4 results
Assessing climate adaptation options for cereal-based systems in the eastern Indo-Gangetic Plains, South Asia
- K. Tesfaye, A. Khatri-Chhetri, P. K. Aggarwal, F. Mequanint, P. B. Shirsath, C. M. Stirling, M. L. Jat, D. B. Rahut, O. Erenstein
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- Journal:
- The Journal of Agricultural Science / Volume 157 / Issue 3 / April 2019
- Published online by Cambridge University Press:
- 28 August 2019, pp. 189-210
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New farming systems and management options are needed in South Asia as the intensive rice–wheat production system is set to become increasingly unsustainable under climate change. In the current study, six cropping systems options/treatments varying in tillage, crop establishment method, residue management, crop sequence and fertilizer and water management were evaluated using a cropping systems model under current (1980–2009) and future (2030 and 2050) climate scenarios in the state of Bihar, India. The treatments were current farmers' practice (CP), best fertilizer and water management practices, zero tillage (ZT) with no crop residue retention, ZT with partial crop residue retention (ZTPR), future conservation agriculture-based rice–wheat intensive cropping system (FCS-1) and future conservation agriculture-based maize–wheat intensive cropping system (FCS-2). The results indicate that climate change is likely to reduce rice–wheat system productivity under CP by 4% across Bihar. All the crop management options studied increased yield, water productivity and net returns over that of the CP under the current and future climate scenarios. However, the ZTPR treatment gave significantly higher relative yield, lower annual yield variability and a higher benefit-cost-ratio than the other treatments across cropping system components and climate periods. Although all the new cropping system treatments had a positive yield implication under the current climate (compared to CP), they did not contribute to adaptation under the future climate except FCS-2 in wheat. It is concluded that adaptation to future climate must integrate both cropping system innovations, and genetic improvements in stress tolerance.
9 Phase 3 Randomized, Double-blind, Placebo-Controlled Studies Evaluating Efficacy and Safety of Extended-Release Viloxazine for Pediatric ADHD
- Azmi Nasser, Janet K. Johnson, Toyin Adewole, Tesfaye Liranso, Ronald Marcus
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- Journal:
- CNS Spectrums / Volume 24 / Issue 1 / February 2019
- Published online by Cambridge University Press:
- 12 March 2019, pp. 177-178
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Study Objectives
Although stimulants are commonly used for attention-deficit/hyperactivity disorder (ADHD), 10–30% of patients have an inadequate response, adverse events, or comorbidities preventing use. Thus, there is a need for safe, effective nonstimulant options. Extended-release viloxazine (SPN-812), a nonstimulant, is currently in development for the treatment of ADHD in children and adolescents. SPN-812 is a structurally distinct, bicyclic norepinephrine reuptake inhibitor with selective serotonergic activity. Results of the Phase 2 program demonstrated efficacy (improved mean ADHD Rating Scale-IV total score) and safety of SPN-812 in children (6–12 years), as well as an onset of action within 1–2 weeks.
MethodFour ongoing Phase 3 randomized, double-blind, placebo-controlled, outpatient, US studies are investigating the efficacy and safety of once-daily SPN-812 for ADHD in children (ages 6–11; 100–400mg) and adolescents (ages 12–17; 200–600mg). Two studies are enrolling children and two are enrolling adolescents. Eligible subjects are required to have minimum baseline scores of ≥28 for ADHD-RS-5 and ≥4 for Clinical Global Impression-Severity scale (CGI-S). These studies will randomize ∼1200 subjects, with ∼800 subjects receiving SPN-812 over a 1–3-week titration and 5-week maintenance period. The primary endpoint in all studies is mean change from baseline to end of study (EOS) in ADHD-RS-5 total score for SPN-812 vs. placebo. Secondary endpoints include change from baseline to EOS in 30% responder rate (% change: ADHD RS 5); Hyperactivity/Impulsivity and Inattention ADHD-RS-5 subscale scores; Conners 3 Rating Scale (parent and self-report); CGI-S/CGI-I (Improvement); Weiss Functional Impairment Rating Scale (parent report); Parenting Stress Index (children); and Stress Index for Parents of Adolescents (adolescents) after 6–8 weeks of treatment. Safety is assessed via adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and the Columbia-Suicide Severity Rating Scale. Phase 3 completers are offered the option of enrolling in an open-label extension study (OLE; up to 3 years) with a starting dose of 100/200mg (children/adolescents). Data will be summarized with descriptive statistics and analyzed using appropriate statistical methods.
ResultsAs of August 2018, enrollment in 1 child study is complete, and the other 3 trials are at ∼89%; rollover into the OLE is ∼90%.
ConclusionsThere is an unmet need for nonstimulant ADHD treatment for children and adolescents that is effective, long-acting, and well tolerated. SPN-812 is being investigated in four Phase 3 randomized, placebo-controlled studies for the treatment of children and adolescents with ADHD, based on demonstrated efficacy and safety in the Phase 2 program.
This study is an encore of a poster presentation at the 2018 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP).
Funding Acknowledgements: Supernus Pharmaceuticals, Inc.
Assessing Radiation Emergency Preparedness Planning by Using Community Assessment for Public Health Emergency Response (CASPER) Methodology
- Mawuli K. Nyaku, Amy F. Wolkin, Jevon McFadden, Jim Collins, Michelle Murti, Amy Schnall, Shane Bies, Martha Stanbury, Jennifer Beggs, Tesfaye M. Bayleyegn
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- Journal:
- Prehospital and Disaster Medicine / Volume 29 / Issue 3 / June 2014
- Published online by Cambridge University Press:
- 06 June 2014, pp. 262-269
- Print publication:
- June 2014
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Introduction
Approximately 1.2 million persons in Oakland County, Michigan (USA) reside less than 50 miles from the Fermi Nuclear Power Plant, Unit 2, but information is limited regarding how residents might react during a radiation emergency. Community Assessment for Public Health Emergency Response (CASPER) survey methodology has been used in disaster and nondisaster settings to collect reliable and accurate population-based public health information, but it has not been used to assess household-level emergency preparedness for a radiation emergency. To improve emergency preparedness plans in Oakland County, including how residents might respond during a radiation emergency, Oakland County Health Division (OCHD), with assistance from the Centers for Disease Control and Prevention (CDC) and the Michigan Department of Community Health (MDCH), conducted a CASPER survey.
MethodsDuring September 2012, a 2-stage cluster sampling design was used to select 210 representative households in Oakland County. By using in-person surveys, the proportion of households with essential needs and supplies, how residents might respond to public health authorities’ instructions, and their main source for obtaining information during a radiation emergency were assessed. Data were weighted to account for the complex sampling design.
ResultsOf the goal of 210 households, 192 (91.4%) surveys were completed: 64.7% and 85.4% of respondents indicated having 3-day supplies of water and of nonperishable food, respectively; 62.8% had a 7-day supply of prescription medication for each person who needed it. Additionally, 64.2% had a working carbon monoxide detector; 67.1% had a first-aid kit; and 52% had an alternative heat source. In response to instructions from public health officials during a radiation emergency, 93.3% of all respondents would report to a radiation screening center; 96% would evacuate; and 91.8% would shelter-in-place. During a radiation emergency, 55.8% of respondents indicated their main information source would be television, 18.4% radio, and 13.6% the Internet. The most trusted source for information would be the local public health department (36.5%), local news (23%), a physician (11.2%), and family members (11.1%). Including completed and incomplete interviews, refusals, and nonrespondents, 517 total households were contacted.
ConclusionsCASPER data regarding how residents might react during a radiation emergency provided objective and quantifiable information that will be used to develop Oakland County's radiation emergency preparedness plans. Survey information demonstrates the feasibility and usefulness of CASPER methodology for radiation emergency preparedness planning.
,Nyaku MK ,Wolkin AF ,McFadden J ,Collins J ,Murti M ,Schnall A ,Bies S ,Stanbury M ,Beggs J .Bayleyegn TM Assessing Radiation Emergency Preparedness Planning by Using Community Assessment for Public Health Emergency Response (CASPER) Methodology . Prehosp Disaster Med.2014 ;29 (3 ):1 -9 .
Expression analysis of regulatory microRNAs in bovine cumulus oocyte complex and preimplantation embryos
- W.S. Abd El Naby, T.H. Hagos, M.M. Hossain, D. Salilew-Wondim, A.Y. Gad, F. Rings, M.U. Cinar, E. Tholen, C. Looft, K. Schellander, M. Hoelker, D. Tesfaye
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MicroRNAs (miRNAs) are small endogenous molecules that are involved in a diverse of cellular process. However, little is known about their abundance in bovine oocytes and their surrounding cumulus cells during oocyte development. To elucidate this situation, we investigated the relative expression pattern of sets of miRNAs between bovine oocyte and the surrounding cumulus cells during in vitro maturation using miRNA polymerase chain reaction (PCR) array. Results revealed that a total of 47 and 51 miRNAs were highly abundant in immature and matured oocytes, respectively, compared with their surrounding cumulus cells. Furthermore, expression analysis of six miRNAs enriched in oocyte miR-205, miR-150, miR-122, miR-96, miR-146a and miR-146b-5p at different maturation times showed a dramatic decrease in abundance from 0 h to 22 h of maturation. The expression of the same miRNAs in preimplantation stage embryos was found to be highly abundant in early stages of embryo development and decreased after the 8-cell stage to the blastocyst stage following a typical maternal transcript profile. Similar results were obtained by localization of miR-205 in preimplantation stage embryos, in which signals were higher up to the 4-cell stage and reduced thereafter. miR-205 and miR-210 were localized in situ in ovarian follicles and revealed a spatio-temporal expression during follicular development. Interestingly, the presence or absence of oocytes or cumulus cells during maturation was found to affect the expression of miRNAs in each of the two cell types. Hence, our results showed the presence of distinct sets of miRNAs in oocytes or cumulus cells and the presence of their dynamic degradation during bovine oocyte maturation.
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