Clinical research is a growing field and demands well prepared researchers from all _reas of health graduation courses. The complexity and variety of methods appied to clinical research, as well as the ethical issues brought by the proposition of protocols in this _rea require adequate training and background. Graduate students, both from master and PhD courses, need to enhance their knowledge and practice in the topics related to clinical research. To present and to discuss ethical basis and main methods of clinical research based on good practice principles. At the end of the discipline, graduate students will be able to write a research protocol, to analyze their project data and to elaborate a publication in their research field. Medical School (FM) São Paulo, Pinheiros campus 1. Ethical and bioethical principles 2. Research question 3. Clinical variables: biomarkers and surrogate endpoints 4. Statistical basis 5. Study design 6. Sampling, validity, bias, randomization and blinding 7. Advanced statistical methods 8. Sample size calculation 9. Assessment of adverse effects and medication adherence 10. Adaptative design and interim analyses 11. Propensity scores 12. Writing a protocol 13. Clinical research as a profession 14. Publishing Wu Tu Hsing Raymundo Soares de Azevedo Neto 30 MPT5795 15 Being an on-line discipline, presence is evaluated by student participation in the discussion forum at least once each week, and the quality of comments posted are graded. Week assignments and a final exam at the end of the discipline compose the final grade of the student. http://www.fm.usp.br/en/portal/

The subject, besides fulfilling the primary aim of the “gstrictu senso”h post-graduation of training researchers, combines the need for stimulation, starting at a brilliant idea (the Concept of Intellectual Capital, where the knowledge or creativity can be converted into economic value) up to the development of products, and their branding and patenting. To present the postgraduate students the understanding, skills and attitudes which must be developed to enable getting a brand and patent, from the conception of an idea – To stimulate the creativity of the postgraduate student in the creation of innovative products, which could become innovations with their institutional domain guaranteed. Medical School (FM) São Paulo, Pinheiros campus Define what intellectual property is, and identify its importance for Brazilian industry Since when have people sought to protect intellectual property? What is intellectual property? What does intellectual property cover? Current regulationary framework that deals with intellectual property in Brazil Conceptualize about what copyright and related rights are and their implications What guarantees copyright in Brazil? Copyright Related rights Explain what the rights are over a computer program Computer Program Identify what industrial property is and its applications: patents of invention and utility model, trade mark, industrial design and geographical indications. Who guarantees and grants the right of industrial property in Brazil? What does the expression industrial property cover? What is the purpose of industrial property Patent of Invention and Utility Model Industrial Design Registration Trademark Registration Registration of Geographical Indications Repression of Unfair Competition Current regulatory framework to support innovation in Brazil Having ideas in Gastroenterolgy (a. innovation which could be patented; b. methods for scientifically developing an idea; c. putting the project into practice. – Idea Development Projects, trademarks and patents in Endoscopy and Interventional Radiology – Idea Development Projects, trademarks and patents in Surgery. Orlando de Castro e Silva J_nior, Eduardo Guimar_es Hourneaux de Moura, Wanderley Marques Bernardo 34 MGT5773 4 Concepts which involve the proposed subject: – Idea: The word derives from the Greek idea or eidea, etiological root is eidos _ image. Its significance, since its origin, implies a controversy between the theory of emission (Plato) and that of intromission (Aristotle). At the center of the controversy is the concept of the representation of the real (reality). For Plato, the idea we have from something proves the main principal, of the _intelligible world_, which constituted the Universal Idea, a category which is the basis of his philosophy, idealism. So, the idea of it is a projection of knowledge: upon seeing it, the eyes, emitting rays of light, project the image of the same thing, which exists within us as the universal principle (emission). This doctrine is designed by _idealism_. For Aristotle, the idea of the thing comes from sense experience, from the _world of contingent phenomena_: the things emit copies of themselves, through the light, copies assimilated by senses and interpretated by innate or acquired knowledge (intromission), a doctrine that founds the concept of _realism_. The (brilliant) idea is the basis of everything (four steps: preparation, incubation, illumination and verification). Any time lost after a brilliant idea could be responsible for inhibiting the motivation which created idea, or even raise doubts whether the brilliant idea is really good or not. – Intellectual property: refers, in the broad sense, to the creations of human spirit and to the protective rights of the interests of the creators over their creations. – Trademark: Is a visually perceptible sign capable of distinguishing the goods or services of a company, especially in relation to other competitors. – Patent: is a title of temporary ownership over an invention of utility model, granted by the State. With this right, the inventor has the right to prevent third-parties, without their consent, of producing, using, putting for sale, selling or importing the subject of their patent and/or process or product obtained directly by a process patented by him. _Assessment by: above 75% presence in lesson, presentation of seminars with pre-determined topics, performance and interest demonstrated during the discussions. http://www.fm.usp.br/en/portal/

Despite unprecedented efforts to control malaria, this disease still represents a major public health problem, particularly in Africa. Challenges such as the search for more sensitive point-of-care methods, resistance to antimalarials and to insecticides, strategies to measure transmission, understanding of the immunity and decreases lethality are challenges for the control and elimination. Malaria is the most widespread parasitic disease, putting at risk about 3.3 billion people worldwide, with 198 million cases and 584,000 deaths, especially in children under five years of age and pregnant women. Leishmaniasis and arboviruses such as dengue are among the vector-borne diseases considered neglected by the World Health Organization. Neglected tropical diseases are a group of communicable diseases occrurring in tropical and subtropical conditions in 149 countries and affect more than one billion people, at the cost of billions of dollars each year. They affect mainly populations that live in poverty, in contact with vectors of infectious agents. About 450 million people in sub-Saharan Africa are at risk of contracting tropical diseases. However, according to the WHO, they also affect Latin America, the Middle East and Asia and can emerge in other regions. Leishmaniasis accounts for 1.5 to 2 million new cases per year, with an average lethality of 7%, mainly due to the visceral type. In recent years there has been a resurgence of different arboviruses, among them dengue, chikungunya and Zika virus, whose ability to adapt to different vectors had an impact on the geographical expansion of these diseases. Although most cases present benignly, these arboviruses can occur with severe manifestations. The risk of transmission of these diseases is not limited to populations living in areas at risk, but also to travelers, due to globalization and ease of displacement, thus increasing the concern of worldwide dissemination. The extent of these diseases, coupled with the complex mechanisms of the agent-host-vector relationship in the different phases of the transmission chain, suggests that it is appropriate for academic and public health institutions to devote themselves to the study of the variables involved in their evolution. Thus, the knowledge related to the agents, the hosts, the vectors and the interaction between them, is fundamental to draw efficient strategies of control. In this context, the main challenges are the critical and accurate evaluation of parasitological and molecular diagnostic methods; the immunological mechanisms involved in the etiologic agent-man-vector relationship; the genetic mechanisms of drug resistance; the importance of travel medicine, in order to guide and prevent the risk of infection. It is proposed here a course at a postgraduate level that will provide students with the conditions to develop a critical vision, that arises from the knowledge of challenges, proposals for control and research perspectives in the related field. Training teachers and researchers to develop research on malaria and the main neglected tropical diseases, with an approach in epidemiology and clinical-laboratory diagnosis, encouraging and stimulating the critical thinking related to the knowledge in these diseases. Medical School (FM) São Paulo, Pinheiros campus 1. Challenges for malaria control: biological, epidemiological and environmental components; dynamics of transmission in different endemicities; determinants of malaria; characteristics of extra-Amazonian malaria; 2. New perspectives in laboratory diagnosis of malaria: performance of molecular protocols and adequacy of their use in different situations; critical analysis of immunochromatographic assays for the detection of specific antigens and antibodies; 3. Development of immunity in malaria: main mechanisms involved in the cellular and humoral immune response; current state of vaccine development; 4. Immunopathogenic aspects of malaria and correlation with clinical manifestations: characteristics of severe malaria; 5. Chemotherapy; genetics of antimalarial resistance and major molecular markers; 6. Challenges for the control of leishmaniasis: determinants of the disease endemicity, mechanisms related to environmental factors contributing to the spread of the disease; 7. Diversity of Leishmania species occurring in Brazil: geographical location; clinical forms of disease; species and genotypes of Leishmania-related therapeutic response; 8. Innate and adaptive immunity in leishmaniasis: immunopathogenic aspects of the different clinical forms of tegumentary and visceral leishmaniasis; 9. Clinical-laboratory diagnosis of leishmaniasis; clinical aspects in immunocompetent and co-infected patients with HIV; difference in clinical manifestations and therapeutic response; evaluation of laboratory methods currently employed in the diagnosis of visceral and tegumentary leishmaniasis; perspectives of new antigens and different diagnostic platforms; molecular tools used in the species-specific diagnosis of leishmaniasis; 10. Challenges for the control of arboviruses of urban occurrence: biological, epidemiological and environmental components; dynamics of transmission in different scenarios; vectors and host susceptibility; 11. Challenges for serological and molecular diagnosis of arbovirus; 12. Immunopathogenic aspects of arboviruses and correlation with clinical manifestations; 13. Traveler’s medicine: critical analysis of prevention measures and chemoprophylaxis Marcos Boulos, Jos_ Angelo Lauletta Lindoso, S_lvia Maria F_tima di Santi 50 MIP5714 5 Elaboration of a project as a mechanism of evaluation of the student’s perception of the importance of each theme presented. Presentation of seminars with discussion of results of published studies http://www.fm.usp.br/en/portal/

HIV / AIDS infection is a serious health problem today and its repercussions are felt in many aspects of human life. Well-conducted scientific research can contribute to the generation of knowledge in coping with this epidemic, focusing on components of the complex network of related biopsychosocial factors. Considering that the technical preparation for the planning and execution of scientific research is essential for the training of the researcher, this discipline intends to offer subsidies to the process of elaboration, reading and critical analysis of research projects applied to the deepening the knowledge regarding HIV infection AIDS, with emphasis on the interdisciplinary approach. A) To discuss the process of scientific investigation that has as object the study of HIV / AIDS infection, including its planning, main approaches, methods and techniques. B) To provide subsidies for the formulation of research projects focused on this theme. C) To enable students to analyze literature about the subject, through a fair interpretation of the most frequently used research methods. D) To stimulate the interdisciplinary approach in scientific research related to HIV / AIDS infection Medical School (FM) São Paulo, Pinheiros campus • Fundamentals of scientific research: observation and experimentation; metering; probability, Induction; • Research planning: the research process; • Selection and formulation of the scientific inquiry of the research; • Bibliographic research survey; • Research planning: study designs applied to HIV / AIDS infection (quantitative observational and intervention studies, qualitative studies); • Selection of subjects for the research: sample calculation and sampling criteria, recruitment of subjects; • Data collection and use of data as a source of information (quality and quantity); • Measurement of results (accuracy); • Planning of the analysis and interpretation of results; • The research report; • Ethical aspects of research involving human beings; • Research funding. Aluisio Augusto Cotrim Segurado, Ana Marli Christovam Sartori, Eliana Battaggia Gutierrez 70 MIP5734 5 The selection of students for the subject will require the submission of scientific research proposal related to HIV / AIDS infection. The evaluation will be based on the attribution of a concept regarding the interest and participation of the students in the proposed activities – classes, seminars, guided exercises, as well as the presentation of an individual research project at the end of the course. http://www.fm.usp.br/en/portal/

The epidemiological methodology, along with its traditional use in the area of Collective Health, has been used as a privileged instrument in conducting clinical research. Epidemiology techniques have been useful in addressing the issues that characterize clinical work, both from the perspective of health services and from scientific research. The aim of this course is to systematize the existing knowledge about the application of this methodology in the development of technical-scientific production in Clinic, as well as in the implementation of its practice. To understand the application of epidemiological methodology in clinical research; To know the basic technical elements for elaboration and conduction of research projects; Encourage the ability to critically evaluate scientific articles published in the medical literature; To provide instruments for the improvement of clinical practice, based on the critical evaluation of the literature. Medical School (FM) São Paulo, Pinheiros campus The course will consist of theoretical classes, seminars and practical classes, covering the following topics: Definition of Epidemiology and its main concepts; Studies on diagnostic tests; Prognostic studies; Experimental Studies; Tracking; Systematic reviews; Critical reading of medical publications; Discussion of research projects in Clinical Epidemiology. Moises Goldbaum, Moacyr Roberto Cuce Nobre, Paulo Rossi Menezes 35 MPR5730 6 The evaluation will consist of attendance, participation and presentation of seminars and individual test. http://www.fm.usp.br/en/portal/

Two aspects justify this discipline. The first one concerns the great demand existing in the HC / FMUSP complex on the debate and understanding of projects / studies that use epidemiological methodology, and articles published in scientific journals. The second aspect concerns the possibility of integrating the different fields and disciplinary areas of research of the complex, facilitating the incorporation and understanding of the methodological instruments by the graduate students and discussing the validity of the use of these instruments in specific researches. Discuss current epidemiological and related issues Analysing the validity of studies using epidemiological methodology Understand subjects relevant to the postgraduate in the health area Medical School (FM) São Paulo, Pinheiros campus The course will be given in the form of seminars. Papers will be analyzed from epidemiological studies or on topics important for research in the health area, published or to be submitted for publication in national and foreign scientific journals, and projects / studies that use epidemiological methodology. Eventually, faculty and researchers from the institution or from other institutions may present a topic related to their area of research. Jose Eluf Neto 25 MPR5749 4 Presentation and participation in seminars http://www.fm.usp.br/en/portal/

This course is justified by the main objective of the “Strito-Sensu” Graduate Program, which is to train teachers and researchers, responsible for promoting and developing scientific advances, but also know how to transmit them and carry the basic tools for a continuous learning. The didactics must be inserted within the principle of the integral formation of the students that will be trained in the current techniques of transmission of the knowledge. Therefore, didactics is a fundamental foundation in the training of these PG students. On the other hand, it can be observed that there is an intimate relationship between didactics and research, since its dissemination and communication to the scientific community and, even to the laity, must be clear, exact and follow ethical principles within established standards. ournals have specific, internationally established rules and, both publications and presentations, must adhere to the basic principles: ethics, accuracy, clarity, exemption, synthesis and conclusion with no other interests. For all these reasons the Discipline of Didactics in the formation of new PGs is justified. Provide postgraduate students with the basic principles of Didactics fundamentals and techniques, based on efficiency, propriety, precision and clarity in scientific expositions, whether oral or written. The form and content of the presentations are analyzed according to the theoretical bases and practical training. Medical School (FM) São Paulo, Pinheiros campus 1.Objectives and forms of scientific communication 2.Principles and methods of oral communication 3. How to prepare a lesson or scientific communication 4. Principles and methods of audio-visual scientific communication 5.Principles and methods of written scientific communication 6.Principles and methods of distance scientific communication 7.Use of projections: computation 8.Exhibition of themes in Poster 9. How to identify or highlight highlights in an oral presentation 10.Criteria for programming courses for: Undergraduate, Residency and Postgraduate Jose Antonio Franchini Ramires, Paulo Cury Rezende 16 MCP5823 3 1. Presentation of two seminars: 1) free themes with oral presentation and 2) data of the thesis project with presentation in the English language. 2. Elaboration of the program of a course for undergraduate students and / or specialization applying the acquired knowledge and evaluation of the discipline._ http://www.fm.usp.br/en/portal/

The concept of translational science has as principles the practical implementation of knowledge acquired through research for citizens and society. The student should understand, upon his admission into the graduate program, all stages of preparation of a project, from the formulation of the hypothesis, to structuring, raising of funds, achievement of the goals and practical application of knowledge. – We will encourage students to present their project structured as a paper in English. -The teachers will evaluate the content and form of presentation, developing an objective set of guidelines in partnership with students to guide the development of research. Contribute to the consolidation of the researchers’ training, improving their critical capacity to question the results of a study and its potential application; -To understand the concepts and implementation of the dissemination of knowledge; -Preparation of the paper, from the choice of the journal to the review of article; -Understand, discuss, analyze and develop research projects in various fields. Medical School (FM) São Paulo, Pinheiros campus Roberto Kalil Filho, Ludhmila Abrah_o Hajjar 45 MCP5868 4 Frequency, performance and participation during lectures and discussions (the responsible teachers are present in all classes). The course will be offered every semester. Students will present, in the form of a seminar structured as a paper, which will have a duration of 15 minutes. -There will be in-depth examination of the content and form of presentation of the project with the preparation of a plan that should contemplate the graduate program�fs period. http://www.fm.usp.br/en/portal/

In the last decades, the cancer treatment has advanced significantly and improved patients’ survival. As a result, cardiovascular complications related to chemotherapy have had a higher impact in their overall survival and quality of. Thus, understanding cardiotoxicity related to cancer treatment, the main medications involved, the potential for reversibility and the management of patients at risk of toxicity has become part of the daily practice of clinical cardiology. Additionally, the potential cardiotoxicity of newer cancer treatment drug is yet to be defined. The collaboration of the Cancer Institute of the State of S_o Paulo and the Heart Institute of the Hospital das Cl_nicas of the Medical School of the University of S_o Paulo, with extensive interaction between cardiologists and oncologists, provides a unique setting for the development of research in the field. The present course aims to bring the discussion on the development of the science related to the field to postgraduate students. Discipline aimed at postdoctoral physicians and other health professionals with scientific interest in the area of Cardio-Oncology. The main objective is to enable students to apply the key fundamental Cardio-oncology concepts in research and clinical practice. Medical School (FM) São Paulo, Pinheiros campus Topics to be addressed: 1. Critical analysis of the studies on cardiotoxicity by Anthracyclines, Trastuzumab and tyrosine kinase inhibitors; 2. Radiotherapy and cardiovascular system; 3. Effects of endocrine therapy for breast and prostate cancer and cardiovascular complications; 4. Peculiarities in the treatment of heart failure and coronary disease in cancer patients, evidence gaps and opportunities for research; 5. Pericardium diseases in cancer patients. Roberto Kalil Filho, Ludhmila Abrah_o Hajjar, M_rcio Sommer Bittencourt 42 MCP5872 2 Frequency, performance and participation during lectures and discussions (the responsible teachers are present in all classes) – On-line questionnaires http://www.fm.usp.br/en/portal/

The risk assessment and treatment of heart rhythm disorders have been modified and advanced substantially in recent years, as a consequence of the development of the technology and recognition of the anatomical and electrophysiological substrates, autonomic modulation and, more recently, molecular origins of cardiac arrhythmias. These instruments provided earlier and more accurate diagnoses, as well as deepened pathophysiological knowledge at the functional, macroscopic and even at the ultra structural level. In this context, there has been constant progresses and accelerated development of new therapeutic options, pharmacological and non-pharmacological, for patients suffering from heart rhythm disorders. Therefore, the understanding of the methods used for its investigation, as well as the development of adequate critical analysis in the decision making to treat them are fundamental for the improvement of researchers in this broad area of __cardiology. To update and motivate a critical analysis of the diagnosis approaches and management (both clinical and interventionists) of cardiac arrhythmias and syncope, as well as of prevention of sudden cardiac death. At the end, the student is expected to achieve a critical sense on the interpretation of the methods, recognizing its potentialities and limitations. Core Question How to diagnose and manage a patient with arrhythmia or syncope, recognizing the risk of sudden cardiac death and achieving the better therapeutic option, considering cost-effectiveness and the influence on the patient’s quality of life. Medical School (FM) São Paulo, Pinheiros campus The course will be divided into 4 modules. The teachers will give classes on the state of the art of the selected topics and the students will be requested to prepare specific seminars. At the end, there will be an evaluation based on their performance in the seminars (content and didactics) and their participation in the discussions. Denise Tessariol Hachul, Mauricio Ibrahim Scanavacca, Francisco Carlos da Costa Darrieux 12 MCP5875 2 Performance in the presentation and the content of seminars Assiduity Participation in discussions. http://www.fm.usp.br/en/portal/

Rhinosinusitis, gastro-gastro esophageal reflux disease, vocal fold dyskinesia, anxiety / depression, obesity, sleep apnea, as well as, heart failure or presence of foreign body in the airways, among others, may aggravate or undermine asthma. The high percentage of these co-morbidities in asthmatics has led to an intense debate reflected in the literature on the cause-consequence relationship between both. However, even in relation to rhinitis – allergic disease present in 80% of asthmatics – the pathophysiological connection is inferred, due to the absence of conclusive evidence. The challenge of treating the uncontrolled asthmatic patient with associated morbidities, measuring the impact of the latter, and the need to address them determine the characterization of difficult-to-control asthma. Likewise, symptomatic patients treated as asthmatics and with a low response to treatment, not clinically controlled, may not have asthma. Or they may have adherence to treatment of less than 50%, as well as being exposed to environmental factors, also leading to difficult asthma control. At the request of the World Health Organization, a group of global experts has developed a classification that defines severe asthma in 3 types: 1) untreated or poorly treated asthma related to lack of adequate treatment due to lack of inputs or health infrastructure; 2) difficult to control asthma in patients who are poorly or partially controlled by the presence of comorbidities and / or continuous exposure to triggers and / or low adherence to treatment; and 3) severe asthma dependent on high doses of continuous corticosteroids with High risk of known adverse events or severe asthma refractory to treatment, even at high doses. This discipline aims to clarify the differences between these types of asthma, but focuses on the second type where the aforementioned factors confuse it with the other two types. To present and discuss the current concept of difficult-to-control asthma – called “problematic” – considering the particularities that classify it in some studies as severe asthma. The definition of asthma as morbidity characterized by symptoms such as dyspnea, dry cough and wheezing, commonly leads to the axiom “all that wheeze is asthma.” Morbidities from other systems are often present in asthmatics or mimic asthma. Similarly, low adherence to treatment and continuous exposure to triggers lead to uncontrolled asthma. To clarify the relationships between asthma and these morbidities, as well as to identify and treat these factors, it is essential to differentiate an uncontrolled asthma from severe (or both at the same time), including with regard to care and research outcomes. At the end of the course the student will master the concepts necessary for critical analysis of the evidences and plan research projects in the area of __physiopathology, management and treatment of difficult to control asthma Medical School (FM) São Paulo, Pinheiros campus Lecture 1: 1 hour – Definition of severe asthma vs. difficult to control asthma: is it possible to separate them? Lesson 2: 1 hour – How to measure control objectively and evaluate it after treatment of co-morbidities associated with difficult-to-control asthma. Seminars: 5 hours (presentation of articles by students, followed by group discussion) A) Is it asthma or not? Morbidities that mimic asthma B) Is severe asthmatic adherent to treatment? Causes and consequences C) Atopy, rhinitis, sinusitis and asthma control D) Obesity, gastro-esophageal reflux,sleep apnea and asthma control E) Anxiety, depression, vocal cord dyskinesia and asthma F) Asthma and COPD overlap Practical Class: 4 hours Pulmonology oupatient clinic Study Hours: 4 hours Alberto Cukier, Rafael Stelmach 13 MCP5881 2 This discipline has didactic continuity with the Discipline “Severe Asthma: Phenotypes and their Implications”. It is suggested the student be enrolled in both. Minimum number of students: 6 Maximum number of students: 12 Presence, participation in seminars and practical activities http://www.fm.usp.br/en/portal/

The discipline is justified in the post-graduate context that aims at the production of high level scientific knowledge, which recognizes the importance of choosing a suitable research method in front of the research question previously formulated, be it of a basic or applied nature, with observational or experimental design, considering their bias and control powers, in the planning, execution and analysis phases. The course aims to provide a basic training on the nature of scientific knowledge, studying the fundamentals of methodology; Preparing students for the identification of problems, concepts and arguments that influence the theoretical, technical and operational strategies of health research with a special focus on those applied to clinical practice. Medical School (FM) São Paulo, Pinheiros campus Basic principles of the scientific method in health. Ethics in research. Planning and control of biases that promote the internal and external validity of the studies. Causal and statistical inference. Clinical relevance and statistical significance. Main types of designs for clinical studies, in view of clinical epidemiology. Descriptive measures of frequency and association between study variables. Common mistakes and biases in the development of research projects. Critical analysis of scientific articles. Application of basic statistical knowledge for the interpretation of association measures and random bias. Moacyr Roberto Cuce Nobre 61 MCP5884 2 The evaluation will be done through participation in lessons and seminars where research projects, literature papers and conceitual material are presented and discussed. http://www.fm.usp.br/en/portal/