WorldWideScience

Sample records for human clinical research

  1. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research Past ... the forefront of human health research today are clinical trials—studies that use human volunteers to help medical ...

  2. [Clinical research XXIV. From clinical judgment to ethics in research on humans].

    Science.gov (United States)

    Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O

    2014-01-01

    Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.

  3. Hepcidin modulation in human diseases: From research to clinic

    Institute of Scientific and Technical Information of China (English)

    Alberto Piperno; Raffaella Mariani; Paola Trombini; Domenico Girelli

    2009-01-01

    By modulating hepcidin production, an organism controls intestinal iron absorption, iron uptake and mobilization from stores to meet body iron need. In recent years there has been important advancement in our knowledge of hepcidin regulation that also has implications for understanding the physiopathology of some human disorders. Since the discovery of hepcidin and the demonstration of its pivotal role in iron homeostasis, there has been a substantial interest in developing a reliable assay of the hormone in biological fluids. Measurement of hepcidin in biological fluids can improve our understanding of iron diseases and be a useful tool for diagnosis and clinical management of these disorders. We reviewed the literature and our own research on hepcidin to give an updated status of the situation in this rapidly evolving field.

  4. Clinical Research

    DEFF Research Database (Denmark)

    Christensen, Irene

    2016-01-01

    This paper is about the logic of problem solving and the production of scientific knowledge through the utilisation of clinical research perspective. Ramp-up effectiveness, productivity, efficiency and organizational excellence are topics that continue to engage research and will continue doing s...... for years to come. This paper seeks to provide insights into ramp-up management studies through providing an agenda for conducting collaborative clinical research and extend this area by proposing how clinical research could be designed and executed in the Ramp- up management setting....

  5. [Introduction of neuroethics: out of clinic, beyond academia in human brain research].

    Science.gov (United States)

    Fukushi, Tamami; Sakura, Osamu

    2008-11-01

    Higher cognitive function in human brain is one of well-developed fields of neuroscience research in the 21st century. Especially functional magnetic resonance imaging (fMRI) and near infrared recording system have brought so many non-clinical researchers whose background is such as cognitive psychology, economics, politics, pedagogy, and so on, to the human brain mapping study. Authors have introduced the ethical issues related to incidental findings during the fMRI recording for non-clinical purpose, which is a typical problem derived from such expanded human brain research under non clinical condition, that is, neuroethics. In the present article we would introduce neuroethical issues in contexts of "out of clinic" and "beyond academia".

  6. Implementing genomics and pharmacogenomics in the clinic: The National Human Genome Research Institute's genomic medicine portfolio.

    Science.gov (United States)

    Manolio, Teri A

    2016-10-01

    Increasing knowledge about the influence of genetic variation on human health and growing availability of reliable, cost-effective genetic testing have spurred the implementation of genomic medicine in the clinic. As defined by the National Human Genome Research Institute (NHGRI), genomic medicine uses an individual's genetic information in his or her clinical care, and has begun to be applied effectively in areas such as cancer genomics, pharmacogenomics, and rare and undiagnosed diseases. In 2011 NHGRI published its strategic vision for the future of genomic research, including an ambitious research agenda to facilitate and promote the implementation of genomic medicine. To realize this agenda, NHGRI is consulting and facilitating collaborations with the external research community through a series of "Genomic Medicine Meetings," under the guidance and leadership of the National Advisory Council on Human Genome Research. These meetings have identified and begun to address significant obstacles to implementation, such as lack of evidence of efficacy, limited availability of genomics expertise and testing, lack of standards, and difficulties in integrating genomic results into electronic medical records. The six research and dissemination initiatives comprising NHGRI's genomic research portfolio are designed to speed the evaluation and incorporation, where appropriate, of genomic technologies and findings into routine clinical care. Actual adoption of successful approaches in clinical care will depend upon the willingness, interest, and energy of professional societies, practitioners, patients, and payers to promote their responsible use and share their experiences in doing so.

  7. The survey of clinical human experimentation research in ethical review of postgraduates students.

    Science.gov (United States)

    Xu, Yifan; Zhu, Zheng; Wang, Liyu

    2012-06-01

    An anonymous questionnaire was used to investigate the status quo of ethics review of human subject experiments among postgraduate students in clinical practice with the main conclusions as follows: Human subject experiments make up a large ratio of clinical research; the construction of an ethics review has been initially formulated, but there exists a gap in ethics awareness between advisors and the postgraduates with the desperate need to receive ethics review. It is necessary to realize the importance of informed consent and to strengthen the strict supervision of placebo application.

  8. The research subject advocate at minority Clinical Research Centers: an added resource for protection of human subjects.

    Science.gov (United States)

    Easa, David; Norris, Keith; Hammatt, Zoë; Kim, Kari; Hernandez, Esther; Kato, Kambrie; Balaraman, Venkataraman; Ho, Tammy; Shomaker, Samuel

    2005-01-01

    In early 2001, the National Institutes of Health (NIH) created the research subject advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human participants in clinical research studies. We describe the RSA position in the context of clinical research, with a particular emphasis on the role of the RSA in two of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants. The RSA also conducts workshops, training and education sessions, and consultation with investigators to foster enhanced communication and adherence to ethical standards and safety regulations. Although we cannot yet provide substantive evidence of positive outcomes, this article illuminates the value of the RSA position in ensuring that safety of research participants is accorded the highest priority at CRCs. On the basis of initial results, we conclude that the RSA is an effective mechanism for achieving the NIH goal of maintaining the utmost scrutiny of protocols involving human subjects.

  9. [Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research and commentary].

    Science.gov (United States)

    Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

    2011-07-01

    This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

  10. [Draft of guidelines for human body dissection for clinical anatomy education and research and commentary].

    Science.gov (United States)

    Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

    2011-06-01

    This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

  11. Health, human rights, and the conduct of clinical research within oppressed populations

    Directory of Open Access Journals (Sweden)

    Mills Edward J

    2007-11-01

    Full Text Available Abstract Background Clinical trials evaluating interventions for infectious diseases require enrolling participants that are vulnerable to infection. As clinical trials are conducted in increasingly vulnerable populations, issues of protection of these populations become challenging. In settings where populations are forseeably oppressed, the conduct of research requires considerations that go beyond common ethical concerns and into issues of international human rights law. Discussion Using examples of HIV prevention trials in Thailand, hepatitis-E prevention trials in Nepal and malaria therapeutic trials in Burma (Myanmar, we address the inadequacies of current ethical guidelines when conducting research within oppressed populations. We review existing legislature in the United States and United Kingdom that may be used against foreign investigators if trial hardships exist. We conclude by making considerations for research conducted within oppressed populations.

  12. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... NICHD Publications Data Sharing and Other Resources Research Clinical Trials & Clinical Research Skip sharing on social media links ... health care providers, and researchers. Find NICHD-Supported Clinical Trials Use this link to find a list of ...

  13. Human Induced Pluripotent Stem Cells from Basic Research to Potential Clinical Applications in Cancer

    Directory of Open Access Journals (Sweden)

    Teresa de Souza Fernandez

    2013-01-01

    Full Text Available The human induced pluripotent stem cells (hiPSCs are derived from a direct reprogramming of human somatic cells to a pluripotent stage through ectopic expression of specific transcription factors. These cells have two important properties, which are the self-renewal capacity and the ability to differentiate into any cell type of the human body. So, the discovery of hiPSCs opens new opportunities in biomedical sciences, since these cells may be useful for understanding the mechanisms of diseases in the production of new diseases models, in drug development/drug toxicity tests, gene therapies, and cell replacement therapies. However, the hiPSCs technology has limitations including the potential for the development of genetic and epigenetic abnormalities leading to tumorigenicity. Nowadays, basic research in the hiPSCs field has made progress in the application of new strategies with the aim to enable an efficient production of high-quality of hiPSCs for safety and efficacy, necessary to the future application for clinical practice. In this review, we show the recent advances in hiPSCs’ basic research and some potential clinical applications focusing on cancer. We also present the importance of the use of statistical methods to evaluate the possible validation for the hiPSCs for future therapeutic use toward personalized cell therapies.

  14. Clinical trials of a matrix metalloproteinase inhibitor in human periodontal disease. SDD Clinical Research Team.

    Science.gov (United States)

    Ashley, R A

    1999-06-30

    After demonstration by Golub et al. of the ability of the tetracyclines to inhibit elevated collagenolytic activity in animal models of periodontal diseases, a clinical development program was initiated to demonstrate the potential of a subantimicrobial dose of doxycycline (SDD) to augment and maintain the improvements in clinical parameters of adult periodontitis (AP) afforded by conventional nonsurgical periodontal therapy. Clinical trials were carried out in which a number of different SDD dosing regimens and placebo were compared in patients administered a variety of adjunctive nonsurgical therapies. Measured parameters included levels of collagenase activity in gingival crevicular fluid (GCF) and gingival specimens, clinical attachment levels (cALv), probing pocket depths (PD), bleeding on probing (BOP), and subtraction radiographic measurements of alveolar bone height. When used as an adjunct to either scaling and root planing or supragingival scaling and dental prophylaxis, SDD was shown to reduce collagenase levels in both GCF and gingival biopsies, to augment and maintain cALv gains and PD reductions, to reduce BOP, and to prevent loss of alveolar bone height. These clinical responses arose in the absence of any significant effects on the subgingival microflora and without evidence of an increase in the incidence or severity of adverse reactions relative to the control groups. It is proposed that one of the mechanisms of action of SDD is as an inhibitor of pathologically elevated MMPs, including neutrophil and bone cell collagenases (MMP-8 and MMP-13), which are associated with the host response in chronic AP, and that SDD provides a novel systemic approach to the management of AP.

  15. A Clinical Service to Support the Return of Secondary Genomic Findings in Human Research

    Science.gov (United States)

    Darnell, Andrew J.; Austin, Howard; Bluemke, David A.; Cannon, Richard O.; Fischbeck, Kenneth; Gahl, William; Goldman, David; Grady, Christine; Greene, Mark H.; Holland, Steven M.; Hull, Sara Chandros; Porter, Forbes D.; Resnik, David; Rubinstein, Wendy S.; Biesecker, Leslie G.

    2016-01-01

    Human genome and exome sequencing are powerful research tools that can generate secondary findings beyond the scope of the research. Most secondary genomic findings are of low importance, but some (for a current estimate of 1%–3% of individuals) confer high risk of a serious disease that could be mitigated by timely medical intervention. The impact and scope of secondary findings in genome and exome sequencing will only increase in the future. There is considerable agreement that high-impact findings should be returned to participants, but many researchers performing genomic research studies do not have the background, skills, or resources to identify, verify, interpret, and return such variants. Here, we introduce a proposal for the formation of a secondary-genomic-findings service (SGFS) that would support researchers by enabling the return of clinically actionable sequencing results to research participants in a standardized manner. We describe a proposed structure for such a centralized service and evaluate the advantages and challenges of the approach. We suggest that such a service would be of greater benefit to all parties involved than present practice, which is highly variable. We encourage research centers to consider the adoption of a centralized SGFS. PMID:26942283

  16. Comparative wound healing--are the small animal veterinarian's clinical patients an improved translational model for human wound healing research?

    Science.gov (United States)

    Volk, Susan W; Bohling, Mark W

    2013-01-01

    Despite intensive research efforts into understanding the pathophysiology of both chronic wounds and scar formation, and the development of wound care strategies to target both healing extremes, problematic wounds in human health care remain a formidable challenge. Although valuable fundamental information regarding the pathophysiology of problematic wounds can be gained from in vitro investigations and in vivo studies performed in laboratory animal models, the lack of concordance with human pathophysiology has been cited as a major impediment to translational research in human wound care. Therefore, the identification of superior clinical models for both chronic wounds and scarring disorders should be a high priority for scientists who work in the field of human wound healing research. To be successful, translational wound healing research should function as an intellectual ecosystem in which information flows from basic science researchers using in vitro and in vivo models to clinicians and back again from the clinical investigators to the basic scientists. Integral to the efficiency of this process is the incorporation of models which can accurately predict clinical success. The aim of this review is to describe the potential advantages and limitations of using clinical companion animals (primarily dogs and cats) as translational models for cutaneous wound healing research by describing comparative aspects of wound healing in these species, common acute and chronic cutaneous wounds in clinical canine and feline patients, and the infrastructure that currently exists in veterinary medicine which may facilitate translational studies and simultaneously benefit both veterinary and human wound care patients.

  17. Milestones in Medical Research, The Human Genome and ClinicalTrials.gov | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... turn Javascript on. Milestones in Medical Research, The Human Genome and ClinicalTrials.gov Past Issues / Fall 2010 Table of Contents Donald West King, M.D. FNLM ... genetic foundation of all human beings; the second, a comprehensive information service to ...

  18. National Human Genome Research Institute

    Science.gov (United States)

    ... the Director Organization Reports & Publications Español The National Human Genome Research Institute conducts genetic and genomic research, funds ... Landscape Social Media Videos Image Gallery Fact Sheets Human Genome Project Clinical Studies Genomic Careers DNA Day Calendar ...

  19. Children's rights in clinical research.

    Science.gov (United States)

    Bragadóttir, H

    2000-01-01

    To address the use of children and children's genetic information in research, analyze Icelandic laws as an example, review existing literature on children in clinical research, and describe nurses' actions as children's advocates. An integrated literature review was conducted using theoretical and empirical literature on children as human subjects in clinical research. Five Icelandic laws were analyzed. Legal protection of children as human subjects is an international issue and is lacking in Icelandic legislation. In spite of an identified need to protect children as human subjects, research on children's rights in clinical research is scarce. Nurses have not taken an active stance in protecting children as human subjects. The recently passed Bill on Health Sector Database in Iceland raises questions about protection of human subjects regardless of age and stature. The effects of this Icelandic case could have international implications regarding centralized health care databases, ownership of data, and related ethical and legal decisions.

  20. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  1. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Eye Health Information > Clinical Trials in Vision Research Clinical Trials in Vision Research Clinical studies depend on people ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials are ...

  2. CME ON CLINICAL RESEARCH

    Directory of Open Access Journals (Sweden)

    Suneel. I. Majagi

    2012-06-01

    , monitor and supervise the clinical trials or the research projects. Ethical decision is taken without coercion, influence, inducement and intimidation. Dr.S.S.Torgal (JNMC spoke on “Introduction to clinical trials”. A systematic study of a new drug in human subjects to generate data for discovering and/or verifying the clinical, pharmacological (pharmacodynamic / pharmacokinetic and/or adverse effects with the objective of determining safety and/or efficacy of the new drug is known as clinical trial (Phase I, II, III and IV. There are many types of trials viz., Prevention trials, Screening trials, Diagnostic trials, Treatment trials, Quality of life trials and Compassionate use trials. The Clinical Trials Registry-India (CTRI is an online register of clinical trials being conducted in India.In the second scientific session, Dr.A.Shrivastav (KLE Hospital talked on “Conducting clinical trials-Investigators perspective”. He explained about good clinical practice, role of primary investigator, CROs, DCGI, site management office (SMO, regulatory requirements and data management. Essential trial documents include protocol, informed consent form, investigators brochure etc. Study team at site consists of investigator, co/sub-investigator, clinical research/study coordinator, research nurse, pharmacist, unblinded personnel etc. Dr.S.I.Majagi (JNMC gave a lecture on “Pharmacovigilance” which is a science of activities relating to the detection, assessment, understanding and prevention of adverse drug reactions (ADR or any other medicine related problem. He explained about history, need, objectives, applications, methods (spontaneous reports etc, organizations involved (WHO, National pharmacovigilance center etc in pharmacovigilance, Risk assessment, Risk management (RM, goals of RM, Risk minimization action plan(Risk MAP, tools of RM process and Signal: detection, sources, data, data interpretation, selection or rejection, strengthening (by assessment criteria

  3. Clinical research informatics

    CERN Document Server

    Richesson, Rachel L

    2012-01-01

    This book provides foundational coverage of key areas, concepts, constructs, and approaches of medical informatics as it applies to clinical research activities, in both current settings and in light of emerging policies. The field of clinical research is fully characterized (in terms of study design and overarching business processes), and there is emphasis on information management aspects and informatics implications (including needed activities) within various clinical research environments. The purpose of the book is to provide an overview of clinical research (types), activities, and are

  4. Clinical trials and E-health: impact of new information technology applied to clinical trials (including source data-medical records) and to human and drug research.

    Science.gov (United States)

    Béhier, Jehan-Michel; Reynier, Jean-Charles; Bertoye, Pierre-Henri; Vray, Muriel

    2010-01-01

    Within the last few years, new technology has come to play an important part in our professional and private daily environment. Healthcare has not escaped this progressive mutation with computers reaching the bedside. Clinical research has also shown growing interest in these new tools available to the clinical investigator, the patient, as well as to specialist departments for diagnosis and follow-up of patients, and to the different professions in clinical research. If the use of new technology seems to make life easier, by centralizing data or by simplifying data-sharing between different teams, it is still a matter of private data which must remain reliable, confidential and secure, whether it is being used in ordinary healthcare or in academic or industrial research. The aim of the round table was to estimate the impact of new information technology applied to clinical trials (including source data-medical records) and to human and drug research. First, an inventory was made of the development of these new technologies in the healthcare system. The second point developed was identification of expected benefits in order to issue guidelines for their good use and hazard warnings in clinical trials. Finally, the impact of these new technologies on the investigator as well as the project manager was analysed.

  5. A learning activity to introduce undergraduate students to bioethics in human clinical research: a case study.

    Science.gov (United States)

    Segarra, Ignacio; Gomez, Manuel

    2014-12-01

    We developed a pharmacology practicum assignment to introduce students to the research ethics and steps involved in a clinical trial. The assignment included literature review, critical analysis of bioethical situations, writing a study protocol and presenting it before a simulated ethics committee, a practice interview with a faculty member to obtain informed consent, and a student reflective assessment and self-evaluation. Students were assessed at various steps in the practicum; the learning efficiency of the activity was evaluated using an independent survey as well as students' reflective feedback. Most of the domains of Bloom's and Fink's taxonomies of learning were itemized and covered in the practicum. Students highly valued the translatability of theoretical concepts into practice as well as the approach to mimic professional practice. This activity was within a pharmacy program, but may be easily transferable to other medical or health sciences courses.

  6. Serodiagnosis of Mycobacterium avium complex disease in humans: translational research from basic mycobacteriology to clinical medicine.

    Science.gov (United States)

    Kobayashi, Kazuo

    2014-01-01

    Rapid and accurate diagnosis of infectious diseases, including mycobacterial disease such as tuberculosis (TB) and diseases due to nontuberculous mycobacteria (NTM), is a very important element of global health. The gold standard in diagnosis of mycobacterial diseases remains clinical examination, combined with direct microscopic examination of sputum and culture of bacteria. Culture of slowly growing mycobacteria, including Mycobacterium tuberculosis and NTM (such as M. avium complex: MAC), can take up to 4 to 6 weeks, and in 10-20% of cases the bacillus is not successfully cultivated. Diagnosis of MAC pulmonary disease (MAC-PD) is complicated and time-consuming (usually at least 1 month). I have characterized the nature of MAC antigens and immune responses from the aspect of basic mycobacteriology, and then translated to clinical science. My multicenter study in Japan has demonstrated the usefulness of a serodiagnostic test to determine serum IgA antibodies against mycobacterial glycopeptidolipid (GPL) core antigen for diagnosing MAC-PD within a few hours. To validate in a larger number of patients, at diverse geographic locations, and among other races, the test was also assessed the usefulness internationally in the United States and Taiwan. In this review, I discuss development of serodiagnosis of MAC-PD by translational research and international collaboration study.

  7. Clinical Research Methodology 2: Observational Clinical Research.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.

  8. Clinical research: regulatory issues.

    Science.gov (United States)

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

  9. Capturing all disease-causing mutations for clinical and research use: toward an effortless system for the Human Variome Project.

    Science.gov (United States)

    Cotton, Richard G H; Al Aqeel, Aida I; Al-Mulla, Fahd; Carrera, Paola; Claustres, Mireille; Ekong, Rosemary; Hyland, Valentine J; Macrae, Finlay A; Marafie, Makia J; Paalman, Mark H; Patrinos, George P; Qi, Ming; Ramesar, Rajkumar S; Scott, Rodney J; Sijmons, Rolf H; Sobrido, María-Jesús; Vihinen, Mauno

    2009-12-01

    The collection of genetic variants that cause inherited disease (causative mutation) has occurred for decades albeit in an ad hoc way, for research and clinical purposes. More recently, the access to collections of mutations causing specific diseases has become essential for appropriate genetic health care. Because information has accumulated, it has become apparent that there are many gaps in our ability to correctly annotate all the changes that are being identified at ever increasing rates. The Human Variome Project (www.humanvariomeproject.org) was initiated to facilitate integrated and systematic collection and access to this data. This manuscript discusses how collection of such data may be facilitated through new software and strategies in the clinical genetics and diagnostic laboratory communities.

  10. Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools

    Directory of Open Access Journals (Sweden)

    Pressler Taylor R

    2012-05-01

    Full Text Available Abstract Background Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. Methods The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Results Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV of 54.12% and 0.7%, respectively, and a negative predictive value (NPV of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. Conclusions This software is intended to provide an initial list of eligible patients to a

  11. Immunotherapy for human papillomavirus-associated disease and cervical cancer: review of clinical and translational research.

    Science.gov (United States)

    Lee, Sung Jong; Yang, Andrew; Wu, T C; Hung, Chien Fu

    2016-09-01

    Cervical cancer is the fourth most lethal women's cancer worldwide. Current treatments against cervical cancer include surgery, radiotherapy, chemotherapy, and anti-angiogenic agents. However, despite the various treatments utilized for the treatment of cervical cancer, its disease burden remains a global issue. Persistent infection of human papillomavirus (HPV) has been identified as an essential step of pathogenesis of cervical cancer and many other cancers, and nation-wide HPV screening as well as preventative HPV vaccination program have been introduced globally. However, even though the commercially available prophylactic HPV vaccines, Gardasil (Merck) and Cervarix (GlaxoSmithKline), are effective in blocking the entry of HPV into the epithelium of cervix through generation of HPV-specific neutralizing antibodies, they cannot eliminate the pre-existing HPV infection. For these reason, other immunotherapeutic options against HPV-associated diseases, including therapeutic vaccines, have been continuously explored. Therapeutic HPV vaccines enhance cell-mediated immunity targeting HPV E6 and E7 antigens by modulating primarily dendritic cells and cytotoxic T lymphocyte. Our review will cover various therapeutic vaccines in development for the treatment of HPV-associated lesions and cancers. Furthermore, we will discuss the potential of immune checkpoint inhibitors that have recently been adopted and tested for their treatment efficacy against HPV-induced cervical cancer.

  12. Construction of ethics in clinical research: clinical trials registration

    OpenAIRE

    C. A. Caramori

    2007-01-01

    Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...

  13. Ageism and clinical research.

    Science.gov (United States)

    Briggs, R; Robinson, S; O'Neill, D

    2012-10-01

    Despite being the most significant consumers of health care resources and medications worldwide, recent international research has highlighted the under-representation of older participants from clinical trials. This creates problems for physicians as the patients seen in clinical practice are not representative of those on which medical treatments and interventions have been trialled, and we need to consider whether results (both negative and positive) from these trials are applicable to these patients. Our aim was to gauge whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals. We audited all clinical research proposals submitted to the Research Ethics committee (REC) covering the teaching hospitals attached to Trinity College Dublin (TCD) from July 2008 to July 2011 inclusive, recording exclusion of patients based on an arbitrary upper age limit. Of the 226 relevant trials studied, 31(13.7%) excluded participants based solely on an arbitrary upper age limit. 22 (9.8%) of the relevant trials were submitted by geriatricians, none of which excluded patients based solely on age. Over 50% (12 of 22) trials submitted by neurology/psychiatry excluded patients based on an upper age limit. The mean upper age limit used over all trials as a cut-off was 69.2 years of age. As well as this, the majority of the remaining trials also contained other exclusion criteria, especially those based on cognitive function which further limited participation of older people. While we found that a significant proportion of clinical trials submitted to the TCD REC still excluded patients based arbitrarily on an upper age limit, participation rates of older people seem to be higher in this Irish centre than that seen in international trials. Significant room for improvement still remains however and there needs to be a promotion of greater awareness of the need for developing, testing and licensing medicines so that it mirrors the

  14. Development and Application of a Clinical Microsystem Simulation Methodology for Human Factors-Based Research of Alarm Fatigue.

    Science.gov (United States)

    Kobayashi, Leo; Gosbee, John W; Merck, Derek L

    2017-07-01

    (1) To develop a clinical microsystem simulation methodology for alarm fatigue research with a human factors engineering (HFE) assessment framework and (2) to explore its application to the comparative examination of different approaches to patient monitoring and provider notification. Problems with the design, implementation, and real-world use of patient monitoring systems result in alarm fatigue. A multidisciplinary team is developing an open-source tool kit to promote bedside informatics research and mitigate alarm fatigue. Simulation, HFE, and computer science experts created a novel simulation methodology to study alarm fatigue. Featuring multiple interconnected simulated patient scenarios with scripted timeline, "distractor" patient care tasks, and triggered true and false alarms, the methodology incorporated objective metrics to assess provider and system performance. Developed materials were implemented during institutional review board-approved study sessions that assessed and compared an experimental multiparametric alerting system with a standard monitor telemetry system for subject response, use characteristics, and end-user feedback. A four-patient simulation setup featuring objective metrics for participant task-related performance and response to alarms was developed along with accompanying structured HFE assessment (questionnaire and interview) for monitor systems use testing. Two pilot and four study sessions with individual nurse subjects elicited true alarm and false alarm responses (including diversion from assigned tasks) as well as nonresponses to true alarms. In-simulation observation and subject questionnaires were used to test the experimental system's approach to suppressing false alarms and alerting providers. A novel investigative methodology applied simulation and HFE techniques to replicate and study alarm fatigue in controlled settings for systems assessment and experimental research purposes.

  15. An externally head-mounted wireless neural recording device for laboratory animal research and possible human clinical use.

    Science.gov (United States)

    Yin, Ming; Li, Hao; Bull, Christopher; Borton, David A; Aceros, Juan; Larson, Lawrence; Nurmikko, Arto V

    2013-01-01

    In this paper we present a new type of head-mounted wireless neural recording device in a highly compact package, dedicated for untethered laboratory animal research and designed for future mobile human clinical use. The device, which takes its input from an array of intracortical microelectrode arrays (MEA) has ninety-seven broadband parallel neural recording channels and was integrated on to two custom designed printed circuit boards. These house several low power, custom integrated circuits, including a preamplifier ASIC, a controller ASIC, plus two SAR ADCs, a 3-axis accelerometer, a 48MHz clock source, and a Manchester encoder. Another ultralow power RF chip supports an OOK transmitter with the center frequency tunable from 3GHz to 4GHz, mounted on a separate low loss dielectric board together with a 3V LDO, with output fed to a UWB chip antenna. The IC boards were interconnected and packaged in a polyether ether ketone (PEEK) enclosure which is compatible with both animal and human use (e.g. sterilizable). The entire system consumes 17mA from a 1.2Ahr 3.6V Li-SOCl2 1/2AA battery, which operates the device for more than 2 days. The overall system includes a custom RF receiver electronics which are designed to directly interface with any number of commercial (or custom) neural signal processors for multi-channel broadband neural recording. Bench-top measurements and in vivo testing of the device in rhesus macaques are presented to demonstrate the performance of the wireless neural interface.

  16. [Clinical research VI. Clinical relevance].

    Science.gov (United States)

    Talavera, Juan O; Rivas-Ruiz, Rodolfo

    2011-01-01

    Usually, in clinical practice the maneuver selected is the one that achieves a favorable outcome with a direct percentage of superiority of at least 10 %, or when the number needed to treat is approximately equal to 10. While this percentage difference is practical for estimating the magnitude of an association, we need to differentiate the impact measures (attributable risk, preventable fraction), measures of association (RR, OR, HR), and frequency measures (incidence and prevalence) applicable when the outcome is nominal. And we must identify ways to measure the strength of association and the magnitude of the association when the outcome variable is quantitative. It is not uncommon to interpret the measures of association as if they were impact measures. For example, for a RR of 0.68, it is common to assume a 32 % reduction of the outcome, but we must consider that this is a relative reduction, which comes from relations of 0.4/0.6, 0.04/0.06, or 0.00004/0.00006. However the direct reduction is 20 % (60 % - 40 %), 2 %, and 2 per 100,000, respectively. Therefore, to estimate the impact of a maneuver it is important to have the direct difference and/or NNT.

  17. From the ideal market to the ideal clinic: constructing a normative standard of fairness for human subjects research.

    Science.gov (United States)

    Phillips, Trisha

    2011-02-01

    Preventing exploitation in human subjects research requires a benchmark of fairness against which to judge the distribution of the benefits and burdens of a trial. This paper proposes the ideal market and its fair market price as a criterion of fairness. The ideal market approach is not new to discussions about exploitation, so this paper reviews Wertheimer's inchoate presentation of the ideal market as a principle of fairness, attempt of Emanuel and colleagues to apply the ideal market to human subjects research, and Ballantyne's criticisms of both the ideal market and the resulting benchmark of fairness. It argues that the criticism of this particular benchmark is on point, but the rejection of the ideal market is mistaken. After presenting a complete account of the ideal market, this paper proposes a new method for applying the ideal market to human subjects research and illustrates the proposal by considering a sample case.

  18. Capturing all disease-causing mutations for clinical and research use : Toward an effortless system for the Human Variome Project

    NARCIS (Netherlands)

    Cotton, Richard G. H.; Al Aqeel, Aida I.; Al-Mulla, Fahd; Carrera, Paola; Claustres, Mireille; Ekong, Rosemary; Hyland, Valentine J.; Macrae, Finlay A.; Marafie, Makia J.; Paalman, Mark H.; Patrinos, George P.; Qi, Ming; Ramesar, Rajkumar S.; Scott, Rodney J.; Sijmons, Rolf H.; Sobrido, Maria-Jesus; Vihinen, Mauno

    2009-01-01

    The collection of genetic variants that cause inherited disease (causative mutation) has occurred for decades albeit in an ad hoc way, for research and clinical purposes. More recently, the access to collections of mutations causing specific diseases has become essential for appropriate genetic heal

  19. Human Research Program

    Data.gov (United States)

    National Aeronautics and Space Administration — Strategically, the HRP conducts research and technology development that: 1) enables the development or modification of Agency-level human health and performance...

  20. Human Subjects Issues in AIDS Research.

    Science.gov (United States)

    Bayer, Ronald, Ed.

    1990-01-01

    Six articles are presented on the use of human subjects in research on acquired immune deficiency syndrome (AIDS). Topics include the ethics of human experimentation, female and pediatric AIDS patients, Human Immunodeficiency Virus (HIV) infection and AIDS among correctional inmates, community-based AIDS research, and clinical trials of HIV…

  1. Medical Schools, Clinical Research, and Ethical Leadership

    Science.gov (United States)

    Makarushka, Julia L.; Lally, John J.

    1974-01-01

    Recent discussion of the ethical problems of biomedical human experimentation has drawn attention to the responsibility of the medical schools for training new clinical investigators and for safeguarding the rights and welfare of the subjects of clinical research conducted in the medical schools and their affiliated hospitals. (Author)

  2. Clinical Research In The International Medical University

    Directory of Open Access Journals (Sweden)

    Sivalingam Nalliah

    2008-12-01

    Full Text Available Clinical research refers to any field ofresearch involving human subjects. Clinicians asresearchers are well placed in contributing to research asthey have access to human subjects and are able to applyresearch results for better patient outcome. The need forclinician-scientists as a dedicated breed is henceimplied. Clinical research has low priority in the agendaof academic clinicians for various reasons. Strategies toovercome such a malady include training in researchmethodology and creating a permissive environment forthe conduct of research. The IMU has introducedseveral measures to enhance clinical research and has avibrant postgraduate program. The BMedSc programmehas seen an increase in MBBS students taking thisdegree. Research is part of the curriculum before theSemester 7 examinations. Clinicians have beenincreasingly seen to be involved in research. Theenhancement of clinical research through encouragingformal clinical research training and development of theMBBS-PhD programs could further enhance clinicalresearch at the IMU. Attention to logistic constraints,improvement in collaboration with the CRC-MOH andother agencies and the close working relationship withscientists will propel clinical research to higher levels.

  3. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  4. Clinical research 6: writing and research.

    Science.gov (United States)

    Endacott, Ruth

    2008-07-01

    This six-part research series is aimed at clinicians who wish to develop research skills, or who have a particular clinical problem that they think could be addressed through research. The series aims to provide insight into the decisions that researchers make in the course of their work, and to also provide a foundation for decisions that nurses may make in applying the findings of a study to practice in their own Unit or Department. The series emphasises the practical issues encountered when undertaking research in critical care settings; readers are encouraged to source research methodology textbooks for more detailed guidance on specific aspects of the research practice.

  5. Salvinorin A: A Mini Review of Physical and Chemical Properties Affecting Its Translation from Research to Clinical Applications in Humans.

    Science.gov (United States)

    Orton, Edward; Liu, Renyu

    2014-01-01

    Salvinorin A is a potent and selective agonist of kappa opioid receptors in the brain. Recent studies in several animal models have revealed that Salvinorin A has anti-addiction, anti-depression properties and exhibits pronounced neuroprotective effects against hypoxia/ischemia induced brain damage, and have raised interest in potential clinical applications in several acute pathologies involving oxygen deficiency in the brain. This review focuses on the chemical and physical properties of Salvinorin A and their impact on development of a rational formulation to enable its translation from a research compound to a novel therapeutic agent.

  6. Prostaglandins in clinical research

    Energy Technology Data Exchange (ETDEWEB)

    Sinzinger, H.; Schror, K.

    1987-01-01

    This book contains over 50 selections. Some of the titles are: Investigation of Selective Iloprost Binding Sites on Human Platelet Membranes; Effect of Irradiation on Thromboxane and Platelet Sensitivity In Vivo in patients with Cervical Cancer; Platelets, Eicosanoids, and Coronary Vasopasm; Experimental Variables Affecting Thromboxane B/sub 2/ Formation in Human Whole Blood; and Beneficial Effects of Thromboxane Receptor Antagonists in Acute Cardiovascular Crises.

  7. Clinical research before informed consent.

    Science.gov (United States)

    Miller, Franklin G

    2014-06-01

    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  8. Converging clinical and engineering research on neurorehabilitation

    CERN Document Server

    Torricelli, Diego; Pajaro, Marta

    2013-01-01

    Restoring human motor and cognitive function has been a fascinating research area during the last century. Interfacing the human nervous system with electro-mechanical rehabilitation machines is facing its crucial passage from research to clinical practice, enhancing the potentiality of therapists, clinicians and researchers to rehabilitate, diagnose and generate knowledge. The 2012 International Conference on Neurorehabilitation (ICNR2012, www.icnr2012.org) brings together researchers and students from the fields of Clinical Rehabilitation, Applied Neurophysiology and Biomedical Engineering, covering a wide range of research topics:   · Clinical Impact of Technology · Brain-Computer Interface in Rehabilitation · Neuromotor & Neurosensory modeling and processing · Biomechanics in Rehabilitation · Neural Prostheses in Rehabilitation · Neuro-Robotics in Rehabilitation · Neuromodulation   This Proceedings book includes general contributions from oral and poster sessions, as well as from special sess...

  9. Integrating clinical research into clinical decision making

    Directory of Open Access Journals (Sweden)

    Mark R Tonelli

    2011-01-01

    Full Text Available Evidence-based medicine has placed a general priority on knowledge gained from clinical research for clinical decision making. However, knowledge derived from empiric, population-based research, while valued for its ability to limit bias, is not directly applicable to the care of individual patients. The gap between clinical research and individual patient care centers on the fact that empiric research is not generally designed to answer questions of direct relevance to individual patients. Clinicians must utilize other forms of medical knowledge, including pathophysiologic rationale and clinical experience, in order to arrive at the best medical decision for a particular patient. In addition, clinicians must also elucidate and account for the goals and values of individual patients as well as barriers and facilitators of care inherent in the system in which they practice. Evidence-based guidelines and protocols, then, can never be prescriptive. Clinicians must continue to rely on clinical judgment, negotiating potentially conflicting warrants for action, in an effort to arrive at the best decision for a particular patient.

  10. SPECIAL ARTICLE Clinical research

    African Journals Online (AJOL)

    were standing on firm and safe ground, all things were in truth insecure ... research by those who forget that Wilhelm Roentgen was studying .... While cheap and easy to do these ... In adults the condition may appear to relate to promiscuity ...

  11. Population Genomics and the Statistical Values of Race: An Interdisciplinary Perspective on the Biological Classification of Human Populations and Implications for Clinical Genetic Epidemiological Research

    Science.gov (United States)

    Maglo, Koffi N.; Mersha, Tesfaye B.; Martin, Lisa J.

    2016-01-01

    The biological status and biomedical significance of the concept of race as applied to humans continue to be contentious issues despite the use of advanced statistical and clustering methods to determine continental ancestry. It is thus imperative for researchers to understand the limitations as well as potential uses of the concept of race in biology and biomedicine. This paper deals with the theoretical assumptions behind cluster analysis in human population genomics. Adopting an interdisciplinary approach, it demonstrates that the hypothesis that attributes the clustering of human populations to “frictional” effects of landform barriers at continental boundaries is empirically incoherent. It then contrasts the scientific status of the “cluster” and “cline” constructs in human population genomics, and shows how cluster may be instrumentally produced. It also shows how statistical values of race vindicate Darwin's argument that race is evolutionarily meaningless. Finally, the paper explains why, due to spatiotemporal parameters, evolutionary forces, and socio-cultural factors influencing population structure, continental ancestry may be pragmatically relevant to global and public health genomics. Overall, this work demonstrates that, from a biological systematic and evolutionary taxonomical perspective, human races/continental groups or clusters have no natural meaning or objective biological reality. In fact, the utility of racial categorizations in research and in clinics can be explained by spatiotemporal parameters, socio-cultural factors, and evolutionary forces affecting disease causation and treatment response. PMID:26925096

  12. Population Genomics and the Statistical Values of Race:An Interdisciplinary Perspective on the Biological Classification of Human Populations and Implications for Clinical Genetic Epidemiological Research

    Directory of Open Access Journals (Sweden)

    Koffi N. Maglo

    2016-02-01

    Full Text Available The biological status and biomedical significance of the concept of race as applied to humans continue to be contentious issues despite the use of advanced statistical and clustering methods to determine continental ancestry. It is thus imperative for researchers to understand the limitations as well as potential uses of the concept of race in biology and biomedicine. This paper deals with the theoretical assumptions behind cluster analysis in human population genomics. Adopting an interdisciplinary approach, it demonstrates that the hypothesis that attributes the clustering of human populations to frictional effects of landform barriers at continental boundaries is empirically incoherent. It then contrasts the scientific status of the cluster and cline constructs in human population genomics, and shows how cluster may be instrumentally produced. It also shows how statistical values of race vindicate Darwin’s argument that race is evolutionarily meaningless. Finally, the paper explains why, due to spatiotemporal parameters, evolutionary forces and socio-cultural factors influencing population structure, continental ancestry may be pragmatically relevant to global and public health genomics. Overall, this work demonstrates that, from a biological systematic and evolutionary taxonomical perspective, human races/continental groups or clusters have no natural meaning or objective biological reality. In fact, the utility of racial categorizations in research and in clinics can be explained by spatiotemporal parameters, socio-cultural factors and evolutionary forces affecting disease causation and treatment response.

  13. CLARA: an integrated clinical research administration system.

    Science.gov (United States)

    Bian, Jiang; Xie, Mengjun; Hogan, William; Hutchins, Laura; Topaloglu, Umit; Lane, Cheryl; Holland, Jennifer; Wells, Thomas

    2014-10-01

    Administration of human subject research is complex, involving not only the institutional review board but also many other regulatory and compliance entities within a research enterprise. Its efficiency has a direct and substantial impact on the conduct and management of clinical research. In this paper, we report on the Clinical Research Administration (CLARA) platform developed at the University of Arkansas for Medical Sciences. CLARA is a comprehensive web-based system that can streamline research administrative tasks such as submissions, reviews, and approval processes for both investigators and different review committees on a single integrated platform. CLARA not only helps investigators to meet regulatory requirements but also provides tools for managing other clinical research activities including budgeting, contracting, and participant schedule planning.

  14. Yoga clinical research review.

    Science.gov (United States)

    Field, Tiffany

    2011-02-01

    In this paper recent research is reviewed on the effects of yoga poses on psychological conditions including anxiety and depression, on pain syndromes, cardiovascular, autoimmune and immune conditions and on pregnancy. Further, the physiological effects of yoga including decreased heartrate and blood pressure and the physical effects including weight loss and increased muscle strength are reviewed. Finally, potential underlying mechanisms are proposed including the stimulation of pressure receptors leading to enhanced vagal activity and reduced cortisol. The reduction in cortisol, in turn, may contribute to positive effects such as enhanced immune function and a lower prematurity rate. Copyright © 2010 Elsevier Ltd. All rights reserved.

  15. How do researchers decide early clinical trials?

    Science.gov (United States)

    Grankvist, Hannah; Kimmelman, Jonathan

    2016-06-01

    Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research.

  16. Clinical research in surgery: threats and opportunities.

    Science.gov (United States)

    Ceelen, Wim P

    2014-01-01

    Surgery is a discipline which profoundly affects human integrity. Therefore, there is an ethical and scientific imperative that surgical practice depends on the best possible trial-based evidence. Traditionally, the quality and quantity of clinical research have been lagging behind other disciplines in clinical medicine. However, recent collaborative initiatives, such as the IDEAL framework which tests surgical innovation, international registries, and quality assurance platforms, the development of modified randomized controlled trials and alternative trial designs as well as the impending reforms of the regulatory framework surrounding nonpharmaceutical interventions and devices offer significant and timely opportunities to enhance the relevance of clinical research in surgery. Here, we provide an overview of the current state of clinical research in surgery, identify possible obstacles, and discuss realistic and emerging solutions that have the potential to change the way surgical research is organized, funded, and translated to the patient's benefit.

  17. Masters in clinical veterinary research.

    Science.gov (United States)

    Barr, Frances

    2016-08-20

    A new masters qualification from the BSAVA aims to encourage and support clinical research in practice. As Frances Barr explains, it is aimed at those looking for a professional challenge. British Veterinary Association.

  18. Cleveland Clinic Rehabilitation Research Program

    Science.gov (United States)

    2014-10-01

    functional impairments of the arm and hand , effects are weak and invariable. Limited succcess of rehabilitation is speculated to be associated with...Award Number: W81XWH-11-1-0707 TITLE: Cleveland Clinic Rehabilitation Research Program PRINCIPAL INVESTIGATOR: Vernon Lin, MD PhD CONTRACTING...CONTRACT NUMBER Cleveland Clinic Rehabilitation Research Program 5b. GRANT NUMBER W81XWH-11-1-0707 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d

  19. Review of In Vivo Bone Strain Studies and Finite Element Models of the Zygomatic Complex in Humans and Nonhuman Primates: Implications for Clinical Research and Practice.

    Science.gov (United States)

    Prado, Felippe Bevilacqua; Freire, Alexandre Rodrigues; Cláudia Rossi, Ana; Ledogar, Justin A; Smith, Amanda L; Dechow, Paul C; Strait, David S; Voigt, Tilman; Ross, Callum F

    2016-12-01

    The craniofacial skeleton is often described in the clinical literature as being comprised of vertical bony pillars, which transmit forces from the toothrow to the neurocranium as axial compressive stresses, reinforced transversely by buttresses. Here, we review the literature on bony microarchitecture, in vivo bone strain, and finite-element modeling of the facial skeleton of humans and nonhuman primates to address questions regarding the structural and functional existence of facial pillars and buttresses. Available bone material properties data do not support the existence of pillars and buttresses in humans or Sapajus apella. Deformation regimes in the zygomatic complex emphasize bending and shear, therefore conceptualizing the zygomatic complex of humans or nonhuman primates as a pillar obscures its patterns of stress, strain, and deformation. Human fossil relatives and chimpanzees exhibit strain regimes corroborating the existence of a canine-frontal pillar, but the notion of a zygomatic pillar has no support. The emerging consensus on patterns of strain and deformation in finite element models (FEMs) of the human facial skeleton corroborates hypotheses in the clinical literature regarding zygomatic complex function, and provide new insights into patterns of failure of titanium and resorbable plates in experimental studies. It is suggested that the "pillar and buttress" model of human craniofacial skeleton function be replaced with FEMs that more accurately and precisely represent in vivo function, and which can serve as the basis for future research into implants used in restoration of occlusal function and fracture repair. Anat Rec, 299:1753-1778, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  20. Human subjects research handbook: Protecting human research subjects. Second edition

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-30

    This handbook serves as a guide to understanding and implementing the Federal regulations and US DOE Orders established to protect human research subjects. Material in this handbook is directed towards new and continuing institutional review board (IRB) members, researchers, institutional administrators, DOE officials, and others who may be involved or interested in human subjects research. It offers comprehensive overview of the various requirements, procedures, and issues relating to human subject research today.

  1. Visual research in clinical education.

    Science.gov (United States)

    Bezemer, Jeff

    2017-01-01

    The aim of this paper is to explore what might be gained from collecting and analysing visual data, such as photographs, scans, drawings, video and screen recordings, in clinical educational research. Its focus is on visual research that looks at teaching and learning 'as it naturally occurs' in the work place, in simulation centres and other sites, and also involves the collection and analysis of visual learning materials circulating in these sites. With the ubiquity of digital recording devices, video data and visual learning materials are now relatively cheap to collect. Compared to other domains of education research visual materials are not widely used in clinical education research. The paper sets out to identify and reflect on the possibilities for visual research using examples from an ethnographic study on surgical and inter-professional learning in the operating theatres of a London hospital. The paper shows how visual research enables recognition, analysis and critical evaluation of (1) the hidden curriculum, such as the meanings implied by embodied, visible actions of clinicians; (2) the ways in which clinical teachers design multimodal learning environments using a range of modes of communication available to them, combining, for instance, gesture and speech; (3) the informal assessment of clinical skills, and the intricate relation between trainee performance and supervisor feedback; (4) the potentialities and limitations of different visual learning materials, such as textbooks and videos, for representing medical knowledge. The paper concludes with theoretical and methodological reflections on what can be made visible, and therefore available for analysis, explanation and evaluation if visual materials are used for clinical education research, and what remains unaccounted for if written language remains the dominant mode in the research cycle. Opportunities for quantitative analysis and ethical implications are also discussed. © 2016 John Wiley

  2. [Research activity in clinical biochemistry

    DEFF Research Database (Denmark)

    Jorgensen, H.L.; Larsen, B.; Ingwersen, P.

    2008-01-01

    BACKGROUND: Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched...... Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained....... RESULTS: 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry...

  3. Bias in clinical intervention research

    DEFF Research Database (Denmark)

    Gluud, Lise Lotte

    2006-01-01

    Research on bias in clinical trials may help identify some of the reasons why investigators sometimes reach the wrong conclusions about intervention effects. Several quality components for the assessment of bias control have been suggested, but although they seem intrinsically valid, empirical...

  4. Adaptation to prolonged bedrest in man: A compendium of research. [bibliographies on clinical medicine and human pathology

    Science.gov (United States)

    Greenleaf, J. E.; Greenleaf, C. J.; Vanderveer, D.; Dorchak, K. J.

    1976-01-01

    A compilation of major studies that describe the clinical observations and elucidate the physiological mechanisms of the adaptive process of man undergoing prolonged bed rest is presented. Additional studies are included that provide background information in the form of reviews or summaries of the process. Wherever possible a detailed annotation is provided under the subheadings: (1) purpose, (2) procedure and methods, (3) results, and (4) conclusions. Additional references are provided in a selected bibliography.

  5. [Network Research on Human Papillomavirus].

    Science.gov (United States)

    Almeida-Gutiérrez, Eduardo; Paniagua, Ramón; Furuya, María ElenaYuriko

    2015-01-01

    In order to increase the research in important health questions at a national and institutional levels, the Human Papillomavirus Research Network of the Health Research Coordination of the Instituto Mexicano del Seguro Social offers this supplement with the purpose of assisting patients that daily look for attention due to the human papillomavirus or to cervical cancer.

  6. Writing a clinical research paper

    Directory of Open Access Journals (Sweden)

    Ajao Oluwole

    1999-01-01

    Full Text Available A well-known unwritten law in institutions of higher learning is that of "Publish or perish". The duties of a University teacher, in order of priority are teaching, research and service. Reasons for writing clinical research papers are to get promoted, to get research grants and to make known, one′s findings in order to improve patients′ care. Writing papers is also a means of delivering continuous education, therefore publication is essential for any one pursuing an academic career. Research papers can be in the form of case reports, retrospective studies, prospective studies and laboratory or animal research. Two popular formats of writing papers are: The Vancouver Style and the Harvard System.

  7. Human Performance Research Center

    Data.gov (United States)

    Federal Laboratory Consortium — Biochemistry:Improvements in energy metabolism, muscular strength and endurance capacity have a basis in biochemical and molecular adaptations within the human body....

  8. New frontiers in human assisted reproduction ‑ from research to clinical practice: Several considerations (Review).

    Science.gov (United States)

    Gizzo, Salvatore; Noventa, Marco; Quaranta, Michela; Venturella, Roberta; Vitagliano, Amerigo; Gangemi, Michele; D'Antona, Donato

    2016-11-01

    In the era of very late, or advanced, motherhood, in which 'egg banks', 'social' egg‑freezing, egg donation and surrogacy represent a potential solution to a number of obstacles to human reproduction, what is the role of scientists and clinicians involved in assisted reproduction? In light of the apprehension that, in the future, through fertility treatment infertility may be passed on to the offspring, boundaries of medical vs. 'social' infertility are being created. Scientists and clinicians are joining forces in a synergistic effort to improve the effectiveness of infertility care by introducing novel therapeutic protocols with the intent of customising care and improving cost‑effectiveness, testing novel drugs and formulations, and searching for novel markers (for estimating biological age) and nomograms (to optimise the yield of a controlled ovarian hyperstimulation cycle). On the other hand, political, social and health institutions are doing little to educate young women with respect to disinformation and to increase their awareness regarding age as the predominant factor that contributes towards the decline in fertility. Nevertheless, despite the great advances that have been made, 38 years after the birth of the first baby via in vitro fertilisation, the intricate road leading from the antral follicle to the fully developed baby continues to be designated as being too 'expensive', 'empirical', 'mysterious' or 'bound by ethics', with few significant improvements in terms of real cost‑effectiveness.

  9. 78 FR 14806 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-03-07

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Special Emphasis Panel: Clinically Relevant... grant applications. Place: National Human Genome Research Institute, 4th Floor Conference Room,...

  10. Research and clinical practice relationship

    Directory of Open Access Journals (Sweden)

    Ashammakhi N

    2008-01-01

    Full Text Available To The Editor: I highly value and greet the authors for their editorial. Many important issues related to medical education and its future in Libya have been discussed in this paper [1]. One important point that has been addressed and I feel deserves attention is the “abnormal” relationship between clinical practice and research in Libya. From discussions with colleagues, this problem somehow has evolved from a misconception about educational and training systems that may have occurred in the past. It may also be related to the lack of attention to research that has long existed in Libya [2,3]. The other aspect, shared with many other developing countries, is the misconception of research as unimportant or a luxury aspect of medicine. When it comes to understanding how a system (including healthcare can be updated and developed, the answer is vague! One important reason is a lack of understanding of the impact that research has on developing methods. In developed countries, research is the main academic distinction that leads to appointments for coveted positions in the system and is an important factor for academic promotion. In Libya, there remain arguments about who will be awarded Chair of university clinical departments. Such a post should no doubt be given to those with established academic achievements. When highly qualified persons are at the top of the pyramid this leads to further progress and enhanced research and advancement. The authors have discussed the point of having proper search committees for leadership and faculty positions. I believe that it will help eliminate the current stagnation and help to create innovative solutions. This should lead to improved medical education, health services, and ultimately impact the quality of life of all Libyan citizens.

  11. Researching Human Rights in Prisons

    Directory of Open Access Journals (Sweden)

    Bronwyn Naylor

    2015-04-01

    Full Text Available This paper examines two issues: the author’s recent research on the capacity of prisons to incorporate human rights considerations into their routine management; and the methods employed in this research in prisons in two Australian jurisdictions. The first element examines the impact of formal human rights instruments on prison management and on the lived experiences of prisoners, and the potential for the practical application of human rights obligations in this environment. The second gives closer analysis to the specific use of qualitative methodologies in carrying out this research, and the potential implications of methodology for subsequent acceptance of research findings by governments.

  12. Science Translational Medicine – improving human health care worldwide by providing an interdisciplinary forum for idea exchange between basic scientists and clinical research practitioners

    Directory of Open Access Journals (Sweden)

    Forsythe, Katherine

    2010-09-01

    Full Text Available Science Translational Medicine’s mission is to improve human health care worldwide by providing a forum for communication and interdisciplinary idea exchange between basic scientists and clinical research practitioners from all relevant established and emerging disciplines. The weekly journal debuted in October 2009 and is published by the American Association for the Advancement of Science (AAAS, the publisher of Science and Science Signaling. The journal features peer-reviewed research articles, perspectives and commentary, and is guided by an international Advisory Board, led by Chief Scientific Adviser, Elias A. Zerhouni, M.D., former Director of the National Institutes of Health, and Senior Scientific Adviser, Elazer R. Edelman, M.D., Ph.D., Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology, Massachusetts Institute of Technology. The Science Translational Medicine editorial team is led by Katrina L. Kelner, Ph.D., AAAS. A profound transition is required for the science of translational medicine. Despite 50 years of advances in our fundamental understanding of human biology and the emergence of powerful new technologies, the rapid transformation of this knowledge into effective health measures is not keeping pace with the challenges of global health care. Creative experimental approaches, novel technologies, and new ways of conducting scientific explorations at the interface of established and emerging disciplines are now required to an unprecedented degree if real progress is to be made. To aid in this reinvention, Science and AAAS have created a new interdisciplinary journal, Science Translational Medicine. The following interview exemplefies the pioneering content found in Science Translational Medicine. It is an excerpt from a Podcast interview with Dr. Samuel Broder, former director of the National Cancer Institute and current Chief Medical Officer at Celera. The Podcast was produced in tangent with Dr

  13. Biological Databases for Human Research

    Institute of Scientific and Technical Information of China (English)

    Dong Zou; Lina Ma; Jun Yu; Zhang Zhang

    2015-01-01

    The completion of the Human Genome Project lays a foundation for systematically studying the human genome from evolutionary history to precision medicine against diseases. With the explosive growth of biological data, there is an increasing number of biological databases that have been developed in aid of human-related research. Here we present a collection of human-related biological databases and provide a mini-review by classifying them into different categories according to their data types. As human-related databases continue to grow not only in count but also in volume, challenges are ahead in big data storage, processing, exchange and curation.

  14. Biological Databases for Human Research

    Science.gov (United States)

    Zou, Dong; Ma, Lina; Yu, Jun; Zhang, Zhang

    2015-01-01

    The completion of the Human Genome Project lays a foundation for systematically studying the human genome from evolutionary history to precision medicine against diseases. With the explosive growth of biological data, there is an increasing number of biological databases that have been developed in aid of human-related research. Here we present a collection of human-related biological databases and provide a mini-review by classifying them into different categories according to their data types. As human-related databases continue to grow not only in count but also in volume, challenges are ahead in big data storage, processing, exchange and curation. PMID:25712261

  15. Clinical and Technical Phosphoproteomic Research

    Directory of Open Access Journals (Sweden)

    Ferreira Antonio

    2011-06-01

    Full Text Available Abstract An encouraging approach for the diagnosis and effective therapy of immunological pathologies, which would include cancer, is the identification of proteins and phosphorylated proteins. Disease proteomics, in particular, is a potentially useful method for this purpose. A key role is played by protein phosphorylation in the regulation of normal immunology disorders and targets for several new cancer drugs and drug candidates are cancer cells and protein kinases. Protein phosphorylation is a highly dynamic process. The functioning of new drugs is of major importance as is the selection of those patients who would respond best to a specific treatment regime. In all major aspects of cellular life signalling networks are key elements which play a major role in inter- and intracellular communications. They are involved in diverse processes such as cell-cycle progression, cellular metabolism, cell-cell communication and appropriate response to the cellular environment. A whole range of networks that are involved in the regulation of cell development, differentiation, proliferation, apoptosis, and immunologic responses is contained in the latter. It is so necessary to understand and monitor kinase signalling pathways in order to understand many immunology pathologies. Enrichment of phosphorylated proteins or peptides from tissue or bodily fluid samples is required. The application of technologies such as immunoproteomic techniques, phosphoenrichments and mass spectrometry (MS is crucial for the identification and quantification of protein phosphorylation sites in order to advance in clinical research. Pharmacodynamic readouts of disease states and cellular drug responses in tumour samples will be provided as the field develops. We aim to detail the current and most useful techniques with research examples to isolate and carry out clinical phosphoproteomic studies which may be helpful for immunology and cancer research. Different phosphopeptide

  16. Sharing clinical research data: workshop summary

    National Research Council Canada - National Science Library

    Olson, Steve; Downey, Autumn S

    2013-01-01

    Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data...

  17. Clinical Research Strategies for Fructose Metabolism12

    Science.gov (United States)

    Laughlin, Maren R.; Bantle, John P.; Havel, Peter J.; Parks, Elizabeth; Klurfeld, David M.; Teff, Karen; Maruvada, Padma

    2014-01-01

    Fructose and simple sugars are a substantial part of the western diet, and their influence on human health remains controversial. Clinical studies in fructose nutrition have proven very difficult to conduct and interpret. NIH and USDA sponsored a workshop on 13–14 November 2012, “Research Strategies for Fructose Metabolism,” to identify important scientific questions and parameters to be considered while designing clinical studies. Research is needed to ascertain whether there is an obesogenic role for fructose-containing sugars via effects on eating behavior and energy balance and whether there is a dose threshold beyond which these sugars promote progression toward diabetes and liver and cardiovascular disease, especially in susceptible populations. Studies tend to fall into 2 categories, and design criteria for each are described. Mechanistic studies are meant to validate observations made in animals or to elucidate the pathways of fructose metabolism in humans. These highly controlled studies often compare the pure monosaccharides glucose and fructose. Other studies are focused on clinically significant disease outcomes or health behaviors attributable to amounts of fructose-containing sugars typically found in the American diet. These are designed to test hypotheses generated from short-term mechanistic or epidemiologic studies and provide data for health policy. Discussion brought out the opinion that, although many mechanistic questions concerning the metabolism of monosaccharide sugars in humans remain to be addressed experimentally in small highly controlled studies, health outcomes research meant to inform health policy should use large, long-term studies using combinations of sugars found in the typical American diet rather than pure fructose or glucose. PMID:24829471

  18. Clinical research strategies for fructose metabolism.

    Science.gov (United States)

    Laughlin, Maren R; Bantle, John P; Havel, Peter J; Parks, Elizabeth; Klurfeld, David M; Teff, Karen; Maruvada, Padma

    2014-05-01

    Fructose and simple sugars are a substantial part of the western diet, and their influence on human health remains controversial. Clinical studies in fructose nutrition have proven very difficult to conduct and interpret. NIH and USDA sponsored a workshop on 13-14 November 2012, "Research Strategies for Fructose Metabolism," to identify important scientific questions and parameters to be considered while designing clinical studies. Research is needed to ascertain whether there is an obesogenic role for fructose-containing sugars via effects on eating behavior and energy balance and whether there is a dose threshold beyond which these sugars promote progression toward diabetes and liver and cardiovascular disease, especially in susceptible populations. Studies tend to fall into 2 categories, and design criteria for each are described. Mechanistic studies are meant to validate observations made in animals or to elucidate the pathways of fructose metabolism in humans. These highly controlled studies often compare the pure monosaccharides glucose and fructose. Other studies are focused on clinically significant disease outcomes or health behaviors attributable to amounts of fructose-containing sugars typically found in the American diet. These are designed to test hypotheses generated from short-term mechanistic or epidemiologic studies and provide data for health policy. Discussion brought out the opinion that, although many mechanistic questions concerning the metabolism of monosaccharide sugars in humans remain to be addressed experimentally in small highly controlled studies, health outcomes research meant to inform health policy should use large, long-term studies using combinations of sugars found in the typical American diet rather than pure fructose or glucose. © 2014 American Society for Nutrition.

  19. Bringing ayahuasca to the clinical research laboratory.

    Science.gov (United States)

    Riba, Jordi; Barbanoj, Manel J

    2005-06-01

    Since the winter of 1999, the authors and their research team have been conducting clinical studies involving the administration of ayahuasca to healthy volunteers. The rationale for conducting this kind of research is twofold. First, the growing interest of many individuals for traditional indigenous practices involving the ingestion of natural psychotropic drugs such as ayahuasca demands the systematic study of their pharmacological profiles in the target species, i.e., human beings. The complex nature of ayahuasca brews combining a large number of pharmacologically active compounds requires that research be carried out to establish the safety and overall pharmacological profile of these products. Second, the authors believe that the study of psychedelics in general calls for renewed attention. Although the molecular and electrophysiological level effects of these drugs are relatively well characterized, current knowledge of the mechanisms by which these compounds modify the higher order cognitive processes in the way they do is still incomplete, to say the least. The present article describes the development of the research effort carried out at the Autonomous University of Barcelona, commenting on several methodological aspects and reviewing the basic clinical findings. It also describes the research currently underway in our laboratory, and briefly comments on two new studies we plan to undertake in order to further our knowledge of the pharmacology of ayahuasca.

  20. Frequently Asked Questions about Clinical Research

    Science.gov (United States)

    ... conducted with human subjects, or material of human origin, in which the researcher directly interacts with human ... The placebo effect is the phenomenon of patients feeling better simply because they think they are receiving ...

  1. Clinical research monitoring: scenarios and challenges

    Directory of Open Access Journals (Sweden)

    Gustavo Adolfo Sierra Romero

    2013-01-01

    Full Text Available Clinical research is essential for the development of new drugs, diagnostic tests and new devices. Clinical monitoring is implemented to improve the quality of research and attain high ethical and scientific standards. This review discusses the role of clinical monitors, taking into account the variety of scenarios in which medical research is developed, and highlights the challenges faced by research teams to ensure that patients rights are respected and that the social role of scientific research is preserved. Specific emphasis is given to the ethical dilemmas related to the multiple roles which clinical monitors play in the research framework, mainly those involving the delicate equilibrium between the loyalty to the sponsor and to the research subjects. The essential role of clinical monitoring for research developed in poor healthcare scenarios is highlighted as an approach to get the local infrastructure strengthening needed to achieve an adequate level of good clinical practices.

  2. [Clinical research V. Sample size].

    Science.gov (United States)

    Talavera, Juan O; Rivas-Ruiz, Rodolfo; Bernal-Rosales, Laura Paola

    2011-01-01

    In clinical research it is impossible and inefficient to study all patients with a specific pathology, so it is necessary to study a sample of them. The estimation of the sample size before starting a study guarantees the stability of the results and allows us to foresee the feasibility of the study depending on the availability of patients and cost. The basic structure of sample size estimation is based on the premise that seeks to demonstrate, among other cases, that the observed difference between two or more maneuvers in the subsequent state is real. Initially, it requires knowing the value of the expected difference (δ) and its data variation (standard deviation). These data are usually obtained from previous studies. Then, other components must be considered: a (alpha), percentage of error in the assertion that the difference between means is real, usually 5 %; and β, error rate accepting the claim that the no-difference between the means is real, usually ranging from 15 to 20 %. Finally, these values are substituted into the formula or in an electronic program for estimating sample size. While summary and dispersion measures vary with the type of variable according to the outcome, the basic structure is the same.

  3. Stuttering: Clinical and research update.

    Science.gov (United States)

    Perez, Hector R; Stoeckle, James H

    2016-06-01

    To provide an update on the epidemiology, genetics, pathophysiology, diagnosis, and treatment of developmental stuttering. The MEDLINE and Cochrane databases were searched for past and recent studies on the epidemiology, genetics, pathophysiology, diagnosis, and treatment of developmental stuttering. Most recommendations are based on small studies, limited-quality evidence, or consensus. Stuttering is a speech disorder, common in persons of all ages, that affects normal fluency and time patterning of speech. Stuttering has been associated with differences in brain anatomy, functioning, and dopamine regulation thought to be due to genetic causes. Attention to making a correct diagnosis or referral in children is important because there is growing consensus that early intervention with speech therapy for children who stutter is critical. For adults, stuttering can be associated with substantial psychosocial morbidity including social anxiety and low quality of life. Pharmacologic treatment has received attention in recent years, but clinical evidence is limited. The mainstay of treatment for children and adults remains speech therapy. A growing body of research has attempted to uncover the pathophysiology of stuttering. Referral for speech therapy remains the best option for children and adults. Copyright© the College of Family Physicians of Canada.

  4. Protecting human subjects in research.

    Science.gov (United States)

    Orticio, Lily P

    2009-01-01

    The quest for advancing scientific knowledge through human experimentations using vulnerable groups is traced back to ancient history, when Herophilus performed vivisections on prisoners. The violation of the rights of human subjects through the 20th century led to the formulation of the Nuremberg Code in 1947 and the Declaration of Helsinki in 1964. In the United States, the most infamous was the Tuskegee public health study that resulted in the enactment of the National Research Act that authorized the creation of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research in 1974. In spite of existing federal regulations, the system of protecting human subjects is still flawed. Transparency of conflict ofinterest, clarity, and strict adherence to institutional guidelines are critical in safeguarding the rights and safety of human subjects and the integrity of research. Education on ethics and emerging complex ethical issues, global awareness, and governmental cooperation and sanctions are important steps in addressing the inadequacies in protecting the most vulnerable populations in experimentations worldwide. Investigators must always remember that the primary safeguards of protecting human life rest in their hands.

  5. Research Priority of Clinical Linguistics in Iran

    OpenAIRE

    Ahadi MR

    2016-01-01

    Background Study in clinical linguistics can reflect and requirements of this area, and can contribute to effective and useful changes in this area. Objectives Since there have been a few studies in the field of clinical linguistics in Iran, this research can pave the way to find research priorities of clinical linguistics in our country. Materials and Methods Studies related to l...

  6. Extending the rails: how research reshapes clinics.

    Science.gov (United States)

    Petty, JuLeigh; Heimer, Carol A

    2011-06-01

    The purpose of clinical research is to create the scientific foundation for medical practice. In this way of thinking, the effect on medical practice occurs after the research has been completed. Social studies of science have debunked the standard model of scientific research, observing that changes in practice associated with research occur not just because of the results of research but also because of the practice of research. Drawing on fieldwork in HIV clinics in the US, South Africa,Thailand, and Uganda, we argue that clinical trials shape medical practice by altering the organizations in which both medical treatment and clinical trials take place. Three general processes are central to this transformation: the modification of material environments, the reorganization of bureaucratic relations, and the prioritization of research values. These processes unfold somewhat differently in the clinics of poorer countries than in those of wealthier ones.

  7. Infant intersubjectivity: research, theory, and clinical applications.

    Science.gov (United States)

    Trevarthen, C; Aitken, K J

    2001-01-01

    We review research evidence on the emergence and development of active "self-and-other" awareness in infancy, and examine the importance of its motives and emotions to mental health practice with children. This relates to how communication begins and develops in infancy, how it influences the individual subject's movement, perception, and learning, and how the infant's biologically grounded self-regulation of internal state and self-conscious purposefulness is sustained through active engagement with sympathetic others. Mutual self-other-consciousness is found to play the lead role in developing a child's cooperative intelligence for cultural learning and language. A variety of preconceptions have animated rival research traditions investigating infant communication and cognition. We distinguish the concept of "intersubjectivity", and outline the history of its use in developmental research. The transforming body and brain of a human individual grows in active engagement with an environment of human factors--organic at first, then psychological or inter-mental. Adaptive, human-responsive processes are generated first by interneuronal activity within the developing brain as formation of the human embryo is regulated in a support-system of maternal tissues. Neural structures are further elaborated with the benefit of intra-uterine stimuli in the foetus, then supported in the rapidly growing forebrain and cerebellum of the young child by experience of the intuitive responses of parents and other human companions. We focus particularly on intrinsic patterns and processes in pre-natal and post-natal brain maturation that anticipate psychosocial support in infancy. The operation of an intrinsic motive formation (IMF) that developed in the core of the brain before birth is evident in the tightly integrated intermodal sensory-motor coordination of a newborn infant's orienting to stimuli and preferential learning of human signals, by the temporal coherence and intrinsic

  8. Protocol Writing in Clinical Research

    Science.gov (United States)

    Al-Jundi, Azzam

    2016-01-01

    Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition. PMID:28050522

  9. Infectious Disease Clinical Research Program (IDCRP)

    Data.gov (United States)

    Federal Laboratory Consortium — Our mission is to conduct infectious disease clinical research of importance to the military through a unique, adaptive, and collaborative network, to inform health...

  10. MR spectroscopy in clinical research

    DEFF Research Database (Denmark)

    Henriksen, O

    1994-01-01

    affections of the myocardium. In the liver 31P MRS appears to be rather insensitive and non-specific, but absolute quantification of metabolite concentrations and using metabolic "stress models" may prove useful in the future. The clinical role of MRS in oncology is still unclear, but it may be useful...... energy metabolism, loss of neurones, and lactate production in a large number of brain diseases. Furthermore, 31P and 1H MRS may be particularly clinically useful in evaluation of various disorders in skeletal muscle. In the heart 31P MRS seems at the moment the most suitable for evaluation of global...

  11. Antiphospholipid Syndrome Clinical Research Task Force Report

    NARCIS (Netherlands)

    Erkan, D.; Derksen, R.; Levy, R.; Machin, S.; Ortel, T.; Pierangeli, S.; Roubey, R.; Lockshin, M.

    2011-01-01

    The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing gui

  12. Aspectos Éticos de la Investigación Clínica en seres humanos Clinic research in human beings: Ethical aspect

    Directory of Open Access Journals (Sweden)

    Carlos M Albornoz López del Castillo

    2003-08-01

    Full Text Available La ética de la experimentación con seres humanos no es sólo una de las áreas fundamentales de la bioética, sino también una de las problemáticas que le dieron origen. Se describen en este trabajo algunas implicaciones éticas de la experimentación en seres humanos; se analizan el origen y evolución de la bioética, los aspectos regulatorios para la realización de ensayos clínicos y su valoración moral, los tipos de experimentación; la realidad mundial y cubana en cuanto a investigación clínica y tecnología y el consentimiento informado. Se concluye que el criterio ético fundamental de las investigaciones en seres humanos es su disposición al servicio del hombreThe ethics of experimentation with human beings is not only one of the fundamental areas of bioethics, but also one of the problems that originated this field. In this work some ethical implications of experimentation in human beings are described; the origin and evolution of bioethics are analyzed, the regulatory aspects for the realization of clinical trials and their moral valuation, the experimentation types; international and Cuban reality as for clinical investigation and technology and the informed consent. It is assumed that the fundamental ethical approach of the investigations with human beings is its disposition to serve mankind

  13. Paternalism and fairness in clinical research.

    Science.gov (United States)

    Jansen, Lynn A; Wall, Steven

    2009-03-01

    In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right to participate in clinical research and that considerations of distributive fairness justify some paternalistic protections of research subjects.

  14. 48 CFR 207.172 - Human research.

    Science.gov (United States)

    2010-10-01

    ... compliance with 32 CFR Part 219, Protection of Human Subjects; and (b) Must have a Human Research Protection... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Human research. 207.172... OF DEFENSE ACQUISITION PLANNING ACQUISITION PLANNING Acquisition Plans 207.172 Human research. Any...

  15. Translational research into species differences of endocrine toxicity via steroidogenesis inhibition by SMP-028 — For human safety in clinical study

    Energy Technology Data Exchange (ETDEWEB)

    Nishizato, Yohei, E-mail: yohei-nishizato@ds-pharma.co.jp [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Imai, Satoki [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Okahashi, Noriko [Research Planning and Intelligence, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Yabunaka, Atsushi; Kunimatsu, Takeshi [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Kikuchi, Kaoru [Innovative Drug Discovery Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan); Yabuki, Masashi [Preclinical Research Laboratories, Dainippon Sumitomo Pharma Co., Ltd., 33-94, Enoki-cho, Suita, Osaka 564-0053 (Japan)

    2014-05-01

    SMP-028 is a drug candidate developed for the treatment of asthma. In a 13-week repeated dose toxicity study of SMP-028 in rats and monkeys, differences of endocrine toxicological events between rats and monkeys were observed. In rats, these toxicological events mainly consisted of pathological changes in the adrenal, testis, ovary, and the other endocrine-related organs. On the other hand, in monkeys, no toxicological events were observed. The goal of this study is to try to understand the reason why only rats, but not monkeys, showed toxicological events following treatment with SMP-028 and to eventually predict the possible toxicological effect of this compound on human endocrine organs. Our results show that SMP-028 inhibits neutral cholesterol esterase more strongly than other steroidogenic enzymes in rats. Although SMP-028 also inhibits monkeys and human neutral cholesterol esterase, this inhibition is much weaker than that of rat neutral cholesterol esterase. These results indicate (1) that the difference in endocrine toxicological events between rats and monkeys is mainly due to inhibition of steroidogenesis by SMP-028 in rats, not in monkeys, and (2) that SMP-028 may not affect steroidogenesis in humans and therefore might cause no endocrine toxicological events in clinical studies. - Highlights: • SMP-028 inhibits neutral CEase more strongly than other steroidogenic enzymes in rats. • Inhibition of neutral CEase in rats by SMP-028 suppresses steroidogenesis in vivo. • SMP-028 does not inhibit neutral CEase in monkeys in vivo. • Steroidogenesis pathway in monkeys treated with SMP-028 was not suppressed. • SMP-028 may not inhibit LIPE in humans in vivo.

  16. Chloracne: From clinic to research

    Directory of Open Access Journals (Sweden)

    Qiang Ju

    2012-03-01

    Full Text Available Chloracne is the most sensitive and specific marker for a possible dioxin (2,3,7,8-tetrachlorodibenzo-p-dioxin intoxication. It is clinically characterized by multiple acneiform comedone-like cystic eruptions mainly involving face in the malar, temporal, mandibular, auricular/retroauricular regions, and the genitalia, often occurring in age groups not typical for acne vulgaris. Histopathology is essential for a definite diagnosis, which exhibits atrophy or absence of sebaceous glands as well as infundibular dilatation or cystic formation of hair follicles, hyperplasia of epidermis, and hyperpigmentation of stratum corneum. The appearance of chloracne and its clinical severity does not correlate with the blood levels of dioxins. Pathogenesis of chloracne remains largely unclear. An “aryl hydrocarbon receptor”-mediated signaling pathway affecting the multipotent stem cells in the pilosebaceous units is probably the major molecular mechanism inducing chloracne. Chloracne is resistant to all the available treatment modalities used to treat acne. The aim of treatment is to lower or to eliminate the accumulated dioxins in the body at the very beginning of intoxication, e.g., by using dioxin-chelating substances such as synthetic dietary fat substitutes. The problem of dioxin contamination and its potential health hazards should be taken seriously in the wave of industrial globalization in the twenty-first century. Clinicians, especially dermatologists, are in the forefront of early diagnosis of dioxin intoxication.

  17. New projections of clinical research in Ecuador

    Directory of Open Access Journals (Sweden)

    Thelvia I. Ramos

    2016-01-01

    Full Text Available The accelerated development of the pharmaceutical industry, particularly the industry of biologics products, has brought an increase in clinical research and strengthening regulatory agencies to achieve product registration studies in the shortest time and with the required quality under the rules of Good Clinical Practice. For improvement of this type of research arise Contract Research Organizations (CRO, which allow the development of research and provide services ranging from preclinical studies to conducting and realization of clinical trials. For instance, these companies should know the peculiarities of the product and, to demonstrate safety, efficacy and entrance to pharmaceutical market with a precise indication. In this article we hereby inform you the first CRO in Ecuador to meet these standards for clinical research.

  18. Retooling institutional support infrastructure for clinical research.

    Science.gov (United States)

    Snyder, Denise C; Brouwer, Rebecca N; Ennis, Cory L; Spangler, Lindsey L; Ainsworth, Terry L; Budinger, Susan; Mullen, Catherine; Hawley, Jeffrey; Uhlenbrauck, Gina; Stacy, Mark

    2016-05-01

    Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can divert investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a similar transition.

  19. Human Factors Research and Nuclear Safety.

    Science.gov (United States)

    Moray, Neville P., Ed.; Huey, Beverly M., Ed.

    The Panel on Human Factors Research Needs in Nuclear Regulatory Research was formed by the National Research Council in response to a request from the Nuclear Regulatory Commission (NRC). The NRC asked the research council to conduct an 18-month study of human factors research needs for the safe operation of nuclear power plants. This report…

  20. Implementing human factors in clinical practice

    Science.gov (United States)

    Timmons, Stephen; Baxendale, Bryn; Buttery, Andrew; Miles, Giulia; Roe, Bridget; Browes, Simon

    2015-01-01

    Objectives To understand whether aviation-derived human factors training is acceptable and useful to healthcare professionals. To understand whether and how healthcare professionals have been able to implement human factors approaches to patient safety in their own area of clinical practice. Methods Qualitative, longitudinal study using semi-structured interviews and focus groups, of a multiprofessional group of UK NHS staff (from the emergency department and operating theatres) who have received aviation-derived human factors training. Results The human factors training was evaluated positively, and thought to be both acceptable and relevant to practice. However, the staff found it harder to implement what they had learned in their own clinical areas, and this was principally attributed to features of the informal organisational cultures. Conclusions In order to successfully apply human factors approaches in hospital, careful consideration needs to be given to the local context and informal culture of clinical practice. PMID:24631959

  1. Clinical science and human behavior.

    Science.gov (United States)

    Plaud, J J

    2001-09-01

    The debate between mentalism/cognitivism and behaviorism is analyzed, and it is concluded that behaviorism is the philosophy more closely associated with psychology as a behavioral science, the cognitive approach being more closely aligned with biological science. Specific objections to mentalistic interpretations of behavioral phenomena are detailed, and examples from clinical psychology are used to show the importance of behavioral approaches in applied domains. It is argued that the relation between behavior theory and clinical psychology is critical to the continued advancement of applied psychology. Behavior analysis is offered as a direct, applied extension of behavior theory as well as a highly practical and effective approach for understanding, explaining, and modifying the factors that contribute to and maintain maladaptive behaviors.

  2. Individual Library Research Clinics for College Freshmen.

    Science.gov (United States)

    Becker, Karen A.

    1993-01-01

    Describes a program of Library Research Clinics developed at Northern Illinois University to teach bibliographic instruction (BI) to one or two students at a time as an alternative to teaching BI in large first-year English classes. Implementation of the clinics with educationally disadvantaged students and with honor students is reviewed.…

  3. Human Tissue Research: Who Owns the Results.

    Science.gov (United States)

    Wagner, Allen B.

    1987-01-01

    Ownership issues in the results of research generally and of human tissue research specifically are explored. While acknowledging some uncertainty in the law, it is found that human tissue may be lawfully accessed for research and that use of human tissue does not modify the general allocation of interests. (MSE)

  4. Ethical Considerations in Human Movement Research.

    Science.gov (United States)

    Olivier, Steve

    1995-01-01

    Highlights ethical issues for human subject research, identifying principles that form the construct of a code of research ethics and evaluating against this construct past human experimentation and current research in human movement studies. The efficacy of legislation and self-regulation is examined. Particular attention is given to the context…

  5. Highlights of the 2012 research workshop: Using nutrigenomics and metabolomics in clinical nutrition research

    Science.gov (United States)

    The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Research Workshop, "Using Nutrigenomics and Metabolomics in Clinical Nutrition Research," was held on January 21, 2012, in Orlando, Florida. The conference brought together experts in human nutrition who use nutrigenomic and meta...

  6. The Social Value of Knowledge and International Clinical Research.

    Science.gov (United States)

    Wenner, Danielle M

    2015-08-01

    In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context-dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings. © 2013 John Wiley & Sons Ltd.

  7. Pharmacy Administration and Clinical Practice Research Agenda.

    Science.gov (United States)

    Hepler, Charles D.

    1987-01-01

    Research needs for pharmacy administration and clinical pharmacy include study of the relationship of pharmacists and society, management methods for providing health care services, pharmacist training and socialization, competence evaluation, formative and summative research on drug use control, and organizational decision making. (MSE)

  8. Pharmacy Administration and Clinical Practice Research Agenda.

    Science.gov (United States)

    Hepler, Charles D.

    1987-01-01

    Research needs for pharmacy administration and clinical pharmacy include study of the relationship of pharmacists and society, management methods for providing health care services, pharmacist training and socialization, competence evaluation, formative and summative research on drug use control, and organizational decision making. (MSE)

  9. Research Issues in Clinical Data Warehousing

    DEFF Research Database (Denmark)

    Pedersen, Torben Bach; Jensen, Christian Søndergaard

    1998-01-01

    to data warehousing technologies, over those posed by conventional data warehouse applications. This article presents a number of exciting new research challenges posed by clinical applications, to be met by the database research community. These include the need for complex-data modeling features...

  10. How Can a Clinical Research Approach Contribute to Knowledge-Building for the Teaching Profession?

    Science.gov (United States)

    Bulterman-Bos, Jacquelien

    2017-01-01

    This article explains what clinical research is and why it is necessary. The term "clinical" refers to an academic way of solving practical problems. Clinical research starts from a view of science that not only acknowledges the value of rational analysis and empirical research, but also acknowledges the need for human skills and…

  11. How Can a Clinical Research Approach Contribute to Knowledge-Building for the Teaching Profession?

    Science.gov (United States)

    Bulterman-Bos, Jacquelien

    2017-01-01

    This article explains what clinical research is and why it is necessary. The term "clinical" refers to an academic way of solving practical problems. Clinical research starts from a view of science that not only acknowledges the value of rational analysis and empirical research, but also acknowledges the need for human skills and…

  12. Transitioning from Clinical to Qualitative Research Interviewing

    Directory of Open Access Journals (Sweden)

    Matthew R. Hunt BSc (PT, PhD

    2011-09-01

    Full Text Available In this paper one aspect of the transition that must be made by experienced clinicians who become involved in conducting qualitative health research is examined, specifically, the differences between clinical and research interviewing. A clinician who is skillful and comfortable carrying out a clinical interview may not initially apprehend the important differences between these categories and contexts of interviewing. This situation can lead to difficulties and diminished quality of data collection because the purpose, techniques and orientation of a qualitative research interview are distinct from those of the clinical interview. Appreciation of these differences between interview contexts and genres, and strategies for addressing challenges associated with these differences, can help clinician researchers to become successful qualitative interviewers.

  13. Evaluation Method and Application Research on the Rational Clinical Use of Recombinant Human Insulin%重组人胰岛素临床合理使用评价方法及应用研究

    Institute of Scientific and Technical Information of China (English)

    关众

    2015-01-01

    目的:探讨重组人胰岛素合理性评价方法与应用研究。方法依据有关DUE操作方法,拟定重组人胰岛素合理性评价方法。结果观察重组人胰岛素合理用药评价与管理模式可行性。结论本研究建立的重组人胰岛素合理性评价体系适合临床合理用药评价,也为临床中合理用药提供新切入点。%Objective To investigate the method and application of recombinant human insulin rationality evaluation research. Methods According to relevant DUE operation method, recombinant human insulin rationality evaluation method. Results To observe the feasibility evaluation and management mode of recombinant human insulin of rational use of drugs. Conclusion This study established recombinant human insulin rationality evaluation system suitable for clinical rational drug use evaluation, and also provide new breakthrough point for clinical rational drug use in.

  14. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  15. Electronic health records to facilitate clinical research.

    Science.gov (United States)

    Cowie, Martin R; Blomster, Juuso I; Curtis, Lesley H; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faiez; Zalewski, Andrew

    2017-01-01

    Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

  16. The research progress and clinical application of human CD10 molecule%CD10分子的研究进展及临床应用

    Institute of Scientific and Technical Information of China (English)

    刘芸; 廖晓龙

    2014-01-01

    CD10分子最初作为普通急性淋巴细胞白血病抗原(CALLA)被发现,是一个相对分子质量为90 000-110 000Ⅱ型单链穿膜糖蛋白.CD10分子广泛分布在各种组织,具有中性肽链内切酶(NEP)的功能,并且表达在不同的组织,其功能不尽相同.目前广泛应用于用血液系统肿瘤以及部分实体肿瘤的诊断和预后判断,还用于造血细胞分化发育研究和部分组织干细胞的研究.%Human CD10 molecul,which was found as the common acute lymphoblastic leukemia anti-gen (CALLA),is a type Ⅱ single-chain transmembrane glycoprotein (90 000-110 000),expressed broadly on varied tissues.CD10 is a neutral endopeptidase (NEP),and it performs different function in different organs.Anti CD10 antibodies are used for the detection and prognosis of leukemia and solid tumor,as well as for research in hematopoietic and tissue stem cells.

  17. A review of clinical research in orthodontics.

    Science.gov (United States)

    Tulloch, J F; Antczak-Bouckoms, A A; Tuncay, O C

    1989-06-01

    The orthodontic journals should provide valid and reliable information that helps clinicians make appropriate decisions about patient care. The nature of the published literature has not been categorized. The American Journal of Orthodontics and Dentofacial Orthopedics (formerly the American Journal of Orthodontics) was reviewed for the years 1976, 1981, and 1986, to determine the frequency of clinical articles, the topics reported, the study designs used to obtain information, the senior author affiliation, and the major funding sources. This review demonstrates that more than half the articles in this Journal report data on patients, with the majority focusing on the evaluation or description of therapeutic interventions. Academic institutions contribute the majority of the clinical research, although only a few student theses are published. The major support for this work continues to be from departmental resources with little external funding. Despite the introduction of powerful research designs such as randomized clinical trials, these methods have not been widely adopted for orthodontic clinical research. The case report (study containing fewer than 10 patients with no control nor comparison group) continues to be the most frequently published format. Clinicians should become aware of the inherent weakness in the research designs generally used and recognize the limited information that can be obtained from such methods. Support for this research needs to be greatly expanded if the more powerful type of study required to provide valid and reliable clinical information is to be continued.

  18. Statistics in clinical research: Important considerations.

    Science.gov (United States)

    Barkan, Howard

    2015-01-01

    Statistical analysis is one of the foundations of evidence-based clinical practice, a key in conducting new clinical research and in evaluating and applying prior research. In this paper, we review the choice of statistical procedures, analyses of the associations among variables and techniques used when the clinical processes being examined are still in process. We discuss methods for building predictive models in clinical situations, and ways to assess the stability of these models and other quantitative conclusions. Techniques for comparing independent events are distinguished from those used with events in a causal chain or otherwise linked. Attention then turns to study design, to the determination of the sample size needed to make a given comparison, and to statistically negative studies.

  19. Role perceptions of nurse clinical research coordinators

    Directory of Open Access Journals (Sweden)

    Jones CT

    2013-09-01

    Full Text Available Carolynn Thomas Jones, Lynda L Wilson School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA Abstract: Nursing roles in clinical research have evolved in the last 3 decades and include diverse responsibilities and job titles. Nurse clinical research coordinators’ (NCRCs roles include study planning, implementation, participant recruitment and retention, assessment of participants’ responses to clinical protocols, data management, and evaluation. The purpose of this study was to examine NCRCs’ perceptions of 59 specific clinical research activities that have been proposed as a taxonomy of NCRC activities. Participants were asked to check whether each of the 59 activities is being performed, and whether those activities should be performed, by NCRCs. The sample included 61 NCRCs who were attending the annual meeting of the International Association of Clinical Research Nurses. The percentage of respondents who indicated that the 59 activities are being performed by NCRCs at their sites ranged from 55%–98.4%. The percentage of respondents who indicated that the 59 activities should be performed by NCRCs ranged from 61.7%–88.5%. There were eight activities that fewer than 70% of the respondents reported should be performed by NCRCs. Chi-square analyses were conducted to determine whether there was a difference in the distribution of responses to the “are performed” versus “should be performed” responses for each of the 59 activities. There were significant differences in the distributions for 49 of the activities. The percentage of nurses responding “are performed” was higher than the percentage of responses to the “should be performed” items for 41 of these 49 activities. Findings suggest that further research is needed to validate the extent to which the taxonomy of clinical research nurse (CRN roles is a valid reflection of the actual practice of NCRCs, and also to explore reasons for the

  20. Clinical research ethics in Irish healthcare: diversity, dynamism and medicalization.

    LENUS (Irish Health Repository)

    Condell, Sarah L

    2012-11-01

    Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early \\'rite of passage\\' in the category of \\'labouring the doctorate\\'. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of \\'medicalized\\' research ethics is further explored including its meaning for nursing or midwifery research.

  1. Factors influencing nurses' participation in clinical research.

    Science.gov (United States)

    Jacobson, Ann F; Warner, Andrea M; Fleming, Eileen; Schmidt, Bruce

    2008-01-01

    Clinical research is necessary for developing nursing's body of knowledge and improving the quality of gastroenterology nursing care. The support and participation of nursing staff are crucial to conducting interventional research. Identification of characteristics of nurses and their work settings that facilitate or impede participation in research is needed. The purpose of this descriptive correlational study was to examine the effect of personal and professional characteristics and attitudes about nursing research on staff nurses' participation in a clinical nursing research project. A questionnaire measuring nurses' attitudes, perceptions of availability of support, and research use was distributed to staff nurses working on an endoscopy lab and two same-day surgery units where a nursing research study had recently been conducted. Investigator-developed items measured nurses' attitudes about the utility and feasibility of the interventions tested in the original study. A total of 36 usable questionnaires comprised the sample. Factor analysis of the two questionnaires resulted in three-factor (Importance of Research, Interest in Research, and Environment Support of Research) and two-factor (Value of Cognitive-Behavioral Interventions [CBIs] and Participation in Study) solutions, respectively. There were no statistically significant differences in mean scores for the five factors between nurses who did (n = 19) and those who did not (n = 17) participate in the original study. The Participation in Research Factor was significantly negatively correlated with years in nursing (r = -.336, p body of knowledge about factors that facilitate or impede staff nurses' involvement in research. This knowledge will be useful for nurse researchers planning intervention studies to forecast and foster staff nurse involvement in their projects. Findings may also be useful to nurse managers, nurse educators, and staff development personnel in assessing and promoting staff nurses

  2. Framework conditions facilitating paediatric clinical research

    Directory of Open Access Journals (Sweden)

    Alfarez Deborah

    2011-02-01

    Full Text Available Abstract The use of unlicensed and "off-label" medicines in children is widespread. Between 50-80% of the medicines currently administered to children have neither been tested nor authorized for their use in the paediatric population which represents approximately 25% of the whole European population. On 26 January 2007, entered into force the European Regulation of Paediatric Medicines. It aims at the quality of research into medicines for children but without subjecting the paediatric population to unnecessary clinical trial. This article addresses ethical and legal issues arising from the regulation and makes recommendations for the framework conditions facilitating the development of clinical research with children.

  3. [Clinical research III. The causality studies].

    Science.gov (United States)

    Talavera, Juan O; Wacher-Rodarte, Niels H; Rivas-Ruiz, Rodolfo

    2011-01-01

    The need to solve a clinical problem leads us to establish a starting point to address (risk, prognosis or treatment studies), all these cases seek to attribute causality. Clinical reasoning described in the book Clinical Epidemiology. The architecture of clinical research, offers a simple guide to understanding this phenomenon. And proposes three basic components: baseline, maneuver and outcome. In this model, different systematic errors (bias) are described, which may be favored by omitting characteristics of the three basic components. Thus, omissions in the baseline characteristics cause an improper assembly of the population and susceptibility bias, omissions in the application or evaluation of the maneuver provoke performance bias, and omissions in the assessment of out-come cause detection bias and transfer bias. Importantly, if this way of thinking facilitates understanding of the causal phenomenon, the appropriateness of the variables to be selected in the studies to which attribute or not causality, require additional arguments for evaluate clinical relevance.

  4. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Science.gov (United States)

    2010-08-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application; Availability... the availability of a draft guidance for industry and researchers entitled ``The Radioactive...

  5. Bibliography of clinical research in malaysia: methods and brief results.

    Science.gov (United States)

    Teng, C L; Zuhanariah, M N; Ng, C S; Goh, C C

    2014-08-01

    This article describes the methodology of this bibliography. A search was conducted on the following: (1) bibliographic databases (PubMed, Scopus, and other databases) using search terms that maximize the retrieval of Malaysian publications; (2) Individual journal search of Malaysian healthrelated journals; (3) A targeted search of Google and Google Scholar; (4) Searching of Malaysian institutional repositories; (5) Searching of Ministry of Health and Clinical Research Centre website. The publication years were limited to 2000- 2013. The citations were imported or manually entered into bibliographic software Refworks. After removing duplicates, and correcting data entry errors, PubMed's Medical Subject Headings (MeSH terms) were added. Clinical research is coded using the definition "patient-oriented-research or research conducted with human subjects (or on material of human origin) for which the investigator directly interacts with the human subjects at some point during the study." A bibliography of citations [n=2056] that fit the criteria of clinical research in Malaysia in selected topics within five domains was generated: Cancers [589], Cardiovascular diseases [432], Infections [795], Injuries [142], and Mental Health [582]. This is done by retrieving citations with the appropriate MESH terms, as follow: For cancers (Breast Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms), for cardiovascular diseases (Coronary Disease; Hypertension; Stroke), for infections (Dengue; Enterovirus Infections, HIV Infections; Malaria; Nipah Virus; Tuberculosis), for injuries (Accidents, Occupational; Accidents, Traffic; Child Abuse; Occupational Injuries), for mental health (Depression; Depressive Disorder; Depressive Disorder, Major; Drug Users; Psychotic Disorders; Suicide; Suicide, Attempted; Suicidal Ideation; Substance- Related Disorders).

  6. 78 FR 55752 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-09-11

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Special Emphasis Panel; Clinical Sites for..., Scientific Review Branch, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC...

  7. Human Research Program Integrated Research Plan. Revision A January 2009

    Science.gov (United States)

    2009-01-01

    The Integrated Research Plan (IRP) describes the portfolio of Human Research Program (HRP) research and technology tasks. The IRP is the HRP strategic and tactical plan for research necessary to meet HRP requirements. The need to produce an IRP is established in HRP-47052, Human Research Program - Program Plan, and is under configuration management control of the Human Research Program Control Board (HRPCB). Crew health and performance is critical to successful human exploration beyond low Earth orbit. The Human Research Program (HRP) is essential to enabling extended periods of space exploration because it provides knowledge and tools to mitigate risks to human health and performance. Risks include physiological and behavioral effects from radiation and hypogravity environments, as well as unique challenges in medical support, human factors, and behavioral or psychological factors. The Human Research Program (HRP) delivers human health and performance countermeasures, knowledge, technologies and tools to enable safe, reliable, and productive human space exploration. Without HRP results, NASA will face unknown and unacceptable risks for mission success and post-mission crew health. This Integrated Research Plan (IRP) describes HRP s approach and research activities that are intended to address the needs of human space exploration and serve HRP customers and how they are integrated to provide a risk mitigation tool. The scope of the IRP is limited to the activities that can be conducted with the resources available to the HRP; it does not contain activities that would be performed if additional resources were available. The timescale of human space exploration is envisioned to take many decades. The IRP illustrates the program s research plan through the timescale of early lunar missions of extended duration.

  8. Influences upon pediatricians’ willingness to refer patients to clinical research

    Directory of Open Access Journals (Sweden)

    Jeanne Dalen

    2010-03-01

    Full Text Available Jeanne Dalen1, Robert D Annett2, Janet L Brody1, Mandy L Perryman31Center for Family and Adolescent Research, Oregon Research Institute, Portland, OR, USA; 2University of New Mexico Health Sciences Center, Albuquerque, NM, USA; 3School of Education and Human Development, Lynchburg College, Lynchburg, UA, USAPurpose: The purpose of this brief report is to determine factors that influence the willingness of pediatricians to refer their patients to clinical research and to explore the relationship between pediatrician characteristics and self-reported number of patients referred to clinical research.Method: Forty-three pediatricians from an academic pediatrics department of a university children’s hospital in Albuquerque, New Mexico rated how influential 10 reasons would be in their decision to refer a patient to pediatric clinical research.Results: Differences among the influences for pediatrician referral to research were observed. The most influential consideration for referral was the scientific merit of the study, followed by patient benefit. Contextual factors and physician compensation were identified as the least important reasons pediatricians refer patients to research. Analyses also revealed significant relationships between referrals made and percentage of time spent in research activities.Conclusions: Pediatricians may be more likely to refer their patients to clinical research studies when they believe the purpose of the study is meaningful to patients as well as to future patient populations. In addition, characteristics of the individual pediatricians may play an important role in actual referral behavior.Keywords: recruitment, clinical research, adolescent research, pediatrician attitudes

  9. Blockchain technology for improving clinical research quality.

    Science.gov (United States)

    Benchoufi, Mehdi; Ravaud, Philippe

    2017-07-19

    Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key to addressing these challenges and should draw the attention of the whole clinical research community.Blockchain brings the Internet to its definitive decentralisation goal. The core principle of Blockchain is that any service relying on trusted third parties can be built in a transparent, decentralised, secure "trustless" manner at the top of the Blockchain (in fact, there is trust, but it is hardcoded in the Blockchain protocol via a complex cryptographic algorithm). Therefore, users have a high degree of control over and autonomy and trust of the data and its integrity. Blockchain allows for reaching a substantial level of historicity and inviolability of data for the whole document flow in a clinical trial. Hence, it ensures traceability, prevents a posteriori reconstruction and allows for securely automating the clinical trial through what are called Smart Contracts. At the same time, the technology ensures fine-grained control of the data, its security and its shareable parameters, for a single patient or group of patients or clinical trial stakeholders.In this commentary article, we explore the core functionalities of Blockchain applied to clinical trials and we illustrate concretely its general principle in the context of consent to a trial protocol. Trying to figure out the potential impact of Blockchain implementations in the setting of clinical trials will shed new light on how modern clinical trial methods could evolve and benefit from Blockchain technologies in order to tackle the aforementioned challenges.

  10. Clinical Research of Lung Cangcer in China

    Institute of Scientific and Technical Information of China (English)

    WYUilong; GLLijia

    2002-01-01

    Summary Many valuable clinical researches of lung cancer,such as systematic mediastinal lymph node dissection,debulking operation for non-small cell lung cancer and lobectomy or pneumonectomy combined with extended resection of the heart and great vessels have been made in recent in recent years China.The long-term survival of resectable lung cancer is similar to that of developed country.Some prospective randomized chinical trials for adjuvant or neoadjuvant therapy of lung cancer were made.Early Early lung cancer after complete resection does not need adjuvant radiotherapy.The values of pre-or post-operation chemotherapy need to be evaluated.Now larger multicenter randomized clinical trials according to evidence-based medicine are needed for Chinse lung cancer clinical research.

  11. Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University.

    Science.gov (United States)

    Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

    2017-01-01

     The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.

  12. Uterus transplantation: animal research and human possibilities.

    Science.gov (United States)

    Brännström, Mats; Diaz-Garcia, Cesar; Hanafy, Ash; Olausson, Michael; Tzakis, Andreas

    2012-06-01

    Uterus transplantation research has been conducted toward its introduction in the human as a treatment of absolute uterine-factor infertility, which is considered to be the last frontier to conquer for infertility research. In this review we describe the patient populations that may benefit from uterus transplantation. The animal research on uterus transplantation conducted during the past two decades is summarized, and we describe our views regarding a future research-based human attempt.

  13. Promoting translational research in human and veterinary medical virology.

    Science.gov (United States)

    Tang, Yi-Wei

    2013-07-26

    Translational research serves as a bench-to-field "translation" of basic scientific research into practical diagnostic procedures and therapies useful in human and veterinary clinical services. The productivity of translational research involving infectious diseases relevant to both human and animal health (e.g., influenza diagnosis and epidemiology using emerging molecular detection and identification methods) can be maximized when both human and veterinary medical virology disciplines are integrated. Influenza viruses are continually evolving through site-specific mutation and segment reassortment, and these processes occur in all potential carrier species - including birds, humans, and many agriculturally important animals. This evolutionary plasticity occasionally allows "novel" influenzas to move from animal hosts to humans, potentially causing destructive pandemics; therefore, a rapid laboratory technique that can detect and identify "novel" influenza viruses is clinically and epidemiologically desirable. A technique-focused translational research approach is pursued to enhance detection and characterization of emerging influenza viruses circulating in both humans and other animal hosts. The PLEX-ID System, which incorporates multi-locus PCR and electrospray ionization/mass spectrometry, uses deliberately nonspecific primers that amplify all known variants (all H/N subtypes) of influenza virus, including human, other mammalian, and avian influenzas, and is therefore likely to generate analyzable amplicons from any novel influenza that might emerge in any host. Novel technology development and implementation such as the PLEX-ID System forms a key component of human and veterinary medical virology translational research. Copyright © 2013 Elsevier B.V. All rights reserved.

  14. On controversial statistical issues in clinical research

    Directory of Open Access Journals (Sweden)

    Chow SC

    2015-05-01

    Full Text Available Shein-Chung Chow,1 Fuyu Song2 1Duke University School of Medicine, Durham, NC, USA; 2Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, People's Republic of China Abstract: In clinical development of a test treatment under investigation, clinical trials are often conducted for evaluation of safety and efficacy of the test treatment. To provide an accurate and reliable assessment, adequate and well-controlled clinical trials using valid study designs are necessarily conducted for obtaining substantial evidence of safety and efficacy of the test treatment under investigation. In practice, however, some debatable issues are commonly encountered regardless compliance with good statistics practice and good clinical practice. These issues include, but are not limited to: 1 appropriateness of statistical hypotheses for clinical investigation; 2 correctness of power analysis assumptions; 3 integrity of randomization and blinding; 4 post hoc endpoint selection; 5 impact of protocol amendments on the characteristics of the trial population; 6 multiplicity in clinical trials; 7 missing data imputation; 8 adaptive design methods; and 9 independence of a data monitoring committee. In this article, these issues are briefly described. The impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation are discussed with examples whenever applicable. Some recommendations regarding possible resolutions of these issues are also provided. Keywords: data safety monitoring committee, endpoint selection, integrity of blinding, missing data imputation, multiplicity, protocol amendment, two-stage adaptive designs

  15. How can we improve clinical research in clinical practice with better research outcome?

    Science.gov (United States)

    Woo, Keng Thye; Wong, Kok Seng; Lee, Evan J C; Chan, Choong Meng

    2011-11-01

    This paper explains some of the difficulties doctors face when taking up a career in research. It describes the efforts by the government and the Ministry of Health (MOH) to nurture the Clinician Scientist Programme. The nature of research and the mindset of clinicians who are passionate about research are explored and the reasons which drive some of them to pursue a research career. It discusses the need to have structured training for research and how continuing research education is necessary for the researcher. The paper discusses the goals for research and how we can achieve better research outcomes and the importance of good mentorship. It suggests ways to engage more doctors in research in the restructured hospitals by overcoming some of the problems they encounter. Finally, it relates the Biomedical Science initiative of the government through the National Research Foundation and the various programmes in Translational Clinical Research available for clinicians who are keen on a research career.

  16. Research Priority of Clinical Linguistics in Iran

    Directory of Open Access Journals (Sweden)

    Ahadi

    2016-04-01

    Full Text Available Background Study in clinical linguistics can reflect and requirements of this area, and can contribute to effective and useful changes in this area. Objectives Since there have been a few studies in the field of clinical linguistics in Iran, this research can pave the way to find research priorities of clinical linguistics in our country. Materials and Methods Studies related to linguistics and speech therapy were collected and studied since their appearance in the literature up to 2012 to determine the number of studies performed on clinical linguistics and its evolutionary trend. Results The most and least numbers of studies conducted by speech therapists on linguistics are related to phonetics/phonology (37% and pragmatics (14%, respectively. In linguistics, there are a few studies on disorders (0.02%, which are mostly in the domain of aphasia (40%; therefore, other disorders should be investigated too. Conclusions The number of linguistic studies on language and speech therapy is more than that of the studies in which clinical data are used to study the theories and hypotheses. Therefore, it is necessary to consider this area seriously and guide the studies toward the theories proposed in the related disorders. Thus, attention must be paid to pragmatic and semantic domains of the disorder which are considered less.

  17. Human cysticercosis: parasitology, pathology, clinical manifestations and available treatment.

    Science.gov (United States)

    Webbe, G

    1994-10-01

    Human cysticercosis is a global health problem and neurocysticercosis a serious clinical syndrome. The diagnosis of neurocysticercosis can now be made with a high degree of accuracy by scrutiny of clinical signs and symptoms in combination with X-ray, computed tomography or magnetic resonance imaging, serological tests and laboratory examinations. Differential clinical diagnosis with tumor, and vascular and inflammatory conditions, may however, prove difficult in nonendemic areas. The management of cysticercosis has been radically changed by the advent of effective chemotherapy. Both the heterocyclic pyrazinoisoquinoline compound, praziquantel and the benzimidazole carbamate, albendazole, have now been extensively tested and successfully used for treatments of neurocysticercosis, usually in combination with corticosteroids. The definition of appropriate criteria and guidelines for the use of chemotherapy, may however, require further research. Surgical interventions continue to play an important role in certain clinical presentations. Recent advances in immunological research hold realistic promise for the development of a vaccine against Taenia solium.

  18. Integrated Extravehicular Activity Human Research Plan: 2017

    Science.gov (United States)

    Abercromby, Andrew

    2017-01-01

    Multiple organizations within NASA as well as industry and academia fund and participate in research related to extravehicular activity (EVA). In October 2015, representatives of the EVA Office, the Crew and Thermal Systems Division (CTSD), and the Human Research Program (HRP) at NASA Johnson Space Center agreed on a formal framework to improve multi-year coordination and collaboration in EVA research. At the core of the framework is an Integrated EVA Human Research Plan and a process by which it will be annually reviewed and updated. The over-arching objective of the collaborative framework is to conduct multi-disciplinary cost-effective research that will enable humans to perform EVAs safely, effectively, comfortably, and efficiently, as needed to enable and enhance human space exploration missions. Research activities must be defined, prioritized, planned and executed to comprehensively address the right questions, avoid duplication, leverage other complementary activities where possible, and ultimately provide actionable evidence-based results in time to inform subsequent tests, developments and/or research activities. Representation of all appropriate stakeholders in the definition, prioritization, planning and execution of research activities is essential to accomplishing the over-arching objective. A formal review of the Integrated EVA Human Research Plan will be conducted annually. Coordination with stakeholders outside of the EVA Office, CTSD, and HRP is already in effect on a study-by-study basis; closer coordination on multi-year planning with other EVA stakeholders including academia is being actively pursued. Details of the preliminary Integrated EVA Human Research Plan are presented including description of ongoing and planned research activities in the areas of: physiological and performance capabilities; suit design parameters; EVA human health and performance modeling; EVA tasks and concepts of operations; EVA informatics; human-suit sensors; suit

  19. Basic Science Research and the Protection of Human Research Participants

    Science.gov (United States)

    Eiseman, Elisa

    2001-03-01

    Technological advances in basic biological research have been instrumental in recent biomedical discoveries, such as in the understanding and treatment of cancer, HIV/AIDS, and heart disease. However, many of these advances also raise several new ethical challenges. For example, genetic research may pose no physical risk beyond that of obtaining the initial blood sample, yet it can pose significant psychological and economic risks to research participants, such as stigmatization, discrimination in insurance and employment, invasion of privacy, or breach of confidentiality. These harms may occur even when investigators do not directly interact with the person whose DNA they are studying. Moreover, this type of basic research also raises broader questions, such as what is the definition of a human subject, and what kinds of expertise do Institutional Review Boards (IRBs) need to review the increasingly diverse types of research made possible by these advances in technology. The National Bioethics Advisory Commission (NBAC), a presidentially appointed federal advisory committee, has addressed these and other ethical, scientific and policy issues that arise in basic science research involving human participants. Two of its six reports, in particular, have proposed recommendations in this regard. "Research Involving Human Biological Materials: Ethical and Policy Guidance" addresses the basic research use of human tissues, cells and DNA and the protection of human participants in this type of research. In "Ethical and Policy Issues in the Oversight of Human Research" NBAC proposes a definition of research involving human participants that would apply to all scientific disciplines, including physical, biological, and social sciences, as well as the humanities and related professions, such as business and law. Both of these reports make it clear that the protection of research participants is key to conducting ethically sound research. By ensuring that all participants in

  20. Action research methodology in clinical pharmacy

    DEFF Research Database (Denmark)

    Nørgaard, Lotte Stig; Sørensen, Ellen Westh

    2016-01-01

    study? What learning and/or changes took place? What challenges/pitfalls had to be overcome? What were the influence/consequences for the involved parts? When to use If you want to implement new services and want to involve staff and others in the process, an AR methodology is very suitable. The basic......Introduction The focus in clinical pharmacy practice is and has for the last 30-35 years been on changing the role of pharmacy staff into service orientation and patient counselling. One way of doing this is by involving staff in change process and as a researcher to take part in the change process...... is defined as an approach to research which is based on a problem-solving relationship between researchers and clients, which aims at both solving a problem and at collaboratively generating new knowledge. Research questions relevant in AR-studies are: what was the working process in this change oriented...

  1. Human Research Program Integrated Research Plan. Revision C

    Science.gov (United States)

    Steinberg, Susan

    2011-01-01

    Crew health and performance are critical to successful human exploration beyond low Earth orbit. The Human Research Program (HRP) is essential to enabling extended periods of space exploration because it provides knowledge and tools to mitigate risks to human health and performance. Risks include physiological effects from radiation and hypogravity environments, as well as unique challenges in medical support, human factors, and behavioral or psychological factors. The Human Research Program (HRP) delivers human health and performance countermeasures, knowledge, technologies and tools to enable safe, reliable, and productive human space exploration. Without HRP results, NASA will face unknown and unacceptable risks for mission success and post-mission crew health. This Integrated Research Plan (IRP) describes (1) HRP's approach and research activities that are intended to address the needs of human space exploration and serve HRP customers and (2) the method of integration for risk mitigation. The scope of the IRP is limited to the activities that can be conducted with the resources available to the HRP; it does not contain activities that would be performed if additional resources were available. The timescale of human space exploration is envisioned to take many decades. The IRP illustrates the program s research plan through the timescale of early lunar missions of extended duration.

  2. [Ear keloid and clinical research progress].

    Science.gov (United States)

    Du, Guangyuan; Zhu, Jiang

    2014-04-01

    Keloid refers to the damaged skin due to excessive fibroblast proliferation. Ear is one predilection site. The pathogenesis of ear keloid is not very clear, and the treatment is also varied. Surgery, postoperative radiotherapy and laser treatment, steroid hormones, pressure therapy are the basic treatment methods. Integrated application of a variety of treatments, classification research and new materials using revealed the prospect for the treatment of the disease. This thesis reviews literature about ear keloid in recent 10 years, and introduces this disease and clinical research progress.

  3. Standard operating procedures for clinical research departments.

    Science.gov (United States)

    Kee, Ashley Nichole

    2011-01-01

    A set of standard operating procedures (SOPs) provides a clinical research department with clear roles, responsibilities, and processes to ensure compliance, accuracy, and timeliness of data. SOPs also serve as a standardized training program for new employees. A practice may have an employee that can assist in the development of SOPs. There are also consultants that specialize in working with a practice to develop and write practice-specific SOPs. Making SOPs a priority will save a practice time and money in the long run and make the research practice more attractive to corporate study sponsors.

  4. The clinical applicability of music therapy research

    DEFF Research Database (Denmark)

    Wigram, Anthony Lewis

    practitioners in all three areas (and beyond) can demonstrate, through previous and current research, that the music therapy service and interventions they provide are relevant and effective (Ansdell, Pavicevic & Proctor, 2004; Gold, Voracek and Wigram, 2004; Vink, 2003; Wigram 2002). Documentation of research...... in lengthy and complex theses is seldom accessible to the practitioner working ‘at the coal-face’; and sometimes lacks clear direction on how the results are applicable in everyday therapy. For results to be implemented in clinical practice and disseminated to colleagues in related fields as well as senior...

  5. The clinical applicability of music therapy research

    DEFF Research Database (Denmark)

    Wigram, Anthony Lewis

    practitioners in all three areas (and beyond) can demonstrate, through previous and current research, that the music therapy service and interventions they provide are relevant and effective (Ansdell, Pavicevic & Proctor, 2004; Gold, Voracek and Wigram, 2004; Vink, 2003; Wigram 2002). Documentation of research...... in lengthy and complex theses is seldom accessible to the practitioner working ‘at the coal-face’; and sometimes lacks clear direction on how the results are applicable in everyday therapy. For results to be implemented in clinical practice and disseminated to colleagues in related fields as well as senior...

  6. The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research.

    Science.gov (United States)

    Berry, Donald A

    2015-05-01

    Clinical trials are the final links in the chains of knowledge and for determining the roles of therapeutic advances. Unfortunately, in an important sense they are the weakest links. This article describes two designs that are being explored today: platform trials and basket trials. Both are attempting to merge clinical research and clinical practice.

  7. Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policy. European Society of Human Genetics and European Society of Human Reproduction and Embryology.

    Science.gov (United States)

    Harper, Joyce C; Geraedts, Joep; Borry, Pascal; Cornel, Martina C; Dondorp, Wybo; Gianaroli, Luca; Harton, Gary; Milachich, Tanya; Kääriäinen, Helena; Liebaers, Inge; Morris, Michael; Sequeiros, Jorge; Sermon, Karen; Shenfield, Françoise; Skirton, Heather; Soini, Sirpa; Spits, Claudia; Veiga, Anna; Vermeesch, Joris Robert; Viville, Stéphane; de Wert, Guido; Macek, Milan

    2013-11-01

    In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and assisted reproductive technology (ART), and published an extended background paper, recommendations and two Editorials. Seven years later, in March 2012, a follow-up interdisciplinary workshop was held, involving representatives of both professional societies, including experts from the European Union Eurogentest2 Coordination Action Project. The main goal of this meeting was to discuss developments at the interface between clinical genetics and ARTs. As more genetic causes of reproductive failure are now recognised and an increasing number of patients undergo testing of their genome before conception, either in regular health care or in the context of direct-to-consumer testing, the need for genetic counselling and preimplantation genetic diagnosis (PGD) may increase. Preimplantation genetic screening (PGS) thus far does not have evidence from randomised clinical trials to substantiate that the technique is both effective and efficient. Whole-genome sequencing may create greater challenges both in the technological and interpretational domains, and requires further reflection about the ethics of genetic testing in ART and PGD/PGS. Diagnostic laboratories should be reporting their results according to internationally accepted accreditation standards (International Standards Organisation - ISO 15189). Further studies are needed in order to address issues related to the impact of ART on epigenetic reprogramming of the early embryo. The legal landscape regarding assisted reproduction is evolving but still remains very heterogeneous and often contradictory. The lack of legal harmonisation and uneven access to infertility treatment and PGD/PGS fosters considerable cross-border reproductive care in Europe and beyond. The aim of this paper is to complement previous publications and provide

  8. Human Research and Complexity Theory

    Science.gov (United States)

    Horn, James

    2008-01-01

    The disavowal of positivist science by many educational researchers has resulted in a deepening polarization of research agendas and an epistemological divide that appears increasingly difficult to span. Despite a turning away from science altogether by some, and thus toward various forms of poststructuralist inquiry, this has not held back the…

  9. Ramucirumab: preclinical research and clinical development

    Directory of Open Access Journals (Sweden)

    Aprile G

    2014-10-01

    Full Text Available Giuseppe Aprile,1 Erika Rijavec,2 Caterina Fontanella,1 Karim Rihawi,1 Francesco Grossi21Department of Oncology, University Hospital of Udine, Udine, Italy; 2Lung Cancer Unit, National Cancer Institut “San Martino”, Genoa, ItalyAbstract: Ramucirumab (IMC-1121B, LY3009806, a fully humanized monoclonal antibody directed against the extracellular domain of vascular endothelial growth factor receptor 2 (VEGFR-2, is a new therapeutic option that selectively inhibits the human VEGFR-2 with a much greater affinity than its natural ligands. Based on the promising results of both preclinical and early clinical studies, ramucirumab has been tested in different tumor types either alone or in combination with chemotherapy. While it has recently been granted its first US Food and Drug Administration approval for use as a single agent in patients with advanced or metastatic gastric cancer or gastroesophageal junction carcinoma, its role for metastatic breast cancer or advanced non-small-cell lung cancer is still debated. The aims of this review are to recall and discuss the most significant preclinical and clinical studies that led to the development of ramucirumab and to present the results of the randomized clinical trials that have tested its efficacy in different malignancies, including gastric and lung cancer. Keywords: ramucirumab, gastric cancer, lung cancer, breast cancer, antiangiogenic

  10. Ramucirumab: preclinical research and clinical development.

    Science.gov (United States)

    Aprile, Giuseppe; Rijavec, Erika; Fontanella, Caterina; Rihawi, Karim; Grossi, Francesco

    2014-01-01

    Ramucirumab (IMC-1121B, LY3009806), a fully humanized monoclonal antibody directed against the extracellular domain of vascular endothelial growth factor receptor 2 (VEGFR-2), is a new therapeutic option that selectively inhibits the human VEGFR-2 with a much greater affinity than its natural ligands. Based on the promising results of both preclinical and early clinical studies, ramucirumab has been tested in different tumor types either alone or in combination with chemotherapy. While it has recently been granted its first US Food and Drug Administration approval for use as a single agent in patients with advanced or metastatic gastric cancer or gastroesophageal junction carcinoma, its role for metastatic breast cancer or advanced non-small-cell lung cancer is still debated. The aims of this review are to recall and discuss the most significant preclinical and clinical studies that led to the development of ramucirumab and to present the results of the randomized clinical trials that have tested its efficacy in different malignancies, including gastric and lung cancer.

  11. Current clinical research in orthodontics: a perspective.

    Science.gov (United States)

    Baumrind, Sheldon

    2006-10-01

    This essay explores briefly the approach of the Craniofacial Research Instrumentation Laboratory to the systematic and rigorous investigation of the usual outcome of orthodontic treatment in the practices of experienced clinicians. CRIL's goal is to produce a shareable electronic database of reliable, valid, and representative data on clinical practice as an aid in the production of an improved environment for truly evidence-based orthodontic treatment.

  12. Periprosthetic Joint Infections: Clinical and Bench Research

    Directory of Open Access Journals (Sweden)

    Laurence Legout

    2013-01-01

    Full Text Available Prosthetic joint infection is a devastating complication with high morbidity and substantial cost. The incidence is low but probably underestimated. Despite a significant basic and clinical research in this field, many questions concerning the definition of prosthetic infection as well the diagnosis and the management of these infections remained unanswered. We review the current literature about the new diagnostic methods, the management and the prevention of prosthetic joint infections.

  13. Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective.

    Science.gov (United States)

    Ripley, Elizabeth B D; Macrina, Frank L; Markowitz, Monika

    2006-12-01

    REGULATORY GUIDELINES LEAVE determination of coercion and undue influence of research participants open to interpretation. A web-based survey was conducted of the research ethics committees members at Virginia Commonwealth University (VCU) to evaluate their perspectives on paying participants in clinical research via general questions, as well as 8 short cases involving hypertension placebo-controlled trials, a pilot exercise study, a survey of substance abusers, a healthy-volunteer pharmacokinetic study, a twin study involving DNA samples, and an asthma medication study in children. Research ethics committee members were asked to state what payment they would consider appropriate for a given type of protocol. The results suggest that risk, time required, reimbursement for expenses, and inconvenience were important in determining appropriate payment, while income and funding source were not. The case studies revealed wide variation in recommended payments both within type of study and between studies.

  14. Human Polymorphisms as Clinical Predictors in Leprosy

    Directory of Open Access Journals (Sweden)

    Ernesto Prado Montes de Oca

    2011-01-01

    Full Text Available Genetic and serum markers in human host can predict leprosy susceptibility per se as well as be useful in classification and/or prediction of clinical variants and immunological responses in leprosy. Adequate and timely assessment of potential risks associated with these 38 host leprosy genes could diminish epidemiological burden and improve life quality of patients with this still prevalent mycobacterial disease.

  15. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  16. Distal symmetrical polyneuropathy: definition for clinical research.

    Science.gov (United States)

    England, J D; Gronseth, G S; Franklin, G; Miller, R G; Asbury, A K; Carter, G T; Cohen, J A; Fisher, M A; Howard, J F; Kinsella, L J; Latov, N; Lewis, R A; Low, P A; Sumner, A J

    2005-01-01

    The objective of this report was to develop a case definition of "distal symmetrical polyneuropathy" to standardize and facilitate clinical research and epidemiological studies. A formalized consensus process was employed to reach agreement after a systematic review and classification of evidence from the literature. The literature indicates that symptoms alone have relatively poor diagnostic accuracy in predicting the presence of polyneuropathy; signs are better predictors of polyneuropathy than symptoms; and single abnormalities on examination are less sensitive than multiple abnormalities in predicting the presence of polyneuropathy. The combination of neuropathic symptoms, signs, and electrodiagnostic findings provides the most accurate diagnosis of distal symmetrical polyneuropathy. A set of case definitions was rank ordered by likelihood of disease. The highest likelihood of polyneuropathy (useful for clinical trials) occurs with a combination of multiple symptoms, multiple signs, and abnormal electrodiagnostic studies. A modest likelihood of polyneuropathy (useful for field or epidemiological studies) occurs with a combination of multiple symptoms and multiple signs when the results of electrodiagnostic studies are not available. A lower likelihood of polyneuropathy occurs when electrodiagnostic studies and signs are discordant. For research purposes, the best approach for defining distal symmetrical polyneuropathy is a set of case definitions rank ordered by estimated likelihood of disease. The inclusion of this formalized case definition in clinical and epidemiological research studies will ensure greater consistency of case selection.

  17. Negotiation skills for clinical research professionals

    Directory of Open Access Journals (Sweden)

    Sanjay Hake

    2011-01-01

    Full Text Available Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors.

  18. Mapping Frontier Research in the Humanities

    DEFF Research Database (Denmark)

    Whereas the classical sciences were organized around academic disciplines, knowledge production today is increasingly interdisciplinary and distributed across a variety of societal sectors. Classical disciplines have not only specialized and multiplied; they are increasingly interacting with extra...... of impact and styles of reasoning, both in classical and interdisciplinary fields of the humanities. From this perspective, a more composite picture of human culture, language and history can emerge from humanities research. It goes beyond the picture of rational agents, and situates human interaction...

  19. Animal research as a basis for clinical trials.

    Science.gov (United States)

    Faggion, Clovis M

    2015-04-01

    Animal experiments are critical for the development of new human therapeutics because they provide mechanistic information, as well as important information on efficacy and safety. Some evidence suggests that authors of animal research in dentistry do not observe important methodological issues when planning animal experiments, for example sample-size calculation. Low-quality animal research directly interferes with development of the research process in which multiple levels of research are interconnected. For example, high-quality animal experiments generate sound information for the further planning and development of randomized controlled trials in humans. These randomized controlled trials are the main source for the development of systematic reviews and meta-analyses, which will generate the best evidence for the development of clinical guidelines. Therefore, adequate planning of animal research is a sine qua non condition for increasing efficacy and efficiency in research. Ethical concerns arise when animal research is not performed with high standards. This Focus article presents the latest information on the standards of animal research in dentistry, more precisely in the field of implant dentistry. Issues on precision and risk of bias are discussed, and strategies to reduce risk of bias in animal research are reported.

  20. [Clinical research I. The importance of the research design].

    Science.gov (United States)

    Talavera, Juan O

    2011-01-01

    The endeavor of clinical research to study a group of patients is to make a diagnosis, estimate the prognosis and prove a treatment. For this purpose is used the scientific method: 1) the architectural arrangement, which can be divided into cause-effect and the process of research; 2) the methodological approach, which includes controlled clinical trials, cohorts, case control, and cross-sectional designs; 3) the goal-oriented approach, in which studies on diagnostic tests, prognosis, treatment and risk or causal factors are grouped. The designs mentioned above are considered primary studies; it means that the information was obtained directly from the subjects studied. There is a second category of studies, which uses information obtained from the primary studies. This is the reason why they are considered as secondary or integrative studies.

  1. Animal models of frailty: current applications in clinical research.

    Science.gov (United States)

    Kane, Alice E; Hilmer, Sarah N; Mach, John; Mitchell, Sarah J; de Cabo, Rafael; Howlett, Susan E

    2016-01-01

    The ethical, logistical, and biological complications of working with an older population of people inherently limits clinical studies of frailty. The recent development of animal models of frailty, and tools for assessing frailty in animal models provides an invaluable opportunity for frailty research. This review summarizes currently published animal models of frailty including the interleukin-10 knock-out mouse, the mouse frailty phenotype assessment tool, and the mouse clinical frailty index. It discusses both current and potential roles of these models in research into mechanisms of frailty, interventions to prevent/delay frailty, and the effect of frailty on outcomes. Finally, this review discusses some of the challenges and opportunities of translating research findings from animals to humans.

  2. Human Subjects Research and the Physics Classroom

    Science.gov (United States)

    Kubitskey, Beth W.; Thomsen, Marshall

    2012-01-01

    Physics Education Research is a form of social science research in that it uses human subjects. As physicists we need to be aware of the ethical and legal ramifications of performing this research, taking into account the fundamental differences between working with substances and working with people. For several decades, the federal government…

  3. Adult human brain cell culture for neuroscience research.

    Science.gov (United States)

    Gibbons, Hannah M; Dragunow, Mike

    2010-06-01

    Studies of the brain have progressed enormously through the use of in vivo and in vitro non-human models. However, it is unlikely such studies alone will unravel the complexities of the human brain and so far no neuroprotective treatment developed in animals has worked in humans. In this review we discuss the use of adult human brain cell culture methods in brain research to unravel the biology of the normal and diseased human brain. The advantages of using adult human brain cells as tools to study human brain function from both historical and future perspectives are discussed. In particular, studies using dissociated cultures of adult human microglia, astrocytes, oligodendrocytes and neurons are described and the applications of these types of study are evaluated. Alternative sources of human brain cells such as adult neural stem cells, induced pluripotent stem cells and slice cultures of adult human brain tissue are also reviewed. These adult human brain cell culture methods could benefit basic research and more importantly, facilitate the translation of basic neuroscience research to the clinic for the treatment of brain disorders. Copyright 2009 Elsevier Ltd. All rights reserved.

  4. Department of Veterans Affairs Geriatric Research, Education and Clinical Centers: translating aging research into clinical geriatrics.

    Science.gov (United States)

    Supiano, Mark A; Alessi, Cathy; Chernoff, Ronni; Goldberg, Andrew; Morley, John E; Schmader, Kenneth E; Shay, Kenneth

    2012-07-01

    Department of Veterans Affairs (VA) Geriatric Research, Education and Clinical Centers (GRECCs) originated in 1975 in response to the rapidly aging veteran population. Since its inception, the GRECC program has made major contributions to the advancement of aging research, geriatric training, and clinical care within and outside the VA. GRECCs were created to conduct translational research to enhance the clinical care of future aging generations. GRECC training programs also provide leadership in educating healthcare providers about the special needs of older persons. GRECC programs are also instrumental in establishing robust clinical geriatric and aging research programs at their affiliated university schools of medicine. This report identifies how the GRECC program has successfully adapted to changes that have occurred in VA since 1994, when the program's influence on U.S. geriatrics was last reported, focusing on its effect on advancing clinical geriatrics in the last 10 years. This evidence supports the conclusion that, after more than 30 years, the GRECC program remains a vibrant "jewel in the crown of the VA" and is poised to make contributions to aging research and clinical geriatrics well into the future. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

  5. Data management in clinical research: An overview

    Directory of Open Access Journals (Sweden)

    Binny Krishnankutty

    2012-01-01

    Full Text Available Clinical Data Management (CDM is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM.

  6. Fruit Flies Help Human Sleep Research

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Fruit Flies Help Human Sleep Research Past Issues / Summer 2007 ... courtesy of NIGMS Neuroscientist Chiara Cirelli uses experimental fruit flies to study sleep. Although it may be tough ...

  7. The Weiland Medal: Clinical Research in Hand Surgery

    Science.gov (United States)

    Chung, Kevin C.

    2015-01-01

    Clinical research designed to enhance the quality of healthcare has always received a great deal of national attention. Outcomes studies, clinical trials, and evidence-based research are key components of clinical research that have advanced the field of hand surgery. The purpose of the Weiland Award is to encourage innovations and progress in clinical research in hand surgery for the betterment of patients and to promote hand surgery’s visibility in American medicine. This article will highlight my efforts in clinical research through three specific research themes: (1) outcomes research, (2) economic analysis, and (3) evidence-based research and quality assessment in healthcare. PMID:20117312

  8. Updating freeze: Aligning animal and human research

    NARCIS (Netherlands)

    Hagenaars, M.A.; Oitzl, M.S.; Roelofs, K.

    2014-01-01

    Freezing is widely used as the main outcome measure for fear in animal studies. Freezing is also getting attention more frequently in human stress research, as it is considered to play an important role in the development of psychopathology. Human models on defense behavior are largely based on anim

  9. Educational Research: The Importance of the Humanities

    Science.gov (United States)

    Smith, Richard

    2015-01-01

    It is one sign of the lack of understanding of the value of the humanities, to educational research and inquiry as well as to our world more widely, that such justifications of them as are offered frequently take a crudely instrumental form. The humanities (which in this essay are not distinguished from the arts) are welcomed insofar as they are…

  10. When is surgery research? Towards an operational definition of human research.

    Science.gov (United States)

    Margo, C E

    2001-02-01

    The distinction between clinical practice and surgical research may seem trivial, but this distinction can become a complex issue when innovative surgeries are substituted for standard care without patient knowledge. Neither the novelty nor the risk of a new surgical procedure adequately defines surgical research. Some institutions tacitly allow the use of new surgical procedures in series of patients without informing individuals that they are participating in a scientific study, as long as no written protocol or hypothesis exists. Institutions can justify this practice by viewing human research in narrow terms as an activity outlined in a formal protocol. Application of limited definitions, however, erodes patients' rights and risks losing public confidence in how biomedical research is conducted. I propose an operational definition of human research also be recognised. Enforcing more rigid and less ambiguous guidelines of human research may curtail enrolment into some studies, but it will also protect patients from being used as subjects without their knowledge.

  11. Research on disaster prevention by human factor

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Bok Youn; Kang, Chang Hee; Kang, Sun Duck; Jo, Young Do [Korea Institute of Geology Mining and Materials, Taejon (Korea)

    1998-12-01

    Mining, by its very nature, requires workers and technology to function in an unpredictable environment that can not easily be engineered to accommodate human factors. Miners' physical and cognitive capabilities are sometimes stretched to the point that 'human error' in performance result. Mine safety researchers estimate that 50-85% of all mining injuries are due, in large part, to human error. Further research suggests that the primary causes of these errors in performance lie outside the individual and can be minimized by improvements in equipment design, work environments, work procedures and training. The human factors research is providing the science needed to determine which aspects of the mining environment can be made more worker-friendly and how miners can work more safely in environments that can not be improved. Underground mines have long been recognized as an innately hazardous and physically demanding work environment. Recently, mining is becoming a more complicated process as more sophisticated technologies are introduced. The more complicated or difficult the tasks to be performed, the more critical it is to have a systematic understanding of the humans, the technology, the environments, and how they interact. Human factors is a key component in solving most of today's mine safety and health problems. Human factors research primarily centered around solving problems in the following four areas: 1) How mining methods and equipment affect safety, 2) Evaluating the fit between miner's physical capabilities and the demands of their job, 3) Improving miner's ability to perceive and react to hazards, 4) Understanding how organizational and managerial variables influence safety. Human factor research was begun during the World war II. National Coal Board (British Coal) of Great Britain commenced ergonomics in 1969, and Bureau of Mine of United States started human factor researches in same year. Japan has very short history

  12. Human research ethics committees in technical universities.

    Science.gov (United States)

    Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

    2014-07-01

    Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee.

  13. Menstrual questionnaires for clinical and research use.

    Science.gov (United States)

    Matteson, Kristen A

    2017-04-01

    Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB. Copyright © 2016. Published by Elsevier Ltd.

  14. Cardiomyopathy in Friedreich Ataxia: Clinical Findings and Research

    Science.gov (United States)

    Payne, R. Mark; Wagner, Gregory R.

    2013-01-01

    Friedreich ataxia is the most common human ataxia and results from inadequate production of the frataxin protein, most often due to a triplet expansion in the nuclear FXN gene. The gene cannot be transcribed to generate the messenger RNA for frataxin. Frataxin is an iron-binding protein targeted to the mitochondrial matrix. In its absence, multiple iron-sulfur-dependent proteins in mitochondria and the cytosol lack proper assembly, destroying mitochondrial and nuclear function. Mitochondrial oxidant stress may also participate in ongoing cellular injury. Although progressive and debilitative ataxia is the most prominent clinical finding, hypertrophic cardiomyopathy with heart failure is the most common cause of early death in this disease. There is no cure. In this review we cover recent basic and clinical findings regarding the heart in Friedreich ataxia, offer recommendations for clinical management of the cardiomyopathy in this disease, and point out new research directions to advance the field. PMID:22764179

  15. Selecting measures for human factors research.

    Science.gov (United States)

    Kantowitz, B H

    1992-08-01

    Selecting measures is a necessary component of human factors research. Proper selection must take into account the representation problem (how is the assignment of numbers to objects or phenomena justified?) and the uniqueness problem (to what degree is this assignment unique?). Other key human factors measurement issues include subject representativeness, variable representativeness, and setting representativeness. It is difficult to create a single measure that captures essential characteristics of complex systems. Several examples illustrate how theory can guide measurement selection in such diverse human factors research as vigilance, turning off warning alarms, information requirements for military command centers, subjective workload, heart-rate signal analysis, and heat stress in nuclear power plants.

  16. Clinical research progress of tuberculous meningitis

    Directory of Open Access Journals (Sweden)

    Zhan-yun MA

    2014-08-01

    Full Text Available Tuberculous meningitis is an infectious disease of central nervous system caused by Mycobacterium tuberculosis. It mainly invades into brain meninges and parenchyma, and may spread to the spinal cord and spinal meninges. The disability rate and mortality rate of this disease are very high. In recent years, incidence of tuberculosis increased significantly due to the increase of drug-resistant tuberculosis cases, population mobility, acquired immunodeficiency syndrome (AIDS epidemic and other factors. Tuberculosis is still a worldwide serious threat to human life and health, especially in the underdeveloped and developing countries. China is the world's largest developing country with large population, so tuberculosis prevention and control is still a quite severe problem. In this paper, the clinical manifestations, diagnosis and differential diagnosis, treatment progress of tuberculous meningitis were reviewed systematically. doi: 10.3969/j.issn.1672-6731.2014.08.004

  17. Human Experimentation: Impact on Health Education Research.

    Science.gov (United States)

    Vacalis, T. Demetri; Griffis, Kathleen

    1980-01-01

    The problems of the use of humans as subjects of medical research and the protection of their rights are discussed. Issues include the use of informed consent, the evaluation of risks and benefits, and the review of research plans by a committee. (JD)

  18. Research in the Humanities: Ideals and Idols

    Science.gov (United States)

    Gombrich, E. H.

    1973-01-01

    Research in the humanities should be done in areas of interest, under circumstances conducive to intellectual study and should not be undertaken for the purposes of gathering all information on a subject, for the purpose of seeking the novel, in order to apply the latest research tools, or totally because the subject is being taught and…

  19. Human Research Program: 2010 Annual Report

    Science.gov (United States)

    2010-01-01

    2010 was a year of solid performance for the Human Research Program in spite of major changes in NASA's strategic direction for Human Spaceflight. Last year, the Program completed the final steps in solidifying the management foundation, and in 2010 we achieved exceptional performance from all elements of the research and technology portfolio. We transitioned from creating building blocks to full execution of the management tools for an applied research and technology program. As a team, we continue to deliver the answers and technologies that enable human exploration of space. While the Agency awaits strategic direction for human spaceflight, the Program is well positioned and critically important to helping the Agency achieve its goals.

  20. Barriers to Effective Deliberation in Clinical Research Oversight.

    Science.gov (United States)

    Wenner, Danielle M

    2016-09-01

    Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call "deliberative pathologies," or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research.

  1. Integrated Extravehicular Activity Human Research Plan: 2016

    Science.gov (United States)

    Abercromby, Andrew F. J.; Ross, Amy J.; Cupples, J. Scott; Rajulu, Sudhakar; Norcross, Jason R.; Chappell, Steven P.

    2016-01-01

    Multiple organizations within NASA and outside of NASA fund and participate in research related to extravehicular activity (EVA). In October 2015, representatives of the EVA Office, the Crew and Thermal Systems Division (CTSD), and the Human Research Program (HRP) at NASA Johnson Space Center agreed on a formal framework to improve multi-year coordination and collaboration in EVA research. At the core of the framework is an Integrated EVA Human Research Plan and a process by which it will be annually reviewed and updated. The over-arching objective of the collaborative framework is to conduct multi-disciplinary cost-effective research that will enable humans to perform EVAs safely, effectively, comfortably, and efficiently, as needed to enable and enhance human space exploration missions. Research activities must be defined, prioritized, planned and executed to comprehensively address the right questions, avoid duplication, leverage other complementary activities where possible, and ultimately provide actionable evidence-based results in time to inform subsequent tests, developments and/or research activities. Representation of all appropriate stakeholders in the definition, prioritization, planning and execution of research activities is essential to accomplishing the over-arching objective. A formal review of the Integrated EVA Human Research Plan will be conducted annually. External peer review of all HRP EVA research activities including compilation and review of published literature in the EVA Evidence Report is will also continue at a frequency determined by HRP management. Coordination with stakeholders outside of the EVA Office, CTSD, and HRP is already in effect on a study-by-study basis; closer coordination on multi-year planning with other EVA stakeholders including academia is being actively pursued. Details of the current Integrated EVA Human Research Plan are presented including description of ongoing and planned research activities in the areas of

  2. HUMAN OCULAR DIROFILARIOSIS: CLINICAL AND EPIDEMIOLOGICAL FEATURES

    Directory of Open Access Journals (Sweden)

    Marija Trenkić-Božinović

    2014-03-01

    Full Text Available Dirofilarioses are zoonoses caused by filaria of the genus Dirofilaria, the parasites of domestic and wild animals. People are just random carriers of this parasite. In Europe, human dirofilariosis is caused by two species: Dirofilaria repens ( D. repens, also known as a species of The Old World , usually with the superficial localization of infection, and D. immitis, which is present throughout the world, and causes, beside superficial, visceral dirofilariosis. So far, based on the data from reference literature, it can be observed that in Serbia about 34 cases of human dirofilariosis have been diagnosed and published. It is assumed that the prevalence of this parasitosis is significantly higher as our country is an endemic area for dirofilariosis in dogs and the region where species of mosquitoes, which are transitory hosts and vectors of Dirofilaria spp., are present. The clinical picture of dirofilariosis depends on the type and location of the parasite in the human body. In our country, patients diagnosed with dirofilariosis had subcutaneous or subconjunctival infection in the majority of cases. Ocular dirofilariosis may affect the orbit and the periorbital region, the skin of the eyelids, the conjunctiva, the Tenon membrane, a retrobulbar space or has an intrabulbar localization. These patients may have a severe disability, and surgery alone can be complicated due to localization. The aim of this review is to highlight the importance of this unexpected important zoonoses, with special emphasis on the importance within the ophthalmic practice.

  3. Nature and governance of veterinary clinical research conducted in the UK.

    Science.gov (United States)

    Fordyce, P; Mullan, S

    2017-01-21

    In order to quantify the amount of clinical research conducted on client-owned animals under the Veterinary Surgeons Act 1966, and the nature and extent of any ethical review of that research, a questionnaire was sent to 6 UK veterinary schools, 1 charity veterinary clinic and 12 private referral clinics. The questionnaire examined whether and how much clinical research respondents undertook, and the composition of any ethical review panels examining research proposals. The questionnaire revealed a substantial amount of clinical research was conducted in the UK, with over 200 veterinary surgeons involved in the year of the survey, with at least 170 academic papers involving clinical research published by respondents in the same year. However, it proved impossible to quantify the full extent of clinical research in the UK. All UK veterinary schools required ethical review of clinical research. The composition and working practices of their ethical review panels generally reflected skill sets in ethical review panels set-up under statute to consider the ethics of non-clinical biomedical research on animals and clinical research conducted on human patients. The process for review of clinical research in the private sector was less clear. British Veterinary Association.

  4. The Weiland Medal: Clinical Research in Hand Surgery

    OpenAIRE

    Chung, Kevin C.

    2010-01-01

    Clinical research designed to enhance the quality of healthcare has always received a great deal of national attention. Outcomes studies, clinical trials, and evidence-based research are key components of clinical research that have advanced the field of hand surgery. The purpose of the Weiland Award is to encourage innovations and progress in clinical research in hand surgery for the betterment of patients and to promote hand surgery’s visibility in American medicine. This article will highl...

  5. Human RAG mutations: biochemistry and clinical implications.

    Science.gov (United States)

    Notarangelo, Luigi D; Kim, Min-Sung; Walter, Jolan E; Lee, Yu Nee

    2016-04-01

    The recombination-activating gene 1 (RAG1) and RAG2 proteins initiate the V(D)J recombination process, which ultimately enables the generation of T cells and B cells with a diversified repertoire of antigen-specific receptors. Mutations of the RAG genes in humans are associated with a broad spectrum of clinical phenotypes, ranging from severe combined immunodeficiency to autoimmunity. Recently, novel insights into the phenotypic diversity of this disease have been provided by resolving the crystal structure of the RAG complex, by developing novel assays to test recombination activity of the mutant RAG proteins and by characterizing the molecular and cellular basis of immune dysregulation in patients with RAG deficiency.

  6. Metapsychological and clinical issues in psychosomatics research.

    Science.gov (United States)

    Press, Jacques

    2016-02-01

    The author starts by treating the general epistemological problems inherent to research and emphasizes that all investigation takes place between two poles: a creative pole and one that is defensive in relation to the unknown and formlessness. In the psychosomatic field, an additional difficulty resides in the western dualistic vision of the relationship between psyche and soma which influences our way of thinking about the body as well as about otherness. The author continues by exploring Pierre Marty's psychosomatic model. Its psychosomatic monism is revolutionary but incomplete and creates a distance with the other, the somatizing patient, resulting in a medically oriented nosology symptomatic of the impossibility to think about some of the most important aspects of counter-transference. With the help of clinical material, the author considers these unthought aspects and some of their theoretical implications, particularly the way of understanding the negative often so prevalent with these patients. Based on these reflections as well as Freud's on beyond the pleasure principle and Winnicott's theorization on the fear of breakdown, the author suggests some directions for research. Somatic illness might occur when the attempts at filling the cracks created by a breakdown are unsuccessful.

  7. Cultural psychiatry. Theoretical, clinical, and research issues.

    Science.gov (United States)

    Lewis-Fernández, R; Kleinman, A

    1995-09-01

    As a discipline, cultural psychiatry has matured considerably in recent years and the ongoing quality of its theoretical, clinical, and research development holds great promise. The contemporary emphasis on culture as process permits a deeper analysis of the complexities of sociosomatics--the translation of meanings and social relations into bodily experience--and, thus, of the social course of illness. We also are learning a great deal more about cultural processes that affect therapy, including ethnopharmacologic and culturally valid family interventions that are directly relevant to patient care and mental health policy. And an important set of studies is examining the trauma experienced by refugees and immigrants. But at the same time many disquieting findings still point to the limited impact of cultural psychiatry on knowledge creation and clinical application in psychiatry. The failure of the cultural validation of DSM-IV is only the most dismaying. The persistent misdiagnosis of minority patients and the continued presence of racial bias in some treatment recommendations are also disheartening, as is the seeming contempt of many mainstream psychiatrists for culturally defined syndromes and folk healing systems. Widespread inattention to ethnic issues in medical ethics is another source of dismay. It is for these reasons that the culture of psychiatry itself becomes as important as the culture of patients as a topic for research and intervention. Most of the world still suffers from a terrible lack of basic mental health services, including life-saving medications and hospital beds. In the face of these limitations, and because of the increasing multicultural and pluralistic reality of contemporary life, the growing interpretive bridges linking indigenous systems of illness classification and healing to Western nosologies and therapeutic modalities become even more essential and the reluctance of mainstream clinicians to explore folk healing methods more

  8. 76 FR 1212 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-01-07

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Eligibility of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... areas of biomedical, behavioral and clinical science research. The panel meeting will be open to the...

  9. 76 FR 79273 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-12-21

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Eligibility of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... biomedical, behavioral, and clinical science research. The panel meeting will be open to the public for...

  10. 78 FR 28292 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-05-14

    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Research and Development and Clinical Science Research and Development Services Scientific Merit Review... areas of biomedical, behavioral and clinical science research. The panel meetings will be open to the...

  11. Collaborative Research in the Digital Humanities

    CERN Document Server

    Deegan, Marilyn

    2012-01-01

    Collaboration within digital humanities is both a pertinent and a pressing topic as the traditional mode of the humanist, working alone in his or her study, is supplemented by explicitly co-operative, interdependent and collaborative research. This is particularly true where computational methods are employed in large-scale digital humanities projects. This book, which celebrates the contributions of Harold Short to this field, presents fourteen essays by leading authors in the digital humanities. It addresses several issues of collaboration, from the multiple perspectives of institutions, pro

  12. Integrating Spaceflight Human System Risk Research

    Science.gov (United States)

    Mindock, Jennifer; Lumpkins, Sarah; Anton, Wilma; Havenhill, Maria; Shelhamer, Mark; Canga, Michael

    2016-01-01

    NASA is working to increase the likelihood of human health and performance success during exploration missions as well as to maintain the subsequent long-term health of the crew. To manage the risks in achieving these goals, a system modelled after a Continuous Risk Management framework is in place. "Human System Risks" (Risks) have been identified, and approximately 30 are being actively addressed by NASA's Human Research Program (HRP). Research plans for each of HRP's Risks have been developed and are being executed. Inter-disciplinary ties between the research efforts supporting each Risk have been identified; however, efforts to identify and benefit from these connections have been mostly ad hoc. There is growing recognition that solutions developed to address the full set of Risks covering medical, physiological, behavioural, vehicle, and organizational aspects of exploration missions must be integrated across Risks and disciplines. This paper discusses how a framework of factors influencing human health and performance in space is being applied as the backbone for bringing together sometimes disparate information relevant to the individual Risks. The resulting interrelated information enables identification and visualization of connections between Risks and research efforts in a systematic and standardized manner. This paper also discusses the applications of the visualizations and insights into research planning, solicitation, and decision-making processes.

  13. Boom in clinical research industry: a dangerous trend.

    Science.gov (United States)

    Bajpai, Vikas; Saraya, Anoop

    2009-01-01

    Over the last decade or so India has witnessed a phenomenal growth in the clinical trial industry. The projections forecast a continuing growth of this trend. It has been predicted that by 2011 India will be in charge of 15% of global clinical trials. The enthusiasm for the growth of this industry in India is shared not just by the major pharmaceutical companies and CROs but also equally so by government agencies. The raison d'être for medical research is that it should lead to maximum possible benefit to the largest number of people. Hence, an examination of the extent to which public good is served can act as a measure for objective analysis of this exponential increase in the clinical trial industry. After all it is the health and lives of the people that are at stake. On the face of it, it would seem that all trials testing the safety and efficacy of various molecules, by their very nature work towards public welfare as they are indispensible to the development of any drug including the life-saving ones. An increasing number of clinical trials at all stages in a product's life cycle are funded by the pharmaceutical industry. It would then seem that the industry-sponsored medical research is necessarily furthering the larger objective of human wellbeing. However, the operations of the pharmaceutical industry, the nature of the processes involved and the operative motives are a bit too complex to facilitate this larger objective so simply, just as yet. This warrants a closer look at the various aspects of industry-sponsored clinical research.

  14. Current issues in medically assisted reproduction and genetics in Europe: research, clinical practice, ethics, legal issues and policyEuropean Society of Human Genetics and European Society of Human Reproduction and Embryology

    OpenAIRE

    Harper, Joyce C; Geraedts, Joep; Borry, Pascal; Cornel, Martina C.; Dondorp, Wybo; Gianaroli, Luca; Harton, Gary; Milachich, Tanya; Kääriäinen, Helena; Liebaers, Inge; Morris, Michael; Sequeiros, Jorge; Sermon, Karen; Shenfield, Françoise; Skirton, Heather

    2013-01-01

    In March 2005, a group of experts from the European Society of Human Genetics and European Society of Human Reproduction and Embryology met to discuss the interface between genetics and assisted reproductive technology (ART), and published an extended background paper, recommendations and two Editorials. Seven years later, in March 2012, a follow-up interdisciplinary workshop was held, involving representatives of both professional societies, including experts from the European Union Eurogent...

  15. Future requirements. Clinical investigations

    DEFF Research Database (Denmark)

    Qvist, V.

    2002-01-01

    Biocompatability, Cariology, Clinical trials, Dental materials, Helath services research, Human, Pedodontics......Biocompatability, Cariology, Clinical trials, Dental materials, Helath services research, Human, Pedodontics...

  16. Continuing Education in Research Ethics for the Clinical Nurse.

    Science.gov (United States)

    Jeffers, Brenda Recchia

    2002-01-01

    Review of professional nursing statements, federal policy, and recommendations for protection of human research subjects resulted in a topic and content outline for research ethics training for nurses. Suggestions for continuing education programs on research ethics were formulated. (SK)

  17. Continuing Education in Research Ethics for the Clinical Nurse.

    Science.gov (United States)

    Jeffers, Brenda Recchia

    2002-01-01

    Review of professional nursing statements, federal policy, and recommendations for protection of human research subjects resulted in a topic and content outline for research ethics training for nurses. Suggestions for continuing education programs on research ethics were formulated. (SK)

  18. Interior Design Research: A Human Ecosystem Model.

    Science.gov (United States)

    Guerin, Denise A.

    1992-01-01

    The interior ecosystems model illustrates effects on the human organism of the interaction of the natural, behavioral, and built environment. Examples of interior lighting and household energy consumption show the model's flexibility for organizing study variables in interior design research. (SK)

  19. Interior Design Research: A Human Ecosystem Model.

    Science.gov (United States)

    Guerin, Denise A.

    1992-01-01

    The interior ecosystems model illustrates effects on the human organism of the interaction of the natural, behavioral, and built environment. Examples of interior lighting and household energy consumption show the model's flexibility for organizing study variables in interior design research. (SK)

  20. [Source data management in clinical researches].

    Science.gov (United States)

    Ho, Effie; Yao, Chen; Zhang, Zi-bao; Liu, Yu-xiu

    2015-11-01

    Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.

  1. Trends in research involving human beings in Brazil.

    Science.gov (United States)

    Silva, Ricardo Eccard da; Novaes, Maria Rita Carvalho; Pastor, Elza Martínez; Barragan, Elena; Amato, Angélica Amorim

    2015-02-01

    Developing countries have experienced a dramatic increase in the number of clinical studies in the last decades. The aim of this study was to describe 1) the number of clinical trials submitted to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa) from 2007 to 2012 and the number of human-subject research projects approved by research ethics committees (RECs) and the National Research Ethics Committee (Comissão Nacional de Ética em Pesquisa, CONEP) in Brazil from 2007 to 2011 and 2) the diseases most frequently studied in Brazilian states in clinical trials approved in the country from 2009 to 2012, based on information from an Anvisa databank. Two databases were used: 1) the National Information System on Research Ethics Involving Human Beings (Sistema Nacional de Informação Sobre Ética em Pesquisa envolvendo Seres Humanos, SISNEP) and 2) Anvisa's Clinical Research Control System (Sistema de Controle de Pesquisa Clínica, SCPC). Data from the SCPC indicated an increase of 32.7% in the number of clinical trials submitted to Anvisa, and data from the SISNEP showed an increase of 69.9% in those approved by RECs and CONEP (from 18 160 in 2007 to 30 860 in 2011). Type 2 diabetes (26.0%) and breast cancer (20.5%)-related to the main causes of mortality in Brazil-were the two most frequently studied diseases. The so-called “neglected diseases,” such as dengue fever, were among the least studied diseases in approved clinical trials, despite their significant impact on social, economic, and health indicators in Brazil. Overall, the data indicated 1) a clear trend toward more research involving human beings in Brazil, 2) good correspondence between diseases most studied in clinical trials approved by Anvisa and the main causes of death in Brazil, and 3) a low level of attention to neglected diseases, an issue that should be considered in setting future research priorities, given their socioeconomic and health effects.

  2. Integrating spaceflight human system risk research

    Science.gov (United States)

    Mindock, Jennifer; Lumpkins, Sarah; Anton, Wilma; Havenhill, Maria; Shelhamer, Mark; Canga, Michael

    2017-10-01

    NASA is working to increase the likelihood of exploration mission success and to maintain crew health, both during exploration missions and long term after return to Earth. To manage the risks in achieving these goals, a system modelled after a Continuous Risk Management framework is in place. ;Human System Risks; (Risks) have been identified, and 32 are currently being actively addressed by NASA's Human Research Program (HRP). Research plans for each of HRP's Risks have been developed and are being executed. Inter-disciplinary ties between the research efforts supporting each Risk have been identified; however, efforts to identify and benefit from these connections have been mostly ad hoc. There is growing recognition that solutions developed to address the full set of Risks covering medical, physiological, behavioural, vehicle, and organizational aspects of exploration missions must be integrated across Risks and disciplines. This paper discusses how a framework of factors influencing human health and performance in space is being applied as the backbone for bringing together sometimes disparate information relevant to the individual Risks. The resulting interrelated information enables identification and visualization of connections between Risks and research efforts in a systematic and standardized manner. This paper also discusses the applications of the visualizations and insights into research planning, solicitation, and decision-making processes.

  3. Clinical impact of human breast milk metabolomics.

    Science.gov (United States)

    Cesare Marincola, Flaminia; Dessì, Angelica; Corbu, Sara; Reali, Alessandra; Fanos, Vassilios

    2015-12-01

    Metabolomics is a research field concerned with the analysis of metabolome, the complete set of metabolites in a given cell, tissue, or biological sample. Being able to provide a molecular snapshot of biological systems, metabolomics has emerged as a functional methodology in a wide range of research areas such as toxicology, pharmacology, food technology, nutrition, microbial biotechnology, systems biology, and plant biotechnology. In this review, we emphasize the applications of metabolomics in investigating the human breast milk (HBM) metabolome. HBM is the recommended source of nutrition for infants since it contains the optimal balance of nutrients for developing babies, and it provides a range of benefits for growth, immunity, and development. The molecular mechanisms beyond the inter- and intra-variability of HBM that make its composition unique are yet to be well-characterized. Although still in its infancy, the study of HBM metabolome has already proven itself to be of great value in providing insights into this biochemical variability in relation to mother phenotype, diet, disease, and lifestyle. The results of these investigations lay the foundation for further developments useful to identify normal and aberrant biochemical changes as well as to develop strategies to promote healthy infant feeding practices.

  4. Clinical research training of Peruvian neurologists: a baseline assessment

    Directory of Open Access Journals (Sweden)

    Gian Carlos Navarro-Chumbes

    2010-05-01

    Full Text Available In Peru, despite a strong clinical research infrastructure in Lima, and Masters degree programs in epidemiology at three universities, few neurologists participate in clinical research. It was our objective to identify perceived needs and opportunities for increasing clinical research capacity and training opportunities for Peruvian neurologists. We conducted a descriptive, cross-sectional survey of Peruvian neurologists in Lima and Arequipa, Peru. Forty-eight neurologists completed written surveys and oral interviews. All neurologists reported interest in clinical research, but noted that lack of time and financial resources limited their ability to participate. Although most neurologists had received some training in epidemiology and research design as medical students or residents, the majority felt these topics were not adequately covered. Neurologists in Arequipa noted international funding for clinical research was uncommon outside the capital city of Lima. We concluded that clinical research is important to Peruvian neurologists. The three main barriers to increased participation in clinical research identified by neurologists were insufficient training in clinical research methodology, meager funding opportunities, and lack of dedicated time to participate in clinical research. Distance learning holds promise as a method for providing additional training in clinical research methodology, especially for neurologists who may have difficulty traveling to larger cities for additional training.

  5. Clinical research training of Peruvian neurologists: a baseline assessment.

    Science.gov (United States)

    Navarro-Chumbes, Gian Carlos; Montano-Torres, Silvia Margarita; Díaz-Vásquez, Alberto; Zunt, Joseph Raymond

    2010-06-21

    In Peru, despite a strong clinical research infrastructure in Lima, and Masters degree programs in epidemiology at three universities, few neurologists participate in clinical research. It was our objective to identify perceived needs and opportunities for increasing clinical research capacity and training opportunities for Peruvian neurologists. We conducted a descriptive, cross-sectional survey of Peruvian neurologists in Lima and Arequipa, Peru. Forty-eight neurologists completed written surveys and oral interviews. All neurologists reported interest in clinical research, but noted that lack of time and financial resources limited their ability to participate. Although most neurologists had received some training in epidemiology and research design as medical students or residents, the majority felt these topics were not adequately covered. Neurologists in Arequipa noted international funding for clinical research was uncommon outside the capital city of Lima. We concluded that clinical research is important to Peruvian neurologists. The three main barriers to increased participation in clinical research identified by neurologists were insufficient training in clinical research methodology, meager funding opportunities, and lack of dedicated time to participate in clinical research. Distance learning holds promise as a method for providing additional training in clinical research methodology, especially for neurologists who may have difficulty traveling to larger cities for additional training.

  6. Integrating computerized clinical decision support systems into clinical work: A meta-synthesis of qualitative research.

    Science.gov (United States)

    Miller, Anne; Moon, Brian; Anders, Shilo; Walden, Rachel; Brown, Steven; Montella, Diane

    2015-12-01

    Computerized clinical decision support systems (CDSS) are an emerging means for improving healthcare safety, quality and efficiency, but meta-analyses findings are mixed. This meta-synthesis aggregates qualitative research findings as possible explanations for variable quantitative research outcomes. Qualitative studies published between 2000 and 2013 in English, involving physicians, registered and advanced practice nurses' experience of CDSS use in clinical practice were included. PubMed and CINAHL databases were searched. Study titles and abstracts were screened against inclusion criteria. Retained studies were appraised against quality criteria. Findings were extracted iteratively from studies in the 4th quartile of quality scores. Two reviewers constructed themes inductively. A third reviewer applied the defined themes deductively achieving 92% agreement. 3798 unique records were returned; 56 met inclusion criteria and were reviewed against quality criteria. 9 studies were of sufficiently high quality for synthetic analysis. Five major themes (clinician-patient-system integration; user interface usability; the need for better 'algorithms'; system maturity; patient safety) were defined. Despite ongoing development, CDSS remains an emerging technology. Lack of understanding about and lack of consideration for the interaction between human decision makers and CDSS is a major reason for poor system adoption and use. Further high-quality qualitative research is needed to better understand human-system interaction issues. These issues may continue to confound quantitative study results if not addressed. Copyright © 2015. Published by Elsevier Ireland Ltd.

  7. A European perspective--the European clinical research infrastructures network.

    Science.gov (United States)

    Demotes-Mainard, J; Kubiak, C

    2011-11-01

    Evaluating research outcomes requires multinational cooperation in clinical research for optimization of treatment strategies and comparative effectiveness research, leading to evidence-based practice and healthcare cost containment. The European Clinical Research Infrastructures Network (ECRIN) is a distributed ESFRI (European Strategy Forum on Research Infrastructures) roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific potential. Servicing multinational trials started during its preparatory phase, and ECRIN will now apply for an ERIC (European Research Infrastructures Consortium) status by 2011. By creating a single area for clinical research in Europe, this achievement will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of the research and education capacity, tackling the major societal challenges starting with the area of healthy ageing, and removing barriers to bring ideas to the market.

  8. Research on Chinese Visible Human Project

    Institute of Scientific and Technical Information of China (English)

    ZhangShaoxiang

    2003-01-01

    “Visible Human Project (VHP)” was initiated by US National Library of Medicine in 1989, and in August 1991, the library signed a contract with Health Science Center of the University of Col-orado to formally carry out the project. According-ly, research team at the University of Colorado col-lected a structural data set of human body after obtaining successive sectiona/ images. A digital image data set of a complete human male cadaver was acquired and made available for public use in November 1994, which aroused worldwide enthu-siasm in this field, and remarkable social and eco-nomic benefit has been gained. Thereafter, some countries initiated their visible human project one after another. Korea started 5-year“Visible Kore-an Human (VKH)” project (Mar. 2000--Feb.2005) in 2000, and the first data set derived from apatient with cerebroma was acquired in 2001. Chi-na began its project in 1999. The first data set of Chinese visible human was obtained at The Third Military Medical University in October 2002. Before that, by utilizing data made public by US VHP, Chi-nese scientists in informatics had exerted them-selves on preliminary work to pave the way for fur-ther achievement. Now that VHP research is such a promising scientific field to meet the need of digital era and will be increasingly common in many areas related with structure and function of human body,the deployment of Chinese Visible Human Project(CVHP) is of great strategic significance with re-gard to science and technology.

  9. Smart Extraction and Analysis System for Clinical Research.

    Science.gov (United States)

    Afzal, Muhammad; Hussain, Maqbool; Khan, Wajahat Ali; Ali, Taqdir; Jamshed, Arif; Lee, Sungyoung

    2017-05-01

    With the increasing use of electronic health records (EHRs), there is a growing need to expand the utilization of EHR data to support clinical research. The key challenge in achieving this goal is the unavailability of smart systems and methods to overcome the issue of data preparation, structuring, and sharing for smooth clinical research. We developed a robust analysis system called the smart extraction and analysis system (SEAS) that consists of two subsystems: (1) the information extraction system (IES), for extracting information from clinical documents, and (2) the survival analysis system (SAS), for a descriptive and predictive analysis to compile the survival statistics and predict the future chance of survivability. The IES subsystem is based on a novel permutation-based pattern recognition method that extracts information from unstructured clinical documents. Similarly, the SAS subsystem is based on a classification and regression tree (CART)-based prediction model for survival analysis. SEAS is evaluated and validated on a real-world case study of head and neck cancer. The overall information extraction accuracy of the system for semistructured text is recorded at 99%, while that for unstructured text is 97%. Furthermore, the automated, unstructured information extraction has reduced the average time spent on manual data entry by 75%, without compromising the accuracy of the system. Moreover, around 88% of patients are found in a terminal or dead state for the highest clinical stage of disease (level IV). Similarly, there is an ∼36% probability of a patient being alive if at least one of the lifestyle risk factors was positive. We presented our work on the development of SEAS to replace costly and time-consuming manual methods with smart automatic extraction of information and survival prediction methods. SEAS has reduced the time and energy of human resources spent unnecessarily on manual tasks.

  10. Binge eating disorder: from clinical research to clinical practice.

    Science.gov (United States)

    Goracci, Arianna; Casamassima, Francesco; Iovieno, Nadia; di Volo, Silvia; Benbow, Jim; Bolognesi, Simone; Fagiolini, Andrea

    2015-01-01

    This case report describes the clinical course of a young woman suffering from binge eating disorder (BED) associated with obesity. It illustrates the efficacy of different medications in the treatment of BED and related conditions and is followed by the comments and clinical observations of 2 practicing psychiatrists. The issues described in this paper have important clinical implications and are topical, given that BED is now recognized as a specific disorder in the new Diagnostic and Statistical Manual of Mental Disorders, fifth edition classification system, but neither the US Food and Drug Administration nor any other regulatory agency has yet approved a drug for treatment of this disease, despite its very prevalent and disabling nature. Growing evidence from the fields of psychopathology and neurobiology, including preclinical and clinical studies, converges to support the idea that "overeating" has much in common with other behavioral addictions, and substance abuse treatment agents may show promise for the treatment of BED.

  11. Targeting hedgehog signaling in cancer: research and clinical developments

    Directory of Open Access Journals (Sweden)

    Xie J

    2013-10-01

    Full Text Available Jingwu Xie, Christopher M Bartels, Scott W Barton, Dongsheng GuWells Center for Pediatric Research, Division of Hematology and Oncology, Department of Pediatrics, Indiana University Simon Cancer Center, Indiana University, Indianapolis, IN, USAAbstract: Since its first description in Drosophila by Drs Nusslein-Volhard and Wieschaus in 1980, hedgehog (Hh signaling has been implicated in regulation of cell differentiation, proliferation, tissue polarity, stem cell maintenance, and carcinogenesis. The first link of Hh signaling to cancer was established through studies of Gorlin syndrome in 1996 by two independent teams. Later, it was shown that Hh signaling may be involved in many types of cancer, including skin, leukemia, lung, brain, and gastrointestinal cancers. In early 2012, the US Food and Drug Administration approved the clinical use of Hh inhibitor Erivedge/vismodegib for treatment of locally advanced and metastatic basal cell carcinomas. With further investigation, it is possible to see more clinical applications of Hh signaling inhibitors. In this review, we will summarize major advances in the last 3 years in our understanding of Hh signaling activation in human cancer, and recent developments in preclinical and clinical studies using Hh signaling inhibitors.Keywords: hedgehog, smoothened, PTCH1, cancer, signal transduction, clinical trials, animal model

  12. 3 CFR - Guidelines for Human Stem Cell Research

    Science.gov (United States)

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Guidelines for Human Stem Cell Research Presidential Documents Other Presidential Documents Memorandum of July 30, 2009 Guidelines for Human Stem Cell Research..., scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent...

  13. International Space Station Research Benefits for Humanity

    Science.gov (United States)

    Thumm, Tracy; Robinson, Julie A.; Johnson-Green, Perry; Buckley, Nicole; Karabadzhak, George; Nakamura, Tai; Kamigaichi, Shigeki; Sorokin, Igor V.; Zell, Martin; Fuglesang, Christer; Sabbagh, Jean; Pignataro, Salvatore

    2012-01-01

    The ISS partnership has seen a substantial increase in research accomplished, crew efforts devoted to research, and results of ongoing research and technology development. The ISS laboratory is providing a unique environment for research and international collaboration that benefits humankind. Benefits come from the engineering development, the international partnership, and from the research results. Benefits can be of three different types: scientific discovery, applications to life on Earth, and applications to future exploration. Working across all ISS partners, we identified key themes where the activities on the ISS improve the lives of people on Earth -- not only within the partner nations, but also in other nations of the world. Three major themes of benefits to life on earth emerged from our review: benefits to human health, education, and Earth observation and disaster response. Other themes are growing as use of the ISS continues. Benefits to human health range from advancements in surgical technology, improved telemedicine, and new treatments for disease. Earth observations from the ISS provide a wide range of observations that include: marine vessel tracking, disaster monitoring and climate change. The ISS participates in a number of educational activities aimed to inspire students of all ages to learn about science, technology, engineering and mathematics. To date over 63 countries have directly participated in some aspect of ISS research or education. In summarizing these benefits and accomplishments, ISS partners are also identifying ways to further extend the benefits to people in developing countries for the benefits of humankind.

  14. Human Hallucinogen Research: Guidelines for Safety

    Science.gov (United States)

    Johnson, Matthew W.; Richards, William A.; Griffiths, Roland R.

    2010-01-01

    There has recently been a renewal of human research with classical hallucinogens (psychedelics). This paper first briefly discusses the unique history of human hallucinogen research, and then reviews the risks of hallucinogen administration and safeguards for minimizing these risks. Although hallucinogens are relatively safe physiologically and are not considered drugs of dependence, their administration involves unique psychological risks. The most likely risk is overwhelming distress during drug action (“bad trip”), which could lead to potentially dangerous behavior such as leaving the study site. Less common are prolonged psychoses triggered by hallucinogens. Safeguards against these risks include the exclusion of volunteers with personal or family history of psychotic disorders or other severe psychiatric disorders, establishing trust and rapport between session monitors and volunteer before the session, careful volunteer preparation, a safe physical session environment, and interpersonal support from at least two study monitors during the session. Investigators should probe for the relatively rare hallucinogen persisting perception disorder in follow up contact. Persisting adverse reactions are rare when research is conducted along these guidelines. Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science. PMID:18593734

  15. The effect of the European Clinical Trials Directive on published drug research in anaesthesia.

    Science.gov (United States)

    Walker, E; Hankins, M C; White, S M

    2009-09-01

    The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessment.

  16. [Ethical principles in human scientific research].

    Science.gov (United States)

    Cruz-Coke, R

    1994-07-01

    Hippocrates was the first physician to use the scientific method to find rational and not religious or mythic causes, for the etiology of diseases. Hippocrates and Aristoteles did not dare to dissect the human body. Afterwards however, many scientists such as Herophilus, Erasitastrus, Vesalus and Fallopio, performed experiments in human beings using vivisection. According to that age's ideas, there was no cruelty in performing vivisection in criminals, since useful knowledge for the progress of medicine and relief of diseases was obtained. Only during the nineteenth century and with Claude Bernard (1865), the ethical principles of systematic scientific research in humans were defined. These principles were violated by nazi physicians during Hitler's dictatorship in Germany (1933-1945). As a response to these horrors, the Ethical Codes of Nuremberg (1947) and Geneva (1948), that reestablished all the strength of Hippocratic principles, were dictated. The Nuremberg rules enact that a research subject must give a voluntary consent, that the experiment must by necessary and exempt of death risk, that the research must be qualified and that the experiment must be discontinued if there is a risk for the subject. The Geneva statement is a modernized hippocratic oath that protects patient's life above all. These classical rules, in force at the present time, are the essential guides that must be applied by physicians and researchers.

  17. Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy.

    Science.gov (United States)

    Hadi, Muhammad Abdul; José Closs, S

    2016-06-01

    The use of qualitative research methodology is well established for data generation within healthcare research generally and clinical pharmacy research specifically. In the past, qualitative research methodology has been criticized for lacking rigour, transparency, justification of data collection and analysis methods being used, and hence the integrity of findings. Demonstrating rigour in qualitative studies is essential so that the research findings have the "integrity" to make an impact on practice, policy or both. Unlike other healthcare disciplines, the issue of "quality" of qualitative research has not been discussed much in the clinical pharmacy discipline. The aim of this paper is to highlight the importance of rigour in qualitative research, present different philosophical standpoints on the issue of quality in qualitative research and to discuss briefly strategies to ensure rigour in qualitative research. Finally, a mini review of recent research is presented to illustrate the strategies reported by clinical pharmacy researchers to ensure rigour in their qualitative research studies.

  18. Conducting research in clinical psychology practice: Barriers, facilitators, and recommendations.

    Science.gov (United States)

    Smith, Kirsten V; Thew, Graham R

    2017-09-01

    The combination of clinical psychologists' therapeutic expertise and research training means that they are in an ideal position to be conducting high-quality research projects. However, despite these skills and the documented benefits of research to services and service users, research activity in practice remains low. This article aims to give an overview of the advantages of, and difficulties in conducting research in clinical practice. We reviewed the relevant literature on barriers to research and reflected on our clinical and research experiences in a range of contexts to offer practical recommendations. We considered factors involved in the planning, sourcing support, implementation, and dissemination phases of research, and outline suggestions to improve the feasibility of research projects in post-qualification roles. We suggest that research leadership is particularly important within clinical psychology to ensure the profession's continued visibility and influence within health settings. Clinical implications Emerging evidence suggests that clinical settings that foster research are associated with better patient outcomes. Suggestions to increase the feasibility of research projects in clinical settings are detailed. Limitations The present recommendations are drawn from the authors' practical experience and may need adaptation to individual practitioners' settings. This study does not attempt to assess the efficacy of the strategies suggested. © 2017 The Authors. British Journal of Clinical Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

  19. Defining the primary research question in veterinary clinical studies.

    Science.gov (United States)

    Giuffrida, Michelle A

    2016-09-01

    A thoughtful, clearly defined research question should be the foundation of any clinical trial or research study. The research question helps determine key study methods, and defining a specific research question helps avoid problems with inadequate sample size, inappropriate design, or multiple statistical comparisons. Rationales and strategies for formulating research questions and using them to define study protocols are discussed, with a focus on application in clinical trials.

  20. Usability: Human Research Program - Space Human Factors and Habitability

    Science.gov (United States)

    Sandor, Aniko; Holden, Kritina L.

    2009-01-01

    The Usability project addresses the need for research in the area of metrics and methodologies used in hardware and software usability testing in order to define quantifiable and verifiable usability requirements. A usability test is a human-in-the-loop evaluation where a participant works through a realistic set of representative tasks using the hardware/software under investigation. The purpose of this research is to define metrics and methodologies for measuring and verifying usability in the aerospace domain in accordance with FY09 focus on errors, consistency, and mobility/maneuverability. Usability metrics must be predictive of success with the interfaces, must be easy to obtain and/or calculate, and must meet the intent of current Human Systems Integration Requirements (HSIR). Methodologies must work within the constraints of the aerospace domain, be cost and time efficient, and be able to be applied without extensive specialized training.

  1. Opportunities and challenges for clinical and cardiovascular research in Latin America.

    Science.gov (United States)

    Silva, Honorio; Sungar, Elif; Kleinstiver, Sandra J; Rubin, Robert H

    2006-01-01

    Latin America in the past two decades has increasingly become a significant contributor of clinical research. The future capacity of clinical and specifically cardiovascular research has the potential to positively affect human health in the region and foster economic growth. However, the challenges of conducting clinical research in Latin America include a need for logistical support from local governments, continued commitment to education of physicians and ethics committees, and creation of oversight bodies to guarantee the highest quality of research. Bibliometric analyses were conducted to assess trends in clinical research. Latin American investigators demonstrated a tendency to publish clinical results in local and regional journals. The region offers many opportunities for clinical research including large treatment-naive patient populations and most importantly motivated investigators capable of producing high-quality results. Strategies to foster clinical research in Latin America must be based on development of a positive regulatory environment, leveraged protection of intellectual property, creation of alliances between private and public sectors with incentives for investment in science and technology, and finally focus on areas of clinical expertise such as cardiovascular disease, epidemiology, gastroenterology, and infectious diseases. Fostering the creation of research alliances across and between continents will help in establishing the supportive environment for dissemination of important ethical clinical research in the region.

  2. On improving research methodology in clinical trials.

    Science.gov (United States)

    Berger, Vance W; Matthews, J Rosser; Grosch, Eric N

    2008-06-01

    Research plays a vital role within biomedicine. Scientifically appropriate research provides a basis for appropriate medical decisions; conversely, inappropriate research may lead to flawed ;best medical practices' which, when followed, contribute to avoidable morbidity and mortality. Although an all-encompassing definition of ;appropriate medical research' is beyond the scope of this article, the concept clearly entails (among other things) that research methods be continually revised and updated as better methods become available. Despite the advent of evidence-based medicine, many research methods have become ;standard' even though there are legitimate scientific reasons to question the conclusions reached by such methods. We first illustrate prominent examples of inappropriate (yet regimented) research methods that are in widespread use. Second, as a way to improve the situation, we suggest a model of research that relies on standardized statistical analyses that individual researchers must consider as a default, but are free to challenge when they can marshal sufficient scientific evidence to demonstrate that the challenge is warranted. Third, we characterize the current system as analogous to ;unnatural selection' in the biological world and argue that our proposed model of research will enable ;natural' to replace ;unnatural' selection in the choice of research methodologies. Given the pervasiveness of inappropriate research methods, we believe that there are strong scientific and ethical reasons to create such a system, that, if properly designed, will both facilitate creativity and ensure methodological rigor while protecting the public at large from the threats posed by poor medical treatment decisions resulting from flawed research methodology.

  3. Future directions in human-environment research.

    Science.gov (United States)

    Moran, Emilio F; Lopez, Maria Claudia

    2016-01-01

    Human-environment research in the 21st century will need to change in major ways. It will need to integrate the natural and the social sciences; it will need to engage stakeholders and citizens in the design of research and in the delivery of science for the benefit of society; it will need to address ethical and democratic goals; and it will need to address a myriad of important theoretical and methodological challenges that continue to impede progress in the advance of sustainability science. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. RESEARCH ON HUMAN RESOURCES MOTIVATION AND SATISFACTION

    Directory of Open Access Journals (Sweden)

    Zoltan-Bela FARKAS

    2014-06-01

    Full Text Available Many research studies on the human resources performance of the educational system have proved that pupils/students’ educational success depends, to a high degree, on the level of human resource motivation, as well as on their degree of professional satisfaction. Teachers’ who show a high level of motivation, both intrinsic and extrinsic, invest more into their activity, are more creative and more efficient in problem solving. The paper debates the results of an empirical study regarding the influence of pre-university teachers’ motivation and satisfaction regarding the general work conditions on their work performance by measuring the present motivation and satisfaction level. Furthermore, the determinant factors of their satisfaction with the work place are determined and analyzed. Finally, based on the statistical data process we will conclude and debate on the research hypothesis validation and the empirical model related to motivation – satisfaction – performance interdependences.

  5. Animal models of osteogenesis imperfecta: applications in clinical research

    Directory of Open Access Journals (Sweden)

    Enderli TA

    2016-09-01

    Full Text Available Tanya A Enderli, Stephanie R Burtch, Jara N Templet, Alessandra Carriero Department of Biomedical Engineering, Florida Institute of Technology, Melbourne, FL, USA Abstract: Osteogenesis imperfecta (OI, commonly known as brittle bone disease, is a genetic disease characterized by extreme bone fragility and consequent skeletal deformities. This connective tissue disorder is caused by mutations in the quality and quantity of the collagen that in turn affect the overall mechanical integrity of the bone, increasing its vulnerability to fracture. Animal models of the disease have played a critical role in the understanding of the pathology and causes of OI and in the investigation of a broad range of clinical therapies for the disease. Currently, at least 20 animal models have been officially recognized to represent the phenotype and biochemistry of the 17 different types of OI in humans. These include mice, dogs, and fish. Here, we describe each of the animal models and the type of OI they represent, and present their application in clinical research for treatments of OI, such as drug therapies (ie, bisphosphonates and sclerostin and mechanical (ie, vibrational loading. In the future, different dosages and lengths of treatment need to be further investigated on different animal models of OI using potentially promising treatments, such as cellular and chaperone therapies. A combination of therapies may also offer a viable treatment regime to improve bone quality and reduce fragility in animals before being introduced into clinical trials for OI patients. Keywords: OI, brittle bone, clinical research, mouse, dog, zebrafish

  6. Fraud and misconduct in clinical research: A concern

    Science.gov (United States)

    Gupta, Ashwaria

    2013-01-01

    Fraud and misconduct in clinical research is widespread. Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines being available, unavailability of internationally harmonized framework for managing research fraud and misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud could be of various types and due to various reasons. Whatever the circumstances be, any fraud should be dealt with strictly and regulations should be in place to prevent its occurrence. PMID:23833741

  7. [Mental issues of clinical research interviews in an intercultural context].

    Science.gov (United States)

    Kim, M-S; Derivois, D

    2013-10-01

    The interview is an intersubjective meeting in which the stakes are complex. This frequently used method in social and human sciences research brings to the foreground various mental processes. Despite its clear distinction from the therapeutic interview, due to its purpose and the origin of the request, the research interview generates for both the participant and the researcher unconscious phenomena and contributes to the epistemological reflection inherent to the clinical approach. The aim of this article is to demonstrate that the mental processes mobilized in the participants and in the researcher, who belong to the same culture of origin during the research interview, may be analyzed in four dimensions: intrapsychique, intersubjective, projective and group. So as to illustrate the various mental processes that are engaged, a research conducted in clinical intercultural psychology regarding the adaptive processes and the identity strategies of Korean mothers living in France or in Quebec is used. In order to offer maximum freedom of expression to the participants, the interviews were conducted in Korean, and then translated into French. The intrapsychic dimension is illustrated by an example from the interview with a 44-year-old Korean woman met in Paris. Following the Rogerian theory (1952, 1961), we understand that the participant comes to a coherent reorganization of her own conception throughout the interview, allowing her to speak and to think about her autobiography. From the interaction between two subjectivities, the thought and the discourse are involved in the co-construction of meaning. The understanding of the intersubjective dimension is supported by the theory of Winnicott (1971), developed for the transitional space. Like the mother-child relationship in the game device, the mental permeability available to the researcher is supposed to guarantee the development of the interviewee's confidence. The example of the interview conducted with another

  8. Qualitative research: adding drive and dimension to clinical research.

    Science.gov (United States)

    Rusinová, Katerĭna; Pochard, Frédéric; Kentish-Barnes, Nancy; Chaize, Marine; Azoulay, Elie

    2009-01-01

    Qualitative research and its methods stem from the social sciences and can be used to describe and interpret complex phenomena that involve individuals' views, beliefs, preferences, and subjective responses to places and people. Thus, qualitative research explores the many subjective factors that may influence patient outcomes, staff well-being, and healthcare quality, yet fail to lend themselves to the hypothesis-testing approach that characterizes quantitative research. Qualitative research is valuable in the intensive care unit to explore organizational and cultural issues and to gain insight into social interactions, healthcare delivery processes, and communication. Qualitative research generates explanatory models and theories, which can then serve to devise interventions, whose efficacy can be studied quantitatively. Thus, qualitative research works synergistically with quantitative research, providing new impetus to the research process and a new dimension to research findings. Qualitative research starts with conceptualizing the research question, choosing the appropriate qualitative strategy, and designing the study; rigorous methods specifically designed for qualitative research are then used to conduct the study, analyze the data, and verify the findings. The researcher is the data-collecting instrument, and the data are the participants' words and behaviors. Data coding methods are used to describe experiences, discover themes, and build theories. In this review, we outline the rationale and methods for conducting qualitative research to inform critical care issues. We provide an overview of available qualitative methods and explain how they can work in close synergy with quantitative methods. To illustrate the effectiveness of combining different research methods, we will refer to recent qualitative studies conducted in the intensive care unit.

  9. Use of media for recruiting clinical research volunteers in Ecuador

    National Research Council Canada - National Science Library

    Peñaherrera, Carlos Andrés; Palacios, Michael; Duarte, María Carolina; Santibáñez, Rocío; Tamariz, Leonardo; Palacio, Ana

    2015-01-01

    .... Given the emergence of clinical research in Ecuador, a study of this kind in the local population will be beneficial for future research, and is probably applicable to other countries in the region...

  10. Transforming ocular surface stem cell research into successful clinical practice

    Directory of Open Access Journals (Sweden)

    Virender S Sangwan

    2014-01-01

    Full Text Available It has only been a quarter of a century since the discovery of adult stem cells at the human corneo-scleral limbus. These limbal stem cells are responsible for generating a constant and unending supply of corneal epithelial cells throughout life, thus maintaining a stable and uniformly refractive corneal surface. Establishing this hitherto unknown association between ocular surface disease and limbal dysfunction helped usher in therapeutic approaches that successfully addressed blinding conditions such as ocular burns, which were previously considered incurable. Subsequent advances in ocular surface biology through basic science research have translated into innovations that have made the surgical technique of limbal stem cell transplantation simpler and more predictable. This review recapitulates the basic biology of the limbus and the rationale and principles of limbal stem cell transplantation in ocular surface disease. An evidence-based algorithm is presented, which is tailored to clinical considerations such as laterality of affliction, severity of limbal damage and concurrent need for other procedures. Additionally, novel findings in the form of factors influencing the survival and function of limbal stem cells after transplantation and the possibility of substituting limbal cells with epithelial stem cells of other lineages is also discussed. Finally this review focuses on the future directions in which both basic science and clinical research in this field is headed.

  11. Towards a European Clinical Research Infrastructures Network: the ECRIN programme.

    Science.gov (United States)

    Demotes-Mainard, Jacques

    2004-01-01

    On the basis of the interconnection of national networks of clinical research centres (CRCs) and clinical trials units (CTUs), the European Clinical Research Infrastructures Network (ECRIN) programme aims to develop an infrastructure allowing for bottom-up harmonisation of the support and training for, and practice of, clinical research, and to provide public sponsors for biotechnology small and medium-sized companies (SMEs) with support for translational research and multicentre clinical studies in Europe. This will be achieved through an application to the next FP6 'Integrated Infrastructure Initiatives' call. However, prior work is required to improve the reciprocal knowledge of partners in the ECRIN consortium and, as a first step, country-specific workshops will be organised by national networks in order to address the organisation of CRC/CTUs and national networks, and their interaction with the national environment of clinical research; this will enable in-depth discussion addressing the bottlenecks hampering transnational studies.

  12. Human subjects protection issues in QUERI implementation research: QUERI Series

    Directory of Open Access Journals (Sweden)

    Ritchie Mona

    2008-02-01

    Full Text Available Abstract Background Human Subjects protections approaches, specifically those relating to research review board oversight, vary throughout the world. While all are designed to protect participants involved in research, the structure and specifics of these institutional review boards (IRBs can and do differ. This variation affects all types of research, particularly implementation research. Methods In 2001, we began a series of inter-related studies on implementing evidence-based collaborative care for depression in Veterans Health Administration primary care. We have submitted more than 100 IRB applications, amendments, and renewals, and in doing so, we have interacted with 13 VA and University IRBs across the United States (U.S.. We present four overarching IRB-related themes encountered throughout the implementation of our projects, and within each theme, identify key challenges and suggest approaches that have proved useful. Where applicable, we showcase process aids developed to assist in resolving a particular IRB challenge. Results There are issues unique to implementation research, as this type of research may not fit within the traditional Human Subjects paradigm used to assess clinical trials. Risks in implementation research are generally related to breaches of confidentiality, rather than health risks associated with traditional clinical trials. The implementation-specific challenges discussed are: external validity considerations, Plan-Do-Study-Act cycles, risk-benefit issues, the multiple roles of researchers and subjects, and system-level unit of analysis. Discussion Specific aspects of implementation research interact with variations in knowledge, procedures, and regulatory interpretations across IRBs to affect the implementation and study of best methods to increase evidence-based practice. Through lack of unambiguous guidelines and local liability concerns, IRBs are often at risk of applying both variable and inappropriate or

  13. Electronic health records: new opportunities for clinical research.

    Science.gov (United States)

    Coorevits, P; Sundgren, M; Klein, G O; Bahr, A; Claerhout, B; Daniel, C; Dugas, M; Dupont, D; Schmidt, A; Singleton, P; De Moor, G; Kalra, D

    2013-12-01

    Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role. Whilst EHRs used for routine clinical care have some limitations at present, as discussed in this review, new improved systems and emerging research infrastructures are being developed to ensure that EHRs can be used for secondary purposes such as clinical research, including the design and execution of clinical trials for new medicines. EHR systems should be able to exchange information through the use of recently published international standards for their interoperability and clinically validated information structures (such as archetypes and international health terminologies), to ensure consistent and more complete recording and sharing of data for various patient groups. Such systems will counteract the obstacles of differing clinical languages and styles of documentation as well as the recognized incompleteness of routine records. Here, we discuss some of the legal and ethical concerns of clinical research data reuse and technical security measures that can enable such research while protecting privacy. In the emerging research landscape, cooperation infrastructures are being built where research projects can utilize the availability of patient data from federated EHR systems from many different sites, as well as in international multilingual settings. Amongst several initiatives described, the EHR4CR project offers a promising method for clinical research. One of the first achievements of this project was the development of a protocol feasibility prototype which is used for finding patients eligible for clinical trials from multiple sources.

  14. Challenges of Research and Human Capital Development in Nigeria

    Science.gov (United States)

    Chikwe, Christian K.; Ogidi, Reuben C.; Nwachukwu, K.

    2015-01-01

    The paper discussed the challenges of research and human capital development in Nigeria. Research and human capital development are critical to the development of any nation. Research facilitates human capital development. A high rating in human capital development indices places a country among the leading countries of the world. The paper…

  15. Enhancing electronic health records to support clinical research.

    Science.gov (United States)

    Vawdrey, David K; Weng, Chunhua; Herion, David; Cimino, James J

    2014-01-01

    The "Learning Health System" has been described as an environment that drives research and innovation as a natural outgrowth of patient care. Electronic health records (EHRs) are necessary to enable the Learning Health System; however, a source of frustration is that current systems fail to adequately support research needs. We propose a model for enhancing EHRs to collect structured and standards-based clinical research data during clinical encounters that promotes efficiency and computational reuse of quality data for both care and research. The model integrates Common Data Elements (CDEs) for clinical research into existing clinical documentation workflows, leveraging executable documentation guidance within the EHR to support coordinated, standardized data collection for both patient care and clinical research.

  16. Inservice Education in a Clinical Research Hospital

    Science.gov (United States)

    Ellis, Geraldine

    1971-01-01

    Orientation, training, and in-service programs are designed to provide assurance that nursing care standards will be met. Describes how to familiarize staff with the meaning of research, with its demand for repetition and precision, and the many ways in which nursing personnel actually provide support to the research physician. (RB)

  17. Information Technology for Clinical, Translational and Comparative Effectiveness Research. Findings from the Yearbook 2015 Section on Clinical Research Informatics.

    Science.gov (United States)

    Daniel, C; Choquet, R

    2015-08-13

    To summarize excellent current research in the field of Bioinformatics and Translational Informatics with application in the health domain and clinical care. We provide a synopsis of the articles selected for the IMIA Yearbook 2015, from which we attempt to derive a synthetic overview of current and future activities in the field. As last year, a first step of selection was performed by querying MEDLINE with a list of MeSH descriptors completed by a list of terms adapted to the section. Each section editor has evaluated separately the set of 1,594 articles and the evaluation results were merged for retaining 15 articles for peer-review. The selection and evaluation process of this Yearbook's section on Bioinformatics and Translational Informatics yielded four excellent articles regarding data management and genome medicine that are mainly tool-based papers. In the first article, the authors present PPISURV a tool for uncovering the role of specific genes in cancer survival outcome. The second article describes the classifier PredictSNP which combines six performing tools for predicting disease-related mutations. In the third article, by presenting a high-coverage map of the human proteome using high resolution mass spectrometry, the authors highlight the need for using mass spectrometry to complement genome annotation. The fourth article is also related to patient survival and decision support. The authors present datamining methods of large-scale datasets of past transplants. The objective is to identify chances of survival. The current research activities still attest the continuous convergence of Bioinformatics and Medical Informatics, with a focus this year on dedicated tools and methods to advance clinical care. Indeed, there is a need for powerful tools for managing and interpreting complex, large-scale genomic and biological datasets, but also a need for user-friendly tools developed for the clinicians in their daily practice. All the recent research and

  18. 人胚胎神经干细胞移植治疗脑瘫患儿的临床研究%Clinical research of Human embryonic stem cell transplantation for treatment of cerebral palsy

    Institute of Scientific and Technical Information of China (English)

    张晓英; 侯成智

    2012-01-01

    Objective; Cerebral palsy is perinatal acquired progressive encephalopathy caused by congenital movement disorders and abnormal postures disease. International cerebral palsy risk for 1% -5%. China's cerebral palsy risk for 1. 8% -4% , An annual increase of 400 000 children patients with cerebral palsy in China. Cerebral palsy have currently no effective treatment methods, In recent years, there are more and more embryonic cells derived neural stem cell for the treatment of cerebral palsy research, provide a broad space to the treatment of cerebral palsy. Embryonic stem cell derived neural stem cells in morphology and function are the same with neuronal properties, With host neurons cell synapses connect, Receiving the impulse of host cell, get together with Patient's brain, achieve the function of regeneration, Treat cerebral palsy Fundamentally. The purpose of the topic is to discuss the possibility, safety and effectiveness of Human embryonic stem cell transplantation for treatment of cerebral palsy. Methods; Extract of fetal's brain tissue, In vitro differentiation and induce to the neural stem cells. Transplant the P2-51 -5× 105-8 neural stem cells to human's brain with Lumbar puncture puncture or the puncture of carotid artery. 3 -4times in one course of a treatment, Interval a week, 2-3 courses of treatment in one year. Results; There are 25 cases of cerebral palsy patients in clinical treatment, 23 cases Improve, 2 cases invalid. Conclusions; Transplantation in the treatment of cerebral palsy with Human embryonic neural stem cell is safe and Effective.%目的 脑瘫是围产期获得性非进行性脑病导致的先天性运动障碍及姿势异常疾病或综合征.国际上脑瘫的发病率为1%~5%,我国脑瘫的发病率为1.8%~4%,每年新增小儿脑瘫患儿40万.脑瘫目前还无有效的治疗手段.近年来,神经干细胞移植治疗脑瘫的研究越来越多,提供了广阔的空间.人胚胎细胞来源的神经干细胞在形

  19. [Review of legislation regarding clinical research in the Spanish health care system and hospital pharmacy services].

    Science.gov (United States)

    Laguna-Goya, Noa; Serrano, M Antonia; Gómez-Chacón, Cristina

    2009-01-01

    The call for public funding for the Spanish Health Care System clinical research with drugs for human use projects Subprogramme highlights the need for hospital pharmacy services to include the manufacture of investigational drugs which are the subject of a clinical trial, developed by either a researcher or a group of researchers, within its activities. This article discusses the legislation concerning the manufacture of investigational drugs and the requirements that the pharmacy services must meet in order to develop, distribute, or conceal an investigational drug in a clinical trial sponsored by a professional from the SHS.

  20. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  1. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2012-05-02

    ... Development and Clinical Science Research and Development Services Scientific Merit Review Board, Notice of... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... science research. The panel meetings will be open to the public for approximately one-half hour at the...

  2. The role of the nurse research facilitator in building research capacity in the clinical setting.

    Science.gov (United States)

    Jamerson, Patricia A; Vermeersch, Patricia

    2012-01-01

    With little guidance in the literature regarding best practices, clinical institutions have used different organizational models to meet the challenges of building research capacity. This article provides recommendations regarding the most productive models based on review of historical clinical research facilitation models and the results of a survey regarding extant models conducted among research facilitators who were members of the Midwest Nursing Research Society.

  3. Clinical human brucellosis in Malaysia: a case report

    Directory of Open Access Journals (Sweden)

    Tyagita Hartady

    2014-04-01

    Full Text Available Clinical human brucellosis is quite rare in Malaysia although seroconverters are relatively more. This report describes a case of clinical human brucellosis in Malaysia. This case involved a 29-year-old research assistant in a veterinary microbiology laboratory. She complained of intermittent fever, anorexia, profuse sweating, malaise, headache, normotensive (110/60 mm Hg, muscle pain, and arthralgia for 3 d. Blood tests against dengue and malaria were negative thus she was prescribed vitamin C, paracetamol and cough syrup for common flu. The complaints, however, persisted on and off for the next 1 month. She eventually developed anemia and hypotension (90/50 mm Hg and started to show reduced body weight. Abdominal palpations revealed hepatomegaly and splenomegaly with pain. Thus, brucellosis was suspected before the Rose-Bengal plate test was performed, which revealed the presence of high level of antibody against Brucella. The same test was repeated after 14 d and the results confirmed the presence of high antibody level against Brucella. Following serum agglutination test, a diagnosis of brucellosis was made and she was eventually prescribed rifampicine p.o. once a day combined with doxycycline p.o. twice a day for 6 consecutive weeks before she made a full recovery.

  4. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences

    Science.gov (United States)

    National Academies Press, 2011

    2011-01-01

    Comprehensive research and a highly-trained workforce are essential for the improvement of health and health care both nationally and internationally. During the past 40 years the National Research Services Award (NRSA) Program has played a large role in training the workforce responsible for dramatic advances in the understanding of various…

  5. [Path to the execution of explorative clinical researches in National Cerebral and Cardiovascular Center (NCVC)].

    Science.gov (United States)

    Yamamoto, Haruko

    2013-01-01

    In the Ministry of Health, Labour and Welfare's (MHLW) "5-year plan for activating clinical trials", we have put in place the infrastructure including human resources for supporting not only commercial clinical trials but also those initiated by academic researchers, including clinical research coordinator (CRC) support and consultation for planning clinical trial with biostatistician. We also prepared a data management unit and trained data managers for academic clinical trials. In 2011, the National Cerebral and Cardiovascular Center (NCVC) was selected one of the sites of the MHLW project of structure improvement to execute early phase clinical trials. To clinically develop medical devices invented by the NCVC researchers involved in the project, animal experiments which meet the GLP standards must be finished before the first-in-human clinical trial. We are planning to create the units containing human resources for developing medical devices such as professionals in regulatory affairs, safety tests, and Good Laboratory Practice (GLP) systems. Creation of a smooth pathway from the preclinical to the clinical phases will be key to the efficient development of new medical devices.

  6. Legitimating Clinical Research in the Study of Organizational Culture.

    Science.gov (United States)

    Schein, Edgar H.

    1993-01-01

    Argues that traditional research model used in industrial-organizational psychology is not useful in understanding deeper dynamics of organizations, especially those phenomena labeled as "cultural." Contends that use of data obtained during clinical and consulting work should be legitimated as valid research data. Spells out clinical model and…

  7. International Partnerships for Clinical Cancer Research

    Science.gov (United States)

    CGH co-sponsors the 2015 International Symposium on Cancer Clinical Trials and related meetings held in partnership with the Japanese National Cancer Center (JNCC) and Embassies of France, Korea, United Kingdom (UK), and United States (US) in Tokyo on May 14 - 15, 2015.

  8. Clinical Investigation Program. Annual Research Progress Report.

    Science.gov (United States)

    1980-09-30

    Stereoscope 79/118 $6149.00 Ion Generator 78/116 $5000.00 Poultry Cages 79/301 $2929.00 Microtome/Cryostat 79/304 $5494.72 Tissue Embedder 79/300... Mycology : Assessment of bacteriologic and seroligic parameters of clinically-important mycoses normal and immunologic comprised host. Presented: American

  9. Bioinformatics Approaches for Human Gut Microbiome Research

    Directory of Open Access Journals (Sweden)

    Zhijun Zheng

    2016-07-01

    Full Text Available The human microbiome has received much attention because many studies have reported that the human gut microbiome is associated with several diseases. The very large datasets that are produced by these kinds of studies means that bioinformatics approaches are crucial for their analysis. Here, we systematically reviewed bioinformatics tools that are commonly used in microbiome research, including a typical pipeline and software for sequence alignment, abundance profiling, enterotype determination, taxonomic diversity, identifying differentially abundant species/genes, gene cataloging, and functional analyses. We also summarized the algorithms and methods used to define metagenomic species and co-abundance gene groups to expand our understanding of unclassified and poorly understood gut microbes that are undocumented in the current genome databases. Additionally, we examined the methods used to identify metagenomic biomarkers based on the gut microbiome, which might help to expand the knowledge and approaches for disease detection and monitoring.

  10. Research priorities for Chagas disease, human African trypanosomiasis and leishmaniasis.

    Science.gov (United States)

    2012-01-01

    This report provides a review and analysis of the research landscape for three diseases - Chagas disease, human African trypanosomiasis and leishmaniasis - that disproportionately afflict poor and remote populations with limited access to health services. It represents the work of the disease reference group on Chagas Disease, Human African Trypanosomiasis and Leishmaniasis (DRG3) which was established to identify key research priorities through review of research evidence and input from stakeholders' consultations. The diseases, which are caused by related protozoan parasites, are described in terms of their epidemiology and diseases burden, clinical forms and pathogenesis, HIV coinfection, diagnosis, drugs and drug resistance, vaccines, vector control, and health-care interventions. Priority areas for research are identified based on criteria such as public health relevance, benefit and impact on poor populations and equity, and feasibility. The priorities are found in the areas of diagnostics, drugs, vector control, asymptomatic infection, economic analysis of treatment and vector control methods, and in some specific issues such as surveillance methods or transmission-blocking vaccines for particular diseases. This report will be useful to researchers, policy and decision-makers, funding bodies, implementation organizations, and civil society. This is one of ten disease and thematic reference group reports that have come out of the TDR Think Tank, all of which have contributed to the development of the Global Report for Research on Infectious Diseases of Poverty, available at: www.who.int/tdr/stewardship/global_report/en/index.html.

  11. Tissue-engineered models of human tumors for cancer research

    Science.gov (United States)

    Villasante, Aranzazu; Vunjak-Novakovic, Gordana

    2015-01-01

    Introduction Drug toxicity often goes undetected until clinical trials, which are the most costly and dangerous phase of drug development. Both the cultures of human cells and animal studies have limitations that cannot be overcome by incremental improvements in drug-testing protocols. A new generation of bioengineered tumors is now emerging in response to these limitations, with potential to transform drug screening by providing predictive models of tumors within their tissue context, for studies of drug safety and efficacy. An area that could greatly benefit from these models is cancer research. Areas covered In this review, the authors first describe the engineered tumor systems, using Ewing's sarcoma as an example of human tumor that cannot be predictably studied in cell culture and animal models. Then, they discuss the importance of the tissue context for cancer progression and outline the biomimetic principles for engineering human tumors. Finally, they discuss the utility of bioengineered tumor models for cancer research and address the challenges in modeling human tumors for use in drug discovery and testing. Expert opinion While tissue models are just emerging as a new tool for cancer drug discovery, they are already demonstrating potential for recapitulating, in vitro, the native behavior of human tumors. Still, numerous challenges need to be addressed before we can have platforms with a predictive power appropriate for the pharmaceutical industry. Some of the key needs include the incorporation of the vascular compartment, immune system components, and mechanical signals that regulate tumor development and function. PMID:25662589

  12. Eli Lilly and Company's bioethics framework for human biomedical research.

    Science.gov (United States)

    Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

    2015-11-01

    Current ethics and good clinical practice guidelines address various aspects of pharmaceutical research and development, but do not comprehensively address the bioethical responsibilities of sponsors. To fill this void, in 2010 Eli Lilly and Company developed and implemented a Bioethics Framework for Human Biomedical Research to guide ethical decisions. (See our companion article that describes how the framework was developed and implemented and provides a critique of its usefulness and limitations.) This paper presents the actual framework that serves as a company resource for employee education and bioethics deliberations. The framework consists of four basic ethical principles and 13 essential elements for ethical human biomedical research and resides within the context of our company's mission, vision and values. For each component of the framework, we provide a high-level overview followed by a detailed description with cross-references to relevant well regarded guidance documents. The principles and guidance described should be familiar to those acquainted with research ethics. Therefore the novelty of the framework lies not in the foundational concepts presented as much as the attempt to specify and compile a sponsor's bioethical responsibilities to multiple stakeholders into one resource. When such a framework is employed, it can serve as a bioethical foundation to inform decisions and actions throughout clinical planning, trial design, study implementation and closeout, as well as to inform company positions on bioethical issues. The framework is, therefore, a useful tool for translating ethical aspirations into action - to help ensure pharmaceutical human biomedical research is conducted in a manner that aligns with consensus ethics principles, as well as a sponsor's core values.

  13. Protecting the vulnerable: testing times for clinical research ethics.

    Science.gov (United States)

    Schüklenk, U

    2000-09-01

    This paper describes a number of historical breaches of research ethics. Typically the victims of such breaches belong to vulnerable populations, such as prisoners, mentally disabled people, women and people in developing countries. This article provides a brief introduction to the main ethical approaches in bioethics. Subsequently it looks at a number of currently discussed ethical issues in clinical research ethics, notably the ethics standards of clinical trials in developing countries, the use of prisoners and incompetent people in clinical research, and the modus operandi of research ethics committees.

  14. Pre-clinical research in small animals using radiotherapy technology. A bidirectional translational approach

    Energy Technology Data Exchange (ETDEWEB)

    Tillner, Falk; Buetof, Rebecca [Technische Univ. Dresden (Germany). OncoRay - National Center for Radiation Research in Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Technische Univ. Dresden (Germany). Dept. of Radiation Oncology; Thute, Prasad [Technische Univ. Dresden (Germany). OncoRay - National Center for Radiation Research in Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Krause, Mechthild [Technische Univ. Dresden (Germany). OncoRay - National Center for Radiation Research in Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Technische Univ. Dresden (Germany). Dept. of Radiation Oncology; German Cancer Consortium (DKTK), Dresden (Germany); German Cancer Research Center (DKFZ), Heidelberg (Germany); Enghardt, Wolfgang [Technische Univ. Dresden (Germany). OncoRay - National Center for Radiation Research in Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Technische Univ. Dresden (Germany). Dept. of Radiation Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany). Inst. of Radiooncology

    2014-07-01

    For translational cancer research, pre-clinical in-vivo studies using small animals have become indispensable in bridging the gap between in-vitro cell experiments and clinical implementation. When setting up such small animal experiments, various biological, technical and methodical aspects have to be considered. In this work we present a comprehensive topical review based on relevant publications on irradiation techniques used for pre-clinical cancer research in mice and rats. Clinical radiotherapy treatment devices for the application of external beam radiotherapy and brachytherapy as well as dedicated research irradiation devices are feasible for small animal irradiation depending on the animal model and the experimental goals. In this work, appropriate solutions for the technological transfer of human radiation oncology to small animal radiation research are summarised. Additionally, important information concerning the experimental design is provided such that reliable and clinically relevant results can be attained.

  15. Clinical and molecular research of neuroacanthocytosis

    Institute of Scientific and Technical Information of China (English)

    Lihong Zhang; Suping Wang; Jianwen Lin

    2013-01-01

    Neuroacanthocytosis is an autosomal recessive or dominant inherited disease characterized by widespread, non-specific nervous system symptoms, or spiculated "acanthocytic" red blood cells. The clinical manifestations typically involve chorea and dystonia, or a range of other movement disorders. Psychiatric and cognitive symptoms may also be present. The two core neuroacanthocytosis syndromes, in which acanthocytosis is atypical, are autosomal recessive chorea-acanthocytosis and X-linked McLeod syndrome. Acanthocytes are found in a smaller proportion of patients with Huntington's disease-like 2 and pantothenate kinase-associated neurodegeneration. Because the clinical manifestations are diverse and complicated, in this review we present features of inheritance, age of onset, neuroimaging and laboratory findings, as well as the spectrum of central and peripheral neurological abnormalities and extraneuronal involvement to help distinguish the four specific syndromes.

  16. [Clinical research XXI. From the clinical judgment to survival analysis].

    Science.gov (United States)

    Rivas-Ruiz, Rodolfo; Pérez-Rodríguez, Marcela; Palacios, Lino; Talavera, Juan O

    2014-01-01

    Decision making in health care implies knowledge of the clinical course of the disease. Knowing the course allows us to estimate the likelihood of occurrence of a phenomenon at a given time or its duration. Within the statistical models that allow us to have a summary measure to estimate the time of occurrence of a phenomenon in a given population are the linear regression (the outcome variable is continuous and normally distributed -time to the occurrence of the event-), logistic regression (outcome variable is dichotomous, and it is evaluated at one single interval), and survival curves (outcome event is dichotomous, and it can be evaluated at multiple intervals). The first reference we have of this type of analysis is the work of the astronomer Edmond Halley, an English physicist and mathematician, famous for the calculation of the appearance of the comet orbit, recognized as the first periodic comet (1P/Halley's Comet). Halley also contributed in the area of health to estimate the mortality rate for a Polish population. The survival curve allows us to estimate the probability of an event occurring at different intervals. Also, it leds us to estimate the median survival time of any phenomenon of interest (although the used term is survival, the outcome does not need to be death, it may be the occurrence of any other event).

  17. [Clinical research XXIII. From clinical judgment to meta-analyses].

    Science.gov (United States)

    Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Noyola-Castillo, Maura E; Talavera, Juan O

    2014-01-01

    Systematic reviews (SR) are studies made in order to ask clinical questions based on original articles. Meta-analysis (MTA) is the mathematical analysis of SR. These analyses are divided in two groups, those which evaluate the measured results of quantitative variables (for example, the body mass index -BMI-) and those which evaluate qualitative variables (for example, if a patient is alive or dead, or if he is healing or not). Quantitative variables generally use the mean difference analysis and qualitative variables can be performed using several calculations: odds ratio (OR), relative risk (RR), absolute risk reduction (ARR) and hazard ratio (HR). These analyses are represented through forest plots which allow the evaluation of each individual study, as well as the heterogeneity between studies and the overall effect of the intervention. These analyses are mainly based on Student's t test and chi-squared. To take appropriate decisions based on the MTA, it is important to understand the characteristics of statistical methods in order to avoid misinterpretations.

  18. First-in-human clinical trials of imaging devices: an example from optical imaging.

    Science.gov (United States)

    Gibbs-Strauss, Summer L; Rosenberg, Mireille; Clough, Barbara L; Troyan, Susan L; Frangioni, John V

    2009-01-01

    Clinical translation of scientific discoveries is often the long-term goal of academic medical research. However, this goal is not always realized due to the complicated path between bench research and clinical use. In this review, we outline the fundamental steps required for first-in-human testing of a new imaging device, and use the FLARE() (Fluorescence-Assisted Resection and Exploration) near-infrared fluorescence optical imaging platform as an example.

  19. Data management by using R: big data clinical research series.

    Science.gov (United States)

    Zhang, Zhongheng

    2015-11-01

    Electronic medical record (EMR) system has been widely used in clinical practice. Instead of traditional record system by hand writing and recording, the EMR makes big data clinical research feasible. The most important feature of big data research is its real-world setting. Furthermore, big data research can provide all aspects of information related to healthcare. However, big data research requires some skills on data management, which however, is always lacking in the curriculum of medical education. This greatly hinders doctors from testing their clinical hypothesis by using EMR. To make ends meet, a series of articles introducing data management techniques are put forward to guide clinicians to big data clinical research. The present educational article firstly introduces some basic knowledge on R language, followed by some data management skills on creating new variables, recoding variables and renaming variables. These are very basic skills and may be used in every project of big data research.

  20. The value of formal clinical research training in initiating a career as a clinical investigator.

    Science.gov (United States)

    Kapoor, Karan; Wu, Bechien U; Banks, Peter A

    2011-12-01

    The aim of this study was to determine whether formal clinical research training is of value in the initiation of a successful career as a clinical investigator. We conducted a retrospective review of the career choices of all 25 fellows who entered the Academic Clinical Research Track at Brigham and Women's Hospital since its inception in 1995 and examined the impact of formal clinical research training during their fellowship on their career choice. The primary measure of a successful career as a clinical investigator was the obtainment of external funding for clinical research within 3 years of completion of fellowship. Thirteen of the 25 fellows (52%) received a Master of Public Health (MPH) degree at the Harvard School of Public Health during their fellowship. Ten of these 13 fellows (77%) obtained external funding for clinical research within 3 years of completion of their fellowship. None of the 5 fellows who had already obtained an MPH degree prior to their fellowship and none of the 7 fellows who completed a 7-week summer Program in Clinical Effectiveness but did not complete an MPH degree attempted to receive external funding for clinical research within 3 years of completion of their fellowship. We conclude that formal clinical research training culminating in an MPH degree was extremely valuable in the initiation of a successful career as a clinical investigator.

  1. Human Defensins: Potential Tools for Clinical Applications

    Directory of Open Access Journals (Sweden)

    Matthias Wenghoefer

    2012-02-01

    Full Text Available As components of the innate immune system, antimicrobial peptides in the form of human defensins play an important role in host defense by serving as the epithelial layer’s biochemical barrier against local infections. Recent studies have shown these molecules to have far more additional cellular functions besides their antimicrobial activity. Defensins play a role in cell division, attraction and maturation of immune cells, differentiation and reorganization of epithelial tissues, wound healing and tumor suppression. This multitude of function makes human defensins appear to be excellent tools for therapeutic approaches. These antimicrobial peptides may be used directly as a remedy against bacterial and viral infections. Furthermore, the application of human defensins can be used to promote wound healing and epithelial reorganization. In particular, human β-defensins have a strong impact on osteoblast proliferation and differentiation. Human β-defensins have already been applied as a vaccination against HIV-1. Another potentially useful characteristic of defensins is their suitability as diagnostic markers in cancer therapy. In particular, α-defensins have already been used for this purpose. Human α-defensin-3, for example, has been described as a tumor marker for lymphocytes. High gene expression levels of α-defensin-3 and -4 have been detected in benign oral neoplasia, α-defensin-6 is considered to be a tumor marker for colon cancer.

  2. Echocardiography as a Research and Clinical Tool in Veterinary Medicine

    OpenAIRE

    Allen, D G

    1982-01-01

    Echocardiography is the accepted term for the study of cardiac ultrasound. Although a relatively new tool for the study of the heart in man it has already found wide acceptance in the area of cardiac research and in the study of clinical cardiac disease. Animals had often been used in the early experiments with cardiac ultrasound, but only recently has echocardiography been used as a research and clinical tool in veterinary medicine. In this report echocardiography is used in the research of ...

  3. In Defense of a Social Value Requirement for Clinical Research

    OpenAIRE

    Wendler, David; Rid, Annette

    2017-01-01

    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recogni...

  4. Towards supporting scholarship in research by clinical pharmacy faculty

    Directory of Open Access Journals (Sweden)

    Pickard AS

    2006-12-01

    Full Text Available Objective: The objective of this study was to assess the need for research support, faculty development, and topics of interest to clinical track pharmacy faculty that would facilitate scholarship in research.Methods: A cross-sectional survey of pharmacy practice-based faculty at University of Illinois at Chicago (UIC completed via the web in November 2005.Results: Of 39 clinical track faculty respondents (48% response rate, 100% indicated they were interested in being co-investigator or 77% lead investigator on a research grant proposal. The majority of respondents expressed “a lot” or “extreme” interest in receiving methodological guidance and administrative support in order to pursue research interests. The greatest interest in research support services related to sample size calculations, selection of appropriate statistical tests, grant writing, and writing for journals. Barriers to research cited by faculty included lack of confidence in ability, the need for balancing responsibilities, and reward for efforts. Suggestions included the creation of specific research interest groups, research seminars, formal mentoring and statistical support services.Conclusions: Clinical-track faculty are interested in research-related scholarship but typically lack the confidence or skills to lead research. While this study was limited to UIC clinical faculty, UIC faculty are attracted from Colleges of Pharmacy across North America and it is notable that such barriers can be quickly identified using a brief web-based survey in order to inform a plan that provides resources and support for research by clinical pharmacy faculty.

  5. Transforming Research Management Systems at Mayo Clinic

    Science.gov (United States)

    Smith, Steven C.; Gronseth, Darren L.

    2011-01-01

    In order for research programs at academic medical centers and universities to survive and thrive in the increasingly challenging economic, political and regulatory environment, successful transformation is extremely important. Transformation and quality management techniques are increasingly well established in medical practice organizations. In…

  6. Integration of clinical research documentation in electronic health records.

    Science.gov (United States)

    Broach, Debra

    2015-04-01

    Clinical trials of investigational drugs and devices are often conducted within healthcare facilities concurrently with clinical care. With implementation of electronic health records, new communication methods are required to notify nonresearch clinicians of research participation. This article reviews clinical research source documentation, the electronic health record and the medical record, areas in which the research record and electronic health record overlap, and implications for the research nurse coordinator in documentation of the care of the patient/subject. Incorporation of clinical research documentation in the electronic health record will lead to a more complete patient/subject medical record in compliance with both research and medical records regulations. A literature search provided little information about the inclusion of clinical research documentation within the electronic health record. Although regulations and guidelines define both source documentation and the medical record, integration of research documentation in the electronic health record is not clearly defined. At minimum, the signed informed consent(s), investigational drug or device usage, and research team contact information should be documented within the electronic health record. Institutional policies should define a standardized process for this integration in the absence federal guidance. Nurses coordinating clinical trials are in an ideal position to define this integration.

  7. The biology of infertility: research advances and clinical challenges

    Science.gov (United States)

    Matzuk, Martin M; Lamb, Dolores J

    2013-01-01

    Reproduction is required for the survival of all mammalian species, and thousands of essential ‘sex’ genes are conserved through evolution. Basic research helps to define these genes and the mechanisms responsible for the development, function and regulation of the male and female reproductive systems. However, many infertile couples continue to be labeled with the diagnosis of idiopathic infertility or given descriptive diagnoses that do not provide a cause for their defect. For other individuals with a known etiology, effective cures are lacking, although their infertility is often bypassed with assisted reproductive technologies (ART), some accompanied by safety or ethical concerns. Certainly, progress in the field of reproduction has been realized in the twenty-first century with advances in the understanding of the regulation of fertility, with the production of over 400 mutant mouse models with a reproductive phenotype and with the promise of regenerative gonadal stem cells. Indeed, the past six years have witnessed a virtual explosion in the identification of gene mutations or polymorphisms that cause or are linked to human infertility. Translation of these findings to the clinic remains slow, however, as do new methods to diagnose and treat infertile couples. Additionally, new approaches to contraception remain elusive. Nevertheless, the basic and clinical advances in the understanding of the molecular controls of reproduction are impressive and will ultimately improve patient care. PMID:18989307

  8. Deep sequencing of HIV: clinical and research applications.

    Science.gov (United States)

    Chabria, Shiven B; Gupta, Shaili; Kozal, Michael J

    2014-01-01

    Human immunodeficiency virus (HIV) exhibits remarkable diversity in its genomic makeup and exists in any given individual as a complex distribution of closely related but nonidentical genomes called a viral quasispecies, which is subject to genetic variation, competition, and selection. This viral diversity clinically manifests as a selection of mutant variants based on viral fitness in treatment-naive individuals and based on drug-selective pressure in those on antiretroviral therapy (ART). The current standard-of-care ART consists of a combination of antiretroviral agents, which ensures maximal viral suppression while preventing the emergence of drug-resistant HIV variants. Unfortunately, transmission of drug-resistant HIV does occur, affecting 5% to >20% of newly infected individuals. To optimize therapy, clinicians rely on viral genotypic information obtained from conventional population sequencing-based assays, which cannot reliably detect viral variants that constitute <20% of the circulating viral quasispecies. These low-frequency variants can be detected by highly sensitive genotyping methods collectively grouped under the moniker of deep sequencing. Low-frequency variants have been correlated to treatment failures and HIV transmission, and detection of these variants is helping to inform strategies for vaccine development. Here, we discuss the molecular virology of HIV, viral heterogeneity, drug-resistance mutations, and the application of deep sequencing technologies in research and the clinical care of HIV-infected individuals.

  9. Muscle pain: animal and human experimental and clinical studies.

    Science.gov (United States)

    Marchettini, P

    1993-10-01

    The search for the identification of the sensory apparatus encoding muscle pain sensation in humans is recounted. Basic neurophysiologic animal studies, leading to a description of slowly conducting afferent from muscle and definition of high threshold polymodal muscle nociceptors, and pioneer psychophysic human studies together with recent microneurographic experiments in humans are described. The phenomena of muscle pain broad localization and distant referral are discussed, and clinical implications are extrapolated to interpret muscle pain as a localizing sign of mononeuropathy or radiculopathy. The identification of human muscle nociceptors has defined the scientific standard to test emerging clinical descriptions having muscle pain as a symptom.

  10. A survey of patients' attitudes to clinical research.

    LENUS (Irish Health Repository)

    Desmond, A

    2011-04-01

    Every year hundreds of patients voluntarily participate in clinical trials across Ireland. However, little research has been done as to how patients find the experience. This survey was conducted in an attempt to ascertain clinical trial participants\\' views on their experience of participating in a clinical trial and to see and how clinical trial participation can be improved. One hundred and sixty-six clinical trial participants who had recently completed a global phase IV cardiovascular endpoint clinical trial were sent a 3-page questionnaire. Ninety-one (91%) respondents found the experience of participating in a clinical trial a good one with 85 (84.16%) respondents saying they would recommend participating in a clinical trial to a friend or relative and eighty-five (87.63%) respondents feeling they received better healthcare because they had participated in a clinical trial.

  11. Collaboration - Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    Despite great strides in proteomics and the growing number of articles citing the discovery of potential biomarkers, the actual rate of introduction of Food and Drug Administration (FDA) approved protein analytes has been relatively unchanged over the past 10 years. One of reasons for the lack of new protein-based biomarkers approved has been a lack of information and understanding by the proteomics research community to the regulatory process used by the FDA.

  12. [Clinical research IX. From the clinical judgment to the clinical trial].

    Science.gov (United States)

    Talavera, Juan O; Rivas-Ruiz, Rodolfo

    2012-01-01

    Two strategies to understand and document causality are: 1) clinical reasoning (CR) and 2) clinical trial (CT). CR identifies: basal state, maneuver and outcome. These components show us the complex of causality, its identification and control allows us to avoid systematic errors, such as: at baseline-improper assembly and susceptibility bias, during the application of the maneuver-performance bias, and at measurement of outcome-detection and transfer bias. In the CT tactics attempt to separate the effect of the main maneuver from the effect of other components that participate in causality previously described in CR. CT takes advantage of its characteristics: the opportunity to manipulate the maneuver and the temporality into the causal relationship. Some features to highlight are: the allocation of the maneuver, blinding of the maneuver, the feasibility of early interruption of the maneuver, the analysis according to maneuver adherence, the groups to compare, the timing of comparative maneuver, and the informed consent. Each occasion the clinician applies all this knowledge and skills, in a conscious way and structured, he improves his efficiency and align medical practice with clinical research.

  13. Integrative data analysis in clinical psychology research.

    Science.gov (United States)

    Hussong, Andrea M; Curran, Patrick J; Bauer, Daniel J

    2013-01-01

    Integrative data analysis (IDA), a novel framework for conducting the simultaneous analysis of raw data pooled from multiple studies, offers many advantages including economy (i.e., reuse of extant data), power (i.e., large combined sample sizes), the potential to address new questions not answerable by a single contributing study (e.g., combining longitudinal studies to cover a broader swath of the lifespan), and the opportunity to build a more cumulative science (i.e., examining the similarity of effects across studies and potential reasons for dissimilarities). There are also methodological challenges associated with IDA, including the need to account for sampling heterogeneity across studies, to develop commensurate measures across studies, and to account for multiple sources of study differences as they impact hypothesis testing. In this review, we outline potential solutions to these challenges and describe future avenues for developing IDA as a framework for studies in clinical psychology.

  14. Visual Acuity Reporting in Clinical Research Publications.

    Science.gov (United States)

    Tsou, Brittany C; Bressler, Neil M

    2017-06-01

    Visual acuity results in publications typically are reported in Snellen or non-Snellen formats or both. A study in 2011 suggested that many ophthalmologists do not understand non-Snellen formats, such as logarithm of the Minimum Angle of Resolution (logMAR) or Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores. As a result, some journals, since at least 2013, have instructed authors to provide approximate Snellen equivalents next to non-Snellen visual acuity values. To evaluate how authors currently report visual acuity and whether they provide Snellen equivalents when their reports include non-Snellen formats. From November 21, 2016, through December 14, 2016, one reviewer evaluated visual acuity reporting among all articles published in 4 ophthalmology clinical journals from November 2015 through October 2016, including 3 of 4 journals that instructed authors to provide Snellen equivalents for visual acuity reported in non-Snellen formats. Frequency of formats of visual acuity reporting and frequency of providing Snellen equivalents when non-Snellen formats are given. The 4 journals reviewed had the second, fourth, fifth, and ninth highest impact factors for ophthalmology journals in 2015. Of 1881 articles reviewed, 807 (42.9%) provided a visual acuity measurement. Of these, 396 (49.1%) used only a Snellen format; 411 (50.9%) used a non-Snellen format. Among those using a non-Snellen format, 145 (35.3%) provided a Snellen equivalent while 266 (64.7%) provided only a non-Snellen format. More than half of all articles in 4 ophthalmology clinical journals fail to provide a Snellen equivalent when visual acuity is not in a Snellen format. Since many US ophthalmologists may not comprehend non-Snellen formats easily, these data suggest that editors and publishing staff should encourage authors to provide Snellen equivalents whenever visual acuity data are reported in a non-Snellen format to improve ease of understanding visual acuity measurements.

  15. [Application of Delphi method in traditional Chinese medicine clinical research].

    Science.gov (United States)

    Bi, Ying-fei; Mao, Jing-yuan

    2012-03-01

    In recent years, Delphi method has been widely applied in traditional Chinese medicine (TCM) clinical research. This article analyzed the present application situation of Delphi method in TCM clinical research, and discussed some problems presented in the choice of evaluation method, classification of observation indexes and selection of survey items. On the basis of present application of Delphi method, the author analyzed the method on questionnaire making, selection of experts, evaluation of observation indexes and selection of survey items. Furthermore, the author summarized the steps of application of Delphi method in TCM clinical research.

  16. Human iPSC-derived neurons and lymphoblastoid cells for personalized medicine research in neuropsychiatric disorders

    Science.gov (United States)

    Gurwitz, David

    2016-01-01

    The development and clinical implementation of personalized medicine crucially depends on the availability of high-quality human biosamples; animal models, although capable of modeling complex human diseases, cannot reflect the large variation in the human genome, epigenome, transcriptome, proteome, and metabolome. Although the biosamples available from public biobanks that store human tissues and cells may represent the large human diversity for most diseases, these samples are not always sufficient for developing biomarkers for patient-tailored therapies for neuropsychiatric disorders. Postmortem human tissues are available from many biobanks; nevertheless, collections of neuronal human cells from large patient cohorts representing the human diversity remain scarce. Two tools are gaining popularity for personalized medicine research on neuropsychiatric disorders: human induced pluripotent stem cell-derived neurons and human lymphoblastoid cell lines. This review examines and contrasts the advantages and limitations of each tool for personalized medicine research.

  17. A Framework for Human Microbiome Research

    Science.gov (United States)

    2012-06-14

    microbiome ) exist throughout the human body, with fundamental roles in human health and disease . The National Institutes of Health (NIH)-funded Human...roles in human health and disease . The National Institutes of Health (NIH)-funded Human Microbiome Project Consortium has established a population...human health and disease . The National Institutes of Health (NIH)-funded Human Microbiome Project Consortium has established a population-scale

  18. Quality assurance and best research practices for non-regulated veterinary clinical studies.

    Science.gov (United States)

    Davies, R; London, C; Lascelles, B; Conzemius, M

    2017-08-16

    Veterinary clinical trials generate data that advance the transfer of knowledge from clinical research to clinical practice in human and veterinary settings. The translational success of non-regulated and regulated veterinary clinical studies is dependent upon the reliability and reproducibility of the data generated. Clinician-scientists that conduct veterinary clinical studies would benefit from a commitment to research quality assurance and best practices throughout all non-regulated and regulated research environments. Good Clinical Practice (GCP) guidance documents from the FDA provides principles and procedures designed to safeguard data integrity, reliability and reproducibility. While these documents maybe excessive for clinical studies not intended for regulatory oversight it is important to remember that research builds on research. Thus, the quality and accuracy of all data and inference generated throughout the research enterprise remains vulnerable to the impact of potentially unreliable data generated by the lowest performing contributors. The purpose of this first of a series of statement papers is to outline and reference specific quality control and quality assurance procedures that should, at least in part, be incorporated into all veterinary clinical studies.

  19. Human-Robot Interaction Directed Research Project

    Science.gov (United States)

    Sandor, Aniko; Cross, Ernest V., II; Chang, Mai Lee

    2014-01-01

    Human-robot interaction (HRI) is a discipline investigating the factors affecting the interactions between humans and robots. It is important to evaluate how the design of interfaces and command modalities affect the human's ability to perform tasks accurately, efficiently, and effectively when working with a robot. By understanding the effects of interface design on human performance, workload, and situation awareness, interfaces can be developed to appropriately support the human in performing tasks with minimal errors and with appropriate interaction time and effort. Thus, the results of research on human-robot interfaces have direct implications for the design of robotic systems. This DRP concentrates on three areas associated with interfaces and command modalities in HRI which are applicable to NASA robot systems: 1) Video Overlays, 2) Camera Views, and 3) Command Modalities. The first study focused on video overlays that investigated how Augmented Reality (AR) symbology can be added to the human-robot interface to improve teleoperation performance. Three types of AR symbology were explored in this study, command guidance (CG), situation guidance (SG), and both (SCG). CG symbology gives operators explicit instructions on what commands to input, whereas SG symbology gives operators implicit cues so that operators can infer the input commands. The combination of CG and SG provided operators with explicit and implicit cues allowing the operator to choose which symbology to utilize. The objective of the study was to understand how AR symbology affects the human operator's ability to align a robot arm to a target using a flight stick and the ability to allocate attention between the symbology and external views of the world. The study evaluated the effects type of symbology (CG and SG) has on operator tasks performance and attention allocation during teleoperation of a robot arm. The second study expanded on the first study by evaluating the effects of the type of

  20. CLINICAL RESEARCH ON BAMBUTEROL SOLUTION AND TABLET

    Institute of Scientific and Technical Information of China (English)

    张希龙; 夏锡荣; 施毅; 郑培德

    2003-01-01

    Objective To evaluate the efficacy and safety of a new long-acting β2 agonist hydrochloric bambuterol for treating asthma.Methods Using randomized, single-blind control and open trials, 254 patients were divided into three groups: treatment group (100 cases), control group(50 cases) and open group(104 cases) .The treatment group and the open group were further divided into two subgroups (tablet group and solution group) and were treated with either bambuterol tablet or solution at a dose of 10-20mg, once daily in the evening for 4 weeks and meanwhile dose titration was undertaken.Results The clinical control percentages were 54%, 46% and 49.07%, 62.75%, and the efficacy percentages were 88%, 94% and 92.4%, 92.17% respectively in the treatment subgroups and open subgroups. The lung function had been significantly improved at the end of 2 weeks’ treatment. The dose titration suggests that the proper dose may be 20mg/ day for some asthmatic patients. The incidence of adverse effects was 7.77% in tablet gro

  1. Progress in clinical research of asteroid hyalosis

    Directory of Open Access Journals (Sweden)

    Xiao-Xue Liu

    2017-08-01

    Full Text Available Asteroid Hyalosis(AHis a common clinical disease, which has been considered a benign disorder as it rarely impairs visual acuity. It was often discovered when the patient was treated for other eye diseases. The mechanism was unclear. Its characteristic B-ultrasound property makes the B-ultrasound a very helpful diagnostic technique. In the case of the patients with other fundus diseases associated with AH, optical coherence tomography(OCTand fluorescein angiography(FAmay be used to reduce the interference from asteroid bodies, therefore improve the fundus visibility. Recent studies have shown that AH can incorporate with many other eye diseases. For example, in patients with cataracts, asteroid hyalosis can cause surface calcification of silicone plate intraocular lenses, which in most cases may lead to the need for explantation of the calcified intraocular lenses. The efficacy of pars plana vitrectomy(PPV, the removal of some, or all, of the eye's vitreous humor for AH remains controversial. In this paper, we provide a review of the recent literature on AH disease: the etiology, diagnosis and treatment. We hope to thus improve the awareness and outcomes of AH disease.

  2. Conflict of interest in clinical research

    Directory of Open Access Journals (Sweden)

    Ravindra B Ghooi

    2015-01-01

    Full Text Available Increased focus on ethical review of research demands a number of improvements in the existing system. Although these are being implemented, some factors that have received less attention in the past could be examined. One of these is conflict of interest. Such conflicts could exist for investigators, ethics committee (EC members, and even the regulators. Guidance for identification and management of conflicts has been issued by many countries and Indian rules also speak about these conflicts. Greater clarity would help investigators and ECs manage conflicts more effectively. It is admitted that conflicts cannot be done away with, but their timely identification, disclosure, and management can reduce their impact and bring more transparency and accountability to trials in this country.

  3. Clinical Research Informatics for Big Data and Precision Medicine.

    Science.gov (United States)

    Weng, C; Kahn, M G

    2016-11-10

    To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors.

  4. Clinical significance in nursing research: A discussion and descriptive analysis.

    Science.gov (United States)

    Polit, Denise F

    2017-05-10

    It is widely understood that statistical significance should not be equated with clinical significance, but the topic of clinical significance has not received much attention in the nursing literature. By contrast, interest in conceptualizing and operationalizing clinical significance has been a "hot topic" in other health care fields for several decades. The major purpose of this paper is to briefly describe recent advances in defining and quantifying clinical significance. The overview covers both group-level indicators of clinical significance (e.g., effect size indexes), and individual-level benchmarks (e.g., the minimal important change index). A secondary purpose is to describe the extent to which developments in clinical significance have penetrated the nursing literature. A descriptive analysis of a sample of primary research articles published in three high-impact nursing research journals in 2016 was undertaken. A total of 362 articles were electronically searched for terms relating to statistical and clinical significance. Of the 362 articles, 261 were reports of quantitative studies, the vast majority of which (93%) included a formal evaluation of the statistical significance of the results. By contrast, the term "clinical significance" or related surrogate terms were found in only 33 papers, and most often the term was used informally, without explicit definition or assessment. Raising consciousness about clinical significance should be an important priority among nurse researchers. Several recommendations are offered to improve the visibility and salience of clinical significance in nursing science. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Clinical research: making it work in the outpatient dialysis facility.

    Science.gov (United States)

    Doss, Sheila; Schiller, Brigitte; Fox, Rosemary; Moran, John

    2009-01-01

    Performing clinical research in the outpatient dialysis facility can be very challenging. Research protocols define time-specific and detailed procedures to be performed. In dialysis units where staff members are responsible for the delivery of life-sustaining therapy to an aging end stage renal disease patient population with multiple co-morbidities, these requirements can easily be considered too burdensome to be implemented successfully. In the authors'facility, clinical research has been successfully implemented with a close team approach supported by a dedicated research group and unit staff

  6. Progress through Collaboration - Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The National Cancer Institute (NCI), through the Office of Cancer Clinical Proteomics Research (OCCPR), has signed two Memorandums of Understanding (MOUs) in the areas of sharing proteomics reagents and protocols and also in regulatory science.

  7. Compliance in Early-Phase Cancer Clinical Trials Research

    OpenAIRE

    Kurzrock, Razelle; Stewart, David J

    2013-01-01

    The issue of compliance in a research environment in which investigators are subject to disciplinary action if they fail to ensure that patients adhere precisely to the intense monitoring mandates of a clinical trial is explored.

  8. Behavioral treatment of rumination: Research and clinical applications.

    Science.gov (United States)

    Luiselli, James K

    2015-09-01

    This brief review describes research on rumination treatment that emphasizes functional analysis, recent intervention methods (supplemental feeding, fixed-time stimulus presentation, continuous access to preferred stimulation), clinical implications, and procedural recommendations.

  9. [Progress of orthodontics in the clinical and basic research].

    Science.gov (United States)

    Zhao, Zhi-He

    2008-06-01

    In recent years, clinical diagnostic and treatment techniques of orthodontics have been developed rapidly. The orthopedic mechanism of malocclusion has been the hot spot of basic research of orthodontics.

  10. Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

    Science.gov (United States)

    De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W

    2016-01-01

    Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.

  11. Integrating research, clinical practice and translation: the Singapore experience.

    Science.gov (United States)

    Liu, Jiang; Wong, Damon Wing Kee; Zhang, Zhuo; Lee, Beng-Hai; Gao, Xinting; Yin, Fengshou; Zhang, Jielin; Htoo, Min Thet

    2013-01-01

    We introduce the experiences of the Singapore ocular imaging team, iMED, in integrating image processing and computer-aided diagnosis research with clinical practice and knowledge, towards the development of ocular image processing technologies for clinical usage with potential impact. In this paper, we outline key areas of research with their corresponding image modalities, as well as providing a systematic introduction of the datasets used for validation.

  12. Clinical significance of human alpha-fetoprotein

    Energy Technology Data Exchange (ETDEWEB)

    Yachnin, S.

    1978-01-01

    Deviations from the normal of alpha-fetoprotein (AFP) concentrations in fetal serum, amniotic fluid, maternal serum and adult human serum can be explained by understanding the normal physiology and the pathophysiology of AFP synthesis and metabolism. AFP is the prototype of oncofetal markers. Emphasis is given to the usefulness of elevated serum AFP levels in the diagnosis and management of primary hepatomas and tumors of germ cell origin. The ability to detect neural tube defects early in gestation by monitoring maternal serum and amniotic fluid AFP concentrations is discussed.

  13. Sex differences in health research and clinical guideline development

    NARCIS (Netherlands)

    Keuken, D.G.

    2008-01-01

    In current medical practice, research based evidence is an important foundation for clinical decision making. Clinical practice guidelines are a major instrument for keeping physicians up-to-date about this evidence. In order to provide optimal care to both men and women, it is important that sex di

  14. Radioactive isotopes in clinical medicine and research. Abstracts

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-07-01

    The review on the International Symposium on radioactive isotopes in clinical medicine and research in Bad Hofgastein, Austria, 9-12 January 2008, contains 42 papers and 29 poster contributions on the following topics: radiopharmaceutical sciences; radiopharmaceutical sciences in oncology and cardiology; therapy; endocrinology; molecular imaging; clinical PET; physics: image processing; instrumentation, neurology, psychiatry.

  15. Human computer interaction issues in Clinical Trials Management Systems.

    Science.gov (United States)

    Starren, Justin B; Payne, Philip R O; Kaufman, David R

    2006-01-01

    Clinical trials increasingly rely upon web-based Clinical Trials Management Systems (CTMS). As with clinical care systems, Human Computer Interaction (HCI) issues can greatly affect the usefulness of such systems. Evaluation of the user interface of one web-based CTMS revealed a number of potential human-computer interaction problems, in particular, increased workflow complexity associated with a web application delivery model and potential usability problems resulting from the use of ambiguous icons. Because these design features are shared by a large fraction of current CTMS, the implications extend beyond this individual system.

  16. Clinical diabetes research using data mining: a Canadian perspective.

    Science.gov (United States)

    Shah, Baiju R; Lipscombe, Lorraine L

    2015-06-01

    With the advent of the digitization of large amounts of information and the computer power capable of analyzing this volume of information, data mining is increasingly being applied to medical research. Datasets created for administration of the healthcare system provide a wealth of information from different healthcare sectors, and Canadian provinces' single-payer universal healthcare systems mean that data are more comprehensive and complete in this country than in many other jurisdictions. The increasing ability to also link clinical information, such as electronic medical records, laboratory test results and disease registries, has broadened the types of data available for analysis. Data-mining methods have been used in many different areas of diabetes clinical research, including classic epidemiology, effectiveness research, population health and health services research. Although methodologic challenges and privacy concerns remain important barriers to using these techniques, data mining remains a powerful tool for clinical research. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

  17. Expand and Regularize Federal Funding for Human Pluripotent Stem Cell Research

    Science.gov (United States)

    Owen-Smith, Jason; Scott, Christopher Thomas; McCormick, Jennifer B.

    2012-01-01

    Human embryonic stem cell (hESC) research has sparked incredible scientific and public excitement, as well as significant controversy. hESCs are pluripotent, which means, in theory, that they can be differentiated into any type of cell found in the human body. Thus, they evoke great enthusiasm about potential clinical applications. They are…

  18. Expand and Regularize Federal Funding for Human Pluripotent Stem Cell Research

    Science.gov (United States)

    Owen-Smith, Jason; Scott, Christopher Thomas; McCormick, Jennifer B.

    2012-01-01

    Human embryonic stem cell (hESC) research has sparked incredible scientific and public excitement, as well as significant controversy. hESCs are pluripotent, which means, in theory, that they can be differentiated into any type of cell found in the human body. Thus, they evoke great enthusiasm about potential clinical applications. They are…

  19. 76 FR 72957 - 4th Annual Trauma Spectrum Conference: Bridging the Gap Between Research and Clinical Practice of...

    Science.gov (United States)

    2011-11-28

    ... HUMAN SERVICES National Institutes of Health 4th Annual Trauma Spectrum Conference: Bridging the Gap... Annual Trauma Spectrum Conference: Bridging the Gap Between Research and Clinical Practice of... conference information, visit the Trauma Spectrum Conference Web site at...

  20. Information Presentation: Human Research Program - Space Human Factors and Habitability, Space Human Factors Engineering Project

    Science.gov (United States)

    Holden, Kristina L.; Sandor, Aniko; Thompson, Shelby G.; Kaiser, Mary K.; McCann, Robert S.; Begault, D. R.; Adelstein, B. D.; Beutter, B. R.; Wenzel, E. M.; Godfroy, M.; Stone, L. S.

    2010-01-01

    The goal of the Information Presentation Directed Research Project (DRP) is to address design questions related to the presentation of information to the crew. The major areas of work, or subtasks, within this DRP are: 1) Displays, 2) Controls, 3) Electronic Procedures and Fault Management, and 4) Human Performance Modeling. This DRP is a collaborative effort between researchers atJohnson Space Center and Ames Research Center. T

  1. [Experience of a research Ethics Committee and the challenges of the new Chilean legislation on research in human beings].

    Science.gov (United States)

    Oyarzún G, Manuel; Pinto C, María Eugenia; Raineri B, Gina G; Amigo, Hugo; Cifuentes O, Lucía; González, María Julieta; Horwitz, Nina; Marshall F, Claudia; Orellana V, Gricel

    2014-07-01

    The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law 20.120: "On scientific research in human beings, its genome and forbidding human cloning" establishes the ethical principles that must be accomplished in every research involving human beings. Article 28 of the Law 20.584 "Regulation of the rights and duties of health care users", forbids the participation of handicapped people who cannot express their will in scientific research. Article 13 states that people not related directly with patient care cannot have access to his clinical records (with the exception of people with notarial authorization by the patient). CEISH proposes that, in case of people with intellectual deficiency, the decision to approve a scientific research should be analyzed on an individual basis. If the person is capable of expressing his or her will or has stated his or her consent beforehand, the research can be authorized. If the person cannot express his or her will, the scientific research cannot take place. In prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records. In retrospective studies, consent should be obtained from the patient when personal information is going to be used. If the information is nameless, the consent can be disregarded.

  2. Integrating utilization-focused evaluation with business process modeling for clinical research improvement.

    Science.gov (United States)

    Kagan, Jonathan M; Rosas, Scott; Trochim, William M K

    2010-10-01

    New discoveries in basic science are creating extraordinary opportunities to design novel biomedical preventions and therapeutics for human disease. But the clinical evaluation of these new interventions is, in many instances, being hindered by a variety of legal, regulatory, policy and operational factors, few of which enhance research quality, the safety of study participants or research ethics. With the goal of helping increase the efficiency and effectiveness of clinical research, we have examined how the integration of utilization-focused evaluation with elements of business process modeling can reveal opportunities for systematic improvements in clinical research. Using data from the NIH global HIV/AIDS clinical trials networks, we analyzed the absolute and relative times required to traverse defined phases associated with specific activities within the clinical protocol lifecycle. Using simple median duration and Kaplan-Meyer survival analysis, we show how such time-based analyses can provide a rationale for the prioritization of research process analysis and re-engineering, as well as a means for statistically assessing the impact of policy modifications, resource utilization, re-engineered processes and best practices. Successfully applied, this approach can help researchers be more efficient in capitalizing on new science to speed the development of improved interventions for human disease.

  3. Plucked Human Hair Shafts and Biomolecular Medical Research

    Directory of Open Access Journals (Sweden)

    Kevin Schembri

    2013-01-01

    Full Text Available The hair follicle is a skin integument at the boundary between an organism and its immediate environment. The biological role of the human hair follicle has lost some of its ancestral importance. However, an indepth investigation of this miniorgan reveals hidden complexity with huge research potential. An essential consideration when dealing with human research is the awareness of potential harm and thus the absolute need not to harm—a rule aptly qualified by the Latin term “primum non nocere” (first do no harm. The plucked hair shaft offers such advantages. The use of stem cells found in hair follicles cells is gaining momentum in the field of regenerative medicine. Furthermore, current diagnostic and clinical applications of plucked hair follicles include their use as autologous and/or three-dimensional epidermal equivalents, together with their utilization as surrogate tissue in pharmacokinetic and pharmacodynamics studies. Consequently, the use of noninvasive diagnostic procedures on hair follicle shafts, posing as a surrogate molecular model for internal organs in the individual patient for a spectrum of human disease conditions, can possibly become a reality in the near future.

  4. Establishing community advisory boards for clinical trial research in ...

    African Journals Online (AJOL)

    trial research in Malawi: engendering ethical conduct in research. Abstract ... participants; minimise risk and balance benefit; and fairly ... on the Harmonisation of Good Clinical Practice (ICHGCP) to faculty ... of, and acceptable to the community'10. They can ..... any study-related questions and concerns community members ...

  5. Clinical teaching and learning: from theory and research to application.

    Science.gov (United States)

    Conn, Jennifer J; Lake, Fiona R; McColl, Geoffrey J; Bilszta, Justin L C; Woodward-Kron, Robyn

    2012-05-07

    Learning in the clinical setting is the cornerstone of medical school education, but there are strong imperatives to optimise the ways in which students acquire clinical expertise. Deliberate practice is characterised by attention, concentration, effort and repetition of skills; it is an important tool for developing and maintaining professional expertise. Research has led to a greater understanding of how medical students develop core clinical skills, especially in the areas of diagnostic reasoning, communication and physical examination. Advances in information technology and instructional design are helping to strengthen the links between formal educational activities and opportunistic learning in the clinical setting.

  6. Guidance for researchers developing and conducting clinical trials in practice-based research networks (PBRNs).

    Science.gov (United States)

    Dolor, Rowena J; Schmit, Kristine M; Graham, Deborah G; Fox, Chester H; Baldwin, Laura Mae

    2014-01-01

    There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. The "Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks" offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. © Copyright 2014 by the American Board of Family Medicine.

  7. Physiopathology of human embryonic implantation: clinical incidences.

    Directory of Open Access Journals (Sweden)

    Pauline Demailly

    2010-01-01

    Full Text Available Embryo implantation consists of a series of events promoting the invasion of the endometrium and then the uterine arterial system by the extra-embryonic trophoblast. In order for this semi-heterologous implantation to succeed, the endometrium has to first undergo a number of structural and biochemical changes (decidualization. The decidua's various constituents subsequently play a role in the embryonic implantation. The third step is the transformation of the uterine vascular system and the growth of the placenta, which will provide the foetoplacental unit with nutrients. Several physiopathological aspects will be discussed: 1 the implantation window, regulated by maternal and embryonic hormonal secretions and thus influenced by any defects in the latter: dysharmonic luteal phase, 21-hydroxylase block, abnormal integrin expression, 2 the successive trophoblast invasions of uterine vessels which, when defective, lead to early embryo loss or late-onset vascular pathologies, as preeclampsia, 3 the pregnancy's immunological equilibrium, with a spontaneously tolerated semi-allogeneic implant, 4 the impact of pro-coagulant factors (thrombophilia on the pregnancy's progression, 5 the environment of the uterus, ranging from hydrosalpinx to uterine contractions. In summary, the least anatomical or physiological perturbation can interfere with human embryonic implantation - a very particular phenomenon and a true biological paradox.

  8. [The adoption of Jardé law modifies the legal framework of clinical research in France].

    Science.gov (United States)

    Maillols-Perroy, Anne-Catherine; Tillet, Yves

    2012-01-01

    The Jardé law is adopted further to the Public Health Act No. 2004-806 which transposed into French law the Directive 2001/20/EC on clinical trials of medicinal products, made effective by the implementing Decree 2006-477 of April 26, 2006. The main novelty introduced by the Jardé law is to unify all "research organized and practiced on human beings for the development of biological or medical knowledge" and to facilitate its effective conduct, without however excluding from the scope of the law routine care and non-interventional research. The favorable opinion of the French Ethical Research Committee (comité de protection des personnes or "CCP") will now be required before launching any research on human beings, after validation of the risk/benefit ratio of said research. Applicable requirements and procedures - including information and consent - are adapted to each category of clinical research. New provisions are adopted to address special situations, previously forgotten. Finally, if Ethics committees were up until now freely chosen, they will, in two years' time, be randomly assigned. Thus, the Jardé law amends substantially the legal framework of clinical research in France. The question is whether these new national provisions will be compatible with those from the next revision of the so called "clinical trials" directive 2001/20/EC. In any case, the Jarde law will only come into force when all required implementing measures have been adopted.

  9. In Defense of a Social Value Requirement for Clinical Research.

    Science.gov (United States)

    Wendler, David; Rid, Annette

    2017-02-01

    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies.

  10. Clinical Research Environment in India: Challenges and Proposed Solutions.

    Science.gov (United States)

    Burt, Tal; Sharma, Pooja; Dhillon, Savita; Manchanda, Mukul; Mittal, Sanjay; Trehan, Naresh

    2014-11-01

    India has compelling need and keen aspirations for indigenous clinical research. Notwithstanding this need and previously reported growth the expected expansion of Indian clinical research has not materialized. We reviewed the scientific literature, lay press reports, and ClinicalTrials.gov data for information and commentary on projections, progress, and impediments associated with clinical trials in India. We also propose targeted solutions to identified challenges. The Indian clinical trial sector grew by (+) 20.3% CAGR (compound annual growth rate) between 2005 and 2010 and contracted by (-) 14.6% CAGR between 2010 and 2013. Phase-1 trials grew by (+) 43.5% CAGR from 2005-2013, phase-2 trials grew by (+) 19.8% CAGR from 2005-2009 and contracted by (-) 12.6% CAGR from 2009-2013, and phase-3 trials grew by (+) 13.0% CAGR from 2005-2010 and contracted by (-) 28.8% CAGR from 2010-2013. This was associated with a slowing of the regulatory approval process, increased media coverage and activist engagement, and accelerated development of regulatory guidelines and recuperative initiatives. We propose the following as potential targets for restorative interventions: Regulatory overhaul (leadership and enforcement of regulations, resolution of ambiguity in regulations, staffing, training, guidelines, and ethical principles [e.g., compensation]).Education and training of research professionals, clinicians, and regulators.Public awareness and empowerment. After a peak in 2009-2010, the clinical research sector in India appears to be experiencing a contraction. There are indications of challenges in regulatory enforcement of guidelines; training of clinical research professionals; and awareness, participation, partnership, and the general image amongst the non-professional media and public. Preventative and corrective principles and interventions are outlined with the goal of realizing the clinical research potential in India.

  11. Review of human hand microbiome research.

    Science.gov (United States)

    Edmonds-Wilson, Sarah L; Nurinova, Nilufar I; Zapka, Carrie A; Fierer, Noah; Wilson, Michael

    2015-10-01

    Recent advances have increased our understanding of the human microbiome, including the skin microbiome. Despite the importance of the hands as a vector for infection transmission, there have been no comprehensive reviews of recent advances in hand microbiome research or overviews of the factors that influence the composition of the hand microbiome. A comprehensive and systematic database search was conducted for skin microbiome-related articles published from January 1, 2008 to April 1, 2015. Only primary research articles that used culture-independent, whole community analysis methods to study the healthy hand skin microbiome were included. Eighteen articles were identified containing hand microbiome data. Most focused on bacteria, with relatively little reported on fungi, viruses, and protozoa. Bacteria from four phyla were found across all studies of the hand microbiome (most to least relative abundance): Firmicutes, Actinobacteria, Proteobacteria, Bacteroidetes. Key factors that impacted the hand microbiome composition included temporal and biogeographical dynamics, as well as intrinsic (age, gender) and extrinsic (product use, cohabitants, pet-ownership) variables. There was more temporal variability in the composition of the hand microbiome than in other body sites, making identification of the "normal" microbiome of the hands challenging. The microbiome of the hands is in constant flux as the hands are a critical vector for transmitting microorganisms between people, pets, inanimate objects and our environments. Future studies need to resolve methodological influences on results, and further investigate factors which alter the hand microbiome including the impact of products applied to hands. Increased understanding of the hand microbiome and the skin microbiome in general, will open the door to product development for disease prevention and treatment, and may lead to other applications, including novel diagnostic and forensic approaches.

  12. Differential network analysis in human cancer research.

    Science.gov (United States)

    Gill, Ryan; Datta, Somnath; Datta, Susmita

    2014-01-01

    A complex disease like cancer is hardly caused by one gene or one protein singly. It is usually caused by the perturbation of the network formed by several genes or proteins. In the last decade several research teams have attempted to construct interaction maps of genes and proteins either experimentally or reverse engineer interaction maps using computational techniques. These networks were usually created under a certain condition such as an environmental condition, a particular disease, or a specific tissue type. Lately, however, there has been greater emphasis on finding the differential structure of the existing network topology under a novel condition or disease status to elucidate the perturbation in a biological system. In this review/tutorial article we briefly mention some of the research done in this area; we mainly illustrate the computational/statistical methods developed by our team in recent years for differential network analysis using publicly available gene expression data collected from a well known cancer study. This data includes a group of patients with acute lymphoblastic leukemia and a group with acute myeloid leukemia. In particular, we describe the statistical tests to detect the change in the network topology based on connectivity scores which measure the association or interaction between pairs of genes. The tests under various scores are applied to this data set to perform a differential network analysis on gene expression for human leukemia. We believe that, in the future, differential network analysis will be a standard way to view the changes in gene expression and protein expression data globally and these types of tests could be useful in analyzing the complex differential signatures.

  13. Information-seeking behavior and use of information resources by clinical research coordinators.

    Science.gov (United States)

    Wessel, Charles B; Tannery, Nancy H; Epstein, Barbara A

    2006-01-01

    The study sought to understand the literature searching experiences and skills of clinical research coordinators at a large academic medical center. The Health Sciences Library System, University of Pittsburgh, conducted a survey of clinical research coordinators at the University of Pittsburgh and the University of Pittsburgh Medical Center to solicit their perceived use and knowledge of the library's electronic resources. The University of Pittsburgh Institutional Review Board (IRB) is a "high volume IRB" that monitors human subject research at both the University of Pittsburgh and the University of Pittsburgh Medical Center. More than 3,500 human research studies and clinical trials are active at any given time. Many studies entail more than minimal risk to human subjects, with the majority evaluating or including a drug or medical device. Clinical research coordinators are involved in most of these studies or trials. Their roles and responsibilities focus on managing many aspects of the study or clinical trial. As a first step in understanding the literature searching experiences and skills of these research coordinators, baseline data were gathered from this group in November 2004. The data from this survey indicate that clinical research coordinators are a population who would benefit from training by academic medical center librarians in how to use electronic library resources and services. A Web-based survey solicited participants' information (gender, education, job title) and role in the IRB process (job responsibilities, number studies they manage). The majority of the survey questions focused on the use of specific electronic library resources, the type of information wanted, and the types of problems encountered.

  14. Clinical Trial and Research Study Recruiters' Verbal Communication Behaviors.

    Science.gov (United States)

    Morgan, Susan E; Mouton, Ashton; Occa, Aurora; Potter, Jonell

    2016-07-01

    The lack of accrual to research studies and clinical trials is a persistent problem with serious consequences: Advances in medical science depend on the participation of large numbers of people, including members of minority and underserved populations. The current study examines a critical determinant of accrual: the approach of patients by professional recruiters who request participation in research studies and clinical trials. Findings indicate that recruiters use a number of verbal strategies in the communication process, including translating study information (such as simplifying, using examples, and substituting specific difficult or problematic words), using linguistic reframing or metaphors, balancing discussions of research participation risks with benefits, and encouraging potential participants to ask questions. The identification of these verbal strategies can form the basis of new communication protocols that will help medical and nonmedical professionals communicate more clearly and effectively with patients and other potential participants about research studies and clinical trials, which should lead to increased accrual in the future.

  15. Clinical characteristics and lung function in older children vertically infected with Human Immunodeficiency Virus in Malawi

    OpenAIRE

    Mwalukomo, Thandie; Rylance, Sarah; Webb, Emily; Anderson, Suzanne; O'Hare, Bernadette Ann-Marie; van Oosterhout, Joep J; Ferrand, Rashida A.; Corbett, Elizabeth L; Rylance, Jamie

    2015-01-01

    T. M. was funded by the Commonwealth scholarship, with research costs from a grant fom Helse Nord Northern Norway Regional Health Authority. E. L. C., R. A. F., and J. R. are supported by Wellcome Trust Fellowships (Senior Fellowship in Clinical Sciences WT091769, Career Development Fellowship WT095878 and Clinical PhD Fellowship 086756/B/08/Z, respectively). Background Antiretroviral therapy (ART) has led to increased survival of children with vertically acquired human immunodeficiency vi...

  16. Environmental Health Research Involving Human Subjects: Ethical Issues

    Directory of Open Access Journals (Sweden)

    David B. Resnik

    2008-01-01

    Full Text Available This article reviews some of the ethical issues that arise in environmental health research with human subjects, such as minimizing risks to subjects, balancing benefits and risks in research, intentional exposure studies with human subjects, protecting third parties in research, informing subjects about environmental hazards, communicating health information to subjects, and protecting privacy and confidentiality.

  17. Qualitative Research in Palliative Care: Applications to Clinical Trials Work.

    Science.gov (United States)

    Lim, Christopher T; Tadmor, Avia; Fujisawa, Daisuke; MacDonald, James J; Gallagher, Emily R; Eusebio, Justin; Jackson, Vicki A; Temel, Jennifer S; Greer, Joseph A; Hagan, Teresa; Park, Elyse R

    2017-08-01

    While vast opportunities for using qualitative methods exist within palliative care research, few studies provide practical advice for researchers and clinicians as a roadmap to identify and utilize such opportunities. To provide palliative care clinicians and researchers descriptions of qualitative methodology applied to innovative research questions relative to palliative care research and define basic concepts in qualitative research. Body: We describe three qualitative projects as exemplars to describe major concepts in qualitative analysis of early palliative care: (1) a descriptive analysis of clinician documentation in the electronic health record, (2) a thematic content analysis of palliative care clinician focus groups, and (3) a framework analysis of audio-recorded encounters between patients and clinicians as part of a clinical trial. This study provides a foundation for undertaking qualitative research within palliative care and serves as a framework for use by other palliative care researchers interested in qualitative methodologies.

  18. Physician participation in clinical research and trials: issues and approaches

    Directory of Open Access Journals (Sweden)

    Sami F Shaban

    2011-03-01

    Full Text Available Sayeeda Rahman1, Md Anwarul Azim Majumder1, Sami F Shaban2, Nuzhat Rahman3, Moslehuddin Ahmed4, Khalid Bin Abdulrahman5, Urban JA D’Souza61Department of Clinical Sciences, School of Life Sciences, University of Bradford, West Yorkshire, Bradford, UK; 2Department of Medical Education, Faculty of Medicine and Health Sciences, UAE University, Al-Ain, United Arab Emirates; 3Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA; 4Department of Community Medicine, Uttara Adhunik Medical College, Dhaka, Bangladesh; 5Department of Family Medicine and Medical Education, College of Medicine, Al-Imam University, Riyadh, Saudi Arabia; 6Department of Post Graduate Studies, School of Medicine, University Malaysia Sabah, Kota Kinabalu, Sabah, MalaysiaAbstract: The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system- or organization-related as well as research- and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and

  19. Human-Computer Interaction and Information Management Research Needs

    Data.gov (United States)

    Networking and Information Technology Research and Development, Executive Office of the President — In a visionary future, Human-Computer Interaction HCI and Information Management IM have the potential to enable humans to better manage their lives through the use...

  20. Protections for Subjects in Human Research with Pesticides

    Science.gov (United States)

    All pesticide research using human subjects must meet our strict protective standards before we would consider using them in evaluating pesticides. EPA's regulation “Protections for Subjects in Human Research” was promulgated in 2006 and amended in 2013.

  1. Social justice and research using human biological material: A ...

    African Journals Online (AJOL)

    commercial medical research that uses human biological material, such as blood samples or other ... and provide that a person from whose body human biological material is withdrawn for .... part of investigators and institutions. This could be ...

  2. Human subject research for engineers a practical guide

    CERN Document Server

    de Winter, Joost C F

    2017-01-01

    This Brief introduces engineers to the main principles in ethics, research design, statistics, and publishing of human subject research. In recent years, engineering has become strongly connected to disciplines such as biology, medicine, and psychology. Often, engineers (and engineering students) are expected to perform human subject research. Typical human subject research topics conducted by engineers include human-computer interaction (e.g., evaluating the usability of software), exoskeletons, virtual reality, teleoperation, modelling of human behaviour and decision making (often within the framework of ‘big data’ research), product evaluation, biometrics, behavioural tracking (e.g., of work and travel patterns, or mobile phone use), transport and planning (e.g., an analysis of flows or safety issues), etc. Thus, it can be said that knowledge on how to do human subject research is indispensable for a substantial portion of engineers. Engineers are generally well trained in calculus and mechanics, but m...

  3. Exploring the value of qualitative research films in clinical education.

    Science.gov (United States)

    Toye, Fran; Jenkins, Sue; Seers, Kate; Barker, Karen

    2015-11-27

    Many healthcare professionals use both quantitative and qualitative research to inform their practice. The usual way to access research findings is through peer-reviewed publications. This study aimed to understand the impact on healthcare professionals of watching and discussing a short research based film. The film, 'Struggling to be me' portrays findings from a qualitative synthesis exploring people's experiences of chronic pain, and was delivered as part of an inter-professional postgraduate e-learning module. The innovation of our study is to be the first to explore the impact of qualitative research portrayed through the medium of film in clinical education. All nineteen healthcare professionals enrolled on the course in December 2013 took part in on-line interviews or focus groups. We recorded and transcribed the interviews verbatim and used the methods of Grounded Theory to analyse the interview transcripts. Watching and discussing the film became a stimulus for learning : (a) A glimpse beneath the surface explored a pro-active way of seeing the person behind the pain (b) Pitfalls of the Medical Model recognised the challenge, for both patient and clinician, of 'sitting with' rather than 'fixing' an ill person; (c) Feeling bombarded by despair acknowledged the intense emotions that the clinicians brings to the clinical encounter; (d) Reconstructing the clinical encounter as a shared journey reconstructed the time-constrained clinical encounter as a single step on a shared journey towards healing, rather than fixing. Films portraying qualitative research findings can stimulate a pro-active and dialectic form of knowing. Research-based qualitative films can make qualitative findings accessible and can be a useful resource in clinical training. Our research presents, for the first time, specific learning themes for clinical education.

  4. Bacteriophage Therapy: Advances in Formulation Strategies and Human Clinical Trials.

    Science.gov (United States)

    Vandenheuvel, Dieter; Lavigne, Rob; Brüssow, Harald

    2015-11-01

    Recently, a number of phage therapy phase I and II safety trials have been concluded, showing no notable safety concerns associated with the use of phage. Though hurdles for efficient treatment remain, these trials hold promise for future phase III clinical trials. Interestingly, most phage formulations used in these clinical trials are straightforward phage suspensions, and not much research has focused on the processing of phage cocktails in specific pharmaceutical dosage forms. Additional research on formulation strategies and the stability of phage-based drugs will be of key importance, especially with phage therapy advancing toward phase III clinical trials.

  5. Characteristics desired in clinical data warehouse for biomedical research.

    Science.gov (United States)

    Shin, Soo-Yong; Kim, Woo Sung; Lee, Jae-Ho

    2014-04-01

    Due to the unique characteristics of clinical data, clinical data warehouses (CDWs) have not been successful so far. Specifically, the use of CDWs for biomedical research has been relatively unsuccessful thus far. The characteristics necessary for the successful implementation and operation of a CDW for biomedical research have not clearly defined yet. THREE EXAMPLES OF CDWS WERE REVIEWED: a multipurpose CDW in a hospital, a CDW for independent multi-institutional research, and a CDW for research use in an institution. After reviewing the three CDW examples, we propose some key characteristics needed in a CDW for biomedical research. A CDW for research should include an honest broker system and an Institutional Review Board approval interface to comply with governmental regulations. It should also include a simple query interface, an anonymized data review tool, and a data extraction tool. Also, it should be a biomedical research platform for data repository use as well as data analysis. The proposed characteristics desired in a CDW may have limited transfer value to organizations in other countries. However, these analysis results are still valid in Korea, and we have developed clinical research data warehouse based on these desiderata.

  6. Genetic Modification of Preimplantation Embryos: Toward Adequate Human Research Policies

    OpenAIRE

    Dresser, Rebecca

    2004-01-01

    Citing advances in transgenic animal research and setbacks in human trials of somatic cell genetic interventions, some scientists and others want to begin planning for research involving the genetic modification of human embryos. Because this form of genetic modification could affect later-born children and their offspring, the protection of human subjects should be a priority in decisions about whether to proceed with such research. Yet because of gaps in existing federal policies, embryo mo...

  7. Evolution of Clinical Proteomics and its Role in Medicine | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    NCI's Office of Cancer Clinical Proteomics Research authored a review of the current state of clinical proteomics in the peer-reviewed Journal of Proteome Research. The review highlights outcomes from the CPTC program and also provides a thorough overview of the different technologies that have pushed the field forward. Additionally, the review provides a vision for moving the field forward through linking advances in genomic and proteomic analysis to develop new, molecularly targeted interventions.

  8. NASA Human Research Wiki - An Online Collaboration Tool

    Science.gov (United States)

    Barr, Y. R.; Rasbury, J.; Johnson, J.; Barsten, K.; Saile, L.; Watkins, S. D.

    2011-01-01

    In preparation for exploration-class missions, the Exploration Medical Capability (ExMC) element of NASA's Human Research Program (HRP) has compiled a large evidence base, which previously was available only to persons within the NASA community. The evidence base is comprised of several types of data, for example: information on more than 80 medical conditions which could occur during space flight, derived from several sources (including data on incidence and potential outcomes of these medical conditions, as captured in the Integrated Medical Model's Clinical Finding Forms). In addition, approximately 35 gap reports are included in the evidence base, identifying current understanding of the medical challenges for exploration, as well as any gaps in knowledge and/or technology that would need to be addressed in order to provide adequate medical support for these novel missions. In an effort to make the ExMC information available to the general public and increase collaboration with subject matter experts within and outside of NASA, ExMC has developed an online collaboration tool, very similar to a wiki, titled the NASA Human Research Wiki. The platform chosen for this data sharing, and the potential collaboration it could generate, is a MediaWiki-based application that would house the evidence, allow "read only" access to all visitors to the website, and editorial access to credentialed subject matter experts who have been approved by the Wiki's editorial board. Although traditional wikis allow users to edit information in real time, the NASA Human Research Wiki includes a peer review process to ensure quality and validity of information. The wiki is also intended to be a pathfinder project for other HRP elements that may want to use this type of web-based tool. The wiki website will be released with a subset of the data described and will continue to be populated throughout the year.

  9. More ethical and more efficient clinical research: multiplex trial design.

    Science.gov (United States)

    Keus, Frederik; van der Horst, Iwan C C; Nijsten, Maarten W

    2014-08-14

    Today's clinical research faces challenges such as a lack of clinical equipoise between treatment arms, reluctance in randomizing for multiple treatments simultaneously, inability to address interactions and increasingly restricted resources. Furthermore, many trials are biased by extensive exclusion criteria, relatively small sample size and less appropriate outcome measures. We propose a 'Multiplex' trial design that preserves clinical equipoise with a continuous and factorial trial design that will also result in more efficient use of resources. This multiplex design accommodates subtrials with appropriate choice of treatment arms within each subtrial. Clinical equipoise should increase consent rates while the factorial design is the best way to identify interactions. The multiplex design may evolve naturally from today's research limitations and challenges, while principal objections seem absent. However this new design poses important infrastructural, organisational and psychological challenges that need in depth consideration.

  10. Computer science security research and human subjects: emerging considerations for research ethics boards.

    Science.gov (United States)

    Buchanan, Elizabeth; Aycock, John; Dexter, Scott; Dittrich, David; Hvizdak, Erin

    2011-06-01

    This paper explores the growing concerns with computer science research, and in particular, computer security research and its relationship with the committees that review human subjects research. It offers cases that review boards are likely to confront, and provides a context for appropriate consideration of such research, as issues of bots, clouds, and worms enter the discourse of human subjects review.

  11. Human Research Program Science Management: Overview of Research and Development Activities

    Science.gov (United States)

    Charles, John B.

    2007-01-01

    An overview of research and development activities of NASA's Human Research Science Management Program is presented. The topics include: 1) Human Research Program Goals; 2) Elements and Projects within HRP; 3) Development and Maintenance of Priorities; 4) Acquisition and Evaluation of Research and Technology Proposals; and 5) Annual Reviews

  12. Human bite of the hand: clinical and surgical approach

    OpenAIRE

    Simancas-Pereira Hernán; Fonseca-Caro John Fredy; Acevedo-Granados Camilo Andrés

    2012-01-01

    Introduction: human bites of the hand carries a risk of infection and functional and/oraesthetic complications, according to the mechanism of trauma, duration and specificfactors of the victim and the aggressor. The management of acute episodes isessential and must be an interdisciplinary care.Objective: to review human bites of the hand.Methodology: Thematic review which included the evaluation of clinical casereports published in the last fifteen years in English and Spanish, obtained by el...

  13. Human Motion Video Analysis in Clinical Practice (Review)

    OpenAIRE

    V.V. Borzikov; N.N. Rukina; O.V. Vorobyova; A.N. Kuznetsov; A. N. Belova

    2015-01-01

    The development of new rehabilitation approaches to neurological and traumatological patients requires understanding of normal and pathological movement patterns. Biomechanical analysis of video images is the most accurate method of investigation and quantitative assessment of human normal and pathological locomotion. The review of currently available methods and systems of optical human motion analysis used in clinical practice is presented here. Short historical background is provi...

  14. Can clinical tests help monitor human papillomavirus vaccine impact?

    Science.gov (United States)

    Meites, Elissa; Lin, Carol; Unger, Elizabeth R; Steinau, Martin; Patel, Sonya; Markowitz, Lauri E; Hariri, Susan

    2013-09-01

    As immunization programs for human papillomavirus (HPV) are implemented more widely around the world, interest is increasing in measuring their impact. One early measurable impact of HPV vaccine is on the prevalence of specific HPV types in a population. In low-resource settings, a potentially attractive strategy would be to monitor HPV prevalence using clinical cervical cancer screening test results to triage specimens for HPV typing. We assessed this approach in a nationally representative population of U.S. females aged 14-59 years. Using self-collected cervico-vaginal swab specimens from 4,150 women participating in the National Health and Nutrition Examination Survey during 2003-2006, we evaluated type-specific HPV prevalence detected by the Roche linear array (LA) research test on all specimens, compared with type-specific HPV prevalence detected by LA conducted only on specimens positive by the digene hybrid capture 2 (HC-2) clinical test. We calculated weighted prevalence estimates and their 95% confidence intervals (CIs), and examined relative type-specific HPV prevalence according to the two testing approaches. The population prevalence of oncogenic HPV vaccine types 16/18 was 6.2% (CI:5.4-7.1) by LA if all specimens were tested, and 2.4% (CI:1.9-3.0) if restricted to positive HC-2. Relative prevalence of individual HPV types was similar for both approaches. Compared with typing all specimens, a triage approach would require testing fewer specimens, but a greater reduction in HPV prevalence or a larger group of specimens would be needed to detect vaccine impact. Further investigation is warranted to inform type-specific HPV monitoring approaches around the world.

  15. Genetic modification of preimplantation embryos: toward adequate human research policies.

    Science.gov (United States)

    Dresser, Rebecca

    2004-01-01

    Citing advances in transgenic animal research and setbacks in human trials of somatic cell genetic interventions, some scientists and others want to begin planning for research involving the genetic modification of human embryos. Because this form of genetic modification could affect later-born children and their offspring, the protection of human subjects should be a priority in decisions about whether to proceed with such research. Yet because of gaps in existing federal policies, embryo modification proposals might not receive adequate scientific and ethical scrutiny. This article describes current policy shortcomings and recommends policy actions designed to ensure that the investigational genetic modification of embryos meets accepted standards for research on human subjects.

  16. Toward an Ontology-Based Framework for Clinical Research Databases

    Science.gov (United States)

    Kong, Y. Megan; Dahlke, Carl; Xiang, Qun; Qian, Yu; Karp, David; Scheuermann, Richard H.

    2010-01-01

    Clinical research includes a wide range of study designs from focused observational studies to complex interventional studies with multiple study arms, treatment and assessment events, and specimen procurement procedures. Participant characteristics from case report forms need to be integrated with molecular characteristics from mechanistic experiments on procured specimens. In order to capture and manage this diverse array of data, we have developed the Ontology-Based eXtensible conceptual model (OBX) to serve as a framework for clinical research data in the Immunology Database and Analysis Portal (ImmPort). By designing OBX around the logical structure of the Basic Formal Ontology (BFO) and the Ontology for Biomedical Investigations (OBI), we have found that a relatively simple conceptual model can represent the relatively complex domain of clinical research. In addition, the common framework provided by BFO makes it straightforward to develop data dictionaries based on reference and application ontologies from the OBO Foundry. PMID:20460173

  17. Clinical cancer research: the past, present and the future.

    Science.gov (United States)

    DeVita, Vincent T; Eggermont, Alexander M M; Hellman, Samuel; Kerr, David J

    2014-11-01

    In the past decade, we have witnessed unprecedented changes and some remarkable advances that have enabled true personalized medicine. Nevertheless, many challenges in clinical cancer research remain and need to be overcome if we are to witness similar progress in the next decade. Such hurdles include, but are not limited to, clinical development and testing of multiple agents in combination, design of clinical trials to best accommodate the ever increasing knowledge of heterogeneity of the disease, regulatory challenges relating to drug development and trial design, and funding for basic research. With this in mind, we asked four leading cancer researchers from around the world, and who have been associated with the journal since its launch in November 2004 what, in their opinion, we have learnt over the past 10 years and how we should progress in the next 10 years.

  18. [Conflicts of interests in clinical research in primary health care].

    Science.gov (United States)

    González-de Paz, L; Navarro-Rubio, M D; Sisó-Almirall, A

    2014-03-01

    Conflicts of interests between professionals and patients in biomedical research, is an ethical problem. None of the laws in Spain mention whether the clinical researcher has to clarify to participants the reasons why it proposes them to participate in a clinical trial. In this article, conflicts of interests in research are discussed in the context of primary healthcare. In this area conflicts of interests might alter the confidence between patients and healthcare professionals. Finally, we suggest some practical strategies that can help participants make the decision to participate in a clinical trial more willingly and freely. Copyright © 2013 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

  19. Artificial Sight Basic Research, Biomedical Engineering, and Clinical Advances

    CERN Document Server

    Humayun, Mark S; Chader, Gerald; Greenbaum, Elias

    2008-01-01

    Artificial sight is a frontier area of modern ophthalmology combining the multidisciplinary skills of surgical ophthalmology, biomedical engineering, biological physics, and psychophysical testing. Many scientific, engineering, and surgical challenges must be surmounted before widespread practical applications can be realized. The goal of Artificial Sight is to summarize the state-of-the-art research in this exciting area, and to describe some of the current approaches and initiatives that may help patients in a clinical setting. The Editors are active researchers in the fields of artificial sight, biomedical engineering and biological physics. They have received numerous professional awards and recognition for their work. The artificial sight team at the Doheny Eye Institute, led by Dr. Mark Humayun, is a world leader in this area of biomedical engineering and clinical research. Key Features Introduces and assesses the state of the art for a broad audience of biomedical engineers, biophysicists, and clinical...

  20. Global and cultural perinatal nursing research: improving clinical practice.

    Science.gov (United States)

    Callister, Lynn Clark

    2011-01-01

    High-quality perinatal nursing care should be based on the best evidence including research findings, clinical expertise, and the preferences of women and their families. Principles of perinatal research initiatives are defined, with suggested research priorities designed to close current gaps in the micro and macro environments of perinatal nursing throughout the world. Nearly a decade ago, the following question was asked, "Where is the 'E' (evidence) in maternal child health?" Improving the quality and safety of perinatal nursing care for culturally diverse women globally is the primary goal of nurse researchers leading the future of perinatal healthcare.

  1. Integrating historical clinical and financial data for pharmacological research

    OpenAIRE

    Deshmukh Vikrant G; Sower N Brett; Hunter Cheri Y; Mitchell Joyce A

    2011-01-01

    Abstract Background Retrospective research requires longitudinal data, and repositories derived from electronic health records (EHR) can be sources of such data. With Health Information Technology for Economic and Clinical Health (HITECH) Act meaningful use provisions, many institutions are expected to adopt EHRs, but may be left with large amounts of financial and historical clinical data, which can differ significantly from data obtained from newer systems, due to lack or inconsistent use o...

  2. Closing the Gap between Research Evidence and Clinical Practice: Jordanian Nurses' Perceived Barriers to Research Utilisation

    Science.gov (United States)

    Al Khalaileh, Murad; Al Qadire, Mohammad; Musa, Ahmad S.; Al-Khawaldeh, Omar A.; Al Qudah, Hani; Alhabahbeh, Atalla

    2016-01-01

    Background: The nursing profession is a combination of theory and practical skill, and nurses are required to generate and develop knowledge through implementing research into clinical practice. Considerable number of barriers could hind implementing research findings into practice. Barriers to research utilisation are not identified in the…

  3. Isolation, cryopreservation and culture of human amnion epithelial cells for clinical applications.

    Science.gov (United States)

    Murphy, Sean V; Kidyoor, Amritha; Reid, Tanya; Atala, Anthony; Wallace, Euan M; Lim, Rebecca

    2014-12-21

    Human amnion epithelial cells (hAECs) derived from term or pre-term amnion membranes have attracted attention from researchers and clinicians as a potential source of cells for regenerative medicine. The reason for this interest is evidence that these cells have highly multipotent differentiation ability, low immunogenicity, and anti-inflammatory functions. These properties have prompted researchers to investigate the potential of hAECs to be used to treat a variety of diseases and disorders in pre-clinical animal studies with much success. hAECs have found widespread application for the treatment of a range of diseases and disorders. Potential clinical applications of hAECs include the treatment of stroke, multiple sclerosis, liver disease, diabetes and chronic and acute lung diseases. Progressing from pre-clinical animal studies into clinical trials requires a higher standard of quality control and safety for cell therapy products. For safety and quality control considerations, it is preferred that cell isolation protocols use animal product-free reagents. We have developed protocols to allow researchers to isolate, cryopreserve and culture hAECs using animal product-free reagents. The advantage of this method is that these cells can be isolated, characterized, cryopreserved and cultured without the risk of delivering potentially harmful animal pathogens to humans, while maintaining suitable cell yields, viabilities and growth potential. For researchers moving from pre-clinical animal studies to clinical trials, these methodologies will greatly accelerate regulatory approval, decrease risks and improve the quality of their therapeutic cell population.

  4. Nursing students learning to utilize nursing research in clinical practice.

    Science.gov (United States)

    Mattila, Lea-Riitta; Eriksson, Elina

    2007-08-01

    The purpose of the study was to examine the significance of a learning assignment in relation to research skills and learning of nursing students in clinical practice. The learning assignment included an oral presentation of a nursing research article, which the students gave to their fellow students and ward nurses. The students also chaired the discussion after the presentation. The target group for the study was nursing students of a Finnish polytechnic who had been studying for 2-2 1/2 years and had accomplished a minimum of 120 ECTS credits of the total of 210 ECTS credits. When participating in the study, the students were completing a six-week clinical practice of optional studies. The data were collected with a questionnaire designed for the study. It consisted of six open-ended questions. Three of the questions were related to learning of research skills. Two questions were concerned with learning during the ongoing clinical practice. The final question inquired the students' views on the development of the learning assignment. The students received the questionnaire before the commencement of their clinical practice, and they returned it to the other researcher after their clinical practice. The questionnaire was given to 80 students, of which 50 returned it; the response rate was 63%. The data were analysed by content analysis question by question. According to the results, the learning assignment advanced the understanding of research concepts for the majority of the students. In particular, the students reported that the oral presentation clarified the research concepts, and the structure of a scientific article was also elucidated. The students stated that the assignment generated ideas concerning the development of nursing care. In relation to the ongoing clinical practice, the assignment advanced patient encounters and interaction, and bearing responsibility the most. Proposals for the further development of the learning assignment were expressed by

  5. Human Nutrition Research Conducted at State Agricultural Experiment Stations and 1890/Tuskegee Agricultural Research Programs.

    Science.gov (United States)

    Driskell, Judy A.; Myers, John R.

    1989-01-01

    Cooperative State Research Service-administered and state-appropriated State Agriculture Experiment Station funds for human nutrition research increased about two-fold from FY70-FY86, while the percentage of budget expended for this research decreased. (JOW)

  6. Human Nutrition Research Conducted at State Agricultural Experiment Stations and 1890/Tuskegee Agricultural Research Programs.

    Science.gov (United States)

    Driskell, Judy A.; Myers, John R.

    1989-01-01

    Cooperative State Research Service-administered and state-appropriated State Agriculture Experiment Station funds for human nutrition research increased about two-fold from FY70-FY86, while the percentage of budget expended for this research decreased. (JOW)

  7. The NASA Human Research Wiki - An Online Collaboration Tool

    Science.gov (United States)

    Barr, Yael; Rasbury, Jack; Johnson, Jordan; Barstend, Kristina; Saile, Lynn; Watkins, Sharmi

    2012-01-01

    The Exploration Medical Capability (ExMC) element is one of six elements of the Human Research Program (HRP). ExMC is charged with decreasing the risk of: "Inability to adequately recognize or treat an ill or injured crew member" for exploration-class missions In preparation for exploration-class missions, ExMC has compiled a large evidence base, previously available only to persons within the NASA community. ExMC has developed the "NASA Human Research Wiki" in an effort to make the ExMC information available to the general public and increase collaboration within and outside of NASA. The ExMC evidence base is comprised of several types of data, including: (1)Information on more than 80 medical conditions which could occur during space flight (a)Derived from several sources (b)Including data on incidence and potential outcomes, as captured in the Integrated Medical Model s (IMM) Clinical Finding Forms (CliFFs). (2)Approximately 25 gap reports (a)Identify any "gaps" in knowledge and/or technology that would need to be addressed in order to provide adequate medical support for these novel missions.

  8. Veterinary clinical research database for homeopathy: placebo-controlled trials.

    Science.gov (United States)

    Clausen, J; Albrecht, H; Mathie, R T

    2013-04-01

    Veterinary homeopathy has led a somewhat shadowy existence since its first introduction. Only in the last three decades has the number of clinical trials increased considerably. This literature is generally not well perceived, which may be partly a consequence of the diffuse and somewhat inaccessible nature of some of the relevant research publications. The Veterinary Clinical Research Database for Homeopathy (VetCR) was launched in 2006 to provide information on existing clinical research in veterinary homeopathy and to facilitate the preparation of systematic reviews. The aim of the present report is to provide an overview of this first database on clinical research in veterinary homeopathy, with a special focus on its content of placebo controlled clinical trials and summarising what is known about placebo effects in animals. In April 2012, the VetCR database contained 302 data records. Among these, 203 controlled trials were identified: 146 randomised and 57 non-randomised. In 97 of those 203 trials, the homeopathic medical intervention was compared to placebo. A program of formal systematic reviews of peer-reviewed randomised controlled trials in veterinary homeopathy is now underway; detailed findings from the program's data extraction and appraisal approach, including the assessment of trial quality (risk of bias), will be reported in due course. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. MOLECULAR ANALYSIS OF HUMAN SPERMATOZOA: POTENTIAL FOR INFERTILITY RESEARCH

    Science.gov (United States)

    Gordon Research Conference: Mammalian Gametogenesis and Embryogenesis New London, CT, July 1-6, 2000Molecular Analysis of Human Spermatozoa: Potential for Infertility ResearchDavid Miller 1, David Dix2, Robert Reid 3, Stephen A Krawetz 3 1Reproductive ...

  10. MOLECULAR ANALYSIS OF HUMAN SPERMATOZOA: POTENTIAL FOR INFERTILITY RESEARCH

    Science.gov (United States)

    Gordon Research Conference: Mammalian Gametogenesis and Embryogenesis New London, CT, July 1-6, 2000Molecular Analysis of Human Spermatozoa: Potential for Infertility ResearchDavid Miller 1, David Dix2, Robert Reid 3, Stephen A Krawetz 3 1Reproductive ...

  11. Regulatory environment for clinical research: Recent past and expected future

    Science.gov (United States)

    Bhave, Amita; Menon, Suresh

    2017-01-01

    In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest.

  12. Realization of results of innovational research in clinical oncological

    Directory of Open Access Journals (Sweden)

    A. D. Kaprin

    2015-01-01

    Full Text Available We present a brief overview of major innovative scientific research conducted at the research oncological Institute n. a. P. A. Herzen over the last decade, and the results of their the introduction into clinical practice. On the basis of 36 patents of the for the invention in Russian Federation we developed new medical technologies for diagnosis, treatment and rehabilitation of cancer patients, permission for clinical use in the territory of the Russian Federation issued by the Federal service on surveillance in healthcare and social development.

  13. Research on Human-Robot Joint System for Lunar Exploration

    Science.gov (United States)

    Zhang, Wei

    The lunar exploration in China is in progress. In order to reduce human workload and costs, and conduct researches more effectively and efficiently, human-robot joint systems are necessary for lunar exploration. The concept of human-robot joint system for lunar exploration is studied in this paper. The possible collaborative ways between human and robots and the collaborative activities which can be conducted for lunar exploration are discussed. Moreover, the preliminary configuration of a human-robot joint system is presented.

  14. India's growing clinical research sector: opportunity for global companies.

    Science.gov (United States)

    Varawalla, Nermeen

    2007-06-01

    Backed by a compelling foundation of essential requirements necessary for effective clinical trial conduct, and aided by initiatives that address concerns of data quality, regulatory timelines and IP protection, the clinical development sector in India has experienced annual revenue growth rates of 25% in the past two to three years, and is poised to participate substantially in global drug development. As both clinical trial sponsors and CROs increase their research capabilities in India, the clinical development sector is facing challenges with staff resourcing and facilities. Existing initiatives in the clinical sector must continue, and further investment must be made by stakeholders to overcome the current limitations in sector growth. Furthermore, global organizations seeking to derive long-term sustainable revenue growth and competitive advantage in the global marketplace from their business units in India must establish an appropriate organizational culture and an effective intra-organizational and industry interface for their operations.

  15. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

    Science.gov (United States)

    Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy

    2014-07-01

    The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs.

  16. Biobanking informatics infrastructure to support clinical and translational research.

    Science.gov (United States)

    Lasalle, Bernie; Varner, Michael; Botkin, Jeff; Jackson, Marc; Stark, Louisa; Cessna, Melissa; Orthner, Carolyn; Hulse, Nathan; Bernasconi, Aldo; Madsen, Randy; Schultz, Dustin; Bradshaw, Richard; Mitchell, Joyce

    2013-01-01

    The University of Utah Health Sciences (UUHSC) and Intermountain Healthcare (IH) support high value clinical and translational research programs. The Utah Biohealth Initiative will facilitate next generation research by leveraging the combined resources of both institutions through an infrastructure which links biospecimens and electronic health records (EHR). During phase I of the Utah BioHealth Initiative (UBI) the participating institutions developed a legal, regulatory and information technology infrastructure that supports clinical and translational research, and advances our understanding of health and disease, improves healthcare value and health for current and future generations of Utahns. We used the Federated Utah Research and Translational Health electronic Repository (FURTHeR) 1 to combine EHR and biospecimen data from an actual study populated by both institutions to demonstrate the robustness of the infrastructure.

  17. Key Points of Ethics Review on the Clinical Research Involving in Human Biomaterials and Genetic Data%利用人的生物样本和遗传信息研究的伦理审查要点∗

    Institute of Scientific and Technical Information of China (English)

    黄瑾; 林云; 段露清

    2016-01-01

    涉及人的生物样本和遗传信息的研究在精准医学的推动下越来越重要,但由于生物样本和遗传信息的特殊性,保护不力,会影响捐赠者的利益和权利,其伦理审查方式引起极大关注。结合国际伦理审查准则和具体实践,对生物样本和遗传信息中知情同意的特点和伦理审查要点进行了论述,认为尊重受试者权益和福祉始终应放在伦理审查的首位;伦理委员会应该对特殊情况下免知情同意书做出谨慎审查,充分权衡受试者的风险和试验的负担。%With the promotion of the precision medicine, clinical research involving in biological sample and genetic data is becoming more and more important. However, due to the specificity of biological samples and the genetic information, these cannot be well protected, which will affect the donor's interests and rights, the ethical re-view caused broad concerns. Combined with the international ethical standards and practice, this paper discussed the characteristics of informed consent and ethical review key points in the biological samples and genetic informa-tion. It suggested that respecting for the donors' interests and welfare should be put in the first place of ethical re-view. Ethics review board should review the exemption of informed consent carefully in the specific situations and balance the risk of the objects and the burden of the research fully.

  18. Space Human Factors: Research to Application

    Science.gov (United States)

    Woolford, Barbara

    2008-01-01

    Human Factors has been instrumental in preventing potential on-orbit hazards and increasing overall crew safety. Poor performance & operational learning curves on-orbit are mitigated. Human-centered design is applied to optimize design and minimize potentially hazardous conditions, especially with larger crew sizes and habitat constraints. Lunar and Mars requirements and design developments are enhanced, based on ISS Lessons Learned.

  19. HOSPITAL MANAGEMENT AND THE CREATION OF VALUE THROUGH CLINICAL RESEARCH

    Directory of Open Access Journals (Sweden)

    Arribas Fontaneda J

    2014-01-01

    Full Text Available Healthcare research should have a bearing on good clinical practice, but to measure the impact of knowledge generation on the quality of life of society has been shown to be a complex process to approach. This article attempts to analyse the effect that research activity has on patient satisfaction in a Spanish public hospital. It also opens the door for further studies that associate knowledge generation with the specific performance indicators of this type of organisation.

  20. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis.

    Science.gov (United States)

    Ross, Joseph S

    2016-09-20

    The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process.

  1. Anaerococcus nagyae sp. nov., isolated from human clinical specimens

    NARCIS (Netherlands)

    Veloo, A C M; Vries , de E. D.; Jean-Pierre, H; van Winkelhoff, A J

    We describe a new Anaerococcus species isolated from human clinical specimens. Analyses of 16S rRNA gene sequences of three strains showed <98% similarity with its closest relative Anaerococcus octavius. Phylogenetically the isolated strains form a cluster and can be differentiated from other

  2. Anal human papillomavirus DNA in women at a colposcopy clinic.

    NARCIS (Netherlands)

    Hauwers, K.W.M. d'

    2012-01-01

    OBJECTIVES: To describe the type-specific prevalence of anal and cervical human papillomavirus (HPV) infections and the cytology in HIV-negative women without a history of cervical cancer, attending a colposcopy clinic. To examine if an HPV positive anal smear is related to anal pathology and

  3. Anal human papillomavirus DNA in women at a colposcopy clinic.

    NARCIS (Netherlands)

    Hauwers, K.W.M. d'

    2012-01-01

    OBJECTIVES: To describe the type-specific prevalence of anal and cervical human papillomavirus (HPV) infections and the cytology in HIV-negative women without a history of cervical cancer, attending a colposcopy clinic. To examine if an HPV positive anal smear is related to anal pathology and conseq

  4. Anaerococcus degenerii sp nov., isolated from human clinical specimens

    NARCIS (Netherlands)

    Veloo, A. C. M.; Elgersma, P. E.; van Winkelhoff, A. J.

    Four clinical isolates of gram-positive strict anaerobic cocci were isolated from four different human mixed anaerobic infections. The taxonomical status of the four strains could not be established using standard identification techniques. The biochemical features of the strains were established

  5. Bulls and bears: the stock market and clinical pathology research.

    Science.gov (United States)

    Khong, T Y

    2009-09-01

    To analyse the level of funded research in clinical pathology in a recent bear and bull market to act as a predictor for future funding during the current global financial crisis. The level of funding for research published in three clinical pathology journals in 2005 and 2008 to coincide with the bear market of March 2000 to October 2002 and with the subsequent bull market to October 2007 was determined using a Medline query. Other parameters examined were the type of article, affiliation of the first author and the pathology subspecialty. Approximately 30% of publications were funded and did not differ between the 2 years studied. Original research papers were more likely to be funded than case reports or reviews. Research from university departments of pathology was more likely to be funded than from hospital pathology departments but there were more publications from hospital pathology departments. The proportion of research in the different subspecialties that was funded did not differ significantly between each other and between 2005 and 2008. Based on data from the previous bear market, which was the longest and deepest of the post 1950 era, and the subsequent bull market, which led to the all-time high in the Dow Jones Industrial Index, funding for clinical pathology research does not seem to be affected by bull or bear markets.

  6. Confounding Effect in Clinical Research of Otolaryngology and Its Control.

    Science.gov (United States)

    Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming

    2015-06-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect.

  7. 76 FR 58023 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-09-19

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Initial Review Group; Genome Research Review... Review, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20892,...

  8. 76 FR 28056 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2011-05-13

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Initial Review Group, Genome Research Review... Scientific Review, National Human Genome Research Institute, National Institutes of Health, Bethesda,...

  9. 77 FR 28888 - National Human Genome Research Institute Notice of Closed Meeting

    Science.gov (United States)

    2012-05-16

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute Notice of Closed... of Committee: National Human Genome Research Institute Initial Review Group; Genome Research Review... applications. Place: National Human Genome Research Institute, 3635 Fishers Lane, Suite 4076, ] Rockville,...

  10. Climate change, human health, and biomedical research: analysis of the National Institutes of Health research portfolio.

    Science.gov (United States)

    Jessup, Christine M; Balbus, John M; Christian, Carole; Haque, Ehsanul; Howe, Sally E; Newton, Sheila A; Reid, Britt C; Roberts, Luci; Wilhelm, Erin; Rosenthal, Joshua P

    2013-04-01

    According to a wide variety of analyses and projections, the potential effects of global climate change on human health are large and diverse. The U.S. National Institutes of Health (NIH), through its basic, clinical, and population research portfolio of grants, has been increasing efforts to understand how the complex interrelationships among humans, ecosystems, climate, climate variability, and climate change affect domestic and global health. In this commentary we present a systematic review and categorization of the fiscal year (FY) 2008 NIH climate and health research portfolio. A list of candidate climate and health projects funded from FY 2008 budget appropriations were identified and characterized based on their relevance to climate change and health and based on climate pathway, health impact, study type, and objective. This analysis identified seven FY 2008 projects focused on climate change, 85 climate-related projects, and 706 projects that focused on disease areas associated with climate change but did not study those associations. Of the nearly 53,000 awards that NIH made in 2008, approximately 0.17% focused on or were related to climate. Given the nature and scale of the potential effects of climate change on human health and the degree of uncertainty that we have about these effects, we think that it is helpful for the NIH to engage in open discussions with science and policy communities about government-wide needs and opportunities in climate and health, and about how NIH's strengths in human health research can contribute to understanding the health implications of global climate change. This internal review has been used to inform more recent initiatives by the NIH in climate and health.

  11. Hard paternalism, fairness and clinical research: why not?

    Science.gov (United States)

    Edwards, Sarah J L; Wilson, James

    2012-02-01

    Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons. First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for regulators to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize.

  12. Limitations and sources of bias in clinical knee cartilage research.

    Science.gov (United States)

    Worthen, Jamie; Waterman, Brian R; Davidson, Philip A; Lubowitz, James H

    2012-09-01

    The purpose of this study was to systematically review the limitations and biases inherent to surgical trials on the management of knee chondral defects. A literature search of PubMed/Medline, CINAHL (Cumulative Index to Nursing and Allied Health Literature), EMBASE, and the Cochrane Central Register of Controlled Trials was conducted in September 2010 and updated in August 2011 to identify all English-language, Level I evidence, prospective, randomized controlled trials published from 1996 to present. The keyword search included the following: "autologous chondrocyte," "cartilage graft," "cartilage repair," "chondroplasty," "microfracture," "mosaicplasty," and/or "osteochondral." Nonoperative studies, nonhuman studies, ex vivo studies, non-knee studies, and/or studies with follow-up of less than 1 year were excluded. A systematic review was performed on all included studies, and limitations and/or biases were identified and quantitated. Of 15,311 citations, 33 abstracts were reviewed and 11 prospective, randomized controlled trials were included. We identified 9 major limitations (subject age, subject prior surgery, subject duration of symptoms, lesion location, lesion size, lesion number, procedure selection, procedure standardization, and limited histologic analysis) and 7 common biases (selection, performance, transfer, nonresponder, detection, publication, and study design). Level I therapeutic studies investigating the surgical management of human knee cartilage defects have substantial identified biases and limitations. This review has limitations because other classifications of bias or limitation exist. Optimal management of cartilage defects is controversial, and future rigorous research methods could minimize common biases through strict study design and patient selection criteria, larger patient enrollment, more extended follow-up, and standardization of clinical treatment pathways. Level I, systematic review of Level I studies. Copyright © 2012

  13. Reimagining Human Research Protections for 21st Century Science

    Science.gov (United States)

    Bietz, Matthew; Bae, Deborah; Bigby, Barbara; Devereaux, Mary; Fowler, James; Waldo, Ann; Weibel, Nadir; Patrick, Kevin; Klemmer, Scott; Melichar, Lori

    2016-01-01

    Background Evolving research practices and new forms of research enabled by technological advances require a redesigned research oversight system that respects and protects human research participants. Objective Our objective was to generate creative ideas for redesigning our current human research oversight system. Methods A total of 11 researchers and institutional review board (IRB) professionals participated in a January 2015 design thinking workshop to develop ideas for redesigning the IRB system. Results Ideas in 5 major domains were generated. The areas of focus were (1) improving the consent form and process, (2) empowering researchers to protect their participants, (3) creating a system to learn from mistakes, (4) improving IRB efficiency, and (5) facilitating review of research that leverages technological advances. Conclusions We describe the impetus for and results of a design thinking workshop to reimagine a human research protections system that is responsive to 21st century science. PMID:28007687

  14. Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

    Directory of Open Access Journals (Sweden)

    Elisabeth De Smit

    2016-02-01

    Full Text Available Background Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. Aims To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs and Research Governance Offices (RGOs across Australia. Methods In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA, for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Results Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a “National Ethics Application Form” and three a “Low Negligible Risk” form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22 and panel review turnaround time (range nine to 136 days. Conclusion We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently

  15. 59th Medical Wing Clinical Research Division Clinical Investigations Program Posters (Count: 2)

    Science.gov (United States)

    2017-05-08

    publication, the 59th Clinical Research Division may pay for your basic journal publishing charges (to include costs for tables and black and white photos...Health Sciences Education (GHSE) {SGS O&M); SGS R&D; Tri-Service Nursing Research Program (TSNRP): Defense Medical Research & Development Program (DMRDP...should be accomplished no later than 30 days before final clearance is required to publish/present your materials. If you have any questions or

  16. PARTAKE survey of public knowledge and perceptions of clinical research in India.

    Directory of Open Access Journals (Sweden)

    Tal Burt

    Full Text Available BACKGROUND: A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE - Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program. OBJECTIVE: To study public knowledge and perceptions of clinical research. METHODS: A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India. RESULTS: Interviewees were 18-84 old (mean: 39.6, SD ± 16.6, 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware: 'research benefits society' (94.1%/3.5%/2.3%, 'the government protects against unethical clinical research' (56.7%/26.3%/16.9%, 'research hospitals provide better care' (67.2%/8.7%/23.9%, 'confidentiality is adequately protected' (54.1%/12.3%/33.5%, 'participation in research is voluntary' (85.3%/5.8%/8.7%; 'participants treated like 'guinea pigs'' (20.7%/53.2%/26.0%, and 'compensation for participation is adequate' (24.7%/12.9%/62.3%. CONCLUSIONS: Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation, and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross

  17. Clinical research and industrial sponsoring: avenues towards transparency and credibility.

    Science.gov (United States)

    Hildebrandt, M; Ludwig, W-D

    2003-12-01

    Clinical research is intended to serve the patient, in the pursuit of a deepened understanding of physiological interactions and their changes in disease, and of potentially beneficial implications for the patient. The impetus to perform clinical research is shaped by various intentions, such as the desire to provide cure or relief, striving for personal and professional success, public attention, financial considerations, or simply scientific curiosity. A similarly wide range of diverging interests must be assumed to impinge on diagnostic and therapeutic decisions in clinical work. How are we to perform clinical research and therapy with the patients' benefit in mind, in view of such a complex motivational status, and how are we to perceive the peculiar interests of those influencing clinical work, including ourselves? In this review, we attempt to elucidate the complex pathways of interaction between physicians and industrial sponsors. Special attention will be paid to the following topics: the pharmaceutical market, public interests, legal and ethical issues, conflicts of interest, and the potential impact of industry-sponsored drug trials on medical information and subsequent therapeutic decisions. We will conclude with recommendations for an acceptable position in the tension between cooperation and corruptibility, a position that grants priority to the patient's needs rather than third party interests. Copyright 2003 S. Karger GmbH, Freiburg

  18. The UK clinical research network - has it been a success for dermatology clinical trials?

    Directory of Open Access Journals (Sweden)

    Charlesworth Lisa

    2011-06-01

    Full Text Available Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS. Methods This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. Results In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Conclusions Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales, and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

  19. Close range photogrammetry--a clinical dental research tool.

    Science.gov (United States)

    Chadwick, R G

    1992-08-01

    Photogrammetry is the art, science and technology of obtaining reliable information about physical objects through processes of recording and interpreting photographic images. This review outlines the principles of the technique and summarizes the various methodologies and applications in clinical dental research.

  20. Biospecimen Core Resource - Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The purpose of this notice is to notify the community that the National Cancer Institute's (NCI’s) Office of Cancer Clinical Proteomics Research (OCCPR) is seeking sources to establish a Biospecimen Core Resource (BCR), capable of receiving, qualifying, processing, and distributing annotated biospecimens.

  1. Tumor Cold Ischemia - Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    In a recently published manuscript in the journal of Molecular and Cellular Proteomics, researchers from the National Cancer Institutes (NCI) Clinical Proteomic Tumor Analysis Consortium (CPTAC) investigated the effect of cold ischemia on the proteome of fresh frozen tumors.

  2. The integration of similar clinical research data collection instruments.

    Science.gov (United States)

    Cohen, Dorothy B; Frawley, Sandra J; Shifman, Mark A; Miller, Perry L; Brandt, Cynthia

    2003-01-01

    We devised an algorithm for integrating similar clinical research data collection instruments to create a common measurement instrument. We tested this algorithm using questions from several similar surveys. We encountered differing levels of granularity among questions and responses across surveys resulting in either the loss of granularity or data. This algorithm may make survey integration more systematic and efficient.

  3. Patient involvement in clinical research: why, when, and how

    Directory of Open Access Journals (Sweden)

    Sacristán JA

    2016-04-01

    Full Text Available José A Sacristán,1 Alfonso Aguarón,2 Cristina Avendaño-Solá,3 Pilar Garrido,4 Juan Carrión,5 Alipio Gutiérrez,6 Robert Kroes,7 Angeles Flores11Medical Department, Lilly Spain, 2Myeloma Patients Europe, 3Research Ethics Committee, University Hospital Puerta de Hierro, 4Oncology Department, Hospital Ramón y Cajal, 5FEDER (Spanish Federation for Rare Diseases, 6National Association of Health Journalists, Madrid, Spain; 7Clinical Open Innovation, Lilly Europe, Amsterdam, the Netherlands Abstract: The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1 setting priorities, 2 study leadership and design, 3 improved access to clinical trials, 4 preparation and oversight of the information provided to participants, 5 post-study evaluation of the patient experience, and 6 the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient.Keywords: patients, research, clinical trials, bioethics, engagement

  4. Religion, spirituality and cardiovascular disease: research, clinical implications, and opportunities in Brazil.

    Science.gov (United States)

    Lucchese, Fernando A; Koenig, Harold G

    2013-03-01

    In this paper we comprehensively review published quantitative research on the relationship between religion, spirituality (R/S), and cardiovascular (CV) disease, discuss mechanisms that help explain the associations reported, examine the clinical implications of those findings, and explore future research needed in Brazil on this topic. First, we define the terms religion, spirituality, and secular humanism. Next, we review research examining the relationships between R/S and CV risk factors (smoking, alcohol/drug use, physical inactivity, poor diet, cholesterol, obesity, diabetes, blood pressure, and psychosocial stress). We then review research on R/S, cardiovascular functions (CV reactivity, heart rate variability, etc.), and inflammatory markers (IL-6, IFN-γ, CRP, fibrinogen, IL-4, IL-10). Next we examine research on R/S and coronary artery disease, hypertension, stroke, dementia, cardiac surgery outcomes, and mortality (CV mortality in particular). We then discuss mechanisms that help explain these relationships (focusing on psychological, social, and behavioral pathways) and present a theoretical causal model based on a Western religious perspective. Next we discuss the clinical applications of the research, and make practical suggestions on how cardiologists and cardiac surgeons can sensitively and sensibly address spiritual issues in clinical practice. Finally, we explore opportunities for future research. No research on R/S and cardiovascular disease has yet been published from Brazil, despite the tremendous interest and involvement of the population in R/S, making this an area of almost unlimited possibilities for researchers in Brazil.

  5. Human reporter genes: potential use in clinical studies

    Energy Technology Data Exchange (ETDEWEB)

    Serganova, Inna [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Ponomarev, Vladimir [Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Blasberg, Ronald [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States)], E-mail: blasberg@neuro1.mskcc.org

    2007-10-15

    The clinical application of positron-emission-tomography-based reporter gene imaging will expand over the next several years. The translation of reporter gene imaging technology into clinical applications is the focus of this review, with emphasis on the development and use of human reporter genes. Human reporter genes will play an increasingly more important role in this development, and it is likely that one or more reporter systems (human gene and complimentary radiopharmaceutical) will take leading roles. Three classes of human reporter genes are discussed and compared: receptors, transporters and enzymes. Examples of highly expressed cell membrane receptors include specific membrane somatostatin receptors (hSSTrs). The transporter group includes the sodium iodide symporter (hNIS) and the norepinephrine transporter (hNET). The endogenous enzyme classification includes human mitochondrial thymidine kinase 2 (hTK2). In addition, we also discuss the nonhuman dopamine 2 receptor and two viral reporter genes, the wild-type herpes simplex virus 1 thymidine kinase (HSV1-tk) gene and the HSV1-tk mutant (HSV1-sr39tk). Initial applications of reporter gene imaging in patients will be developed within two different clinical disciplines: (a) gene therapy and (b) adoptive cell-based therapies. These studies will benefit from the availability of efficient human reporter systems that can provide critical monitoring information for adenoviral-based, retroviral-based and lenteviral-based gene therapies, oncolytic bacterial and viral therapies, and adoptive cell-based therapies. Translational applications of noninvasive in vivo reporter gene imaging are likely to include: (a) quantitative monitoring of gene therapy vectors for targeting and transduction efficacy in clinical protocols by imaging the location, extent and duration of transgene expression; (b) monitoring of cell trafficking, targeting, replication and activation in adoptive T-cell and stem/progenitor cell therapies

  6. Clinical Application of Neuroplastic Brain Research in Eating Disorder Treatment

    Directory of Open Access Journals (Sweden)

    Abigail H. Natenshon

    2016-12-01

    Neurophysiological and psychophysiological treatment interventions, by carving new neuronal pathways and creating connectivity that augments brain circuitry, carry the potential to remediate body image and self-image distortions, reintegrating the fragmented eating disordered core self. To date, intentional partnering between therapist, ED patient, and neuroplastic brain has been rarely applied in the clinical milieu and minimally referenced in the treatment literature. By bringing current neuroplasticity research into frontline practice, ED practitioners not only bridge the research/practice gap, but redefine new directions for future ED research.

  7. Social and behavioral research in genomic sequencing: approaches from the Clinical Sequencing Exploratory Research Consortium Outcomes and Measures Working Group.

    Science.gov (United States)

    Gray, Stacy W; Martins, Yolanda; Feuerman, Lindsay Z; Bernhardt, Barbara A; Biesecker, Barbara B; Christensen, Kurt D; Joffe, Steven; Rini, Christine; Veenstra, David; McGuire, Amy L

    2014-10-01

    The routine use of genomic sequencing in clinical medicine has the potential to dramatically alter patient care and medical outcomes. To fully understand the psychosocial and behavioral impact of sequencing integration into clinical practice, it is imperative that we identify the factors that influence sequencing-related decision making and patient outcomes. In an effort to develop a collaborative and conceptually grounded approach to studying sequencing adoption, members of the National Human Genome Research Institute's Clinical Sequencing Exploratory Research Consortium formed the Outcomes and Measures Working Group. Here we highlight the priority areas of investigation and psychosocial and behavioral outcomes identified by the Working Group. We also review some of the anticipated challenges to measurement in social and behavioral research related to genomic sequencing; opportunities for instrument development; and the importance of qualitative, quantitative, and mixed-method approaches. This work represents the early, shared efforts of multiple research teams as we strive to understand individuals' experiences with genomic sequencing. The resulting body of knowledge will guide recommendations for the optimal use of sequencing in clinical practice.

  8. Common Data Elements for Clinical Research in Friedreich Ataxia

    Science.gov (United States)

    Lynch, David R.; Pandolfo, Massimo; Schulz, Jorg B.; Perlman, Susan; Delatycki, Martin B.; Payne, R. Mark; Shaddy, Robert; Fischbeck, Kenneth H.; Farmer, Jennifer; Kantor, Paul; Raman, Subha V.; Hunegs, Lisa; Odenkirchen, Joanne; Miller, Kristy; Kaufmann, Petra

    2012-01-01

    Background To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich ataxia, a neurological disorder that involves multiple organ systems. Methods To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: Ataxia and Performance Measures; Biomarkers; Cardiac and Other Clinical Outcomes; and Demographics, Laboratory Tests and Medical History. The basic development process included: Identification of international experts in Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment. Results The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The Subgroups’ recommendations are classified as core, supplemental or exploratory. Template case report forms were created for many of the core tests. Conclusions The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia. PMID:23239403

  9. NAS Human Factors Safety Research Laboratory

    Data.gov (United States)

    Federal Laboratory Consortium — This laboratory conducts an integrated program of research on the relationship of factors concerning individuals, work groups, and organizations as employees perform...

  10. Human embryonic stem cell research: ethical and legal issues.

    Science.gov (United States)

    Robertson, J A

    2001-01-01

    The use of human embryonic stem cells to replace damaged cells and tissues promises future hope for the treatment of many diseases. However, many countries now face complex ethical and legal questions as a result of the research needed to develop these cell-replacement therapies. The challenge that must be met is how to permit research on human embryonic tissue to occur while maintaining respect for human life generally.

  11. Leaders, leadership and future primary care clinical research

    Directory of Open Access Journals (Sweden)

    Qureshi Nadeem

    2008-09-01

    Full Text Available Abstract Background A strong and self confident primary care workforce can deliver the highest quality care and outcomes equitably and cost effectively. To meet the increasing demands being made of it, primary care needs its own thriving research culture and knowledge base. Methods Review of recent developments supporting primary care clinical research. Results Primary care research has benefited from a small group of passionate leaders and significant investment in recent decades in some countries. Emerging from this has been innovation in research design and focus, although less is known of the effect on research output. Conclusion Primary care research is now well placed to lead a broad re-vitalisation of academic medicine, answering questions of relevance to practitioners, patients, communities and Government. Key areas for future primary care research leaders to focus on include exposing undergraduates early to primary care research, integrating this early exposure with doctoral and postdoctoral research career support, further expanding cross disciplinary approaches, and developing useful measures of output for future primary care research investment.

  12. Resident Research Fundamentals Course Human Research Curves in the Road

    Science.gov (United States)

    2017-09-27

    Division may pay for your basic journal publishing charges (to include costs for tables and black and white photos). We cannot pay for reprints. If you...SGS R&D: Tri-Service Nursing Research Program (TSNRP): Defense Medical Research & Development Program (DMROP): NIH; Congressionally Directed...30 days before final clearance Is required to publish/present your materials. If you have any questions or concerns. please contact the S9 CRD

  13. Psychobiology and psychopharmacology: issues in clinical research training.

    Science.gov (United States)

    Janowsky, D S; Glick, I D; Lash, L; Mitnick, L; Klein, D F; Goodwin, F K; Hanin, I; Nemeroff, C; Robins, L

    1986-02-01

    Although the scope of basic studies in psychopharmacology and psychobiology has been expanding steadily for about 30 years, relatively few clinical psychiatrists, psychologists, and psychopharmacologists now choose to become researchers or teachers in these disciplines. Such training is crucial to the future vitality of both academic and private-practice psychiatry, and in view of increasing constraints on training funds, student researchers may well be an endangered species. With these concerns in mind, at its 1984 meeting, the American College of Neuropsychopharmacology's Education and Training Committee organized a symposium of investigators, administrators, and former trainees to explore aspects of effective clinical research training in psychobiology and psychopharmacology. Aspects discussed included mentoring, settings and content of training, depth versus breadth of curriculum, and the effect of a critical mass of colleagues at various stages of professional development. Following a brief overview, selected panelists addressed the issues from their individual perspectives.

  14. Animal Models and Bone Histomorphometry: Translational Research for the Human Research Program

    Science.gov (United States)

    Sibonga, Jean D.

    2010-01-01

    This slide presentation reviews the use of animal models to research and inform bone morphology, in particular relating to human research in bone loss as a result of low gravity environments. Reasons for use of animal models as tools for human research programs include: time-efficient, cost-effective, invasive measures, and predictability as some model are predictive for drug effects.

  15. Attitudes of medical students towards human genome research and genetic counselling and testing

    Directory of Open Access Journals (Sweden)

    Schäfer, Mike Steffen

    2005-04-01

    Full Text Available Purpose: The study aimed to describe students' attitudes towards human genome research and towards genetic counselling and testing at cancer patients. The background of this investigation provided the increasing relevance ob human genetics research for clinical practice.Methods: A total of 167 medical students (54% female, aged 24 +/- 2 years from the second phase of their studies were surveyed in obligatory courses at the University of Leipzig, using a standardized questionnaire. Topics of the survey were attitudes towards human genome research and genetic counselling and testing at cancer patients as well as general values and socio-demographic data of the students.Results: The students consider human genome research as relevant and evaluate it positively, mainly based on expectations of medical uses. Genetic counselling and testing at cancer patients as an application of human genetics is also evaluated as important. The students attribute high relevance to clinical procedures for identification of genetic backgrounds for cancer (family history, information about genetic diagnostic. Nevertheless, deficits in their medical education are highlighted und reflected upon: the increased integration of human genetic content into medical curricula is demanded.Discussion: In accordance with the newly formulated „Approbationsordnung für Ärzte", the results suggest that current human genetic development should be more emphasized in medical education. This could be realized by an enlarged ratio of human genetic courses within curricula and by the transformation of these courses from facultative into obligatory.

  16. Clinical trials and contract research organizations in India.

    Science.gov (United States)

    Mukherjee, Shoibal

    2012-06-01

    Economics and demography are driving drug development to the developing world. India needs this opportunity to build research skills required to combat its enormous disease burden. A variety of global and local contract research organizations (CROs) that specialize in the execution of research to develop health care products operate in India today. CROs assure quality and compliance to regulations while coordinating with tertiary providers such as a site management organization and the central laboratory. Back room operations to manage, analyze, and report data form a bulk of the employment generated by clinical research, absorbing programmers, data managers, biostatisticians,and medical writers. Despite rapid growth and strong potential, India remains a minor contributor to global pharmaceutical research because of policy stagnation, regulatory gaps, and misinformed controversies in the media.

  17. Teaching clinical reasoning by making thinking visible: an action research project with allied health clinical educators.

    Science.gov (United States)

    Delany, Clare; Golding, Clinton

    2014-01-30

    Clinical reasoning is fundamental to all forms of professional health practice, however it is also difficult to teach and learn because it is complex, tacit, and effectively invisible for students. In this paper we present an approach for teaching clinical reasoning based on making expert thinking visible and accessible to students. Twenty-one experienced allied health clinical educators from three tertiary Australian hospitals attended up to seven action research discussion sessions, where they developed a tentative heuristic of their own clinical reasoning, trialled it with students, evaluated if it helped their students to reason clinically, and then refined it so the heuristic was targeted to developing each student's reasoning skills. Data included participants' written descriptions of the thinking routines they developed and trialed with their students and the transcribed action research discussion sessions. Content analysis was used to summarise this data and categorise themes about teaching and learning clinical reasoning. Two overriding themes emerged from participants' reports about using the 'making thinking visible approach'. The first was a specific focus by participating educators on students' understanding of the reasoning process and the second was heightened awareness of personal teaching styles and approaches to teaching clinical reasoning. We suggest that the making thinking visible approach has potential to assist educators to become more reflective about their clinical reasoning teaching and acts as a scaffold to assist them to articulate their own expert reasoning and for students to access and use.

  18. Teaching clinical reasoning by making thinking visible: an action research project with allied health clinical educators

    Science.gov (United States)

    2014-01-01

    Background Clinical reasoning is fundamental to all forms of professional health practice, however it is also difficult to teach and learn because it is complex, tacit, and effectively invisible for students. In this paper we present an approach for teaching clinical reasoning based on making expert thinking visible and accessible to students. Methods Twenty-one experienced allied health clinical educators from three tertiary Australian hospitals attended up to seven action research discussion sessions, where they developed a tentative heuristic of their own clinical reasoning, trialled it with students, evaluated if it helped their students to reason clinically, and then refined it so the heuristic was targeted to developing each student’s reasoning skills. Data included participants’ written descriptions of the thinking routines they developed and trialed with their students and the transcribed action research discussion sessions. Content analysis was used to summarise this data and categorise themes about teaching and learning clinical reasoning. Results Two overriding themes emerged from participants’ reports about using the ‘making thinking visible approach’. The first was a specific focus by participating educators on students’ understanding of the reasoning process and the second was heightened awareness of personal teaching styles and approaches to teaching clinical reasoning. Conclusions We suggest that the making thinking visible approach has potential to assist educators to become more reflective about their clinical reasoning teaching and acts as a scaffold to assist them to articulate their own expert reasoning and for students to access and use. PMID:24479414

  19. Field and laboratory methods in human milk research.

    Science.gov (United States)

    Miller, Elizabeth M; Aiello, Marco O; Fujita, Masako; Hinde, Katie; Milligan, Lauren; Quinn, E A

    2013-01-01

    Human milk is a complex and variable fluid of increasing interest to human biologists who study nutrition and health. The collection and analysis of human milk poses many practical and ethical challenges to field workers, who must balance both appropriate methodology with the needs of participating mothers and infants and logistical challenges to collection and analysis. In this review, we address various collection methods, volume measurements, and ethical considerations and make recommendations for field researchers. We also review frequently used methods for the analysis of fat, protein, sugars/lactose, and specific biomarkers in human milk. Finally, we address new technologies in human milk research, the MIRIS Human Milk Analyzer and dried milk spots, which will improve the ability of human biologists and anthropologists to study human milk in field settings.

  20. MEDES clinical research facility as a tool to prepare ISSA space flights

    Science.gov (United States)

    Maillet, A.; Traon, A. Pavy-Le

    This new multi-disciplinary medical experimentation center provides the ideal scientific, medical and technical environment required for research programs and to prepare international space station Alpha (ISSA) missions, where space and healthcare industries can share their expertise. Different models are available to simulate space flight effects (bed-rest, confinement,…). This is of particular interest for research in Human psychology, physiology, physiopathology and ergonomics, validation of biomedical materials and procedures, testing of drugs, and other healthcare related products. This clinical research facility (CRF) provides valuable services in various fields of Human research requiring healthy volunteers. CRF is widely accessible to national and international, scientific, medical and industrial organisations. Furthermore, users have at their disposal the multi-disciplinary skills of MEDES staff and all MEDES partners on a single site.

  1. Research Workshop on Expert Judgment, Human Error, and Intelligent Systems

    OpenAIRE

    Silverman, Barry G.

    1993-01-01

    This workshop brought together 20 computer scientists, psychologists, and human-computer interaction (HCI) researchers to exchange results and views on human error and judgment bias. Human error is typically studied when operators undertake actions, but judgment bias is an issue in thinking rather than acting. Both topics are generally ignored by the HCI community, which is interested in designs that eliminate human error and bias tendencies. As a result, almost no one at the workshop had met...

  2. Foresight scanning: future directions of clinical and pharmaceutical research.

    Science.gov (United States)

    Foster, Brian C

    2008-01-01

    Foresight Scanning: Future Directions of Clinical and Pharmaceutical Research. Brian C. Foster, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada ABSTRACT The Canadian Society for Pharmaceutical Sciences Satellite Symposium on Foresight Scanning, May 26 and 27, 2008, Nordegg, Alberta, Canada, focussed on the future directions of clinical and pharmaceutical research. The symposium brought together a group of clinicians, regulatory scientists, researchers and students to examine where clinical, pharmaceutical, and regulatory science might be in 10 to 15 years. Industry, regulatory, analytical, and clinical perspectives were presented and discussed, as well as the impact of exogenous (indirect) and endogenous (direct) change drivers. Unconditional funding was provided by Bayer HealthCare; they had no input on the direction of the meeting or selection of speakers. It was envisioned that the more important endogenous drivers may not be new information or changes in technology, policy, regulation, or health care delivery, but amplification of long-term underlying trends by emergence of new technologies, convergence of existing technologies or new communication and collaboration vehicles such as Web 2.0.

  3. Clinical research of traditional Chinese medicine in big data era.

    Science.gov (United States)

    Zhang, Junhua; Zhang, Boli

    2014-09-01

    With the advent of big data era, our thinking, technology and methodology are being transformed. Data-intensive scientific discovery based on big data, named "The Fourth Paradigm," has become a new paradigm of scientific research. Along with the development and application of the Internet information technology in the field of healthcare, individual health records, clinical data of diagnosis and treatment, and genomic data have been accumulated dramatically, which generates big data in medical field for clinical research and assessment. With the support of big data, the defects and weakness may be overcome in the methodology of the conventional clinical evaluation based on sampling. Our research target shifts from the "causality inference" to "correlativity analysis." This not only facilitates the evaluation of individualized treatment, disease prediction, prevention and prognosis, but also is suitable for the practice of preventive healthcare and symptom pattern differentiation for treatment in terms of traditional Chinese medicine (TCM), and for the post-marketing evaluation of Chinese patent medicines. To conduct clinical studies involved in big data in TCM domain, top level design is needed and should be performed orderly. The fundamental construction and innovation studies should be strengthened in the sections of data platform creation, data analysis technology and big-data professionals fostering and training.

  4. 重组人乳头瘤病毒疫苗临床评价研究进展%Research progress regarding the clinical evaluation on recombinant human papillomavirus vaccines

    Institute of Scientific and Technical Information of China (English)

    何文刚; 赵骏; 黄守杰; 吴婷

    2016-01-01

    HPV感染除能引起尖锐湿疣等良性病变外,还能引起宫颈等生殖器部位恶性肿瘤.目前国外已有3个HPV疫苗上市.临床试验数据表明HPV疫苗对成年年轻女性均具较好的保护性,能预防90%~100%疫苗相关型别HPV感染所致疾病.年长女性接种该疫苗的有效性虽低于成年年轻女性,但仍可受益.在未成年女性中进行的桥接试验表明,9~14岁者接种2针次HPV疫苗的免疫应答非劣效于成年女性接种3针次该疫苗.HPV疫苗能减少高度宫颈上皮内瘤变(CIN2+)患者手术后复发,对非疫苗型别HPV感染也有一定交叉保护作用.HPV疫苗的安全性已被广泛认可,可在适龄女性人群中推广使用.%Human papillomavirus (HPV) is the main cause for cervical cancer,anogenital cancers and genital warts.Three HPV vaccines have been licensed abroad.Data from clinical trials showed high efficacy of the HPV vaccines in young women with 90%-100% vaccine-related HPV diseases prevented.Though efficacy of the vaccine appears lower in older women,this population can still benefit from vaccination.Immunobriging trials show that the two-dose schedule in 9-14 years old girls elicits non-inferior immune response than the three-dose one in young adults.In addition,HPV vaccines can reduce the recurrent rates in CIN2 + patients after therapeutic surgery and the vaccines have cross-protection aganist diseases caused by non-vaccine type HPV.Safety data on HPV vaccines are assuring.Thus HPV vaccine should be widely used in adolescent girls and women of appropriate age groups.

  5. Research on automatic human chromosome image analysis

    Science.gov (United States)

    Ming, Delie; Tian, Jinwen; Liu, Jian

    2007-11-01

    Human chromosome karyotyping is one of the essential tasks in cytogenetics, especially in genetic syndrome diagnoses. In this thesis, an automatic procedure is introduced for human chromosome image analysis. According to different status of touching and overlapping chromosomes, several segmentation methods are proposed to achieve the best results. Medial axis is extracted by the middle point algorithm. Chromosome band is enhanced by the algorithm based on multiscale B-spline wavelets, extracted by average gray profile, gradient profile and shape profile, and calculated by the WDD (Weighted Density Distribution) descriptors. The multilayer classifier is used in classification. Experiment results demonstrate that the algorithms perform well.

  6. Big Data Clinical Research: Validity, Ethics, and Regulation.

    Science.gov (United States)

    Balas, E Andrew; Vernon, Marlo; Magrabi, Farah; Gordon, Lynne Thomas; Sexton, Joanne

    2015-01-01

    Electronic Health Records (EHR) promise improvement for patient care and also offer great value for biomedical research including clinical, public health, and health services research. Unfortunately, the full potential of EHR big data research has remained largely unrealized. The purpose of this study was to identify rate limiting factors, and develop recommendations to better balance unrestricted extramural EHR access with legitimate safeguarding of EHR data in retrospective research. By exploring primary, secondary, and tertiary sources, this review identifies external constraints and provides a comparative analysis of social influencers in retrospective EHR-based research. Results indicate that EHRs have the advantage of reflecting the reality of patient care but also show a frequency of between 4.3-86% of incomplete and inaccurate data in various fields. The rapid spread of alternative analytics for health data challenges traditional interpretations of confidentiality protections. A confusing multiplicity of controls creates barriers to big data EHR research. More research on the use of EHR big data is likely to improve accuracy and validity. Information governance and research approval processes should be simplified. Comprehensive regulatory policies that do not exclusively cover health care entities, are needed. Finally, new computing safeguards are needed to address public concerns, like research access only to aggregate data and not to individually identifiable information.

  7. Stem Cells: A Renaissance in Human Biology Research.

    Science.gov (United States)

    Wu, Jun; Izpisua Belmonte, Juan Carlos

    2016-06-16

    The understanding of human biology and how it relates to that of other species represents an ancient quest. Limited access to human material, particularly during early development, has restricted researchers to only scratching the surface of this inherently challenging subject. Recent technological innovations, such as single cell "omics" and human stem cell derivation, have now greatly accelerated our ability to gain insights into uniquely human biology. The opportunities afforded to delve molecularly into scarce material and to model human embryogenesis and pathophysiological processes are leading to new insights of human development and are changing our understanding of disease and choice of therapy options.

  8. Participating in Clinical Trials

    Science.gov (United States)

    ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  9. Validity of the Research Diagnostic Criteria for Temporomandibular Disorders Axis I in clinical and research settings.

    NARCIS (Netherlands)

    Steenks, M.H.; Wijer, A. de

    2009-01-01

    The lack of standardized diagnostic criteria for defining clinical subtypes of temporomandibular disorders (TMD) was the main motive to create the Research Diagnostic Criteria for TMD (RDC/TMD), which were provided to allow standardization and replication of research into the most common forms of mu

  10. Clinical research and service centre: an institutional profile and programmes.

    Science.gov (United States)

    Salam, M A

    1997-09-01

    The International Center for Diarrheal Disease Research, Bangladesh's (ICDDR,B) Clinical Research and Service Center (CRSC) provides free treatment to diarrheal patients; provides preventive health care to children and mothers; conducts clinical research upon diarrheal diseases and related aspects of nutrition; and provides training to health care providers in managing diarrheal diseases and conducting clinical and operations research. 930,860 patients were treated at CRSC during 1987-96 and more than 110,000 patients are now being treated annually at the facility. While most CRSC patients come from Dhaka city and its suburbs, some also come from remote corners of the country. About 60% of the center's patients are children under age 5 years and most patients are socioeconomically disadvantaged. For example, almost half of patients' mothers have no formal education. The CRSC, commonly known as the Cholera Hospital, is unique in that about 94% of its patients are mainly cared for by trained nurses either in the Oral Rehydration Triage or Short Stay Ward of the hospital. About 40% of patients are discharged within 1-2 hours and 60% within 12 hours. Approximately 80% of the children attending the CRSC are malnourished. Mothers are taught how to improve the nutritional status of their children, simple ways to generate income for the family, and the merits of breast feeding.

  11. Stem cell research in stroke: how far from the clinic?

    Science.gov (United States)

    Lindvall, Olle; Kokaia, Zaal

    2011-08-01

    Stem cell-based approaches hold much promise as potential novel treatments to restore function after stroke. Studies in animal models have shown that stem cell transplantation can improve function by replacing neurons or by trophic actions, modulation of inflammation, promotion of angiogenesis, remyelination and axonal plasticity, and neuroprotection. Endogenous neural stem cells are also potential therapeutic targets because they produce new neurons after stroke. Clinical trials are ongoing but there is currently no proven stem cell-based therapy for stroke. Preclinical studies and clinical research will be needed to optimize the therapeutic benefit and minimize the risks of stem cells in stroke.

  12. Auditing clinical research data: objectives, applications and results.

    Science.gov (United States)

    Justice, R L

    1983-01-01

    Formal auditing of clinical research data has become a standard contemporary practice within the pharmaceutical industry. Its basic purpose is to provide documentation relevant to an assessment of the quality and integrity of data collected in the course of a clinical trial. This paper outlines the audit procedures developed within one major pharmaceutical firm. These procedures require an intensive investigation of internal and external aspects of study management, records management, data entry, data analysis and statistical report preparation. A qualitative evaluation of the results achieved by this auditing procedure are presented.

  13. Human dignity and consent in research biobanking

    African Journals Online (AJOL)

    2012-12-02

    Dec 2, 2012 ... Research biobanking raises numerous ethical questions.1 This ... ethical and legal reflections on the notion of informed consent in ... Faculty of Theology and Philosophy, Australian Catholic University, Brisbane, Australia.

  14. Exploring the feasibility and synergistic value of the One Health approach in clinical research

    DEFF Research Database (Denmark)

    Cordoba Currea, Gloria Cristina; Sørensen, Tina Møller; Holm, Anne;

    2015-01-01

    diagnostic pathways (i.e., 16 possiblecombinations of diagnostic tools) to gold standard in human and veterinary primary care practice in Denmark.Fifty primary care practices and 100 veterinary clinics will each consecutively include 20 human patients or 8–10dogs, respectively. Data will be collected......Background: The One Health approach is emerging in response to the development of bacterial resistance. To thebest of our knowledge, the possibility to use this approach in a clinical context has not yet been explored. Thus, inthis paper, we report the procedures to implement a prospective...... observational study of diagnostic pathways in humanand canine patients with suspected urinary tract infection as a means to assess the feasibility and synergistic value ofsetting up One Health clinical research projects and interventions. Methods/design: A prospective observational study will compare different...

  15. The ethics of cloning and human embryo research.

    Science.gov (United States)

    Saran, Madeleine

    2002-01-01

    The successful cloning experiments that led to Dolly in 1997 have raised many ethical and policy questions. This paper will focus on cloning research in human embryonic cells. The possible gains of the research will be judged against the moral issues of doing research on a person. This paper concludes that while the embryo has some moral status, its moral status is outweighed by the multitude of benefits that embryonic stem cell research will bring to humanity. Policy suggestions are given for dealing with this new and developing field of stem cell research.

  16. [Research on humans suffering from dementia].

    Science.gov (United States)

    Helmchen, H

    2015-09-01

    The urgent necessity for dementia research is justified by the prevalence and increase in dementia associated with the demographic changes, for which no causal treatment is available; however, during the progressive course dementia destroys the capacity for self-determination of persons affected and thereby an essential prerequisite for participation in research, i.e. a valid consent to a research intervention. Accordingly, not only sufficient information about all issues which are relevant for decision making by potential participants but also a flawless assessment of the capacity to consent are important; however, currently this is not satisfactorily possible. This article attempts to answer questions associated with these problems, such as how consent can be established, including that of a surrogate for consent of potential research participants by whom consent is no longer possible. In a second section the benefit-risk evaluation, which is also underdeveloped, will be dealt with using two concrete research examples, a diagnostic and a therapeutic research intervention for patients with dementia.

  17. Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice

    DEFF Research Database (Denmark)

    Smed, Marie; Getz, Kenneth A.

    2014-01-01

    on to sponsor companies and may ultimately assist in positioning new products and driving commercialization success. This study evaluates site characteristics that influence the acquisition and sharing of knowledge gained through clinical trial experience. The impact of 2 central site characteristics......, although both academic and independent sites generate the same level of knowledge, academic sites share more of this knowledge with sponsor companies. This study suggests new strategies that sponsors can leverage to drive greater transfer of clinical research knowledge into clinical practice and ultimately...

  18. Two-Photon and Second Harmonic Microscopy in Clinical and Translational Cancer Research

    Science.gov (United States)

    PERRY, SETH W.; BURKE, RYAN M.; BROWN, EDWARD B.

    2012-01-01

    Application of two-photon microscopy (TPM) to translational and clinical cancer research has burgeoned over the last several years, as several avenues of pre-clinical research have come to fruition. In this review, we focus on two forms of TPM—two-photon excitation fluorescence microscopy, and second harmonic generation microscopy—as they have been used for investigating cancer pathology in ex vivo and in vivo human tissue. We begin with discussion of two-photon theory and instrumentation particularly as applicable to cancer research, followed by an overview of some of the relevant cancer research literature in areas that include two-photon imaging of human tissue biopsies, human skin in vivo, and the rapidly developing technology of two-photon microendoscopy. We believe these and other evolving two-photon methodologies will continue to help translate cancer research from the bench to the bedside, and ultimately bring minimally invasive methods for cancer diagnosis and treatment to therapeutic reality. PMID:22258888

  19. Writing a research proposal: the critical first step for successful clinical research.

    Science.gov (United States)

    Saunderlin, G

    1994-01-01

    The proposal is a key element in the thesis or clinical research project. It identifies what is to be studied, why the topic is relevant, and how the research will be conducted. The proposal is a detailed plan or "blueprint" for the intended study, and once it is completed, the research project should flow smoothly. Writing a proposal may seem like a daunting undertaking, but a little thought and preparation will make it easier. In this article, the author provides a sample research proposal and a set of instructions that the beginning researcher should find helpful.

  20. Clinical research during a public health emergency: a systematic review of severe pandemic influenza management.

    Science.gov (United States)

    Ortiz, Justin R; Rudd, Kristina E; Clark, Danielle V; Jacob, Shevin T; West, T Eoin

    2013-05-01

    Rigorous evaluation of clinical interventions in the setting of a public health emergency is necessary to identify best practices, to develop clinical management guidelines, and to inform resource allocation. The 2009 influenza A (H1N1) pandemic necessitated care of critically ill patients around the world. To inform the World Health Organization Public Health Research Agenda for Influenza, we conducted a systematic review to identify clinical interventions other than antiviral therapies that would benefit severely ill 2009 H1N1 influenza patients (adults and children) in both high- and low-resource settings. PubMed, EMBASE, Cochrane Central Register of Clinical Trials, and Cochrane Database of Systematic Reviews; hand search of abstracts from six professional society annual conferences and bibliographies of clinical review articles; and personal communication with leaders in the field. English language; human studies; citations added to databases from January 1, 2009 (Cochrane databases) or March 15, 2009 (PubMed and EMBASE) through January 31, 2012; randomized controlled trials, prospective cohort studies, or systematic reviews/meta-analyses of non-antiviral clinical interventions in hospitalized 2009 influenza A (H1N1) patients. The search identified 2,452 articles. Thirty-six potentially relevant articles were read. Seven articles met criteria. All were observational studies. One study found benefit of convalescent plasma infusion, three studies found no benefit of corticosteroids, and three studies had mixed results on the benefit of extracorporeal lung support. No study was applicable to health care delivery in low-resource settings. There is a paucity of high quality clinical research to inform clinical care of severe H1N1 influenza, and we found no beneficial interventions appropriate for low-resource settings. This may be due to the logistical difficulties of conducting clinical research in response to a public health emergency. Our investigation

  1. What’s Wrong with Human/Nonhuman Chimera Research?

    Science.gov (United States)

    Hyun, Insoo

    2016-01-01

    The National Institutes of Health (NIH) is poised to lift its funding moratorium on research involving chimeric human/nonhuman embryos, pending further consideration by an NIH steering committee. The kinds of ethical concerns that seem to underlie this research and chimera research more generally can be adequately addressed. PMID:27574863

  2. Ethical Issues in the Use of Humans for Research.

    Science.gov (United States)

    Bashaw, W. L.

    The APA Ethical Principles, the University of Georgia policy, standard research texts, and research literature on specific methodologies, all in relation to ethical issues in human research, are discussed. The 10 APA principles state, in essence, that the investigator is responsible for what happens, that confidentiality and the protection of the…

  3. Human genome program report. Part 2, 1996 research abstracts

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-11-01

    This report contains Part 2 of a two-part report to reflect research and progress in the US Department of Energy Human Genome Program from 1994 through 1996, with specified updates made just before publication. Part 2 consists of 1996 research abstracts. Attention is focused on the following: sequencing; mapping; informatics; ethical, legal, and social issues; infrastructure; and small business innovation research.

  4. Human Genome Program Report. Part 2, 1996 Research Abstracts

    Science.gov (United States)

    1997-11-01

    This report contains Part 2 of a two-part report to reflect research and progress in the US Department of Energy Human Genome Program from 1994 through 1996, with specified updates made just before publication. Part 2 consists of 1996 research abstracts. Attention is focused on the following: sequencing; mapping; informatics; ethical, legal, and social issues; infrastructure; and small business innovation research.

  5. Research Dissemination in Creative Arts, Humanities and the Social Sciences

    Science.gov (United States)

    Bazeley, Pat

    2006-01-01

    An ethnographic case study of issues related to research performance and promotion of research was conducted within the Creative and Performing Arts, Humanities and Social Sciences (AHSS) disciplines of a regional university. The purpose of the study was to explore a variety of ways in which the research work of those disciplines could be made…

  6. Research Challenges and Opportunities for Clinically Oriented Academic Radiology Departments.

    Science.gov (United States)

    Decker, Summer J; Grajo, Joseph R; Hazelton, Todd R; Hoang, Kimberly N; McDonald, Jennifer S; Otero, Hansel J; Patel, Midhir J; Prober, Allen S; Retrouvey, Michele; Rosenkrantz, Andrew B; Roth, Christopher G; Ward, Robert J

    2016-01-01

    Between 2004 and 2012, US funding for the biomedical sciences decreased to historic lows. Health-related research was crippled by receiving only 1/20th of overall federal scientific funding. Despite the current funding climate, there is increased pressure on academic radiology programs to establish productive research programs. Whereas larger programs have resources that can be utilized at their institutions, small to medium-sized programs often struggle with lack of infrastructure and support. To address these concerns, the Association of University Radiologists' Radiology Research Alliance developed a task force to explore any untapped research productivity potential in these smaller radiology departments. We conducted an online survey of faculty at smaller clinically funded programs and found that while they were interested in doing research and felt it was important to the success of the field, barriers such as lack of resources and time were proving difficult to overcome. One potential solution proposed by this task force is a collaborative structured research model in which multiple participants from multiple institutions come together in well-defined roles that allow for an equitable distribution of research tasks and pooling of resources and expertise. Under this model, smaller programs will have an opportunity to share their unique perspective on how to address research topics and make a measureable impact on the field of radiology as a whole. Through a health services focus, projects are more likely to succeed in the context of limited funding and infrastructure while simultaneously providing value to the field.

  7. Nurses’ Research Behavior and Barriers to Research Utilization Into Clinical Nursing Practice: a Closer Look

    Directory of Open Access Journals (Sweden)

    Efstratios Athanasakis

    2013-01-01

    Full Text Available Background: It is widely accepted that utilization of the best-known research evidence in nursing practice entails improvement of nursing care received by patients and strengthening of nursing profession.Aim: The aim of this paper was the review of nurses’ research behavior and the barriers that nurses meet in order to utilize research evidence into clinical nursing practice.Methodology: There has been conducted a literature search in Pubmed and Science Direct libraries, using specific search terms. An important inclusion criterion for the studies was the use of barriers to research utilization scale (BRUS, along or combined with another instrument.Results: A total of 37 original papers included in the present article. A table of the top five barriers to research utilization scale has been conducted. Data from the table indicate that the existence of barriers to incorporation of evidence into practice comes mainly from clinical settings characteristics. In addition, issues about nursing education, nurses’ research and reading habits, facilitators of research utilization and their relevance for nursing staff and clinical practice are also discussed.Conclusions: Since the barriers to research utilization are well identified in the nursing literature and there is a wealth of information on this subject, the next step is to find ways to overcome them and value the impact of the relevant interventions towards research utilization behavior.

  8. Tasks of research in forensic medicine - different study types in clinical research and forensic medicine.

    Science.gov (United States)

    Madea, Burkhard; Saukko, Pekka; Musshoff, Frank

    2007-01-17

    In the last years the research output of forensic medicine has sometimes been regarded as insufficient and as of poor quality, especially when parameters as impact factors and external funding were taken into account. However, forensic medicine has different tasks compared to clinical medicine. The main difference between basic subjects, clinical and forensic medicine is not a lack of scientific efficiency in forensic medicine but is a result of the questions asked, the available methods and specific aims. In contrast to natural-scientific research, forensic science has furthermore important intersections with arts and socio-scientific disciplines. Etiologic and pathogenetic research is of only limited relevance in forensic medicine. Thus, forensic medicine is excluded from these research fields, which are mainly supported by external funding. In forensic medicine research mainly means applied research regarding findings, the probative value and reconstruction as well as examination at different points of intersection between medicine and law. Clinical types of research such as controlled randomised, prospective cross-sectional, cohort or case-control studies can only rarely be applied in forensic medicine due to the area specific research fields (e.g. thantatology, violent death, vitality, traffic medicine, analytical toxicology, hemogenetics and stain analysis). The types of studies which are successfully established in forensic medicine are comparison of methods, sensitivity studies, validation of methods, kinetic examinations etc. Tasks of research in forensic medicine and study types, which may be applied will be addressed.

  9. Pre-clinical Orthotopic Murine Model of Human Prostate Cancer.

    Science.gov (United States)

    Shahryari, Varahram; Nip, Hannah; Saini, Sharanjot; Dar, Altaf A; Yamamura, Soichiro; Mitsui, Yozo; Colden, Melissa; Bucay, Nathan; Tabatabai, Laura Z; Greene, Kirsten; Deng, Guoren; Tanaka, Yuichiro; Dahiya, Rajvir; Majid, Shahana

    2016-08-29

    To study the multifaceted biology of prostate cancer, pre-clinical in vivo models offer a range of options to uncover critical biological information about this disease. The human orthotopic prostate cancer xenograft mouse model provides a useful alternative approach for understanding the specific interactions between genetically and molecularly altered tumor cells, their organ microenvironment, and for evaluation of efficacy of therapeutic regimens. This is a well characterized model designed to study the molecular events of primary tumor development and it recapitulates the early events in the metastatic cascade prior to embolism and entry of tumor cells into the circulation. Thus it allows elucidation of molecular mechanisms underlying the initial phase of metastatic disease. In addition, this model can annotate drug targets of clinical relevance and is a valuable tool to study prostate cancer progression. In this manuscript we describe a detailed procedure to establish a human orthotopic prostate cancer xenograft mouse model.

  10. Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research.

    Science.gov (United States)

    Glickman, Seth W; Ndubuizu, Adanma; Weinfurt, Kevin P; Hamilton, Carol D; Glickman, Lawrence T; Schulman, Kevin A; Cairns, Charles B

    2011-03-01

    Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical research. This inherently limits the societal benefits of the research and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical research, the authors critically evaluated LEP consent requirements posted on the Web sites of 134 academic health centers in March 2008. They found wide variability with regard to consent policies and striking interinstitutional differences in posted IRB policies and attitudes toward consent of LEP patients in research. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the research, yet the consent process is often resource-intensive and complex. The authors suggest that more uniform and specific guidance from federal agencies for enrollment of LEP patients in clinical research be established and that this guidance explicitly recalibrate the current balance between autonomy and justice. Investigators and institutional review boards should also develop streamlined best practices to reduce unnecessary effort and expense associated with recruitment of LEP individuals. LEP individuals should have fair access to clinical research in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

  11. Risk Mitigation during Human Electromuscular Incapacitation Research

    Science.gov (United States)

    2015-04-30

    kinase, CK- MB, and Troponin I. Changes can also occur in the electrocardiogram (EKG) with myocardial injury, such as a myocardial infarction or heart...for further evaluation. No evidence of myocardial infarction was found and the level was ɘ.3 ng/mL eight hours later. Jauchem et al. found no...Clinically, this is considered an indeterminate level, less than the lower limit for positive diagnosis of myocardial injury. Vilke et al. studied 32

  12. MARINE ACCIDENTS RESEARCHED THROUGH HUMAN FACTOR PRISMA

    Directory of Open Access Journals (Sweden)

    Branislav M Ćorović

    2013-07-01

    Full Text Available We are aware of a large number of marine accidents that result in numerous casualties and even deaths and substantial negative environmental effects. The objective of this paper is to indicate factors that contribute to human errors which is identified as the most frequent cause to marine accidents. Despite rapid technological development and safety legislation, this paper identifies the human factor as the waekest link in maritime safety system. This analysis could lead to decrease of vessel accidents. In addition, starting from the European Maritime Safety Agency data and by linear regression model application, we have obtained the trend of number of ships involved in marine accidents as well as the trend of lives lost in marine accidents  in and around European Union waters.

  13. [The importance of clinical observations for medical research].

    Science.gov (United States)

    Koller, F

    1976-10-30

    Medical progress owes a great deal to the fundamental medical sciences and to the application of chemistry, physics and mathematics to medical problems. However, clinical observations and investigations are still of decisive importance in any field of medicine. By a feed-back mechanism they may even stimulate and fertilize fundamental medical sciences. Thus, our knowledge of the blood coagulation mechanism has been considerably enlarged by clinical analysis of hereditary bleeding disorders. - Chemotherapy of neoplastic diseases started from clinical observations during World War I (production of leucopenia by sulfur mustard gas). - Surgical procedures and their consequences have contributed greatly to our knowledge of thyroid function, of the segmental anatomy of the lung, and of the conduction system of the heart. - Observations of side effects of drugs have often enlarged or completely changed their primary clinical indications: from antibacterial sulfonamides, anti-diabetic, antihypertensive and powerful diuretic drugs have been developed, and from histaminics the modern neuroleptics and antidepressants. - Fundamental immunology has been enormously activated by clinical transplantation of kidney and bone marrow. Selective immunological defects in men, real experiments of nature, contributed much to our knowledge of the various types of allergic response. The quality of clinical investigations, particularly of controlled clinical trials, has been considerably improved during the last two decades. Although it is an applied science the reliability of its results is to-day comparable with that of "pure" natural sciences. However, medicine is more than a natural science: examples of outstanding scientists who at the same time were great and human physicians are presented.

  14. Human Immunodeficiency Virus (HIV) Research (AIDS)

    Science.gov (United States)

    1993-07-15

    Polonis V, Corts K, Hoc"en-Lewis C, Eddy G. Production of functionally defective HIV-l reverse transcriptase can be initiated by a human peripheral blood... Interamericana , Mexico-Buenos Aires - Madrid. 1989. Ruiz Manuscript 1989 Ruiz NM, Ramirez-Rhonda CH. Tratamiento quirurjico de endocarditis. Chapter in...M.D.; Editorial Interamericana , Mexico-Buenos Aires - Madrid, 1989. Ruiz Manuscript 1989 Rivera G, Ruiz NM. Principios generales en el tratemiento

  15. Research on Normal Human Plantar Pressure Test

    Directory of Open Access Journals (Sweden)

    Liu Xi Yang

    2016-01-01

    Full Text Available FSR400 pressure sensor, nRF905 wireless transceiver and MSP40 SCM are used to design the insole pressure collection system, LabVIEW is used to make HMI of data acquisition, collecting a certain amount of normal human foot pressure data, statistical analysis of pressure distribution relations about five stages of swing phase during walking, using the grid closeness degree to identify plantar pressure distribution pattern recognition, and the algorithm simulation, experimental results demonstrated this method feasible.

  16. Anaerococcus nagyae sp. nov., isolated from human clinical specimens.

    Science.gov (United States)

    Veloo, A C M; de Vries, E D; Jean-Pierre, H; van Winkelhoff, A J

    2016-04-01

    We describe a new Anaerococcus species isolated from human clinical specimens. Analyses of 16S rRNA gene sequences of three strains showed octavius. Phylogenetically the isolated strains form a cluster and can be differentiated from other species of the genus Anaerococcus based on its phenotypic characteristics and its MALDI-TOF MS profile. We propose the name Anaerococcus nagyae, with A. nagyae DSM101193 (accession number KU043522) as the type strain. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Identities of Microbacterium spp. Encountered in Human Clinical Specimens▿

    OpenAIRE

    Gneiding, Kathrina; Frodl, Reinhard; Funke, Guido

    2008-01-01

    In the present study, 50 strains of yellow-pigmented gram-positive rods that had been isolated from human clinical specimens and collected over a 5-year period were further characterized by phenotypic and molecular genetic methods. All 50 strains belonged to the genus Microbacterium, and together they represented 18 different species. Microbacterium oxydans (n = 11), M. paraoxydans (n = 9), and M. foliorum (n = 7) represented more than half of the strains included in the present study. The is...

  18. The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet)

    Science.gov (United States)

    de Andrade, Joao; Schwarz, Marvin; Collard, Harold R.; Gentry-Bumpass, Tedryl; Colby, Thomas; Lynch, David; Schwarz, M.; Zisman, D. A.; Hunninghake, G.; Chapman, J.; Olman, M.; Lubell, S.; Morrison, L. D.; Steele, M. P.; Haram, T.; Roman, J.; Perez, R.; Perez, T.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Brown, K. K.; Schwarz, M.; Bair, C.; Kervitsky, D.; Lasky, J. A.; Ditta, S.; deAndrade, J.; Thannickal, V. J.; Stewart, M.; Zisman, D. A.; Lynch, J.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J. A.; Wolters, P. J.; Jeffrey, R.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; White, S. R.; Brown, C.; Garic, I.; Maleckar, S.; Martinez, F. J.; Flaherty, K. R.; Han, M.; Moore, B.; Toews, G. B.; Dahlgren, D.; Raghu, G.; Hayes, J.; Snyder, M.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Monroy, V.; Wang, M.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Becker, R. C.; Eisenstein, E. L.; MacIntyre, N. R.; Morrison, L. D; Rochon, J.; Steele, M. P.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Anderson, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Ingham, M.; Kagan, E.; Kaur, J.; Matti, C.; McClelland, J.; Meredith, A.; Nguyen, T.; Pesarchick, J.; Roberts, R. S.; Tate, W.; Thomas, T.; Walker, J.; Whelan, D.; Winsor, J.; Yang, Q.; Yow, E.; Reynolds, H. Y.; Tian, X.; Kiley, J.; Noth, I.; Olman, M.; Schwarz, M.; Toews, G. B.; Hunninghake, G.; Culver, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Wehrmann, R.; Morrison, L. D.; Steele, M. P.; Haram, T.; Kidd, R.; Kallay, M.; Lyda, E.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Sahn, S.; O’Banner, N.; Stokes, F.; Brown, K. K.; Bair, C.; Kervitsky, D.; Ettinger, N. A.; Merli, S.; de Andrade, J.; Thannickal, V. J.; Stewart, M.; Belperio, J.; Lynch, J. P.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J.; Wolters, P.; Eller, A.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; Maleckar, S.; Rahimova, G.; Sardin, L.; Roman, J.; Perez, R.; Perez, T.; Glassberg, M.; Simonet, E.; Martinez, F. J.; Baumann, K.; Chan, K.; Chughtai, A.; Gross, B.; Flaherty, K. R.; Han, M. L.; Hyzy, R.; Kazerooni, E.; Moore, B.; Myers, J.; Toews, G. B.; White, E.; Dahlgren, D.; Rossman, M.; Kreider, M.; Le, K.; Fitzgerald, J.; Glazer, C.; Scholand, M. B.; Brewster, L.; Johnson, A.; Raghu, G.; Berry-Bell, P.; Snydsman, A.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Kinser, K.; Richardson, R.; Mason, W.; Kaner, R. J.; Bandong, K.; Antin-Ozerkis, D.; Holm, C.; Estrom, J.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Eisenstein, E. L.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Beci, R.; Calvert, S.; Gentry-Bumpass, T.; Hill, D.; Hofmann, P. V.; Hwang, K.; Kaur, J.; Matti, C.; Meredith, A.; Pesarchick, J.; Ramey, S.; Roberts, R. S.; Sharlow, A.; Winsor, J.; Yang, Q.; Yow, E.; Weinmann, G. G.; Reynolds, H.; Schmetter, B.; Tian, X.; Kiley, J.; Martinez, F. J.; Raghu, G.; Schwarz, M.; Toews, G. B.; Zibrak, J.; Demersky, A.; Vey, M.; Rosas, I. O.; Debrosse, P.; Culver, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Wehrmann, R.; Morrison, L. D.; Steele, M. P.; Haram, T.; Kidd, R.; Kallay, M.; Lyda, E.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Sahn, S.; O’Banner, N.; Stokes, F.; Padilla, M.; Berhanu, G.; Brown, K. K.; Bair, C.; Kervitsky, D.; Ettinger, N. A.; Merli, S.; Criner, G. J.; Swift, I. Q.; Satti, A.; Cordova, F.; Patel, N.; West, K.; Jones, G.; Lasky, J. A.; Ditta, S.; de Andrade, J.; Thannickal, V. J.; Stewart, M.; Belperio, J.; Lynch, J. P.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J.; Wolters, P.; Eller, A.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; Maleckar, S.; Rahimova, G.; Sardin, L.; Roman, J.; Perez, R.; Perez, T.; Glassberg, M.; Simonet, E.; Martinez, F. J.; Baumann, K.; Chan, K.; Chughtai, A.; Gross, B.; Flaherty, K. R.; Han, M. L.; Hyzy, R.; Kazerooni, E.; Moore, B.; Myers, J.; Toews, G. B.; White, E.; Dahlgren, D.; Rossman, M.; Kreider, M.; Le, K.; Fitzgerald, J.; Glazer, C.; Scholand, M. B.; Brewster, L.; Johnson, A.; Raghu, G.; Berry-Bell, P.; Snydsman, A.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Bandong, K.; Antin-Ozerkis, D.; Holm, C.; Estrom, J.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Becker, R. C.; Eisenstein, E. L.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Huang, K.; Kaur, J.; Matti, C.; Meredith, A.; Pesarchick, J.; Ramey, S.; Roberts, R. S.; Sharlow, A.; Winsor, J.; Yow, E.; Weinmann, G. G.; Reynolds, H.; Schmetter, B.; Tian, X.; Kiley, J.

    2015-01-01

    BACKGROUND: The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes. METHODS: The diagnostic process was based on review of clinical data and high-resolution CT scans with central review of lung biopsies when available. The AC worked closely with the data coordinating center to obtain clinical, radiologic, and histologic data and to communicate with the clinical centers. The AC used a multidisciplinary discussion model with four clinicians, one radiologist, and one pathologist to adjudicate diagnosis and outcome measures. RESULTS: The IPFnet trials screened 1,015 subjects; of these, 23 cases required review by the AC to establish eligibility. The most common diagnosis for exclusion was suspected chronic hypersensitivity pneumonitis. The AC reviewed 88 suspected acute exacerbations (AExs), 93 nonelective hospitalizations, and 16 cases of bleeding. Determination of AEx presented practical challenges to adjudicators, as necessary clinical data were often not collected, particularly when subjects were evaluated outside of the primary study site. CONCLUSIONS: The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as they incorporate AExs and hospitalizations as outcome measures. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00517933, NCT00650091, NCT00957242; URL: www.clinicaltrials.gov PMID

  19. Integrating historical clinical and financial data for pharmacological research

    Directory of Open Access Journals (Sweden)

    Deshmukh Vikrant G

    2011-11-01

    Full Text Available Abstract Background Retrospective research requires longitudinal data, and repositories derived from electronic health records (EHR can be sources of such data. With Health Information Technology for Economic and Clinical Health (HITECH Act meaningful use provisions, many institutions are expected to adopt EHRs, but may be left with large amounts of financial and historical clinical data, which can differ significantly from data obtained from newer systems, due to lack or inconsistent use of controlled medical terminologies (CMT in older systems. We examined different approaches for semantic enrichment of financial data with CMT, and integration of clinical data from disparate historical and current sources for research. Methods Snapshots of financial data from 1999, 2004 and 2009 were mapped automatically to the current inpatient pharmacy catalog, and enriched with RxNorm. Administrative metadata from financial and dispensing systems, RxNorm and two commercial pharmacy vocabularies were used to integrate data from current and historical inpatient pharmacy modules, and the outpatient EHR. Data integration approaches were compared using percentages of automated matches, and effects on cohort size of a retrospective study. Results During 1999-2009, 71.52%-90.08% of items in use from the financial catalog were enriched using RxNorm; 64.95%-70.37% of items in use from the historical inpatient system were integrated using RxNorm, 85.96%-91.67% using a commercial vocabulary, 87.19%-94.23% using financial metadata, and 77.20%-94.68% using dispensing metadata. During 1999-2009, 48.01%-30.72% of items in use from the outpatient catalog were integrated using RxNorm, and 79.27%-48.60% using a commercial vocabulary. In a cohort of 16304 inpatients obtained from clinical systems, 4172 (25.58% were found exclusively through integration of historical clinical data, while 15978 (98% could be identified using semantically enriched financial data. Conclusions

  20. Single cell analysis contemporary research and clinical applications

    CERN Document Server

    Cossarizza, Andrea

    2017-01-01

    This book highlights the current state of the art in single cell analysis, an area that involves many fields of science – from clinical hematology, functional analysis and drug screening, to platelet and microparticle analysis, marine biology and fundamental cancer research. This book brings together an eclectic group of current applications, all of which have a significant impact on our current state of knowledge. The authors of these chapters are all pioneering researchers in the field of single cell analysis. The book will not only appeal to those readers more focused on clinical applications, but also those interested in highly technical aspects of the technologies. All of the technologies identified utilize unique applications of photon detection systems.

  1. The DSM and Professional Practice: Research, Clinical, and Institutional Perspectives.

    Science.gov (United States)

    Halpin, Michael

    2016-06-01

    How mental illnesses are defined has significant ramifications, given the substantial social and individual repercussions of these conditions. Using actor-network theory, I analyze how mental health professionals use the Diagnostic and Statistical Manual of Mental Disorders (DSM) in their work. Drawing on observations of a neuropsychological laboratory and interviews with 27 professionals (i.e., psychiatrists, psychologists), I investigate how the DSM is used in research, clinical, and institutional work. In research, the DSM influences study design and exclusion/inclusion criteria. In the clinic, the DSM influences how disorders are conceptualized and diagnosed. Institutionally, the DSM aligns the patient-professional encounter to insurance and pharmaceutical interests. I conclude that the DSM operates as multiple, context-specific taxonomies that pervasively influence professional practices, such that all possible actions must orient to DSM criteria, with professionals both a source and an object of institutionalized gaze.

  2. Multisystemic Therapy(®) : Clinical Overview, Outcomes, and Implementation Research.

    Science.gov (United States)

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

    Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes. © 2016 Family Process Institute.

  3. Knowledge Creation in Clinical Product Development Management Research

    DEFF Research Database (Denmark)

    Karlsson, Christer; Sköld, Martin

    2012-01-01

    This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including that on t......This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including...... that on the most adjacent approaches, in order to characterize and position the different approaches. Field or application data are used to identify how the approach has been used and developed in publications in major journals in the field. After the introduction, which presents the brief characteristics...

  4. [Quality inspection of clinical research in traditional Chinese medicine].

    Science.gov (United States)

    Li, Rui; Weng, Wei-liang; Tian, Yuan-xiang; Li, Qiu-yan; Lu, Fang

    2010-05-01

    Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D Program", we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.

  5. New perspectives in human stem cell therapeutic research

    Directory of Open Access Journals (Sweden)

    Trounson Alan

    2009-06-01

    Full Text Available Abstract Human stem cells are in evaluation in clinical stem cell trials, primarily as autologous bone marrow studies, autologous and allogenic mesenchymal stem cell trials, and some allogenic neural stem cell transplantation projects. Safety and efficacy are being addressed for a number of disease state applications. There is considerable data supporting safety of bone marrow and mesenchymal stem cell transplants but the efficacy data are variable and of mixed benefit. Mechanisms of action of many of these cells are unknown and this raises the concern of unpredictable results in the future. Nevertheless there is considerable optimism that immune suppression and anti-inflammatory properties of mesenchymal stem cells will be of benefit for many conditions such as graft versus host disease, solid organ transplants and pulmonary fibrosis. Where bone marrow and mesenchymal stem cells are being studied for heart disease, stroke and other neurodegenerative disorders, again progress is mixed and mostly without significant benefit. However, correction of multiple sclerosis, at least in the short term is encouraging. Clinical trials on the use of embryonic stem cell derivatives for spinal injury and macular degeneration are beginning and a raft of other clinical trials can be expected soon, for example, the use of neural stem cells for killing inoperable glioma and embryonic stem cells for regenerating β islet cells for diabetes. The change in attitude to embryonic stem cell research with the incoming Obama administration heralds a new co-operative environment for study and evaluation of stem cell therapies. The Californian stem cell initiative (California Institute for Regenerative Medicine has engendered global collaboration for this new medicine that will now also be supported by the US Federal Government. The active participation of governments, academia, biotechnology, pharmaceutical companies, and private investment is a powerful consortium for

  6. 78 FR 79703 - Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research...

    Science.gov (United States)

    2013-12-31

    ...: Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact... in writing. Proposed Collection: Application Process for Clinical Research Training and Medical... Clinical Research Training and Medical Education, NIH Clinical Center, 10 Center Drive, MSC 1158,...

  7. Beyond "utilitarianism": maximizing the clinical impact of moral judgment research.

    Science.gov (United States)

    Rosas, Alejandro; Koenigs, Michael

    2014-01-01

    The use of hypothetical moral dilemmas--which pit utilitarian considerations of welfare maximization against emotionally aversive "personal" harms--has become a widespread approach for studying the neuropsychological correlates of moral judgment in healthy subjects, as well as in clinical populations with social, cognitive, and affective deficits. In this article, we propose that a refinement of the standard stimulus set could provide an opportunity to more precisely identify the psychological factors underlying performance on this task, and thereby enhance the utility of this paradigm for clinical research. To test this proposal, we performed a re-analysis of previously published moral judgment data from two clinical populations: neurological patients with prefrontal brain damage and psychopathic criminals. The results provide intriguing preliminary support for further development of this assessment paradigm.

  8. Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research-Clinical Divide.

    Science.gov (United States)

    Wolf, Susan M; Burke, Wylie; Koenig, Barbara A

    2015-01-01

    Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a "layered" approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.

  9. Untapped Potential of Observational Research to Inform Clinical Decision Making: American Society of Clinical Oncology Research Statement.

    Science.gov (United States)

    Visvanathan, Kala; Levit, Laura A; Raghavan, Derek; Hudis, Clifford A; Wong, Sandra; Dueck, Amylou; Lyman, Gary H

    2017-06-01

    ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.

  10. Recombinant human thrombopoietin: basic biology and evaluation of clinical studies.

    Science.gov (United States)

    Kuter, David J; Begley, C Glenn

    2002-11-15

    Thrombocytopenia is a common medical problem for which the main treatment is platelet transfusion. Given the increasing use of platelets and the declining donor population, identification of a safe and effective platelet growth factor could improve the management of thrombocytopenia. Thrombopoietin (TPO), the c-Mpl ligand, is the primary physiologic regulator of megakaryocyte and platelet development. Since the purification of TPO in 1994, 2 recombinant forms of the c-Mpl ligand--recombinant human thrombopoietin (rhTPO) and pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF)--have undergone extensive clinical investigation. Both have been shown to be potent stimulators of megakaryocyte growth and platelet production and are biologically active in reducing the thrombocytopenia of nonmyeloablative chemotherapy. However, neither TPO has demonstrated benefit in stem cell transplantation or leukemia chemotherapy. Other clinical studies have investigated the use of TPO in treating chronic nonchemotherapy-induced thrombocytopenia associated with myelodysplastic syndromes, idiopathic thrombocytopenic purpura, thrombocytopenia due to human immunodeficiency virus, and liver disease. Based solely on animal studies, TPO may be effective in reducing surgical thrombocytopenia and bleeding, ex vivo expansion of pluripotent stem cells, and as a radioprotectant. Ongoing and future studies will help define the clinical role of recombinant TPO and TPO mimetics in the treatment of chemotherapy- and nonchemotherapy-induced thrombocytopenia.

  11. Identities of Microbacterium spp. encountered in human clinical specimens.

    Science.gov (United States)

    Gneiding, Kathrina; Frodl, Reinhard; Funke, Guido

    2008-11-01

    In the present study, 50 strains of yellow-pigmented gram-positive rods that had been isolated from human clinical specimens and collected over a 5-year period were further characterized by phenotypic and molecular genetic methods. All 50 strains belonged to the genus Microbacterium, and together they represented 18 different species. Microbacterium oxydans (n = 11), M. paraoxydans (n = 9), and M. foliorum (n = 7) represented more than half of the strains included in the present study. The isolation of strains belonging to M. hydrocarbonoxydans (n = 2), M. esteraromaticum (n = 1), M. oleivorans (n = 1), M. phyllosphaerae (n = 1), and M. thalassium (n = 1) from humans is reported for the first time. Microbacterium sp. strain VKM Ac-1389 (n = 1) and the previously uncultured Microbacterium sp. clone YJQ-29 (n = 1) probably represent new species. Comprehensive antimicrobial susceptibility data are given for the 50 Microbacterium isolates. This study is, so far, the largest on Microbacterium spp. encountered in human clinical specimens and outlines the heterogeneity of clinical Microbacterium strains.

  12. Identities of Microbacterium spp. Encountered in Human Clinical Specimens▿

    Science.gov (United States)

    Gneiding, Kathrina; Frodl, Reinhard; Funke, Guido

    2008-01-01

    In the present study, 50 strains of yellow-pigmented gram-positive rods that had been isolated from human clinical specimens and collected over a 5-year period were further characterized by phenotypic and molecular genetic methods. All 50 strains belonged to the genus Microbacterium, and together they represented 18 different species. Microbacterium oxydans (n = 11), M. paraoxydans (n = 9), and M. foliorum (n = 7) represented more than half of the strains included in the present study. The isolation of strains belonging to M. hydrocarbonoxydans (n = 2), M. esteraromaticum (n = 1), M. oleivorans (n = 1), M. phyllosphaerae (n = 1), and M. thalassium (n = 1) from humans is reported for the first time. Microbacterium sp. strain VKM Ac-1389 (n = 1) and the previously uncultured Microbacterium sp. clone YJQ-29 (n = 1) probably represent new species. Comprehensive antimicrobial susceptibility data are given for the 50 Microbacterium isolates. This study is, so far, the largest on Microbacterium spp. encountered in human clinical specimens and outlines the heterogeneity of clinical Microbacterium strains. PMID:18799696

  13. Basic and clinical researches of parasitosis in China revisited

    Institute of Scientific and Technical Information of China (English)

    JIANG Ci-peng

    2005-01-01

    @@ Two years ago, an editorial regarding basic or clinical studies of several parasitosis in China was published.1 As is known to all, some parasitic diseases, especially schistosomiasis and echino-coccosis, are still prevalent in the south and west of China, respectively. Therefore, it is significant to review a few research papers in the field of medical parasitology and write another editorial.

  14. Evidence Based Dental Care: Integrating Clinical Expertise with Systematic Research

    OpenAIRE

    2014-01-01

    Clinical dentistry is becoming increasingly complex and our patients more knowledgeable. Evidence-based care is now regarded as the “gold standard” in health care delivery worldwide. The basis of evidence based dentistry is the published reports of research projects. They are, brought together and analyzed systematically in meta analysis, the source for evidence based decisions. Activities in the field of evidence-based dentistry has increased tremendously in the 21st century, more and more p...

  15. Italian law on assisted conception: clinical and research implications.

    Science.gov (United States)

    Manna, Claudio; Nardo, Luciano G

    2005-11-01

    The Italian law 40/2004 regulating the use of assisted conception will remain on the statutes after the failure of the referendum in June 2005. Italy is now one of the most restrictive countries in the world in the field of assisted conception. It is thought that the new regulations, which have already increased 'reproductive tourism' in Italian subfertile couples, will also have clinical and research implications.

  16. ASBMB Journal Club - Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    On Wednesday, November 12, 2014 from 2:00 PM to 3:00 PM EST, Daniel Liebler, PhD (Vanderbilt University) and Karin Rodland, PhD (Pacific Northwestern National Laboratory) and Ruedi Aebersold, PhD (Swiss Federal Institute of Technology) will share their research insight as part of the ASBMB Journal Club.  Both Doctors Liebler and Rodland are Principal Investigators in the NCI’s Clinical Proteomic Tumor Analysis Consortium.

  17. 75 FR 10488 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2010-03-08

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Special Emphasis Panel; NHGRI MAP Review... Human Genome Research Institute Special Emphasis Panel; LRP 2010 Teleconference. Date: April 7,...

  18. 77 FR 61770 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-10-11

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Special Emphasis Panel; Genomic Medicine RFAs..., Human Genome Research, National Institutes of Health, HHS) ] Dated: October 4, 2012. David...

  19. 78 FR 20933 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-04-08

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Special Emphasis Panel Loan Repayment Program... applications. Place: National Human Genome Research Institute, Room 3055, 5635 Fishers Lane, Rockville,...

  20. 76 FR 35223 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-06-16

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Special Emphasis Panel, Sequencing Centers...D, Scientific Review Officer, Scientific Review Branch, National Human Genome Research...

  1. 77 FR 60706 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-10-04

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed.... Name of Committee: National Human Genome Research Institute Special Emphasis Panel; Special Emphasis... Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of...

  2. 75 FR 52538 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-08-26

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Special Emphasis Panel. Date: November 19-20..., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute,...

  3. 75 FR 8374 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-02-24

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... of Committee: National Human Genome Research Institute Special Emphasis Panel, Revolutionary..., National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4076,...

  4. 78 FR 68856 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-11-15

    ... HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed... Review Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes... of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes...

  5. Ethics, standards, and procedures of animal and human chronobiology research.

    Science.gov (United States)

    Touitou, Yvan; Smolensky, Michael H; Portaluppi, Francesco

    2006-01-01

    The majority of research papers published in Chronobiology International report the findings of investigations conducted on laboratory animals and human beings. The editors and the readers of the journal expect the authors of submitted manuscripts to have made an important contribution to biological rhythm and related research through the ethical conduct of investigations and unbiased and accurate reporting of findings. Authors of scientific papers are required to disclose any potential conflict of interest. The journal accepts only papers that are original work, no part of which has been submitted for publication elsewhere, except as brief abstracts. The journal and its editors endorse the compliance of investigators to the principles of the Declaration of Helsinki of the World Medical Association, which relate to the conduct of ethical research on human beings, and the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, which relate to the conduct of ethical research on laboratory and other animals. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the investigative methods conform to the standards of good research practice. This article updates the ethical policies, standards, and procedures for manuscripts submitted to Chronobiology International that involve human and animal biological rhythm research, both from the perspective of the criteria of quality chronobiology investigation and from the perspective of humane and ethical research on human beings and animals.

  6. Citation Analysis May Severely Underestimate the Impact of Clinical Research as Compared to Basic Research

    Science.gov (United States)

    van Eck, Nees Jan; Waltman, Ludo; van Raan, Anthony F. J.; Klautz, Robert J. M.; Peul, Wilco C.

    2013-01-01

    Background Citation analysis has become an important tool for research performance assessment in the medical sciences. However, different areas of medical research may have considerably different citation practices, even within the same medical field. Because of this, it is unclear to what extent citation-based bibliometric indicators allow for valid comparisons between research units active in different areas of medical research. Methodology A visualization methodology is introduced that reveals differences in citation practices between medical research areas. The methodology extracts terms from the titles and abstracts of a large collection of publications and uses these terms to visualize the structure of a medical field and to indicate how research areas within this field differ from each other in their average citation impact. Results Visualizations are provided for 32 medical fields, defined based on journal subject categories in the Web of Science database. The analysis focuses on three fields: Cardiac & cardiovascular systems, Clinical neurology, and Surgery. In each of these fields, there turn out to be large differences in citation practices between research areas. Low-impact research areas tend to focus on clinical intervention research, while high-impact research areas are often more oriented on basic and diagnostic research. Conclusions Popular bibliometric indicators, such as the h-index and the impact factor, do not correct for differences in citation practices between medical fields. These indicators therefore cannot be used to make accurate between-field comparisons. More sophisticated bibliometric indicators do correct for field differences but still fail to take into account within-field heterogeneity in citation practices. As a consequence, the citation impact of clinical intervention research may be substantially underestimated in comparison with basic and diagnostic research. PMID:23638064

  7. Citation analysis may severely underestimate the impact of clinical research as compared to basic research.

    Directory of Open Access Journals (Sweden)

    Nees Jan van Eck

    Full Text Available BACKGROUND: Citation analysis has become an important tool for research performance assessment in the medical sciences. However, different areas of medical research may have considerably different citation practices, even within the same medical field. Because of this, it is unclear to what extent citation-based bibliometric indicators allow for valid comparisons between research units active in different areas of medical research. METHODOLOGY: A visualization methodology is introduced that reveals differences in citation practices between medical research areas. The methodology extracts terms from the titles and abstracts of a large collection of publications and uses these terms to visualize the structure of a medical field and to indicate how research areas within this field differ from each other in their average citation impact. RESULTS: Visualizations are provided for 32 medical fields, defined based on journal subject categories in the Web of Science database. The analysis focuses on three fields: Cardiac & cardiovascular systems, Clinical neurology, and Surgery. In each of these fields, there turn out to be large differences in citation practices between research areas. Low-impact research areas tend to focus on clinical intervention research, while high-impact research areas are often more oriented on basic and diagnostic research. CONCLUSIONS: Popular bibliometric indicators, such as the h-index and the impact factor, do not correct for differences in citation practices between medical fields. These indicators therefore cannot be used to make accurate between-field comparisons. More sophisticated bibliometric indicators do correct for field differences but still fail to take into account within-field heterogeneity in citation practices. As a consequence, the citation impact of clinical intervention research may be substantially underestimated in comparison with basic and diagnostic research.

  8. Unique roles of SPET brain imaging in clinical and research studies. Lessons from Parkinson's disease research.

    Science.gov (United States)

    Seibyl, J; Jennings, D; Tabamo, R; Marek, K

    2005-06-01

    The increasing availability of PET imaging in nuclear medicine expands the armamentarium of clinical and research tools for improving diagnosis and treatment of neuropsychiatric disorders. Nonetheless, the role of SPECT imaging remains critical to both research and clinical practice. The development of rational strategies for guiding the selection of imaging modalities flows from primarily the nature of the clinical or research question and the availability of appropriate radiopharmaceuticals. There has been extensive SPECT and PET work in Parkinson's disease (PD) which highlights the value of both these scintigraphic modalities. Three main areas of interest in PD include imaging for improving diagnostic accuracy, for monitoring the progression of disease, and for assessing the therapeutic efficacy of drugs with neuroprotective potential. The demands of the clinical or research question posed to imaging dictates the selection of radiotracer and imaging modality. Diagnosis of PD represents the easiest challenge with many imaging biomarkers showing high sensitivity for detecting abnormal reduction of dopaminergic function based on qualitative review of images. On the other hand, using imaging to evaluate treatments which purportedly slow the rate of disease progression, indicated by the reduction in the rate of loss in a quantitative imaging signal in patients studied over time, represents the most rigorous requirement of the imaging measure. In each of these applications presynaptic markers of dopaminergic function using SPECT and PET have been extremely valuable. Review of neuroimaging studies of PD provides a useful example of optimized approaches to clinical and research studies in neuropsychiatric disorders.

  9. [The clinical use of cryopreserved human skin allografts for transplantation].

    Science.gov (United States)

    Martínez-Flores, Francisco; Chacón-Gómez, María; Madinaveitia-Villanueva, Juan Antonio; Barrera-Lopez, Araceli; Aguirre-Cruz, Lucinda; Querevalu-Murillo, Walter

    2015-01-01

    The biological recovery of human skin allografts is the gold standard for preservation in Skin Banks. However, there is no worldwide consensus about specific allocation criteria for preserved human skin allografts with living cells. A report is presented on the results of 5 years of experience of using human skin allografts in burned patient in the Skin and Tissue Bank at the "Instituto Nacional de Rehabilitacion" The human skin allografts were obtained from multi-organ donors. processed and preserved at -80 °C for 12 months. Allocation criteria were performed according to blood type match, clinical history, and burned body surface. Up to now, the Skin and Tissue Bank at 'Instituto Nacional de Rehabilitacion" has processed and recovered 125,000 cm(2) of human skin allografts. It has performed 34 surgical implants on 21 burned patients. The average of burn body surface was 59.2%. More than two-thirds (67.7%) of recipients of skin allografts were matched of the same to type blood of the donor, and 66.6% survived after 126 days hospital stay. It is proposed to consider recipient's blood group as allocation criteria to assign tissue; and use human skin allografts on patiens affected with burns over 30% of body surface (according the "rule of the 9"). Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

  10. Clinical Pharmacology Research Internships at the Interface between Academia and Industry: Students' Perceptions and Scientific Output.

    Science.gov (United States)

    Goulooze, Sebastiaan C; Franson, Kari L; Cohen, Adam F; Rissmann, Robert

    2017-01-08

    The Centre for Human Drug Research (CHDR) is a non-profit clinical research institute at the interface between academia and the pharmaceutical industry. CHDR hosts a research internship programme for undergraduate (bio)medical students. The aim of this study was (i) to investigate the student perceptions of the undergraduate research internship and (ii) to quantify the scientific output related to these internships. We surveyed former interns at the CHDR from the year 2007 to 2014 and quantified their scientific output with a PubMed search. There was a response rate to the survey of 61%, with a good overall rating of the internships. Many students considered their internship at CHDR to be (much) more broad (55%) and with a (much) stricter planning (48%), compared to previous internships at academic research groups. In turn, there were many aspects reported to be similar to academic research internships such as focus on research methodology and 'outcome-drivenness'. Twenty-four per cent of the internships resulted in a co-authorship on papers published in peer-reviewed journals with an average impact factor of 3.3. In conclusion, with appropriate management and supervision, effective research electives are possible in the more commercial environment of a clinical research organization.

  11. Human transcriptome array for high-throughput clinical studies.

    Science.gov (United States)

    Xu, Weihong; Seok, Junhee; Mindrinos, Michael N; Schweitzer, Anthony C; Jiang, Hui; Wilhelmy, Julie; Clark, Tyson A; Kapur, Karen; Xing, Yi; Faham, Malek; Storey, John D; Moldawer, Lyle L; Maier, Ronald V; Tompkins, Ronald G; Wong, Wing Hung; Davis, Ronald W; Xiao, Wenzhong

    2011-03-01

    A 6.9 million-feature oligonucleotide array of the human transcriptome [Glue Grant human transcriptome (GG-H array)] has been developed for high-throughput and cost-effective analyses in clinical studies. This array allows comprehensive examination of gene expression and genome-wide identification of alternative splicing as well as detection of coding SNPs and noncoding transcripts. The performance of the array was examined and compared with mRNA sequencing (RNA-Seq) results over multiple independent replicates of liver and muscle samples. Compared with RNA-Seq of 46 million uniquely mappable reads per replicate, the GG-H array is highly reproducible in estimating gene and exon abundance. Although both platforms detect similar expression changes at the gene level, the GG-H array is more sensitive at the exon level. Deeper sequencing is required to adequately cover low-abundance transcripts. The array has been implemented in a multicenter clinical program and has generated high-quality, reproducible data. Considering the clinical trial requirements of cost, sample availability, and throughput, the GG-H array has a wide range of applications. An emerging approach for large-scale clinical genomic studies is to first use RNA-Seq to the sufficient depth for the discovery of transcriptome elements relevant to the disease process followed by high-throughput and reliable screening of these elements on thousands of patient samples using custom-designed arrays.

  12. Development, implementation and critique of a bioethics framework for pharmaceutical sponsors of human biomedical research.

    Science.gov (United States)

    Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

    2015-11-01

    Pharmaceutical human biomedical research is a multi-dimensional endeavor that requires collaboration among many parties, including those who sponsor, conduct, participate in, or stand to benefit from the research. Human subjects' protections have been promulgated to ensure that the benefits of such research are accomplished with respect for and minimal risk to individual research participants, and with an overall sense of fairness. Although these protections are foundational to clinical research, most ethics guidance primarily highlights the responsibilities of investigators and ethics review boards. Currently, there is no published resource that comprehensively addresses bioethical responsibilities of industry sponsors; including their responsibilities to parties who are not research participants, but are, nevertheless key stakeholders in the endeavor. To fill this void, in 2010 Eli Lilly and Company instituted a Bioethics Framework for Human Biomedical Research. This paper describes how the framework was developed and implemented and provides a critique based on four years of experience. A companion article provides the actual document used by Eli Lilly and Company to guide ethical decisions regarding all phases of human clinical trials. While many of the concepts presented in this framework are not novel, compiling them in a manner that articulates the ethical responsibilities of a sponsor is novel. By utilizing this type of bioethics framework, we have been able to develop bioethics positions on various topics, provide research ethics consultations, and integrate bioethics into the daily operations of our human biomedical research. We hope that by sharing these companion papers we will stimulate discussion within and outside the biopharmaceutical industry for the benefit of the multiple parties involved in pharmaceutical human biomedical research.

  13. Breath analysis: clinical research to the end-user market.

    Science.gov (United States)

    Smith, T

    2011-09-01

    Breath research is now well established and is solving some of the applications in the area of identifying volatiles for medical diagnosis. This paper looks at how this research has been taken to an end-user market. It is not intended to be an indepth study of the science but simply to draw attention to the role of the commercial link between the researcher and end-user. This market is not only in research but exists in hospitals, clinics, sports medicine and even homecare. The link between research and the end-user market is a vital one to avoid breath analysis being the tool of researchers only. The ubiquitous use of breath analysis depends upon it. This is a review of some of the success stories in commercializing the important breath analysis research that has been conducted over the last few decades. In order to make breath analysis the new blood test, products that have end-user appeal need to be developed and routes to market established.

  14. Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine.

    Science.gov (United States)

    Green, Robert C; Goddard, Katrina A B; Jarvik, Gail P; Amendola, Laura M; Appelbaum, Paul S; Berg, Jonathan S; Bernhardt, Barbara A; Biesecker, Leslie G; Biswas, Sawona; Blout, Carrie L; Bowling, Kevin M; Brothers, Kyle B; Burke, Wylie; Caga-Anan, Charlisse F; Chinnaiyan, Arul M; Chung, Wendy K; Clayton, Ellen W; Cooper, Gregory M; East, Kelly; Evans, James P; Fullerton, Stephanie M; Garraway, Levi A; Garrett, Jeremy R; Gray, Stacy W; Henderson, Gail E; Hindorff, Lucia A; Holm, Ingrid A; Lewis, Michelle Huckaby; Hutter, Carolyn M; Janne, Pasi A; Joffe, Steven; Kaufman, David; Knoppers, Bartha M; Koenig, Barbara A; Krantz, Ian D; Manolio, Teri A; McCullough, Laurence; McEwen, Jean; McGuire, Amy; Muzny, Donna; Myers, Richard M; Nickerson, Deborah A; Ou, Jeffrey; Parsons, Donald W; Petersen, Gloria M; Plon, Sharon E; Rehm, Heidi L; Roberts, J Scott; Robinson, Dan; Salama, Joseph S; Scollon, Sarah; Sharp, Richard R; Shirts, Brian; Spinner, Nancy B; Tabor, Holly K; Tarczy-Hornoch, Peter; Veenstra, David L; Wagle, Nikhil; Weck, Karen; Wilfond, Benjamin S; Wilhelmsen, Kirk; Wolf, Susan M; Wynn, Julia; Yu, Joon-Ho

    2016-06-02

    Despite rapid technical progress and demonstrable effectiveness for some types of diagnosis and therapy, much remains to be learned about clinical genome and exome sequencing (CGES) and its role within the practice of medicine. The Clinical Sequencing Exploratory Research (CSER) consortium includes 18 extramural research projects, one National Human Genome Research Institute (NHGRI) intramural project, and a coordinating center funded by the NHGRI and National Cancer Institute. The consortium is exploring analytic and clinical validity and utility, as well as the ethical, legal, and social implications of sequencing via multidisciplinary approaches; it has thus far recruited 5,577 participants across a spectrum of symptomatic and healthy children and adults by utilizing both germline and cancer sequencing. The CSER consortium is analyzing data and creating publically available procedures and tools related to participant preferences and consent, variant classification, disclosure and management of primary and secondary findings, health outcomes, and integration with electronic health records. Future research directions will refine measures of clinical utility of CGES in both germline and somatic testing, evaluate the use of CGES for screening in healthy individuals, explore the penetrance of pathogenic variants through extensive phenotyping, reduce discordances in public databases of genes and variants, examine social and ethnic disparities in the provision of genomics services, explore regulatory issues, and estimate the value and downstream costs of sequencing. The CSER consortium has established a shared community of research sites by using diverse approaches to pursue the evidence-based development of best practices in genomic medicine.

  15. Use of clinical alerting to improve the collection of clinical research data.

    Science.gov (United States)

    Haerian, Krystl; McKeeby, Jon; Dipatrizio, Gary; Cimino, James J

    2009-11-14

    Data errors in electronic health records have been shown to have the potential to adversely impact the conclusions drawn from clinical research. We prospectively studied the efficacy of a new alert to infer errors in previously stored data and to decrease the frequency of data entry errors, in an attempt to improve the quality of data for clinical trials. For the purpose of this study, we monitored data entry errors in height or weight measurements. We predetermined the criteria for probable error as a ten percent variance from a patient's reference value. The care provider entering a value satisfying our error criteria received a disruptive pop-up alert message. The study revealed a significant decrease in the frequency of data errors stored in the EHR, from 2.4% before the alert to 0.9% after the alert. These findings have implications for the development of clinical research trial data collection support tools.

  16. Justice in human research ethics. A conceptual and practical guide.

    Science.gov (United States)

    Pieper, Ian; Thomson, Colin J H

    2013-03-01

    One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice--hether distributive or commutative--and what counts as a just distribution or exchange--are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researches on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.

  17. Construction of a shared system-based real-world clinical research system.

    Science.gov (United States)

    Wu, Huikun; Li, Xiaodong; Yang, Fan; Xie, Dan; Li, Hui; Huang, Jingjing; Guo, Mingxing

    2014-09-01

    Hubei Provincial Hospital of Traditional Chinese Medicine established research outpatient clinics to contribute to the major disease-entity research conducted by the National Traditional Chinese Medicine Clinical Research Base and to the construction of the National Traditional Chinese Medicine Treatment and Clinical Research Information Sharing System. With a view of developing a "real-world traditional Chinese medicine clinical research paradigm," these clinics explored the mode of constructing research outpatient clinics from the aspects of clinical research, health management, and characteristics diagnosis and treatment.

  18. Human embryonic stem cell research debates: a confucian argument.

    Science.gov (United States)

    Tsai, D F-C

    2005-11-01

    Human embryonic stem cell research can bring about major biomedical breakthroughs and thus contribute enormously to human welfare, yet it raises serious moral problems because it involves using human embryos for experiment. The "moral status of the human embryo" remains the core of such debates. Three different positions regarding the moral status of the human embryo can be categorised: the "all" position, the "none" position, and the "gradualist" position. The author proposes that the "gradualist" position is more plausible than the other two positions. Confucius's moral principle of jen, which proposes a unique theory of "love of gradation", and the principle of yi, which advocates "due treatment for persons", are then explored. The author then argues that our moral obligations to do good to other living organisms, persons, and our families are different. Putting together the "gradualist" position on the human embryo, and Confucius's theories of "love of gradation" and "due treatment for persons", the author concludes that the early embryo has less ethical significance than the later fetus and adult human. The moral obligation we have toward persons is clearer and stronger than that which we have toward human embryos. Embryo research is justifiable if it brings enormous welfare to human persons that cannot be otherwise achieved. The "love of gradation" requires us, however, to extend love and respect towards other entities according to their different status. We should therefore be very cautious in using human embryos for research, acknowledging the gradualist nature of their moral status.

  19. A LARGE HUMAN CENTRIFUGE FOR EXPLORATION AND EXPLOITATION RESEARCH

    Directory of Open Access Journals (Sweden)

    Jack J.W.A. van Loon

    2012-06-01

    Full Text Available This paper addresses concepts regarding the development of an Altered Gravity Platform (AGP that will serve as a research platform for human space exploration. Space flight causes a multitude of physiological problems, many of which are due to gravity level transitions. Going from Earth's gravity to microgravity generates fluid shifts, space motion sickness, cardiovascular deconditioning among other changes, and returning to a gravity environment again puts the astronauts under similar stressors. A prolonged stay in microgravity provokes additional deleterious changes such as bone loss, muscle atrophy and loss of coordination or specific psychological stresses. To prepare for future manned space exploration missions, a ground-based research test bed for validating countermeasures against the deleterious effects of g-level transitions is needed. The proposed AGP is a large rotating facility (diameter > 150 m, where gravity levels ranging from 1.1 to 1.5g are generated, covering short episodes or during prolonged stays of weeks or even months. On this platform, facilities are built where a crew of 6 to 8 humans can live autonomously. Adaptation from 1 g to higher g levels can be studied extensively and monitored continuously. Similarly, re-adaptation back to 1 g, after a prolonged period of altered g can also be investigated. Study of the physiological and psychological adaptation to changing g-levels will provide instrumental and predictive knowledge to better define the ultimate countermeasures that are needed for future successful manned space exploration missions to the Moon, Mars and elsewhere. The AGP initiative will allow scientific top experts in Europe and worldwide to investigate the necessary scientific, operational, and engineering inputs required for such space missions. Because so many different physiological systems are involved in adaptation to gravity levels, a multidisciplinary approach is crucial. One of the final and crucial

  20. Clinical data mining and research in the allergy office.

    Science.gov (United States)

    Dalan, Dan

    2010-06-01

    More data are anticipated from the expected increase in use of electronic health records (EHRs). Upcoming initiatives require reporting of quality measures, meaningful use of clinical decision support, alert systems, and pharmacovigilance - knowledge resulting through use of EHRs. Data mining is a new tool that will help us manage information and derive knowledge from these data, and is a part of evolving new disciplines of informatics and knowledge management. Studies are reported from smaller clinic data marts to larger repositories and warehouses in various health systems, biomedical registries, and the medical literature on the Internet. Data mining technologies show promise and challenges. Outcome measures as structured data and narrative text can be mined with human assistance and newer automated natural language processing software. Despite advances, the growing diversity of clinic EHRs lack integration and interoperability with Internet-based biomedical databases. Allergists have the capability to mine clinic EHRs to discover new information, which may be hidden in charts. A central allergy computer can serve not just as a registry but also allows functionalities to enable EHRs' meaningful use. Harmonization of technological and organizational standards will allow seamless use of new natural language processing (NLP) tools and ontologies through a semantic web.

  1. Aquaporins in Salivary Glands: From Basic Research to Clinical Applications

    Directory of Open Access Journals (Sweden)

    Christine Delporte

    2016-01-01

    Full Text Available Salivary glands are involved in saliva secretion that ensures proper oral health. Aquaporins are expressed in salivary glands and play a major role in saliva secretion. This review will provide an overview of the salivary gland morphology and physiology of saliva secretion, and focus on the expression, subcellular localization and role of aquaporins under physiological and pathophysiological conditions, as well as clinical applications involving aquaporins. This review is highlighting expression and localization of aquaporins in human, rat and mouse, the most studied species and is pointing out possible difference between major salivary glands, i.e., parotid, submandibular and sublingual glands.

  2. Confounding Effect in Clinical Research of Otolaryngology and Its Control

    Institute of Scientific and Technical Information of China (English)

    Yong-qiang Yu; Ming Zhang; Dong-yan Huang; Susan Armijo Olivo; Huai-an Yang; Yagesh Bambanini; Lyn Sonnenberg; renda Clark; Gabriela Constantinescu; Jason Qian Yu

    2015-01-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research’s conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research’s design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research’s design in which appropriate methods have been applied to prevent this effect. They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect.

  3. Review of clinical and laboratory features of human Brucellosis

    Directory of Open Access Journals (Sweden)

    Mantur B

    2007-01-01

    Full Text Available Infection with Brucella spp. continues to pose a human health risk globally despite strides in eradicating the disease from domestic animals. Brucellosis has been an emerging disease since the discovery of Brucella melitensis by Sir David Bruce in 1887. Although many countries have eradicated B. abortus from cattle, in some areas B. melitensis and B. suis have emerged as causes of this infection in cattle, leading to human infections. Currently B. melitensis remains the principal cause of human brucellosis worldwide including India. The recent isolation of distinct strains of Brucella from marine mammals as well as humans is an indicator of an emerging zoonotic disease. Brucellosis in endemic and non-endemic regions remains a diagnostic puzzle due to misleading non-specific manifestations and increasing unusual presentations. Fewer than 10% of human cases of brucellosis may be clinically recognized and treated or reported. Routine serological surveillance is not practiced even in Brucella - endemic countries and we suggest that this should be a part of laboratory testing coupled with a high index of clinical suspicion to improve the level of case detection. The screening of family members of index cases of acute brucellosis in an endemic area should be undertaken to pick up additional unrecognised cases. Rapid and reliable, sensitive and specific, easy to perform and automated detection systems for Brucella spp. are urgently needed to allow early diagnosis and adequate antibiotic therapy in time to decrease morbidity / mortality. The history of travel to endemic countries along with exposure to animals and exotic foods are usually critical to making the clinical diagnosis. Laboratory testing is indispensable for diagnosis. Therefore alertness of clinician and close collaboration with microbiologist are essential even in endemic areas to correctly diagnose and treat this protean human infection. Existing treatment options, largely based on

  4. Clinical research in neonates and infants: Challenges and perspectives.

    Science.gov (United States)

    Coppini, Raffaele; Simons, Sinno H P; Mugelli, Alessandro; Allegaert, Karel

    2016-04-30

    To date, up to 65% of drugs used in neonates and infants are off-label or unlicensed, as they were implemented in clinical care without the usual regulatory phases of pharmacological drug development. Pharmacotherapy in this age group is still mainly based on the individual clinical expertise of specialized pediatricians. Pharmacological trials involving neonates are indeed more difficult to perform: appropriate dosing is hampered by the rapid physiological changes occurring at this stage of development, and the selection of proper end-points and biomarkers is complicated by the limited knowledge of the pathophysiology of the specific diseases of infancy. Moreover, there are many ethical challenges in planning and conducting drug studies in pediatric patients (especially in newborns and infants). In the current review, we address some challenges and discuss possible perspectives to stimulate scientific and clinical pharmacological research in neonates and infants. We hereby aim to illustrate the add on value of the regulatory framework for model-based neonatal medicinal development currently used in Europe and the United States. We provide several examples of successful recent pharmacological trials performed in neonates and infants. In these examples, success was ensured by the implementation of specific pharmacokinetic assessments, thanks to accurate drug dosing achieved with a combination of dose validation, population pharmacokinetics and mathematical models of drug clearance and distribution; moreover, age-specific pharmacodynamics was considered via appropriate evaluations of drug efficacy with end-points adapted to the peculiar pathophysiology of diseases in this age group. These "pharmacological" challenges add to the ethical challenges that are always present in planning and conducting clinical studies in neonates and infants and support the opinion that clinical research in pediatrics should be evaluated by ad hoc ethical committees with specific

  5. Clinical trial network for the promotion of clinical research for rare diseases in Japan: muscular dystrophy clinical trial network.

    Science.gov (United States)

    Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi

    2016-07-11

    Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to

  6. Advancing probiotic research in humans in the United States: Challenges and strategies.

    Science.gov (United States)

    Sanders, Mary Ellen; Shane, Andi L; Merenstein, Daniel J

    2016-01-01

    This is a summary from a workshop convened as part of the 13(th) annual meeting of the International Scientific Association for Probiotics and Prebiotics. A group of 24 stakeholders, including clinical experts, researchers, federal government officials, funding agencies, lawyers and industry experts met to review the challenges of the current regulatory approach to human research on probiotics in the USA and to discuss ways to move research forward. There was agreement that some of the current regulatory requirements imposed on probiotic research in the United States hindered research progress and increased cost without improving study subject safety. Many situations were outlined by clinical investigators demonstrating the impact of regulatory delays on research progress. Additionally, research is compromised when study designs and outcomes require manipulation so as to invoke less burdensome regulatory requirements. These responses by investigators to regulatory requirements have placed United States' researchers at a disadvantage. The public ultimately suffer when research to clarify the role of these products on health is stalled. Workshop participants concurred that regulatory oversight should balance study subject vulnerability with documented safety for the intended use for the probiotic strain, and that human research on foods and supplements should not be be regulated as drug research. Challenges and potential improvement strategies are discussed.

  7. Human Microbiome and Learning Healthcare Systems: Integrating Research and Precision Medicine for Inflammatory Bowel Disease.

    Science.gov (United States)

    Chuong, Kim H; Mack, David R; Stintzi, Alain; O'Doherty, Kieran C

    2017-03-10

    Healthcare institutions face widespread challenges of delivering high-quality and cost-effective care, while keeping up with rapid advances in biomedical knowledge and technologies. Moreover, there is increased emphasis on developing personalized or precision medicine targeted to individuals or groups of patients who share a certain biomarker signature. Learning healthcare systems (LHS) have been proposed for integration of research and clinical practice to fill major knowledge gaps, improve care, reduce healthcare costs, and provide precision care. To date, much discussion in this context has focused on the potential of human genomic data, and not yet on human microbiome data. Rapid advances in human microbiome research suggest that profiling of, and interventions on, the human microbiome can provide substantial opportunity for improved diagnosis, therapeutics, risk management, and risk stratification. In this study, we discuss a potential role for microbiome science in LHSs. We first review the key elements of LHSs, and discuss possibilities of Big Data and patient engagement. We then consider potentials and challenges of integrating human microbiome research into clinical practice as part of an LHS. With rapid growth in human microbiome research, patient-specific microbial data will begin to contribute in important ways to precision medicine. Hence, we discuss how patient-specific microbial data can help guide therapeutic decisions and identify novel effective approaches for precision care of inflammatory bowel disease. To the best of our knowledge, this expert analysis makes an original contribution with new insights poised at the emerging intersection of LHSs, microbiome science, and postgenomics medicine.

  8. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2010-05-21

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... Research and Development Service on the relevance and feasibility of proposed projects and the scientific... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development...

  9. Human memory research: Current hypotheses and new perspectives

    Directory of Open Access Journals (Sweden)

    Antônio Jaeger

    Full Text Available Abstract Research on human memory has increased significantly in the last few decades. Inconsistencies and controversies inherent to such research, however, are rarely articulated on published reports. The goal of the present article is to present and discuss a series of open questions related to major topics on human memory research that can be addressed by future research. The topics covered here are visual working memory, recognition memory, emotion and memory interaction, and methodological issues of false memories studies. Overall, the present work reveals a series of open questions and alternative analysis which could be useful for the process of hypothesis generation, and consequently for the design and implementation of future research on human memory.

  10. Scientific Merit Review of Directed Research Tasks Within the NASA Human Research Program

    Science.gov (United States)

    Charles, John B.

    2010-01-01

    The Human Research Program is instrumental in developing and delivering research findings, health countermeasures, and human systems technologies for spacecraft. :HRP is subdivided into 6 research entities, or Elements. Each Element is charged with providing the Program with knowledge and capabilities to conduct research to address the human health and performance risks as well as advance the readiness levels of technology and countermeasures. Project: An Element may be further subdivided into Projects, which are defined as an integrated set of tasks undertaken to deliver a product or set of products

  11. Mapping gene associations in human mitochondria using clinical disease phenotypes.

    Directory of Open Access Journals (Sweden)

    Curt Scharfe

    2009-04-01

    Full Text Available Nuclear genes encode most mitochondrial proteins, and their mutations cause diverse and debilitating clinical disorders. To date, 1,200 of these mitochondrial genes have been recorded, while no standardized catalog exists of the associated clinical phenotypes. Such a catalog would be useful to develop methods to analyze human phenotypic data, to determine genotype-phenotype relations among many genes and diseases, and to support the clinical diagnosis of mitochondrial disorders. Here we establish a clinical phenotype catalog of 174 mitochondrial disease genes and study associations of diseases and genes. Phenotypic features such as clinical signs and symptoms were manually annotated from full-text medical articles and classified based on the hierarchical MeSH ontology. This classification of phenotypic features of each gene allowed for the comparison of diseases between different genes. In turn, we were then able to measure the phenotypic associations of disease genes for which we calculated a quantitative value that is based on their shared phenotypic features. The results showed that genes sharing more similar phenotypes have a stronger tendency for functional interactions, proving the usefulness of phenotype similarity values in disease gene network analysis. We then constructed a functional network of mitochondrial genes and discovered a higher connectivity for non-disease than for disease genes, and a tendency of disease genes to interact with each other. Utilizing these differences, we propose 168 candidate genes that resemble the characteristic interaction patterns of mitochondrial disease genes. Through their network associations, the candidates are further prioritized for the study of specific disorders such as optic neuropathies and Parkinson disease. Most mitochondrial disease phenotypes involve several clinical categories including neurologic, metabolic, and gastrointestinal disorders, which might indicate the effects of gene defects

  12. SPR-HPV技术检测宫颈人乳头瘤病毒感染状况的临床分析研究%Clinical analysis and research on infection status of human papillomavirus detected by SPR-HPV technology

    Institute of Scientific and Technical Information of China (English)

    李恬; 唐良萏; 卞度宏; 贾英; 黄新; 张新华

    2013-01-01

    Objective: To understand the infection status of human papillomavirus ( HPV) in female patients from the hospital by SPR - HPV technology. Methods: SPR - HPV technology was used to detect 24 kinds of HPV gene subtypes in cervical exfoliative cells and genital tract secretions of 1 000 women. Results: The total HPV infection rate was 28. 2% (282/1 000) , 22 subtypes were detected; 211 women (21. 1% ) were found with single infection of HPV, including 94 women with abnormal cytological Results: 71 women (7. 1% ) were found with multiple infection of HPV, including 32 women with abnormal cytological Results: there was no statistically significant difference between the women with single infection of HPV and the women with multiple infection of HPV (χ2 = 0. 005 5, P > 0. 05); among 211 women with single infection of HPV, 186 women were found with high risk HPV infection, including 90 women with abnormal cytological results ; 25 women were found with low risk HPV infection, including 4 women with abnormal cytological Results: there was statistically significant difference (χ2 =9.37, P < 0.005) . Among 211 women with single infection of HPV, the top four high risk HPV genotypes were HPV16, HPV58, HPV52, and HPV51, 54 women (25. 29% ) were found with HPV16 infection; HPV single infection was the main type a-mong HPV infection, among 151 women with abnormal cytological results, 94 women were found with single infection of HPV. Conclusion: The infection rate of HPV among women from the hospital was at a middle level compared with other areas in China, single infection and high risk infection were the main type. Appropriate HPV screening should be conducted among the cases receiving opportunistic screening in clinic , and regular follow - up should be performed, which is helpful to prevent and find cervical malignant lesions timely and reduce the damage of cervical malignant lesions to women.%目的:用SPR-HPV技术了解重庆医科大学附属第一医院就诊女性人

  13. Ethical considerations in clinical training, care and research in psychopharmacology.

    Science.gov (United States)

    Strous, Rael D

    2011-04-01

    Psychopharmacology is a powerful tool in psychiatry; however, it is one that demands responsibility in order to deal with the ethical complexities that accompany advances in the field. It is important that questions are asked and that ethical mindfulness and sensitivity are developed along with clinical skills. In order to cultivate and deepen ethical awareness and subsequently solve issues in optimal fashion, investment should be made in the development of an ethical decision-making process as well as in education in the ethics of psychopharmacology to trainees in the field at all stages of their educational development. A clear approach to identifying ethical problems, engaging various ethical concepts in considering solutions and then applying these principles in problem resolution is demanded. An openness in identifying and exploring issues has become crucial to the future development and maturation of psychopharmacologists, both research and clinical. Consideration must be given to the social implications of psychopharmacological practice, with the best interests of patients always paramount. From both a research and clinical perspective, psychopharmacology has to be practised with fairness, sensitivity and ethical relevance to all. While ethical issues related to psychopharmacological practice are varied and plentiful, this review focuses on advances in technology and biological sciences, personal integrity, special populations, and education and training.

  14. A survey of NAPNAP members' clinical and professional research priorities.

    Science.gov (United States)

    Sawin, Kathleen J; Lewin, Linda C; Niederhauser, Victoria P; Brady, Margaret A; Jones, Dolores; Butz, Arlene; Gallo, Agatha M; Schindler, Christine A; Trent, Cynthia A

    2012-01-01

    The purpose of this methodological article is to describe the development, implementation, and analysis of the survey used to determine NAPNAP members' ranking of research priorities, to describe the top priorities ranked by participants, and to determine if priorities differed by area of practice (primary, acute, or specialty care) or participant age. A cross-sectional descriptive design with an online survey was used. Completed by 324 NAPNAP members, the survey consisted of a demographic section and 90 statements in two domains: Clinical Priorities and Professional Role Priorities. Survey respondents strongly supported the top priorities with an average overall mean score of 4.0 or above on a 5-point Likert scale. Only three of the top 10 clinical and professional priorities differed by area of practice. No clinical priorities and only three professional priorities differed by age. The survey results were used to develop the NAPNAP Research Agenda. Both the survey results and the agenda can provide guidance for the NAPNAP Board, committees and interests groups as they develop initiatives and programs. Copyright © 2012 National Association of Pediatric Nurse Practitioners. Published by Mosby, Inc. All rights reserved.

  15. Clinical genetic research 3: Genetics ELSI (Ethical, Legal, and Social Issues) research.

    Science.gov (United States)

    Pullman, Daryl; Etchegary, Holly

    2015-01-01

    ELSI (Ethical, Legal, and Social Issues) is a widely used acronym in the bioethics literature that encompasses a broad range of research areas involved in examining the various impacts of science and technology on society. In Canada, GE3LS (Genetics, Ethical, Economic, Environmental, Legal, Social issues) is the term used to describe ELSI studies. It is intentionally more expansive in that GE3LS explicitly brings economic and environmental issues under its purview. ELSI/GE3LS research has become increasingly important in recent years as there has been a greater emphasis on "translational research" that moves genomics from the bench to the clinic. The purpose of this chapter is to outline a range of ELSI-related work that might be conducted as part of a large scale genetics or genomics research project, and to provide some practical insights on how a scientific research team might incorporate a strong and effective ELSI program within its broader research mandate. We begin by describing the historical context of ELSI research and the development of GE3LS research in the Canadian context. We then illustrate how some ELSI research might unfold by outlining a variety of research questions and the various methodologies that might be employed in addressing them in an area of ELSI research that is encompassed under the term "public engagement." We conclude with some practical pointers about how to build an effective ELSI/GE3LS team and focus within a broader scientific research program.

  16. Development of Clinical Data Mart of HMG-CoA Reductase Inhibitor for Varied Clinical Research

    Science.gov (United States)

    Kim, Hyunah; Jeong, Yoo Jin; Kim, Tong Min; Yang, So Jung; Baik, Sun Jung; Lee, Seung-Hwan; Cho, Jae Hyoung

    2017-01-01

    Background The increasing use of electronic medical record (EMR) systems for documenting clinical medical data has led to EMR data being increasingly accessed for clinical trials. In this study, a database of patients who were prescribed statins for the first time was developed using EMR data. A clinical data mart (CDM) was developed for cohort study researchers. Methods Seoul St. Mary's Hospital implemented a clinical data warehouse (CDW) of data for ~2.8 million patients, 47 million prescription events, and laboratory results for 150 million cases. We developed a research database from a subset of the data on the basis of a study protocol. Data for patients who were prescribed a statin for the first time (between the period from January 1, 2009 to December 31, 2015), including personal data, laboratory data, diagnoses, and medications, were extracted. Results We extracted initial clinical data of statin from a CDW that was established to support clinical studies; the data was refined through a data quality management process. Data for 21,368 patients who were prescribed statins for the first time were extracted. We extracted data every 3 months for a period of 1 year. A total of 17 different statins were extracted. It was found that statins were first prescribed by the endocrinology department in most cases (69%, 14,865/21,368). Conclusion Study researchers can use our CDM for statins. Our EMR data for statins is useful for investigating the effectiveness of treatments and exploring new information on statins. Using EMR is advantageous for compiling an adequate study cohort in a short period. PMID:28256114

  17. Evolution of clinical research: A history before and beyond james lind

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2010-01-01

    Full Text Available The evolution of clinical research traverses a long and fascinating journey. From the first recorded trial of legumes in biblical times to the first randomized controlled of trial of streptomycin in 1946, the history of clinical trial covers a wide variety of challenges - scientific, ethical and regulatory. The famous 1747 scurvy trial conducted by James Lind contained most elements of a controlled trial. The UK Medical Research Council′s (MRC trial of patulin for common cold in 1943 was the first double blind controlled trial. This paved the way for the first randomized control trial of streptomycin in pulmonary tuberculosis carried out in 1946 by MRC of the UK. This landmark trial was a model of meticulousness in design and implementation, with systematic enrolment criteria and data collection compared with the ad hoc nature of other contemporary research. Over the years, as the discipline of controlled trials grew in sophistication and influence, the streptomycin trial continues to be referred to as ground breaking. The ethical advances in human protection include several milestones - Nuremberg Code, Declaration of Helsinki, Belmont Report, and 1996, International Conference on Harmonization Good Clinical Practice guidance. In parallel to ethical guidelines, clinical trials started to become embodied in regulation as government authorities began recognizing a need for controlling medical therapies in the early 20th century. As the scientific advances continue to occur, there will be new ethical and regulatory challenges requiring dynamic updates in ethical and legal framework of clinical trials.

  18. Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.

    Science.gov (United States)

    Evers, David L; Fowler, Carol B; Mason, Jeffrey T; Mimnall, Rebecca K

    2015-08-01

    Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. These are the absence of maximum limits to risk and the potential for institutional review boards to include questionable benefits to subjects and society when weighing the risks and benefits of research protocols. The lack of a duty of medical care by physician-investigators to research subjects is likewise of concern. The transparency of microbial challenge experiments and the safety concerns raised in this work may stimulate further dialogue on the risks to participants of human experimentation.

  19. Assessing research impact in academic clinical medicine: a study using Research Excellence Framework pilot impact indicators

    Directory of Open Access Journals (Sweden)

    Ovseiko Pavel V

    2012-12-01

    Full Text Available Abstract Background Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE developed proposals for the Research Excellence Framework (REF to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. Methods The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford’s REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university’s Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate. Results The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. Conclusions While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing

  20. Research of Human Postural Balance Parameters

    Directory of Open Access Journals (Sweden)

    Julius Griškevičius

    2011-02-01

    Full Text Available In present article postural balance between subjects with stroke and healthy subjects, is being investigated with eyes opened and eyes closed. In the research participated 30 healthy subjects and 15 subjects with stroke. At the same time two experimental measurements were performed – postural balance was measured using balance platform and oscillations of the centre of mass were observed using two-axial accelerometer. It was noted, that amplitudes of subjects with stroke were larger almost two times than control group’s of healthy subjects. It was find out, that ratios of pressure distribution on both left and right legs are in range from 1 to 0.9 for healthy subjects, and ratios below 0.9 are common for subjects with stroke. When subjects were standing with eyes closed, sway amplitudes were higher and the ratios of load distribution on left and right legs were lower.Article in Lithuanian