On a family of integrable systems on S2S^2 with a cubic integral of motion

We discuss a family of integrable systems on the sphere $S^2$ with an additional integral of third order in momenta. This family contains the Coryachev-Chaplygin top, the Goryachev system, the system recently discovered by Dullin and Matveev and two new integrable systems. On the non-physical sphere with zero radius all these systems are isomorphic to each other.Comment: LaTeX, 8 page

Planning a Clinical Trial Programme for Medicinal Products for the Treatment of Axial Spondyloarthritis

The criteria for diagnosis and classification of spondyloarthritides (SpAs) have undergone significant changes over the past 10 years. The emergence of new diagnostic methods and availability of new information on the prognosis of the disease outcome made it possible to distinguish a separate group of SpAs—axial SpA. Axial SpA is distinguished as a separate disease due to its high social significance, and special mechanisms of its development. The development of medicinal products for the treatment of axial SpA has some specific features, which requires preparation of specific recommendations for conducting clinical trials of such products. The aim of the study was to elaborate a methodological approach to clinical research and evaluation of efficacy and safety of medicinal products for systemic treatment of axial SpA. The study took into account the requirements/recommendations of the European Medicines Agency for planning clinical trials of medicinal products for the treatment of axial SpA, in order to streamline evaluation of national and foreign clinical trial results. The paper identifies the main stages of clinical trials, and proposes criteria for assessing product efficacy at each stage. It defines methods and tools for assessing clinical trial endpoints, which are necessary for evaluation of treatment effects. The paper describes specific aspects of clinical trial designs and their duration, and identifies the objectives of exploratory and confirmatory clinical trials. It also reviews treatment goals and treatment outcome evaluation. The study results could be used in elaboration of recommendations for clinical research of new medicinal products for axial SpA

Планирование программы клинических исследований препаратов для лечения аксиального спондилоартрита

The criteria for diagnosis and classification of spondyloarthritides (SpAs) have undergone significant changes over the past 10 years. The emergence of new diagnostic methods and availability of new information on the prognosis of the disease outcome made it possible to distinguish a separate group of SpAs—axial SpA. Axial SpA is distinguished as a separate disease due to its high social significance, and special mechanisms of its development. The development of medicinal products for the treatment of axial SpA has some specific features, which requires preparation of specific recommendations for conducting clinical trials of such products. The aim of the study was to elaborate a methodological approach to clinical research and evaluation of efficacy and safety of medicinal products for systemic treatment of axial SpA. The study took into account the requirements/recommendations of the European Medicines Agency for planning clinical trials of medicinal products for the treatment of axial SpA, in order to streamline evaluation of national and foreign clinical trial results. The paper identifies the main stages of clinical trials, and proposes criteria for assessing product efficacy at each stage. It defines methods and tools for assessing clinical trial endpoints, which are necessary for evaluation of treatment effects. The paper describes specific aspects of clinical trial designs and their duration, and identifies the objectives of exploratory and confirmatory clinical trials. It also reviews treatment goals and treatment outcome evaluation. The study results could be used in elaboration of recommendations for clinical research of new medicinal products for axial SpA.В последнее десятилетие критерии диагностики и классификация спондилоартритов претерпели существенные изменения. Появление новых диагностических методов и накопление информации по прогнозу исхода заболевания привели к выделению отдельной группы спондилоартритов – аксиального спондилоартрита. Выделение этого заболевания связано со специфическими механизмами его развития и высокой социальной значимостью. Разработка лекарственных препаратов, применяющихся при терапии больных аксиальным спондилоартритом, имеет ряд особенностей, что требует подготовки специальных рекомендаций для проведения клинических исследований лекарственных препаратов. Цель работы – формирование методического подхода к проведению клинических исследований и оценке эффективности и безопасности лекарственных средств для системного лечения аксиального спондилоартрита. Для гармонизации экспертной оценки результатов национальных и зарубежных клинических исследований работа была проведена с учетом требований/ рекомендаций Европейского агентства по лекарственным средствам по планированию клинических исследований лекарственных препаратов для лечения аксиального спондилоартрита. В работе выделены этапы клинических исследований, определены критерии оценки эффективности для каждого из этапов. Охарактеризованы методы и инструменты анализа конечных точек клинических исследований, необходимых для оценки влияния терапевтических воздействий. Описаны особенности дизайнов клинических исследований и длительность их проведения. Выделены задачи поисковых и подтверждающих клинических исследований. Рассмотрены цели лечения, показатели результатов лечения. Результаты исследования целесообразно использовать при разработке рекомендаций по программе клинического изучения новых препаратов для лечения аксиального спондилоартрита

Spherical model of the Stark effect in external scalar and vector fields

The Bohr-Sommerfeld quantization rule and the Gamow formula for the width of quasistationary level are generalized by taking into account the relativistic effects, spin and Lorentz structure of interaction potentials. The relativistic quasi-classical theory of ionization of the Coulomb system (V_{Coul}=-\xi/r) by radial-constant long-range scalar (S_{l.r.}=(1-\lambda)(\sigma r+V_0)) and vector (V_{l.r.}=\lambda(\sigma r+V_0)) fields is constructed. In the limiting cases the approximated analytical expressions for the position E_r and width \Gamma of below-barrier resonances are obtained. The strong dependence of the width \Gamma of below-barrier resonances on both the bound level energy and the mixing constant \lambda is detected. The simple analytical formulae for asymptotic coefficients of the Dirac radial wave functions at zero and infinity are also obtained.Comment: 25 pages, 4 figures. Submitted to Int. J. Mod. Phys.

On integrable system on S2S^2 with the second integral quartic in the momenta

We consider integrable system on the sphere $S^2$ with an additional integral of fourth order in the momenta. At the special values of parameters this system coincides with the Kowalevski-Goryachev-Chaplygin system.Comment: LaTeX, 6 page

On bi-hamiltonian geometry of some integrable systems on the sphere with cubic integral of motion

We obtain bi-Hamiltonian structure for a family of integrable systems on the sphere S with an additional integral of third order in momenta. These results are applied to the Goryachev system and Goryachev-Chaplygin top for which we give an explicit procedure to find the separated coordinates and the separated relations.Comment: 11 pages, LaTeX with AMS fonts, corrected typo

Skyrme-Rpa Description of Dipole Giant Resonance in Heavy and Superheavy Nuclei

The E1(T=1) isovector dipole giant resonance (GDR) in heavy and super-heavy deformed nuclei is analyzed over a sample of 18 rare-earth nuclei, 4 actinides and three chains of super-heavy elements (Z=102, 114 and 120). Basis of the description is self-consistent separable RPA (SRPA) using the Skyrme force SLy6. The self-consistent model well reproduces the experimental data (energies and widths) in the rare-earth and actinide region. The trend of the resonance peak energies follows the estimates from collective models, showing a bias to the volume mode for the rare-earths isotopes and a mix of volume and surface modes for actinides and super-heavy elements. The widths of the GDR are mainly determined by the Landau fragmentation which in turn is found to be strongly influenced by deformation. A deformation splitting of the GDR can contribute about one third to the width and about 1 MeV further broadening can be associated to mechanism beyond the mean-field description (escape, coupling with complex configurations).Comment: 9 pages, 12 figures, 2 table

Planning of clinical trial programmes for medicines for the treatment of obesity

Scientific relevance. Obesity is a significant public health problem. Currently, the Russian Federation and the other Member States of the Eurasian Economic Union (EAEU) do not have regulatory documents and recommendations for planning clinical trials (CTs) of new (original) medicines for the treatment of obesity.Aim. The study aimed to provide recommendations on the basic principles of planning and conducting CTs of medicines for the treatment of obesity.Discussion. The authors reviewed the requirements for conducting CTs of medicines for the treatment of obesity set forth by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). In addition, the authors analysed approaches to CTs providing for a reliable evaluation of the efficacy and safety of medicines for the treatment of obesity. The primary endpoint of such CTs is a statistically significant loss of at least 5% of the baseline weight after 12 months of treatment. Secondary endpoints include assessments of abdominal obesity reduction, subcutaneous and visceral fat reduction, and the medicinal product’s effect on maintaining a reduced body weight.Conclusions. In addition, CTs should investigate the effects of treatment on cardiovascular risk factors and cardiovascular morbidity/mortality. A CT protocol should define the intercurrent events that should be considered in the analysis of trial results. When investigating the safety of medicines for the treatment of obesity, studies should focus on neuropsychiatric safety, the potential for abuse/addiction and withdrawal reactions, and the development of valvulopathy and pulmonary hypertension. These recommendations may be of use to experts evaluating clinical development programmes or marketing authorisation submissions for medicines for the treatment of obesity