Lack Of Adverse Effect Research Articles

Co-produced Positive Psychotherapy for Acute Psychiatric Ward Patients and Staff: an Evaluation of Feasibility and Acceptability

Aim: To investigate feasibility and acceptability of positive psychotherapy for acute psychiatric ward patients and staff, when delivered by non-psychology clinical staff, and co-produced with staff with lived experience. Method: Group or individual strengths-based positive psychotherapy was led by an activity coordinator and co-facilitated by a peer support worker with lived experience of mental health problems. It was delivered for acute ward patients and staff. Feasibility was measured by completion of session components and percentage of participants able to identify a strength, plan a strength-based activity, and activity completion. Acceptability was measured by comparing pre- and post-session mood, and with helpfulness ratings and narrative feedback. Results: Participants (n = 22) included 12 patients and 10 staff members. Participants were mainly female and of white or mixed ethnicity. Most patients had a psychotic disorder. Staff were nurses and healthcare assistants. The most identified strengths were self-regulation, social intelligence and perseverance. Typical activities included activity-scheduling, sleep hygiene, walking, gardening and cooking. High completion rates for components and activities indicated feasibility. Lack of adverse effect on mood, high helpfulness ratings, and positive feedback indicated acceptability. Conclusion: This evaluation indicates that non-psychology staff can deliver psychological interventions, that interventions can be co-produced with staff with lived experience, and that patient and staff participants can collaborate on these interventions. This shows how psychological interventions on acute wards can be inclusive, positively impact on ward culture, and be more widely delivered to support patients and staff.

Safety assessment of β-fructofuranosidase from Aspergillus brunneoviolaceus

β-Fructofuranosidase (β-D-fructofuranoside fructohydrolase; EC 3.2.1.26) is used in the production of fructo-oligosaccharides that are commonly used by the food industry as prebiotics for their purported health benefits. The β-fructofuranosidase discussed herein is obtained from a novel source organism that is a non-genetically modified strain of Aspergillus brunneoviolaceus, which phylogenetically belongs to the Aspergillus section Nigri. The safety of β-fructofuranosidase was evaluated in a series of toxicology studies as prescribed by Tier 1 toxicity testing by the European Food Safety Authority, including an evaluation of the mutagenicity and genotoxicity potential using the in vitro bacterial reverse mutation and mammalian chromosomal aberration assays, as well as systemic toxicity in a 90-day oral subchronic toxicity study in Sprague-Dawley rats. β-Fructofuranosidase was demonstrated to lack mutagenic or genotoxic potential based on the results of the in vitro assays due to absence of increased revertant colonies in the bacterial reverse mutation test and incidence of chromosome aberrations in the chromosomal aberration assay. Administration of β-fructofuranosidase by gavage at doses up to 1200 mg total organic solids (TOS)/kg body weight/day for 90 days did not elicit any systemic toxic effects in rats based on a lack of adverse effect in any study parameter, and therefore the no-observed-adverse-effect level of β-fructofuranosidase was concluded to be 1200 mg TOS/kg body weight/day, the highest dose tested. The results of the toxicology studies on β-fructofuranosidase from A. brunneoviolaceus demonstrate this species to be a safe and suitable source of enzymes for use by the food industry.

Biodegradable Periodic Mesoporous Organosilica (BPMO) Loaded with Daunorubicin: A Promising Nanoparticle-Based Anticancer Drug.

Biodegradable periodic mesoporous organosilica (BPMO) nanoparticles have emerged as a promising type of nanocarrier for drug delivery, given the biodegradable feature is advantageous for clinical translation. In this paper, we report synthesis and characterization of daunorubicin (DNR) loaded BPMO. DNR was loaded onto rhodamine B‐labeled BPMO that contain tetrasulfide bonds. Tumor spheroids and chicken egg tumor models were used to characterize the activity in biological settings. In the first experiment we examined the uptake of BPMO into tumor spheroids prepared from ovarian cancer cells. BPMO were efficiently taken up into tumor spheroids and inhibited their growth. In the chicken egg tumor model, intravenous injection of DNR‐loaded BPMO led to the elimination of ovarian tumor. Lack of adverse effect on organs such as lung appears to be due to excellent tumor accumulation of BPMO. Thus, DNR‐loaded BPMO represents a promising nanodrug compared with free DNR currently used in cancer therapy. OK

Partial replacement of board-certified specialist-grade physicians with emergency medicine trainees in a busy emergency department: Lack of adverse effect on time to physician

Objectives: Standard emergency department (ED) operation goals include minimization of the time interval between patients' initial ED presentation and initial emergency physician (EP) evaluation. Following up on previous work defining factors influencing the “time to physician” (tMD) in a busy ED, the current study was undertaken to evaluate whether tMD was adversely impacted by the ED's partial replacement of specialist-grade EPs with emergency medicine (EM) trainees (at the resident and fellow level). Methods: This retrospective study was conducted for four months (September–December 2015) using an ED administrative database (EDAD) in an urban academic tertiary ED with an annual census of approximately 500,000; during the four study months, the ED census was 165,969. To minimize confounding by time of day and related factors, data analysis focused solely on the “day shift” (0600–1400) of each of the study period's 122 days. EDAD data were combined with EP rostering data to generate a multivariate linear regression model that assessed the dependent variable tMD, for significant changes associated with increasing proportion – not necessarily always the same as increasing the absolute number of trainees (i.e., summed residents and fellows as a total percent of all on-duty EPs). There were trainees in the study ED throughout the study, but the trainee numbers as a proportion of the overall physician staffing fluctuated, thus providing a basis for analysis. The model adjusted for covariates previously demonstrated to impact tMD at the study center. Analyses were conducted with Stata 14MP, with statistical significance defined at p < 0.05 and confidence intervals (CIs) reported at the 95% level. Results: In an acceptable regression model that adjusted for multiple parameters influencing tMD, the introduction of a covariate representing the proportion of on-duty trainee physicians was very small in magnitude (β estimate 0.07, 95% CI − 0.16 to 0.30) and not statistically significant (p = 0.53). Conclusions: A multivariate analysis adjusting for variables contributing to tMD showed no indication of adverse tMD impact from partial replacement of board-certified specialist-grade EPs with EM trainees given adequate supervision by properly trained faculty.

Is Epidural Analgesia a Predictor of Low Newborn Apgar? A Hospital-Based Observational Study

A painful labor induces adverse maternal effects and increases fetal stress, yet evidence of lack of adverse effect of epidural anesthesia to the newborn Apgar score has been inconsistent. The aim of this study was to investigate maternal, newborn and anesthetic factors associated with a low Apgar score, in particular the effect of modality and timing of epidural analgesia, since this may allow for an appropriate neonatal care planning. We retrospectively analyzed the labor process of 1850 out of 2006 parturients/participants/deliveries at Centro Hospitalar do Porto in 2014. Our primary outcome was newborn Apgar score at fifth minute post-partum. Statistical significance was set as a p value inferior to 0.05. Seventy-one newborns (3.8%) had Apgar score below 7 and 1779 (96.2%) above or equal to 7 at fifth minute. None of the variables identified as maternal age, BMI, previous labor, gestational age, cervix dilation and newborn weight have proved to be different between groups of Apgar below and above 7 (t-test). There was also no significant difference between newborns with Apgar above or below 7 in what concerned initiation of labor, mode of epidural analgesia, previous cesarean, type of delivery and newborn sex (Chi-squared). Median hour of birth and median labor length since beginning of epidural analgesia were not different between the two groups of outcome (Kruskall Wallis). The multivariable model showed that the risk for low Apgar was not independently associated with any of the variables analyzed (Chi-squared Omnibus). In our study, modality and timing of epidural analgesia was not a predictor of low neonate Apgar score at fifth minute postpartum. Nonetheless, we demonstrated that epidural analgesia of low concentration local anesthetics with opioids was non-inferior to the opioid-free variety.

Mode of transmission and the evolution of arbovirus virulence in mosquito vectors.

The traditional assumption that vector-borne pathogens should evolve towards a benign relationship with their arthropod vectors has been challenged on theoretical grounds and empirical evidence. However, in the case of arboviruses (arthropod-borne viruses), although a number of investigators have reported experimental evidence for virus-induced vector mortality, others have failed to detect any significant impact. Whether this variation in the observed level of arbovirus virulence depends on biological traits or experimental design is unclear. Here, we perform a meta-analysis of studies across a range of mosquito-virus systems to show that, overall, arboviruses do reduce the survival of their mosquito vectors, but that the magnitude of the effect depends on the vector/virus taxonomic groups and the mode of virus transmission. Alphaviruses were associated with highest virulence levels in mosquitoes. Horizontal transmission (intrathoracic inoculation or oral infection) was correlated with significant virus-induced mortality, whereas a lack of adverse effect was found for Aedes mosquitoes infected transovarially by bunyaviruses-a group of viruses characterized by high natural rates of vertical transmission in their enzootic vectors. Our findings are consistent with the general prediction that vertically transmitted pathogens should be less virulent than those transmitted horizontally. We conclude that varying degrees of virulence observed among vector-virus systems probably reflect different selective pressures imposed on arboviruses that are primarily transmitted horizontally versus vertically.

Comparison of Three Nondestructive Methods for Determination of Vegetable Surface Area

Surface areas of differently shaped vegetables, namely beet (Beta vulgaris L.), cucumber (Cucumis sativus L.), carrot (Daucus carota L.), and parsnip (Pastinaca sativa L.) were determined by Baugerod's (a linear) method, a shrink-wrap replica method, and image analysis. Values obtained using these methods did not differ significantly for carrots and beets. Surface area values obtained using image analysis were higher than those obtained by Baugerod's method for parsnips (by 23.5%), and higher than Baugerod's and shrink-wrap replica methods for cucumbers (by 11.3% and 12.6%, respectively). A method was considered reproducible if surface area values from five measurements on the same product did not differ significantly (P ≤ 0.05). Surface area values for an individual product varied in the range of 4.7% for Baugerod's method for parsnips, and 6.6% for the shrink wrap replica method for carrots. No significant variation was observed for any of the vegetables when repeated measurements were made using the image analysis method. Image analysis offers rapidity, lack of adverse effect on produce, and the ability to collect and analyze data simultaneously. However, in absence of the necessary equipment for image analysis, Baugerod's method may be used for a product symmetrical around its central axis, after comparing it with a more direct procedure (e.g., shrink-wrap replica method).

Control of film defects in solventborne high-solids coatings: The non-additives vs. a new additives approach

Acetylenic based surfactants have long found utility in compliant coatings such as waterborne systems and are demonstrated here to enhance performance of solventborne high solids systems. Three new additives are shown to reduce surface defects such as craters and orange peel in conventionally spray applied polyester and epoxy paints. Important to this new additive technology is the lack of adverse effect on physical properties, recoatability, and durability of the applied coating. Also discussed are the theory and background of the origins of surface defects with emphasis on the influence of additives on paint rheology, compatibility, and surface tension.

Investigation of Particle Generation during the Low‐Pressure Chemical Vapor Deposition of Borophosphosilicate Glass Films

A particle beam mass spectrometer (PBMS) was used to monitor particle generation during the deposition of borophosphosilicate glass (BPSG) films in a Lam Research Corporation DSM™ 9800 low‐pressure chemical vapor deposition reactor. The precursors used were tetraethylorthosilicate (TEOS), triethylborate (TEB), phosphine, and oxygen. Typical process pressures ranged from 1–3 Torr, while the process temperatures varied from 775–825°C. The PBMS monitored the flow in the reactor exhaust line, and under typical process conditions detected a high concentration of fine particles (∼105/cm3) whenever TEOS was flowing into the reactor, indicating that the particles are formed by a gas‐phase nucleation process initiated by the decomposition of TEOS. The median particle diameter was determined to be about 0.2 μm. It is not known whether the particle generation occurred within the reactor or in the cooler (∼350°C) exhaust line. Fourier transform infrared, energy‐dispersive X‐ray, and inductively coupled plasma analysis showed that the particles had a composition largely similar to that of BPSG films, suggesting that the particles could have formed within the reactor. However, wafer scanner measurements after deposition detected very few added particles. This lack of adverse effect could imply that the particle generation occurred downstream of the reactor chamber, or that if it did occur within the reactor, the particles were prevented from depositing due to thermophoresis. PBMS measurements also showed the existence of a threshold for process pressure and for TEOS flow rate below which no particle formation was detected. A similar threshold was not observed for film formation.

Lack of adverse effect on quality of life of up to six cycles of chemotherapy in gynecologic cancer patients

Carter J, Johnson P, Saltzman A, Chen D, Carney P, Hartenbach E, Cosin J, Fowler J, Carson L, Twiggs L. Lack of adverse effect on quality of life of up to six cycles of chemotherapy in gynecologic cancer patients. Int JGynecol Cancer 1997; 7: 439–444. The aim of this study was to determine whether the prescription of up to six cycles of chemotherapy adversely affected the quality of life (QOL) of patients with a variety of gynecologic cancers. Over a 29 month period, patients presenting to a single gynecologic oncology clinic and who were prescribed cytotoxic chemotherapy were asked to complete a modified FACT-G quality of life form. Scoring was performed according to the FACT-G scoring guide. Analysis of variance was used to compare the mean transformed scores for each cycle. Sixty patients received a total of 257 cycles of chemotherapy. All patients who were offered the test satisfactorily completed the test. Average age was 56.3 years (range: 16–84). Tumor sites included ovary (N = 29), cervix (N = 15), uterus(N = 12), and vulva (N = 4). The associated histologies included adenocarcinoma (N = 35), squamous (N = 18),sarcoma (N = 6), and germ cell tumor (N = 1). The original stage at diagnosis was stage I (N = 16), stage II (N = 9),stage III (N = 22) and stage IV (N = 13). QOL scores for patients with cervical cancers were significantly inferior to patients with ovarian cancers (P = 0.03), uterine cancers (P = 0.02), and vulvar tumors (P = 0.01). A significant improvement in the physical well-being (PWB) subscale QOL score from cycle 2 to cycle 5 was noted (P = 0.03). Two other subscale QOL scores, emotional well-being(EWB) and functional well-being (FWB), revealed an overall improvement from cycle 1 to cycle 6; however, these results did not reach statistical significance. A general downward trend was noted in the social well-being (SWB) and relationship with doctor (RWD) subscale scores. Moreover, overall quality of life, as represented by the summed individual scores, was not significantly affected over the treatment cycles. Again, while an improvement was noted with progressive cycles, these results did not reach statistical significance. This study confirms that the prescription of up to six cycles of cytotoxic chemotherapy to patients with gynecologic cancers results in an overall improvement in subscale and overall QOL; however, the changes noted did not reach statistical significance.

Lack of adverse effect with smoking and nicotine replacement therapy

Lack of adverse effect with smoking and nicotine replacement therapy

Effect of dinitroaniline herbicides on rhizobia, nodulation and N2(C2H2) fixation of four groundnut cultivars

SummaryField, greenhouse and laboratory investigations were conducted to determine the effect of four dinitroaniline herbicides on rhizobia, nodulation and nitrogen fixation of four groundnut cultivars. Benefin, dinitramine and nitralin used at recommended levels decreased nodule dry weight, nitrogenase activity and total nitrogen of groundnut tops and pod yield in three cultivars Kadiri 71‐1, Kadiri‐2, ICGS‐11 and not for a fourth cultivar, Kadiri‐3 of groundnut (Arachis hypogaea L.), but fluchloralin used at the recommended level increased the nodulation rate, nitrogenase activity and total nitrogen of groundnut tops and pod yield compared to untreated plants. Studies were conducted in vitro to determine the relative toxicity of the herbicides on four Rhizobium strains isolated from the nodules of four cultivars of groundnut. It was found that various strains of rhizobia differ in their sensitivity to different rates of the herbicides tested. Carbon dioxide exchange rate (CER) of all the cultivars which received herbicide treatment was measured at different time intervals to determine the relationship between photosynthesis and inhibition of nodulation. The lack of adverse effect on the CER of four cultivars when treated at recommended concentrations indicated that nitrogen fixation was affected in cultivars Kadiri 71‐1, Kadiri‐2 and ICGS‐11 due to inhibition of nodulation.

A New Procedure for Transmitter Attachment: Effects on Brood Attendance and Chick Feeding Rates by Male Common Terns

A transmitter crystal and battery were covered with epoxy and wired to a size 2 USFWS aluminum leg band. The male partners of 10 Common Tern (Sterna hirundo) pairs were captured during late incubation at a Port Colborne, Ontario tern colony and the transmitter units fixed to their legs. The total package weighed an average 1.08 g more than the usual mass of a single band. The brood attendance patterns and feeding frequency rates of transmittered-males and of their female partners were contrasted over a 20-day period with those of non-transmittered males and their partners. No differences were found. Advantages of the attachment procedure are speed of attachment, light mass, rapid loss of antennae following battery exhaustion, and lack of adverse effect on parental behavior.

Doxepin and ethanol interaction

The effect of short-term oral administration of doxepin, a tricyclic antidepressant, on voluntary drinking of ethanol was studied in the rat as a function of sex. The effects of doxepin on ethanol and acetaldehyde metabolizing enzymes of hepatic and selected endocrine tissues were made in the presence and in the absence of ethanol. A reduction in voluntary ethanol intake was determined after the initial doxepin dose. This effect was not apparent during continued drug administration. Subsequently, a statistically insignificant reduction of ethanol drinking was noted 24 h and 72 h post-drug termination. Hepatic alcohol and aldehyde dehydrogenase were not altered from respective controls by doxepin in the presence and absence of ethanol. Epididymal and testicular adlehyde dehydrogenase were inhibited by doxepin from control in rats maintained on ethanol or water, respectively. The results suggest lack of adverse effect of doxepin on peripheral metabolism of alcohol metabolizing enzymes as compared to adverse interaction with acetaldehyde metabolizing enzyme in the endocrine tissues studied.

Blood concentrations of 2,3-butanedione monoxime and some blood biochemical changes in Bubalus bubalis after intramuscular administration of this cholinesterase reactivator.

The blood levels of cholinesterase reactivator 2,3-butanedione monoxime were determined in buffalo calves following single intramuscular doses of 20 and 50 mg/kg body weight. Blood cholinesterases and other enzymatic activities were monitored at various times. The drug was rapidly absorbed with half-life of 0.09-0.12 h. The peak 2,3-butanedione monoxime blood concentrations of 24.7 +/- 0.3 and 38.9 +/- 1.7 micrograms/ml occurred at 10 min after 20 and 50 mg/kg doses, respectively. The elimination half-life varied between 3.05 +/- 0.12 and 3.80 +/- 0.19 h. Lack of adverse effect of 2,3-butanedione monoxime on blood cholinesterases and other enzymes indicated that intramuscular doses as high as 50 mg/kg may be safely employed in buffaloes.

New developments in the measurement of the hemagglutinin content of influenza virus vaccines by single-radial-immunodiffusion

A variety of detergents were compared as solubilizing agents for the measurement of the hemagglutinin (HA) content of influenza vaccines by the single-radial-immunodiffusion (SRID) assay. The surfactant, Emulphogene (BC-720), was found to be generally the most satisfactory of the detergents tested against a variety of vaccine strains. In particular, the zone size for B/Hong Kong and A/USSR/77 strains was found to be unaffected by a wide range of BC-720 concentrations (1–4%) in contrast to the variable reaction size obtained with different concentrations of sodium sarkosyl sulfate (SSS). Little difference in zone size was observed between SSS and BC-720 detergents when testing A/Texas/77 antigens. The action of BC-720 was relatively mild as shown by the lack of adverse effect on previously solubilized A/USSR/77 and B/Hong Kong/73 HA.