical events and defined to be an "enriched" patient. The model defines the enrichment based on the top 10 minimum mean square error output parameters that describe the three clinical outcomes. Cox proportional hazard models were utilized to evaluate the outcome measures. Among 285 patients, the mean age was 74±12 years with a mean follow-up of 4.3±2.6 years, and 154 (54%) were treated with warfarin. After propensity score adjustment, warfarin use was associated with a slightly increased risk of adverse outcomes (including stroke, myocardial infarction, and hemorrhage), though it did not attain statistical significance (adjusted hazard ratio [aHR] =1.22; 95% confidence interval [CI] 0.75-1.97; p =0.42). Within the neural net model, subjects at high risk of adverse outcomes were identified and labeled as "enriched." Following propensity score adjustment, enriched subjects were associated with an 81% higher risk of adverse outcomes as compared to nonenriched subjects (aHR=1.81; 95% CI, 1.15-2.88; p =0.01). Enrichment methodology improves the statistical discrimination of meaningful endpoints when used in a health records-based analysis.

Open-label, randomized, multicenter, phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long-term use in patients with acne vulgaris: A secondary publication.

PubMed

Kawashima, Makoto; Nagare, Toshitaka; Katsuramaki, Tsuneo

2017-06-01

An open-label, randomized, multicenter study was conducted to evaluate the safety and efficacy of long-term use of 2.5% and 5% benzoyl peroxide (BPO) gels administrated once daily for 52 weeks to Japanese patients with acne vulgaris. The efficacy of the study drugs was evaluated by counting inflammatory lesions and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. In total, 458 subjects were included in the efficacy and safety analyses. The total lesion count, the efficacy end-point, was similarly changed both in the 2.5% and 5% BPO groups over the course of the study. The median rates of reduction from baseline to week 12 were approximately 65%. Thereafter, the counts were maintained at a reduced level without increasing until week 52. The median rates at week 52 were approximately 80%. Similar trends were observed for inflammatory and non-inflammatory lesion counts. Bacteriological evaluation indicated similar distribution of the minimum inhibitory concentration of each of the antibacterial drugs against Propionibacterium acnes between the values at baseline and at week 52, suggesting that long-term use did not result in changes in the drug sensitivity. The incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5% BPO group. Many of the adverse events occurred within the first month and were mild or moderate in severity and transient. The results suggest that both 2.5% and 5% BPO gels are effective and safe for long-term treatment of patients with acne vulgaris. © 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

Association between intraoperative hypotension and 30-day mortality, major adverse cardiac events, and acute kidney injury after non-cardiac surgery: A meta-analysis of cohort studies.

PubMed

Gu, Wan-Jie; Hou, Bai-Ling; Kwong, Joey S W; Tian, Xin; Qian, Yue; Cui, Yin; Hao, Jing; Li, Ju-Chen; Ma, Zheng-Liang; Gu, Xiao-Ping

2018-05-01

The association between intraoperative hypotension (IOH) and postoperative outcomes is not fully understood. We performed a meta-analysis to determine whether IOH is associated with increased risk of 30-day mortality, major adverse cardiac events (MACEs) and acute kidney injury (AKI) after non-cardiac surgery. We searched PubMed and Embase through May 2016 to identify cohort studies that investigated the association between IOH and risk of 30-day mortality, MACEs, or AKI in adult patients after non-cardiac surgery. Ascertainment of IOH and assessment of outcomes were defined by the individual study. Considering the level of clinical heterogeneity, adjusted odds ratios (ORs) with 95% confidence interval (CIs) were pooled using a random-effects model. This meta-analysis is registered on PROSPERO (CRD42016049405). We included 14 cohort studies that were heterogeneous in terms of definition of IOH. IOH alone was associated with increased risk of 30-day mortality (OR 1.29 [95% CI, 1.19-1.41]), MACEs (OR 1.59 [95% CI, 1.23-2.05]), especially myocardial injury (OR 1.67 [95% CI, 1.31-2.13]), and AKI (OR 1.39 [95% CI, 1.09-1.77]). Triple low (IOH coincident with low bispectral index and low minimum alveolar concentration) also predicts increased risk of 30-day mortality (OR 1.32 [95% CI, 1.03-1.68]). IOH alone significantly increases the risk of postoperative 30-day mortality, MACEs, especially myocardial injury, and AKI in adult patients after non-cardiac surgery. Triple low also predicts increased risk of 30-day mortality after non-cardiac surgery. These findings provide evidence that IOH should be recognized as an independent risk factor for postoperative adverse outcomes after non-cardiac surgery. Copyright © 2018 Elsevier B.V. All rights reserved.

Comparative Study Using 100–300 Versus 300–500 μm Microspheres for Symptomatic Patients Due to Enlarged-BPH Prostates

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

Gonçalves, Octavio Meneghelli, E-mail: octaviogalvao@hotmail.com; Carnevale, Francisco Cesar, E-mail: francisco.carnevale@criep.com.br; Moreira, Airton Mota, E-mail: motamoreira@gmail.com

PurposeThe purpose of the study was to compare safety and efficacy outcomes following prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with 100–300 versus 300–500 μm tris-acryl gelatin microspheres.Materials and MethodsPatients were prospectively treated between August 2011 and June 2013 to receive PAE with 100–300 μm (group A) or 300–500 μm (group B) tris-acryl gelatin microspheres. Patients were followed for a minimum of 12 months and were assessed for changes in International Prostate Symptom Score (IPSS), quality of life (QoL) index, prostate volume determined by magnetic resonance imaging, serum prostate specific antigen (PSA),more » and maximum urine flow rate (Q{sub max}), as well as any treatment-related adverse events.ResultsFifteen patients were included in each group, and PAE was technically successful in all cases. Both groups experienced significant improvement in mean IPSS, QoL, prostate volume, PSA, and Q{sub max} (p < 0.05 for all). The differences observed between the two groups included a marginally insignificant more adverse events (p = 0.066) and greater mean serum PSA reduction at 3 months of follow-up (p = 0.056) in group A.ConclusionsBoth 100–300 and 300–500 μm microspheres are safe and effective embolic agents for PAE to treat LUTS-related to BPH. Although functional and imaging outcomes did not differ significantly following use of the two embolic sizes, the greater incidence of adverse events with 100–300 μm microspheres suggests that 300–500 μm embolic materials may be more appropriate.« less

The effect of tidal forces on the minimum energy configurations of the full three-body problem

NASA Astrophysics Data System (ADS)

Levine, Edward

We investigate the evolution of minimum energy configurations for the Full Three Body Problem (3BP). A stable ternary asteroid system will gradually become unstable due to the Yarkovsky-O'Keefe-Radzievskii-Paddack (YORP) effect and an unpredictable trajectory will ensue. Through the interaction of tidal torques, energy in the system will dissipate in the form of heat until a stable minimum energy configuration is reached. We present a simulation that describes the dynamical evolution of three bodies under the mutual effects of gravity and tidal torques. Simulations show that bodies do not get stuck in local minima and transition to the predicted minimum energy configuration.

Adverse Effects and Surgical Complications in Pediatric Patients Undergoing Vagal Nerve Stimulation for Drug-Resistant Epilepsy.

PubMed

Trezza, A; Landi, A; Grioni, D; Pirillo, D; Fiori, L; Giussani, C; Sganzerla, E P

2017-01-01

Vagal nerve stimulation (VNS) is an effective treatment for drug-resistant epilepsy that is not suitable for resective surgery, both in adults and in children. Few reports describe the adverse effects and complications of VNS. The aim of our study was to present a series of 33 pediatric patients who underwent VNS for drug-resistant epilepsy and to discuss the adverse effects and complications through a review of the literature.The adverse effects of VNS are usually transient and are dependent on stimulation of the vagus and its efferent fibers; surgical complications of the procedure may be challenging and patients sometimes require further surgery; generally these complications affect VNS efficacy; in addition, hardware complications also have to be taken into account.In our experience and according to the literature, adverse effects and surgical and hardware complications are uncommon and can usually be managed definitely. Careful selection of patients, particularly from a respiratory and cardiac point of view, has to be done before surgery to limit the incidence of some adverse effects.

Leveraging 3D chemical similarity, target and phenotypic data in the identification of drug-protein and drug-adverse effect associations.

PubMed

Vilar, Santiago; Hripcsak, George

2016-01-01

Drug-target identification is crucial to discover novel applications for existing drugs and provide more insights about mechanisms of biological actions, such as adverse drug effects (ADEs). Computational methods along with the integration of current big data sources provide a useful framework for drug-target and drug-adverse effect discovery. In this article, we propose a method based on the integration of 3D chemical similarity, target and adverse effect data to generate a drug-target-adverse effect predictor along with a simple leveraging system to improve identification of drug-targets and drug-adverse effects. In the first step, we generated a system for multiple drug-target identification based on the application of 3D drug similarity into a large target dataset extracted from the ChEMBL. Next, we developed a target-adverse effect predictor combining targets from ChEMBL with phenotypic information provided by SIDER data source. Both modules were linked to generate a final predictor that establishes hypothesis about new drug-target-adverse effect candidates. Additionally, we showed that leveraging drug-target candidates with phenotypic data is very useful to improve the identification of drug-targets. The integration of phenotypic data into drug-target candidates yielded up to twofold precision improvement. In the opposite direction, leveraging drug-phenotype candidates with target data also yielded a significant enhancement in the performance. The modeling described in the current study is simple and efficient and has applications at large scale in drug repurposing and drug safety through the identification of mechanism of action of biological effects.

77 FR 40048 - Registration Review; Pesticide Dockets Opened for Review and Comment and Other Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... adverse human health impacts or environmental effects from exposure to the pesticide(s) discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... its intended function without unreasonable adverse effects on human health or the environment...

77 FR 18810 - Registration Review; Pesticide Dockets Opened for Review and Comment and Other Docket Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... adverse human health impacts or environmental effects from exposure to the pesticide(s) discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... its intended function without unreasonable adverse effects on human health or the environment...

75 FR 35810 - Registration Review; Pesticide Dockets Opened for Review and Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-23

... disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides... can still be used without unreasonable adverse effects on human health or the environment. A pesticide... function without unreasonable adverse effects on human health or the environment. Registration review...

75 FR 60119 - Registration Review; Antimicrobial Pesticide Dockets Opened for Review and Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-29

... disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides... can still be used without unreasonable adverse effects on human health or the environment. A pesticide... its intended function without unreasonable adverse effects on human health or the environment...

76 FR 79173 - Registration Review; Pesticide Dockets Opened for Review and Comment, and Notice of Availability...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... adverse human health impacts or environmental effects from exposure to the pesticides discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... adverse effects on human health or the environment. Registration review dockets contain information that...

76 FR 38166 - Registration Review; Pesticide Dockets Opened for Review and Comment and Other Docket Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

... adverse human health impacts or environmental effects from exposure to the pesticides discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... perform its intended function without unreasonable adverse effects on human health or the environment...

Adverse effects of public health interventions: a conceptual framework.

PubMed

Lorenc, Theo; Oliver, Kathryn

2014-03-01

Public health interventions may have a range of adverse effects. However, there is limited guidance as to how evaluations should address the possibility of adverse effects. This discussion paper briefly presents a framework for thinking about the potential harms of public health interventions, focusing on the following categories: direct harms; psychological harms; equity harms; group and social harms; and opportunity harms. We conclude that the possibility of adverse effects needs to be taken into account by those implementing and evaluating interventions, and requires a broad perspective on the potential impacts of public health strategies.

Minimum Wage Effects on Educational Enrollments in New Zealand

ERIC Educational Resources Information Center

Pacheco, Gail A.; Cruickshank, Amy A.

2007-01-01

This paper empirically examines the impact of minimum wages on educational enrollments in New Zealand. A significant reform to the youth minimum wage since 2000 has resulted in some age groups undergoing a 91% rise in their real minimum wage over the last 10 years. Three panel least squares multivariate models are estimated from a national sample…

Minimum Wage and Community College Attendance: How Economic Circumstances Affect Educational Choices

ERIC Educational Resources Information Center

Williams, Betsy

2013-01-01

How do changes in minimum wages affect community college enrollment and employment? In particular, among adults without associate's or bachelor's degrees who may earn near the minimum wage, do endowment effects of a higher minimum wage encourage school attendance? Among adults without associate's or bachelor's degrees who may earn near the minimum…

Employment Effects of Minimum and Subminimum Wages. Recent Evidence.

ERIC Educational Resources Information Center

Neumark, David

Using a specially constructed panel data set on state minimum wage laws and labor market conditions, Neumark and Wascher (1992) presented evidence that countered the claim that minimum wages could be raised with no cost to employment. They concluded that estimates indicating that minimum wages reduced employment on the order of 1-2 percent for a…

Does the Minimum Wage Affect Welfare Caseloads?

ERIC Educational Resources Information Center

Page, Marianne E.; Spetz, Joanne; Millar, Jane

2005-01-01

Although minimum wages are advocated as a policy that will help the poor, few studies have examined their effect on poor families. This paper uses variation in minimum wages across states and over time to estimate the impact of minimum wage legislation on welfare caseloads. We find that the elasticity of the welfare caseload with respect to the…

78 FR 7467 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-01

... Effectiveness of a Proposed Rule Change Relating to Minimum Volume Orders January 28, 2013. Pursuant to Section... to codify the ``Minimum Volume Order.'' The text of the proposed rule change is provided below... Circular. (a)-(v) No changes. (w) Minimum Volume Order. A minimum volume order is an order represented in...

The Neurobiology of Intervention and Prevention in Early Adversity.

PubMed

Fisher, Philip A; Beauchamp, Kate G; Roos, Leslie E; Noll, Laura K; Flannery, Jessica; Delker, Brianna C

2016-01-01

Early adverse experiences are well understood to affect development and well-being, placing individuals at risk for negative physical and mental health outcomes. A growing literature documents the effects of adversity on developing neurobiological systems. Fewer studies have examined stress neurobiology to understand how to mitigate the effects of early adversity. This review summarizes the research on three neurobiological systems relevant to interventions for populations experiencing high levels of early adversity: the hypothalamic-adrenal-pituitary axis, the prefrontal cortex regions involved in executive functioning, and the system involved in threat detection and response, particularly the amygdala. Also discussed is the emerging field of epigenetics and related interventions to mitigate early adversity. Further emphasized is the need for intervention research to integrate knowledge about the neurobiological effects of prenatal stressors (e.g., drug use, alcohol exposure) and early adversity. The review concludes with a discussion of the implications of this research topic for clinical psychology practice and public policy.

Relational resilience as a potential mediator between adverse childhood experiences and prenatal depression.

PubMed

Howell, Kathryn H; Miller-Graff, Laura E; Schaefer, Lauren M; Scrafford, Kathryn E

2017-08-01

This study examined the indirect effects of individual, relational, and contextual resilience in the relationship between adverse childhood experiences and prenatal depression. Participants included 101 pregnant women. Adverse childhood experiences had a direct effect on depression, B = 1.11, standard error = .44, p = .01, and relational resilience, B = -1.15, standard error = .19, p < .001, but not individual or contextual resilience. With resilience as a mediator, the effect of adverse childhood experiences on depression was no longer significant. Specifically, relational resilience had a significant indirect effect (IE) on the association between adverse childhood experiences and depression, IE = 1.04, boot standard error  = .28 (95% confidence interval  = .58, 1.68). Results emphasize the associated role of relational qualities, such as sense of security and belongingness, with childhood adversity and mental health.

Effects of the Minimum Wage on the Employment Status of Youths. An Update.

ERIC Educational Resources Information Center

Wellington, Alison J.

1991-01-01

Using data from 1954-86, including the 1980s period of relative decline in the value of the minimum wage, a study found that a 10 percent increase in minimum wage reduced teen unemployment by less than 1 percent. In addition, no apparent effect on employment of adults aged 20-24 was found, and minimal differences appeared for sex and race. (SK)

Testing an integral conceptual model of frailty.

PubMed

Gobbens, Robbert J; van Assen, Marcel A; Luijkx, Katrien G; Schols, Jos M

2012-09-01

This paper is a report of a study conducted to test three hypotheses derived from an integral conceptual model of frailty.   The integral model of frailty describes the pathway from life-course determinants to frailty to adverse outcomes. The model assumes that life-course determinants and the three domains of frailty (physical, psychological, social) affect adverse outcomes, the effect of disease(s) on adverse outcomes is mediated by frailty, and the effect of frailty on adverse outcomes depends on the life-course determinants. In June 2008 a questionnaire was sent to a sample of community-dwelling people, aged 75 years and older (n = 213). Life-course determinants and frailty were assessed using the Tilburg frailty indicator. Adverse outcomes were measured using the Groningen activity restriction scale, the WHOQOL-BREF and questions regarding healthcare utilization. The effect of seven self-reported chronic diseases was examined. Life-course determinants, chronic disease(s), and frailty together explain a moderate to large part of the variance of the seven continuous adverse outcomes (26-57%). All these predictors together explained a significant part of each of the five dichotomous adverse outcomes. The effect of chronic disease(s) on all 12 adverse outcomes was mediated at least partly by frailty. The effect of frailty domains on adverse outcomes did not depend on life-course determinants. Our finding that the adverse outcomes are differently and uniquely affected by the three domains of frailty (physical, psychological, social), and life-course determinants and disease(s), emphasizes the importance of an integral conceptual model of frailty. © 2011 Blackwell Publishing Ltd.

Practical approaches to minimizing gastrointestinal and cardiovascular safety concerns with COX-2 inhibitors and NSAIDs

PubMed Central

2005-01-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective in treating the pain and inflammation associated with osteoarthritis and rheumatoid arthritis, but it is well recognized that these agents are associated with substantial gastrointestinal toxicity. Treatment guidelines suggest that patients with one or more risk factors for NSAID associated ulcers should be prescribed preventive treatment. However, well over 80% of such patients may not receive an appropriate therapeutic intervention. Multiple strategies are available to reduce the risk for NSAID associated gastrointestinal complications. First, risk may be reduced by using non-NSAID analgesics. Second, use of the minimum effective dose of the NSAID may reduce risk. Third, co-therapy with a proton pump inhibitor or misoprostol may be desirable in at-risk patients. Use of cyclo-oxygenase-2 inhibitors may also reduce the risk for gastrointestinal events, although this benefit is eliminated in patients who receive aspirin, and cyclo-oxygenase-2 inhibitors may increase cardiovascular adverse events. The optimal management of NSAID related gastrointestinal complications must be based on the individual patient's risk factors for gastrointestinal and cardiovascular disease, as well as on the efficacy and tolerability of both the NSAID and accompanying gastroprotective agent. PMID:16168078

Structure-activity relationship studies of chalcone leading to 3-hydroxy-4,3',4',5'-tetramethoxychalcone and its analogues as potent nuclear factor kappaB inhibitors and their anticancer activities.

PubMed

Srinivasan, Balasubramanian; Johnson, Thomas E; Lad, Rahul; Xing, Chengguo

2009-11-26

Chalcone is a privileged structure, demonstrating promising anti-inflammatory and anticancer activities. One potential mechanism is to suppress nuclear factor kappa B (NF-kappaB) activation. The structures of chalcone-based NF-kappaB inhibitors vary significantly that there is minimum information about their structure-activity relationships (SAR). This study aims to establish SAR of chalcone-based compounds to NF-kappaB inhibition, to explore the feasibility of developing simple chalcone-based potent NF-kappaB inhibitors, and to evaluate their anticancer activities. Three series of chalcones were synthesized in one to three steps with the key step being aldol condensation. These candidates demonstrated a wide range of NF-kappaB inhibitory activities, some of low micromolar potency, establishing that structural complexity is not required for NF-kappaB inhibition. Lead compounds also demonstrate potent cytotoxicity against lung cancer cells. Their cytotoxicities correlate moderately well with their NF-kappaB inhibitory activities, suggesting that suppressing NF-kappaB activation is likely responsible for at least some of the cytotoxicities. One lead compound effectively inhibits lung tumor growth with no signs of adverse side effects.

Analysis of Multi-Antenna GNSS Receiver Performance under Jamming Attacks.

PubMed

Vagle, Niranjana; Broumandan, Ali; Lachapelle, Gérard

2016-11-17

Although antenna array-based Global Navigation Satellite System (GNSS) receivers can be used to mitigate both narrowband and wideband electronic interference sources, measurement distortions induced by array processing methods are not suitable for high precision applications. The measurement distortions have an adverse effect on the carrier phase ambiguity resolution, affecting the navigation solution. Depending on the array attitude information availability and calibration parameters, different spatial processing methods can be implemented although they distort carrier phase measurements in some cases. This paper provides a detailed investigation of the effect of different array processing techniques on array-based GNSS receiver measurements and navigation performance. The main novelty of the paper is to provide a thorough analysis of array-based GNSS receivers employing different beamforming techniques from tracking to navigation solution. Two beamforming techniques, namely Power Minimization (PM) and Minimum Power Distortionless Response (MPDR), are being investigated. In the tracking domain, the carrier Doppler, Phase Lock Indicator (PLI), and Carrier-to-Noise Ratio (C/N₀) are analyzed. Pseudorange and carrier phase measurement distortions and carrier phase position performance are also evaluated. Performance analyses results from simulated GNSS signals and field tests are provided.

Effect of equal channel angular pressing on in vitro degradation of LAE442 magnesium alloy.

PubMed

Minárik, Peter; Jablonská, Eva; Král, Robert; Lipov, Jan; Ruml, Tomáš; Blawert, Carsten; Hadzima, Branislav; Chmelík, František

2017-04-01

Effect of processing by equal channel angular pressing (ECAP) on the degradation behaviour of extruded LAE442 magnesium alloy was investigated in a 0.1M NaCl solution, Kirkland's biocorrosion medium (KBM) and Minimum Essential Medium (MEM), both with and without 10% of foetal bovine serum (FBS). Uniform degradation of as extruded and ECAP processed samples in NaCl solution was observed, nevertheless higher corrosion resistance was found in the latter material. The increase of corrosion resistance due to ECAP was observed also after 14-days immersion in all media used. Higher compactness of the corrosion layer formed on the samples after ECAP was responsible for the observed decrease of corrosion resistance, which was proven by scanning electron microscope investigation. Lower corrosion rate in media with FBS was observed and was explained by additional effect of protein incorporation on the corrosion layer stability. A cytotoxicity test using L929 cells was carried out to investigate possible effect of processing on the cell viability. Sufficient cytocompatibility of the extruded samples was observed with no adverse effects of the subsequent ECAP processing. In conclusion, this in vitro study proved that the degradation behaviour of the LAE442 alloy could be improved by subsequent ECAP processing and this material is a good candidate for future in vivo investigation. Copyright © 2016 Elsevier B.V. All rights reserved.

The efficiency of risedronate in reducing bone resorption after total hip arthroplasty: a meta-analysis of randomized control trials at a minimum of 6 months' follow-up.

PubMed

Yang, Liqing

2018-04-17

Recently risedronate is suggested to be effective for the prevention and treatment of for osteoporosis in total hip arthroplasty. This meta-analysis aimes to evaluate the efficacy of risedronate in reducing femoral periprosthetic bone mineral density loss in patients undergoing primary total hip arthroplasty. A systematic search was performed in Medline (1966-31 October 2017), PubMed (1966-31 October 2017), Embase (1980-31 October 2017), ScienceDirect (1985-31 October 2017) and the Cochrane Library. Only randomized controlled trial (RCT) were included. Fixed/random effect model was used according to the heterogeneity tested by I2 statistic. Meta-analysis was performed using Stata 11.0 software. The outcome measures included periprosthetic bone mineral density, length of stay and adverse effects. Four RCTs including 198 patients met the inclusion criteria. The present meta-analysis showed that there were significant differences between treatment groups in terms of periprosthetic bone mineral density in Gruen zones 1 (standard mean difference (SMD) = 0.758, 95% CI 0.469 to 1.047, P = 0.000), 2 (SMD = 0.814, 95% CI 0.523 to 1.106, P = 0.000), 3 (SMD = 0.340, 95% CI 0.059 to 0.622, P = 0.018), 6 (SMD = 2.400, 95% CI 2.029 to 2.771, P = 0.000), and 7 (SMD = 2.400, 95% CI 2.029 to 2.771, P = 0.000). Oral risedronate could significantly reduce periprosthetic bone resorption around an uncemented femoral stem (Gruen zones 1, 2, 3, 6, and 7) up to 6 months after THA. In addition, no severe adverse events were identified. Future trials of risedronate treatment after THA should focus on clinically relevant end points such as the risks of fracture and revision arthroplasty.

Air Traffic Controllers’ Long-Term Speech-in-Noise Training Effects: A Control Group Study

PubMed Central

Zaballos, María T.P.; Plasencia, Daniel P.; González, María L.Z.; de Miguel, Angel R.; Macías, Ángel R.

2016-01-01

Introduction: Speech perception in noise relies on the capacity of the auditory system to process complex sounds using sensory and cognitive skills. The possibility that these can be trained during adulthood is of special interest in auditory disorders, where speech in noise perception becomes compromised. Air traffic controllers (ATC) are constantly exposed to radio communication, a situation that seems to produce auditory learning. The objective of this study has been to quantify this effect. Subjects and Methods: 19 ATC and 19 normal hearing individuals underwent a speech in noise test with three signal to noise ratios: 5, 0 and −5 dB. Noise and speech were presented through two different loudspeakers in azimuth position. Speech tokes were presented at 65 dB SPL, while white noise files were at 60, 65 and 70 dB respectively. Results: Air traffic controllers outperform the control group in all conditions [P<0.05 in ANOVA and Mann-Whitney U tests]. Group differences were largest in the most difficult condition, SNR=−5 dB. However, no correlation between experience and performance were found for any of the conditions tested. The reason might be that ceiling performance is achieved much faster than the minimum experience time recorded, 5 years, although intrinsic cognitive abilities cannot be disregarded. Discussion: ATC demonstrated enhanced ability to hear speech in challenging listening environments. This study provides evidence that long-term auditory training is indeed useful in achieving better speech-in-noise understanding even in adverse conditions, although good cognitive qualities are likely to be a basic requirement for this training to be effective. Conclusion: Our results show that ATC outperform the control group in all conditions. Thus, this study provides evidence that long-term auditory training is indeed useful in achieving better speech-in-noise understanding even in adverse conditions. PMID:27991470

Medical marijuana patient counseling points for health care professionals based on trends in the medical uses, efficacy, and adverse effects of cannabis-based pharmaceutical drugs.

PubMed

Parmar, Jayesh R; Forrest, Benjamin D; Freeman, Robert A

2016-01-01

The purpose of this report is to present a review of the medical uses, efficacy, and adverse effects of the three approved cannabis-based medications and ingested marijuana. A literature review was conducted utilizing key search terms: dronabinol, nabilone, nabiximols, cannabis, marijuana, smoke, efficacy, toxicity, cancer, multiple sclerosis, nausea, vomiting, appetite, pain, glaucoma, and side effects. Abstracts of the included literature were reviewed, analyzed, and organized to identify the strength of evidence in medical use, efficacy, and adverse effects of the approved cannabis-based medications and medical marijuana. A total of 68 abstracts were included for review. Dronabinol's (Marinol) most common medical uses include weight gain, chemotherapy-induced nausea and vomiting (CINV), and neuropathic pain. Nabiximol's (Sativex) most common medical uses include spasticity in multiple sclerosis (MS) and neuropathic pain. Nabilone's (Cesamet) most common medical uses include CINV and neuropathic pain. Smoked marijuana's most common medical uses include neuropathic pain and glaucoma. Orally ingested marijuana's most common medical uses include improving sleep, reducing neuropathic pain, and seizure control in MS. In general, all of these agents share similar medical uses. The reported adverse effects of the three cannabis-based medications and marijuana show a major trend in central nervous system (CNS)-related adverse effects along with cardiovascular and respiratory related adverse effects. Marijuana shares similar medical uses with the approved cannabis-based medications dronabinol (Marinol), nabiximols (Sativex), and nabilone (Cesamet), but the efficacy of marijuana for these medical uses has not been fully determined due to limited and conflicting literature. Medical marijuana also has similar adverse effects as the FDA-approved cannabis-based medications mainly consisting of CNS related adverse effects but also including cardiovascular and respiratory related adverse effects. Finally, insufficient higher-order evidence to support the widespread use of medical marijuana was found, but a limited amount of moderate-level evidence supports its use in pain and seizure management. Published by Elsevier Inc.

Treatment of Functional Abdominal Pain With Antidepressants: Benefits, Adverse Effects, and the Gastroenterologist's Role.

PubMed

Zar-Kessler, Claire A M; Belkind-Gerson, Jaime; Bender, Suzanne; Kuo, Braden M

2017-07-01

Pediatric functional abdominal pain is often treated with tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). The aim is investigating antidepressant use for treatment efficacy, correlation of response to psychiatric factors, and impact of adverse effects in regard to physicians' prescribing patterns. Retrospective review (2005-2013) children (5-21 years old) with functional abdominal pain treated with SSRI or TCA. Of the 531 cases with functional abdominal pain, 192 initiated SSRIs or TCAs while followed by gastroenterology. Charts reviewed for symptoms, adverse effects, and response: decreased pain or increased daily functioning. Sixty-three of 84 (75%) SSRI patients improved, 56 of 92 (61%) TCA patients improved (P = 0.03). Logistic regression controlling for psychiatric factors: SSRI remained significant over TCA (P = 0.04). Thirty-two of 67 (48%) patients with constipation received TCAs and 26 of 45 (58%) patients with diarrhea received SSRIs (P = 0.64). Three SSRI patients reported gastrointestinal effects, all diarrheal-type symptoms, and 2 TCA patients reported gastrointestinal effects, both constipation, in all it led to discontinuation. Thirteen (29%) of diarrheal-type patients reported adverse effects causing discontinuation as compared to 7 (8%) in the constipation group (P = .01). Twenty-one (25%) SSRI patients reported adverse effects with 5 (6%) mood disturbances. Twenty (22%) TCA patients reported adverse effects, 13 (14%) with mood disturbances (P = .07). Overall, 12 (14%) SSRI patients discontinued medication due to adverse effects, whereas 16 (17%) TCA patients (P = 0.24) did. Patients had significantly greater response to SSRIs than TCAs, remaining significant after controlling for psychiatric factors. Little significance is given to patient's associated gastrointestinal symptoms, frequently resulting in adverse effects and termination of medication.

[Adverse effects of oxcarbazepine].

PubMed

Fang, Shu; Gong, Zhi-Cheng

2015-04-01

Oxcarbazepine is a new antiepileptic drug. The results of clinical trials suggest that oxcarbazepine is well tolerated and has less drug interactions. It is being used more and more widely in clinical practice, but its adverse effects should not be ignored. The most common adverse effects of oxcarbazepine are usually related to the central nervous system and digestive system, including fatigue, drowsiness, diplopia, dizziness, nausea and vomit. The common skin adverse reaction is rash. Long-term use of oxcarbazepine may also cause hyponatremia. This article reviews the literature from China and overseas about the adverse effets of oxcarbazepine over the last 10 years in order to find information about rational clinical use of oxcarbazepine.

The development of search filters for adverse effects of surgical interventions in medline and Embase.

PubMed

Golder, Su; Wright, Kath; Loke, Yoon Kong

2018-06-01

Search filter development for adverse effects has tended to focus on retrieving studies of drug interventions. However, a different approach is required for surgical interventions. To develop and validate search filters for medline and Embase for the adverse effects of surgical interventions. Systematic reviews of surgical interventions where the primary focus was to evaluate adverse effect(s) were sought. The included studies within these reviews were divided randomly into a development set, evaluation set and validation set. Using word frequency analysis we constructed a sensitivity maximising search strategy and this was tested in the evaluation and validation set. Three hundred and fifty eight papers were included from 19 surgical intervention reviews. Three hundred and fifty two papers were available on medline and 348 were available on Embase. Generic adverse effects search strategies in medline and Embase could achieve approximately 90% relative recall. Recall could be further improved with the addition of specific adverse effects terms to the search strategies. We have derived and validated a novel search filter that has reasonable performance for identifying adverse effects of surgical interventions in medline and Embase. However, we appreciate the limitations of our methods, and recommend further research on larger sample sizes and prospective systematic reviews. © 2018 The Authors Health Information and Libraries Journal published by John Wiley & Sons Ltd on behalf of Health Libraries Group.

Adverse Effects of Collagenase in the Treatment of Dupuytren Disease: A Systematic Review.

PubMed

Sanjuan-Cerveró, Rafael; Carrera-Hueso, Francisco J; Vazquez-Ferreiro, Pedro; Gomez-Herrero, Diego

2017-04-01

Collagenase clostridium histolyticum (CCH) has proven to be both safe and effective in the treatment of Dupuytren disease (DD). The medium-term outcomes are similar to those achieved with surgery, and most adverse effects are self-limiting and considered to be mild or moderate. Our objective was to conduct a systematic review of the adverse effects of CCH in DD since the release of the drug to evaluate the incidence, severity, classification, and definitions of these effects. We analyzed the literature in terms of modifications to the original treatment protocol and grouped adverse effects according to their pathophysiological origin. We included 28 clinical studies and five case reports or case series analyzing 4456 patients with a mean age of 63.6 years. Mean follow-up was 7.07 months (range 3-24); the mean number of patients per study was 148 (range 5-1082). The studies did not classify the adverse effects they reported into groups. The most common effects were peripheral edema (54.4%), bruising (42.9%), and upper limb pain (28.3%). Significant biases were observed for use of terminology, demarcation of sites of involvement, severity criteria, and assessment methods. A simpler and clearer consensus-based classification system would enable better evaluation and comparison of the adverse effects of CCH in the treatment of DD. Consideration of inflammatory phenomena as part of the drug's mechanism of action would significantly reduce overall rates of adverse effects.

Association of adverse drug effects with subjective well-being in patients with schizophrenia receiving stable doses of risperidone.

PubMed

Kim, Jong-Hoon; Kim, Min-Jung

2009-01-01

The purpose of the present study was to examine the association of adverse drug effects with subjective well-being in patients with schizophrenia receiving stable doses of risperidone. Thirty outpatients with schizophrenia receiving stable doses of risperidone were comprehensively evaluated for psychopathology, subjective well-being, and adverse drug effects. Subjective well-being was assessed using the Subjective Well-being Under Neuroleptics Scale (SWN). Adverse drug effects were evaluated using the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) and the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS). In correlation analysis controlling for relevant variables, the SWN score had significant negative correlations with the following subscale scores of the LUNSERS: extrapyramidal side effect (EPS) (r = -0.54, P < 0.01), akathisia (r = -0.46, P < 0.05), and autonomic adverse effect (r = -0.44, P < 0.05). The SWN score also had a significant negative correlation with the global severity of EPS as measured by the DIEPSS (r = -0.44, P < 0.05). The results of our study suggest that adverse effects, particularly EPS and akathisia, are significantly associated with subjective well-being, implying the necessity to develop rational strategies to control these variables effectively. The results also suggest that EPS and akathisia continue to be major adverse effects associated with a low level of subjective well-being in patients receiving risperidone. Further studies are required to investigate the multidimensional factors associated with subjective well-being in patients receiving atypical antipsychotics and to determine their relative contributions.

Some considerations of the tolerability of ketamine for ECT anesthesia: a case series and review of the literature.

PubMed

Rasmussen, Keith G; Ritter, Matthew J

2014-12-01

Most anesthetic agents used for electroconvulsive therapy (ECT) have few intrinsic adverse effects. Ketamine, however, is well known to be associated with a variety of adverse effects including nausea, dizziness, and psychotomimetic phenomena. Over the past several decades, there have been numerous reports on the use of ketamine for ECT anesthesia, with varied assessments on how prominent these adverse effects are in the ECT situation. Ketamine has received a resurgence of interest as an ECT anesthetic of late owing to its established independent antidepressant effects and to theoretical reasons why it might lessen the cognitive adverse effects of ECT. In this case series, the author reviews the experience with 14 patients who had undergone ECT who were switched to ketamine as anesthetic from methohexital at the preference of the treating anesthesiologist. All 14 patients spontaneously reported a strong preference not to be given ketamine again due to bothersome adverse effects. The latter consisted of either vestibular-type symptoms (nausea/vomiting, dizziness, and vertigo) or psychotomimetic effects (dissociative phenomena). It is concluded that ketamine is not free of adverse effects when used as an ECT anesthetic. Electroconvulsive therapy clinicians should be vigilant about assessing for these effects when ketamine is used, and consideration should be given to using a benzodiazepine such as diazepam or midazolam at seizure termination when ketamine anesthesia is used to prevent bothersome adverse effects seen upon awakening.

Architectural and Behavioral Systems Design Methodology and Analysis for Optimal Habitation in a Volume-Limited Spacecraft for Long Duration Flights

NASA Technical Reports Server (NTRS)

Kennedy, Kriss J.; Lewis, Ruthan; Toups, Larry; Howard, Robert; Whitmire, Alexandra; Smitherman, David; Howe, Scott

2016-01-01

As our human spaceflight missions change as we reach towards Mars, the risk of an adverse behavioral outcome increases, and requirements for crew health, safety, and performance, and the internal architecture, will need to change to accommodate unprecedented mission demands. Evidence shows that architectural arrangement and habitability elements impact behavior. Net habitable volume is the volume available to the crew after accounting for elements that decrease the functional volume of the spacecraft. Determination of minimum acceptable net habitable volume and associated architectural design elements, as mission duration and environment varies, is key to enabling, maintaining, andor enhancing human performance and psychological and behavioral health. Current NASA efforts to derive minimum acceptable net habitable volumes and study the interaction of covariates and stressors, such as sensory stimulation, communication, autonomy, and privacy, and application to internal architecture design layouts, attributes, and use of advanced accommodations will be presented. Furthermore, implications of crew adaptation to available volume as they transfer from Earth accommodations, to deep space travel, to planetary surface habitats, and return, will be discussed.

Synergistic combination dry powders for inhaled antimicrobial therapy

NASA Astrophysics Data System (ADS)

Heng, Desmond; Lee, Sie Huey; Teo, Jeanette; Ng, Wai Kiong; Chan, Hak-Kim; Tan, Reginald B. H.

2013-06-01

Combination products play an important role in medicine as they offer improved clinical effectiveness, enhanced patient adherence, and reduced administrative costs. In combination antimicrobial therapy, the desired outcome is to extend the antimicrobial spectrum and to achieve a possible synergistic effect. However, adverse antagonistic species may sometimes emerge from such combinations, leading to treatment failure. Therefore, it is crucial to screen the drug candidates for compatibility and possible antagonistic interactions. This work aims to develop a novel synergistic dry powder inhaler (DPI) formulation for antimicrobial combination therapy via the pulmonary route. Binary and ternary combinations were prepared via spray drying on a BUCHI® Nano Spray Dryer B-90. All powders were within the respirable size range, and were consisted of spherical particles that were slightly corrugated. The powers yielded fine particle fractions (of the loaded dose) of over 40% when dispersed using an Aerolizer® DPI at 60 L/min. Time-kill studies carried out against common respiratory tract pathogenic bacteria Pseudomonas aeruginosa, Staphylococcus aureus, Klebsiella pneumonia and Acinetobacter baumannii at 1x the minimum inhibitory concentration (MIC) over 24 hours revealed no antagonistic behavior for both combinations. While the interactions were generally found to be indifferent, a favorable synergistic effect was detected in the binary combination when it was tested against Pseudomonas aeruginosa bacteria.

Comparative clinical evaluation of Kshara Sutra ligation and hemorrhoidectomy in Arsha (hemorrhoids).

PubMed

Gupta, Meva Lal; Gupta, S K; Bhuyan, Chaturbhuja

2011-04-01

Arsha (hemorrhoids) is engorgement of the hemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain, prolapse and discharge. It is manifested due to improper diet, prolonged standing and faulty habits of defecation causing derangement of tridosha, mainly vata dosha. Vitiated dosha localizes in guda vali, pradhana dhamani and mansdhara kala and vitiates twak, mansa, meda and rakta, resulting in the annavaha sroto dushti. Modern management of arsha needs, mainly, a surgical approach, i.e. hemorrhoidectomy, wherein the result was found to be less satisfactory. In this regard, to determine a solution for satisfactory cure, the kshara sutra ligation method in arsha was studied in comparison with hemarrhoidectomy. Kshara sutra ligation in arsha was employed in 35 patients, and 26 patients were dealt with hemorrhoidectomy. The study revealed a better result of the kshara sutra ligation-treated group in comparison with hemorrhoidectomy. The observations revealed that maximum advantages like minimum hospital stay, no bleeding during or after operation, no post-operative anal stenosis, a low cost-effective and more acceptable to different categories of people, etc. were recorded in the kshara sutra-treated group. Statistically, kshara sutra ligation for arsha was found to be highly significant and effective management. No adverse effects were noted during the follow-up period.

Comparative clinical evaluation of Kshara Sutra ligation and hemorrhoidectomy in Arsha (hemorrhoids)

PubMed Central

Gupta, Meva Lal; Gupta, S. K.; Bhuyan, Chaturbhuja

2011-01-01

Arsha (hemorrhoids) is engorgement of the hemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain, prolapse and discharge. It is manifested due to improper diet, prolonged standing and faulty habits of defecation causing derangement of tridosha, mainly vata dosha. Vitiated dosha localizes in guda vali, pradhana dhamani and mansdhara kala and vitiates twak, mansa, meda and rakta, resulting in the annavaha sroto dushti. Modern management of arsha needs, mainly, a surgical approach, i.e. hemorrhoidectomy, wherein the result was found to be less satisfactory. In this regard, to determine a solution for satisfactory cure, the kshara sutra ligation method in arsha was studied in comparison with hemarrhoidectomy. Kshara sutra ligation in arsha was employed in 35 patients, and 26 patients were dealt with hemorrhoidectomy. The study revealed a better result of the kshara sutra ligation-treated group in comparison with hemorrhoidectomy. The observations revealed that maximum advantages like minimum hospital stay, no bleeding during or after operation, no post-operative anal stenosis, a low cost-effective and more acceptable to different categories of people, etc. were recorded in the kshara sutra-treated group. Statistically, kshara sutra ligation for arsha was found to be highly significant and effective management. No adverse effects were noted during the follow-up period. PMID:22408307

Measuring effectiveness of semantic cues in degraded English sentences in non-native listeners.

PubMed

Shi, Lu-Feng

2014-01-01

This study employed Boothroyd and Nittrouer's k (1988) to directly quantify effectiveness in native versus non-native listeners' use of semantic cues. Listeners were presented speech-perception-in-noise sentences processed at three levels of concurrent multi-talker babble and reverberation. For each condition, 50 sentences with multiple semantic cues and 50 with minimum semantic cues were randomly presented. Listeners verbally reported and wrote down the target words. The metric, k, was derived from percent-correct scores for sentences with and without semantics. Ten native and 33 non-native listeners participated. The presence of semantics increased recognition benefit by over 250% for natives, but access to semantics remained limited for non-native listeners (90-135%). The k was comparable across conditions for native listeners, but level-dependent for non-natives. The k for non-natives was significantly different from 1 in all conditions, suggesting semantic cues, though reduced in importance in difficult conditions, were helpful for non-natives. Non-natives as a group were not as effective in using semantics to facilitate English sentence recognition as natives. Poor listening conditions were particularly adverse to the use of semantics in non-natives, who may rely on clear acoustic-phonetic cues before benefitting from semantic cues when recognizing connected speech.

Developing standardized corticosteroid treatment for Duchenne muscular dystrophy.

PubMed

Guglieri, Michela; Bushby, Kate; McDermott, Michael P; Hart, Kimberly A; Tawil, Rabi; Martens, William B; Herr, Barbara E; McColl, Elaine; Wilkinson, Jennifer; Kirschner, Janbernd; King, Wendy M; Eagle, Michele; Brown, Mary W; Willis, Tracey; Hirtz, Deborah; Shieh, Perry B; Straub, Volker; Childs, Anne-Marie; Ciafaloni, Emma; Butterfield, Russell J; Horrocks, Iain; Spinty, Stefan; Flanigan, Kevin M; Kuntz, Nancy L; Baranello, Giovanni; Roper, Helen; Morrison, Leslie; Mah, Jean K; Manzur, Adnan Y; McDonald, Craig M; Schara, Ulrike; von der Hagen, Maja; Barohn, Richard J; Campbell, Craig; Darras, Basil T; Finkel, Richard S; Vita, Giuseppe; Hughes, Imelda; Mongini, Tiziana; Pegoraro, Elena; Wicklund, Matthew; Wilichowski, Ekkehard; Bryan Burnette, W; Howard, James F; McMillan, Hugh J; Thangarajh, Mathula; Griggs, Robert C

2017-07-01

Despite corticosteroids being the only treatment documented to improve strength and function in boys with Duchenne muscular dystrophy (DMD) corticosteroid prescription is inconsistent and in some countries, corticosteroids are not prescribed. We are conducting a clinical trial that (1) compares the 3 most frequently prescribed corticosteroid regimes; (2) standardizes treatment of DMD complications; and (3) standardizes prevention of corticosteroid side effects. Investigators at 38 sites in 5 countries plan to recruit 300 boys aged 4-7 who are randomly assigned to one of three regimens: daily prednisone; daily deflazacort; or intermittent prednisone (10days on/10days off). Boys are followed for a minimum of 3years to assess the relative effectiveness and adverse event profiles of the different regimens. The primary outcome is a 3-dimensional variable consisting of log-transformed time to rise from the floor, forced vital capacity, and subject/parent satisfaction with treatment, each averaged over all post-baseline visits. The study protocol includes evidence- and consensus-based treatment of DMD complications and of corticosteroid side effects. This study seeks to establish a standard corticosteroid regimen for DMD. Since all new interventions for DMD are being developed as add-on therapies to corticosteroids, defining the optimum regimen is of importance for all new treatments. Copyright © 2017. Published by Elsevier Inc.

Comparison of the treatment efficacy between tigecycline plus high-dose cefoperazone-sulbactam and tigecycline monotherapy against ventilator-associated pneumonia caused by extensively drug-resistant Acinetobacter baumannii.

PubMed

Qin, Youfa; Zhang, Jie; Wu, Lei; Zhang, Dailong; Fu, Lunjiao; Xue, Xiaoyan

2018-03-01

The present study examined the effect of high-dose cefoperazone-sulbactam combined with tigecycline against ventilator-associated pneumonia (VAP) caused by extensively drug-resistant Acinetobacter baumannii(XDR-AB). 42 patients with VAP due to XDR-AB infection were randomized into two groups: the TIG group (received tigecycline injection) and the TIG+CFS group (received tigecycline and cefoperazone-sulbactam (1 : 1) injection). Pulsed field gel electrophoresis (PFGE) was used for genotyping the isolated XDR-AB. The microdilution method was used to test the minimum inhibitory concentration (MIC) of cefoperazone-sulbactam or tigecycline in vitro and the combined effect was determined with the checkerboard method. The total combined effectiveness rate (including all patients who demonstrated an improved condition) was significantly higher in the TIG+CFS group (85.7%) compared with the TIG group (47.6%) (p = 0.010). No significant differences were noted with regard to the adverse reactions between the two groups. The 42 isolated XDR-AB strains were classified into four types. The MIC of the two drugs in combination was significantly lower than that of each drug used alone (p < 0.05). High dose of cefoperazone-sulbactam can improve the antimicrobial activity of tigecycline against XDR-AB.
.

Alcohol and cannabis: Comparing their adverse health effects and regulatory regimes.

PubMed

Hall, Wayne

2017-04-01

The claim that the adverse health effects of cannabis are much less serious than those of alcohol has been central to the case for cannabis legalisation. Regulators in US states that have legalised cannabis have adopted regulatory models based on alcohol. This paper critically examines the claim about adverse health effects and the wisdom of regulating cannabis like alcohol. First, it compares what we know about the adverse health effects of alcohol and cannabis. Second, it discusses the uncertainties about the long term health effects of sustained daily cannabis use. Third, it speculates about how the adverse health effects of cannabis may change after legalisation. Fourth, it questions the assumption that alcohol provides the best regulatory model for a legal cannabis market. Fifth, it outlines the major challenges in regulating cannabis under the liberal alcohol-like regulatory regimes now being introduced. Copyright © 2016 Elsevier B.V. All rights reserved.

Abandoned Mine Lands Program - Division of Mining, Land, and Water

Science.gov Websites

, safety, general welfare and property from extreme danger resulting from the adverse effects of past coal mining practices. 2. Protection of public health, safety and general welfare from adverse effects of past lands and waters and the environment previously degraded by adverse effects of past coal mining

Where to Start with Pesticide Incidents

Science.gov Websites

. Manufacturers are required by law to submit reports of adverse effects to the US EPA. Attention Physicians and . Manufacturers are required by law to submit reports of adverse effects to the US EPA. Consider contacting your . Please submit reports using our quick and easy Veterinary Pesticide Adverse Effects Reporting portal

75 FR 80496 - Registration Review; Pesticide Dockets Opened for Review and Comment and Other Docket Actions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-22

... high and adverse human health impacts or environmental effects from exposure to the pesticide(s... can still be used without unreasonable adverse effects on human health or the environment. A pesticide... perform its intended function without unreasonable adverse effects on human health or the environment...

78 FR 18586 - Registration Review; Pesticide Dockets Opened for Review and Comment and Other Docket Acts

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... adverse human health impacts or environmental effects from exposure to the pesticide(s) discussed in this... without unreasonable adverse effects on human health or the environment. A pesticide's registration review... perform its intended function without unreasonable adverse effects on human health or the environment...

The Effect of the Minimum Compensating Cash Balance on School District Investments.

ERIC Educational Resources Information Center

Dembowski, Frederick L.

Banks are usually reimbursed for their checking account services either by a fixed service charge or by requiring a minimum or minimum-average compensating cash balance. This paper demonstrates how to determine the optimal minimum balance for a school district to maintain in its account. It is assumed that both the bank and the school district use…

[Adverse Effect Predictions Based on Computational Toxicology Techniques and Large-scale Databases].

PubMed

Uesawa, Yoshihiro

2018-01-01

　Understanding the features of chemical structures related to the adverse effects of drugs is useful for identifying potential adverse effects of new drugs. This can be based on the limited information available from post-marketing surveillance, assessment of the potential toxicities of metabolites and illegal drugs with unclear characteristics, screening of lead compounds at the drug discovery stage, and identification of leads for the discovery of new pharmacological mechanisms. This present paper describes techniques used in computational toxicology to investigate the content of large-scale spontaneous report databases of adverse effects, and it is illustrated with examples. Furthermore, volcano plotting, a new visualization method for clarifying the relationships between drugs and adverse effects via comprehensive analyses, will be introduced. These analyses may produce a great amount of data that can be applied to drug repositioning.

[Similarity of Clinically Significant Neuropsychiatric Adverse Reactions Listed in Package Inserts between the Anti-influenza Drugs Oseltamivir and Amantadine (Possibility Attributable to Common Pharmacological Effects)].

PubMed

Ono, Hideki; Okamura, Maya; Fukushima, Akihiro

2018-06-20

  The anti-influenza virus drug oseltamivir has been reported to have several pharmacological actions including blocking of nicotinic acetylcholine receptor channels and activation of the dopaminergic system. These pharmacological actions highly overlap those of amantadine, another anti-influenza virus drug authorized in Japan, and ester-type local anesthetics. Moreover, oseltamivir and amantadine can clinically induce similar adverse neuropsychiatric reactions. In the present study, from the database of the Pharmaceuticals and Medical Devices Agency (PMDA), we surveyed 2,576 drugs for which neuropsychiatric side effects similar to those of oseltamivir, amantadine and local anesthetics (abnormal behavior, confusion, consciousness disturbance, convulsion, delirium, delusion, hallucination, myoclonus, tremor) are listed as "clinically significant adverse reactions", and found 327 that had at least one of these adverse reactions. Other neuraminidase inhibitors (laninamivir, peramivir and zanamivir) did not elicit such adverse reactions. By discussing the pharmacological effects of drugs that elicit these adverse reactions, we propose that the similarity of adverse neuropsychiatric reactions between oseltamivir and amantadine is possibly attributable to their common pharmacological effects.

Anomalies of hydrological cycle components during the 2007 heat wave in Bulgaria

NASA Astrophysics Data System (ADS)

Mircheva, Biliana; Tsekov, Milen; Meyer, Ulrich; Guerova, Guergana

2017-12-01

Heat waves have large adverse social, economic and environmental effects which include increased mortality, transport restrictions and a decreased agricultural production. The estimated economic losses of the 2007 heat wave in South-east Europe exceed 2 billion EUR with 19 000 hospitalisation in Romania only. Understanding the changes of the hydrological cycle components is essential for early forecasting of heat wave occurrence. Valuable insight of two components of the hydrological cycle, namely Integrated Water Vapour (IWV) and Terrestrial Water Storage Anomaly (TWSA), is now possible using observations from Global Navigation Satellite System (GNSS) and Gravity Recovery And Climate Experiment (GRACE) mission. In this study anomalies of temperature, precipitation, IWV and TWS in 2007 are compared to 2003-2013 period for Sofia, Bulgaria. In 2007, positive temperature anomalies are observed in January, February and July. There are negative IWV and precipitation anomalies in July 2007 that coincides with the heat wave in Bulgaria. TWSA in 2007 are negative in January, May and from July to October being largest in August. Long-term trends of: 1) temperatures have a local maximum in March 2007, 2) TWSA has a local minimum in May 2007, 3) IWV has a local minimum in September 2007, and 4) precipitation has a local maximum in July 2007. The TWSA interannual trends in Bulgaria, Hungary and Poland show similar behaviour as indicated by cross correlation coefficients of 0.9 and 0.7 between Bulgaria and Hungary and Bulgaria and Poland respectively. ALADIN-Climate describes the anomalies of temperature and IWV more successfully than those of precipitation and TWS.

Association of salivary gland hypofunction with diabetes mellitus and drugs among the elderly in Karachi, Pakistan.

PubMed

Lone, Muneeb Ahmed; Shaikh, Sameer; Lone, Maham Muneeb; Afaq, Ashar; Lone, Mohid Abrar

2017-05-01

Studies from Pakistan on salivary dysfunction are lacking, and the Pakistani elderly population is rapidly growing. Among the most common problems in the elderly that could have a deleterious impact on their quality of life are salivary gland hypofunction (SGH), diabetes mellitus (DM), and the intake of drugs with adverse effects on salivary function. In the present study, we aimed to find the association of SGH with DM and drugs among the elderly in Karachi, Pakistan. The inclusion criterion was affirmative answers to a series of standardized questions related to the symptoms of dry mouth. A total of 110 individuals were selected from a convenience sample of 200 people aged between 60 and 70 years. Diabetes, drug use, and SGH in the participants were determined by detailed medical and drug history, clinical examination, and sialometry. Similar to their international counterparts, the majority of the study participants demonstrated objective evidence of SGH. More importantly SGH was found to be statistically significant with respect to DM and medication (P < 0.05). For participants on medication, the minimum and maximum salivary flow rates were found to be 0.09 mL/min and 0.3 ml/min, respectively, whereas the minimum and maximum salivary flow rates in diabetic participants were 0.01 mL/min and 0.09 mL/min, respectively. In the present study, the majority of elderly participants whose presenting complaint was oral dryness was found to have objective evidence of SGH, with a statistically-significant association with DM and drugs. © 2016 John Wiley & Sons Australia, Ltd.

Jobs Taken by Mothers Moving from Welfare to Work and the Effects of Minimum Wages on This Transition.

ERIC Educational Resources Information Center

Brandon, Peter D.

The potential effects of raising the minimum wage on the earnings of mothers moving from welfare to work were examined by analyzing the differences that existed in the late 1980s in the various states' minimum wage rates and data from three waves of the Survey of Income and Program Participation for the years 1985-1990 (during which time 13 states…

Clinical and Radiographic Mid-Term Outcomes After Total Shoulder Replacement: A Retrospective Study Protocol Including 400 Anatomical and Reverse Prosthetic Implants

PubMed Central

Merolla, Giovanni; Tartarone, Antonio; Porcellini, Giuseppe

2016-01-01

Objectives: To obtain outcomes data on anatomical and reverse total shoulder arthroplasty by analysis of clinical scores and standard radiographs. Subject selection and enrollment: 400 consecutive series of patients replaced with anatomical and reverse total shoulder arthroplasty (minimum 3 years follow-up). Study Design: retrospective monocenter. Preoperative assessment: Demographics, clinical scores (Constant-Murley) as available, shoulder X-ray (AP, outlet and axillary views) . Last follow-up: Postoperative radiographhs and clinical scores. Adverse events and complications to be reported as occurred since implantation. Statistical analysis: Data collected will be summarized and analyzed for statistical significance. PMID:27326389

The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

PubMed

Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

2018-04-20

A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

Cost Effectiveness of Gastroprotection with Proton Pump Inhibitors in Older Low-Dose Acetylsalicylic Acid Users in the Netherlands.

PubMed

Chau, Sek Hung; Sluiter, Reinier L; Kievit, Wietske; Wensing, Michel; Teichert, Martina; Hugtenburg, Jacqueline G

2017-05-01

The present study aimed to assess the cost effectiveness of concomitant proton pump inhibitor (PPI) treatment in low-dose acetylsalicylic acid (LDASA) users at risk of upper gastrointestinal (UGI) adverse effects as compared with no PPI co-medication with attention to the age-dependent influence of PPI-induced adverse effects. We used a Markov model to compare the strategy of PPI co-medication with no PPI co-medication in older LDASA users at risk of UGI adverse effects. As PPIs reduce the risk of UGI bleeding and dyspepsia, these risk factors were modelled together with PPI adverse effects for LDASA users 60-69, 70-79 (base case) and 80 years and older. Incremental cost-utility ratios (ICURs) were calculated as cost per quality-adjusted life-year (QALY) gained per age category. Furthermore, a budget impact analysis assessed the expected changes in expenditure of the Dutch healthcare system following the adoption of PPI co-treatment in all LDASA users potentially at risk of UGI adverse effects. PPI co-treatment of 70- to 79-year-old LDASA users, as compared with no PPI, resulted in incremental costs of €100.51 at incremental effects of 0.007 QALYs with an ICUR of €14,671/QALY. ICURs for 60- to 69-year-old LDASA users were €13,264/QALY and €64,121/QALY for patients 80 years and older. Initiation of PPI co-treatment for all Dutch LDASA users of 60 years and older at risk of UGI adverse effects but not prescribed a PPI (19%) would have cost €1,280,478 in the first year (year 2013 values). PPI co-medication in LDASA users at risk of UGI adverse effects is generally cost effective. However, this strategy becomes less cost effective with higher age, particularly in patients aged 80 years and older, mainly due to the increased risks of PPI-induced adverse effects.

Minimum Surface-Effect Microgripper Design for Force-Reflective Telemanipulation of a Microscopic Environment

NASA Technical Reports Server (NTRS)

Goldfarb, Michael; Celanovic, Nikola

1996-01-01

This paper describes the fundamental physical motivations for minimum surface effect design, and presents a microgripper that incorporates a piezoelectric ceramic actuator and a flexure-based structure and transmission. The microgripper serves effectively as a one degree-of-freedom prototype of minimum surface effect micromanipulator design. Data is presented that characterizes the microgripper performance under both pure position and pure force control, followed by a discussion of the attributes and limitations of flexure-based design. The microgripper is interfaced with a force-reflective macrogripper, and the pair controlled with a hybrid position/force scheme. Data is presented that illustrates the effective operation of the telerobotic pair.

Caregivers' willingness-to-pay for Alzheimer's disease medications in Canada.

PubMed

Oremus, Mark; Tarride, Jean-Eric; Pullenayegum, Eleanor; Clayton, Natasha; Mugford, Gerry; Godwin, Marshall; Huan, Allen; Bacher, Yves; Villalpando, Juan-Manual; Gill, Sudeep S; Lanctôt, Krista L; Herrmann, Nathan; Raina, Parminder

2015-01-01

We studied caregivers' willingness-to-pay for Alzheimer's disease drug therapy. We recruited 216 caregivers of persons with mild or moderate Alzheimer's disease and presented them with four scenarios describing a hypothetical Alzheimer's disease medication. The scenarios described the medication as capable of either treating the symptoms of disease or modifying the course of disease. The scenarios also presented two different probabilities of adverse effects occurrence, i.e., 0% or 30%. Most caregivers said they would pay out-of-pocket for the medication, with support for such payment ranging from 68% to 93%, depending on the specific scenario. The highest level of support was for the 'disease modifying and no adverse effects' scenario, while the lowest level was for the 'symptom treatment and 30% chance of adverse effects' scenario. On average, caregivers' monthly willingness-to-pay out-of-pocket for the medication ranged from $214 to $277 (Canadian dollars). Dollar amounts were highest for the 'disease modifying and no adverse effects' scenario and lowest for the 'symptom treatment and 30% chance of adverse effects' scenario. Support for out-of-pocket payment and specific dollar amounts were highest when the medication did not involve adverse effects. Caregivers placed more value on the absence of adverse effects than on drug efficacy. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

The Italian Pharmacovigilance Program: An Observational Study of Adverse Effects of Natalizumab in Multiple Sclerosis Therapy.

PubMed

Giacoppo, Sabrina; Ruscica, Maria; Grimaldi, Luigi Maria; Bramanti, Placido; Mazzon, Emanuela

2017-09-02

BACKGROUND This study shows the results of a regional pharmacovigilance program on Natalizumab therapy in relapsing-remitting multiple sclerosis (RR-MS) patients after 3 years of experience. MATERIAL AND METHODS The primary objectives of this study were to estimate the incidence of expected and unexpected adverse effects correlated to Natalizumab therapy in a cohort of 88 RR-MS patients from Sicily, Italy, and to investigate the procedures adopted by the physicians to minimize the risk of developing severe adverse reactions correlated to Natalizumab therapy. Secondary objectives of this study were to evaluate the effectiveness of Natalizumab therapy for a careful examination of the risk/benefit ratio and to assess the actions undertaken in case of adverse reactions. RESULTS Among 88 RR-MS patients, 55.68% did not report any type of adverse reaction, 35.22% showed expected adverse reactions (58.70% slight, 22.58% moderate, and 19.35% severe), and 9.10% showed unexpected adverse effects (62.50% slight, 25.00% moderate, and 12.50% severe). Approximately 4.54% of the patients treated with Natalizumab interrupted the therapy. Overall, among all patients, 56.62% showed ameliorated condition, 32.53% had stable disease condition, and 10.85% worsened. CONCLUSIONS We provide a short overview of evidence, which may be useful to better characterize the efficacy and potential adverse effects correlated to Natalizumab therapy.

The Italian Pharmacovigilance Program: An Observational Study of Adverse Effects of Natalizumab in Multiple Sclerosis Therapy

PubMed Central

Giacoppo, Sabrina; Ruscica, Maria; Grimaldi, Luigi Maria; Bramanti, Placido; Mazzon, Emanuela

2017-01-01

Background This study shows the results of a regional pharmacovigilance program on Natalizumab therapy in relapsing-remitting multiple sclerosis (RR-MS) patients after 3 years of experience. Material/Methods The primary objectives of this study were to estimate the incidence of expected and unexpected adverse effects correlated to Natalizumab therapy in a cohort of 88 RR-MS patients from Sicily, Italy, and to investigate the procedures adopted by the physicians to minimize the risk of developing severe adverse reactions correlated to Natalizumab therapy. Secondary objectives of this study were to evaluate the effectiveness of Natalizumab therapy for a careful examination of the risk/benefit ratio and to assess the actions undertaken in case of adverse reactions. Results Among 88 RR-MS patients, 55.68% did not report any type of adverse reaction, 35.22% showed expected adverse reactions (58.70% slight, 22.58% moderate, and 19.35% severe), and 9.10% showed unexpected adverse effects (62.50% slight, 25.00% moderate, and 12.50% severe). Approximately 4.54% of the patients treated with Natalizumab interrupted the therapy. Overall, among all patients, 56.62% showed ameliorated condition, 32.53% had stable disease condition, and 10.85% worsened. Conclusions We provide a short overview of evidence, which may be useful to better characterize the efficacy and potential adverse effects correlated to Natalizumab therapy. PMID:28864818

Drug metabolism and transport gene polymorphisms and efavirenz adverse effects in Brazilian HIV-positive individuals.

PubMed

de Almeida, Tailah Bernardo; de Azevedo, Marcelo Costa Velho Mendes; Pinto, Jorge Francisco da Cunha; Ferry, Fernando Rafael de Almeida; da Silva, Guilherme Almeida Rosa; de Castro, Izana Junqueira; Baker, Paxton; Tanuri, Amilcar; Haas, David W; Cardoso, Cynthia C

2018-06-03

There are limited data regarding efavirenz pharmacogenetics in admixed populations. The Brazilian population is highly admixed. In a Brazilian cohort, we sought to characterize associations between efavirenz adverse effects (all-cause and CNS) and polymorphisms in seven genes known or suspected to affect efavirenz metabolism and transport. We studied 225 HIV-positive individuals who had been prescribed efavirenz-containing regimens at a hospital in Rio de Janeiro, Brazil. Eighty-nine cases had efavirenz adverse effects, including 43 with CNS adverse effects, while 136 controls had no adverse effect of any antiretroviral after treatment for at least 6 months. A total of 67 candidate polymorphisms in ABCB1, CYP2A6, CYP2B6, CYP3A4, CYP3A5, NR1I2 and NR1I3 genes were selected for association analysis. Admixture was assessed using 28 ancestry-informative polymorphisms previously validated for the Brazilian population. Associations were evaluated with logistic regression models adjusted for sex and genetic ancestry. There was extensive African, European and Native American admixture in the cohort. Increased all-cause adverse effects were associated with the CYP2B6 genotype combination 15582CC-516TT-983TT (OR = 7.26, P = 0.003) and with the CYP2B6 slow metabolizer group 516TT or 516GT-983CT (OR = 3.10, P = 0.04). CNS adverse effects were nominally associated with CYP3A4 rs4646437 (OR = 4.63, P = 0.014), but not after adjusting for multiple comparisons. In a highly admixed Brazilian cohort, the CYP2B6 slow metabolizer genotype was associated with an increased risk of efavirenz adverse effects.

Influence of the ventilatory mode on acute adverse effects and facial thermography after noninvasive ventilation

PubMed Central

Pontes, Suzy Maria Montenegro; Melo, Luiz Henrique de Paula; Maia, Nathalia Parente de Sousa; Nogueira, Andrea da Nóbrega Cirino; Vasconcelos, Thiago Brasileiro; Pereira, Eanes Delgado Barros; Bastos, Vasco Pinheiro Diógenes; Holanda, Marcelo Alcantara

2017-01-01

ABSTRACT Objective: To compare the incidence and intensity of acute adverse effects and the variation in the temperature of facial skin by thermography after the use of noninvasive ventilation (NIV). Methods: We included 20 healthy volunteers receiving NIV via oronasal mask for 1 h. The volunteers were randomly divided into two groups according to the ventilatory mode: bilevel positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP). Facial thermography was performed in order to determine the temperature of the face where it was in contact with the mask and of the nasal dorsum at various time points. After removal of the mask, the volunteers completed a questionnaire about adverse effects of NIV. Results: The incidence and intensity of acute adverse effects were higher in the individuals receiving BiPAP than in those receiving CPAP (16.1% vs. 5.6%). Thermographic analysis showed a significant cooling of the facial skin in the two regions of interest immediately after removal of the mask. The more intense acute adverse effects occurred predominantly among the participants in whom the decrease in the mean temperature of the nasal dorsum was lower (14.4% vs. 7.2%). The thermographic visual analysis of the zones of cooling and heating on the face identified areas of hypoperfusion or reactive hyperemia. Conclusions: The use of BiPAP mode was associated with a higher incidence and intensity of NIV-related acute adverse effects. There was an association between acute adverse effects and less cooling of the nasal dorsum immediately after removal of the mask. Cutaneous thermography can be an additional tool to detect adverse effects that the use of NIV has on facial skin. PMID:28538774

The effect of weight and drag on the sinking speed and lift/drag ratio of gliders

NASA Technical Reports Server (NTRS)

Kosin, R

1934-01-01

The most important factors in evaluating performance of gliders are minimum sinking speed and minimum gliding angle. To assure their optimum value the energy necessary for flight, that is, the energy of lift and friction must be kept very low, or in other words, weight and total drag which have a decisive effect on the sinking speed and on the gliding angle, must be kept to a minimum. How great the effect of a reduction of these two quantities will be shown in the following.

Citrate salts for preventing and treating calcium containing kidney stones in adults.

PubMed

Phillips, Rebecca; Hanchanale, Vishwanath S; Myatt, Andy; Somani, Bhaskar; Nabi, Ghulam; Biyani, C Shekhar

2015-10-06

Kidney stones affect people worldwide and have a high rate of recurrence even with treatment. Recurrences are particularly prevalent in people with low urinary citrate levels. These people have a higher incidence of calcium phosphate and calcium oxalate stones. Oral citrate therapy increases the urinary citrate levels, which in turn binds with calcium and inhibits the crystallisation thus reduces stone formation. Despite the widespread use of oral citrate therapy for prevention and treatment of calcium oxalate stones, the evidence to support its clinical efficacy remains uncertain. The objective of this review was to determine the efficacy and adverse events associated with citrate salts for the treatment and prevention of calcium containing kidney stones. We searched the Cochrane Kidney and Transplant Specialised Register to 29 July 2015 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. We included randomised controlled trials (RCTs) that assessed the efficacy and adverse events associated with citrate salts for the treatment and prevention of calcium containing kidney stones in adults treated for a minimum of six months. Two authors assessed studies for inclusion in this review. Data were extracted according to predetermined criteria. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) and 95% CI for continuous outcomes. We included seven studies that included a total of 477 participants, most of whom had oxalate stones. Of these, three studies (247 participants) compared potassium citrate with placebo or no intervention; three (166 participants) compared potassium-sodium citrate with no intervention; and one (64 participants) compared potassium-magnesium citrate with placebo. Overall, quality of the reporting of the included studies was considered moderate to poor, and there was a high risk of attrition bias in two studies.Compared with placebo or no intervention, citrate therapy significantly reduced the stone size (4 studies, 160 participants: RR 2.35, 95% CI 1.36 to 4.05). New stone formation was significantly lower with citrate therapy compared to control (7 studies, 324 participants: RR 0.26, 95% CI 0.10 to 0.68). The beneficial effect on stone size stability was also evident (4 studies, 160 participants: RR 1.97, 95% CI 1.19 to 3.26). Adverse events were reported in four studies, with the main side effects being upper gastrointestinal disturbance and one patient reported a rash. There were more gastrointestinal adverse events in the citrate group; however this was not significant (4 studies, 271 participants: RR 2.55, 95% CI 0.71 to 9.16). There were significantly more dropouts due to adverse events with citrate therapy compared to control (4 studies, 271 participants: RR 4.45, 95% CI 1.28 to 15.50). The need for retreatment was significantly less with citrate therapy compared to control (2 studies, 157 participants: RR 0.22, 95% CI 0.06 to 0.89). Citrate salts prevent new stone formation and reduce further stone growth in patients with residual stones that predominantly contain oxalate. The quality of reported literature remains moderate to poor; hence a well-designed statistically powered multi-centre RCT is needed in order to answer relevant questions concerning the efficacy of citrate salts.

Integrative Approaches to Evaluating Neurotoxicity Data for Risk Assessment.

EPA Science Inventory

Risk assessment classically has been based on single adverse outcomes identified as the Lowest Observable Adverse Effect Level (LOAEL) or the highest dose level in a credible study producing a No Observable Adverse Effect Level (NOAEL). While this approach has been useful overal...

Simulation of hydrodynamics, temperature, and dissolved oxygen in Table Rock Lake, Missouri, 1996-1997

USGS Publications Warehouse

Green, W. Reed; Galloway, Joel M.; Richards, Joseph M.; Wesolowski, Edwin A.

2003-01-01

Outflow from Table Rock Lake and other White River reservoirs support a cold-water trout fishery of substantial economic yield in south-central Missouri and north-central Arkansas. The Missouri Department of Conservation has requested an increase in existing minimum flows through the Table Rock Lake Dam from the U.S. Army Corps of Engineers to increase the quality of fishable waters downstream in Lake Taneycomo. Information is needed to assess the effect of increased minimum flows on temperature and dissolved- oxygen concentrations of reservoir water and the outflow. A two-dimensional, laterally averaged, hydrodynamic, temperature, and dissolved-oxygen model, CE-QUAL-W2, was developed and calibrated for Table Rock Lake, located in Missouri, north of the Arkansas-Missouri State line. The model simulates water-surface elevation, heat transport, and dissolved-oxygen dynamics. The model was developed to assess the effects of proposed increases in minimum flow from about 4.4 cubic meters per second (the existing minimum flow) to 11.3 cubic meters per second (the increased minimum flow). Simulations included assessing the effect of (1) increased minimum flows and (2) increased minimum flows with increased water-surface elevations in Table Rock Lake, on outflow temperatures and dissolved-oxygen concentrations. In both minimum flow scenarios, water temperature appeared to stay the same or increase slightly (less than 0.37 ?C) and dissolved oxygen appeared to decrease slightly (less than 0.78 mg/L) in the outflow during the thermal stratification season. However, differences between the minimum flow scenarios for water temperature and dissolved- oxygen concentration and the calibrated model were similar to the differences between measured and simulated water-column profile values.

A joint ERS/ATS policy statement: what constitutes an adverse health effect of air pollution? An analytical framework.

PubMed

Thurston, George D; Kipen, Howard; Annesi-Maesano, Isabella; Balmes, John; Brook, Robert D; Cromar, Kevin; De Matteis, Sara; Forastiere, Francesco; Forsberg, Bertil; Frampton, Mark W; Grigg, Jonathan; Heederik, Dick; Kelly, Frank J; Kuenzli, Nino; Laumbach, Robert; Peters, Annette; Rajagopalan, Sanjay T; Rich, David; Ritz, Beate; Samet, Jonathan M; Sandstrom, Thomas; Sigsgaard, Torben; Sunyer, Jordi; Brunekreef, Bert

2017-01-01

The American Thoracic Society has previously published statements on what constitutes an adverse effect on health of air pollution in 1985 and 2000. We set out to update and broaden these past statements that focused primarily on effects on the respiratory system. Since then, many studies have documented effects of air pollution on other organ systems, such as on the cardiovascular and central nervous systems. In addition, many new biomarkers of effects have been developed and applied in air pollution studies.This current report seeks to integrate the latest science into a general framework for interpreting the adversity of the human health effects of air pollution. Rather than trying to provide a catalogue of what is and what is not an adverse effect of air pollution, we propose a set of considerations that can be applied in forming judgments of the adversity of not only currently documented, but also emerging and future effects of air pollution on human health. These considerations are illustrated by the inclusion of examples for different types of health effects of air pollution. Copyright ©ERS 2017.

A joint ERS/ATS policy statement: what constitutes an adverse health effect of air pollution? An analytical framework

PubMed Central

Thurston, George D.; Kipen, Howard; Annesi-Maesano, Isabella; Balmes, John; Brook, Robert D.; Cromar, Kevin; De Matteis, Sara; Forastiere, Francesco; Forsberg, Bertil; Frampton, Mark W.; Grigg, Jonathan; Heederik, Dick; Kelly, Frank J.; Kuenzli, Nino; Laumbach, Robert; Peters, Annette; Rajagopalan, Sanjay T.; Rich, David; Ritz, Beate; Samet, Jonathan M.; Sandstrom, Thomas; Sigsgaard, Torben; Sunyer, Jordi; Brunekreef, Bert

2017-01-01

The American Thoracic Society has previously published statements on what constitutes an adverse effect on health of air pollution in 1985 and 2000. We set out to update and broaden these past statements that focused primarily on effects on the respiratory system. Since then, many studies have documented effects of air pollution on other organ systems, such as on the cardiovascular and central nervous systems. In addition, many new biomarkers of effects have been developed and applied in air pollution studies. This current report seeks to integrate the latest science into a general framework for interpreting the adversity of the human health effects of air pollution. Rather than trying to provide a catalogue of what is and what is not an adverse effect of air pollution, we propose a set of considerations that can be applied in forming judgments of the adversity of not only currently documented, but also emerging and future effects of air pollution on human health. These considerations are illustrated by the inclusion of examples for different types of health effects of air pollution. PMID:28077473

Safety of antipsychotics for the treatment of schizophrenia: a focus on the adverse effects of clozapine.

PubMed

De Berardis, Domenico; Rapini, Gabriella; Olivieri, Luigi; Di Nicola, Domenico; Tomasetti, Carmine; Valchera, Alessandro; Fornaro, Michele; Di Fabio, Fabio; Perna, Giampaolo; Di Nicola, Marco; Serafini, Gianluca; Carano, Alessandro; Pompili, Maurizio; Vellante, Federica; Orsolini, Laura; Martinotti, Giovanni; Di Giannantonio, Massimo

2018-05-01

Clozapine, a dibenzodiazepine developed in 1961, is a multireceptorial atypical antipsychotic approved for the treatment of resistant schizophrenia. Since its introduction, it has remained the drug of choice in treatment-resistant schizophrenia, despite a wide range of adverse effects, as it is a very effective drug in everyday clinical practice. However, clozapine is not considered as a top-of-the-line treatment because it may often be difficult for some patients to tolerate as some adverse effects can be particularly bothersome (i.e. sedation, weight gain, sialorrhea etc.) and it has some other potentially dangerous and life-threatening side effects (i.e. myocarditis, seizures, agranulocytosis or granulocytopenia, gastrointestinal hypomotility etc.). As poor treatment adherence in patients with resistant schizophrenia may increase the risk of a psychotic relapse, which may further lead to impaired social and cognitive functioning, psychiatric hospitalizations and increased treatment costs, clozapine adverse effects are a common reason for discontinuing this medication. Therefore, every effort should be made to monitor and minimize these adverse effects in order to improve their early detection and management. The aim of this paper is to briefly summarize and provide an update on major clozapine adverse effects, especially focusing on those that are severe and potentially life threatening, even if most of the latter are relatively uncommon.

Do Holocaust survivors show increased vulnerability or resilience to post-Holocaust cumulative adversity?

PubMed

Shrira, Amit; Palgi, Yuval; Ben-Ezra, Menachem; Shmotkin, Dov

2010-06-01

Prior trauma can hinder coping with additional adversity or inoculate against the effect of recurrent adversity. The present study further addressed this issue by examining whether a subsample of Holocaust survivors and comparison groups, drawn from the Israeli component of the Survey of Health, Ageing, and Retirement in Europe, were differentially affected by post-Holocaust cumulative adversity. Post-Holocaust cumulative adversity had a stronger effect on the lifetime depression of Holocaust survivors than on that of comparisons. However, comparisons were more negatively affected by post-Holocaust cumulative adversity when examining markers of physical and cognitive functioning. Our findings suggest that previous trauma can both sensitize and immunize, as Holocaust survivors show general resilience intertwined with specific vulnerability when confronted with additional cumulative adversity.

The association of minimum wage change on child nutritional status in LMICs: A quasi-experimental multi-country study.

PubMed

Ponce, Ninez; Shimkhada, Riti; Raub, Amy; Daoud, Adel; Nandi, Arijit; Richter, Linda; Heymann, Jody

2017-08-02

There is recognition that social protection policies such as raising the minimum wage can favourably impact health, but little evidence links minimum wage increases to child health outcomes. We used multi-year data (2003-2012) on national minimum wages linked to individual-level data from the Demographic and Health Surveys (DHS) from 23 low- and middle-income countries (LMICs) that had least two DHS surveys to establish pre- and post-observation periods. Over a pre- and post-interval ranging from 4 to 8 years, we examined minimum wage growth and four nutritional status outcomes among children under 5 years: stunting, wasting, underweight, and anthropometric failure. Using a differences-in-differences framework with country and time-fixed effects, a 10% increase in minimum wage growth over time was associated with a 0.5 percentage point decline in stunting (-0.054, 95% CI (-0.084,-0.025)), and a 0.3 percentage point decline in failure (-0.031, 95% CI (-0.057,-0.005)). We did not observe statistically significant associations between minimum wage growth and underweight or wasting. We found similar results for the poorest households working in non-agricultural and non-professional jobs, where minimum wage growth may have the most leverage. Modest increases in minimum wage over a 4- to 8-year period might be effective in reducing child undernutrition in LMICs.

Surveillance of adverse effects during a vaccination campaign against meningitis C.

PubMed

Laribière, Anne; Miremont-Salamé, Ghada; Reyre, Hadrien; Abouelfath, Abdelilah; Liège, Ludovic; Moore, Nicholas; Haramburu, Françoise

2005-12-01

To describe adverse events occurring after mass vaccination with conjugate and nonconjugate vaccines and to assess the incidence of serious adverse effects. A mass immunisation campaign against meningococcal C disease was conducted in two French administrative areas, Landes and Pyrénées atlantiques, for 2 months (from October to December 2002). Adverse events were reported by families and physicians by means of a specific reporting form returned to the pharmacovigilance centre 15 days after vaccination. The target population was 260,630 individuals aged between 2 months and 24 years. About 179,000 children and young adults were vaccinated. A total of 92,711 report forms were received by the pharmacovigilance centre, and 12,695 subjects presented at least one adverse event. The most frequently involved systems/disorders were application site disorders (48.4%), whole-body general disorders (21.8%), central and peripheral nervous system disorders (14.6%), and gastrointestinal system disorders (4.7%). Most of these adverse events were transient and not serious. There were 13 serious adverse events: one each of syncope, fever, headache with fever, neuralgia, serum sickness, arthritis, purpura, facial paralysis, multiple sclerosis, lipoma, and meningism, and two cases of bronchospasm. No significant difference was found in rates of adverse event reports between both vaccines. The estimated incidence of serious adverse effect reports was 7 per 100,000. This campaign was the second immunisation campaign undertaken in France involving both physicians and families as reporters. Although unlabeled adverse effects were identified during this campaign, they were mostly nonserious and have been known to occur with other vaccines.

Diffusion of robotics into clinical practice in the United States: process, patient safety, learning curves, and the public health.

PubMed

Mirheydar, Hossein S; Parsons, J Kellogg

2013-06-01

Robotic technology disseminated into urological practice without robust comparative effectiveness data. To review the diffusion of robotic surgery into urological practice. We performed a comprehensive literature review focusing on diffusion patterns, patient safety, learning curves, and comparative costs for robotic radical prostatectomy, partial nephrectomy, and radical cystectomy. Robotic urologic surgery diffused in patterns typical of novel technology spreading among practicing surgeons. Robust evidence-based data comparing outcomes of robotic to open surgery were sparse. Although initial Level 3 evidence for robotic prostatectomy observed complication outcomes similar to open prostatectomy, subsequent population-based Level 2 evidence noted an increased prevalence of adverse patient safety events and genitourinary complications among robotic patients during the early years of diffusion. Level 2 evidence indicated comparable to improved patient safety outcomes for robotic compared to open partial nephrectomy and cystectomy. Learning curve recommendations for robotic urologic surgery have drawn exclusively on Level 4 evidence and subjective, non-validated metrics. The minimum number of cases required to achieve competency for robotic prostatectomy has increased to unrealistically high levels. Most comparative cost-analyses have demonstrated that robotic surgery is significantly more expensive than open or laparoscopic surgery. Evidence-based data are limited but suggest an increased prevalence of adverse patient safety events for robotic prostatectomy early in the national diffusion period. Learning curves for robotic urologic surgery are subjective and based on non-validated metrics. The urological community should develop rigorous, evidence-based processes by which future technological innovations may diffuse in an organized and safe manner.

A randomized, controlled trial of Veriset™ hemostatic patch in halting cardiovascular bleeding.

PubMed

Glineur, David; Hendrikx, Marc; Krievins, Dainis; Stradins, Peteris; Voss, Bernhard; Waldow, Thomas; Haenen, Luc; Oberhoffer, Martin; Ritchie, Caroline M

2018-01-01

Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsatile arterial bleeding. The aim of this study was to assess the effectiveness and safety of Veriset™ hemostatic patch in treating cardiovascular bleeding. Patients (N=90) scheduled for cardiac or vascular surgery at 12 European institutions were randomized 1:1 to treatment with either Veriset™ hemostatic patch (investigational device) or TachoSil ® (control). After application of the hemostat, according to manufacturer instructions for use, time to hemostasis was monitored. Follow-up occurred up to 90 days post-surgery. Median time to hemostasis was 1.5 min with Veriset™ hemostatic patch, compared to 3.0 min with TachoSil ® ( p <0.0001). Serious adverse events within 30 days post-surgery were experienced by 12/44 (27.3%) patients treated with Veriset™ hemostatic patch and 10/45 (22.2%) in the TachoSil ® group ( p =0.6295). None of these adverse events were device-related, and no reoperations for bleeding were required within 5 days post-surgery in either treatment group. This study reinforces the difference in minimum recommended application time between Veriset™ hemostatic patch and TachoSil ® (30 s versus 3 min respectively). When compared directly at 3 min, Veriset™ displayed no significant difference, showing similar hemostasis and safety profiles on the cardiovascular bleeding sites included in this study.

Predictors of Functional Change in a Skilled Nursing Facility Population.

PubMed

Gustavson, Allison M; Falvey, Jason R; Forster, Jeri E; Stevens-Lapsley, Jennifer E

2017-06-21

Inability to obtain sufficient gains in function during a skilled nursing facility (SNF) stay impacts patients' functional trajectories and susceptibility to adverse events. The purpose of this study was to identify predictors of functional change in patients temporarily residing in an SNF following hospitalization. One hundred forty patients admitted to a single SNF from the hospital who had both evaluation and discharge measures of physical function documented were included. Data from the Minimum Data Set 3.0 and electronic medical record were extracted to record clinical and demographic characteristics. The Short Physical Performance Battery (SPPB) was administered by rehabilitation therapists at evaluation and discharge. The SPPB consists of balance tests, gait speed, and a timed 5-time sit-to-stand test. The Patient Health Questionnaire (PHQ-9) Screening Tool for Depression was the only significant predictor of change in gait speed over an SNF stay. Eighty-seven percent of patients achieved a clinically meaningful change in the SPPB of 1 point or greater from evaluation to discharge, with 78% demonstrating a clinically meaningful change of 0.1 m/s or greater on gait speed. However, 69% of patients demonstrated SPPB scores of 6 points or less and 57% ambulated less than 0.65 m/s at the time of discharge from the SNF, which indicates severe disability. Poor physical function following an SNF stay places older adult at significant risk for adverse events including rehospitalization, future disability, and institutionalization. Understanding the predictors of functional change from evaluation to discharge may direct efforts toward developing innovative and effective interventions to improve function trajectories for older adults following an acute hospitalization.

Minimum alcohol pricing policies in practice: A critical examination of implementation in Canada.

PubMed

Thompson, Kara; Stockwell, Tim; Wettlaufer, Ashley; Giesbrecht, Norman; Thomas, Gerald

2017-02-01

There is an interest globally in using Minimum Unit Pricing (MUP) of alcohol to promote public health. Canada is the only country to have both implemented and evaluated some forms of minimum alcohol prices, albeit in ways that fall short of MUP. To inform these international debates, we describe the degree to which minimum alcohol prices in Canada meet recommended criteria for being an effective public health policy. We collected data on the implementation of minimum pricing with respect to (1) breadth of application, (2) indexation to inflation and (3) adjustments for alcohol content. Some jurisdictions have implemented recommended practices with respect to minimum prices; however, the full harm reduction potential of minimum pricing is not fully realised due to incomplete implementation. Key concerns include the following: (1) the exclusion of minimum prices for several beverage categories, (2) minimum prices below the recommended minima and (3) prices are not regularly adjusted for inflation or alcohol content. We provide recommendations for best practices when implementing minimum pricing policy.

WindVOiCe, a Self-Reporting Survey: Adverse Health Effects, Industrial Wind Turbines, and the Need for Vigilance Monitoring

ERIC Educational Resources Information Center

Krogh, Carmen M. E.; Gillis, Lorrie; Kouwen, Nicholas; Aramini, Jeff

2011-01-01

Industrial wind turbines have been operating in many parts of the globe. Anecdotal reports of perceived adverse health effects relating to industrial wind turbines have been published in the media and on the Internet. Based on these reports, indications were that some residents perceived they were experiencing adverse health effects. The purpose…

20 CFR 655.200 - General description of this subpart and definition of terms.

Code of Federal Regulations, 2011 CFR

2011-04-01

... designee. Adverse effect rate means the wage rate which the OFLC Administrator has determined must be... the prevailing wage rate in the area and/or occupation is the adverse effect rate, if the use (or non... may determine that a wage rate higher than the prevailing wage rate is the adverse effect rate if the...

20 CFR 655.200 - General description of this subpart and definition of terms.

Code of Federal Regulations, 2012 CFR

2012-04-01

... designee. Adverse effect rate means the wage rate which the OFLC Administrator has determined must be... the prevailing wage rate in the area and/or occupation is the adverse effect rate, if the use (or non... may determine that a wage rate higher than the prevailing wage rate is the adverse effect rate if the...

20 CFR 655.200 - General description of this subpart and definition of terms.

Code of Federal Regulations, 2013 CFR

2013-04-01

... designee. Adverse effect rate means the wage rate which the OFLC Administrator has determined must be... the prevailing wage rate in the area and/or occupation is the adverse effect rate, if the use (or non... may determine that a wage rate higher than the prevailing wage rate is the adverse effect rate if the...

20 CFR 655.200 - General description of this subpart and definition of terms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... designee. Adverse effect rate means the wage rate which the OFLC Administrator has determined must be... the prevailing wage rate in the area and/or occupation is the adverse effect rate, if the use (or non... may determine that a wage rate higher than the prevailing wage rate is the adverse effect rate if the...

32 CFR 223.6 - Procedures-identifying and controlling DoD UCNI.

Code of Federal Regulations, 2013 CFR

2013-07-01

... information could reasonably be expected to have an adverse effect on the health and safety of the public or... nuclear weapons in DoD custody. This is called the “adverse effects test.” (2) DoD UCNI shall be... adverse effects test. (2) Information shall be protected as DoD UCNI if it qualifies for one or more of...

32 CFR 223.6 - Procedures-identifying and controlling DoD UCNI.

Code of Federal Regulations, 2014 CFR

2014-07-01

... information could reasonably be expected to have an adverse effect on the health and safety of the public or... nuclear weapons in DoD custody. This is called the “adverse effects test.” (2) DoD UCNI shall be... adverse effects test. (2) Information shall be protected as DoD UCNI if it qualifies for one or more of...

Search strategies to identify information on adverse effects: a systematic review

PubMed Central

Golder, Su; Loke, Yoon

2009-01-01

Objectives: The review evaluated studies of electronic database search strategies designed to retrieve adverse effects data for systematic reviews. Methods: Studies of adverse effects were located in ten databases as well as by checking references, hand-searching, searching citations, and contacting experts. Two reviewers screened the retrieved records for potentially relevant papers. Results: Five thousand three hundred thirteen citations were retrieved, yielding 19 studies designed to develop or evaluate adverse effect filters, of which 3 met the inclusion criteria. All 3 studies identified highly sensitive search strategies capable of retrieving over 95% of relevant records. However, 1 study did not evaluate precision, while the level of precision in the other 2 studies ranged from 0.8% to 2.8%. Methodological issues in these papers included the relatively small number of records, absence of a validation set of records for testing, and limited evaluation of precision. Conclusions: The results indicate the difficulty of achieving highly sensitive searches for information on adverse effects with a reasonable level of precision. Researchers who intend to locate studies on adverse effects should allow for the amount of resources and time required to conduct a highly sensitive search. PMID:19404498

Childhood abuse affects emotional closeness with family in mid- and later life.

PubMed

Savla, J Tina; Roberto, Karen A; Jaramillo-Sierra, Ana L; Gambrel, Laura Eubanks; Karimi, Hassan; Butner, L Michelle

2013-06-01

Knowledge about the effects of early life adversity on kin relationships in later years is sparse. The purpose of this study was to examine if childhood abuse and adversity negatively influences emotional closeness with family in mid- and later life. A second goal was to determine the role of psychosocial resources and personality traits in buffering the effects of early adversities. Gender and cohort differences were explored to see if men were differentially affected than women and whether middle-aged adults (35-49 years old) were differentially affected than older adults (50-74 years old) by the effects of childhood abuse and adversity. Using retrospective accounts of early family abuse and adversities of 1,266 middle aged adults and 1,219 older adults from a large population-based survey, the National Survey of Midlife Development in United States (MIDUS), separate multiple regression analyses were conducted for the two cohorts to examine the effects of childhood emotional and physical abuse and family adversities on perceived emotional closeness with family. Interaction effects between childhood abuse and adversity (e.g., being expelled from school, death of sibling, parental divorce, losing a home to a natural disaster) with psychosocial resources (perceived control and self acceptance), personality characteristics (extraversion and neuroticism), and gender were examined. Results of OLS regressions suggest emotional and physical abuse predicted family closeness in middle-aged adults. Conversely, only emotional abuse predicted family closeness in older adults. Moderation models revealed that high levels of self acceptance were associated with better maintenance of emotional closeness among middle-aged adults who were emotionally and physically abused as children. Older adults with lower extraversion who experienced emotional abuse or reported greater number of adversities in childhood were found to be at higher risk for lower emotional closeness with family. Early life adversities were more detrimental for women. Findings suggest that the aftermath of childhood abuse does not dissipate with time, but continues to influence family relationships in mid- and later life. Identifying the links between childhood adversities and adult relationships can help identify strategic points for intervention to reduce the long-term effects of accumulated adverse experiences over the life course. Published by Elsevier Ltd.

41 CFR 50-203.22 - Effective date of determinations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Public Contracts PUBLIC CONTRACTS, DEPARTMENT OF LABOR 203-RULES OF PRACTICE Minimum Wage Determinations Under the Walsh-Healey Public Contracts Act § 50-203.22 Effective date of determinations. Any minimum wage determination issued as a result of hearings held under this subpart shall take effect not less...

Minimum surface-effect microgripper design for force-reflective telemanipulation of a microscopic environment

NASA Technical Reports Server (NTRS)

Goldfarb, Michael; Celanovic, Nikola

1996-01-01

This paper describes the fundamental physical motivations for a minimum surface effect design, and presents a microgripper that incorporates a piezoelectric ceramic actuator and a flexure-based structure and transmission. The microgripper serves effectively as a one degree-of-freedom prototype of a minimum surface effect micromanipulator design. Data is presented that characterizes the microgripper performance under both pure position and pure force control, followed by a discussion of the attributes and limitations of flexure-based design. The microgripper is interfaced with a force reflective macrogripper, and the pair is controlled with a hybrid position/force scheme. Data is presented that illustrates the effective operation of the telerobotic pair.

Complications During Ketogenic Diet Initiation: Prevalence, Treatment, and Influence on Seizure Outcomes.

PubMed

Lin, Abigail; Turner, Zahava; Doerrer, Sarah C; Stanfield, Anthony; Kossoff, Eric H

2017-03-01

Many centers still admit children for several days to start the ketogenic diet. The exact incidence of adverse effects during the admission and their potential later impact on seizure reduction has not been widely studied. We performed a retrospective study of children with intractable epilepsy electively admitted for ketogenic diet initiation at our institution from 2011 to 2016. Charts were reviewed for adverse effects during the admission period and then examined for seizure reduction and compliance at three months. A rating scale (1 to 4) was created for severity of any adverse events. A total of 158 children were included, with the mean age 4.6 years. Potentially attributable adverse effects occurred in 126 (80%) children, most commonly emesis, food refusal, and hypoglycemia. Seventy-three (46%) children received some form of intervention by the medical team, most commonly the administration of juice (24%). Younger age was correlated with an increased likelihood of moderate to severe adverse effects during admission, often repeated hypoglycemia (3.6 versus 4.9 years, P = 0.04). Fasting was more likely to result in lethargy and a single blood glucose in the 30 to 40 mg/dL range, but it was not correlated with emesis, repeated hypoglycemia, or higher adverse effect scores. There was no statistically significant correlation between the severity of adverse effects and the three-month seizure reduction. Mild easily treated adverse effects occurred in most children admitted for the ketogenic diet. Younger children were at greater risk for significant difficulties and should be monitored closely. Because fasting led to more lethargy and hypoglycemia, it may be prudent to avoid this in younger children. Copyright © 2017 Elsevier Inc. All rights reserved.

[Serious systemic adverse events associated with allergen-specific immunotherapy in children with asthma].

PubMed

Dai, Li; Huang, Ying; Wang, Ying; Han, Huan-Li; Li, Qu-Bei; Jiang, Yong-Hui

2014-01-01

To retrospectively assess serious systemic adverse effects of standardized dust-mite vaccine in children with asthma. Medical records of 704 children (5-17 years in age) with asthma between January, 2005 and December, 2011 were reviewed. Serious systemic adverse events following treatment with a standardized dust-mite vaccine in these children were analyzed. A total of 336 systemic adverse reactions were observed in 17.0% (120/704) of the patients analyzed of these adverse reactions, 18 (5.4%) were serious (level 3), 318 (94.6%) were not serious (below level 3), and no single case of anaphylactic shock (level 4) was recorded. Systemic adverse events occurred most frequently in the 5 to 11-year age group and in the summer season (from June to August). In the 18 severe cases, the peak expiratory flow (PEF) dropped by 20% immediately after the vaccine injection, and other major clinical symptoms included cough, wheezing and urticaria. All children with serious systemic adverse effects were given inhaled hormone and atomized short-acting beta agonists, oral antihistamines, intravenous dexamethasone and/or intramuscular adrenaline. After these treatments, the clinical symptoms were significantly relieved. The rate of serious systemic adverse events following allergen-specific immunotherapy is relatively low in children with allergic asthma. Conventional medications are effective in managing these immunotherapy-associated adverse events.

Mismatch or allostatic load? Timing of life adversity differentially shapes gray matter volume and anxious temperament.

PubMed

Kuhn, Manuel; Scharfenort, Robert; Schümann, Dirk; Schiele, Miriam A; Münsterkötter, Anna L; Deckert, Jürgen; Domschke, Katharina; Haaker, Jan; Kalisch, Raffael; Pauli, Paul; Reif, Andreas; Romanos, Marcel; Zwanzger, Peter; Lonsdorf, Tina B

2016-04-01

Traditionally, adversity was defined as the accumulation of environmental events (allostatic load). Recently however, a mismatch between the early and the later (adult) environment (mismatch) has been hypothesized to be critical for disease development, a hypothesis that has not yet been tested explicitly in humans. We explored the impact of timing of life adversity (childhood and past year) on anxiety and depression levels (N = 833) and brain morphology (N = 129). Both remote (childhood) and proximal (recent) adversities were differentially mirrored in morphometric changes in areas critically involved in emotional processing (i.e. amygdala/hippocampus, dorsal anterior cingulate cortex, respectively). The effect of adversity on affect acted in an additive way with no evidence for interactions (mismatch). Structural equation modeling demonstrated a direct effect of adversity on morphometric estimates and anxiety/depression without evidence of brain morphology functioning as a mediator. Our results highlight that adversity manifests as pronounced changes in brain morphometric and affective temperament even though these seem to represent distinct mechanistic pathways. A major goal of future studies should be to define critical time periods for the impact of adversity and strategies for intervening to prevent or reverse the effects of adverse childhood life experiences. © The Author (2015). Published by Oxford University Press.

Mismatch or allostatic load? Timing of life adversity differentially shapes gray matter volume and anxious temperament

PubMed Central

Kuhn, Manuel; Scharfenort, Robert; Schümann, Dirk; Schiele, Miriam A.; Münsterkötter, Anna L.; Deckert, Jürgen; Domschke, Katharina; Haaker, Jan; Kalisch, Raffael; Pauli, Paul; Reif, Andreas; Romanos, Marcel; Zwanzger, Peter

2016-01-01

Traditionally, adversity was defined as the accumulation of environmental events (allostatic load). Recently however, a mismatch between the early and the later (adult) environment (mismatch) has been hypothesized to be critical for disease development, a hypothesis that has not yet been tested explicitly in humans. We explored the impact of timing of life adversity (childhood and past year) on anxiety and depression levels (N = 833) and brain morphology (N = 129). Both remote (childhood) and proximal (recent) adversities were differentially mirrored in morphometric changes in areas critically involved in emotional processing (i.e. amygdala/hippocampus, dorsal anterior cingulate cortex, respectively). The effect of adversity on affect acted in an additive way with no evidence for interactions (mismatch). Structural equation modeling demonstrated a direct effect of adversity on morphometric estimates and anxiety/depression without evidence of brain morphology functioning as a mediator. Our results highlight that adversity manifests as pronounced changes in brain morphometric and affective temperament even though these seem to represent distinct mechanistic pathways. A major goal of future studies should be to define critical time periods for the impact of adversity and strategies for intervening to prevent or reverse the effects of adverse childhood life experiences. PMID:26568620

Design of a triple-bend isochronous achromat with minimum coherent-synchrotron-radiation-induced emittance growth

NASA Astrophysics Data System (ADS)

Venturini, M.

2016-06-01

Using a 1D steady-state free-space coherent synchrotron radiation (CSR) model, we identify a special design setting for a triple-bend isochronous achromat that yields vanishing emittance growth from CSR. When a more refined CSR model with transient effects is included in the analysis, numerical simulations show that the main effect of the transients is to shift the emittance growth minimum slightly, with the minimum changing only modestly.

Design of a triple-bend isochronous achromat with minimum coherent-synchrotron-radiation-induced emittance growth

DOE PAGES

Venturini, M.

2016-06-09

Using a 1D steady-state free-space coherent synchrotron radiation (CSR) model, we identify a special design setting for a triple-bend isochronous achromat that yields vanishing emittance growth from CSR. When a more refined CSR model with transient effects is included in the analysis, numerical simulations show that the main effect of the transients is to shift the emittance growth minimum slightly, with the minimum changing only modestly.

Impact of extended duty hours on medical trainees

PubMed Central

Weiss, Pnina; Kryger, Meir; Knauert, Melissa

2018-01-01

Many studies on resident physicians have demonstrated that extended work hours are associated with a negative impact on well-being, education, and patient care. However, the relationship between the work schedule and the degree of impairment remains unclear. In recent years, because of concerns for patient safety, national minimum standards for duty hours have been instituted (2003) and revised (2011). These changes were based on studies of the effects of sleep deprivation on human performance and specifically on the effect of extended shifts on resident performance. These requirements necessitated significant restructuring of resident schedules. Concerns were raised that these changes have impaired continuity of care, resident education and supervision, and patient safety. We review the studies on the effect of extended work hours on resident well-being, education, and patient care as well as those assessing the effect of work hour restrictions. Although many studies support the adverse effects of extended shifts, there are some conflicting results due to factors such as heterogeneity of protocols, schedules, subjects, and environments. Assessment of the effect of work hour restrictions has been even more difficult. Recent data demonstrating that work hour limitations have not been associated with improvement in patient outcomes or resident education and well-being have been interpreted as support for lifting restrictions in some specialties. However, these studies have significant limitations and should be interpreted with caution. Until future research clarifies duty hours that optimize patient outcomes, resident education, and well-being, it is recommended that current regulations be followed. PMID:29073389

Environmental Assessment of the General Plan and Maintenance of Patrick Air Force Base, Florida

DTIC Science & Technology

2012-07-17

water consumption . Per the National Energy Conservation Policy Act, sustainable design principles and life-cycle cost- effective technologies will...attached EA concluded that no significant adverse effects will result. No significant adverse cumulative impacts will result from activities associated...resources will be considered an adverse effect , however, sufficient documentation had been received for Facilities 1322, 1327, 1330, 1425, 1432, 1437 and

ACHP | News

Science.gov Websites

referred a disputed no adverse effect finding to the ACHP pursuant to 36 CFR § 800.5(c)(3) or provided the ACHP a notice of an adverse effect pursuant to 36 CFR § 800.6(a)(1), the deadline for a response from , if the ACHP received a referral of a disputed no adverse effect finding five days before the shutdown

Early adversity and risk for moderate to severe unipolar depressive disorder in adolescence and adulthood: A register-based study of 978,647 individuals.

PubMed

Dahl, Signe Kirk; Larsen, Janne Tidselbak; Petersen, Liselotte; Ubbesen, Mads Bonde; Mortensen, Preben Bo; Munk-Olsen, Trine; Musliner, Katherine Louise

2017-05-01

Early adversity is a known risk factor for unipolar depression. We examined the impact of 9 types of early adversity on risk for moderate to severe unipolar depression in adolescence or adulthood, and evaluated whether these effects were moderated by gender and adversity timing. We conducted a prospective, population-based cohort study using Danish national registers. The sample included all individuals born in Denmark between 1980 and 1998 (N=978,647). Exposure to early adversity was assessed from ages 0-15. Types of adversity included parental illness, incarceration, death, disability, and psychiatric diagnosis; family disruption; out-of-home care; and childhood abuse. Individuals were followed from age 15 until first in- or outpatient depression diagnosis (ICD-10 codes F32, F33) in a psychiatric hospital, death, emigration, or December 31st, 2013, whichever came first. Hazard ratios (HRs) were calculated using Cox regressions. All adversities were significantly associated with increased risk for moderate to severe adolescent/adult depression (HR range: 1.30-2.72), although the effects were attenuated after mutual adjustment (adjusted HR range: 1.06-1.70). None of the effects were moderated by gender. The effect of family disruption was strongest between ages 0-4 (HR=1.66, 95% CI=1.61-1.71), while the effect of out-of-home care was strongest between ages 10-14 (HR=2.45, 95% CI=2.28-2.64). Untreated and primary-care treated depression were not measured. Our results support past findings that multiple types of early adversity increase risk for moderate to severe unipolar depression in adolescence and adulthood. Certain adversities may be more harmful if they occur during specific developmental time periods. Copyright © 2017 Elsevier B.V. All rights reserved.

Potential adverse effects of omega-3 Fatty acids in dogs and cats.

PubMed

Lenox, C E; Bauer, J E

2013-01-01

Fish oil omega-3 fatty acids, mainly eicosapentaenoic acid and docosahexaenoic acid, are used in the management of several diseases in companion animal medicine, many of which are inflammatory in nature. This review describes metabolic differences among omega-3 fatty acids and outlines potential adverse effects that may occur with their supplementation in dogs and cats with a special focus on omega-3 fatty acids from fish oil. Important potential adverse effects of omega-3 fatty acid supplementation include altered platelet function, gastrointestinal adverse effects, detrimental effects on wound healing, lipid peroxidation, potential for nutrient excess and toxin exposure, weight gain, altered immune function, effects on glycemic control and insulin sensitivity, and nutrient-drug interactions. Copyright © 2013 by the American College of Veterinary Internal Medicine.

Determining size and dispersion of minimum viable populations for land management planning and species conservation

NASA Astrophysics Data System (ADS)

Lehmkuhl, John F.

1984-03-01

The concept of minimum populations of wildlife and plants has only recently been discussed in the literature. Population genetics has emerged as a basic underlying criterion for determining minimum population size. This paper presents a genetic framework and procedure for determining minimum viable population size and dispersion strategies in the context of multiple-use land management planning. A procedure is presented for determining minimum population size based on maintenance of genetic heterozygosity and reduction of inbreeding. A minimum effective population size ( N e ) of 50 breeding animals is taken from the literature as the minimum shortterm size to keep inbreeding below 1% per generation. Steps in the procedure adjust N e to account for variance in progeny number, unequal sex ratios, overlapping generations, population fluctuations, and period of habitat/population constraint. The result is an approximate census number that falls within a range of effective population size of 50 500 individuals. This population range defines the time range of short- to long-term population fitness and evolutionary potential. The length of the term is a relative function of the species generation time. Two population dispersion strategies are proposed: core population and dispersed population.

Preterm premature ruptured membranes: a randomized trial of steroids after treatment with antibiotics.

PubMed

Lewis, D F; Brody, K; Edwards, M S; Brouillette, R M; Burlison, S; London, S N

1996-11-01

To assess the effectiveness of corticosteroids in patients with preterm premature rupture of membranes (PROM) after treatment with a broad-spectrum antibiotic, ampicillin-sulbactam. A randomized clinical trial of corticosteroids in patients with preterm PROM was undertaken after treating these patients for a minimum of 12 hours with ampicillin-sulbactam. No digital vaginal examinations were performed on these patients. Antibiotics were continued for 7 days and the steroids were repeated weekly. No tocolytics were used. The primary outcome measure was the incidence of respiratory distress syndrome (RDS). Secondary outcome measures included latency period and neonatal and maternal infectious morbidity. Seventy-seven patients were enrolled and data about their pregnancies were analyzed. No statistically significant difference in latency period was noted (14.7 days in the steroid group, 15.8 days in the no-steroid group). Both neonatal and maternal infectious morbidity were similar. A significant reduction in the incidence of RDS (18.4 versus 43.6%, P = .03) were observed in the steroid group. These data suggest that treating preterm PROM patients with a broad-spectrum antibiotic before corticosteroids decreases RDS without apparent adverse sequelae.

Optimization study of ethanolic fermentation from oil palm trunk, rubberwood and mixed hardwood hydrolysates using Saccharomyces cerevisiae.

PubMed

Chin, K L; H'ng, P S; Wong, L J; Tey, B T; Paridah, M T

2010-05-01

Ethanolic fermentation using Saccharomyces cerevisiae was carried out on three types of hydrolysates produced from lignocelulosic biomass which are commonly found in Malaysia such as oil palm trunk, rubberwood and mixed hardwood. The effect of fermentation temperature and pH of hydrolysate was evaluated to optimize the fermentation efficiency which defined as maximum ethanol yield in minimum fermentation time. The fermentation process using different temperature of 25 degrees Celsius, 30 degrees Celsius and 40 degrees Celsius were performed on the prepared fermentation medium adjusted to pH 4, pH 6 and pH 7, respectively. Results showed that the fermentation time was significantly reduced with the increase of temperature but an adverse reduction in ethanol yield was observed using temperature of 40 degrees Celsius. As the pH of hydrolysate became more acidic, the ethanol yield increased. Optimum fermentation efficiency for ethanolic fermentation of lignocellulosic hydrolysates using S. cerevisiae can be obtained using 33.2 degrees Celsius and pH 5.3. Copyright 2009 Elsevier Ltd. All rights reserved.

Clinical Outcomes of Intravitreal Preservative-Free Triamcinolone Preparation (Triesence®) for Cystoid Macular Oedema and Inflammation in Patients with Uveitis.

PubMed

Steeples, Laura R; Anand, Nitin; Moraji, Jiten; Jones, Nicholas P

2017-03-20

To assess the outcomes of intravitreal benzyl alcohol-free triamcinolone acetonide suspension in uveitis-related macular oedema. Single-center retrospective cohort study of 66 injections to 44 eyes of 40 patients. Uveitis diagnosis, systemic and local therapy, intraocular pressure (IOP), central retinal thickness (CRT), number of injections, time to re-injection and side-effects were noted during 6-months minimum follow-up. Sixty eight percent of eyes received a single injection. 18% required 2 injections, and 13% received ≥3 injections with mean time to second and third injections of 25.5 and 52.7 weeks, respectively. 90% of injections were unilateral. Mean CRT reduced, and by 12-weeks visual acuity improvement >0.3logMar was achieved in 46%. Cataract progression (47%) and IOP>21 mmHg (45%) were the commonest adverse events. Preservative-free triamcinolone is an additional option for uveitis-related macular oedema, particularly in unilateral cases, with favorable CRT and visual outcomes. Repeat injections may be necessary, and the period of efficacy varies between eyes.

Further evaluation of the tropane analogs of haloperidol.

PubMed

Sampson, Dinithia; Bricker, Barbara; Zhu, Xue Y; Peprah, Kwakye; Lamango, Nazarius S; Setola, Vincent; Roth, Bryan L; Ablordeppey, Seth Y

2014-09-01

Previous work from our labs has indicated that a tropane analog of haloperidol with potent D2 binding but designed to avoid the formation of MPP(+)-like metabolites, such as 4-(4-chlorophenyl)-1-(4-(4-fluorophenyl)-4-oxobutyl)pyridin-1-ium (BCPP(+)) still produced catalepsy, suggesting a strong role for the D2 receptor in the production of catalepsy in rats, and hence EPS in humans. This study tested the hypothesis that further modifications of the tropane analog to produce compounds with less potent binding to the D2 receptor than haloperidol, would produce less catalepsy. These tests have now revealed that while haloperidol produced maximum catalepsy, these compounds produced moderate to low levels of catalepsy. Compound 9, with the least binding affinity to the D2R, produced the least catalepsy and highest Minimum Adverse Effective Dose (MAED) of the analogs tested regardless of their affinities at other receptors including the 5-HT1AR. These observations support the hypothesis that moderation of the D2 binding of the tropane analogs could reduce catalepsy potential in rats and consequently EPS in man. Published by Elsevier Ltd.

Estimation of Leakage Potential of Selected Sites in Interstate and Tri-State Canals Using Geostatistical Analysis of Selected Capacitively Coupled Resistivity Profiles, Western Nebraska, 2004

USGS Publications Warehouse

Vrabel, Joseph; Teeple, Andrew; Kress, Wade H.

2009-01-01

With increasing demands for reliable water supplies and availability estimates, groundwater flow models often are developed to enhance understanding of surface-water and groundwater systems. Specific hydraulic variables must be known or calibrated for the groundwater-flow model to accurately simulate current or future conditions. Surface geophysical surveys, along with selected test-hole information, can provide an integrated framework for quantifying hydrogeologic conditions within a defined area. In 2004, the U.S. Geological Survey, in cooperation with the North Platte Natural Resources District, performed a surface geophysical survey using a capacitively coupled resistivity technique to map the lithology within the top 8 meters of the near-surface for 110 kilometers of the Interstate and Tri-State Canals in western Nebraska and eastern Wyoming. Assuming that leakage between the surface-water and groundwater systems is affected primarily by the sediment directly underlying the canal bed, leakage potential was estimated from the simple vertical mean of inverse-model resistivity values for depth levels with geometrically increasing layer thickness with depth which resulted in mean-resistivity values biased towards the surface. This method generally produced reliable results, but an improved analysis method was needed to account for situations where confining units, composed of less permeable material, underlie units with greater permeability. In this report, prepared by the U.S. Geological Survey in cooperation with the North Platte Natural Resources District, the authors use geostatistical analysis to develop the minimum-unadjusted method to compute a relative leakage potential based on the minimum resistivity value in a vertical column of the resistivity model. The minimum-unadjusted method considers the effects of homogeneous confining units. The minimum-adjusted method also is developed to incorporate the effect of local lithologic heterogeneity on water transmission. Seven sites with differing geologic contexts were selected following review of the capacitively coupled resistivity data collected in 2004. A reevaluation of these sites using the mean, minimum-unadjusted, and minimum-adjusted methods was performed to compare the different approaches for estimating leakage potential. Five of the seven sites contained underlying confining units, for which the minimum-unadjusted and minimum-adjusted methods accounted for the confining-unit effect. Estimates of overall leakage potential were lower for the minimum-unadjusted and minimum-adjusted methods than those estimated by the mean method. For most sites, the local heterogeneity adjustment procedure of the minimum-adjusted method resulted in slightly larger overall leakage-potential estimates. In contrast to the mean method, the two minimum-based methods allowed the least permeable areas to control the overall vertical permeability of the subsurface. The minimum-adjusted method refined leakage-potential estimation by additionally including local lithologic heterogeneity effects.

Risk control and the minimum significant risk

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

Seiler, F.A.; Alvarez, J.L.

1996-06-01

Risk management implies that the risk manager can, by his actions, exercise at least a modicum of control over the risk in question. In the terminology of control theory, a management action is a control signal imposed as feedback on the system to bring about a desired change in the state of the system. In the terminology of risk management, an action is taken to bring a predicted risk to lower values. Even if it is assumed that the management action taken is 100% effective and that the projected risk reduction is infinitely well known, there is a lower limitmore » to the desired effects that can be achieved. It is based on the fact that all risks, such as the incidence of cancer, exhibit a degree of variability due to a number of extraneous factors such as age at exposure, sex, location, and some lifestyle parameters such as smoking or the consumption of alcohol. If the control signal is much smaller than the variability of the risk, the signal is lost in the noise and control is lost. This defines a minimum controllable risk based on the variability of the risk over the population considered. This quantity is the counterpart of the minimum significant risk which is defined by the uncertainties of the risk model. Both the minimum controllable risk and the minimum significant risk are evaluated for radiation carcinogenesis and are shown to be of the same order of magnitude. For a realistic management action, the assumptions of perfectly effective action and perfect model prediction made above have to be dropped, resulting in an effective minimum controllable risk which is determined by both risk limits. Any action below that effective limit is futile, but it is also unethical due to the ethical requirement of doing more good than harm. Finally, some implications of the effective minimum controllable risk on the use of the ALARA principle and on the evaluation of remedial action goals are presented.« less

Geospatial association between adverse birth outcomes and arsenic in groundwater in New Hampshire, USA.

PubMed

Shi, Xun; Ayotte, Joseph D; Onda, Akikazu; Miller, Stephanie; Rees, Judy; Gilbert-Diamond, Diane; Onega, Tracy; Gui, Jiang; Karagas, Margaret; Moeschler, John

2015-04-01

There is increasing evidence of the role of arsenic in the etiology of adverse human reproductive outcomes. Because drinking water can be a major source of arsenic to pregnant women, the effect of arsenic exposure through drinking water on human birth may be revealed by a geospatial association between arsenic concentration in groundwater and birth problems, particularly in a region where private wells substantially account for water supply, like New Hampshire, USA. We calculated town-level rates of preterm birth and term low birth weight (term LBW) for New Hampshire, by using data for 1997-2009 stratified by maternal age. We smoothed the rates by using a locally weighted averaging method to increase the statistical stability. The town-level groundwater arsenic probability values are from three GIS data layers generated by the US Geological Survey: probability of local groundwater arsenic concentration >1 µg/L, probability >5 µg/L, and probability >10 µg/L. We calculated Pearson's correlation coefficients (r) between the reproductive outcomes (preterm birth and term LBW) and the arsenic probability values, at both state and county levels. For preterm birth, younger mothers (maternal age <20) have a statewide r = 0.70 between the rates smoothed with a threshold = 2,000 births and the town mean arsenic level based on the data of probability >10 µg/L; for older mothers, r = 0.19 when the smoothing threshold = 3,500; a majority of county level r values are positive based on the arsenic data of probability >10 µg/L. For term LBW, younger mothers (maternal age <25) have a statewide r = 0.44 between the rates smoothed with a threshold = 3,500 and town minimum arsenic concentration based on the data of probability >1 µg/L; for older mothers, r = 0.14 when the rates are smoothed with a threshold = 1,000 births and also adjusted by town median household income in 1999, and the arsenic values are the town minimum based on probability >10 µg/L. At the county level for younger mothers, positive r values prevail, but for older mothers, it is a mix. For both birth problems, the several most populous counties-with 60-80 % of the state's population and clustering at the southwest corner of the state-are largely consistent in having a positive r across different smoothing thresholds. We found evident spatial associations between the two adverse human reproductive outcomes and groundwater arsenic in New Hampshire, USA. However, the degree of associations and their sensitivity to different representations of arsenic level are variable. Generally, preterm birth has a stronger spatial association with groundwater arsenic than term LBW, suggesting an inconsistency in the impact of arsenic on the two reproductive outcomes. For both outcomes, younger maternal age has stronger spatial associations with groundwater arsenic.

Cinnamon: A systematic review of adverse events.

PubMed

Hajimonfarednejad, Mahdie; Ostovar, Mohadeseh; Raee, Mohammad Javad; Hashempur, Mohammad Hashem; Mayer, Johannes Gottfried; Heydari, Mojtaba

2018-04-05

Cinnamon, from the genus Cinnamomum and Lauraceae family, has been used as a popular spice for thousands of years around the world. Many studies have shown therapeutic effects of cinnamon including its antimicrobial, antiviral, antifungal, antioxidant, antitumor, antihypertensive, antilipemic, antidiabetic, gastroprotective, and immunomodulatory effects. Due to popular use of cinnamon and several human reports on adverse events associated with short or long term use of cinnamon, we aimed to systematically review its human reports of adverse event. Databases including Medline, Scopus, Science Direct, Embase, PubMed Central and Google scholar were searched using the key words "cinnamon" or "cinnamomum" for clinical trials, case reports and case series. Also spontaneous reports about adverse effects of cinnamon were collected from five national and international spontaneous reporting schemes. Thirty eight clinical trials were found, five of them reported adverse events. Twenty case reports and seven case series, as well as, spontaneous reports including 160 adverse events were also included. The most frequent adverse events were gastrointestinal disorders and allergic reactions which were self-limiting in the majority of cases. The available data suggests that despite the safety of cinnamon use as a spice and/or flavoring agent, its use may be associated with significant adverse effects in medicinal uses with larger doses or longer duration of use and should be clinically monitored. Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

42 CFR 84.87 - Compressed gas filters; minimum requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Compressed gas filters; minimum requirements. 84.87...-Contained Breathing Apparatus § 84.87 Compressed gas filters; minimum requirements. All self-contained breathing apparatus using compressed gas shall have a filter downstream of the gas source to effectively...

42 CFR 84.87 - Compressed gas filters; minimum requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Compressed gas filters; minimum requirements. 84.87...-Contained Breathing Apparatus § 84.87 Compressed gas filters; minimum requirements. All self-contained breathing apparatus using compressed gas shall have a filter downstream of the gas source to effectively...

42 CFR 84.87 - Compressed gas filters; minimum requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Compressed gas filters; minimum requirements. 84.87...-Contained Breathing Apparatus § 84.87 Compressed gas filters; minimum requirements. All self-contained breathing apparatus using compressed gas shall have a filter downstream of the gas source to effectively...

42 CFR 84.87 - Compressed gas filters; minimum requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Compressed gas filters; minimum requirements. 84.87...-Contained Breathing Apparatus § 84.87 Compressed gas filters; minimum requirements. All self-contained breathing apparatus using compressed gas shall have a filter downstream of the gas source to effectively...

42 CFR 84.87 - Compressed gas filters; minimum requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Compressed gas filters; minimum requirements. 84.87...-Contained Breathing Apparatus § 84.87 Compressed gas filters; minimum requirements. All self-contained breathing apparatus using compressed gas shall have a filter downstream of the gas source to effectively...

Hypnosis control based on the minimum concentration of anesthetic drug for maintaining appropriate hypnosis.

PubMed

Furutani, Eiko; Nishigaki, Yuki; Kanda, Chiaki; Takeda, Toshihiro; Shirakami, Gotaro

2013-01-01

This paper proposes a novel hypnosis control method using Auditory Evoked Potential Index (aepEX) as a hypnosis index. In order to avoid side effects of an anesthetic drug, it is desirable to reduce the amount of an anesthetic drug during surgery. For this purpose many studies of hypnosis control systems have been done. Most of them use Bispectral Index (BIS), another hypnosis index, but it has problems of dependence on anesthetic drugs and nonsmooth change near some particular values. On the other hand, aepEX has an ability of clear distinction between patient consciousness and unconsciousness and independence of anesthetic drugs. The control method proposed in this paper consists of two elements: estimating the minimum effect-site concentration for maintaining appropriate hypnosis and adjusting infusion rate of an anesthetic drug, propofol, using model predictive control. The minimum effect-site concentration is estimated utilizing the property of aepEX pharmacodynamics. The infusion rate of propofol is adjusted so that effect-site concentration of propofol may be kept near and always above the minimum effect-site concentration. Simulation results of hypnosis control using the proposed method show that the minimum concentration can be estimated appropriately and that the proposed control method can maintain hypnosis adequately and reduce the total infusion amount of propofol.

Are we pharmacovigilant enough in ophthalmic practice?

PubMed Central

Dubey, Ashok; Handu, Shailendra S

2013-01-01

No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR) database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI) to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice. PMID:23571233

Is Job Control a Double-Edged Sword? A Cross-Lagged Panel Study on the Interplay of Quantitative Workload, Emotional Dissonance, and Job Control on Emotional Exhaustion.

PubMed

Konze, Anne-Kathrin; Rivkin, Wladislaw; Schmidt, Klaus-Helmut

2017-12-20

Previous meta-analytic findings have provided ambiguous evidence on job control as a buffering moderator of the adverse impact of job demands on psychological well-being. To disentangle these mixed findings, we examine the moderating effect of job control on the adverse effects of quantitative workload and emotional dissonance as distinct work-related demands on emotional exhaustion over time. Drawing on the job demands-control model, the limited strength model of self-control, and the matching principle we propose that job control can facilitate coping with work-related demands but at the same time may also require employees' self-control. Consequently, we argue that job control buffers the adverse effects of quantitative workload while it reinforces the adverse effects of emotional dissonance, which also necessitates self-control. We examine the proposed relations among employees from an energy supplying company ( N = 139) in a cross-lagged panel study with a six-month time lag. Our results demonstrate a mix of causal and reciprocal effects of job characteristics on emotional exhaustion over time. Furthermore, as suggested, our data provides evidence for contrasting moderating effects of job control. That is, job control buffers the adverse effects of quantitative workload while it reinforces the adverse effects of emotional dissonance on emotional exhaustion.

Is Job Control a Double-Edged Sword? A Cross-Lagged Panel Study on the Interplay of Quantitative Workload, Emotional Dissonance, and Job Control on Emotional Exhaustion

PubMed Central

Rivkin, Wladislaw; Schmidt, Klaus-Helmut

2017-01-01

Previous meta-analytic findings have provided ambiguous evidence on job control as a buffering moderator of the adverse impact of job demands on psychological well-being. To disentangle these mixed findings, we examine the moderating effect of job control on the adverse effects of quantitative workload and emotional dissonance as distinct work-related demands on emotional exhaustion over time. Drawing on the job demands-control model, the limited strength model of self-control, and the matching principle we propose that job control can facilitate coping with work-related demands but at the same time may also require employees’ self-control. Consequently, we argue that job control buffers the adverse effects of quantitative workload while it reinforces the adverse effects of emotional dissonance, which also necessitates self-control. We examine the proposed relations among employees from an energy supplying company (N = 139) in a cross-lagged panel study with a six-month time lag. Our results demonstrate a mix of causal and reciprocal effects of job characteristics on emotional exhaustion over time. Furthermore, as suggested, our data provides evidence for contrasting moderating effects of job control. That is, job control buffers the adverse effects of quantitative workload while it reinforces the adverse effects of emotional dissonance on emotional exhaustion. PMID:29261116

Safety of antipsychotics for the treatment of schizophrenia: a focus on the adverse effects of clozapine

PubMed Central

De Berardis, Domenico; Rapini, Gabriella; Olivieri, Luigi; Di Nicola, Domenico; Tomasetti, Carmine; Valchera, Alessandro; Fornaro, Michele; Di Fabio, Fabio; Perna, Giampaolo; Di Nicola, Marco; Serafini, Gianluca; Carano, Alessandro; Pompili, Maurizio; Vellante, Federica; Orsolini, Laura; Martinotti, Giovanni; Di Giannantonio, Massimo

2018-01-01

Clozapine, a dibenzodiazepine developed in 1961, is a multireceptorial atypical antipsychotic approved for the treatment of resistant schizophrenia. Since its introduction, it has remained the drug of choice in treatment-resistant schizophrenia, despite a wide range of adverse effects, as it is a very effective drug in everyday clinical practice. However, clozapine is not considered as a top-of-the-line treatment because it may often be difficult for some patients to tolerate as some adverse effects can be particularly bothersome (i.e. sedation, weight gain, sialorrhea etc.) and it has some other potentially dangerous and life-threatening side effects (i.e. myocarditis, seizures, agranulocytosis or granulocytopenia, gastrointestinal hypomotility etc.). As poor treatment adherence in patients with resistant schizophrenia may increase the risk of a psychotic relapse, which may further lead to impaired social and cognitive functioning, psychiatric hospitalizations and increased treatment costs, clozapine adverse effects are a common reason for discontinuing this medication. Therefore, every effort should be made to monitor and minimize these adverse effects in order to improve their early detection and management. The aim of this paper is to briefly summarize and provide an update on major clozapine adverse effects, especially focusing on those that are severe and potentially life threatening, even if most of the latter are relatively uncommon. PMID:29796248

Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.

PubMed

Weber, Jeffrey; Mandala, Mario; Del Vecchio, Michele; Gogas, Helen J; Arance, Ana M; Cowey, C Lance; Dalle, Stéphane; Schenker, Michael; Chiarion-Sileni, Vanna; Marquez-Rodas, Ivan; Grob, Jean-Jacques; Butler, Marcus O; Middleton, Mark R; Maio, Michele; Atkinson, Victoria; Queirolo, Paola; Gonzalez, Rene; Kudchadkar, Ragini R; Smylie, Michael; Meyer, Nicolas; Mortier, Laurent; Atkins, Michael B; Long, Georgina V; Bhatia, Shailender; Lebbé, Celeste; Rutkowski, Piotr; Yokota, Kenji; Yamazaki, Naoya; Kim, Tae M; de Pril, Veerle; Sabater, Javier; Qureshi, Anila; Larkin, James; Ascierto, Paolo A

2017-11-09

Nivolumab and ipilimumab are immune checkpoint inhibitors that have been approved for the treatment of advanced melanoma. In the United States, ipilimumab has also been approved as adjuvant therapy for melanoma on the basis of recurrence-free and overall survival rates that were higher than those with placebo in a phase 3 trial. We wanted to determine the efficacy of nivolumab versus ipilimumab for adjuvant therapy in patients with resected advanced melanoma. In this randomized, double-blind, phase 3 trial, we randomly assigned 906 patients (≥15 years of age) who were undergoing complete resection of stage IIIB, IIIC, or IV melanoma to receive an intravenous infusion of either nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks (453 patients) or ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks (453 patients). The patients were treated for a period of up to 1 year or until disease recurrence, a report of unacceptable toxic effects, or withdrawal of consent. The primary end point was recurrence-free survival in the intention-to-treat population. At a minimum follow-up of 18 months, the 12-month rate of recurrence-free survival was 70.5% (95% confidence interval [CI], 66.1 to 74.5) in the nivolumab group and 60.8% (95% CI, 56.0 to 65.2) in the ipilimumab group (hazard ratio for disease recurrence or death, 0.65; 97.56% CI, 0.51 to 0.83; P<0.001). Treatment-related grade 3 or 4 adverse events were reported in 14.4% of the patients in the nivolumab group and in 45.9% of those in the ipilimumab group; treatment was discontinued because of any adverse event in 9.7% and 42.6% of the patients, respectively. Two deaths (0.4%) related to toxic effects were reported in the ipilimumab group more than 100 days after treatment. Among patients undergoing resection of stage IIIB, IIIC, or IV melanoma, adjuvant therapy with nivolumab resulted in significantly longer recurrence-free survival and a lower rate of grade 3 or 4 adverse events than adjuvant therapy with ipilimumab. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 238 ClinicalTrials.gov number, NCT02388906 ; Eudra-CT number, 2014-002351-26 .).

Time does not heal all wounds: older adults who experienced childhood adversities have higher odds of mood, anxiety, and personality disorders.

PubMed

Raposo, Sarah M; Mackenzie, Corey S; Henriksen, Christine A; Afifi, Tracie O

2014-11-01

We aimed to examine the prevalence of several types of childhood adversity across adult cohorts, whether age moderates the effect of childhood adversity on mental health, the relationship between childhood adversity and psychopathology among older adults, the dose-response relationship between number of types of childhood adversities and mental disorders in later life, and whether lifetime mental health treatment reduces the odds of psychopathology among older survivors of childhood adversity. In a population-based, cross-sectional study on a nationally representative U.S. sample, we studied 34,653 community-dwelling Americans 20 years and older, including 7,080 adults 65 years and older from Wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions. Trained lay interviewers assessed past-year mood and anxiety disorders and lifetime personality disorders. Participants self-reported childhood adversity based on questions from the Adverse Childhood Experiences Study. Childhood adversity was prevalent across five age cohorts. In our adjusted models, age did not moderate the effect of childhood adversity on mental disorders. Older adults who experienced childhood adversity had higher odds of having mood (odds ratio: 1.73; 95% confidence interval: 1.32-2.28), anxiety (odds ratio: 1.48; 95% confidence interval: 1.20-1.83), and personality disorders (odds ratio: 2.11; 95% confidence interval: 1.75-2.54) after adjusting for covariates. An increasing number of types of childhood adversities was associated with higher odds of personality disorders and somewhat higher odds of anxiety disorders. Treatment-seeking was associated with a reduced likelihood of anxiety and, especially, mood disorders in older adult childhood adversity survivors. These results emphasize the importance of preventing childhood adversity and intervening once it occurs to avoid the negative mental health effects that can last into old age. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Emotion dysregulation mediates the relationship between lifetime cumulative adversity and depressive symptomatology.

PubMed

Abravanel, Benjamin T; Sinha, Rajita

2015-02-01

Repeated exposure to stressful events across the lifespan, referred to as cumulative adversity, is a potent risk factor for depression. Research indicates that cumulative adversity detrimentally affects emotion regulation processes, which may represent a pathway linking cumulative adversity to vulnerability to depression. However, empirical evidence that emotion dysregulation mediates the relationship between cumulative adversity and depression is limited, particularly in adult populations. We examined the direct and indirect effects of cumulative adversity on depressive symptomatology in a large community sample of adults (n = 745) who were further characterized by risk status: never-depressed (n = 638) and "at-risk" remitted mood-disordered (n = 107). All participants completed the Cumulative Adversity Inventory (CAI), the Difficulties in Emotion Regulation Scale (DERS), and the Center for Epidemiologic Studies Depression Scale (CES-D). Bootstrapped confidence intervals were computed to estimate the indirect effect of emotion dysregulation on the relationship between cumulative adversity and depressive symptomatology and to test whether this indirect effect was moderated by risk status. Emotion dysregulation partially and significantly mediated the relationship between cumulative adversity and depressive symptomatology independent of risk status. Overall, cumulative adversity and emotion dysregulation accounted for 50% of the variance in depressive symptomatology. These findings support the hypothesis that disruption of adaptive emotion regulation processes associated with repeated exposure to stressful life events represents an intrapersonal mechanism linking the experience of adverse events to depression. Our results support the utility of interventions that simultaneously emphasize stress reduction and emotion regulation to treat and prevent depressive vulnerability and pathology. Copyright © 2014 Elsevier Ltd. All rights reserved.

Emotion Dysregulation Mediates the Relationship between Lifetime Cumulative Adversity and Depressive Symptomatology

PubMed Central

Abravanel, Benjamin T.; Sinha, Rajita

2014-01-01

Repeated exposure to stressful events across the lifespan, referred to as cumulative adversity, is a potent risk factor for depression. Research indicates that cumulative adversity detrimentally affects emotion regulation processes, which may represent a pathway linking cumulative adversity to vulnerability to depression. However, empirical evidence that emotion dysregulation mediates the relationship between cumulative adversity and depression is limited, particularly in adult populations. We examined the direct and indirect effects of cumulative adversity on depressive symptomatology in a large community sample of adults (n = 745) who were further characterized by risk status: never-depressed (n = 638) and “at-risk” remitted mood-disordered (n = 107). All participants completed the Cumulative Adversity Inventory (CAI), the Difficulties in Emotion Regulation Scale (DERS), and the Center for Epidemiologic Studies Depression Scale (CES-D). Bootstrapped confidence intervals were computed to estimate the indirect effect of emotion dysregulation on the relationship between cumulative adversity and depressive symptomatology and to test whether this indirect effect was moderated by risk status. Emotion dysregulation partially and significantly mediated the relationship between cumulative adversity and depressive symptomatology independent of risk status. Overall, cumulative adversity and emotion dysregulation accounted for 50% of the variance in depressive symptomatology. These findings support the hypothesis that disruption of adaptive emotion regulation processes associated with repeated exposure to stressful life events represents an intrapersonal mechanism linking the experience of adverse events to depression. Our results support the utility of interventions that simultaneously emphasize stress reduction and emotion regulation to treat and prevent depressive vulnerability and pathology. PMID:25528603

Energy drinks and their adverse health effects: A systematic review of the current evidence.

PubMed

Ali, Fahad; Rehman, Hiba; Babayan, Zaruhi; Stapleton, Dwight; Joshi, Divya-Devi

2015-04-01

With the rising consumption of so-called energy drinks over the last few years, there has been a growing body of literature describing significant adverse health events after the ingestion of these beverages. To gain further insight about the clinical spectrum of these adverse events, we conducted a literature review. Using PubMed and Google-Scholar, we searched the literature from January 1980 through May 2014 for articles on the adverse health effects of energy drinks. A total of 2097 publications were found. We then excluded molecular and industry-related studies, popular media reports, and case reports of isolated caffeine toxicity, yielding 43 reports. Energy drink consumption is a health issue primarily of the adolescent and young adult male population. It is linked to increased substance abuse and risk-taking behaviors. The most common adverse events affect the cardiovascular and neurological systems. The most common ingredient in energy drinks is caffeine, and it is believed that the adverse events are related to its effects, as well as potentiating effects of other stimulants in these drinks. Education, regulation, and further studies are required.

Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries

PubMed Central

Restani, Patrizia; Di Lorenzo, Chiara; Garcia-Alvarez, Alicia; Badea, Mihaela; Ceschi, Alessandro; Egan, Bernadette; Dima, Lorena; Lüde, Saskia; Maggi, Franco M.; Marculescu, Angela; Milà-Villarroel, Raimon; Raats, Monique M.; Ribas-Barba, Lourdes; Uusitalo, Liisa; Serra-Majem, Lluís

2016-01-01

Background The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS) have been described. Objectives To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011–2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey. Subjects/Setting From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS. Results Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8%) and 4 as probable (4.6%). Considering the most frequently cited botanicals, eight cases were due to Valeriana officinalis (garden valerian); seven to Camellia sinensis (tea); six to Ginkgo biloba (Maidenhair tree) and Paullinia cupana (guarana). Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems. Conclusions Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors) to become aware of possible new problems associated with the increasing use of food supplements containing botanicals. PMID:26928206

Deployment Health Centers Review, 2016-2017

DTIC Science & Technology

2017-08-21

the short and long-term adverse effects of military service on the physical and mental health of veterans. We recommend that the DHB continue to...adverse effects of military service on the physical and mental health of veterans” by expanding on current clinical, surveillance, and research efforts...the ability to identify, treat, and minimize the short- and long-term adverse effects of military service on the mental and physical health of

[Eye cosmetics--the beauty and the beast].

PubMed

Blumenfeld, Oren; Nathansohn, Nir; Yeshurun, Itamar; Ashkenazi, Isaac

2005-05-01

The use of eye cosmetics is a popular practice in modern times that dates back to ancient civilizations. This practice, however, is not without hazards. The most common adverse effect of eye cosmetics is eyelid dermatitis, although an array of other adverse effects has been reported. This article reviews the different types of eye cosmetics in current use, their composition and the adverse effects of both commercial and traditional products.

Management of common adverse effects in the era of highly active antiretroviral therapy in south east Ethiopia

PubMed Central

Abdella, Sadikalmahdi Hussen; Wabe, Nasir Tajure; Yesuf, Elias Ali

2011-01-01

Background: The combination of antiretroviral therapy is the corner stone of management of patients with human immune deficiency virus infection. Although antiretroviral therapy can reduce viral load to undetectable level, improve the immunity and prolong survival of patients, antiretroviral drugs are associated with many adverse effects that may be severe and affect patient adherence and quality of life. Aims: The aim of this study was to assess management strategies under taken in patient's experienced common adverse effects of highly active antiretroviral therapy in Goba Hospital antiretroviral clinic. Patients and Methods: A cross sectional study of patient record chart of patients who had follow-up during data collection period was done followed by patient interview. Data was filled on well structured questionnaire and analyzed using SPSS for window version 16.0. Results: The common adverse effects were Rash (48.8%), Peripheral neuropathy (36.9%) and Anemia (20.24%). The rate of management was 39.3%. Pyridoxine (36.8%) was commonly prescribed drug for management of Peripheral neuropathy. Chlorphenarimine gel and Iron gluconate were common drugs for management of Rash and Anemia respectively. Use of traditional healers (57.7%) was leading reason for non-management. Conclusion: Rate of management for common adverse effect is low. Education should be given on adverse effects for patients. PMID:22361495

Adverse effects associated with photodynamic therapy (PDT) of port-wine stain (PWS) birthmarks.

PubMed

Yuan, Kai-Hua; Gao, Jian-Hua; Huang, Zheng

2012-12-01

Several Chinese studies suggest that Hemoporfin-mediated photodynamic therapy (PDT) is an alternative treatment for port-wine stain (PWS) birthmarks. To evaluate treatment responses and adverse effects associated with Hemoporfin PDT for the treatment of PWS and their management. The medical records of 700 patients who underwent PDT treatment in our center were retrospectively examined. Treatment-related reactions and adverse effects were reviewed. Different types of PWS lesions and different individuals showed different immediate responses (e.g. swelling, color change, pain). To certain extents these reactions were a useful indicator of the treatment endpoint. Edema and scabbing were the most common post-treatment responses. Short-term (e.g. blister, eczematous dermatitis, cutaneous photosensitivity) and long-term (e.g. pigmentation change, scar formation) adverse effects were generally caused by the phototoxicity associated with the combination of photosensitizer and light exposure. Although PDT is a safe treatment alternative for PWS birthmarks, treatment parameters must be selected for each individual patient and cutaneous changes must be monitored during light irradiation to minimize the risk of adverse effects. Over estimation of required light dosage or failure to recognize cutaneous changes associated with adverse effects can increase the risk of a poor outcome. Copyright © 2012 Elsevier B.V. All rights reserved.

Mining adverse drug reactions from online healthcare forums using hidden Markov model.

PubMed

Sampathkumar, Hariprasad; Chen, Xue-wen; Luo, Bo

2014-10-23

Adverse Drug Reactions are one of the leading causes of injury or death among patients undergoing medical treatments. Not all Adverse Drug Reactions are identified before a drug is made available in the market. Current post-marketing drug surveillance methods, which are based purely on voluntary spontaneous reports, are unable to provide the early indications necessary to prevent the occurrence of such injuries or fatalities. The objective of this research is to extract reports of adverse drug side-effects from messages in online healthcare forums and use them as early indicators to assist in post-marketing drug surveillance. We treat the task of extracting adverse side-effects of drugs from healthcare forum messages as a sequence labeling problem and present a Hidden Markov Model(HMM) based Text Mining system that can be used to classify a message as containing drug side-effect information and then extract the adverse side-effect mentions from it. A manually annotated dataset from http://www.medications.com is used in the training and validation of the HMM based Text Mining system. A 10-fold cross-validation on the manually annotated dataset yielded on average an F-Score of 0.76 from the HMM Classifier, in comparison to 0.575 from the Baseline classifier. Without the Plain Text Filter component as a part of the Text Processing module, the F-Score of the HMM Classifier was reduced to 0.378 on average, while absence of the HTML Filter component was found to have no impact. Reducing the Drug names dictionary size by half, on average reduced the F-Score of the HMM Classifier to 0.359, while a similar reduction to the side-effects dictionary yielded an F-Score of 0.651 on average. Adverse side-effects mined from http://www.medications.com and http://www.steadyhealth.com were found to match the Adverse Drug Reactions on the Drug Package Labels of several drugs. In addition, some novel adverse side-effects, which can be potential Adverse Drug Reactions, were also identified. The results from the HMM based Text Miner are encouraging to pursue further enhancements to this approach. The mined novel side-effects can act as early indicators for health authorities to help focus their efforts in post-marketing drug surveillance.

Assessing the impacts of Saskatchewan's minimum alcohol pricing regulations on alcohol-related crime.

PubMed

Stockwell, Tim; Zhao, Jinhui; Sherk, Adam; Callaghan, Russell C; Macdonald, Scott; Gatley, Jodi

2017-07-01

Saskatchewan's introduction in April 2010 of minimum prices graded by alcohol strength led to an average minimum price increase of 9.1% per Canadian standard drink (=13.45 g ethanol). This increase was shown to be associated with reduced consumption and switching to lower alcohol content beverages. Police also informally reported marked reductions in night-time alcohol-related crime. This study aims to assess the impacts of changes to Saskatchewan's minimum alcohol-pricing regulations between 2008 and 2012 on selected crime events often related to alcohol use. Data were obtained from Canada's Uniform Crime Reporting Survey. Auto-regressive integrated moving average time series models were used to test immediate and lagged associations between minimum price increases and rates of night-time and police identified alcohol-related crimes. Controls were included for simultaneous crime rates in the neighbouring province of Alberta, economic variables, linear trend, seasonality and autoregressive and/or moving-average effects. The introduction of increased minimum-alcohol prices was associated with an abrupt decrease in night-time alcohol-related traffic offences for men (-8.0%, P < 0.001), but not women. No significant immediate changes were observed for non-alcohol-related driving offences, disorderly conduct or violence. Significant monthly lagged effects were observed for violent offences (-19.7% at month 4 to -18.2% at month 6), which broadly corresponded to lagged effects in on-premise alcohol sales. Increased minimum alcohol prices may contribute to reductions in alcohol-related traffic-related and violent crimes perpetrated by men. Observed lagged effects for violent incidents may be due to a delay in bars passing on increased prices to their customers, perhaps because of inventory stockpiling. [Stockwell T, Zhao J, Sherk A, Callaghan RC, Macdonald S, Gatley J. Assessing the impacts of Saskatchewan's minimum alcohol pricing regulations on alcohol-related crime. Drug Alcohol Rev 2017;36:492-501]. © 2016 Australasian Professional Society on Alcohol and other Drugs.

How Safe Are Common Analgesics for the Treatment of Acute Pain for Children? A Systematic Review.

PubMed

Hartling, Lisa; Ali, Samina; Dryden, Donna M; Chordiya, Pritam; Johnson, David W; Plint, Amy C; Stang, Antonia; McGrath, Patrick J; Drendel, Amy L

2016-01-01

Background . Fear of adverse events and occurrence of side effects are commonly cited by families and physicians as obstructive to appropriate use of pain medication in children. We examined evidence comparing the safety profiles of three groups of oral medications, acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids, to manage acute nonsurgical pain in children (<18 years) treated in ambulatory settings. Methods . A comprehensive search was performed to July 2015, including review of national data registries. Two reviewers screened articles for inclusion, assessed methodological quality, and extracted data. Risks (incidence rates) were pooled using a random effects model. Results . Forty-four studies were included; 23 reported on adverse events. Based on limited current evidence, acetaminophen, ibuprofen, and opioids have similar nausea and vomiting profiles. Opioids have the greatest risk of central nervous system adverse events. Dual therapy with a nonopioid/opioid combination resulted in a lower risk of adverse events than opioids alone. Conclusions . Ibuprofen and acetaminophen have similar reported adverse effects and notably less adverse events than opioids. Dual therapy with a nonopioid/opioid combination confers a protective effect for adverse events over opioids alone. This research highlights challenges in assessing medication safety, including lack of more detailed information in registry data, and inconsistent reporting in trials.

Chinese herbal medicine for diabetic peripheral neuropathy.

PubMed

Chen, Wei; Zhang, Yin; Liu, Jian Ping

2011-06-15

Chinese herbal medicine is frequently used for treating diabetic peripheral neuropathy in China. Many controlled trials have been undertaken to investigate its efficacy. To assess the beneficial effects and harms of Chinese herbal medicine for people with diabetic peripheral neuropathy. We searched the Cochrane Neuromuscular Disease Group Specialized Register (15 June 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2010 in The Cochrane Library), MEDLINE (January 1966 to June 2010), EMBASE (January 1980 to June 2010), AMED (January 1985 to June 2010), Chinese Biomedical Database (CBM) (1979 to June 2010), Chinese National Knowledge Infrastructure Database (CNKI) (1979 to June 2010), and VIP Chinese Science and Technique Journals Database (1989 to June 2010). We searched for unpublished literature in the Chinese Conference Papers Database and Chinese Dissertation Database (from inception to March 2010). No language or publication restrictions were used. We included randomized controlled trials of Chinese herbal medicine (with a minimum of four weeks treatment duration) for people with diabetic peripheral neuropathy compared with placebo, no intervention, or conventional interventions. Trials of herbal medicine plus a conventional drug versus the drug alone were also included. Two authors independently extracted data and evaluated trial quality. We contacted study authors for additional information. The data analyses were carried out using Review Manager 5.1 (Cochrane software). Thirty-nine randomized trials involving 2890 participants were included. All trials were conducted and published in China. Thirty different herbal medicines were tested in these trials, including four single herbs (extracts from a single herb), eight traditional Chinese patent medicines, and 18 self-concocted Chinese herbal compound prescriptions. The trials reported on global symptom improvement (including improvement in numbness or pain) and changes in nerve conduction velocity. There was inadequate reporting on adverse events in the included trials. Most of the trials did not mention whether they monitored adverse effects at all. Only two trials reported adverse events: one occurred in the control group in one trial and in which group was unclear in the other trial . Conclusions cannot be drawn from this review about the safety of herbal medicines due to inadequate reporting. Most of the trials were of low methodological quality and therefore the interpretation of any positive findings for the efficacy of the included Chinese herbal medicines for treating diabetic peripheral neuropathy should be made with caution. Based on this systematic review, there is no evidence to support the objective effectiveness and safety of Chinese herbal medicines for diabetic peripheral neuropathy. No well designed, randomized placebo controlled trial with objective outcome measures has been conducted.

The Effect of Minimum Wage Rates on High School Completion

ERIC Educational Resources Information Center

Warren, John Robert; Hamrock, Caitlin

2010-01-01

Does increasing the minimum wage reduce the high school completion rate? Previous research has suffered from (1. narrow time horizons, (2. potentially inadequate measures of states' high school completion rates, and (3. potentially inadequate measures of minimum wage rates. Overcoming each of these limitations, we analyze the impact of changes in…

Long term effects of early adversity on cognitive function.

PubMed

Richards, M; Wadsworth, M E J

2004-10-01

To investigate long term effects of early adverse circumstances on cognitive function. Associations between early material home circumstances, parental divorce, maternal management and understanding, and cognitive function in childhood, adolescence, and adulthood were analysed using multiple linear regression, controlling for sex, parental SES, and birth order in 1339 males and females from the MRC National Survey of Health and Development. Early adverse circumstances were strongly associated with lower cognitive ability in childhood and adolescence, and were detectable on measures of verbal ability, memory, and speed and concentration in midlife. However, these long term effects were mostly explained by the effects of adversity on childhood or adolescent cognitive ability or by differences in educational attainment and adult social class. An exception was the effect of poor material home conditions on visual search speed at 53 years, which was maintained after controlling for adolescent ability, as well as further control for educational attainment, adult social class, physical growth, cigarette smoking, and affective state. There was no evidence of more rapid decline in memory and psychomotor function across middle age in those exposed to early adversity. The effect of early adversity on cognitive function tracks across the life course at least as far as middle age, although there was little evidence from this study of effect amplification over this interval. Nevertheless, in view of the persistence of child poverty in the industrialised world, these findings give cause for concern.

40 CFR 257.25 - Assessment monitoring program.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) Minimum distance between upgradient edge of the unit and downgradient monitoring well screen (minimum... that is likely to be without appreciable risk of deleterious effects during a lifetime. For purposes of this subpart, systemic toxicants include toxic chemicals that cause effects other than cancer or...

40 CFR 257.25 - Assessment monitoring program.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) Minimum distance between upgradient edge of the unit and downgradient monitoring well screen (minimum... that is likely to be without appreciable risk of deleterious effects during a lifetime. For purposes of this subpart, systemic toxicants include toxic chemicals that cause effects other than cancer or...

40 CFR 257.25 - Assessment monitoring program.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) Minimum distance between upgradient edge of the unit and downgradient monitoring well screen (minimum... that is likely to be without appreciable risk of deleterious effects during a lifetime. For purposes of this subpart, systemic toxicants include toxic chemicals that cause effects other than cancer or...

Guillain–Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States

PubMed Central

Ojha, Rohit P; Jackson, Bradford E; Tota, Joseph E; Offutt-Powell, Tabatha N; Singh, Karan P; Bae, Sejong

2014-01-01

Post-marketing surveillance studies provide conflicting evidence about whether Guillain–Barre syndrome occurs more frequently following quadrivalent human papillomavirus (HPV4) vaccination. We aimed to assess whether Guillain–Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among females and males aged 9 to 26 y in the United States. We used adverse event reports received by the United States Vaccine Adverse Event Reporting System (VAERS) between January 1, 2010 and December 31, 2012 to estimate overall, age-, and sex-specific proportional reporting ratios (PRRs) and corresponding Χ2 values for reports of Guillain–Barre syndrome between 5 and 42 d following HPV vaccination. Minimum criteria for a signal using this approach are 3 or more cases, PRR ≥2, and Χ2 ≥ 4. Guillain–Barre syndrome was listed as an adverse event in 45 of 14 822 reports, of which 9 reports followed HPV4 vaccination and 36 reports followed all other vaccines. The overall, age-, and sex-specific PRR estimates were uniformly below 1. In addition, the overall, age-, and sex-specific Χ2 values were uniformly below 3. Our analysis of post-marketing surveillance data does not suggest that Guillain–Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among vaccine-eligible females or males in the United States. Our findings may be useful when discussing the risks and benefits of HPV4 vaccination. PMID:24013368

Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States.

PubMed

Ojha, Rohit P; Jackson, Bradford E; Tota, Joseph E; Offutt-Powell, Tabatha N; Singh, Karan P; Bae, Sejong

2014-01-01

Post-marketing surveillance studies provide conflicting evidence about whether Guillain-Barre syndrome occurs more frequently following quadrivalent human papillomavirus (HPV4) vaccination. We aimed to assess whether Guillain-Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among females and males aged 9 to 26 y in the United States. We used adverse event reports received by the United States Vaccine Adverse Event Reporting System (VAERS) between January 1, 2010 and December 31, 2012 to estimate overall, age-, and sex-specific proportional reporting ratios (PRRs) and corresponding Χ2 values for reports of Guillain-Barre syndrome between 5 and 42 d following HPV vaccination. Minimum criteria for a signal using this approach are 3 or more cases, PRR≥2, and Χ2≥4. Guillain-Barre syndrome was listed as an adverse event in 45 of 14,822 reports, of which 9 reports followed HPV4 vaccination and 36 reports followed all other vaccines. The overall, age-, and sex-specific PRR estimates were uniformly below 1. In addition, the overall, age-, and sex-specific Χ2 values were uniformly below 3. Our analysis of post-marketing surveillance data does not suggest that Guillain-Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among vaccine-eligible females or males in the United States. Our findings may be useful when discussing the risks and benefits of HPV4 vaccination.

Separate and Cumulative Effects of Adverse Childhood Experiences in Predicting Adult Health and Health Care Utilization

ERIC Educational Resources Information Center

Chartier, Mariette J.; Walker, John R.; Naimark, Barbara

2010-01-01

Objectives: Objectives of this population-based study were: (1) to examine the relative contribution of childhood abuse and other adverse childhood experiences to poor adult health and increased health care utilization and (2) to examine the cumulative effects of adverse childhood experiences on adult health and health care utilization. Methods:…

Effect of Two Different Methods of Initiating Atomoxetine on the Adverse Event Profile of Atomoxetine

ERIC Educational Resources Information Center

Greenhill, Laurence L.; Newcorn, Jeffrey H.; Gao, Haitao; Feldman, Peter D.

2007-01-01

Objective: To compare the effects of two different methods for initiating atomoxetine in terms of the incidence of early adverse events. Method: Data on atomoxetine treatment-emergent adverse events in youths, ages 6 to 18 years, were analyzed from five randomized, double-blind, placebo-controlled, acute-phase studies. Two studies involve…

Systemic Administration of the Potential Countermeasure Huperzine Reversibly Inhibits Central and Peripheral Acetylcholinesterase Activity Without Adverse Cognitive-Behavioral Effects

DTIC Science & Technology

2010-01-01

reversibly inhibits 5a. CONTRACT NUMBER central and peripheral acetylcholinesterase activity without adverse cognitive–behavioral effects 5b. GRANT...huperzine reversibly inhibits central and peripheral acetylcholinesterase activity without adverse cognitive–behavioral effects Todd M. Myers a,⁎, Wei Sun b...HUP to enter the brain is also evidenced by studies that use well-documented centrally active anticholinergics to induce cognitive impairments that are

[L-carnitine treatment and fish odor syndrome: an unwaited adverse effect].

PubMed

Rocher, F; Caruba, C; Broly, F; Lebrun, C

2011-01-01

Levocarnitine treatment is usually well tolerated, with essentially dose-dependent diarrhea as the main induced adverse effect. We report a case of fish odor syndrome during levocarnitine treatment which resolved after levocarnitine discontinuation. This adverse effect seems to be correlated with excedent carnitine intake and might be expressed when the elimination pathway becomes saturated or in a situation of deficiency enzymatic metabolism. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Adverse life events and delinquent behavior among Kenyan adolescents: a cross-sectional study on the protective role of parental monitoring, religiosity, and self-esteem.

PubMed

Kabiru, Caroline W; Elung'ata, Patricia; Mojola, Sanyu A; Beguy, Donatien

2014-01-01

Past research provides strong evidence that adverse life events heighten the risk of delinquent behavior among adolescents. Urban informal (slum) settlements in sub-Saharan Africa are marked by extreme adversity. However, the prevalence and consequences of adverse life events as well as protective factors that can mitigate the effects of exposure to these events in slum settlements is largely understudied. We examine two research questions. First, are adverse life events experienced at the individual and household level associated with a higher likelihood of delinquent behavior among adolescents living in two slums in Nairobi, Kenya? Second, are parental monitoring, religiosity, and self-esteem protective against delinquency in a context of high adversity? We used cross-sectional data from 3,064 males and females aged 12-19 years who participated in the Transitions to Adulthood Study. We examined the extent to which a composite index of adverse life events was associated with delinquent behavior (measured using a composite index derived from nine items). We also examined the direct and moderating effects of three protective factors: parental monitoring, religiosity, and self-esteem. Fifty-four percent of adolescents reported at least one adverse life event, while 18% reported three or more adverse events. For both males and females, adversity was positively and significantly associated with delinquency in bivariate and multivariate models. Negative associations were observed between the protective factors and delinquency. Significant adverse events × protective factor interaction terms were observed for parental monitoring (females and males), religiosity (males), and self-esteem (females). Similar to research in high income countries, adverse life events are associated with an increased likelihood of delinquent behavior among adolescents living in urban slums in Kenya, a low-income country. However, parental monitoring, religiosity, and self-esteem may moderate the effect of adversity on delinquent behavior and pinpoint possible avenues to develop interventions to reduce delinquency in resource-poor settings in low and middle income countries.

Dental primer and adhesive containing a new antibacterial quaternary ammonium monomer dimethylaminododecyl methacrylate

PubMed Central

Cheng, Lei; Weir, Michael D.; Zhang, Ke; Arola, Dwayne D.; Zhou, Xuedong; Xu, Hockin H. K.

2013-01-01

Objectives The main reason for restoration failure is secondary caries caused by biofilm acids. Replacing the failed restorations accounts for 50–70% of all operative work. The objectives of this study were to incorporate a new quaternary ammonium monomer (dimethylaminododecyl methacrylate, DMADDM) and nanoparticles of silver (NAg) into a primer and an adhesive, and to investigate their effects on antibacterial and dentin bonding properties. Methods Scotchbond Multi-Purpose (SBMP) served as control. DMADDM was synthesized and incorporated with NAg into primer/adhesive. A dental plaque microcosm biofilm model with human saliva was used to investigate metabolic activity, colony-forming units (CFU), and lactic acid. Dentin shear bond strengths were measured. Results Minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of the new DMADDM were orders of magnitude lower than those of a previous quaternary ammonium dimethacrylate (QADM). Uncured primer with DMADDM had much larger inhibition zones than QADM (p<0.05). Cured primer/adhesive with DMADDM-NAg greatly reduced biofilm metabolic activity (p<0.05). Combining DMADDM with NAg in primer/adhesive resulted in less CFU than DMADDM alone (p<0.05). Lactic acid production by biofilms was reduced by 20-fold via DMADDM-NAg, compared to control. Incorporation of DMADDM and NAg into primer/adhesive did not adversely affect dentin bond strength. Conclusions A new antibacterial monomer DMADDM was synthesized and incorporated into primer/adhesive for the first time. The bonding agents are promising to combat residual bacteria in tooth cavity and invading bacteria at tooth-restoration margins to inhibit caries. DMADDM and NAg are promising for use into a wide range of dental adhesive systems and restoratives. PMID:23353068

Therapeutic plasma concentrations of epsilon aminocaproic acid and tranexamic acid in horses.

PubMed

Fletcher, D J; Brainard, B M; Epstein, K; Radcliffe, R; Divers, T

2013-01-01

Antifibrinolytic drugs such as epsilon aminocaproic acid (EACA) and tranexamic acid (TEA) are used to treat various bleeding disorders in horses. Although horses are hypofibrinolytic compared to humans, dosing schemes have been derived from pharmacokinetic studies targeting plasma concentrations in humans. We hypothesized therapeutic plasma concentrations of antifibrinolytic drugs in horses would be significantly lower than in humans. Our objective was to use thromboleastography (TEG) and an in vitro model of hyperfibrinolysis to predict therapeutic concentrations of EACA and TEA in horses and humans. Citrated plasma collected from 24 random source clinically healthy research horses. Commercial pooled human citrated plasma with normal coagulation parameters was purchased. Minimum tissue plasminogen activator (tPA) concentration to induce complete fibrinolysis within 10 minutes was determined using serial dilutions of tPA in equine plasma. Results used to create an in vitro hyperfibrinolysis model with equine and human citrated plasma, and the minimum concentrations of EACA and TEA required to completely inhibit fibrinolysis for 30 minutes (estimated therapeutic concentrations) determined using serial dilutions of the drugs. Estimated therapeutic concentrations of EACA and TEA were significantly lower in horses (5.82; 95% CI 3.77-7.86 μg/mL and 0.512; 95% CI 0.277-0.748 μg/mL) than in humans (113.2; 95% CI 95.8-130.6 μg/mL and 11.4; 95% CI 8.62-14.1 μg/mL). Current dosing schemes for EACA and TEA in horses may be as much as 20× higher than necessary, potentially increasing cost of treatment and risk of adverse effects. Copyright © 2013 by the American College of Veterinary Internal Medicine.

Efficacy of a single dose of milbemycin oxime/praziquantel combination tablets, Milpro(®), against adult Echinococcus multilocularis in dogs and both adult and immature E. multilocularis in young cats.

PubMed

Cvejic, Dejan; Schneider, Claudia; Fourie, Josephus; de Vos, Christa; Bonneau, Stephane; Bernachon, Natalia; Hellmann, Klaus

2016-03-01

Two single-site, laboratory, negatively controlled, masked, randomised dose confirmation studies were performed: one in dogs, the other in cats. After a period of acclimatisation, both the dogs and cats were orally infected with Echinococcus multilocularis protoscoleces. In the dog study, 10 dogs received a single dose of Milpro® tablets at a minimum dose of 0.5 mg/kg milbemycin oxime and 5 mg/kg praziquantel 18 days post-infection and 10 dogs received no treatment. In the cat study, 10 cats received a single dose of Milpro® tablets at a minimum dose of 2 mg/kg milbemycin oxime and 5 mg/kg praziquantel 7 days post-infection, 10 cats received a single dose of the treatment 18 days post-infection and 10 cats remained untreated. In both studies, intestinal worm counts were performed 23 days post-infection at necropsy. No worms were retrieved from any of the 30 treated animals. Nine of 10 control dogs had multiple worms (geometric mean 91, arithmetic mean 304) and all 10 control cats had multiple worms (geometric mean 216, arithmetic mean 481). The difference in worm counts between all three treated groups and their controls was highly significant (ANOVA p values of log transformed data <0.0001). Efficacy of 100 % was demonstrated for the elimination of adult E. multilocularis in dogs and cats as well as for elimination of immature E. multilocularis in cats as evidenced by the effectiveness of treatment 7 days post-infection. The treatments were well accepted and tolerated, and there were no adverse drug reactions observed.

Outpatient treatment of deep venous thrombosis in diverse inner-city patients.

PubMed

Dunn, A S; Schechter, C; Gotlin, A; Vomvolakis, D; Jacobs, E; Sacks, H S; Coller, B

2001-04-15

We sought to describe the development and outcomes of a hospital-based program designed to provide safe and effective outpatient treatment to a diverse group of patients with acute deep venous thrombosis. Patients enrolled in the program were usually discharged on the day of or the day after presentation. Low- molecular-weight heparin was administered for a minimum of 5 days and warfarin was given for a minimum of 3 months. The hospital provided low-molecular-weight heparin free of charge to patients. Patients received daily home nursing visits to monitor the prothrombin time, assess compliance, and detect complications. The inpatient and outpatient records of the first 89 consecutive patients enrolled in the program were reviewed. Patients were observed for a 3-month period after enrollment. The median length of stay was 1 day. Low-molecular-weight heparin was administered for a mean (+/- standard deviation [SD]) of 4.7 +/- 2.4 days at home. Recurrent thromboembolism was noted in 1 patient (1%), major bleeding in 2 patients (2%), and minor bleeding in 2 patients (2%). No patients died or developed thrombocytopenia. Assuming that patients would have been hospitalized for the duration of treatment with low-molecular-weight heparin, the program eliminated a mean of 4.7 days of hospitalization, with an estimated reduction of $1,645 in total health care costs per patient. This hospital-based program to provide outpatient treatment of deep venous thrombosis to a diverse group of inner-city patients achieved a low incidence of adverse events and substantial health care cost savings. Specific strategies, including providing low-molecular-weight heparin free of charge and daily home nursing visits, can be utilized to facilitate access to outpatient treatment and ensure high-quality care.

PROBABILITY OF CME IMPACT ON EXOPLANETS ORBITING M DWARFS AND SOLAR-LIKE STARS

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

Kay, C.; Opher, M.; Kornbleuth, M., E-mail: ckay@bu.edu

2016-08-01

Solar coronal mass ejections (CMEs) produce adverse space weather effects at Earth. Planets in the close habitable zone of magnetically active M dwarfs may experience more extreme space weather than at Earth, including frequent CME impacts leading to atmospheric erosion and leaving the surface exposed to extreme flare activity. Similar erosion may occur for hot Jupiters with close orbits around solar-like stars. We have developed a model, Forecasting a CME's Altered Trajectory (ForeCAT), which predicts a CME's deflection. We adapt ForeCAT to simulate CME deflections for the mid-type M dwarf V374 Peg and hot Jupiters with solar-type hosts. V374 Peg'smore » strong magnetic fields can trap CMEs at the M dwarfs's Astrospheric Current Sheet, that is, the location of the minimum in the background magnetic field. Solar-type CMEs behave similarly, but have much smaller deflections and do not become trapped at the Astrospheric Current Sheet. The probability of planetary impact decreases with increasing inclination of the planetary orbit with respect to the Astrospheric Current Sheet: 0.5–5 CME impacts per day for M dwarf exoplanets, 0.05–0.5 CME impacts per day for solar-type hot Jupiters. We determine the minimum planetary magnetic field necessary to shield a planet's atmosphere from CME impacts. M dwarf exoplanets require values between tens and hundreds of Gauss. Hot Jupiters around a solar-type star, however, require a more reasonable <30 G. These values exceed the magnitude required to shield a planet from the stellar wind, suggesting that CMEs may be the key driver of atmospheric losses.« less

Determination of the duty cycle of WLAN for realistic radio frequency electromagnetic field exposure assessment.

PubMed

Joseph, Wout; Pareit, Daan; Vermeeren, Günter; Naudts, Dries; Verloock, Leen; Martens, Luc; Moerman, Ingrid

2013-01-01

Wireless Local Area Networks (WLANs) are commonly deployed in various environments. The WLAN data packets are not transmitted continuously but often worst-case exposure of WLAN is assessed, assuming 100% activity and leading to huge overestimations. Actual duty cycles of WLAN are thus of importance for time-averaging of exposure when checking compliance with international guidelines on limiting adverse health effects. In this paper, duty cycles of WLAN using Wi-Fi technology are determined for exposure assessment on large scale at 179 locations for different environments and activities (file transfer, video streaming, audio, surfing on the internet, etc.). The median duty cycle equals 1.4% and the 95th percentile is 10.4% (standard deviation SD = 6.4%). Largest duty cycles are observed in urban and industrial environments. For actual applications, the theoretical upper limit for the WLAN duty cycle is 69.8% and 94.7% for maximum and minimum physical data rate, respectively. For lower data rates, higher duty cycles will occur. Although counterintuitive at first sight, poor WLAN connections result in higher possible exposures. File transfer at maximum data rate results in median duty cycles of 47.6% (SD = 16%), while it results in median values of 91.5% (SD = 18%) at minimum data rate. Surfing and audio streaming are less intensively using the wireless medium and therefore have median duty cycles lower than 3.2% (SD = 0.5-7.5%). For a specific example, overestimations up to a factor 8 for electric fields occur, when considering 100% activity compared to realistic duty cycles. Copyright © 2012 Elsevier Ltd. All rights reserved.

Design of a Minimum Surface-Effect Three Degree-of-Freedom Micromanipulator

NASA Technical Reports Server (NTRS)

Goldfarb, Michael; Speich, John E.

1997-01-01

This paper describes the fundamental physical motivations for small-scale minimum surface-effect design, and presents a three degree-of-freedom micromanipulator design that incorporates a minimum surface-effect approach. The primary focus of the design is the split-tube flexure, a unique small-scale revolute joint that exhibits a considerably larger range of motion and significantly better multi-axis revolute joint characteristics than a conventional flexure. The development of this joint enables the implementation of a small-scale spatially-loaded revolute joint-based manipulator with well-behaved kinematic characteristics and without the backlash and stick-slip behavior that would otherwise prevent precision control

Are There Long-Run Effects of the Minimum Wage?

PubMed Central

Sorkin, Isaac

2014-01-01

An empirical consensus suggests that there are small employment effects of minimum wage increases. This paper argues that these are short-run elasticities. Long-run elasticities, which may differ from short-run elasticities, are policy relevant. This paper develops a dynamic industry equilibrium model of labor demand. The model makes two points. First, long-run regressions have been misinterpreted because even if the short- and long-run employment elasticities differ, standard methods would not detect a difference using US variation. Second, the model offers a reconciliation of the small estimated short-run employment effects with the commonly found pass-through of minimum wage increases to product prices. PMID:25937790

Are There Long-Run Effects of the Minimum Wage?

PubMed

Sorkin, Isaac

2015-04-01

An empirical consensus suggests that there are small employment effects of minimum wage increases. This paper argues that these are short-run elasticities. Long-run elasticities, which may differ from short-run elasticities, are policy relevant. This paper develops a dynamic industry equilibrium model of labor demand. The model makes two points. First, long-run regressions have been misinterpreted because even if the short- and long-run employment elasticities differ, standard methods would not detect a difference using US variation. Second, the model offers a reconciliation of the small estimated short-run employment effects with the commonly found pass-through of minimum wage increases to product prices.

33 CFR 154.1130 - Requirements for prepositioned response equipment.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Additional Response Plan Requirements for a Trans-Alaska Pipeline Authorization Act (TAPAA) Facility...: (a) On-water recovery equipment with a minimum effective daily recovery rate of 30,000 barrels... of a discharge. (c) On-water recovery equipment with a minimum effective daily recovery rate of 40...

33 CFR 154.1130 - Requirements for prepositioned response equipment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Additional Response Plan Requirements for a Trans-Alaska Pipeline Authorization Act (TAPAA) Facility...: (a) On-water recovery equipment with a minimum effective daily recovery rate of 30,000 barrels... of a discharge. (c) On-water recovery equipment with a minimum effective daily recovery rate of 40...

33 CFR 154.1130 - Requirements for prepositioned response equipment.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Additional Response Plan Requirements for a Trans-Alaska Pipeline Authorization Act (TAPAA) Facility...: (a) On-water recovery equipment with a minimum effective daily recovery rate of 30,000 barrels... of a discharge. (c) On-water recovery equipment with a minimum effective daily recovery rate of 40...

33 CFR 154.1130 - Requirements for prepositioned response equipment.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Additional Response Plan Requirements for a Trans-Alaska Pipeline Authorization Act (TAPAA) Facility...: (a) On-water recovery equipment with a minimum effective daily recovery rate of 30,000 barrels... of a discharge. (c) On-water recovery equipment with a minimum effective daily recovery rate of 40...

The effects of interfacial potential on antimicrobial propensity of ZnO nanoparticle

PubMed Central

Arakha, Manoranjan; Saleem, Mohammed; Mallick, Bairagi C.; Jha, Suman

2015-01-01

The work investigates the role of interfacial potential in defining antimicrobial propensity of ZnO nanoparticle (ZnONP) against different Gram positive and Gram negative bacteria. ZnONPs with positive and negative surface potential are tested against different bacteria with varying surface potentials, ranging −14.7 to −23.6 mV. Chemically synthesized ZnONPs with positive surface potential show very high antimicrobial propensity with minimum inhibitory concentration of 50 and 100 μg/mL for Gram negative and positive bacterium, respectively. On other hand, ZnONPs of the same size but with negative surface potential show insignificant antimicrobial propensity against the studied bacteria. Unlike the positively charged nanoparticles, neither Zn2+ ion nor negatively charged ZnONP shows any significant inhibition in growth or morphology of the bacterium. Potential neutralization and colony forming unit studies together proved adverse effect of the resultant nano-bacterial interfacial potential on bacterial viability. Thus, ZnONP with positive surface potential upon interaction with negative surface potential of bacterial membrane enhances production of the reactive oxygen species and exerts mechanical stress on the membrane, resulting in the membrane depolarization. Our results show that the antimicrobial propensity of metal oxide nanoparticle mainly depends upon the interfacial potential, the potential resulting upon interaction of nanoparticle surface with bacterial membrane. PMID:25873247

Synergistically enhanced selective intracellular uptake of anticancer drug carrier comprising folic acid-conjugated hydrogels containing magnetite nanoparticles

NASA Astrophysics Data System (ADS)

Kim, Haneul; Jo, Ara; Baek, Seulgi; Lim, Daeun; Park, Soon-Yong; Cho, Soo Kyung; Chung, Jin Woong; Yoon, Jinhwan

2017-01-01

Targeted drug delivery has long been extensively researched since drug delivery and release at the diseased site with minimum dosage realizes the effective therapy without adverse side effects. In this work, to achieve enhanced intracellular uptake of anticancer drug carriers for efficient chemo-therapy, we have designed targeted multifunctional anticancer drug carrier hydrogels. Temperature-responsive poly(N-isopropylacrylamide) (PNIPAm) hydrogel core containing superparamagnetic magnetite nanoparticles (MNP) were prepared using precipitation polymerization, and further polymerized with amine-functionalized copolymer shell to facilitate the conjugation of targeting ligand. Then, folic acid, specific targeting ligand for cervical cancer cell line (HeLa), was conjugated on the hydrogel surface, yielding the ligand conjugated hybrid hydrogels. We revealed that enhanced intracellular uptake by HeLa cells in vitro was enabled by both magnetic attraction and receptor-mediated endocytosis, which were contributed by MNP and folic acid, respectively. Furthermore, site-specific uptake of the developed carrier was confirmed by incubating with several other cell lines. Based on synergistically enhanced intracellular uptake, efficient cytotoxicity and apoptotic activity of HeLa cells incubated with anticancer drug loaded hybrid hydrogels were successfully achieved. The developed dual-targeted hybrid hydrogels are expected to provide a platform for the next generation intelligent drug delivery systems.

Controlling initial biodegradation of magnesium by a biocompatible strontium phosphate conversion coating.

PubMed

Chen, X B; Nisbet, D R; Li, R W; Smith, P N; Abbott, T B; Easton, M A; Zhang, D-H; Birbilis, N

2014-03-01

A simple strontium phosphate (SrP) conversion coating process was developed to protect magnesium (Mg) from the initial degradation post-implantation. The coating morphology, deposition rate and resultant phases are all dependent on the processing temperature, which determines the protective ability for Mg in minimum essential medium (MEM). Coatings produced at 80 °C are primarily made up of strontium apatite (SrAp) with a granular surface, a high degree of crystallinity and the highest protective ability, which arises from retarding anodic dissolution of Mg in MEM. Following 14 days' immersion in MEM, the SrAp coating maintained its integrity with only a small fraction of the surface corroded. The post-degradation effect of uncoated Mg and Mg coated at 40 and 80 °C on the proliferation and differentiation of human mesenchymal stem cells was also studied, revealing that the SrP coatings are biocompatible and permit proliferation to a level similar to that of pure Mg. The present study suggests that the SrP conversion coating is a promising option for controlling the early rapid degradation rate, and hence hydrogen gas evolution, of Mg implants without adverse effects on surrounding cells and tissues. Copyright © 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Arctigenin preferentially induces tumor cell death under glucose deprivation by inhibiting cellular energy metabolism.

PubMed

Gu, Yuan; Qi, Chunting; Sun, Xiaoxiao; Ma, Xiuquan; Zhang, Haohao; Hu, Lihong; Yuan, Junying; Yu, Qiang

2012-08-15

Selectively eradicating cancer cells with minimum adverse effects on normal cells is a major challenge in the development of anticancer therapy. We hypothesize that nutrient-limiting conditions frequently encountered by cancer cells in poorly vascularized solid tumors might provide an opportunity for developing selective therapy. In this study, we investigated the function and molecular mechanisms of a natural compound, arctigenin, in regulating tumor cell growth. We demonstrated that arctigenin selectively promoted glucose-starved A549 tumor cells to undergo necrosis by inhibiting mitochondrial respiration. In doing so, arctigenin elevated cellular level of reactive oxygen species (ROS) and blocked cellular energy metabolism in the glucose-starved tumor cells. We also demonstrated that cellular ROS generation was caused by intracellular ATP depletion and played an essential role in the arctigenin-induced tumor cell death under the glucose-limiting condition. Furthermore, we combined arctigenin with the glucose analogue 2-deoxyglucose (2DG) and examined their effects on tumor cell growth. Interestingly, this combination displayed preferential cell-death inducing activity against tumor cells compared to normal cells. Hence, we propose that the combination of arctigenin and 2DG may represent a promising new cancer therapy with minimal normal tissue toxicity. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

Systematic review with meta-analysis: highly selective 5-HT4 agonists (prucalopride, velusetrag or naronapride) in chronic constipation.

PubMed

Shin, A; Camilleri, M; Kolar, G; Erwin, P; West, C P; Murad, M H

2014-02-01

Highly selective 5-HT4 agonists have been suggested for the treatment of chronic constipation (CC). To assess the effects of highly selective 5-HT4 agonists (prucalopride, velusetrag or naronapride) on patient-important clinical efficacy outcomes and safety in adults with CC. We searched the medical literature in January 2013 using MEDLINE/Pubmed, Embase, Cochrane Library, and Web of Science/Scopus for randomised, controlled trials of highly selective 5-HT4 agonists in adults with CC, with no minimum duration of therapy (maximum 12 weeks) or date limitations. Data were extracted from intention-to-treat analyses, pooled using a random-effects model, and reported as relative risk (RR), mean differences, or standardised mean differences with 95% confidence intervals (CI). Main outcomes included stool frequency, Patient-Assessment of Constipation Quality of Life (PAC-QOL), PAC of symptoms (PAC-SYM) and adverse events. Thirteen eligible trials were identified: 11 prucalopride, 1 velusetrag, 1 naronapride. Relative to control, treatment with highly selective 5-HT4 agonists was superior for all outcomes: mean ≥3 spontaneous complete bowel movements (SCBM)/week (RR = 1.85; 95% CI 1.23-2.79); mean ≥1 SCBM over baseline (RR = 1.57; 95% CI 1.19, 2.06); ≥1 point improvement in PAC-QOL and PAC-SYM scores. The only active comparator trial of prucalopride and PEG3350 suggested PEG3350 is more efficacious for some end points. Adverse events were more common with highly selective 5-HT4 agonists, but were generally minor; headache was the most frequent. Most trials studied prucalopride. Demonstration of efficacy on patient-important outcomes and a favourable safety profile support the continued use and development of highly selective 5-HT4 agonists in the treatment of chronic constipation. © 2013 John Wiley & Sons Ltd.

Effect of cold compress application on tissue temperature in healthy dogs.

PubMed

Millard, Ralph P; Towle-Millard, Heather A; Rankin, David C; Roush, James K

2013-03-01

To measure the effect of cold compress application on tissue temperature in healthy dogs. 10 healthy mixed-breed dogs. Dogs were sedated with hydromorphone (0.1 mg/kg, IV) and diazepam (0.25 mg/kg, IV). Three 24-gauge thermocouple needles were inserted to a depth of 0.5 (superficial), 1.0 (middle), and 1.5 (deep) cm into a shaved, lumbar, epaxial region to measure tissue temperature. Cold (-16.8°C) compresses were applied with gravity dependence for periods of 5, 10, and 20 minutes. Tissue temperature was recorded before compress application and at intervals for up to 80 minutes after application. Control data were collected while dogs received identical sedation but with no cold compress. Mean temperature associated with 5 minutes of application at the superficial depth was significantly decreased, compared with control temperatures. Application for 10 and 20 minutes significantly reduced the temperature at all depths, compared with controls and 5 minutes of application. Twenty minutes of application significantly decreased temperature at only the middle depth, compared with 10 minutes of application. With this method of cold treatment, increasing application time from 10 to 20 minutes caused a further significant temperature change at only the middle tissue depth; however, for maximal cooling, the minimum time of application should be 20 minutes. Possible changes in tissue temperature and adverse effects of application > 20 minutes require further evaluation.

Tolerance of young infants to a single, large dose of vitamin A: a randomized community trial in Nepal.

PubMed

West, K P; Khatry, S K; LeClerq, S C; Adhikari, R; See, L; Katz, J; Shrestha, S R; Pradhan, E K; Pokhrel, R P; Sommer, A

1992-01-01

A randomized, double-masked trial was carried out in rural Nepal to investigate the incidence and severity of acute side-effects among neonates ( < 1 month of age) and infants aged 1-6 months who received a large, oral dose of vitamin A (15,000 retinol equivalents (RE) (50,000 IU) and 30,000 RE (100,000 IU), respectively) or placebo (75 RE (250 IU) and 150 RE (500 IU), respectively) in oil. Infants (vitamin A group, n = 1461; controls, n = 1379) were assessed for vomiting, loose stools, fever, and irritability during the 24 hours before and after dosing. Fontanelles were palpated 24 hours after dosing. Neonates exhibited no excess risk of adverse side-effects after receiving 15,000 RE. Compared with controls the older infants who ingested 30,000 RE had a 1.6% excess rate of vomiting (95% confidence interval (CI): 0.2-3.0%) and a 0.5% excess rate (95% CI: -0.1 to 1.1%) in the occurrence of bulging fontanelles. There were no other significant differences in the older infants. The controlled, periodic distribution of a single 15,000 RE dose of vitamin A therefore confers no apparent acute risk to young infants; a 30,000 RE dose is associated with a minimum risk of transient, acute side-effects.

Long-term follow-up for efficacy and safety of treatment of retinitis pigmentosa with valproic acid.

PubMed

Bhalla, Sheena; Joshi, Deval; Bhullar, Shaminder; Kasuga, Daniel; Park, Yeonhee; Kay, Christine N

2013-07-01

The purpose of this study was to determine the long-term efficacy and safety of valproic acid (VPA) treatment in patients with pigmentary retinal dystrophies. A retrospective chart review was conducted on 31 patients with a diagnosis of pigmentary retinal dystrophy prescribed VPA at a single centre. Visual field (VF), visual acuity (VA), length of treatment, liver enzymes and side effects were analysed. VF areas were defined using Goldmann VF (GVF) tracings recorded before, during and after VPA treatment using the V4e isopter for each eye. Using custom software, planimetric areas of VF were calculated. Five of the patients (10 eyes) had two Goldmann VF tracings, allowing comparison between baseline and follow-up VF. After 9.8 months of VPA, VF decreased by 0.145 cm(2) (26.478%) (p=0.432). For 22 of the patients (41 eyes), VA data was available, and logarithm of the minimum angle of resolution (logMAR) score changed by 0.056 log units (representing a decline in VA) after 14.9 months on VPA (p=0.002). Twelve patients (38.7%) reported negative side effects related to VPA use. VPA plays a complex role in patients with pigmentary retinal dystrophies and may be associated with VA and field decline as well as adverse side effects. Physicians should use caution with using VPA for pigmentary retinal dystrophies.

Effect of electromagnetic radiation on the coils used in aneurysm embolization.

PubMed

Lv, Xianli; Wu, Zhongxue; Li, Youxiang

2014-06-01

This study evaluated the effects of electromagnetic radiation in our daily lives on the coils used in aneurysm embolization. Faraday's electromagnetic induction principle was applied to analyze the effects of electromagnetic radiation on the coils used in aneurysm embolization. To induce a current of 0.5mA in less than 5 mm platinum coils required to stimulate peripheral nerves, the minimum magnetic field will be 0.86 μT. To induce a current of 0.5 mA in platinum coils by a hair dryer, the minimum aneurysm radius is 2.5 mm (5 mm aneurysm). To induce a current of 0.5 mA in platinum coils by a computer or TV, the minimum aneurysm radius is 8.6 mm (approximate 17 mm aneurysm). The minimum magnetic field is much larger than the flux densities produced by computer and TV, while the minimum aneurysm radius is much larger than most aneurysm sizes to levels produced by computer and TV. At present, the effects of electromagnetic radiation in our daily lives on intracranial coils do not produce a harmful reaction. Patients with coiled aneurysm are advised to avoid using hair dryers. This theory needs to be proved by further detailed complex investigations. Doctors should give patients additional instructions before the procedure, depending on this study.

Effect of Electromagnetic Radiation on the Coils Used in Aneurysm Embolization

PubMed Central

Lv, Xianli; Wu, Zhongxue; Li, Youxiang

2014-01-01

Summary This study evaluated the effects of electromagnetic radiation in our daily lives on the coils used in aneurysm embolization. Faraday’s electromagnetic induction principle was applied to analyze the effects of electromagnetic radiation on the coils used in aneurysm embolization. To induce a current of 0.5mA in less than 5 mm platinum coils required to stimulate peripheral nerves, the minimum magnetic field will be 0.86 μT. To induce a current of 0.5 mA in platinum coils by a hair dryer, the minimum aneurysm radius is 2.5 mm (5 mm aneurysm). To induce a current of 0.5 mA in platinum coils by a computer or TV, the minimum aneurysm radius is 8.6 mm (approximate 17 mm aneurysm). The minimum magnetic field is much larger than the flux densities produced by computer and TV, while the minimum aneurysm radius is much larger than most aneurysm sizes to levels produced by computer and TV. At present, the effects of electromagnetic radiation in our daily lives on intracranial coils do not produce a harmful reaction. Patients with coiled aneurysm are advised to avoid using hair dryers. This theory needs to be proved by further detailed complex investigations. Doctors should give patients additional instructions before the procedure, depending on this study. PMID:24976203

Contributions of early adversity to pro-inflammatory phenotype in infancy: the buffer provided by attachment security.

PubMed

Measelle, Jeffrey R; Ablow, Jennifer C

2018-02-01

Adversity early in life is associated with systemic inflammation by adolescence and beyond. At present, few studies have investigated the associations between different forms of adversity and inflammation during infancy, making it difficult to specify the origins of disease vulnerability. This study examined the association between multiple forms of early adversity - socioeconomic status disadvantage, familial stress, maternal depression, and security of attachment - and individual differences in a composite measure of pro-inflammatory cytokines (IL-1β, IL-6, IL-8, and tumor necrosis factor-alpha) and the inflammatory protein C-reactive protein that were collected via saliva when (n = 49) children were 17 months old. In addition to gauging the direct effects of adversity, we also tested the hypothesis that infants' attachment relationship with their mother might buffer infants against the immunologic effects of early adversity. Results show that familial stress, maternal depression, and security of attachment were directly associated with infant salivary inflammation and that attachment status moderated the effect of maternal depression. The findings suggest that exposure to certain forms of adversity very early in life may engender a pro-inflammatory phenotype with possible life-long implications for health.

Neurological Adverse Effects in Patients of Advanced Colorectal Carcinoma Treated with Different Schedules of FOLFOX

PubMed Central

Najam, Rahila; Mateen, Ahmed

2013-01-01

The study is designed to assess the frequency and severity of few dose limiting neurological adverse effects of four different schedules of FOLFOX. Patients with histologically confirmed advanced colorectal carcinoma (CRC) were included in the study. Toxicity was graded according to CTC v 2.0. The frequency of grade 3 and 4 adverse effects was comparatively assessed in each treatment arm. The difference in the pattern of toxicity between the treatment schedule was evaluated. The most frequent adverse symptom of neurological adverse effect was grade 1 paresthesia in the patients treated with FOLFOX4 schedule. Grade 4 peripheral neuropathy was reported in few patients of FOLFOX7 treatment arm. Frequency and onset of neurological adverse effects like paresthesia, dizziness, and hypoesthesia were significantly different (P < 0.05), whereas frequency and onset of peripheral neuropathy were highly significant (P < 0.01) in each treatment arm of FOLFOX. Peripheral neuropathy was associated with electrolyte imbalance and diabetes in few patients. Frequency of symptoms, for example, paresthesia, is associated with increased number of recurrent exposure to oxaliplatin (increased number of cycles) even at low doses (85 mg/m2), whereas severity of symptoms, for example, peripheral neuropathy, is associated with higher dose (130 mg/m2) after few treatment cycles. PMID:24187619

An over-the-counter central sensitization therapy: a chronic back pain registry study of pain relief, medication use and their adverse effects.

PubMed

Staelin, Richard; Koneru, Sree N; Rawe, Ian M

2017-03-01

Back pain, the most prevalent musculoskeletal chronic pain condition, is usually treated with analgesic medications of questionable efficacy and frequent occurrence of adverse side effects. The objective was to determine the effectiveness of the ActiPatch medical devices in reducing chronic back pain, document medication related adverse side effects and establish their impact on quality of life. Upon completing a 7-day trial, subjects were contacted via email with an assessment form using the Constant Contact email program. A total of 1394 responses were collected from subjects who used the device for back pain. Medication adverse effects are common and impact quality of life in the lay population. ActiPatch is an effective intervention for the majority of subjects for treating chronic back pain, although this requires further investigation in randomized clinical trials.

Childhood adversity moderates the effect of ADH1B on risk for alcohol-related phenotypes in Jewish Israeli drinkers.

PubMed

Meyers, Jacquelyn L; Shmulewitz, Dvora; Wall, Melanie M; Keyes, Katherine M; Aharonovich, Efrat; Spivak, Baruch; Weizman, Abraham; Frisch, Amos; Edenberg, Howard J; Gelernter, Joel; Grant, Bridget F; Hasin, Deborah

2015-01-01

Childhood adversity and genetic variant ADH1B-rs1229984 have each been shown to influence heavy alcohol consumption and disorders. However, little is known about how these factors jointly influence these outcomes. We assessed the main and additive interactive effects of childhood adversity (abuse, neglect and parental divorce) and the ADH1B-rs1229984 on the quantitative phenotypes 'maximum drinks in a day' (Maxdrinks) and DSM-Alcohol Use Disorder (AUD) severity, adjusting for demographic variables, in an Israeli sample of adult household residents (n = 1143) evaluated between 2007 and 2009. Childhood adversity and absence of the protective ADH1B-rs1229984 A allele were associated with greater mean Maxdrinks (mean differences: 1.50; 1.13, respectively) and AUD severity (mean ratios: 0.71; 0.27, respectively). In addition, childhood adversity moderated the ADH1B-rs1229984 effect on Maxdrinks (P < 0.01) and AUD severity (P < 0.05), in that there was a stronger effect of ADH1B-rs1229984 genotype on Maxdrinks and AUD severity among those who had experienced childhood adversity compared with those who had not. ADH1B-rs1229984 impacts alcohol metabolism. Therefore, among those at risk for greater consumption, e.g. those who experienced childhood adversity, ADH1B-rs1229984 appears to have a stronger effect on alcohol consumption and consequently on risk for AUD symptom severity. Evidence for the interaction of genetic vulnerability and early life adversity on alcohol-related phenotypes provides further insight into the complex relationships between genetic and environmental risk factors. © 2013 Society for the Study of Addiction.

The impact of old versus new antiepileptic drugs on costs and patient reported outcomes among older adults.

PubMed

Almalag, Haya M; Alzahrani, Huda; Al-Hussain, Fawaz; Alsemari, Abdulaziz; De Vol, Edward B; Almarzouqi, Manal Rashed; AlRuthia, Yazed S

2018-05-30

The aim of this prospective questionnaire-based cross-sectional study was to examine whether the new generation of Antiepileptic drugs (AEDs) with higher acquisition cost generate lower adverse effects than the old AEDs among a sample of 102 Arabic-speaking older adults (60 years of age or older) with seizure disorders. The mean scores of the Arabic version of the Liverpool Adverse Events Profile (LAEP), which assessed the adverse effects of the AEDs, did not differ between patients taking the old and new generations of AEDs. Despite their 4-fold higher cost, the new generation of AEDs were not characterized by lower LAEP scores of adverse effects. However, higher LAEP scores were associated with better health literacy. In conclusion, the use of new AEDs was not associated with lower self-reported adverse effects scores among Arabic-speaking older adults with seizure disorders despite their higher acquisition costs. Copyright © 2018 Elsevier Inc. All rights reserved.

Non-Verbal Reasoning Ability and Academic Achievement as Moderators of the Relation between Adverse Life Events and Emotional and Behavioural Problems in Early Adolescence: The Importance of Moderator and Outcome Specificity

ERIC Educational Resources Information Center

Flouri, Eirini; Tzavidis, Nikos

2011-01-01

This study was carried out to model the functional form of the effect of contextual risk (number of adverse life events) on emotional and behavioural problems in early adolescence, and to test how intelligence and academic achievement compare as moderators of this effect. The effect of number of adverse life events on emotional and behavioural…

Adverse effects as a consequence of being the subject of orthopaedic manual therapy training, a worldwide retrospective survey.

PubMed

Thoomes-de Graaf, M; Thoomes, E; Carlesso, L; Kerry, R; Rushton, A

2017-06-01

Physical therapists (PTs) use a range of manual therapy techniques developed to an advanced level through postgraduate orthopaedic manipulative physical therapy (OMPT) programmes. The aim of this study was to describe the adverse effects experienced by students after having techniques performed on them as part of their OMPT training. A descriptive online survey of current students and recent graduates (≤5 years)m of OMPT programmes across the 22 Member Organisations of the International Federation of Orthopaedic Manipulative Physical Therapists. The questionnaire was completed by 1640 respondents across 22 countries (1263 graduates, 377 students. Some 60% of respondents reported never having experienced adverse effects during their manual therapy training. Of the 40% who did, 66.4% reported neck pain, 50.9% headache and 32% low back pain. Most reports of neck pain started after a manipulation and/or mobilisation, of which 53.4% lasted ≤24 h, 38.1% > 24 h but <3 months and 13.7% still experienced neck pain to date. A small percentage of respondents (3.3%) reported knowing of a fellow student experiencing a major adverse effect. Mild to moderate adverse effects after practising manual therapy techniques are commonly reported, but usually resolve within 24 h. However, this survey has identified the reported occurrence of major adverse effects that warrant further investigation. Copyright © 2017 Elsevier Ltd. All rights reserved.

The effect of childhood adversity on 4-year outcome in individuals at ultra high risk for psychosis in the Dutch Early Detection Intervention Evaluation (EDIE-NL) Trial.

PubMed

Kraan, Tamar C; Ising, Helga K; Fokkema, Marjolein; Velthorst, Eva; van den Berg, David P G; Kerkhoven, Margot; Veling, Wim; Smit, Filip; Linszen, Don H; Nieman, Dorien H; Wunderink, Lex; Boonstra, Nynke; Klaassen, Rianne M C; Dragt, Sara; Rietdijk, Judith; de Haan, Lieuwe; van der Gaag, Mark

2017-01-01

Childhood adversity is associated with a range of mental disorders, functional impairment and higher health care costs in adulthood. In this study we evaluated if childhood adversity was predictive of adverse clinical and functional outcomes and health care costs in a sample of patients at ultra-high risk (UHR) for developing a psychosis. Structural Equation Modeling was used to examine the effect of childhood adversity on depression, anxiety, transition to psychosis and overall functioning at 4-year follow-up. In addition, we evaluated economic costs of childhood adversity in terms of health care use and productivity loss. Data pertain to 105 UHR participants of the Dutch Early Detection and Intervention Evaluation (EDIE-NL). Physical abuse was associated with higher depression rates (b=0.381, p=0.012) and lower social functional outcome (b=-0.219, p=0.017) at 4-year follow-up. In addition, emotional neglect was negatively associated with social functioning (b=-0.313, p=0.018). We did not find evidence that childhood adversity was associated with transition to psychosis, but the experience of childhood adversity was associated with excess health care costs at follow-up. The data indicate long-term negative effects of childhood adversity on depression, social functioning and health care costs at follow-up in a sample of UHR patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Cognition- and Dementia-Related Adverse Effects With Sacubitril-Valsartan: Analysis of the FDA Adverse Event Report System Database.

PubMed

Perlman, Amichai; Hirsh Raccah, Bruria; Matok, Ilan; Muszkat, Mordechai

2018-05-07

Because neprilysin is involved in the degradation of amyloid-beta, there is concern that the angiotensin-neprilysin inhibitor sacubitril-valsartan could increase the risk for dementia. We analyzed adverse event cases submitted to the Food and Drug Administration Adverse Event Report System from July 2015 to March 2017. Cognition- and dementia-related adverse event cases were defined with the use of broad and narrow structured medical queries. During the period evaluated, 9,004 adverse event reports (out of a total of 2,249,479) involved the use of sacubitril-valsartan. Based on the broad definition, sacubitril-valsartan was associated with cognition- and dementia-related adverse events in 459 reports (5.1%), but this was lower than the proportion of these reports among other medications (6.6%, reporting odds ratio [ROR] 0.72, 95% confidence interval [CI] 0.65-0.79). Restricting the comparison to cases with age >60 years and with the use of a comparator group with heart failure resulted in no association between sacubitril-valsartan and dementia-related adverse events, with the use of both the broad and the narrow definitions (ROR 0.87, 95% CI 0.76-1.02, and ROR 1.06, 95% CI 0.4-3.16, respectively). Sacubitril-valsartan is not associated with a disproportionately high rate of short-term dementia-related adverse effect reports. Long-term studies assessing cognitive outcomes are required to better establish the medication's cognition effects. Copyright © 2018 Elsevier Inc. All rights reserved.

Effect of Abrupt Substitution of Gadobenate Dimeglumine for Gadopentetate Dimeglumine on Rate of Allergic-like Reactions

PubMed Central

Dillman, Jonathan R.; Cohan, Richard H.; Hussain, Hero K.; Khalatbari, Shokoufeh; McHugh, Jonathan B.; Ellis, James H.

2013-01-01

Purpose: To evaluate the effect of abruptly substituting gadobenate dimeglumine for gadopentetate dimeglumine on allergic-like reactions. Materials and Methods: The institutional review board approved and waived patient consent for this HIPAA-compliant retrospective study. Allergic-like reactions related to gadolinium-based contrast media were assessed 2 years before and 3.5 years after gadobenate dimeglumine was substituted for gadopentetate dimeglumine. Reaction rates and severity were compared by using χ2 tests, Fisher exact tests, odds ratios (ORs), and confidence intervals (CIs). Results: Allergic-like reactions (137 mild, 19 moderate, and six severe) occurred in 162 (0.15%) of 105 607 injections of gadolinium-based contrast media (gadopentetate dimeglumine, 31 540; gadobenate dimeglumine, 66 152; other, 7915). Gadobenate dimeglumine was associated with significantly more overall (0.19% [123 of 66 152] vs 0.08% [24 of 31 540]; OR, 2.4; 95% CI: 1.6, 3.8; P < .0001) and mild (0.16% [107 of 66 152] vs 0.06% [18 of 31 540]; OR, 2.8; 95% CI: 1.7, 4.7; P < .0001) allergic-like reactions than was gadopentetate dimeglumine. The reaction rate for gadobenate dimeglumine peaked (maximum per quarter, 0.38% [16 of 4262]; minimum per quarter, 0.07% [three of 4237]) in the 2nd year after it replaced gadopentetate dimeglumine (maximum per quarter, 0.10% [four of 4122]; minimum per quarter, 0.05% [two of 4222]) and then declined in the 3rd year. The final gadobenate dimeglumine reaction rate (last 3 quarters, 0.12% [17 of 14 387]) did not significantly differ from the original baseline reaction rate with gadopentetate dimeglumine. Conclusion: After gadobenate dimeglumine was substituted for gadopentetate dimeglumine, a significant transient increase occurred in the frequency of reported allergic-like reactions that demonstrated a temporal pattern suggestive of the Weber effect (a transient increase in adverse event reporting that tends to peak in the 2nd year after a new agent or indication is introduced). © RSNA, 2012 PMID:23238152

Will Increasing Alcohol Availability By Lowering the Minimum Legal Drinking Age Decrease Drinking and Related Consequences Among Youths?

PubMed Central

Wechsler, Henry

2010-01-01

Alcohol use health consequences are considerable; prevention efforts are needed, particularly for adolescents and college students. The national minimum legal drinking age of 21 years is a primary alcohol-control policy in the United States. An advocacy group supported by some college presidents seeks public debate on the minimum legal drinking age and proposes reducing it to 18 years. We reviewed recent trends in drinking and related consequences, evidence on effectiveness of the minimum legal drinking age of 21 years, research on drinking among college students related to the minimum legal drinking age, and the case to lower the minimum legal drinking age. Evidence supporting the minimum legal drinking age of 21 years is strong and growing. A wide range of empirically supported interventions is available to reduce underage drinking. Public health professionals can play a role in advocating these interventions. PMID:20395573

75 FR 6151 - Minimum Capital

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-08

... (FHFA) is issuing and seeking comment on a proposed rule to effect a provision of the Federal Housing... imposing a temporary increase, for rescinding such an increase and a time frame for review of such an... longer justify the temporary level.\\8\\ To effect the higher temporary minimum capital level, the Director...

Effect of Weight Transfer on a Vehicle's Stopping Distance.

ERIC Educational Resources Information Center

Whitmire, Daniel P.; Alleman, Timothy J.

1979-01-01

An analysis of the minimum stopping distance problem is presented taking into account the effect of weight transfer on nonskidding vehicles and front- or rear-wheels-skidding vehicles. Expressions for the minimum stopping distances are given in terms of vehicle geometry and the coefficients of friction. (Author/BB)

The impact of a federal cigarette minimum pack price policy on cigarette use in the USA.

PubMed

Doogan, Nathan J; Wewers, Mary Ellen; Berman, Micah

2018-03-01

Increasing cigarette prices reduce cigarette use. The US Food and Drug Administration has the authority to regulate the sale and promotion-and therefore the price-of tobacco products. To examine the potential effect of federal minimum price regulation on the sales of cigarettes in the USA. We used yearly state-level data from the Tax Burden on Tobacco and other sources to model per capita cigarette sales as a function of price. We used the fitted model to compare the status quo sales with counterfactual scenarios in which a federal minimum price was set. The minimum price scenarios ranged from $0 to $12. The estimated price effect in our model was comparable with that found in the literature. Our counterfactual analyses suggested that the impact of a minimum price requirement could range from a minimal effect at the $4 level to a reduction of 5.7 billion packs sold per year and 10 million smokers at the $10 level. A federal minimum price policy has the potential to greatly benefit tobacco control and public health by uniformly increasing the price of cigarettes and by eliminating many price-reducing strategies currently available to both sellers and consumers. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Neurologic sequelae associated with foscarnet therapy.

PubMed

Lor, E; Liu, Y Q

1994-09-01

To report three cases of possible foscarnet-induced neurologic sequelae. We report two cases of seizures and one case of hand cramping and finger paresthesia after starting foscarnet therapy with no evidence of predisposing risk factors, such as serum laboratory abnormalities, renal dysfunction, or known central nervous system (CNS) involvement. All three patients had stable laboratory values during therapy and when the neurologic adverse effects occurred. All patients were receiving appropriate dosages of foscarnet. The incidence of seizures in AIDS patients was reviewed. A history of CNS lesions, infections, and/or AIDS per se may increase the risk of a neurologic adverse effect while receiving foscarnet therapy. Acute ionized hypocalcemia may cause these neurologic adverse effects. Ionized hypocalcemia is transitory, is related to the rate of foscarnet infusion, and may not be reflected as a change in total serum calcium concentration. Foscarnet probably contributed to the neurologic adverse effects reported here. Foscarnet may need to be administered at a slower rate than is recommended by the manufacturer. Electrolytes must be monitored closely; however, a neurologic adverse effect may not be foreseen.

Early origins of inflammation: An examination of prenatal and childhood social adversity in a prospective cohort study.

PubMed

Slopen, Natalie; Loucks, Eric B; Appleton, Allison A; Kawachi, Ichiro; Kubzansky, Laura D; Non, Amy L; Buka, Stephen; Gilman, Stephen E

2015-01-01

Children exposed to social adversity carry a greater risk of poor physical and mental health into adulthood. This increased risk is thought to be due, in part, to inflammatory processes associated with early adversity that contribute to the etiology of many adult illnesses. The current study asks whether aspects of the prenatal social environment are associated with levels of inflammation in adulthood, and whether prenatal and childhood adversity both contribute to adult inflammation. We examined associations of prenatal and childhood adversity assessed through direct interviews of participants in the Collaborative Perinatal Project between 1959 and 1974 with blood levels of C-reactive protein in 355 offspring interviewed in adulthood (mean age=42.2 years). Linear and quantile regression models were used to estimate the effects of prenatal adversity and childhood adversity on adult inflammation, adjusting for age, sex, and race and other potential confounders. In separate linear regression models, high levels of prenatal and childhood adversity were associated with higher CRP in adulthood. When prenatal and childhood adversity were analyzed together, our results support the presence of an effect of prenatal adversity on (log) CRP level in adulthood (β=0.73, 95% CI: 0.26, 1.20) that is independent of childhood adversity and potential confounding factors including maternal health conditions reported during pregnancy. Supplemental analyses revealed similar findings using quantile regression models and logistic regression models that used a clinically-relevant CRP threshold (>3mg/L). In a fully-adjusted model that included childhood adversity, high prenatal adversity was associated with a 3-fold elevated odds (95% CI: 1.15, 8.02) of having a CRP level in adulthood that indicates high risk of cardiovascular disease. Social adversity during the prenatal period is a risk factor for elevated inflammation in adulthood independent of adversities during childhood. This evidence is consistent with studies demonstrating that adverse exposures in the maternal environment during gestation have lasting effects on development of the immune system. If these results reflect causal associations, they suggest that interventions to improve the social and environmental conditions of pregnancy would promote health over the life course. It remains necessary to identify the mechanisms that link maternal conditions during pregnancy to the development of fetal immune and other systems involved in adaptation to environmental stressors. Copyright © 2014 Elsevier Ltd. All rights reserved.

A single center, open label study of intradermal administration of an inactivated purified chick embryo cell culture rabies virus vaccine in adults.

PubMed

Recuenco, Sergio; Warnock, Eli; Osinubi, Modupe O V; Rupprecht, Charles E

2017-08-03

In the USA, rabies vaccines (RVs) are licensed for intramuscular (IM) use only, although RVs are licensed for use by the intradermal (ID) route in many other countries. Recent limitations in supplies of RV in the USA reopened discussions on the more efficient use of available biologics, including utilization of more stringent risk assessments, and potential ID RV administration. A clinical trial was designed to compare the immunogenic and adverse effects of a purified chicken embryo cell (PCEC) RV administered ID or IM. Enrollment was designed in four arms, ID Pre-Exposure Prophylaxis (Pre-EP), IM Pre-EP, ID Booster, and IM Booster vaccination. Enrollment included 130 adult volunteers. The arms with IM administration received vaccine according to the current ACIP recommendations: Pre-EP, three 1mL (2.5 I.U.) RV doses, each on day 0, 7, and 21; or a routine Booster, one 1ml dose. The ID groups received the same schedule, but doses administered were in a volume of 0.1mL (0.25 I.U.). The rate of increase in rabies virus neutralizing antibody titers 14-21days after vaccination were similar in the ID and correspondent IM groups. The GMT values for ID vaccination were slightly lower than those for IM vaccination, for both naïve and booster groups, and these differences were statistically significant by t-test. Fourteen days after completing vaccination, all individuals developed RV neutralizing antibody titers over the minimum arbitrary value obtained with the rapid fluorescent focus inhibition test (RFFIT). Antibodies were over the set threshold until the end of the trial, 160days after completed vaccination. No serious adverse reactions were reported. Most frequent adverse reactions were erythema, induration and tenderness, localized at the site of injection. Multi use of 1mL rabies vaccine vials for ID doses of 0.1 was demonstrated to be both safe and inmunogenic. Copyright © 2017 Elsevier Ltd. All rights reserved.

Adverse effects of oral amiodarone therapy.

PubMed

Sinha, P R; Dube, S; Sujata; Gupta, P R; Avasthey, P; Somani, P N

1992-04-01

Oral amiodarone was administered to 38 patients (25 males, 13 females) with mean age of 43.6 years. Ventricular and supraventricular arrhythmias were present in 30 and 8 patients respectively. Amiodarone was given as 400-1200 mg/day for 1-2 weeks as loading dose and then it was maintained as 100-600 mg/day. The mean duration of therapy was 12.4 months. Adverse effects were noted in 21 (55.3%) cases. The commonest adverse effects observed were asymptomatic corneal microdeposits followed by gastrointestinal, cardiac, neurological and cutaneous disturbances. The drug was withdrawn in 2 (5.3%) patients because of nausea and vomiting. One patient died of pulmonary infiltrations. It is concluded that adverse effects are common with amiodarone but are tolerated well, making this drug an excellent choice for treatment of cardiac arrhythmias.

Adverse effects of anticancer agents that target the VEGF pathway.

PubMed

Chen, Helen X; Cleck, Jessica N

2009-08-01

Antiangiogenesis agents that target the VEGF/VEGF receptor pathway have become an important part of standard therapy in multiple cancer indications. With expanded clinical experience with this class of agents has come the increasing recognition of the diverse adverse effects related to disturbance of VEGF-dependent physiological functions and homeostasis in the cardiovascular and renal systems, as well as wound healing and tissue repair. Although most adverse effects of VEGF inhibitors are modest and manageable, some are associated with serious and life-threatening consequences, particularly in high-risk patients and in certain clinical settings. This Review examines the toxicity profiles of anti-VEGF antibodies and small-molecule inhibitors. The potential mechanisms of the adverse effects, risk factors, and the implications for selection of patients and management are discussed.

15 CFR 971.600 - General.

Code of Federal Regulations, 2010 CFR

2010-01-01

... SERVICE DEEP SEABED MINING REGULATIONS FOR COMMERCIAL RECOVERY PERMITS Environmental Effects § 971.600... in a significant adverse environmental effect. In addition, each permit issued must contain TCRs... (section 109(b)), to prevent a significant adverse environmental effect. Furthermore, each permit issued...

CHEMICAL CHARACTERIZATION & SPECIATION OF MOBILE SOURCE EMISSIONS: HUMAN EXPOSURE IMPLICATIONS & IMPLEMENTATION PERSPECTIVES

EPA Science Inventory

A significant number of epidemiological studies have identified an increase in occurrence of adverse health effects associated with exposures to mobile source emissions. These adverse effects include asthma, other respiratory diseases, cardiovascular effects, cancer, development...

Modelling the adverse effects associated with ecstasy use.

PubMed

Fisk, John E; Murphy, Philip N; Montgomery, Catharine; Hadjiefthyvoulou, Florentia

2011-04-01

Ecstasy, the street name for 3,4-meththylenedioxymethamphetamine, has been associated with a range of psychiatric symptoms and impaired psychological health in both problem and recreational users. The purpose of the present paper is to determine how these impairments are related to the history of polydrug use, and the conditions under which individuals ingest ecstasy. Associations between the variables of interest were investigated utilizing negative binomial regression. Liverpool and Preston in the North West of England. A convenience sample of 159 recreational ecstasy/polydrug users (80 males, 79 females). The sample was composed primarily of undergraduates. The dependent variable was the number of reported ecstasy-related adverse effects. Independent variables included quantitative aspects of ecstasy and other drug use, and the various beliefs and behaviours associated with ecstasy use. The number of adverse effects was associated positively with life-time exposure to ecstasy and negatively with period of abstinence from the drug. Adverse effects were more common among those who consumed ecstasy and alcohol concurrently, but were unrelated to other aspects of polydrug use. They were unaffected by whether the user took precautions when using the drug, and only weakly related to prior beliefs concerning the effects of ecstasy. Greater life-time exposure to ecstasy and consuming the drug concurrently with alcohol increase the likelihood of experiencing adverse effects, including paranoia, poor general health, irritability, confusion and moodiness. Adverse effects decrease with the period of abstinence from the drug. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.

Consequences of violence across the lifespan: Mental health and sleep quality in pregnant women.

PubMed

Miller-Graff, Laura E; Cheng, Philip

2017-09-01

Research has demonstrated that exposure to violence and adversity has negative effects on both mental health and biobehavioral outcomes, such as sleep health. Research examining the relationship between past and recent violence exposure and mental health suggests that the effects of childhood adversity are especially pernicious, but to date, no studies have attempted to disentangle the direct, indirect and relative effects of past year versus childhood exposure to violence and adversity on sleep. The objective of the current study was to examine the direct effects of adverse childhood experiences (ACEs) and past year intimate partner violence (IPV) on different aspects of sleep health in pregnant women. A sample of high-risk pregnant women (n = 101) were interviewed. Mediation analysis with bias-corrected, bootstrapped confidence intervals was used to evaluate direct and indirect effects. Findings indicated that while ACEs had significant direct effects on mental health, past year IPV had stronger effects on sleep quality, latency, and efficiency. ACEs did, however, indirectly affect subjective sleep quality via past year psychological IPV. These findings suggest that sleep disturbance may be a regulatory stress response that is most clearly linked to past year violence and trauma. That is, though long-term sleep disturbance may be evident following childhood adversity, it is likely that this relationship is better explained by the role of childhood adversity in predicting adulthood revictimization or due to long-term mental health difficulties associated with early trauma. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

[Treatment of Epidermal Growth Factor Receptor Inhibitors Associated Adverse Skin Reactions by Zhiyang Pingfu Liquid: a Clinical Study].

PubMed

Wang, Hong-yan; Zou, Chao; Cui, Hui-juan; Bai, Yan-ping; Li, Yuan; Tan, Huang-ying; Wang, Wei; Ju, Hai

2015-07-01

To study the curative effect of Zhiyang Pingfu Liquid (ZPL) in treating epidermal growth factor receptor inhibitors (EGFRIs) associated adverse reactions of the skin. All 54 patients with pathologically confirmed malignant tumor had EGFRIs induced adverse reactions of the skin to various degrees. ZPL was externally applied for them all, once or twice per day, 14 days consisting of one therapeutic course. Changes of adverse skin reactions, time for symptoms relief, adverse skin reaction types suitable for ZPL were observed before and after treatment. EGFRIs associated skin adverse reactions were improved to various degrees after they used ZPL. The shortest symptoms relief time was 1 day while the longest was 12 days, with an average of 6.93 days and the median time 7 days. Compared with before treatment, itching, rash/scaling, acne/acneform eruptions were obviously improved (P < 0.05). ZPL could alleviate EGFRls associated adverse skin reactions, especially showed better effect on itching, rash/scaling, acne/acneform eruptions.

Suicidal ideation in adolescence: examining the role of recent adverse experiences.

PubMed

Thompson, Richard; Proctor, Laura J; English, Diana J; Dubowitz, Howard; Narasimhan, Subasri; Everson, Mark D

2012-02-01

Although there is a well-known link between adverse experiences and suicidal ideation, there has been little study of the effects of recent adverse experiences on suicidal ideation in teenagers. This study examined the association between recent adverse experiences and suicidal ideation in a sample of 740 at-risk 16-year-old youth in the LONGSCAN studies, as well as potential mediators. 8.9% of the youth reported suicidal ideation. Recent adverse experiences, as a class, were associated with suicidal ideation; both recent physical abuse and recent psychological maltreatment were uniquely associated with suicidal ideation. The links between recent adverse experiences and suicidal ideation were significantly mediated by psychological distress. There were also significant main effect associations between both internalizing behavioral problems and low positive achievement expectations and suicidal ideation. Recent adverse experiences are important in understanding suicidal ideation in high risk youth. Copyright © 2011 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

[Analysis of Kudiezi injection's security literature].

PubMed

Chang, Yan-Peng; Xie, Yan-Ming

2012-09-01

By retrieving the relevant database, aim was to achieve the security reported of Kudiezi injection (Yueanxin). To analysis the gender, age, underlying disease, medication dosage, solvent, adverse event/adverse reaction time of occurrence, clinical presentation of patients, It was found the adverse event/adverse reaction usually occur in older people, involving the organs and systems include skin and its appendages, digestive system, nervous system, circulatory system, respiratory system, systemic reaction, part of the adverse event/adverse reaction's cause were not according to the instructions. It was found on the adverse event/adverse reaction of the judgment on the lack of objective evidence, to produce certain effect for objective evaluation of security of Kudiezi injection (Yueanxin).

A simple Bayesian approach to quantifying confidence level of adverse event incidence proportion in small samples.

PubMed

Liu, Fang

2016-01-01

In both clinical development and post-marketing of a new therapy or a new treatment, incidence of an adverse event (AE) is always a concern. When sample sizes are small, large sample-based inferential approaches on an AE incidence proportion in a certain time period no longer apply. In this brief discussion, we introduce a simple Bayesian framework to quantify, in small sample studies and the rare AE case, (1) the confidence level that the incidence proportion of a particular AE p is over or below a threshold, (2) the lower or upper bounds on p with a certain level of confidence, and (3) the minimum required number of patients with an AE before we can be certain that p surpasses a specific threshold, or the maximum allowable number of patients with an AE after which we can no longer be certain that p is below a certain threshold, given a certain confidence level. The method is easy to understand and implement; the interpretation of the results is intuitive. This article also demonstrates the usefulness of simple Bayesian concepts when it comes to answering practical questions.

Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013.

PubMed

Šubelj, Maja; Učakar, Veronika; Kraigher, Alenka; Klavs, Irena

2016-01-01

Adverse events following immunisation (AEFIs) with qHPV reported to the Slovenian AEFI Registry for the first four school years of the vaccination programme were analysed. We calculated annual reporting rates for 11-14 year-old vaccinees with AEFIs, using the number of qHPV doses distributed within the school-based vaccination programme as the denominator. Between September 2009 and August 2013, 211 AEFIs that occurred in 89 vaccinees were reported, a rate of 149.5 vaccinees with AEFI per 100,000 qHPV doses distributed. For five vaccinees, serious AEFIs (8.4 per 100,000 doses distributed) were reported. The highest reporting rates were for fatigue, headache, and fever (≥ 38.0⁰) (53.8, 40.3, and 35.3 per 100,000 qHPV doses distributed, respectively). As no AEFI resulted in permanent sequelae and they all were categorised as serious only due to the criterion of a minimum of one day of hospitalisation, this provides reassurance for the safety of our school-based HPV vaccination programme. Further AEFI surveillance is warranted to provide data for HPV vaccination programme monitoring and evaluation of its safety.

Incidence of Hypocapnia, Hypercapnia, and Acidosis and the Associated Risk of Adverse Events in Preterm Neonates.

PubMed

Brown, Melissa K; Poeltler, Deborah M; Hassen, Kasim O; Lazarus, Danielle V; Brown, Vanessa K; Stout, Jeremiah J; Rich, Wade D; Katheria, Anup C

2018-04-03

Permissive hypercapnia is a lung-protection strategy. We sought to review our current clinical practice for the range of permissive hypercapnia and identify the relationship between P aCO 2 and pH and adverse outcomes. A secondary analysis of a delayed cord-clamping clinical trial was performed on all arterial blood gas tests in the first 72 h in infants < 32 weeks gestational age. All arterial blood gas values were categorized into a clinical range to determine the percent likelihood of occurring in the total sample. The univariate and multivariate relationships of severe adverse events and the time-weighted P aCO 2 , fluctuation of P aCO 2 , maximal and minimal P aCO 2 , base excess, and pH were assessed. 147 infants with birthweight of 1,206 ± 395 g and gestational age of 28 ± 2 weeks were included. Of the 1,316 total samples, < 2% had hypocapnia ( P aCO 2 <30 mm Hg), 47% were normocapnic ( P aCO 2 35-45 mm Hg), 26.5% had mild hypercapnia ( P aCO 2 45-55 mm Hg), 13% had moderate hypercapnia ( P aCO 2 55-65 mm Hg), and 6.5% had severe hypercapnia ( P aCO 2 ≥ 65 mm Hg). There were no adverse events associated with hypocapnia. Subjects with death/severe intraventricular hemorrhage had a higher mean P aCO 2 of 52.3 versus 44.7 (odds ratio [OR] 1.16, 95% CI 1.04-1.29, P = .006), higher variability of P aCO 2 with a standard deviation of 12.6 versus 7.8 (OR 1.15, 95% CI 1.03-1.27, P = .01), and a lower minimum pH of 7.03 versus 7.23 (OR 0, 95% CI 0-0.06, P = .003). There was no significant difference in any variables in subjects who developed other adverse events. The routine targeting of higher than normal P aCO 2 goals may lead to a low incidence of hypocapnia and associated adverse events. Hypercapnia is common, and moderate hypercapnia may increase the risk of neurologic injury and provide little pulmonary benefit. Copyright © 2018 by Daedalus Enterprises.

The Minimum Wage and the Employment of Teenagers. Recent Research.

ERIC Educational Resources Information Center

Fallick, Bruce; Currie, Janet

A study used individual-level data from the National Longitudinal Study of Youth to examine the effects of changes in the federal minimum wage on teenage employment. Individuals in the sample were classified as either likely or unlikely to be affected by these increases in the federal minimum wage on the basis of their wage rates and industry of…

Associations Between Minimum Wage Policy and Access to Health Care: Evidence From the Behavioral Risk Factor Surveillance System, 1996–2007

PubMed Central

Zimmerman, Frederick J.; Ralston, James D.; Martin, Diane P.

2011-01-01

Objectives. We examined whether minimum wage policy is associated with access to medical care among low-skilled workers in the United States. Methods. We used multilevel logistic regression to analyze a data set consisting of individual-level indicators of uninsurance and unmet medical need from the Behavioral Risk Factor Surveillance System and state-level ecological controls from the US Census, Bureau of Labor Statistics, and several other sources in all 50 states and the District of Columbia between 1996 and 2007. Results. Higher state-level minimum wage rates were associated with significantly reduced odds of reporting unmet medical need after control for the ecological covariates, substate region fixed effects, and individual demographic and health characteristics (odds ratio = 0.853; 95% confidence interval = 0.750, 0.971). Minimum wage rates were not significantly associated with being uninsured. Conclusions. Higher minimum wages may be associated with a reduced likelihood of experiencing unmet medical need among low-skilled workers, and do not appear to be associated with uninsurance. These findings appear to refute the suggestion that minimum wage laws have detrimental effects on access to health care, as opponents of the policies have suggested. PMID:21164102

Associations between minimum wage policy and access to health care: evidence from the Behavioral Risk Factor Surveillance System, 1996-2007.

PubMed

McCarrier, Kelly P; Zimmerman, Frederick J; Ralston, James D; Martin, Diane P

2011-02-01

We examined whether minimum wage policy is associated with access to medical care among low-skilled workers in the United States. We used multilevel logistic regression to analyze a data set consisting of individual-level indicators of uninsurance and unmet medical need from the Behavioral Risk Factor Surveillance System and state-level ecological controls from the US Census, Bureau of Labor Statistics, and several other sources in all 50 states and the District of Columbia between 1996 and 2007. Higher state-level minimum wage rates were associated with significantly reduced odds of reporting unmet medical need after control for the ecological covariates, substate region fixed effects, and individual demographic and health characteristics (odds ratio = 0.853; 95% confidence interval = 0.750, 0.971). Minimum wage rates were not significantly associated with being uninsured. Higher minimum wages may be associated with a reduced likelihood of experiencing unmet medical need among low-skilled workers, and do not appear to be associated with uninsurance. These findings appear to refute the suggestion that minimum wage laws have detrimental effects on access to health care, as opponents of the policies have suggested.

Polytraumatization and Trauma Symptoms in Adolescent Boys and Girls: Interpersonal and Noninterpersonal Events and Moderating Effects of Adverse Family Circumstances

ERIC Educational Resources Information Center

Nilsson, Doris Kristina; Gustafsson, Per E.; Svedin, Carl Goran

2012-01-01

The objective of this study was to investigate the cumulative effect of interpersonal and noninterpersonal traumatic life events (IPEs and nIPEs, respectively) on the mental health of adolescents and to determine if the adverse impacts of trauma were moderated by adverse family circumstances (AFC). Adolescents (mean age 16.7 years) from the…

[Irrational use of drugs as a source of drug - induced diseases].

PubMed

Woroń, Jarosław; Porebski, Grzegorz; Kostka-Trabka, Elzbieta; Goszcz, Aleksandra

2007-01-01

The irrational use of medication, by which we understand the administration of drugs for indications where their effectiveness has not been confirmed, the disregard of restrictions and warnings against their use, and the use of drug combinations which do not increase the therapeutic effect but to the contrary increase the risk of adverse drug reactions, is a serious problem encountered in paediatric pharmacotherapy. Each year the centres for monitoring of adverse drug reactions receive many reports, the analysis of which show that the reasons of occurrence of adverse drug reactions after drug administration, are specifically due to irrational use of medications. In order to prevent in an active way the occurrence, of adverse drug reactions following drug administration it is worthwhile to bring to attention the reasons for their occurrence which not infrequently bring about pathological effects. Our work which is based on reports received by the Regional Centre for Adverse Drug Reactions Monitoring in Krakow concerning the occurrence of adverse drug reactions in an attempt to bring to attention in our view important problems in current pharmacotherapy.

Pretreatment Predictors of Adverse Radiation Effects After Radiosurgery for Arteriovenous Malformation

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

Hayhurst, Caroline; Monsalves, Eric; Prooijen, Monique van

Purpose: To identify vascular and dosimetric predictors of symptomatic T2 signal change and adverse radiation effects after radiosurgery for arteriovenous malformation, in order to define and validate preexisting risk models. Methods and Materials: A total of 125 patients with arteriovenous malformations (AVM) were treated at our institution between 2005 and 2009. Eighty-five patients have at least 12 months of clinical and radiological follow-up. Any new-onset headaches, new or worsening seizures, or neurological deficit were considered adverse events. Follow-up magnetic resonance images were assessed for new onset T2 signal change and the volume calculated. Pretreatment characteristics and dosimetric variables were analyzedmore » to identify predictors of adverse radiation effects. Results: There were 19 children and 66 adults in the study cohort, with a mean age of 34 (range 6-74). Twenty-three (27%) patients suffered adverse radiation effects (ARE), 9 patients with permanent neurological deficit (10.6%). Of these, 5 developed fixed visual field deficits. Target volume and 12 Gy volume were the most significant predictors of adverse radiation effects on univariate analysis (p < 0.001). Location and cortical eloquence were not significantly associated with the development of adverse events (p = 0.12). No additional vascular parameters were identified as predictive of ARE. There was a significant target volume threshold of 4 cm{sup 3}, above which the rate of ARE increased dramatically. Multivariate analysis target volume and the absence of prior hemorrhage are the only significant predictors of ARE. The volume of T2 signal change correlates to ARE, but only target volume is predictive of a higher volume of T2 signal change. Conclusions: Target volume and the absence of prior hemorrhage is the most accurate predictor of adverse radiation effects and complications after radiosurgery for AVMs. A high percentage of permanent visual field defects in this series suggest the optic radiation is a critical radiosensitive structure.« less

Good cope, bad cope: adaptive and maladaptive coping strategies following a critical negative work event.

PubMed

Brown, Steven P; Westbrook, Robert A; Challagalla, Goutam

2005-07-01

The authors examined the moderating effects of coping tactics on the relationship between negative emotion and work performance. Findings indicate an adverse effect of emotion on performance; however, this effect is moderated by coping tactics. Venting (expressing one's negative feelings to others) amplified the adverse effects of negative emotion. Self-control had mixed effects: On one hand, it buffered the adverse effects of negative emotion, yet on the other hand, it had a negative direct effect on outcomes. Task focus had a positive direct effect on performance but no buffering (moderating) effect. Implications of these findings for understanding the effects of negative emotion and coping in the workplace are discussed. Copyright 2005 APA, all rights reserved.

"Freshman's week": characteristics associated with participation and experiencing adverse effects.

PubMed

Erevik, E K; Pallesen, S; Vedaa, Ø; Andreassen, C S; Torsheim, T

2018-05-29

"Freshman's week" (FW) is a Norwegian initiation ritual to higher education. Previous research has suggested that FW-participation is associated with better social adjustment to the student setting, as well as heavy alcohol use both during and after the event. In this study, we aimed to identify characteristics associated with participation in FW and characteristics associated with experiencing adverse effects of alcohol use during FW. Students in the city of Bergen, Norway participated in a survey during fall 2015, shortly after FW. The current sample consisted of the first-year students (N = 4, 401, estimated response rate: 49%). The sample's mean age was 24 years (range: 17-73 years), 65% were females, and the majority were born in Norway (93%). Logistic regressions were conducted to identify characteristics associated with participation in FW and experiencing adverse effects. A total of 64% of the first-year students reported participation in FW, and 27% of these reported experiencing at least one adverse alcohol-related effect during FW. Participation in FW was positively associated with being single (OR = 1.29), extroversion (OR = 1.18), and alcohol use (OR = 1.28), and inversely associated with age (OR = 0.70), and having children (OR = 0.36). Several characteristics (e.g., alcohol use (OR = 1.84), extroversion (OR = 0.60), symptoms of depression (OR = 1.60)) were associated with an increased risk of experiencing adverse effects of alcohol use during participation. The current results suggest that initiatives for increasing the participation rate in FW, reducing alcohol use during FW, and decreasing the occurrence of adverse alcohol effects during FW are warranted. Aiming to reduce the focus on alcohol use during FW, and seeking to make FW more available and enjoyable for students with other priorities, students who do not match the stereotype of the typical first-year student, and less sociable students, might both increase participation rate and prevent the occurrence of adverse alcohol effects. Future studies should aim to develop and assess interventions designed to increase participation in FW and reduce the occurrence of adverse effects related to participation.

Suicidal Ideation in Adolescence: Examining the Role of Recent Adverse Experiences

ERIC Educational Resources Information Center

Thompson, Richard; Proctor, Laura J.; English, Diana J.; Dubowitz, Howard; Narasimhan, Subasri; Everson, Mark D.

2012-01-01

Although there is a well-known link between adverse experiences and suicidal ideation, there has been little study of the effects of recent adverse experiences on suicidal ideation in teenagers. This study examined the association between recent adverse experiences and suicidal ideation in a sample of 740 at-risk 16-year-old youth in the LONGSCAN…

Adverse reactions from essential oil-containing natural flea products exempted from Environmental Protection Agency regulations in dogs and cats.

PubMed

Genovese, Allison G; McLean, Mary Kay; Khan, Safdar A

2012-08-01

To describe adverse effects in dogs and cats exposed to Environmental Protection Agency exempted plant-derived flea preventatives containing mixtures of essential oils. Retrospective study from 2006 to 2008. Records of dog and cat cases were reviewed from the American Society for the Prevention of Cruelty to Animals, Animal Poison Control Center database. Thirty-nine cats and 9 dogs with history of exposure to natural flea preventatives. The following information was retrieved from each incident: number of animals, species involved, frequency, types, onset time, duration of clinical signs, exposure appropriateness, final outcome, and treatment information. Ninety-two percent of animals (n = 44) showed presence of one or more adverse effects. The frequency of adverse effects in dogs (n = 8; 89%) and cats (n = 36; 92%) was similar. Onset time of adverse effects in 39 of 44 animals occurred within 24 hours. The duration of signs in 24 animals ranged from 30 minutes to 149 hours. The products were used as per label in 77% animals (n = 37). Of 28 animals with known outcome, 50% (n = 14) recovered with bathing alone while others received intravenous fluids, muscle relaxants, and anticonvulsive medications. Death (1 cat; n = 1/28; 4%) or euthanasia (1 cat and 1 dog; n = 2/28; 7%) was reported in 3 animals. Dogs and cats can experience significant adverse effects when exposed to plant-derived flea preventatives even when used according to label directions. The number of reports of exposure in cats was higher than dogs, but the frequency of reported adverse effects was similar between the 2 species. Agitation and hypersalivation were common in cats, whereas lethargy and vomiting were common in dogs. © Veterinary Emergency and Critical Care Society 2012.

An in-flight simulation of approach and landing of a STOL transport with adverse ground effect

NASA Technical Reports Server (NTRS)

Ellis, D. R.

1976-01-01

The results of an in-flight simulation program undertaken to study the problems of landing a representative STOL transport in the presence of adverse ground effects are presented. Landings were performed with variations in ground effect magnitude, ground effect lag, and thrust response. Other variations covered the effects of augmented lift response, SAS-failures, turbulence, segmented approach, and flare warning. The basic STOL airplane required coordinated use of both stick and throttle for consistently acceptable landings, and the presence of adverse ground effects made the task significantly more difficult. Ground effect lag and good engine response gave noticeable improvement, as did augmented lift response.

Ground experiments for finding principles and working out methods for preventing adverse effects of weightlessness on the human organism

NASA Technical Reports Server (NTRS)

Kakurin, L. I.; Gregoryev, A. I.; Mikhailov, V. M.; Tishler, V. A.

1980-01-01

A comparative assessment of the effectiveness of different prophylactic procedures to prevent the adverse effects of weightlessness is presented. It is concluded that: physical training is most effective but no single method by itself produces the full effect, and an adjustment of regimes to one another enhances the effect. The approved complex of prophylactic procedures affected basic changes occurring in hypokinesia: deficit of muscular activity, no or reduced BP hydrostatic component, reduced volume of blood circulation, reduced hydration level, and the application of various prophylactic complexes during 49 day antiorthostatic hypodynamia eliminated or reduced the adverse effects of weightlessness in simulation.

The Effects of Minimum Wages on Teenage Employment, Enrollment, and Idleness.

ERIC Educational Resources Information Center

Neumark, David

A study described the effects of minimum wages on teenagers by using individual-level panel data on school and work transitions of teenagers. Panel data from 1979-92 measuring transitions among alternative employment and enrollment activities of teenagers were obtained from matched Current Population Surveys data sets. Findings indicated that…

A new approach for minimum phase output definition

NASA Astrophysics Data System (ADS)

Jahangiri, Fatemeh; Talebi, Heidar Ali; Menhaj, Mohammad Bagher; Ebenbauer, Christian

2017-01-01

This paper presents a novel method for output redefinition for linear systems. The approach also determines possible relative degrees for the systems corresponding to any new output vector. To guarantee the minimum phase property with a prescribed relative degree, a set of new conditions is introduced. A key feature of these conditions is that there is no need to any form of transformations which make the scheme suitable for optimisation problems in control to ensure the minimum phase property. Moreover, the results are useful for sensor placement problems and for obtaining minimum phase approximations of non-minimum phase systems. Numerical examples including an example of unmanned aerial vehicle systems are given to demonstrate the effectiveness of the methodology.

When Do Laws Matter? National Minimum-Age-of-Marriage Laws, Child Rights, and Adolescent Fertility, 1989–2007

PubMed Central

Kim, Minzee; Longhofer, Wesley; Boyle, Elizabeth Heger; Nyseth, Hollie

2014-01-01

Using the case of adolescent fertility, we ask the questions of whether and when national laws have an effect on outcomes above and beyond the effects of international law and global organizing. To answer these questions, we utilize a fixed-effect time-series regression model to analyze the impact of minimum-age-of-marriage laws in 115 poor- and middle-income countries from 1989 to 2007. We find that countries with strict laws setting the minimum age of marriage at 18 experienced the most dramatic decline in rates of adolescent fertility. Trends in countries that set this age at 18 but allowed exceptions (for example, marriage with parental consent) were indistinguishable from countries that had no such minimum-age-of-marriage law. Thus, policies that adhere strictly to global norms are more likely to elicit desired outcomes. The article concludes with a discussion of what national law means in a diffuse global system where multiple actors and institutions make the independent effect of law difficult to identify. PMID:25525281

Equalizing secondary path effects using the periodicity of fMRI acoustic noise.

PubMed

Kannan, Govind; Milani, Ali A; Panahi, Issa; Briggs, Richard

2008-01-01

Non-minimum phase secondary path has a direct effect on achieving a desired noise attenuation level in active noise control (ANC) systems. The adaptive noise canceling filter is often a causal FIR filter which may not be able to sufficiently equalize the effect of a non-minimum phase secondary path, since in theory only a non-causal filter can equalize it. However a non-causal stable filter can be found to equalize the non-minimum phase effect of secondary path. Realization of non-causal stable filters requires knowledge of future values of input signal. In this paper we develop methods for equalizing the non-minimum phase property of the secondary path and improving the performance of an ANC system by exploiting the periodicity of fMRI acoustic noise. It has been shown that the scanner noise component is highly periodic and hence predictable which enables easy realization of non-causal filtering. Improvement in performance due to the proposed methods (with and without the equalizer) is shown for periodic fMRI acoustic noise.

Cisapride treatment for gastro-oesophageal reflux in children.

PubMed

Augood, C; MacLennan, S; Gilbert, R; Logan, S

2000-01-01

Gastro-oesophageal reflux (GOR) is an extremely common and usually self limiting condition in infants. When treatment is required, Cisapride, a pro-kinetic agent, has been commonly prescribed for the symptomatic management of GOR. There have been recent reports of possibly serious adverse events e.g. an increased QTc interval, cardiac arrhythmias, and death, associated with the use of Cisapride. To determine the effectiveness of Cisapride for symptoms of GOR in children compared with placebo or any other non-surgical treatments. Searches were conducted of the Cochrane Central Trials Register and the specialised Trials register of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group, MEDLINE and Embase. Reference lists of relevant review articles and identified trials were scrutinised and forward citation searches were performed in the Science Citation Index on all trials identified. Randomised controlled trials that compared oral Cisapride therapy with placebo or with other non-surgical treatments for children with a diagnosis of GOR were included. Only studies in which Cisapride was administered orally for a minimum of one week and which documented at least one of the primary outcomes were included. The primary outcomes were defined as a change in symptoms at the end of treatment, presence of adverse events, occurrence of clinical complications, and weight gain. The secondary outcomes included physiological measures of GOR or histological evidence of oesophagitis. We dichotomised symptoms into 'same or worse' vs 'improved' and calculated summary odds ratios. Continuous measures of GOR (e.g. reflux index) were summarised as a weighted mean difference. All outcomes were analysed using a random effects method. Sensitivity analyses were also performed. Searches identified eight trials which met the inclusion criteria. Seven trials (a total of 236 participants) compared Cisapride with placebo. The odds ratio for 'same or worse' vs 'improved symptoms' at the end of treatment was 0.34 (95%CI 0.10, 1.19), thus showing no statistically significant difference between the two interventions. There was significant heterogeneity between the studies and the funnel plot suggested substantial publication bias. In the sensitivity analysis, the definition of outcomes was changed to 'any symptoms' vs 'no symptoms'. This resulted in the exclusion of three trials (one of them the largest, best quality trial). The resulting pooled odds ratio showed a significant effect of Cisapride (OR 0.19, 95%CI 0.08, 0.44). There were fewer adverse events with placebo than with Cisapride, but the difference was not statistically significant (OR 1.80, 95%CI 0.87, 3.70) and the result was based on small numbers. Cisapride compared with placebo produced a statistically significant reduction in the reflux index (weighted mean difference -6.49, 95%CI -10.13, -2.85), but as reflux index and clinical symptoms are poorly correlated, the clinical importance of this finding is uncertain. Other measures of oesophageal pH monitoring did not reach significance. One included study compared Cisapride with Gaviscon (or Gaviscon and Carobel). The odds ratio for 'same or worse' vs 'improvement' in the Cisapride group compared with Gaviscon was 3.26 (95%CI 0.93, 11.38). We found no clear evidence that Cisapride reduces symptoms of GOR. The results suggested substantial publication bias favouring studies showing a positive effect of Cisapride. Due to reports of serious adverse events, the company will stop marketing the drug as of July 14th, 2000 and therefore a larger study to provide more conclusive evidence of the effect of Cisapride is no longer possible.

The association of bacterial C9-based TTX-like compounds with Prorocentrum minimum opens new uncertainties about shellfish seafood safety.

PubMed

Rodríguez, Inés; Alfonso, Amparo; Alonso, Eva; Rubiolo, Juan A; Roel, María; Vlamis, Aristidis; Katikou, Panagiota; Jackson, Stephen A; Menon, Margassery Lekha; Dobson, Alan; Botana, Luis M

2017-01-20

In 2012, Tetrodotoxin (TTX) was identified in mussels and linked to the presence of Prorocentrum minimum (P. minimum) in Greece. The connexion between TTX and P. minimum was further studied in this paper. First, the presence of TTX-producer bacteria, Vibrio and Pseudomonas spp, was confirmed in Greek mussels. In addition these samples showed high activity as inhibitors of sodium currents (I Na ). P. minimum was before associated with neurotoxic symptoms, however, the nature and structure of toxins produced by this dinoflagellate remains unknown. Three P. minimum strains, ccmp1529, ccmp2811 and ccmp2956, growing in different conditions of temperature, salinity and light were used to study the production of toxic compounds. Electrophysiological assays showed no effect of ccmp2811 strain on I Na , while ccmp1529 and ccmp2956 strains were able to significantly reduce I Na in the same way as TTX. In these samples two new compounds, m/z 265 and m/z 308, were identified and characterized by liquid chromatography tandem high-resolution mass spectrometry. Besides, two TTX-related bacteria, Roseobacter and Vibrio sp, were observed. These results show for the first time that P. minimum produce TTX-like compounds with a similar ion pattern and C9-base to TTX analogues and with the same effect on I Na .