Journal articles on the topic 'National Variety Trials'
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Roy, Snigdha, Dinesh Chandra Roy, Md Mahmud Al Noor, Shampa Rani Ghosh, Farid Ahmed, and Deboprio Roy Sushmoy. "Binamasur-10, the first drought tolerant lentil variety registered in Bangladesh." Research in Agriculture Livestock and Fisheries 6, no. 2 (September 9, 2019): 253–62. http://dx.doi.org/10.3329/ralf.v6i2.43048.
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from International Centre for Agricultural Research in the Dry Areas (ICARDA) including some advanced lines from Bangladesh Institute of Nuclear Agriculture in 2006. During Preliminary Yield Trial, the genotype LG-208 produced 18.62% and 29.47% higher seed yield than the check variety BARI Masur-5 at Ishurdi and Magura respectively. Through advanced yield trials, regional yield trials, on-station and on-farm trials from 2010-11 to 2015-16, it was found that exotic germplasm LG-208 showed better performance than check (BARI Masur-5). Genotype LG-208 had significantly highest seed setting and harvest index under 20% polyethylene glycol (PEG) induced drought and considered as the drought tolerant which showed similar performance with field trials in drought-prone areas (Chapainawabganj and Rajshahi). Based on the superior performance of exotic germplasm LG-208 line, BINA has decided with the National Seed Board (NSB) of Bangladesh to register this line as a high yielding drought tolerant lentil variety, named as Binamasur-10 in 2016.
Res. Agric., Livest. Fish.6(2): 253-262, August 2019
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Talbot, M., A. D. Milner, M. A. E. Nutkins, and J. R. Law. "Effect of interference between plots on yield performance in crop variety trials." Journal of Agricultural Science 124, no. 3 (June 1995): 335–42. http://dx.doi.org/10.1017/s0021859600073299.
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SUMMARYMethods are described for estimating interplot interference in variety trials. The effects on variety yield performance of interference from varieties in adjacent plots was studied for more than 600 UK National and Recommended List variety trials in the years 1987–1991. The crops examined were barley, wheat, oats, grain peas, beans, oilseed rape, forage maize and sugarbeet. Estimates of differences in variety performance may be biased by as much as 4% in some crops. Factors associated with interference included plant height, standing ability and disease susceptibility. An approach is outlined for limiting the effects of interference through controlled randomization within trials.
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Eichi, Vahid Rahimi, Mamoru Okamoto, Trevor Garnett, Paul Eckermann, Benoit Darrier, Matteo Riboni, and Peter Langridge. "Strengths and Weaknesses of National Variety Trial Data for Multi-Environment Analysis: A Case Study on Grain Yield and Protein Content." Agronomy 10, no. 5 (May 24, 2020): 753. http://dx.doi.org/10.3390/agronomy10050753.
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Multi-environment trial studies provide an opportunity for the detailed analysis of complex traits. However, conducting trials across a large number of regions can be costly and labor intensive. The Australian National Variety Trials (NVT) provide grain yield and protein content (GPC) data of over 200 wheat varieties in many and varied environments across the Australian wheat-belt and is representative of similar trials conducted in other countries. Through our analysis of the NVT dataset, we highlight the advantages and limitations in using these data to explore the relationship between grain yield and GPC in the low yielding environments of Australia. Eight environment types (ETs), categorized in a previous study based on the time and intensity of drought stress, were used to analyze the impact of drought on the relationship between grain yield and protein content. The study illustrates the value of comprehensive multi-environment analysis to explore the complex relationship between yield and GPC, and to identify the most appropriate environments to select for a favorable relationship. However, the NVT trial design does not follow the rigor associated with a normal genotype × environment study and this limits the accuracy of the interpretation.
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Mehedi, Md Nazmul Hasan, Md Rafiqul Islam, Md Shamsul Alam, and Sadia Tasmin. "Binamorich-2: A new high yielding Chilli variety of Bangladesh." Archives of Agriculture and Environmental Science 6, no. 3 (September 25, 2021): 329–33. http://dx.doi.org/10.26832/24566632.2021.0603010.
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Chilli is one of the most important spices as well as cash crop in Bangladesh. This study was undertaken at Bangladesh Institute of Nuclear Agriculture (BINA) to characterize the collected germplasm morphologically and select a desirable one for commercial cultivation in Bangladesh. More than fifty chilli germplasm were collected from local and exotic sources were put into evaluation to select desirable ones for directly use as varieties or for future usage as breeding materials. Through observation trials five germplasm were selected considering their better agronomic performance. Selected germplasm was evaluated through different trials at different chilli growing areas of Bangladesh during 2018 to 2020. Recommended cultural management for chilli cultivation was followed. The germplasm, IndoCF-25 produced significantly higher yield both green chilli and dried chilli than control varieties (Binamorich-1 and BARI Morich-1) in most of the trials. Over two years of advanced yield trial and on-farm trial, IndoCF-25 produced higher yield (32.00 t ha-1) while BARImorich-1 produced (12.15 t ha-1). IndoCF-25 was produced the longest plant height (78.8 cm), higher number of fruits (78.8) compared to Binamorich-1 (52.8), longer fruit size (13.95 cm), breadth (5.32 cm) and single fruit weight (11.38 g) compared to the check varieties. IndoCF-25 was found to be moderately tolerant to anthracnose, wilting and mosaic diseases, and also showed lower insect infestation than control varieties. Results of yield trials indicated that IndoCF-25-1 was suitable for cultivation in Bangladesh. Though check variety Binamorich-1 produced the highest yield (34.05 t ha-1) among three tested genotype/varieties, due to the better pungency as well as other quantitative and qualitative performances, BINA has applied for registration of IndoCF-25-1 to the National Seed Board (NSB) of Bangladesh. Consequently, the NSB of Bangladesh registered IndoCF-25-1 as a high yielding better pungent chilli variety in 2020 as Binamorich-2 for commercial cultivation all over Bangladesh.
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Bleyer, A. "Effect of 9–11 on U.S. national cancer clinical trials accrual and lack of effect of National Cancer Institute budget increases." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 6551. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.6551.
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6551 Background: During the past decade, a variety of initiatives have been implemented to improve the accrual of cancer patients on clinical trials. In the U.S., these have included comprehensive reviews and recommendations by the two most recent National Cancer Institute (NCI) administrations, reorganization of the clinical trials infrastructure at the NCI, and campaigns by the NCI Cooperative Groups and their Coalition. During the past six years, additional funds were allocated to this effort as part of the doubling of the NCI budget. The impact of these efforts on national cancer treatment clinical trials was evaluated, with emphasis on age groups. Methods: Accrual data from NCI-sponsored treatment trials conducted between 1997 and 2006 were obtained from the NCI Cancer Therapy Evaluation Program. Entries were analyzed by patient age, gender, race, type of cancer treated, and calendar year of trial entry. Results: Overall, national cancer treatment trial entries declined after 9–11–2001 and in 2003 reached the lowest levels since 1997. As of 2005 accrual recovered to pre 9–11 levels only in 15–29 and >60 year-olds, with the former demonstrating the greatest gain ( Table ). Entries among <15 and 30–49 year- olds declined steadily since 1997 with no evidence for recovery as of 2005 ( Table ). Overall, the estimated proportion of the nation's cancer patients entered onto national treatment trials remains below 3%. Conclusions: Despite continued national and local efforts to increase the participation of cancer patients on clinical trials, accompanied by significant increases in the NIH and NCI budgets, there is little evidence of a beneficial impact. The effect of 9–11 has yet to be overcome, except in young and elderly adults, in whom specific, targeted initiatives appear to have been successful. The latter approaches may be useful to apply to other age groups, particularly in view of the recent cuts in the cooperative group budgets and current mandated decreases in study accruals. No significant financial relationships to disclose. [Table: see text]
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Erickson, Craig, Walter Kaufmann, Dejan Budimirovic, Ave Lachiewicz, Barbara Haas-Givler, Robert Miller, Jayne Weber, et al. "Best Practices in Fragile X Syndrome Treatment Development." Brain Sciences 8, no. 12 (December 15, 2018): 224. http://dx.doi.org/10.3390/brainsci8120224.
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Preclinical studies using animal models of fragile X syndrome have yielded several agents that rescue a wide variety of phenotypes. However, translation of these treatments to humans with the disorder has not yet been successful, shedding light on a variety of limitations with both animal models and human trial design. As members of the Clinical Trials Committee of the National Fragile X Foundation, we have discussed a variety of recommendations at the level of preclinical development, transition from preclinical to human projects, family involvement, and multi-site trial planning. Our recommendations are made with the vision that effective new treatment will lie at the intersection of innovation, rigorous and reproducible research, and stakeholder involvement.
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Fernandez, George C. J. "THE BIPLOT DISPLAY OF THE TALL FESCUE TURF VARIETY TRIAL DATA." HortScience 25, no. 9 (September 1990): 1173e—1173. http://dx.doi.org/10.21273/hortsci.25.9.1173e.
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Tire interpretation of variety trials conducted with many genotypes (G) grown in many environments (E) is usually complicated by the presence of the significant G × E interaction. The common statistical analysis using ANOVA and linear regression techniques are often inadequate to study the complex two-way data structure. The biplot, a multivariate technique provides, a graphical representation of the interaction, which allows the response of each G in each E to be displayed in a two dimensional plot. It displays not only the configuration of G and E, but it also relates the two. The importance of biplot display is illustrated by using the tall fescue variety trial data on mean quality ratings published by the National Turfgrass Evacuation Program. The biplot displays about 60% of the information in the 24 (G) × 23 (E) data matrix. Environments TX3 and GA1 responded differently from other environments. Based on the biplot display genotypes are grouped and their significance will be discussed.
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Gorshkov, V. I. "New ecologically plastic spring rapeseed variety Erebus." Oil Crops 4, no. 192 (December 25, 2022): 113–17. http://dx.doi.org/10.25230/2412-608x-2022-4-192-113-117.
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The spring rapeseed variety Erebus was developed in 2007–2018 by individual selection in F2 from the hybrid combination LK-443-04 × LK-654-06. Ac-cording to the competitive variety trials conducted by the All-Russian Research Rapeseed Institute during 2013-2018, variety Erebus had better results than standard variety Rif in seed yield by 0.12 t/ha or 5.8% and in oil yield the results were higher by 0.08 t/ha. The content of glucosinolates in the seeds was 2.8 µmol/g lower than that one of variety Rif. In 2022, Erebus has been included in the National List of Varieties (Patent № 11441) and approved for pro-duction use in the Central (3), Volga-Vyatsky (4), Central Chernozem (5), Middle Volga (7), Ural (9), West Siberian (10), East Siberian (11) and Far East (12) regions of the Russian Federation.
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Kandel, Manoj, Narayan Bahadur Dhami, and Jiban Shrestha. "Performance evaluation of Barley (Hordeum vulgare L.) genotypes in Dolakha, Nepal: from yielding perspective." Journal of Agriculture and Natural Resources 2, no. 1 (October 25, 2019): 332–37. http://dx.doi.org/10.3126/janr.v2i1.26098.
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Lack of suitable barley varieties that exhibit high yielding is the major factor among several production constraints contributing to low productivity of barley in Nepal. The present study was done to evaluate and recommend the best performing barley genotypes. This study was conducted at research field of Hill Crops Research Program (HCRP), Dolakha, Nepal under National observation nursery (NON), initial evaluation trial (IET), coordinated varietal trials (CVT) and farmer's field trials (FFT) during winter seasons from 2017 to 2018. The results of these trials showed that in NON, genotypes namely B86023-1K2-OK3 (6.16 t/ha), Xveola-28/MATICO"S"10 (4.41 t/ha) and ACC#2079 (4.41 t/ha) produced higher grain yield over Farmer’s variety (3.57 t/ha). The pooled analysis over years of IET revealed that genotypes namely LG-51/Xveola-2-77-0-3-1-1-OK (2.12 t/ha) and B86099-2-1-OK (2.06t/ha) produced higher grain yield over standard check variety (Solu Uwa) (1.85 t/ha) and Farmer’s variety (1.95 t/ha). Similarly results of combined analysis over years of CVT showed that the genotypes namely B90K-007-0-2-2-0-OK (2.14 t/ha) and ICB90-0196-OAP-2K-OK (1.97 t/ha) produced higher grain yield over standard check variety (Solu Uwa) (1.12 t/ha) and Farmer’s variety (1.66 t/ha). In farmer's field trials (FFTs) the genotypes namely Muktinath ( Coll#112-14 (2.64 t/ha)), NB-1003-37/903 (2.23 t/ha) and Xveola-45 (2.04 t/ha) produced higher grain yield which was at par to standard check variety (Soluuwa) (1.58 t/ha) and Farmer’s variety (1.85 kg/ha). It is suggested that the superior genotypes derived from CFFT could be released and then recommended to farmers for general cultivation in Dolakha and similar other environments of Nepal.
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Ahmed, H. M., and K. Ahmed. "DEVELOPMENT OF A NEW OILSEED RAPE VARIETY NIFA SARSON-T20 THROUGH PHYSICAL MUTAGENESIS." Pakistan Journal of Agriculture, Agricultural Engineering and Veterinary Sciences 38, no. 1 (June 22, 2022): 24–30. http://dx.doi.org/10.47432/2022.38.1.4.
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Induced mutagenesis has been proven as one of non-conventional approaches to create genetic variability. In line with the objective to develop a high seed and oil yielding oilseed rape cultivar; 4000 healthy seeds of an advanced rapeseed (Brassica napus L.) line NR-23 having 8 percent moisture were irradiated @ 1, 1.2 and 1.4 kGy in 2010 using cobalt-60 source. Single plant selections were executed based on yield and yield contributing traits following pedigree method of selection from M2-M4 generations. Homozygous progenies of the pedigree number 011-K-16-3 selected from 1 kGy were bulked during 2013. The mutant with line code 011-K-16-3 was evaluated at station and outstation seed yield trials from 2013-14 to 2017-18. The mutant performed better than checks in Preliminary, Advanced, Zonal and National Uniform Rapeseed Yield Trials (NURYT). It has out yielded Hyola-401 and Faisal Canola by 26% and 23%, respectively in the multi-location adaptation seed yield trials conducted at selected sites in the Khyber Pakhtunkhwa (KP) and Punjab. It has also exceeded the national check Faisal Canola by 5% on location mean basis in the NURYT (2016-17 and 2017-18). It maintained its superiority in oil yields over the check Faisal Canola at station and in NURYTs. It is medium maturing, tall (190-205cm) featured with ramification at middle low, tolerant to alternaria blight, high seed yield (3000-3300 kg ha-1); high oil contents (43-46%) and low erucic acid (< 5%). The Provincial Seed Council approved it with name NIFA Sarson-T20 for growing in the Khyber Pakhtunkhwa (KP).
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Podgorny, S. V., O. V. Skripka, A. P. Samofalov, S. N. Gromova, and N. S. Kravchenko. "QUALITY INDICATORS OF WINTER SOFT WHEAT VARIETIES IN ECOLOGICAL VARIETY TRIALS." TAURIDA HERALD OF THE AGRARIAN SCIENCES 4 (24) (November 2020): 143–51. http://dx.doi.org/10.33952/2542-0720-2020-4-24-143-151.
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Improving the quality of wheat grain is an important task of agricultural production. In recent years, the production of strong and valuable wheat, necessary for the production of high-quality baking flour, has decreased. In this regard, the study of the quality of grain varieties of winter wheat in specific soil and climatic conditions of the Rostov region is becoming topical. Therefore, the purpose of our research was to study the main indicators of grain quality of varieties of soft winter wheat (protein and gluten content, flour strength, bread size from 100 g of flour) in ecological variety trials to select the best under conditions of the Rostov region. The studies were carried out on the trial fields of the Laboratory of selection and seed production of winter soft wheat of intensive type of the State Scientific Establishment “Agricultural research center «Donskoy»” (Rostov region) in 2014–2016. Seventy-five varieties were studied in the course of the research. Planting dates – optimal for implementation of agricultural and agro-technical measures. Planter – «Wintersteiger Plotseed S.» Seed placement depth – 4–6 cm. Preceding crop – black fallow. Accounting square of fields – 10 m2, double replication. Seeding rate – 4.5 million seeds per hectare. Grain quality was assessed according to the methods of the national standards of the Russian Federation. Such grain quality indicators as gluten content (according to GOST R 54478-2011), protein mass fraction (as required by GOST 108460-91), baking properties of flour (in a laboratory using the remix method) were determined. The article discusses the main indicators of the quality of grain and flour of winter soft wheat varieties in ecological variety testing and compares them. Analysis of the main indicators of the quality of varieties in trials showed that in the south of the Rostov region in 2014–2016 flour strength and gluten content were the most variable indicators. In terms of protein content (> 14.5 %), 8.0 % of the studied varieties were in full compliance with strong wheat standards; by the gluten content (> 28 %) – 7.0 %; by the flour strength (>280 e.a.) – 9.0 %. Five varieties of winter soft wheat: ‘Aksinya’, ‘Tanais’, ‘Asket’, ‘Nakhodka’, ‘Yumpa’ (Russia) with a complex of economically valuable traits are of greater interest for practical breeding in terms of improving grain quality.
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Unger, Joseph M., Michael Leo LeBlanc, and Charles David Blanke. "The impact of positive SWOG treatment trials on population survival." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 6513. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.6513.
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6513 Background: Recently, tremendous prominence has been given to the investigation of the impact of different research processes as part of the Cancer Moonshot. More than half a century ago, the National Cancer Institute (NCI) established a network of publicly-funded cancer cooperative research groups to systematically advance the science of clinical trial research and the evaluation of new treatments for efficacy and safety. Our objective was to examine the extent to which positive NCI-sponsored cancer treatment trials have benefited cancer patients in the U.S. population. Methods: We used study data from SWOG, an NCI-sponsored Network cooperative research group. We identified all treatment trials over SWOG’s 60-year history (1956-2016) for which the new experimental therapy provided a statistically significant improvement in overall survival. We assumed the new, proven treatments from these trials established new standards for care in the treatment community. Twenty-three treatment trials were identified from a variety of difference cancer types. We estimated population life-years gained from the trials through 2015 by mapping the impact of the new treatments onto the U.S. cancer population, using an area-under-the-survival-curve approach that combined trial-specific hazard function and hazard ratio results with SEER and life-table data. Calculations were age-adjusted. Dollar return on investment was estimated as the ratio of total investment by the National Cancer Institute in the SWOG treatment trial program divided by the estimate of life-years gained. Results: In total, 12,361 patients were enrolled to the 23 positive trials from 1965-2012. We estimated that 3.34 million years of life were gained through 2015. Estimates were greater than 2 million life years gained under 95% of model simulations. The dollar return on investment was $125 per life year gained. Conclusions: SWOG treatment trials have had a substantial impact on population survival for cancer patients over 60 years. The National Cancer Institute’s investment in its cancer cooperative group research program has provided exceptional value and benefit to the American public.
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Nouvini, Rosa, Patricia A. Parker, Charlotte Malling, Kendra Godwin, and Rosario Costas-Muñiz. "Increasing underrepresented minority cancer patient enrollment into cancer clinical trials: A systematic review." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): e18574-e18574. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e18574.
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e18574 Background: Minorities continue to be underrepresented in clinical trials despite the National Institute of Health’s Revitalization Act, passed in 1993, mandating the representation of women and underrepresented minority groups in clinical trials. Studies have shown that although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates in are disproportionately low at 4-6% and 3-6% respectively. We conducted a systematic review exploring interventions aimed at improving clinical trial enrollment for racial and ethnic minorities. Methods: A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies of humans since 1993. Inclusion criteria included peer-reviewed, U.S.-based studies with interventions aimed to recruit underrepresented minority adult cancer patients into cancer clinical trials. We defined underrepresented minority groups as Black, Hispanic/Latino, Asian, American Indian/Alaska Native and Native Hawaiian/other Pacific Islander. Results: A total of 2471 titles and abstracts were identified and 2324 were excluded based on the eligibility criteria. A full text review was conducted of the remaining 147 articles, of which only 9 met criteria for our review. The interventions included patient navigation/coaching (n = 4), a clinical trial educational video (n = 2), institutional research infrastructure changes (n = 1), a relationship building and social marketing recruitment model (n = 1) and cultural competency training for providers (n = 1). Studies were conducted in a variety of practice settings including national cancer institutes and community practices. The quality of evidence was limited by the heterogeneity of study methods, patient representation and bias. Several studies had a homogeneous population of Black patients. Most studies (n = 7) were single arm trials that compared results to either historical controls or those cited in the existing literature; two studies were randomized controlled trials. A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos, the institutional research infrastructure change and the relationship building and social marketing recruitment model. The common threads to many of these successful interventions were support through the cancer care continuum, cultural congruency of research staff and culturally catered clinical trial educational materials. Conclusions: This systematic review illustrates several mechanisms by which to increase cancer clinical trial recruitment for cancer patients of underrepresented minority backgrounds in a variety of clinical settings. Randomized controlled trials with representation of multiple races/ethnicities are needed to further explore the benefits of these interventions.
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BURNS, G. A., T. J. GILLILAND, D. GROGAN, S. WATSON, and P. O'KIELY. "Assessment of herbage yield and quality traits of perennial ryegrasses from a national variety evaluation scheme." Journal of Agricultural Science 151, no. 3 (March 30, 2012): 331–46. http://dx.doi.org/10.1017/s0021859612000251.
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SUMMARYPerennial ryegrass evaluation schemes categorize varieties into three maturity (early, intermediate and late) and two ploidy (diploid and tetraploid) groups, and compare the relative yield, persistence and nutritive quality of varieties within these groups. The present study compared these groups for herbage yield, dry matter (DM) concentration and, using near infrared reflectance spectroscopy (NIRS), four quality characteristics (in vitro content of digestible dry matter (CDDM), water-soluble carbohydrate (WSC) and crude protein (CP) concentrations, and buffering capacity). A total of 1208 plots were sown across 5 years in Irish Recommended List trials and then harvested 6–7 times in each of 2 harvest years. This also allowed an assessment of the effect of sward age. Maturity group had no significant effect on annual herbage yield, quality or DM concentration except for in vitro CDDM (P<0·01) but differed significantly for in vitro CDDM (P<0·01), WSC concentration (P<0·01) and buffering capacity (P<0·05) at the first silage harvest. Tetraploid swards had greater annual herbage yields (P<0·001), in vitro CDDM values (P<0·001) and WSC concentrations (P<0·01), but lower CP and DM concentrations (P<0·001) than diploids. Swards in their first full year produced an additional 5·17 t/ha DM (P<0·001) and had a higher (P<0·01) WSC concentration at the second silage harvest than in their second year, but did not differ significantly for in vitro CDDM and WSC, CP or DM concentrations. The present study showed that differences exist in yield, nutritive quality and ensilability indices between maturity and ploidy groups. These observations justify their assessment in variety comparative trials and facilitates particular groups being selected for individual farming systems to increase efficiency.
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BOMPART, FRANCOIS. "Healthy Volunteers for Clinical Trials in Resource-Poor Settings: National Registries Can Address Ethical and Safety Concerns." Cambridge Quarterly of Healthcare Ethics 28, no. 1 (December 20, 2018): 134–43. http://dx.doi.org/10.1017/s0963180118000476.
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Abstract:Healthy volunteers (HVs) who participate in clinical trials are a vulnerable group that deserves specific protection. We assessed the number and types of studies that involve HVs around the world and outline the methodological barriers to their analysis. We found that tens of thousands of HVs are involved every year in clinical trials in a large variety of countries and that the overwhelming majority of studies are not “first-in-human” but pharmacokinetic studies. The two cornerstones for both ethical and safe participation of HVs in clinical trials are properly obtained informed consent and a minimization of exposure to risk, in particular by avoiding concealed participation in multiple trials. To minimize the risk of exploitation of HVs and their exposure to risk, we propose ways to ensure genuine informed consent, and advocate setting up national healthy volunteer registries as established in France and the U.K.
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Mirza, Aziza, Victoria Yorke-Edwards, Sarah Lensen, Macey L. Murray, Carlos Diaz-Montana, James Carpenter, Matthew R. Sydes, and Sharon B. Love. "Why are feasibility studies accessing routinely collected health data? A systematic review." F1000Research 10 (August 16, 2021): 815. http://dx.doi.org/10.12688/f1000research.52486.1.
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Background: Feasibility trials are often undertaken to determine whether a larger randomised controlled trial (RCT) is achievable. In a recent review, 15 feasibility trials accessed routinely collected health data (RCHD) from UK national databases and registries. This paper looks at attributes of these trials and the reasons why they accessed RCHD. Methods: We extracted data from all publicly available sources for the 15 feasibility studies found in a previous review of trials successfully accessing RCHD in the UK between 2013–2018 for the purpose of informing or supplementing participant data. We extracted trial characteristics, the registry accessed, and the way the RCHD was used. Results: The 15 feasibility RCTs were conducted in a variety of disease areas, and were generally small (median sample size 100, range 41–4061) and individually randomised (60%, 9/15). The primary trial outcome was predominantly administrative (non-clinical) (80%, 12/15) such as feasibility of patient recruitment. They were more likely to recruit from secondary care (67%, 10/15) settings than primary (33%, 5/15). NHS Digital was the most commonly accessed registry (33% (5/15)) with SAIL databank (20% (3/15)), electronic Data Research and Innovation Service (eDRIS) and Paediatric Intensive Care Audit Network (PICANET) (each 13% 2/15) also being accessed. Where the information was clear, the trials used RCHD for data collection during the trial (47%, 7/15), follow-up after the trial (27%, 4/15) and recruitment (13%, 2/15). Conclusions: Between 2013 and 2018, 15 feasibility trials successfully accessed UK RCHD. Feasibility trials would benefit, as with other trials, from guidance on reporting the use of RCHD in protocols and publications.
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Brundage, Michael, David Osoba, Andrea Bezjak, Dongsheng Tu, Michael Palmer, and Joseph Pater. "Lessons Learned in the Assessment of Health-Related Quality of Life: Selected Examples From the National Cancer Institute of Canada Clinical Trials Group." Journal of Clinical Oncology 25, no. 32 (November 10, 2007): 5078–81. http://dx.doi.org/10.1200/jco.2007.11.4645.
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In this article, we provide a brief historical review of the development of patient-reported outcome measurement, analysis, and reporting in clinical trials of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). In doing so, we examine selected lessons learned in furthering the quality of these data and their application to clinical practice. We conclude that sequential institution of key policies within the NCIC CTG and the development of a collective philosophy within the group has enabled the routine incorporation of health-related quality of life into clinical trial protocols according to robust scientific principles; that collection of quality data is possible in a variety of circumstances (although not universally so); that patient-reported data on subjective experiences is likely to be more reliable and valid than conventional toxicity information; and that simple analyses that report group trends as well as individual patient response rates are preferred.
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Ludemann, C. I., C. M. Wims, and D. F. Chapman. "Validation of perennial ryegrass cultivar Forage Value Index rankings using independent trial data." Journal of New Zealand Grasslands 79 (January 1, 2017): 97–101. http://dx.doi.org/10.33584/jnzg.2017.79.562.
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Abstract The current DairyNZ Forage Value Index (FVI) categorises ryegrass cultivar-endophyte combinations into five, 'star rating' groups for dry matter (DM) yield using data from the National Forage Variety Trial (NFVT) system. However, variability in performance of cultivars between trials raises the question of how cultivars with different star ratings perform against each other under different conditions. The validity of the FVI star rating categories for perennial ryegrass was assessed using cultivar DM yield data from two independent trials outside the NFVT system and under dairy cow grazing with white clover. Results from the trials were used in Monte Carlo simulations to provide a probabilistic determination of the likelihood of high FVI rated cultivars outperforming the low FVI rated cultivars. Results indicate selecting high FVI (5 star) perennial ryegrass cultivars over lower FVI (3 star) cultivars deliver greater contributions to dairy operating profit in over 94% of the simulated iterations for the Waikato and Canterbury. Keywords: Forage Value Index, Lolium perenne, plant breeding, selection, cultivars
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Hadley, David, William Jeffery Edenfield, and Debra A. Kientop. "Moving away from the boilerplate: Real-world evidence for clinical trial laboratory criteria." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): e14581-e14581. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e14581.
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e14581 Background: There is a need to enable as many suitable patients onto clinical trials in oncology, that are also representative of patients seen in clinical practice. Currently, oncology trials often require patients to have minimum laboratory tests for hematology and liver function amongst others. We compared the real-world laboratory results and clinical information in TransMed’s patient repository against the requirements of a set of clinical trials to assess patient eligibility retrospectively. Methods: Industry-sponsored clinical trials for follicular lymphoma which started in 2018 were retrieved from the U.S. National Library of Medicine’s clinical trials website. We aimed to find the most common set of diagnosis inclusion criteria and the range of platelet requirements to those observed from real-world data. TransMed’s patient data was collected from its consortium of 205 clinical sites, which includes a variety of source systems at each site, such as electronic medical record systems and laboratory information management systems among others. Results: There were 16 trials which matched our criteria. The most common trial inclusion criteria were for grades 1-3a, progression after at least one line of therapy, and a platelet count > 75 x10-9/L. We found 53 retrospectively-eligible patients who would have met the trial’s main criteria when the patient was between therapies in 2018. At some point within 90 days before starting another therapy, 9% (5/53) of patients failed the requirement for platelet count. Among those, 40% (2/5) were within a 10% drop in the required threshold. Conclusions: We have presented an exemplar combination of cancer diagnosis with a single laboratory test and found patients who could be considered for trials though are deemed ineligible due to a narrowly-missed requirement. Many such tests vary over time, by cancer type, prior treatment, comorbidities and should be considered in the context of other test results. By using real-world evidence at the time of trial design, clinical trials can be optimized to allow improved patient recruitment and expanded availability to patients while ensuring clinical suitability.
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Zeng, Linghe. "History, Changes, Impacts, and Perspectives of the National Cotton Variety Test (NCVT): Sixty Years of the Program." Journal of Cotton Science 25, no. 3 (2021): 205–12. http://dx.doi.org/10.56454/glzb1775.
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The National Cotton Variety Test (NCVT) is a USDA-ARS national program to evaluate cotton varieties/lines developed by major U.S. cotton breeding programs for lint yield, fiber quality, and seed quality in annual trials across the U.S. Cotton Belt. This year is the 60th anniversary of the program, and this review article provides the background, leadership history, original objectives and their changes, and a summary of the impacts in cotton production and accomplishments of the program in cotton research. The NCVT history reflects the efforts of U.S. cotton breeders to improve cotton varieties by addressing environmental influences in cotton production and increasing competition in the global market of raw cotton fibers. The scientific accomplishments reviewed in this article can be used as references and guidelines for future cotton breeding.
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Vilchynska, L. A., and A. S. Gorash. "Yielding and quality indicators of new buckwheat varieties Kamianchanka." Faktori eksperimental'noi evolucii organizmiv 24 (August 30, 2019): 49–52. http://dx.doi.org/10.7124/feeo.v24.1077.
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Aim. To compare the new variety of buckwheat Kamianchanka by individual indicators of suitability for distribution, difference, uniformity and stability with a conditional national variety-standard. Methods. The creation, study, evaluation, reproduction and transfer to the State trials of a new variety was carried out in accordance with the generally accepted methods of state trials. Results. The article presents the main identification indicators of the Kamianchanka buckwheat variety, created in the Podilskyi State Agrarian Engineering University. In terms of the suitability of the variety for distribution, difference, uniformity and stability, the Kamianchanka buckwheat variety exceeds the average yield of the varieties that have passed state registration in the previous five years in the Forest-Steppe Zone. The average yield of the new variety was higher than the conventional standard by 1.7 and 3.7 c / ha, or by 9.3 and 19.6%, respectively. Plant height varied from 73 to 156 cm and was on average 15 cm higher than the standard. The mass of 1000 seeds varied from 25.4-35 g and was higher in the Forest-steppe zone by 3.7-5 g (11.4-11.7%) compared with the conventional standard. A new variety of buckwheat Kamenchanka is sufficiently resistant to biotic and abiotic factors, suitable for cultivation in intensive technologies and mechanized harvesting. Сonclusions. A new variety of buckwheat Kamianchanka is listed in the Register of Plant Varieties of Ukraine for 2019. Recommended for growing farms of various forms of ownership.
Keywords: buckwheat, yield, qualitative parameters, state test.
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Cooke, Robert J., and James C. Reeves. "Plant genetic resources and molecular markers: variety registration in a new era." Plant Genetic Resources 1, no. 2-3 (August 2003): 81–87. http://dx.doi.org/10.1079/pgr200312.
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AbstractVariety registration is an important area of plant genetic resource characterization and utilization. Within the European Union, varieties must be included on a National List (NL) of a member state or on the Common Catalogue (a compilation of the NLs of the member states) before seed can be sold. This requires a series of tests and trials which assess if the variety is distinct, uniform and stable (DUS) and if it has sufficient value for cultivation and use (VCU). The same DUS criteria are also used world-wide for the granting of Plant Breeders' Rights (PBR), an intellectual property protection system. Both DUS and VCU are currently assessed primarily using field-based trials. However, the potential use of biochemical and molecular markers for DUS purposes is being actively investigated and such markers could have an important role to play in maintaining the quality and scope of PBR in an environment where the increasing number of countries involved in DUS testing and the number of variety comparisons to be made are causing logistical difficulties. More recently, given firstly the increase in the availability of markers from expressed regions of the genome, and secondly the possibilities raised by detailed DNA sequencing programmes and the association of markers (particularly single nucleotide polymorphisms, SNPs) with specific genes, the prospects for a more molecular approach to VCU are also being discussed. This paper reviews the current situation with regard to the use of molecular markers for DUS and VCU testing and considers future prospects for variety registration in the 21st century, ‘-omics’, era.
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van, Waes. "Harmonization of rules for VCU testing of maize in comparable agro ecological regions." Genetika 36, no. 1 (2004): 1–11. http://dx.doi.org/10.2298/gensr0401001v.
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In the European Community, a new variety of an agricultural crop must submit official trials for DUS (Distinctness, Uniformity, Stability) and VCU (Value for Cultivation and Use) before commercialisation. The guidelines for those tests are summarized in the European directive 70/457/EU (1970), revised in 2002 (2002/53/EU). The result of the VCU-tests is the admission on the national variety catalogue of new varieties, which are better than the best existing ones. Better varieties in the market can increase the income of the farmers. The progress in breeding can be measured by comparison the level of recent with older (10 - 15 years ago) varieties. Incorporation of new varieties in the culture plan is only justified if they are better than existing varieties and if they have no great weaknesses. Therefore the farmers need criteria for cultivation security and high return (output, yield). The two most important factors for cultivation security are resistance to lodging and to stalk rot. In addition earliness is another important factor for silage maize to attain a sufficient dry matter of the total plant and for corn maize to attain a low moisture content in the grains. Important factors for cost-effectiveness are total dry matter yield and quality for silage and grain yield for corn maize. Until now each EU- country has a separate system for VCU testing. The aim of the VCU-research is to predict the agronomical and technological value of a new variety on a reliable way in comparison with standard varieties. For this purpose there is the necessity for a high number of field trials and analyses; this implicates high national experimentation costs. But the costs for experimentation are only a small fraction of the benefits for the farmers. International cooperation for VCU-testing will become necessary to reduce the costs for the national variety testing systems. However the aim of the research must still be to predict the agronomical value of a new variety with the same reliability as at national level. For the future variety testing should be realized on the basis of comparable agro-ecological regions with the same crop husbandry and use of the crop. These regions must be clearly defined so that the release of varieties corresponds to the high demands for harvest security and good conservation possibilities of the harvested material. The most important criteria for evaluation should be: harvest security, disease resistance, yield and quality. The basis for a good success for international cooperation is a good knowledge of the national systems: searching for similarities and finding a solution for differences. Once a variety on a catalogue in one European country, the breeding company tries to sell the variety in the whole agro-ecological for which the variety is adapted. Therefore it is important that in the surrounding zones, where the variety is tested, the same criteria are valid. In this presentation we will give a proposal for harmonization and international cooperation for controlling the VCU- value of new maize varieties.
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Labuda, Patryk I. "The Flipside of Complementarity." Journal of International Criminal Justice 17, no. 2 (May 1, 2019): 369–90. http://dx.doi.org/10.1093/jicj/mqz019.
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Abstract A variety of human rights dilemmas were left unresolved in Rome. One issue likely to generate controversy is the relationship between the prohibition of double jeopardy, complementarity and minimal fair trial protections for defendants. Under the Rome Statute’s complementarity framework, the International Criminal Court (ICC) must defer to domestic proceedings if a state is handling the same case and the national authorities are not ‘unable or unwilling’ to prosecute the same person. Much ink has been spilt on Article 17 of the Statute and the ensuing case law, but less understood is the flipside of complementarity: under what circumstances is a state not allowed to prosecute defendants over whom the ICC has already exercised jurisdiction? With the case against Germain Katanga in the backdrop, this article argues that the ICC should take a more pro-active role in supervising secondary domestic proceedings against people previously convicted or acquitted in The Hague. Katanga’s return to the Democratic Republic of Congo to serve the remainder of his ICC-mandated sentence triggered a domestic trial implicating a variety of fair trial issues. Under a seldom-used provision in the Rome Statute, Article 108, the ICC Presidency was required to validate or reject Congo’s proceedings against Katanga. Not only did the Presidency allow his case to proceed, it prospectively abdicated any international oversight of national trials, while advancing sweeping normative claims about the irrelevance of human rights to the permissibility of secondary domestic trials. Three years later, Katanga languishes in a Congolese prison with little prospect of justice. Although the Katanga case is based on a unique set of facts, analogous developments in the cases against Saif Al-Islam Gaddafi and Jean-Pierre Bemba point to the growing likelihood of secondary domestic proceedings against people previously tried by the ICC, which in turn raises fundamental questions about the Rome Statute’s prohibition of double jeopardy and its relationship to complementarity and fair trial guarantees.
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Kulke, Matthew H., Lillian L. Siu, Joel E. Tepper, George Fisher, Deborah Jaffe, Daniel G. Haller, Lee M. Ellis, et al. "Future Directions in the Treatment of Neuroendocrine Tumors: Consensus Report of the National Cancer Institute Neuroendocrine Tumor Clinical Trials Planning Meeting." Journal of Clinical Oncology 29, no. 7 (March 1, 2011): 934–43. http://dx.doi.org/10.1200/jco.2010.33.2056.
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Neuroendocrine tumors (NETs) arise from a variety of anatomic sites and share the capacity for production of hormones and vasoactive peptides. Because of their perceived rarity, NETs have not historically been a focus of rigorous clinical research. However, the diagnosed incidence of NETs has been increasing, and the estimated prevalence in the United States exceeds 100,000 individuals. The recent completion of several phase III studies, including those evaluating octreotide, sunitinib, and everolimus, has demonstrated that rigorous evaluation of novel agents in this disease is both feasible and can lead to practice-changing outcomes. The NET Task Force of the National Cancer Institute GI Steering Committee convened a clinical trials planning meeting to identify key unmet needs, develop appropriate study end points, standardize clinical trial inclusion criteria, and formulate priorities for future NET studies for the US cooperative group program. Emphasis was placed on the development of well-designed clinical trials with clearly defined efficacy criteria. Key recommendations include the evaluation of pancreatic NET separately from NETs of other sites and the exclusion of patients with poorly differentiated histologies from trials focused on low-grade histologies. Studies evaluating novel agents for the control of hormonal syndromes should avoid somatostatin analog washout periods when possible and should include quality-of-life end points. Because of the observed long survival after progression of many patients, progression-free survival is recommended as a feasible and relevant primary end point for both phase III studies and phase II studies where a delay in progression is expected in the absence of radiologic responses.
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Grof, B. "Selection of the components of a synthetic variety of Andropogon gayanus." Journal of Agricultural Science 106, no. 3 (June 1986): 629–33. http://dx.doi.org/10.1017/s0021859600063528.
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Andropogon gayanus Kunth var. bisquamulatus Hack, is a polymorphic bunch grass, widely distributed throughout most of the tropical and subtropical savannahs of Africa, south of the Sahara in areas with a long dry season. This grass was introduced into the Colombian Llanos from the Shika Agricultural Research Station, northern Nigeria, in 1974. Subsequent to its introduction, a series of agronomic trials were initiated by Centro Internacional de Agricultura Tropical (CIAT) at the Carimagua Research Centre and various national research institutions in Latin America to evaluate the potential of A. gayanus, primarily in the vast Ultisol and Oxisol savannah regions of the continent. As a result of further evaluation at a number of locations, accession A. gayanus var. bisquamulatus CIAT 621 was released in 1980 in Brazil as cv. Flanaltina and in Colombia as cv. Carimagua 1. During 1982–3 Peru, Venezuela and Panama subsequently released the same accession under the cultivar names of San Martin, Sabanero and Veranero, respectively. It is estimated that 168000 ha have been sown with A. gayanus in Brazil since 1982 (J. E. Ferguson, C. Sere and R. de Andrade, personal communication). Smaller areas have been established in other countries.
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Boktaev, М. V., V. Ya Kovtunenko, B. A. Gol'dvarg, V. V. Panchenko, and A. P. Kalmysh. "The new winter triticale variety ‘Uralan’ for the arid zone of the Republic of Kalmykia." Grain Economy of Russia, no. 5 (October 30, 2020): 63–67. http://dx.doi.org/10.31367/2079-8725-2020-71-5-63-67.
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The scheme of the winter triticale breeding at the National Center of grain named after P. P. Lukiyanenko provides for extensive ecological variety trials in various soil and climatic zones of the Russian Federation that makes it possible to reliably estimate the adaptability of promising breeding material and more reasonably and accurately select varieties for the State Variety Testing (Kovtunenko et al., 2017). The breeding material developed in the department of wheat and triticale breeding and seed production at the NCG named after P. P. Lukiyanenko (Krasnodar) was tested on the experimental plot of the KNIISKh, a branch of the FGBNU “PAFNTs RAS” in the SPOK “Agroniva” of the Tselinny district of the Republic of Kalmykia. The purpose of the current study was to identify the most highly productive breeding lines adaptable to local conditions and, on their basis, to develop new varieties. In the course of joint work begun in 1996, KNIISKh, a branch of the FGBNU “PAFNTs RaS” and the NCG named after P P Lukiyanenko (Krasnodar) developed highly productive joint varieties of winter triticale ‘Khongor', ‘Barun', ‘Bogdo' and ‘Khot'. In 2018 a new variety of winter triticale ‘Uralan', which meets the best world achievements in breeding, has been sent to the State Variety Testing. In 2019 at the Elista GSU, the productivity of the variety ‘Uralan' was 5.37 t/ha, exceeding the standard variety ‘Valentin 90' on 1.4 t/ha. In 2016, the productivity of the new winter triticale variety ‘Uralan' was 6.43 t/ha, which was the absolute maximum identified in the long-term ecological variety trials of this grain crop on the experimental plots of the KNIISKh, a branch of the FGBNU “PAFNTs RAS” in arid conditions of the Republic of Kalmykia. The current paper has presented the productivity data and investigated the feed advantages of the new winter triticale variety ‘Uralan' in 2017-2019.
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Unger, Joseph M., and Mark Fleury. "Nationally representative estimates of the participation of cancer patients in clinical research studies according to the commission on cancer." Journal of Clinical Oncology 39, no. 28_suppl (October 1, 2021): 74. http://dx.doi.org/10.1200/jco.2020.39.28_suppl.74.
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74 Background: The successful conduct of cancer clinical trials hinges on the willingness of patients to participate. The rate of adult clinical trial participation has been regarded as being < 5%. However, national estimates of trial participation are nearly two decades old, and no evidence based on original data sources has been examined for many years. Moreover, studies about trial participation have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other key elements of clinical research, such as quality of life or biorepository studies. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from 1,200 institutions. Methods: The data were from the Commission on Cancer (CoC), a consortium of cancer-related organizations providing accreditation for both academic and community cancer care facilities across the U.S. CoC enrollment data represent 70% of all cases of cancer diagnosed each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality of life, registry, and screening studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (e.g., NCI-designated cancer programs) and pooled. Results: Across the entire U.S. system, the estimated participation rate to cancer treatment trials was 6.3%. Enrollment to treatment trials was highest at NCI-designated comprehensive cancer centers (18.9%), while for community cancer programs (CCPs) and comprehensive CCPs, treatment trial rates were 4.4% and 3.6%, respectively. Nearly 1 in 7 patients participated in biorepository studies (13.4%), including 39.4% at NCI cancer centers. Patients participated in a wide variety of other study types, including registry (8.1%), prevention (6.4%), genetic (3.6%), quality of life (2.9%), economic (2.7%), diagnostic (2.7%), and screening studies (1.8%). At least 25.4% of adult cancer patients were estimated to participate in one or more cancer clinical research studies. Conclusions: In a first-time use of nationally representative enrollment data from the CoC, enrollment to cancer treatment trials was 6.3%, higher than historical estimates of < 5%. Patients participated in a diverse set of other study types, and taken together, at least one quarter of patients participated in a study. Contributions of adult patients with cancer to clinical research is much more comprehensive than previously understood.
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H, Ghanem. "Potential Climate Change Impacts On Imen Barley BYDV Resistant Variety Yields In Tunisia." Agronomy & Agricultural Science 3, no. 2 (November 20, 2020): 1–8. http://dx.doi.org/10.24966/aas-8292/100025.
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Generally, Barley yields vary less under changing weather conditions than those of wheat and most other small grains. A field trials in National Institute of Agricultural Research of Tunisia (INRAT) experimental station in Kef region (Tunisia) during twelve cropping seasons (2008-2019) was conducted to study the relationships between agroclimatic indices and average yields of Imen barley BYDV resistant variety compared to the most important spring barley (Hordeum vulgare L.) varieties (Manel and Rihane). In this paper, results are used as a control to estimate potential impacts of climate change scenarios and pedological conditions on anticipated average yields and total production of these commodities in Kef region by the 2058 period. The agronomic crop model Cropsyst was used to assess the impacts of increased temperature on growth and development varieties shown below in Tunisia, and to examine possible adaptation strategies. The analysis was based on multi-year crop model simulations run with daily weather series 2020-2058 that allowed two average yield levels: grain and biomass. The impacts of 0.2 °C temperature rise obtained by weather generator ClimGen included in Cropsyst on potential yields are positive and induced an increase of 14.4 %/ha for Imen in comparison with Manel 13.7 % and Rihane 10.1 %. Based on a range of available heat units projected by multiple General Circulation Model experiments, a climate change scenario representing +1 °C temperature rise was also applied for the same period and using the same generator. With 1°C temperature rise, average yieldsachievable in field trials could decrease in long term by about 0,16 q/ha (Rihane) and 0.46 t/ha (Manel) (4.7 % and 14 %). Cropsyst yield data, however, indicate an increase of 0.5 % with +1°C temperature rise suggesting the resilience of Imen barley grain production, compared to the two varieties Manel and Rihane.
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Gesell, Sabina B., Jacqueline R. Halladay, Laurie H. Mettam, Mysha E. Sissine, B. Lynette Staplefoote-Boynton, and Pamela W. Duncan. "Using REDCap to track stakeholder engagement: A time-saving tool for PCORI-funded studies." Journal of Clinical and Translational Science 4, no. 2 (February 6, 2020): 108–14. http://dx.doi.org/10.1017/cts.2019.444.
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AbstractBackground:Research Electronic Data Capture (REDCap) is a secure, web-based electronic data capture application for building and managing surveys and databases. It can also be used for study management, data transfer, and data export into a variety of statistical programs. REDcap was developed and supported by the National Center for Advancing Translational Sciences Program and is used in over 3700 institutions worldwide. It can also be used to track and measure stakeholder engagement, an integral element of research funded by the Patient-Centered Outcomes Research Institute (PCORI). Continuously and accurately tracking and reporting on stakeholder engagement activities throughout the life of a PCORI-funded trial can be challenging, particularly in complex trials with multiple types of engagement.Methods:In this paper, we show our approach for collecting and capturing stakeholder engagement activities using a shareable REDCap tool in one of the PCORI’s first large pragmatic clinical trials (the Comprehensive Post-Acute Stroke Services) to inform other investigators planning cluster-randomized pragmatic trials. Benefits and challenges are highlighted for researchers seeking to consistently monitor and measure stakeholder engagement.Conclusions:We describe how REDCap can provide a time-saving approach to capturing how stakeholders engage in a PCORI-funded study and reporting how stakeholders influenced the study in progress reports back to PCORI.
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O'Neil, Bert H., Robert Allen, David R. Spigel, Thomas E. Stinchcombe, Dominic T. Moore, Jordan D. Berlin, and Richard M. Goldberg. "High Incidence of Cetuximab-Related Infusion Reactions in Tennessee and North Carolina and the Association With Atopic History." Journal of Clinical Oncology 25, no. 24 (August 20, 2007): 3644–48. http://dx.doi.org/10.1200/jco.2007.11.7812.
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PurposeTo confirm the anecdotal observation that patients in North Carolina (NC) and Tennessee (TN) treated with cetuximab experience hypersensitivity reactions (HSR) at a much higher rate than are reported nationally and internationally (≤ 3%).Patients and MethodsData from patients treated with cetuximab on clinical trials (n = 88) at three research sites were analyzed for grade 3 or 4 HSR. Additional information was obtained from medical records for patients treated with cetuximab at the University of North Carolina (Chapel Hill, NC) to determine whether history of other significant allergy was a risk factor for HSR to cetuximab.ResultsData for 88 patients on clinical trials and an additional 55 patients treated outside of trials were included in this analysis. Patients had a variety of tumor types. For the clinical trial group (n = 88), the overall rate of grade 3 to 4 HSR was 22%, significantly higher than the rate noted in any large published trial. All HSRs occurred during the first dose. There was a strong relationship between prior allergy history and chance of HSR.ConclusionAt the sites in neighboring NC and TN studied, HSR was far more common than reported in national studies. History of prior allergy is a strong predictor of HSR. Further investigation of more specific predictors of HSR in the US middle south region is warranted, and patients being treated with cetuximab in this area should be observed particularly closely during their first infusion.
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Sobrizal, Sobrizal, Carkum Carkum, Wijaya M. Indriatama, Aryanti Aryanti, and Ita Dwimahyani. "Productivity and Yield Quality of Intersubspecies Crossing of Japonica-Indica." Buletin Plasma Nutfah 24, no. 1 (October 17, 2018): 19. http://dx.doi.org/10.21082/blpn.v24n1.2018.p19-30.
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<p>In the middle of 1980s, rice self-sufficiency in Indonesia has been achieved, but the growth of rice production slowed down since the 1990s. Narrow genetic variability of released rice varieties contributed largely to the occurrence of leveling of potential rice yield over the past decades. To enlarge the genetic variability, an intersubspecies crossing of Koshihikari (japonica) and IR36 (indica) has been performed. Through this crossing, three high yielding and high yield quality promising lines of KI 37, KI 238, and KI 730 have been obtained. The objective of this study was to evaluate the superiorities of these lines through multi-location yield trials, pests, diseases, and grain qualities examinations. Examination methods used followed the release food crops variety procedure issued by the Indonesian Ministry of Agriculture. The result of examinations showed that the average yield of KI 730 was 7.47 t/ha, it was significantly higher than that of Ciherang (6,73 t/ha). KI 730 has a good grain quality, with translucent milled rice, a high percentage of milled rice (78.0%) and head rice (91.01%). The texture of its cooking rice was soft, sticky, with the amylose content of 20.41%. In addition, pests and diseases resistances of KI 730 were better than those of other lines tested. After evaluation by National Food Crops Release Variety Team, the KI 730 line was released as a national superior variety with the name of Tropiko. Tropiko should become an alternative variety to grow widely in order to increase national rice production and farmers income.</p>
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Niebergall-Roth, Elke, Natasha Y. Frank, Christoph Ganss, Markus H. Frank, and Mark A. Kluth. "Skin-Derived ABCB5+ Mesenchymal Stem Cells for High-Medical-Need Inflammatory Diseases: From Discovery to Entering Clinical Routine." International Journal of Molecular Sciences 24, no. 1 (December 21, 2022): 66. http://dx.doi.org/10.3390/ijms24010066.
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The ATP-binding cassette superfamily member ABCB5 identifies a subset of skin-resident mesenchymal stem cells (MSCs) that exhibit potent immunomodulatory and wound healing-promoting capacities along with superior homing ability. The ABCB5+ MSCs can be easily accessed from discarded skin samples, expanded, and delivered as a highly homogenous medicinal product with standardized potency. A range of preclinical studies has suggested therapeutic efficacy of ABCB5+ MSCs in a variety of currently uncurable skin and non-skin inflammatory diseases, which has been substantiated thus far by distinct clinical trials in chronic skin wounds or recessive dystrophic epidermolysis bullosa. Therefore, skin-derived ABCB5+ MSCs have the potential to provide a breakthrough at the forefront of MSC-based therapies striving to fulfill current unmet medical needs. The most recent milestones in this regard are the approval of a phase III pivotal trial of ABCB5+ MSCs for treatment of recessive dystrophic and junctional epidermolysis bullosa by the US Food and Drug Administration, and national market access of ABCB5+ MSCs (AMESANAR®) for therapy-refractory chronic venous ulcers under the national hospital exemption pathway in Germany.
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Sheehan, Jason P., Brian D. Kavanagh, Anthony Asher, and Robert E. Harbaugh. "Inception of a national multidisciplinary registry for stereotactic radiosurgery." Journal of Neurosurgery 124, no. 1 (January 2016): 155–62. http://dx.doi.org/10.3171/2015.1.jns142466.
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Stereotactic radiosurgery (SRS) represents a multidisciplinary approach to the delivery of ionizing high-dose radiation to treat a wide variety of disorders. Much of the radiosurgical literature is based upon retrospective single-center studies along with a few randomized controlled clinical trials. More timely and effective evidence is needed to enhance the consistency and quality of and clinical outcomes achieved with SRS. The authors summarize the creation and implementation of a national SRS registry. The American Association of Neurological Surgeons (AANS) through NeuroPoint Alliance, Inc., started a successful registry effort with its lumbar spine initiative. Following a similar approach, the AANS and NeuroPoint Alliance collaborated with corporate partners and the American Society for Radiation Oncology to devise a data dictionary for an SRS registry. Through administrative and financial support from professional societies and corporate partners, a framework for implementation of the registry was created. Initial plans were devised for a 3-year effort encompassing 30 high-volume SRS centers across the country. Device-specific web-based data-extraction platforms were built by the corporate partners. Data uploaders were then used to port the data to a common repository managed by Quintiles, a national and international health care trials company. Audits of the data for completeness and veracity will be undertaken by Quintiles to ensure data fidelity. Data governance and analysis are overseen by an SRS board comprising equal numbers of representatives from the AANS and NeuroPoint Alliance. Over time, quality outcome assessments and post hoc research can be performed to advance the field of SRS. Stereotactic radiosurgery offers a high-technology approach to treating complex intracranial disorders. Improvements in the consistency and quality of care delivered to patients who undergo SRS should be afforded by the national registry effort that is underway.
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Chamberlain, Marc C. "Treatment options for glioblastoma." Neurosurgical Focus 20, no. 4 (April 2006): E19. http://dx.doi.org/10.3171/foc.2006.20.4.12.
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✓ Following the seminal trial conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC), concurrent temozolomide and radiotherapy has become the new standard of care for patients with newly diagnosed glioblastoma multiforme (GBM). Investigation of emerging therapies (which are now used as salvage therapy) such as small-molecule inhibitors (for example, epidermal growth factor receptor inhibitors) and convection-enhanced delivery (CED) of targeted toxins (for example, interleukin-13/pseudo-monas exotoxin) is likely to build on the EORTC/NCIC treatment platform and will, it is hoped, improve survival rates in patients with GBM. The majority of adjuvant Phase I and II trials being conducted by the brain tumor consortia are based on the EORTC/NCIC treatment platform and have added a targeted therapy in an effort to find a promising synergistic treatment. Furthermore, researchers in the consortia are continuing to explore treatments for recurrent GBM, not otherwise eligible for local therapies, such as CED. The treatments under study include novel cytotoxic chemotherapy as well as small-molecule inhibitors; these are being assessed in a variety of Phase I or II trials.
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Burnham, Tyson S., Monte L. Scott, Benjamin A. Steinberg, Daniel L. Varela, Brian Zenger, and T. Jared Bunch. "Impact of Catheter Ablation on Stroke, Cognitive Decline and Dementia." Arrhythmia & Electrophysiology Review 10, no. 3 (October 27, 2021): 205–10. http://dx.doi.org/10.15420/aer.2021.42.
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AF has been consistently associated with multiple forms of dementia, including idiopathic dementia. Outcomes after catheter ablation for AF are favourable and patients experience a better quality of life, arrhythmia-free survival, and lower rates of hospitalisation compared to patients treated with antiarrhythmic drugs. Catheter ablation is consistently associated with lower rates of stroke compared to AF management without ablation in large national and healthcare system databases. Multiple observational trials have shown that catheter ablation is also associated with a lower risk of cognitive decline, dementia and improved cognitive testing that can be explained through a variety of pathways. Long-term, adequately powered, randomised trials are required to define the role of catheter ablation in the management of AF as a means to lower the risk of cognitive decline, stroke and dementia.
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Ferreira, José Pedro L., Nikos Chatzisarantis, Pedro Miguel Caspar, and Maria João Campos. "Precompetitive Anxiety and Self-Confidence in Athletes with Disability." Perceptual and Motor Skills 105, no. 1 (August 2007): 339–46. http://dx.doi.org/10.2466/pms.105.1.339-346.
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This study examined the precompetition temporal patterning of competitive anxiety components in 42 athletes with disability who participated at the national level and at the national trials for the Paralympic Games in a variety of sports. All subjects completed a modified version of the Competitive State Anxiety Inventory-2 which measures intensity and direction of the competitive anxiety response on three occasions before competition (1 wk., 2 hr., and 20 min.). Analysis suggested that for cognitive and somatic dimensions athletes with disabilities show a similar precompetition anxiety response to athletes without disability. However, there appear to be some differences, particularly in the intensity of self-confidence, as athletes with disability reported a reduction of self-confidence just prior to competition.
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Matthewson, Ainsley, Olena Bereznyakova, Brian Dewar, Alexandra Davis, Mark Fedyk, Vignan Yogendrakumar, Dean A. Fergusson, et al. "Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol." BMJ Open 11, no. 2 (February 2021): e043370. http://dx.doi.org/10.1136/bmjopen-2020-043370.
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IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.
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Ronquillo, Jay G., and William T. Lester. "Practical Aspects of Implementing and Applying Health Care Cloud Computing Services and Informatics to Cancer Clinical Trial Data." JCO Clinical Cancer Informatics, no. 5 (August 2021): 826–32. http://dx.doi.org/10.1200/cci.21.00018.
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PURPOSE Cloud computing has led to dramatic growth in the volume, variety, and velocity of cancer data. However, cloud platforms and services present new challenges for cancer research, particularly in understanding the practical tradeoffs between cloud performance, cost, and complexity. The goal of this study was to describe the practical challenges when using a cloud-based service to improve the cancer clinical trial matching process. METHODS We collected information for all interventional cancer clinical trials from ClinicalTrials.gov and used the Google Cloud Healthcare Natural Language Application Programming Interface (API) to analyze clinical trial Title and Eligibility Criteria text. An informatics pipeline leveraging interoperability standards summarized the distribution of cancer clinical trials, genes, laboratory tests, and medications extracted from cloud-based entity analysis. RESULTS There were a total of 38,851 cancer-related clinical trials found in this study, with the distribution of cancer categories extracted from Title text significantly different than in ClinicalTrials.gov ( P < .001). Cloud-based entity analysis of clinical trial criteria identified a total of 949 genes, 1,782 laboratory tests, 2,086 medications, and 4,902 National Cancer Institute Thesaurus terms, with estimated detection accuracies ranging from 12.8% to 89.9%. A total of 77,702 API calls processed an estimated 167,179 text records, which took a total of 1,979 processing-minutes (33.0 processing-hours), or approximately 1.5 seconds per API call. CONCLUSION Current general-purpose cloud health care tools—like the Google service in this study—should not be used for automated clinical trial matching unless they can perform effective extraction and classification of the clinical, genetic, and medication concepts central to precision oncology research. A strong understanding of the practical aspects of cloud computing will help researchers effectively navigate the vast data ecosystems in cancer research.
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Biosse-Duplan, Garance, Suzanne Murphy, Amer Durrani, and Pippa Corrie. "Evolving treatment landscape: 18 years of managing melanoma in a single patient." BMJ Case Reports 14, no. 11 (November 2021): e246070. http://dx.doi.org/10.1136/bcr-2021-246070.
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A 57-year-old woman diagnosed with primary melanoma was managed with a wide variety of treatments over 18 years. Given her long history of disease, the array of therapies she has received range from those no longer recommended to those recently approved. This case highlights the extraordinary rate at which both the medical and surgical melanoma treatment landscape has evolved, alongside how professional consensus has changed over the past two decades. It also demonstrates the innovation and collaboration required between the patient and the multidisciplinary team, as well as how external factors such as national guidelines, eligibility for clinical trials and drug funding in the National Health Service (NHS) alter a management plan, presenting yet another set of challenges when managing cancer patients in the modern era.
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Romashkan, Sergei, Henry Chang, and Evan C. Hadley. "National Institute on Aging Workshop: Repurposing Drugs or Dietary Supplements for Their Senolytic or Senomorphic Effects: Considerations for Clinical Trials." Journals of Gerontology: Series A 76, no. 6 (February 2, 2021): 1144–52. http://dx.doi.org/10.1093/gerona/glab028.
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Abstract Background Cell senescence is implicated in numerous age-related conditions. Drugs and nutritional supplements developed for a variety of purposes kill senescent cells (senolytics) or suppress their secretions (senomorphics). There is interest in repurposing such drugs to treat or prevent age-related diseases. To date, only small-scale preliminary trials have been conducted. Method At a workshop convened by the National Institute on Aging in August 2019, academic, industry, and government scientists reviewed issues for phase II trials of potentially repurposable drugs, or dietary supplements, to assess benefits and risks of their senolytic (killing senescent cells) or senomorphic (altering senescent cells’ phenotypes) effects in treating or preventing age-related conditions. Results Participants reviewed mechanisms and effects of cellular senescence, senolytics, and senomorphics of several classes and their potential role in treating or preventing disease, modulators of the senescence-associated secretory phenotype, needs for senescence markers, data and specimen resources, infrastructure for planning trials, and potential effects on outcomes in older patients with multimorbidity and polypharmacy. Conclusions Participants noted the importance of considering potential effects of candidate drugs on multiple aging outcomes. It is important to assess drugs’ specificity for killing senescent cells and the balance between senolytic and cytotoxic effects. Markers of specific senescent cell types are needed to assess intervention responses. There are potential interactions with coexisting diseases and their treatments in older persons. Standardized measures could enhance comparisons and pooling of data. Additional characterization of human cell senescent phenotypes is needed for developing better and more specific senolytics and senomorphics.
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Schoonmaker, Michele M., Barbara A. Bernhardt, and Neil A. Holtzman. "FACTORS INFLUENCING HEALTH INSURERS' DECISIONS TO COVER NEW GENETIC TECHNOLOGIES." International Journal of Technology Assessment in Health Care 16, no. 1 (January 2000): 178–89. http://dx.doi.org/10.1017/s026646230016115x.
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Objective: To examine the relative importance of factors influencing health insurers' coverage of new genetic technologies.Methods: A national survey in which the decision makers for private health insurers were asked whether they would cover cystic fibrosis (CF) carrier screening, testing for genetic susceptibility to breast cancer (BRCA test), and medical costs of a clinical trial of gene therapy for CF under a variety of conditions.Results: Respondents' coverage of the two tests and of medical costs of clinical trials was low at the time of the study (4%–15.5% of insurers.) Their coverage of CF carrier screening and BRCA testing would be increased significantly if the group tested was restricted to those at high risk, if detection rates were higher and costs lower, and if testing was endorsed by a national professional group or consensus conference. Coverage of the medical costs of a trial of CF gene therapy would be significantly more likely if the trial was restricted to children or adults with severe CF, safety and effectiveness was proven, and therapy could be administered in a regional hospital or an outpatient setting rather than in a research hospital.Conclusions: Health insurers play a critical role in the diffusion of new genetic technologies. The validity of genetic tests and the safety and effectiveness of new therapies are primary factors influencing health insurers' coverage. Lower costs and approval of professional groups are other factors associated with increased coverage.
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Ahmed, Sultan. "Evaluation of high yielding candidate cotton genotypes tested in National Coordinated Varietal Trial at different locations of Sindh and Balochistan." International Journal of Cotton Research and Technology 2, no. 1 (October 10, 2020): 31. http://dx.doi.org/10.33865/ijcrt.002.01.0355.
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The research was conducted during the two consecutive years 2018 and 2019; twenty eight (28) advance cotton strains were tested in national coordinated varietal trials (NCVT) at seven locations of Sindh and Balochistan. The results revealed highly significant difference among the varieties during both the years. On the basis of two years average performance only two candidate strains GH-Uhad and NIAB-135 showed their stability in yield performance during both the years. Therefore, it is recommended that top two high yielding varieties (GH-Uhad and NIAB-135) with stability in performance must be approved by the provincial seed council of Sindh and Balochistan to revive the cotton production of the provinces as well as national economy and not to waste/garbage this high yielding stuff and also suggested to cotton breeders utilization in hybridization/breeding program to evolve high yield variety.
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Blatch-Jones, Amanda Jane, Wei Pek, Emma Kirkpatrick, and Martin Ashton-Key. "Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study." BMJ Open 8, no. 9 (September 2018): e022233. http://dx.doi.org/10.1136/bmjopen-2018-022233.
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ObjectivesTo assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.Study designCross-sectional study.SettingBoth groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.Main outcome measuresThe proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.ResultsGroup 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed weretesting recruitment(100% in both groups),feasibility(83%, 100%) andsuggestions for further study/investigation(83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study wheretesting recruitment(50%, 73%) andfeasibility(42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study wheretesting recruitment(93%, 100%) andfeasibility(44%, 92%) were the most common study elements reported.Conclusions‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.
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Radchenko, L. A., A. F. Radchenko, Т. L. Ganotskaya, E. G. Filippov, and A. A. Dontsova. "The productivity and resistance to unfavorable environmental factors of the facultative barley varieties sown in the autumn and spring." Grain Economy of Russia, no. 5 (October 30, 2020): 15–20. http://dx.doi.org/10.31367/2079-8725-2020-71-5-15-20.
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The current paper has presented the study results of the facultative barley varieties of the FSBSI “Agricultural Research Center “Donskoy” in the conditions of the Republic of Crimea. The study was carried out in 2017-2019 on the experimental plots of the department of introduction and technologies in field cultivation and animal husbandryof the FSBSI Research Institute of Agriculture of the Crimea, located in the village of Klepinino of Krasnogvardeisky district, in the central steppe zone of the peninsula. There has been studied the productivity of six facultative varieties (developed in the FSBSI “Agricultural Research Center “Donskoy”) in comparison with the variety ‘Dostoyny' (developed in the Breeding and Genetic Institute of the National Center for Seed and Variety Study of the National Academy of Agricultural Sciences of Ukraine). The varieties were sown in the autumn and spring, at the optimum sowing time for winter grain crops. The trials were conducted with the grain crops sown in weedfree fallow and after sunflower. The spring barley variety ‘Strannik' (the Prikumskaya Experimental Breeding Station) was used as a control variety for spring sowing. When sowing in the autumn in weedfree fallow, the varieties ‘Foks 1' and ‘Master' were at the level of the standard variety with the productivity of 6.37 and 6.32 t/ha, respectively. When sowing in the spring, the early ripening varieties ‘Master' (2.92 t/ha), ‘Tigr' (2.88 t/ha) and ‘Foks 1' (2.70 t/ha) were the best ones, which in 2018 and 2019 significantly exceeded the standard variety ‘Dostoyny'. In 2018 the varieties ‘Vivat' and ‘Tigr' formed the productivity at the level of the standard variety when sown after sunflower in the autumn. In 2019 the best yields were produced by the variety ‘Timofey' with 3.62 t/ha (+0.17 t/ha to the standard value) and ‘Master' (+0.10 t/ha). Under more favorable conditions of 2019, when sowing in the spring the facultative varieties ‘Foks 1' and ‘Master' produced 1.89 t/ha, significantly exceeding the standard variety ‘Dostoyny' on 0.64 t/ha each. When sown after sunflower the varieties ‘Master' produced on average 1.2 t/ha (+0.32 t / ha to the standard value) and ‘Foks 1' (+0.15 t/ha).
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Nachilima, Christabell, Godfree Chigeza, Mwila Chibanda, Hapson Mushoriwa, Brian D. Diers, Harun M. Murithi, and Glen L. Hartman. "Evaluation of Foliar Diseases for Soybean Entries in the Pan-African Trials in Malawi and Zambia." Plant Disease 104, no. 8 (August 2020): 2068–73. http://dx.doi.org/10.1094/pdis-12-19-2617-sr.
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Soybean production has expanded worldwide including countries in sub-Saharan Africa. Several national and international agencies and research groups have partnered to improve overall performance of soybean breeding stocks and have introduced new germplasm from Brazil and the United States with the goal of developing new high-yielding cultivars. Part of this effort has been to test improved soybean lines/cultivars accumulated from private and public sources in multilocational trials in sub-Saharan Africa. These trials are known as the Pan-African Soybean Variety Trials, and the entries come from both private and public breeding programs. The objective of this research was to evaluate entries in the trials that include commercial cultivars or advanced experimental lines for the incidence and severity of foliar diseases. All trials were planted in December 2018 with six located in Zambia and one in Malawi. Plants were evaluated during the reproductive growth stages using a visual pretransformed severity rating scale. Foliar disease ratings were recorded for three bacterial diseases, six fungal diseases, one oomycete, and viruses. The overall occurrence of most of the diseases was high except for soybean rust and target spot, which were only found at two and one location, respectively. However, disease severity was generally low, although there were differences in disease severity ratings among the entries at some of the locations for brown spot, downy mildew, frogeye leaf spot, red leaf blotch, and soybean rust.
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Ross, Alyson, Katharine Touchton-Leonard, Li Yang, and Gwenyth Wallen. "A National Survey of Yoga Instructors and their Delivery of Yoga Therapy." International Journal of Yoga Therapy 26, no. 1 (January 1, 2016): 83–91. http://dx.doi.org/10.17761/1531-2054-26.1.83.
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Yoga therapy may improve a variety of symptoms and health conditions, but little is known about how yoga therapy is being delivered in the real world. The purpose of this study was to describe the delivery of yoga therapy by yoga instructors across the U.S. In this cross-sectional survey, certified instructors were recruited from the Iyengar Yoga National Association, United States (IYNAUS) (n = 966) via an email that contained a link to an anonymous online survey that collected information on demographics, their delivery of yoga therapy, and the health conditions and symptoms seen and records kept by the instructors. A total of 487 instructors (50.4%) completed the surve y. Instructors ranged from 28 to 82 years in age (m = 56.4 ± 10.1 years) and had been teaching for 17.0 ± 10.0 years. The majority (n = 384, 81.4%) reported teaching some form of therapeutic yoga either in groups (n = 261, 55%) and/or privately (n = 340, 73.4%). All instructors (100%) reported modifying poses in their regular yoga classes for students because of health conditions or symptoms. Other than attendance, the majority (n = 255, 57.3%) reported keeping no records on their sessions. Students came to instructors for help with over 54 health conditions, most commonly musculoskeletal conditions and injuries (n = 267, 62.8%), followed by pregnancy (n = 56, 13.2%) and hypertension (n = 22, 5.2%). Nearly all (n = 373, 85.6%) reported pain to be the symptom that brought students to yoga therapy most frequently. Whereas yoga in randomized controlled trials typically is delivered to individuals in large, homogenous groups, the instructors reported that most yoga therapy is being provided individually or in small, general therapeutic classes that include a variety of health conditions. Research is needed to examine the effectiveness of yoga therapy under such conditions. A clear set of guidelines for assessing and documenting the effectiveness of yoga therapy using standardized, valid, and reliable methods is needed, particularly for pain-related conditions.
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Fordham, Beth, Thavapriya Sugavanam, Katherine Edwards, Karla Hemming, Jeremy Howick, Bethan Copsey, Hopin Lee, et al. "Cognitive–behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis." Health Technology Assessment 25, no. 9 (February 2021): 1–378. http://dx.doi.org/10.3310/hta25090.
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Background Cognitive–behavioural therapy aims to increase quality of life by changing cognitive and behavioural factors that maintain problematic symptoms. A previous overview of cognitive–behavioural therapy systematic reviews suggested that cognitive–behavioural therapy was effective for many conditions. However, few of the included reviews synthesised randomised controlled trials. Objectives This project was undertaken to map the quality and gaps in the cognitive–behavioural therapy systematic review of randomised controlled trial evidence base. Panoramic meta-analyses were also conducted to identify any across-condition general effects of cognitive–behavioural therapy. Data sources The overview was designed with cognitive–behavioural therapy patients, clinicians and researchers. The Cochrane Library, MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Child Development & Adolescent Studies, Database of Abstracts of Reviews of Effects and OpenGrey databases were searched from 1992 to January 2019. Review methods Study inclusion criteria were as follows: (1) fulfil the Centre for Reviews and Dissemination criteria; (2) intervention reported as cognitive–behavioural therapy or including one cognitive and one behavioural element; (3) include a synthesis of cognitive–behavioural therapy trials; (4) include either health-related quality of life, depression, anxiety or pain outcome; and (5) available in English. Review quality was assessed with A MeaSurement Tool to Assess systematic Reviews (AMSTAR)-2. Reviews were quality assessed and data were extracted in duplicate by two independent researchers, and then mapped according to condition, population, context and quality. The effects from high-quality reviews were pooled within condition groups, using a random-effect panoramic meta-analysis. If the across-condition heterogeneity was I 2 < 75%, we pooled across conditions. Subgroup analyses were conducted for age, delivery format, comparator type and length of follow-up, and a sensitivity analysis was performed for quality. Results A total of 494 reviews were mapped, representing 68% (27/40) of the categories of the International Classification of Diseases, Eleventh Revision, Mortality and Morbidity Statistics. Most reviews (71%, 351/494) were of lower quality. Research on older adults, using cognitive–behavioural therapy preventatively, ethnic minorities and people living outside Europe, North America or Australasia was limited. Out of 494 reviews, 71 were included in the primary panoramic meta-analyses. A modest effect was found in favour of cognitive–behavioural therapy for health-related quality of life (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval –0.05 to 0.50, I 2 = 32%), anxiety (standardised mean difference 0.30, 95% confidence interval 0.18 to 0.43, prediction interval –0.28 to 0.88, I 2 = 62%) and pain (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval –0.28 to 0.74, I 2 = 64%) outcomes. All condition, subgroup and sensitivity effect estimates remained consistent with the general effect. A statistically significant interaction effect was evident between the active and non-active comparator groups for the health-related quality-of-life outcome. A general effect for depression outcomes was not produced as a result of considerable heterogeneity across reviews and conditions. Limitations Data extraction and analysis were conducted at the review level, rather than returning to the individual trial data. This meant that the risk of bias of the individual trials could not be accounted for, but only the quality of the systematic reviews that synthesised them. Conclusion Owing to the consistency and homogeneity of the highest-quality evidence, it is proposed that cognitive–behavioural therapy can produce a modest general, across-condition benefit in health-related quality-of-life, anxiety and pain outcomes. Future work Future research should focus on how the modest effect sizes seen with cognitive–behavioural therapy can be increased, for example identifying alternative delivery formats to increase adherence and reduce dropout, and pursuing novel methods to assess intervention fidelity and quality. Study registration This study is registered as PROSPERO CRD42017078690. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 9. See the NIHR Journals Library website for further project information.
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Macklin, Philip S., Andrew Hall, Jessica Lee, Jane Hair, Valerie Speirs, Gareth J. Thomas, Karin A. Oien, and Clare Verrill. "Barriers to the release of human tissue for clinical trials research in the UK: a national survey of cellular pathology laboratories on behalf of the National Cancer Research Institute’s Cellular Molecular Pathology (CM-Path) initiative." Journal of Clinical Pathology 72, no. 1 (October 1, 2018): 52–57. http://dx.doi.org/10.1136/jclinpath-2018-205476.
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AimTo survey UK cellular pathology departments regarding their attitudes and practices relating to release of human tissue from their diagnostic archives for use in clinical trial research.MethodsA 30-item questionnaire was circulated to the National Cancer Research Institute’s Cellular Molecular Pathology initiative and Confederation of Cancer Biobanks mailing lists. Responses were collected over a 10-month period from November 2016 to August 2017.Results38 departments responded to the survey, the majority of which regularly receive requests for tissue for research purposes. Most requests come from academia and financial support to facilitate tissue release comes from a variety of sources. A range of practices were reported in relation to selection of the most appropriate sample to release, consent checking, costing and governance frameworks.ConclusionsThis survey demonstrates wide variation in practice across the UK and identifies barriers to release of human tissue for clinical trial research. Until we can overcome these obstacles, patient samples will remain inaccessible to research. Therefore, this study highlights the urgent need for clear and coordinated national guidance on this issue.
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HOLLINS, P. D., P. S. KETTLEWELL, and P. PELTONEN-SAINIO. "Relationships between climate and winter cereal grain quality in Finland and their potential for forecasting." Agricultural and Food Science 13, no. 3 (December 4, 2008): 295. http://dx.doi.org/10.2137/1239099042643107.
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Many studies have demonstrated the effects of climate on cereal yield, but there has been little work carried out examining the relationships between climate and cereal grain quality on a national scale. In this study national mean hectolitre weight for both rye and winter wheat in Finland was modelled using monthly gridded accumulated snow depth, precipitation rate, solar radiation and temperature over the period 1971 to 2001. Variables with significant relationships in correlation analysis both before and after difference detrending were further investigated using forward stepwise regression. For rye, March snow depth, and June and July solar radiation accounted for 66% of the year-to-year variance in hectolitre weight, and for winter wheat January snow depth, June solar radiation and August temperature accounted for 62% of the interannual variance in hectolitre weight. Further analysis of national variety trials and weather station data was used to support proposed biological mechanisms. Finally a cross validation technique was used to test forecast models with those variables available by early July by making predictions of above or below the mean hectolitre weight. Analysis of the contingency tables for these predictions indicated that national hectolitre weight forecasts are feasible for both cereals in advance of harvest.;