Chimeric Antigen Receptor-Modified T Cells for Solid Tumors: Challenges and Prospects

PubMed Central

Guo, Yelei; Wang, Yao; Han, Weidong

2016-01-01

Recent studies have highlighted the successes of chimeric antigen receptor-modified T- (CART-) cell-based therapy for B-cell malignancies, and early phase clinical trials have been launched in recent years. The few published clinical studies of CART cells in solid tumors have addressed safety and feasibility, but the clinical outcome data are limited. Although antitumor effects were confirmed in vitro and in animal models, CART-cell-based therapy still faces several challenges when directed towards solid tumors, and it has been difficult to achieve the desired outcomes in clinical practice. Many studies have struggled to improve the clinical responses to and benefits of CART-cell treatment of solid tumors. In this review, the status quo of CART cells and their clinical applications for solid tumors will be summarized first. Importantly, we will suggest improvements that could increase the therapeutic effectiveness of CART cells for solid tumors and their future clinical applications. These interventions will make treatment with CART cells an effective and routine therapy for solid tumors. PMID:26998495

Spirulina in Clinical Practice: Evidence-Based Human Applications

PubMed Central

Karkos, P. D.; Leong, S. C.; Karkos, C. D.; Sivaji, N.; Assimakopoulos, D. A.

2011-01-01

Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and systematic reviews suggest that this alga may improve several symptoms and may even have an anticancer, antiviral and antiallergic effects. Current and potential clinical applications, issues of safety, indications, side-effects and levels of evidence are addressed in this review. Areas of ongoing and future research are also discussed. PMID:18955364

[Research Progress and Prospect of Applications of Finite Element Method in Lumbar Spine Biomechanics].

PubMed

Zhang, Zhenjun; Li, Yang; Liao, Zhenhua; Liu, Weiqiang

2016-12-01

Based on the application of finite element analysis in spine biomechanics,the research progress of finite element method applied in lumbar spine mechanics is reviewed and the prospect is forecasted.The related works,including lumbar ontology modeling,clinical application research,and occupational injury and protection,are summarized.The main research areas of finite element method are as follows:new accurate modeling process,the optimized simulation method,diversified clinical effect evaluation,and the clinical application of artificial lumbar disc.According to the recent research progress,the application prospects of finite element method,such as automation and individuation of modeling process,evaluation and analysis of new operation methods and simulation of mechanical damage and dynamic response,are discussed.The purpose of this paper is to provide the theoretical reference and practical guidance for the clinical lumbar problems by reviewing the application of finite element method in the field of the lumbar spine biomechanics.

Spinal cord injury: promising interventions and realistic goals.

PubMed

McDonald, John W; Becker, Daniel

2003-10-01

Long regarded as impossible, spinal cord repair is approaching the realm of reality as efforts to bridge the gap between bench and bedside point to novel approaches to treatment. It is important to recognize that the research playing field is rapidly changing and that new mechanisms of resource development are required to effectively make the transition from basic science discoveries to effective clinical treatments. This article reviews recent laboratory studies and phase 1 clinical trials in neural and nonneural cell transplantation, stressing that the transition from basic science to clinical applications requires a parallel rather than serial approach, with continuous, two-way feedback to most efficiently translate basic science findings, through evaluation and optimization, to clinical treatments. An example of mobilizing endogenous stem cells for repair is reviewed, with emphasis on the rapid application of basic science to clinical therapy. Successful and efficient transition from basic science to clinical applications requires (1) a parallel rather than a serial approach; (2) development of centers that integrate three spheres of science, translational, transitional, and clinical trials; and (3) development of novel resources to fund the most critically limited step of transitional to clinical trials.

Immunoregulation by Mesenchymal Stem Cells: Biological Aspects and Clinical Applications

PubMed Central

Castro-Manrreza, Marta E.; Montesinos, Juan J.

2015-01-01

Mesenchymal stem cells (MSCs) are multipotent cells capable of differentiation into mesenchymal lineages and that can be isolated from various tissues and easily cultivated in vitro. Currently, MSCs are of considerable interest because of the biological characteristics that confer high potential applicability in the clinical treatment of many diseases. Specifically, because of their high immunoregulatory capacity, MSCs are used as tools in cellular therapies for clinical protocols involving immune system alterations. In this review, we discuss the current knowledge about the capacity of MSCs for the immunoregulation of immunocompetent cells and emphasize the effects of MSCs on T cells, principal effectors of the immune response, and the immunosuppressive effects mediated by the secretion of soluble factors and membrane molecules. We also describe the mechanisms of MSC immunoregulatory modulation and the participation of MSCs as immune response regulators in several autoimmune diseases, and we emphasize the clinical application in graft versus host disease (GVHD). PMID:25961059

Silk Fibroin Biomaterial Shows Safe and Effective Wound Healing in Animal Models and a Randomized Controlled Clinical Trial.

PubMed

Zhang, Wei; Chen, Longkun; Chen, Jialin; Wang, Lingshuang; Gui, Xuexian; Ran, Jisheng; Xu, Guowei; Zhao, Hongshi; Zeng, Mengfeng; Ji, Junfeng; Qian, Li; Zhou, Jianda; Ouyang, Hongwei; Zou, Xiaohui

2017-05-01

Due to its excellent biological and mechanical properties, silk fibroin has been intensively explored for tissue engineering and regenerative medicine applications. However, lack of translational evidence has hampered its clinical application for tissue repair. Here a silk fibroin film is developed and its translational potential is investigated for skin repair by performing comprehensive preclinical and clinical studies to fully evaluate its safety and effectiveness. The silk fibroin film fabricated using all green chemistry approaches demonstrates remarkable characteristics, including transmittance, fluid handling capacity, moisture vapor permeability, waterproofness, bacterial barrier properties, and biocompatibility. In vivo rabbit full-thickness skin defect study shows that the silk fibroin film effectively reduces the average wound healing time with better skin regeneration compared with the commercial wound dressings. Subsequent assessment in porcine model confirms its long-term safety and effectiveness for full-thickness skin defects. Finally, a randomized single-blind parallel controlled clinical trial with 71 patients shows that the silk fibroin film significantly reduces the time to wound healing and incidence of adverse events compared to commercial dressing. Therefore, the study provides systematic preclinical and clinical evidence that the silk fibroin film promotes wound healing thereby establishing a foundation towards its application for skin repair and regeneration in the clinic. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine].

PubMed

Wang, Yue-Xi; Liu, Meng-Yu; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Xue-Yao; Liu, Yu-Qi; Wang, Yan-Ping; Han, Xue-Jie

2017-09-01

To assess the quality and application effect of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine(Guidelines) through the applicability and applicability evaluation respectively. The questionnaire survey was adopted to evaluate the applicability of the Guidelines, including the utilization, quality, and clinical application conditions. The results showed that the familiarity rate and utilization rate of the Guidelines were 85.37%, 48.78%, respectively. The data showed that the familiarity and the utilization rates were different in the working staff with different professional titles. The evaluation level was the lowest given by the staff with junior professional title (70.97%, 29.03%) in comparison. The assessment showed the overall quality of the Guideline was good and slightly low level for the rationality scores of the other therapeutic methods as well as for the recuperation and prevention (80.49%, 85.37%), which was in line with the clinical compliance of the Guideline. The perspective observation of clinical cases was used for the applicability evaluation, including clinical compliance of the Guideline, effect evaluation, and comprehensive assessment, et al. The results showed that the safety score was the highest, followed by the economic issue and efficacy. For the comprehensive evaluation of the applicability, complete applicability accounted for 29.27%, and the general applicability accounted for 87.80%. It was showed in the three index scores of the applicability evaluation that the accumulative score 7-9 scores were 75.65%, 73.89%, 71.12%. Through the applicability and applicability evaluation, the Guideline was satisfactory in the overall quality, high in the safety of clinical application and good in efficacy and economic issues. There are some limits on the development method and technical issues in the Guideline, which is required to be supplemented in the revision. Additionally, the strategy study on the promotion of the Guideline should be enhanced so as to expedite the recognition and utilization of the Guideline. Copyright© by the Chinese Pharmaceutical Association.

[Mechanisms and applications of transcutaneous electrical nerve stimulation in analgesia].

PubMed

Tang, Zheng-Yu; Wang, Hui-Quan; Xia, Xiao-Lei; Tang, Yi; Peng, Wei-Wei; Hu, Li

2017-06-25

Transcutaneous electrical nerve stimulation (TENS), as a non-pharmacological and non-invasive analgesic therapy with low-cost, has been widely used to relieve pain in various clinical applications, by delivering current pulses to the skin area to activate the peripheral nerve fibers. Nevertheless, analgesia induced by TENS varied in the clinical practice, which could be caused by the fact that TENS with different stimulus parameters has different biological mechanisms in relieving pain. Therefore, to advance our understanding of TENS in various basic and clinical studies, we discussed (1) neurophysiological and biochemical mechanisms of TENS-induced analgesia; (2) relevant factors that may influence analgesic effects of TENS from the perspectives of stimulus parameters, including stimulated position, pulse parameters (current intensity, frequency, and pulse width), stimulus duration and used times in each day; and (3) applications of TENS in relieving clinical pain, including post-operative pain, chronic low back pain and labor pain. Finally, we propose that TENS may involve multiple and complex psychological neurophysiological mechanisms, and suggest that different analgesic effects of TENS with different stimulus parameters should be taken into consideration in clinical applications. In addition, to optimize analgesic effect, we recommend that individual-based TENS stimulation parameters should be designed by considering individual differences among patients, e.g., adaptively adjusting the stimulation parameters based on the dynamic ratings of patients' pain.

Bioeffect of lipohemia rabbits irradiated in oral mucosa with 650-nm diode-laser-accompanied oxygen inspiration and clinical application

NASA Astrophysics Data System (ADS)

Yang, Fu-Shou; Tang, Jin-Xian; Liu, Cheng; Yang, Xi-Cheng; Pang, Hi-Xiu

1998-11-01

The study on irradiating in oral mucosa of rabbits with 650 nm diode laser and clinical application has been reported in this paper. The result of animal experiment showed: the obvious decrease of cholesterin and triglyceride has been found among those highly lipohemia rabbits in the experiments of 650nm diode laser irradiating accompanying with oxygen, as well as the parameters of hemorheology obviously being improved, as compared with highly lipohemia rabbits un-irradiating, the statistical analysis showing P < 0.01. In the meantime, the observation of histopathology shows, the lipide decreasing in aorta wall, intramyocardinal membranous layer,and renal interstitial in the group of rabbits which are irradiated with laser and accompanying with oxygen inspiration, and even the perfectly recovered tissue in some rabbits has been seen. This experimental result is significantly for clinical application. The results of clinic application showed, that the patients employed this method which treatment cerebral infarction, lipohemia, the total effective ratio achieved 91.7 percent, perfect effect 30.6 percent.

Cryopreservation of Human Mesenchymal Stem Cells for Clinical Applications: Current Methods and Challenges.

PubMed

Yong, Kar Wey; Wan Safwani, Wan Kamarul Zaman; Xu, Feng; Wan Abas, Wan Abu Bakar; Choi, Jane Ru; Pingguan-Murphy, Belinda

2015-08-01

Mesenchymal stem cells (MSCs) hold many advantages over embryonic stem cells (ESCs) and other somatic cells in clinical applications. MSCs are multipotent cells with strong immunosuppressive properties. They can be harvested from various locations in the human body (e.g., bone marrow and adipose tissues). Cryopreservation represents an efficient method for the preservation and pooling of MSCs, to obtain the cell counts required for clinical applications, such as cell-based therapies and regenerative medicine. Upon cryopreservation, it is important to preserve MSCs functional properties including immunomodulatory properties and multilineage differentiation ability. Further, a biosafety evaluation of cryopreserved MSCs is essential prior to their clinical applications. However, the existing cryopreservation methods for MSCs are associated with notable limitations, leading to a need for new or improved methods to be established for a more efficient application of cryopreserved MSCs in stem cell-based therapies. We review the important parameters for cryopreservation of MSCs and the existing cryopreservation methods for MSCs. Further, we also discuss the challenges to be addressed in order to preserve MSCs effectively for clinical applications.

A Teaching Simulation Is Effective in Improving Athletic Training Students' Football Helmet Facemask Removal Clinical Skills and Confidence

ERIC Educational Resources Information Center

Popp, Jennifer K.; Walker, Stacy E.

2017-01-01

Context: Patient encounters related to acute care skills rarely occur in clinical education, leaving a potential gap in students' skills and confidence. Objective: Investigate the effects of an acute care simulation requiring football helmet facemask removal on clinical skill application and confidence in athletic training students. Design:…

Neuroprotective effect of lidocaine: is there clinical potential?

PubMed Central

Leng, Tiandong; Gao, Xiuren; Dilger, James P; Lin, Jun

2016-01-01

Local anesthetic lidocaine has been shown to be protective in animal models of focal and global ischemia as well as in in vitro hypoxic models. Lidocaine has been tested in patients for its potential protective effect on postoperative cognitive dysfunction. This mini-review summarizes the laboratory and clinical evidences and discusses its clinical applications as neuroprotective agent. PMID:27186318

Clinical applications of plasma based electrosurgical systems

NASA Astrophysics Data System (ADS)

Woloszko, Jean; Endler, Ashley; Ryan, Thomas P.; Stalder, Kenneth R.

2013-02-01

Over the past 18 years, several electrosurgical systems generating a low temperature plasma in an aqueous conductive solution have been commercialized for various clinical applications and have been used in over 10 million patients to date. The most popular utilizations are in arthroscopic surgery, otorhinolaryngology surgery, spine and neurosurgery, urology and wound care. These devices can be configured to bring saline to the tip and to have concomitant aspiration to remove by-products and excess fluid. By tuning the electrode geometry, waveform and fluid dynamic at the tip of the devices, tissue resection and thermal effects can be adjusted individually. This allows one to design products that can operate as precise tissue dissectors for treatment of articular cartilage or debridement of chronic wounds, as well as global tissue debulking devices providing sufficient concomitant hemostasis for applications like tonsillectomies. Effects of these plasma based electrosurgical devices on cellular biology, healing response and nociceptive receptors has also been studied in various models. This talk will include a review of the clinical applications, with product descriptions, results and introductory review of some of the research on the biological effects of these devices.

Mechanisms and Clinical Application of Tetramethylpyrazine (an Interesting Natural Compound Isolated from Ligusticum Wallichii): Current Status and Perspective.

PubMed

Zhao, Yingke; Liu, Yue; Chen, Keji

Tetramethylpyrazine, a natural compound from Ligusticum wallichii ( Chuan Xiong ), has been extensively used in China for cardiovascular and cerebrovascular diseases for about 40 years. Because of its effectiveness in multisystems, especially in cardiovascular, its pharmacological action, clinical application, and the structural modification have attracted broad attention. In this paper its mechanisms of action, the clinical status, and synthetic derivatives will be reviewed briefly.

Closing the gap between science and practice: the need for professional leadership.

PubMed

Eagle, Kim A; Garson, Arthur J; Beller, George A; Sennett, Cary

2003-01-01

Major opportunity exists to better align clinical science and clinical practice. To do so will require efforts not only to develop clinical practice guidelines, but to facilitate their application in practice. The American College of Cardiology operates a program to develop and assess the effectiveness of tools that facilitate the application of guidelines in practice. Here we review what we have learned about the process of guideline implementation, lay out the major research questions that need to be addressed, and argue that professional societies play a critical role in moving from guideline development to application.

Wireless remote control clinical image workflow: utilizing a PDA for offsite distribution

NASA Astrophysics Data System (ADS)

Liu, Brent J.; Documet, Luis; Documet, Jorge; Huang, H. K.; Muldoon, Jean

2004-04-01

Last year we presented in RSNA an application to perform wireless remote control of PACS image distribution utilizing a handheld device such as a Personal Digital Assistant (PDA). This paper describes the clinical experiences including workflow scenarios of implementing the PDA application to route exams from the clinical PACS archive server to various locations for offsite distribution of clinical PACS exams. By utilizing this remote control application, radiologists can manage image workflow distribution with a single wireless handheld device without impacting their clinical workflow on diagnostic PACS workstations. A PDA application was designed and developed to perform DICOM Query and C-Move requests by a physician from a clinical PACS Archive to a CD-burning device for automatic burning of PACS data for the distribution to offsite. In addition, it was also used for convenient routing of historical PACS exams to the local web server, local workstations, and teleradiology systems. The application was evaluated by radiologists as well as other clinical staff who need to distribute PACS exams to offsite referring physician"s offices and offsite radiologists. An application for image workflow management utilizing wireless technology was implemented in a clinical environment and evaluated. A PDA application was successfully utilized to perform DICOM Query and C-Move requests from the clinical PACS archive to various offsite exam distribution devices. Clinical staff can utilize the PDA to manage image workflow and PACS exam distribution conveniently for offsite consultations by referring physicians and radiologists. This solution allows the radiologist to expand their effectiveness in health care delivery both within the radiology department as well as offisite by improving their clinical workflow.

Effects of using mobile device-based academic electronic medical records for clinical practicum by undergraduate nursing students: A quasi-experimental study.

PubMed

Choi, Mona; Lee, HyeongSuk; Park, Joon Ho

2018-02-01

The academic electronic medical record (AEMR) system is applied with the expectation that nursing students will be able to attain competence in healthcare decision-making and nursing informatics competencies. However, there is insufficient evidence regarding the advantage of applying mobile devices to clinical practicum. This study aimed to examine the effect of an experiment that introduced a mobile AEMR application for undergraduate nursing students in their practicum. A quasi-experimental design was used. The subjects were 75 third-year nursing students enrolled in clinical practicum and were divided into an experimental (practicum with AEMR) and a control (conventional practicum) group. Nursing informatics competencies, critical thinking disposition, and satisfaction with clinical practicum were measured before and after the clinical practicum for each group. The usability of the AEMR application was also examined for the experimental group after the experiment. After the experiment, the experimental group showed a significant increase in the informatics knowledge domain of nursing informatics competencies in the post-test. The difference in critical thinking between the experimental and control groups was not statistically significant. Regarding satisfaction with the clinical practicum, the experimental group exhibited a significantly higher level of satisfaction in "preparation of a diagnostic test or laboratory test and understanding of the results" and "nursing intervention and documentation" than the control group. Students who participated in the practicum using the AEMR application considered it useful. The AEMR application was an effective educational method for practicing the immediate documentation of students' observations and interventions and was available at the patients' bedsides. To improve critical thinking, it is necessary to apply a variety of approaches when solving clinical problems. Copyright © 2017 Elsevier Ltd. All rights reserved.

[The effectiveness of fenspiride in the treatment of patients with chronic obstructive pulmonary disease].

PubMed

Butorov, S I; Muntianu, V I

2007-01-01

The purpose of the study was to assess the effectiveness and safety of long-term application of fenspiride, an anti-inflammatory drug, in patients with chronic obstructive pulmonary disease (COPD) under outpatient conditions. The drug was studied on 24 COPD patients. Fenspiride application resulted in improvement in bronchoobstructive syndrome and external respiration parameters, as well as a significant increase in exercise tolerance. In patients with stable stage I COPD, the use of fenspiride as a part of therapeutic regimen leads to better clinical results than in stage II patients. Long-term application of fenspiride in medium therapeutic doses under outpatient conditions is associated with positive clinical effects and leads to significant improvement in quality of life.

Application of Platelet-Rich Plasma to Disorders of the Knee Joint

PubMed Central

Mandelbaum, Bert R.; McIlwraith, C. Wayne

2013-01-01

Importance. The promising therapeutic potential and regenerative properties of platelet-rich plasma (PRP) have rapidly led to its widespread clinical use in musculoskeletal injury and disease. Although the basic scientific rationale surrounding PRP products is compelling, the clinical application has outpaced the research. Objective. The purpose of this article is to examine the current concepts around the basic science of PRP application, different preparation systems, and clinical application of PRP in disorders in the knee. Evidence Acquisition. A systematic search of PubMed for studies that evaluated the basic science, preparation and clinical application of platelet concentrates was performed. The search used terms, including platelet-rich plasma or PRP preparation, activation, use in the knee, cartilage, ligament, and meniscus. Studies found in the initial search and related studies were reviewed. Results. A comprehensive review of the literature supports the potential use of PRP both nonoperatively and intraoperatively, but highlights the absence of large clinical studies and the lack of standardization between method, product, and clinical efficacy. Conclusions and Relevance. In addition to the call for more randomized, controlled clinical studies to assess the clinical effect of PRP, at this point, it is necessary to investigate PRP product composition and eventually have the ability to tailor the therapeutic product for specific indications. PMID:26069674

Clinical applications of breath testing

PubMed Central

Paschke, Kelly M; Mashir, Alquam

2010-01-01

Breath testing has the potential to benefit the medical field as a cost-effective, non-invasive diagnostic tool for diseases of the lung and beyond. With growing evidence of clinical worth, standardization of methods, and new sensor and detection technologies the stage is set for breath testing to gain considerable attention and wider application in upcoming years. PMID:21173863

Clinical applications of bioactive milk components

PubMed Central

Newburg, David S.

2015-01-01

Milk represents a unique resource for translational medicine: It contains a rich pool of biologically active molecules with demonstrated clinical benefits. The ongoing characterization of the mechanistic process through which milk components promote development and immunity has revealed numerous milk-derived compounds with potential applications as clinical therapies in infectious and inflammatory disease, cancer, and other conditions. Lactoferrin is an effective antimicrobial and antiviral agent in high-risk patient populations and a potentially potent adjuvant to chemotherapy in lung cancer. Enteric nutrition formulas supplemented with transforming growth factor β, a milk cytokine, have been shown to promote remission in pediatric Crohn's disease. A number of milk glycans, including human milk oligosaccharides, show promise in preclinical studies as antimicrobial and anti-inflammatory agents. While active preclinical investigations of human milk may soon result in large-scale production of human milk molecules, bovine milk components in many instances represent a practical source of bioactive milk compounds for use in clinical trials. This review summarizes current efforts to translate the compounds derived from human and bovine milk into effective clinical therapies. These efforts suggest a common pathway for the translation of milk-derived compounds into clinical applications. PMID:26011900

Clinical applications of bioactive milk components.

PubMed

Hill, David R; Newburg, David S

2015-07-01

Milk represents a unique resource for translational medicine: It contains a rich pool of biologically active molecules with demonstrated clinical benefits. The ongoing characterization of the mechanistic process through which milk components promote development and immunity has revealed numerous milk-derived compounds with potential applications as clinical therapies in infectious and inflammatory disease, cancer, and other conditions. Lactoferrin is an effective antimicrobial and antiviral agent in high-risk patient populations and a potentially potent adjuvant to chemotherapy in lung cancer. Enteric nutrition formulas supplemented with transforming growth factor β, a milk cytokine, have been shown to promote remission in pediatric Crohn's disease. A number of milk glycans, including human milk oligosaccharides, show promise in preclinical studies as antimicrobial and anti-inflammatory agents. While active preclinical investigations of human milk may soon result in large-scale production of human milk molecules, bovine milk components in many instances represent a practical source of bioactive milk compounds for use in clinical trials. This review summarizes current efforts to translate the compounds derived from human and bovine milk into effective clinical therapies. These efforts suggest a common pathway for the translation of milk-derived compounds into clinical applications.

Review of Virtual Reality Treatment in Psychiatry: Evidence Versus Current Diffusion and Use.

PubMed

Mishkind, Matthew C; Norr, Aaron M; Katz, Andrea C; Reger, Greg M

2017-09-18

This review provides an overview of the current evidence base for and clinical applications of the use of virtual reality (VR) in psychiatric practice, in context of recent technological developments. The use of VR in psychiatric practice shows promise with much of the research demonstrating clinical effectiveness for conditions including post-traumatic stress disorder, anxiety and phobias, chronic pain, rehabilitation, and addictions. However, more research is needed before the use of VR is considered a clinical standard of practice in some areas. The recent release of first generation consumer VR products signals a change in the viability of further developing VR systems and applications. As applications increase so will the need for good quality research to best understand what makes VR effective, and when VR is not appropriate for clinical services. As the field progresses, it is hopeful that the flexibility afforded by this technology will yield superior outcomes and a better understanding of the underlying mechanisms impacting those outcomes.

Laboratory and clinical trials of cocamide diethanolamine lotion against head lice

PubMed Central

Brunton, Elizabeth R.; Brown, Christine M.

2015-01-01

Context. During the late 1990s, insecticide resistance had rendered a number of treatment products ineffective; some companies saw this as an opportunity to develop alternative types of treatment. We investigated the possibility that a surfactant-based lotion containing 10% cocamide diethanolamine (cocamide DEA) was effective to eliminate head louse infestation. Settings and Design. Initial in vitro testing of the lotion formulation versus laboratory reared body/clothing lice, followed by two randomised, controlled, community-based, assessor blinded, clinical studies. Materials and Methods. Preliminary laboratory tests were performed by exposing lice or louse eggs to the product using a method that mimicked the intended use. Clinical Study 1: Children and adults with confirmed head louse infestation were treated by investigators using a single application of aqueous 10% cocamide DEA lotion applied for 60 min followed by shampooing or a single 1% permethrin creme rinse treatment applied to pre-washed hair for 10 min. Clinical Study 2: Compared two treatment regimens using 10% cocamide DEA lotion that was concentrated by hair drying. A single application left on for 8 h/overnight was compared with two applications 7 days apart of 2 h duration, followed by a shampoo wash. Results. The initial laboratory tests showed a pediculicidal effect for a 60 min application but limited ovicidal effect. A longer application time of 8 h or overnight was found capable of killing all eggs but this differed between batches of test material. Clinical Study 1: Both treatments performed badly with only 3/23 (13%) successful treatments using cocamide DEA and 5/25 (23.8%) using permethrin. Clinical Study 2: The single overnight application of cocamide DEA concentrated by hair drying gave 10/56 (17.9%) successes compared with 19/56 (33.9%) for the 2 h application regimen repeated after 1 week. Intention to treat analysis showed no significant difference (p = 0.0523) between the treatments. Over the two studies, there were 18 adverse events possibly or probably associated with treatment, most of which were increased pruritus after treatment. Conclusions. Cocamide DEA 10% lotion, even when concentrated by hair drying, showed limited activity to eliminate head louse infestation. PMID:26557439

Cold Atmospheric Plasma for Medicine: State of Research and Clinical Application

NASA Astrophysics Data System (ADS)

von Woedtke, Thomas

2015-09-01

Basic research in plasma medicine has made excellent progress and resulted in the fundamental insights that biological effects of cold atmospheric plasmas (CAP) are significantly caused by changes of the liquid environment of cells, and are dominated by redox-active species. First CAP sources are CE-certified as medical devices. Main focus of plasma application is on wound healing and treatment of infective skin diseases. Clinical applications in this field confirm the supportive effect of cold plasma treatment in acceleration of healing of chronic wounds above all in cases where conventional treatment fails. Cancer treatment is another actual and emerging field of CAP application. The ability of CAP to kill cancer cells by induction of apoptosis has been proved in vitro. First clinical applications of CAP in palliative care of cancer are realized. In collaboration with Hans-Robert Metelmann, University Medicine Greifswald; Helmut Uhlemann, Klinikum Altenburger Land GmbH Altenburg; Anke Schmidt and Kai Masur, Leibniz Institute for Plasma Science and Technology (INP Greifswald); Renate Schönebeck, Neoplas Tools GmbH Greifswald; and Klaus-Dieter Weltmann, Leibniz Institute for Plasma Science and Technology (INP Greifswald).

[Vaccinations in psychiatry].

PubMed

Dols, A; van den Brink, W; Eikelenboom, P

2009-01-01

Vaccination is a well-known strategy for preventing and treating infections. The purpose of vaccinations is to render antigens harmless by the production of antibodies. In psychiatry there are also situations where antigens that have been introduced from outside or that have developed during an illness constitute a threat to the patient's health. To explore the possible applications of vaccination in psychiatry. In this article we discuss the applications of vaccination in psychiatry on the basis of two examples. In addiction research, trials are being conducted with antibodies against substances such as cocaine and nicotine in order to prevent such addictive substances from crossing the blood-brain barrier and thereby initiating their rewarding effect. The first clinical results are very promising, but vaccines have not yet been applied clinically. With regard to Alzheimer's disease it has been shown by means of animal models that specific antibodies can prevent AlphaBeta aggregation and dissolve existing aggregates. On the basis of these findings various large-scale clinical trials have begun in order to study immunotherapy for Alzheimer's disease. The first clinical results showed little neurocognitive effects. A wellknown study had to be terminated because of side-effects of the therapy, in the form of neuro-encephalitis. Our tentative conclusion is that the clinical application of immunotherapy in psychiatry still has its limitations, but is indeed promising.

From bench to bedside and to health policies: ethics in translational research.

PubMed

Petrini, C

2011-01-01

Translation of biomedical research knowledge to effective clinical treatment is essential to the public good. The first level of translation ("from bench to bedside") corresponds to efficacy studies under controlled conditions with careful attention to internal validity (clinical research). The second level is the translation of results from clinical studies into everyday clinical practice and health decision making. The article summarises the ethical issues involved in the translation of biomedical research advances to clinical applications and to clinical practice. In particular, the article synthesizes theory from clinical ethics, operational design, and philosophy to examine the unique bioethical issues raised by the recent focus on translational research. In this framework safety of study participants and balancing of risk due to treatment with the potential benefits of the research are crucial: in clinical research there is a danger that the emphasis on advancements in scientific knowledge might prevail over the protection of the people who participate in research. These issues involve basic scientists, clinicians and bioethicists because of their application to comparative effectiveness research, clinical trials and evidence-based medicine, as well basic biomedical research.

Effect of concentrated growth factors on beagle periodontal ligament stem cells in vitro.

PubMed

Yu, Bohan; Wang, Zuolin

2014-01-01

Identifying a reliable and effective cytokine or growth factor group has been the focus of stem cell osteogenic induction studies. Concentrated growth factors (CGFs) as the novel generation of platelet concentrate products, appear to exhibit a superior clinical and biotechnological application potential, however, there are few studies that have demonstrated this effect. This study investigated the proliferation and differentiation of periodontal ligament stem cells (PDLSCs) co‑cultured with CGFs. The rate of proliferation was analyzed by cell counting and an MTT assay. Mineralization nodule counts, alkaline phosphatase activity detection, qPCR, western blot analysis and immunohistochemistry were used to analyze mineralization effects. The results showed that CGF significantly promoted the proliferation of PDLSCs, and exhibited a dose‑dependent effect on the activation and differentiation of the stem cells. The application of CGF on PDLSC proliferation and osteoinduction may offer numerous clinical and biotechnological application strategies.

Melaleuca alternifolia and its application against dental plaque and periodontal diseases: A systematic review.

PubMed

Casarin, Maísa; Pazinatto, Josiele; Santos, Roberto Christ Vianna; Zanatta, Fabricio Batistin

2018-02-01

This is a systematic review of clinical and laboratory studies evaluating the effect of Melaleuca alternifolia on periodontopathogens, dental plaque, gingivitis, periodontitis, and inflammatory responses. The PubMed, Cochrane, Web of science, Bireme, Lilacs, Prospero, Open Grey, and Clinical Trials databases were searched to identify potentially eligible studies through October 2016. Of 1,654 potentially eligible studies, 25 were included in the systematic review. Their methodology was evaluated through the Cochrane Handbook for clinical studies and the GRADE system for in vivo/in vitro studies. Although clinical studies must be interpreted with caution due to methodological limitations, laboratory studies have found promising results. In vitro evidences showed that M. alternifolia has bactericidal and bacteriostatic effects against the most prevalent periodontopathogens. Clinical studies found comparable effects to chlorhexidine 0.12% in reducing gingival inflammation, although the antiplaque effect was lower. M. alternifolia also showed antioxidant properties, which are beneficial to the host, allied to the reduction on immune-inflammatory responses to pathogens. This systematic review suggests that the M. alternifolia has potential anti-inflammatory and antimicrobial properties, which can be easily applied to the periodontal tissues. However, further clinical trials are needed to elucidate the clinical relevance of its application. Copyright © 2017 John Wiley & Sons, Ltd.

A Brief Review of OPT101 Sensor Application in Near-Infrared Spectroscopy Instrumentation for Intensive Care Unit Clinics

PubMed Central

Li, Ting; Zhong, Fulin; Pan, Boan; Li, Zebin; Huang, Chong; Deng, Zishan

2017-01-01

The optoelectronic sensor OPT101 have merits in advanced optoelectronic response characteristics at wavelength range for medical near-infrared spectroscopy and small-size chip design with build-in trans-impedance amplifier. Our lab is devoted to developing a series of portable near-infrared spectroscopy (NIRS) devices embedded with OPT101 for applications in intensive care unit clinics, based on NIRS principle. Here we review the characteristics and advantages of OPT101 relative to clinical NIRS instrumentation, and the most recent achievements, including early-diagnosis and therapeutic effect evaluation of thrombus, noninvasive monitoring of patients' shock severity, and fatigue evaluation. The future prospect on OPT101 improvements in noninvasive clinical applications is also discussed. PMID:28757564

Comparing ECT data of two different inpatient clinics: propofol or thiopental?

PubMed

Yazici, Esra; Bosgelmez, Sukriye; Tas, Halil Ibrahim; Karabulut, Umit; Yazici, Ahmet Bulent; Yildiz, Mustafa; Kirpinar, Ismet

2013-10-01

This study compares the data of (modified) electroconvulsive theraphy (ECT) applications from two different inpatient clinics in Turkey: Kocaeli Derince Training and Research Hospital (Clinic-I) and Kocaeli University (Clinic-II). Recorded files of patients from the two clinics were compared in terms of ECT indications, number and duration of seizures, and anesthetic agents used (propofol vs. thiopental). ECT applications occurring between January 2011 and January 2013 were included in the study. A total of 86 patients (9.5% of the inpatients) received ECT in Clinic-I and 103 patients (21.1% of the inpatients) in Clinic-II during the period studied. The yearly ECT rate (treated person rate per 10,000 per year) was 0.59/10,000 for Kocaeli (Turkey) as a whole. The overall number of ECT applications was 539 in Clinic-I and 999 in Clinic-II, and the average number of ECT sessions for each patient was 6.4 ± 2.33 in Clinic-I and 9.69 ± 4.66 in Clinic-II. The majority of indications were depressive disorders and insufficient response to medicine. Patients in the clinic which utilized thiopental as the anesthetic agent experienced more cardiovascular and respiratory side effects than the one which used propofol. The number of ECT sessions required was greater for patients with schizoaffective disorder than for others. The administration of ECT was considered to be a reliable method of treatment in these clinics. With respect to specific anesthetic agents, propofol was found to have less hemodynamic side effects and shorter seizure durations than thiopental.

The application of ozone in dentistry: a systematic review of literature.

PubMed

Azarpazhooh, Amir; Limeback, Hardy

2008-02-01

(1) To systematically review the clinical application and remineralization potentials of ozone in dentistry; (2) To summarize the available in vitro applications of ozone in dentistry. Ovid MEDLINE, CINAHL, etc. (up to April 2007). In vitro or in vivo English language publications, original studies, and reviews were included. Conference papers, abstracts, and posters were excluded. In vitro: Good evidence of ozone biocompatibility with human oral epithelial cells, gingival fibroblast, and periodontal cells; Conflicting evidence of antimicrobial efficacy of ozone but some evidence that ozone is effective in removing the microorganisms from dental unit water lines, the oral cavity, and dentures; Conflicting evidence for the application of ozone in endodontics; Insufficient evidence for the application of ozone in oral surgery and implantology; Good evidence of the prophylactic application of ozone in restorative dentistry prior to etching and the placement of dental sealants and restorations. In vivo: Despite the promising in vitro evidence, the clinical application of ozone in dentistry (so far in management of dental and root caries) has not achieved a strong level of efficacy and cost-effectiveness. While laboratory studies suggest a promising potential of ozone in dentistry, this has not been fully realised in clinical studies to date. More well designed and conducted double-blind randomised clinical trials with adequate sample size, limited or no loss to follow up, and carefully standardised methods of measurement and analyses are needed to evaluate the possible use of ozone as a treatment modality in dentistry.

The Effects of an Interactive Nursing Skills Mobile Application on Nursing Students' Knowledge, Self-efficacy, and Skills Performance: A Randomized Controlled Trial.

PubMed

Kim, Hyunsun; Suh, Eunyoung E

2018-03-01

Clinical nursing practice is important because it helps nursing students experience realities of clinical nursing that cannot be learned through theoretical education. This study aimed to evaluate the effect of an interactive nursing skills mobile application for nursing students. Sixty-six senior nursing students were randomly assigned to experimental or control groups. The experimental group used an interactive nursing skills mobile application for 1 week. The control group was provided with a mobile application containing noninteractive nursing video contents for 1 week. Before (pre-test) and 1 week after (post-test) using the mobile application, participants' knowledge of clinical nursing skills, self-efficacy of nursing practice, and nursing skills performance were assessed. The experimental group showed a significantly higher value for knowledge after 1 week of treatment via their mobile application than the control group (t = 3.34, p = .001). In addition, they showed significantly improved self-efficacy before and after intervention (t = 2.46, p = .017) than the control group. The experimental group's nursing skills performance was also significantly enhanced after intervention (t = 7.05, p < .001), with a significant difference in the degree of improvement (t = 4.47, p < .001). The interactive learner-centered nursing education mobile application with systematic contents was an effective method for students to experience practical nursing skills. Developing and applying a mobile application with other nursing contents that can be effectively used across all range of nursing students is recommended. Copyright © 2018. Published by Elsevier B.V.

Therapeutic risk management of clinical-legal dilemmas: should it be a core competency?

PubMed

Simon, Robert I; Shuman, Daniel W

2009-01-01

Therapeutic risk management of clinical-legal dilemmas achieves an optimal alignment between clinical competence and an understanding of legal concerns applicable to psychiatric practice. Understanding how psychiatry and law interact in frequently occurring clinical situations is essential for effective patient care. Successful management of clinical-legal dilemmas also avoids unnecessary, counterproductive defensive practices.

Physical basics of endovenous laser treatment and potential of innovative developments

NASA Astrophysics Data System (ADS)

Sroka, R.; Esipova, A.; Schmedt, C. G.

2017-04-01

During the last decade, endoluminal laser treatment (ELT) has been rapidly developing. Protocols using radially emitting ELT fibres in combination with infrared laser light show clinical advantages over the bare-fibre technique and near infrared irradiation. Although the clinical response rate is high several side effects occurred. Innovative light application systems and feedback systems are therefore being under development to potentially improve the clinical situation. The irradiation patterns of bare fibres and radially emitting 1-ring and 2-ring fibres were measured using the goniometer technique. The device robustness, device handling and tissue effects were investigated using the established ox-foot-model. Furthermore, temperature measurements were performed either intraluminal within the irradiation field using a tiny temperature sensor and on the outer surface of the vessel wall by means of a thermocamera. All fibres showed sufficient mechanical and thermal robustness. The destruction threshold is far beyond the light powers employed during clinical application. The 1-ring fibre showed very high peak temperatures for a short time, while the 2-ring-fibre hold its somewhat lower maximum temperature for a longer time. Both forms of energy application resulted in the desired shrinkage and destruction effect. In this regard, the handling of the 2-ring fibre appears subjectively more convenient with reduced sticking-related problems. Acute tissue effects could be investigated to improve the understanding especially of the interaction between handling, maneuvers and tissue effects. The 2-ring radially emitting fibre in combination with IR laser light and specific application parameters showed improved handling and safety features.

The Effects of NBF Gingival Gel Application in the Treatment of the Erosive Lichen Planus: Case Report.

PubMed

Popovska, Mirjana; Fidovski, Jasmin; Mindova, Sonja; Dirjanska, Katerina; Ristoska, Stevica; Stefanovska, Emilija; Radojkova-Nikolovska, Vera; Mitic, Kristina; Rusevska, Biljana

2016-03-15

The therapy of erosive lichen planus (ELP) has been particular problem in the treatment of oral lesions. This case of ELP in male patient 29 years old was treated with topic application of the NBF gingival gel, three times a day after meal, previously rinsed with Clorhexidine gluconate 0.12%. After 5 days of treatment, initial improvements were recorded, and after two weeks of application of the NBF gingival gel we observed significant improvement. Clinical monitoring after the fifth day showed mild epithelialization of the eroded mucosa, yet still present erythematous base of the lesion. After the second week the erythema area was significantly reduced and the eroded surfaces of the mucosa were minimal, measured less than 0.5 mm. After the third week there were no erosions to detect on the oral mucosa, yet still present vague redness, which completely pulled after the fourth week. Treatment ended after the fifth week when the topical application of the NBF gingival gel was terminated, and therapy was done, and clinically achieved effects remained stable even after the third month of the treatment. Topic application of the NBF gingival gel with ELP patients showed positive clinical effects in relatively short time period.

The Effects of NBF Gingival Gel Application in the Treatment of the Erosive Lichen Planus: Case Report

PubMed Central

Popovska, Mirjana; Fidovski, Jasmin; Mindova, Sonja; Dirjanska, Katerina; Ristoska, Stevica; Stefanovska, Emilija; Radojkova-Nikolovska, Vera; Mitic, Kristina; Rusevska, Biljana

2016-01-01

The therapy of erosive lichen planus (ELP) has been particular problem in the treatment of oral lesions. This case of ELP in male patient 29 years old was treated with topic application of the NBF gingival gel, three times a day after meal, previously rinsed with Clorhexidine gluconate 0.12%. After 5 days of treatment, initial improvements were recorded, and after two weeks of application of the NBF gingival gel we observed significant improvement. Clinical monitoring after the fifth day showed mild epithelialization of the eroded mucosa, yet still present erythematous base of the lesion. After the second week the erythema area was significantly reduced and the eroded surfaces of the mucosa were minimal, measured less than 0.5 mm. After the third week there were no erosions to detect on the oral mucosa, yet still present vague redness, which completely pulled after the fourth week. Treatment ended after the fifth week when the topical application of the NBF gingival gel was terminated, and therapy was done, and clinically achieved effects remained stable even after the third month of the treatment. Topic application of the NBF gingival gel with ELP patients showed positive clinical effects in relatively short time period. PMID:27275352

Current advances in research and clinical applications of PLGA-based nanotechnology

PubMed Central

Lü, Jian-Ming; Wang, Xinwen; Marin-Muller, Christian; Wang, Hao; Lin, Peter H; Yao, Qizhi; Chen, Changyi

2009-01-01

Co-polymer poly(lactic-co-glycolic acid) (PLGA) nanotechnology has been developed for many years and has been approved by the US FDA for the use of drug delivery, diagnostics and other applications of clinical and basic science research, including cardiovascular disease, cancer, vaccine and tissue engineering. This article presents the more recent successes of applying PLGA-based nanotechnologies and tools in these medicine-related applications. It focuses on the possible mechanisms, diagnosis and treatment effects of PLGA preparations and devices. This updated information will benefit to both new and established research scientists and clinical physicians who are interested in the development and application of PLGA nanotechnology as new therapeutic and diagnostic strategies for many diseases. PMID:19435455

A comparison of dehydration effects of V2-antagonist (OPC-31260) on the inner ear between systemic and round window applications.

PubMed

Takeda, Taizo; Takeda, Setsuko; Kakigi, Akinobu; Okada, Teruhiko; Nishioka, Rie; Taguchi, Daizo

2006-08-01

V2-antagonist (OPC-31260 (OPC)) application to the scala tympani reduced endolymphatic hydrops. In the present study, we investigated whether systemic administration or local infusion via the round window (RW application) of OPC would be more suitable for clinical use. In Experiment 1, the increase ratios of the cross-sectional area of the scala media of experimentally induced endolymphatic hydrops were quantitatively assessed among four groups of non-OPC application, RW application of xanthan gum, systemic application of OPC and RW application of OPC. In Experiment 2, the effects of systemic and RW applications of OPC on plasma vasopressin (p-VP) concentrations and plasma osmolality (p-OSM) were investigated. In Experiment 3, endocochlear DC potential (EP) was measured in guinea pigs with the RW application of OPC. Electron microscopic observations of the stria vascularis and the hair cells were also made. Both systemic and RW applications of OPC significantly reduced endolymphatic hydrops. However, systemic application resulted in the distension of the Reissner's membrane in the non-operated ear, which seemed to be caused by elevated p-VP levels resulting from the systemic application of OPC. In contrast, RW application of OPC produced no apparent toxic effects in the inner ear, as indicated electrophysiological or morphological changes. Thus, drug delivery via the round window is more useful for the clinical application of OPC for medical decompression.

A Study on Fitts' Law Based Gait Symmetric Evaluation and It's Clinic Application.

PubMed

Rencheng, Wang; Meiqin, Zhang; Xiaonan, Deng; Dewen, Jin; Maobin, Wang; Guangqing, Li

2005-01-01

Symmetry, one of the prominent characters of normal human gait, could be destroyed by some special or abnormal factors such as barrier spanning, walking impediment, etc. Therefore, it becomes an important factor used to evaluate qualities and functions of walking. In this paper, the fitts' law based symmetry index calculation is introduced and its application in clinic test is also reported. The results show that the fitts' law based index is effective in clinic evaluation.

Analysis of the Chemical, Pharmacological and Clinical Applications of Polygonum Cuspidatum

NASA Astrophysics Data System (ADS)

Guo, Chenyang; Bai, Ming; Miao, Mingsan; Miao, Yanyan

2018-01-01

Traditional Chinese medicine Polygonum cuspidatum widely used, the larger production, and in the clinical application of more, but the role played by the role of different roles are also different. By reviewing the relevant literatures in recent years, the chemical constituents and pharmacological effects of Polygonum cuspidatum were sorted and summarized, and the role of Polygonum cuspidatum was analyzed, and the function of Polygonum cuspidatum was explored to find out the role of Polygonum cuspidatum in compatibility. Application law. Which can not only study the medicinal mechanism of Polygonum cuspidatum, but also provide the theoretical basis for the medicinal development, clinical treatment and comprehensive utilization of Polygonum cuspidatum.

The Effect of Sequence of Instruction on Students' Cognitive Preferences and Recall in the Context of a Problem-Oriented Method of Teaching.

ERIC Educational Resources Information Center

Boreham, N. C.; And Others

1985-01-01

This study investigated the effects of two sequences of instruction--theory-to-application and application-to-theory--on medical students' cognitive preferences in preclinical science teaching. Results indicate that presenting an example of the clinical application of biochemical theory before presenting the theory itself increased students'…

Procuring interoperability at the expense of usability: a case study of UK National Programme for IT assurance process.

PubMed

Krause, Paul; de Lusignan, Simon

2010-01-01

The allure of interoperable systems is that they should improve patient safety and make health services more efficient. The UK's National Programme for IT has made great strides in achieving interoperability; through linkage to a national electronic spine. However, there has been criticism of the usability of the applications in the clinical environment. Analysis of the procurement and assurance process to explore whether they predetermine usability. Processes separate developers from users, and test products against theoretical assurance models of use rather than simulate or pilot in a clinical environment. The current process appears to be effective for back office systems and high risk applications, but too inflexible for developing applications for the clinical setting. For clinical applications agile techniques are more appropriate. Usability testing should become an integrated part of the contractual process and be introduced earlier in the development process.

Telerehabilitation clinical and vocational applications for assistive technology: research, opportunities, and challenges.

PubMed

Schmeler, Mark R; Schein, Richard M; McCue, Michael; Betz, Kendra

2009-01-01

Rehabilitation service providers in rural or underserved areas are often challenged in meeting the needs of their complex patients due to limited resources in their geographical area. Recruitment and retention of the rural clinical workforce are beset by the ongoing problems associated with limited continuing education opportunities, professional isolation, and the challenges inherent in coordinating rural community healthcare. People with disabilities who live in rural communities also face challenges accessing healthcare. Traveling long distances to a specialty clinic for necessary expertise may be troublesome due to inadequate or unavailable transportation, disability specific limitations, and financial limitations. Distance and lack of access are just two threats to quality of care that now being addressed by the use of videoconferencing, information exchange, and other telecommunication technologies that facilitate telerehabilitation. This white paper illustrates and summarizes clinical and vocational applications of telerehabilitation. We provide definitions related to the fields of telemedicine, telehealth, and telerehabilitation, and consider the impetus for telerehabilitation. We review the telerehabilitation literature for assistive technology applications; pressure ulcer prevention; virtual reality applications; speech-language pathology applications; seating and wheeled mobility applications; vocational rehabilitation applications; and cost-effectiveness. We then discuss external telerehabilitation influencers, such as the positions of professional organizations. Finally, we summarize clinical and policy issues in a limited context appropriate to the scope of this paper.

Isolating the Effects of a Mobile Phone on the Usability and Safety of eHealth Software Applications.

PubMed

Borycki, Elizabeth M; Griffith, Janessa; Monkman, Helen; Reid-Haughian, Cheryl

2017-01-01

Mobile phones are used in conjunction with mobile eHealth software applications. These mobile software applications can be used to access, review and document clinical information. The objective of this research was to explore the relationship between mobile phones, usability and safety. Clinical simulations and semi-structured interviews were used to investigate this relationship. The findings revealed that mobile phones may lead to specific types of usability issues that may introduce some types of errors.

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol.

PubMed

Recio-Rodríguez, José I; Martín-Cantera, Carlos; González-Viejo, Natividad; Gómez-Arranz, Amparo; Arietaleanizbeascoa, Maria S; Schmolling-Guinovart, Yolanda; Maderuelo-Fernandez, Jose A; Pérez-Arechaederra, Diana; Rodriguez-Sanchez, Emiliano; Gómez-Marcos, Manuel A; García-Ortiz, Luis

2014-03-15

New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Clinical Trials.gov Identifier: NCT02016014.

Hey Wait! I Just Thought of Something Else! Advaita and Clinical Hypnosis.

PubMed

Amundson, Jon K; Ross, Marc W; Campbell, Debra

2018-07-01

While much has been made of the value of Buddhist mindfulness in clinical treatment, little attention has been given over to its parallels, if not antecedents in Hindu philosophy. Buddhist traditions in the vipassana, ch'an and zen tradition, and the practices associated, find their roots in Advaita philosophy and practice. This article looks at the useful/effective nature of Advaita and its specific application in clinical hypnosis. The linkage between traditional wisdom sources, psychological investigations of the self and contemporary hypnosis is articulated in the article which follows, and a case example, regarding clinical application, is provided.

Current and Future Clinical Applications of High-Intensity Focused Ultrasound (HIFU) for Pancreatic Cancer.

PubMed

Jang, Hyun Joo; Lee, Jae-Young; Lee, Don-Haeng; Kim, Won-Hong; Hwang, Joo Ha

2010-09-01

High-intensity focused ultrasound (HIFU) is a novel therapeutic modality that permits noninvasive treatment of various benign and malignant solid tumors, including prostatic cancer, uterine fibroids, hepatic tumors, renal tumors, breast cancers, and pancreatic cancers. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumors, including pancreatic cancer. The results of nonrandomized studies of HIFU therapy in patients with pancreatic cancer have suggested that HIFU treatment can effectively alleviate cancer-related pain without any significant complications. This noninvasive method of delivering ultrasound energy into the body has recently been evolving from a method for purely thermal ablation to harnessing the mechanical effects of HIFU to induce a systemic immune response and to enhance targeted drug delivery. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges.

Current and Future Clinical Applications of High-Intensity Focused Ultrasound (HIFU) for Pancreatic Cancer

PubMed Central

Jang, Hyun Joo; Lee, Jae-Young; Lee, Don-Haeng; Kim, Won-Hong

2010-01-01

High-intensity focused ultrasound (HIFU) is a novel therapeutic modality that permits noninvasive treatment of various benign and malignant solid tumors, including prostatic cancer, uterine fibroids, hepatic tumors, renal tumors, breast cancers, and pancreatic cancers. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumors, including pancreatic cancer. The results of nonrandomized studies of HIFU therapy in patients with pancreatic cancer have suggested that HIFU treatment can effectively alleviate cancer-related pain without any significant complications. This noninvasive method of delivering ultrasound energy into the body has recently been evolving from a method for purely thermal ablation to harnessing the mechanical effects of HIFU to induce a systemic immune response and to enhance targeted drug delivery. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges. PMID:21103296

[Rule of Clinical Application of Auricular Acupuncture Based on Data Mining].

PubMed

Bao, Na; Wang, Qiong; Sun, Yan-Hui; Shi, Jing; Li, Xiao-Feng; Xu, Jing; Xing, Hai-Jiao; Zhang, Xuan-Ping; Zhang, Xin; Du, Yu-Zhu; Li, Jun-Lei; Yang, Qing-Qing; Feng, Xin-Xin; Jia, Chun-Sheng; Wang, Jian-Ling

2017-02-25

To explore the rule of clinical application of auricular acupuncture therapy by data mining in order to guide clinical practice. The data base about single auricular acupuncture therapy for different clinical diseases was established by collection, sorting, screening, recording, collation, data extraction, statistic analysis on data samples from journals, academic theses dissertations published in near 60 years. The application rules of auricular therapy including its predominant diseases, stimulus modality, therapeutic effect, and angle of needling were summarized by data mining technique. Auricular acupuncture therapy has been widely and mostly used in the internal medicine department, accounting for 48.56%. Of stimulus modalities, auricular point paste and pressure is applied with the highest frequency, accounting for 64%. The highest effective rate is found in the surgery department diseases(81.41%). Pressure is the most effective stimulus in the internal medi-cine department, and bloodletting combined with paste and pressure in the surgery department, auricular point injection in the gynecology and pediatrics departments, bloodletting in the ophthalmology and otorhinolaryngology department, and auricular point incision in the dermatology department. Auricular point injection has remarkable effect. Bloodletting combined with paste and pressure has nearly the same effect as bloodletting in the same medical department except dematology department. Otherwise, angle of needling is rarely studied. Auricular therapy is widely used and has remarkable effect in treating diseases by using different stimulus modalities. Whereas the angle of needling is rarely studied and future investigation is needed.

Tissue Engineered Constructs: Perspectives on Clinical Translation

PubMed Central

Lu, Lichun; Arbit, Harvey M.; Herrick, James L.; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J.

2015-01-01

In this article, a “bedside to bench and back” approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the US Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or New Drug Application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented. PMID:25711151

Tissue engineered constructs: perspectives on clinical translation.

PubMed

Lu, Lichun; Arbit, Harvey M; Herrick, James L; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J

2015-03-01

In this article, a "bedside to bench and back" approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the U.S. Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or new drug application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented.

Medical laser application: translation into the clinics

NASA Astrophysics Data System (ADS)

Sroka, Ronald; Stepp, Herbert; Hennig, Georg; Brittenham, Gary M.; Rühm, Adrian; Lilge, Lothar

2015-06-01

Medical laser applications based on widespread research and development is a very dynamic and increasingly popular field from an ecological as well as an economic point of view. Conferences and personal communication are necessary to identify specific requests and potential unmet needs in this multi- and interdisciplinary discipline. Precise gathering of all information on innovative, new, or renewed techniques is necessary to design medical devices for introduction into clinical applications and finally to become established for routine treatment or diagnosis. Five examples of successfully addressed clinical requests are described to show the long-term endurance in developing light-based innovative clinical concepts and devices. Starting from laboratory medicine, a noninvasive approach to detect signals related to iron deficiency is shown. Based upon photosensitization, fluorescence-guided resection had been discovered, opening the door for photodynamic approaches for the treatment of brain cancer. Thermal laser application in the nasal cavity obtained clinical acceptance by the introduction of new laser wavelengths in clinical consciousness. Varicose veins can be treated by innovative endoluminal treatment methods, thus reducing side effects and saving time. Techniques and developments are presented with potential for diagnosis and treatment to improve the clinical situation for the benefit of the patient.

[Discussion on efficacy evaluation thought and method for innovation medicine of Chinese herbal compound formula based on clinical application characteristics].

PubMed

Sun, Jian-Ning; Sun, Wen-Yan; Dong, Shi-Fen

2017-03-01

The Chinese herbal compound formula preparation was made based on theory of Chinese medicine, which was confirmed by long period clinical application, and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula, selecting and speeding up the research development of drugs with clinical value shall be paid more attention, and as request of rules involved in new drug research and development, the whole process management should be carried out, including project evaluation, manufacturing process determination, establishment of quality control standards, evaluation for pharmacological and toxic effect, as well as new drug application process. This reviews was aimed to give some proposals for pharmacodynamics research methods involved in exploration of Chinese herbal compound formula preparation, including： ①the endpoint criteria should meet the clinical attribution of new drugs; ②the pre-clinical pharmacodynamics evaluation should be carried on appropriate animal models according to the characteristics of diagnosis and therapy of Chinese medicine and observation indexes; ③during the innovation of drug for infants and children, information on drug action conforming to physiological characteristics of infants and children should be supplied, and the pharmacodynamics and toxicology research shall be conducted in immature rats according to the body weight of children. In a summary, the clinical application characteristics are the important criteria for evaluation of pharmacological effect of innovation medicine of Chinese herbal compound formula. Copyright© by the Chinese Pharmaceutical Association.

Ultrasound elastography: principles, techniques, and clinical applications.

PubMed

Dewall, Ryan J

2013-01-01

Ultrasound elastography is an emerging set of imaging modalities used to image tissue elasticity and are often referred to as virtual palpation. These techniques have proven effective in detecting and assessing many different pathologies, because tissue mechanical changes often correlate with tissue pathological changes. This article reviews the principles of ultrasound elastography, many of the ultrasound-based techniques, and popular clinical applications. Originally, elastography was a technique that imaged tissue strain by comparing pre- and postcompression ultrasound images. However, new techniques have been developed that use different excitation methods such as external vibration or acoustic radiation force. Some techniques track transient phenomena such as shear waves to quantitatively measure tissue elasticity. Clinical use of elastography is increasing, with applications including lesion detection and classification, fibrosis staging, treatment monitoring, vascular imaging, and musculoskeletal applications.

Assessment of Genetics Knowledge and Skills in Medical Students: Insight for a Clinical Neurogenetics Curriculum

ERIC Educational Resources Information Center

Pearl, Phillip L.; Pettiford, Jennifer M.; Combs, Susan E.; Heffron, Ari; Healton, Sean; Hovaguimian, Alexandra; Macri, Charles J.

2011-01-01

The pace of discovery in biochemistry and genetics and its effect on clinical medicine places new curricular challenges in medical school education. We sought to evaluate students' understanding of neurogenetics and its clinical applications to design a pilot curriculum into the clinical neurology clerkship. We utilized a needs assessment and a…

Method of App Selection for Healthcare Providers Based on Consumer Needs.

PubMed

Lee, Jisan; Kim, Jeongeun

2018-01-01

Mobile device applications can be used to manage health. However, healthcare providers hesitate to use them because selection methods that consider the needs of health consumers and identify the most appropriate application are rare. This study aimed to create an effective method of identifying applications that address user needs. Women experiencing dysmenorrhea and premenstrual syndrome were the targeted users. First, we searched for related applications from two major sources of mobile applications. Brainstorming, mind mapping, and persona and scenario techniques were used to create a checklist of relevant criteria, which was used to rate the applications. Of the 2784 applications found, 369 were analyzed quantitatively. Of those, five of the top candidates were evaluated by three groups: application experts, clinical experts, and potential users. All three groups ranked one application the highest; however, the remaining rankings differed. The results of this study suggest that the method created is useful because it considers not only the needs of various users but also the knowledge of application and clinical experts. This study proposes a method for finding and using the best among existing applications and highlights the need for nurses who can understand and combine opinions of users and application and clinical experts.

Topical Vitamin C and the Skin: Mechanisms of Action and Clinical Applications.

PubMed

Al-Niaimi, Firas; Chiang, Nicole Yi Zhen

2017-07-01

OBJECTIVE: This review article details the main mechanisms of action and clinical applications of topical vitamin C on the skin, including its antioxidative, photoprotective, antiaging, and antipigmentary effects. DESIGN: A PubMed search for the relevant articles on vitamin C and the skin was conducted using the following key words: "vitamin C," "ascorbic acid," "ascorbyl-6-palmitate,"and "magnesium ascorbyl phosphate." RESULTS: As one of the most powerful antioxidants in the skin, vitamin C has been shown to protect against photoaging, ultraviolet-induced immunosuppression, and photocarcinogenesis. It also has an antiaging effect by increasing collagen synthesis, stabilizing collagen fibers, and decreasing collagen degradation. It decreases melanin formation, thereby reducing pigmentation. Vitamin C is the primary replenisher of vitamin E and works synergistically with vitamin E in the protection against oxidative damage. CONCLUSION: Topical vitamin C has a wide range of clinical applications, from antiaging and antipigmentary to photoprotective. Currently, clinical studies on the efficacy of topical formulations of vitamin C remain limited, and the challenge lies in finding the most stable and permeable formulation in achieving the optimal results.

Cost-effective (gaming) motion and balance devices for functional assessment: Need or hype?

PubMed

Bonnechère, B; Jansen, B; Van Sint Jan, S

2016-09-06

In the last decade, technological advances in the gaming industry have allowed the marketing of hardware for motion and balance control that is based on technological concepts similar to scientific and clinical equipment. Such hardware is attractive to researchers and clinicians for specific applications. However, some questions concerning their scientific value and the range of future potential applications have yet to be answered. This article attempts to present an objective analysis about the pros and cons of using such hardware for scientific and clinical purposes and calls for a constructive discussion based on scientific facts and practical clinical requests that are emerging from application fields. Copyright © 2016 Elsevier Ltd. All rights reserved.

Medicinal herbs and phytochitodeztherapy in oncology.

PubMed

Treskunov, Karp; Treskunova, Olga; Komarov, Boris; Goroshetchenko, Alex; Glebov, Vlad

2003-01-01

Application of clinical phytology in treatment of oncology diseases was limited by intensive development of chemical pharmaceuticals and surgery. The authors had set the task to develop the computer database for phytotherapy application. The database included full information on patient's clinical status (identified diseases, symptoms, syndromes) and applied phytotherapy treatment. Special attention was paid to the application of phyto preparations containing chitosan. The computer database contains information on 2335 patients. It supports reliable data on efficiency of phytotherapy in general and allows to evaluate the efficiency of some particular medicinal herbs and to develop efficient complex phyto preparations for treatment of specific diseases. The application of phytotherapy in treatment of oncology patients confirmed the positive effect on patient's quality of life. In conclusion it should be emphasized that the present situation of practical application of phytotherapy could be considered as unacceptable because of absence of necessary knowledge and practical experience in using phytotherapy in outpatient clinics, hospitals and medicinal centers.

Group Cognitive-Behavioral Therapy for Insomnia in a VA Mental Health Clinic

ERIC Educational Resources Information Center

Perlman, Lawrence M.; Arnedt, J. Todd; Earnheart, Kristie L.; Gorman, Ashley A.; Shirley, Katherine G.

2008-01-01

Effective cognitive-behavioral therapies for insomnia have been developed over the past 2 decades, but they have not been systematically evaluated in some clinical settings. While insomnia is common among veterans with mental health problems, the availability of effective treatments is limited. We report on the group application of a…

[Impact analysis of shuxuetong injection on abnormal changes of ALT based on generalized boosted models propensity score weighting].

PubMed

Yang, Wei; Yi, Dan-Hui; Xie, Yan-Ming; Yang, Wei; Dai, Yi; Zhi, Ying-Jie; Zhuang, Yan; Yang, Hu

2013-09-01

To estimate treatment effects of Shuxuetong injection on abnormal changes on ALT index, that is, to explore whether the Shuxuetong injection harms liver function in clinical settings and to provide clinical guidance for its safe application. Clinical information of traditional Chinese medicine (TCM) injections is gathered from hospital information system (HIS) of eighteen general hospitals. This is a retrospective cohort study, using abnormal changes in ALT index as an outcome. A large number of confounding biases are taken into account through the generalized boosted models (GBM) and multiple logistic regression model (MLRM) to estimate the treatment effects of Shuxuetong injections on abnormal changes in ALT index and to explore possible influencing factors. The advantages and process of application of GBM has been demonstrated with examples which eliminate the biases from most confounding variables between groups. This serves to modify the estimation of treatment effects of Shuxuetong injection on ALT index making the results more reliable. Based on large scale clinical observational data from HIS database, significant effects of Shuxuetong injection on abnormal changes in ALT have not been found.

Cardiovascular Protective Effects and Clinical Applications of Resveratrol.

PubMed

Cho, Sanghyun; Namkoong, Kyung; Shin, Minji; Park, Jueun; Yang, Eunyeong; Ihm, Jinsoo; Thu, Vu Thi; Kim, Hyoung Kyu; Han, Jin

2017-04-01

Resveratrol is a naturally occurring phenol that is generated by plant species following injury or attack by bacterial and fungal pathogens. This compound was first described as the French Paradox in 1992. Later in 2003, resveratrol was reported to activate sirtuins in yeast cells. Recent experimental studies have found that resveratrol offers a variety of benefits that include both anticarcinogenic and anti-inflammatory effects in addition to the ability to reverse obesity, attenuate hyperglycemia and hyperinsulinemia, protect heart and endothelial function, and increase the life span. Multiple molecular targets are associated with the cardioprotective capabilities of resveratrol, and therefore, resveratrol has potential for a wide range of new therapeutic strategies for atherosclerosis, ischemia/reperfusion, metabolic syndrome, cardiac failure, and inflammatory alterations during aging. Expectations for application in human patients, however, suffer from a lack of sufficient clinical evidence in support of these beneficial effects. This article reviews recently reported basic research results that describe the beneficial effects of resveratrol in an attempt to condense the evidence observed in clinical trials and provide support for the future development of novel clinical therapeutics in patients with cardiovascular diseases.

Optimization of antitumor treatment conditions for transcutaneous CO2 application: An in vivo study.

PubMed

Ueha, Takeshi; Kawamoto, Teruya; Onishi, Yasuo; Harada, Risa; Minoda, Masaya; Toda, Mitsunori; Hara, Hitomi; Fukase, Naomasa; Kurosaka, Masahiro; Kuroda, Ryosuke; Akisue, Toshihiro; Sakai, Yoshitada

2017-06-01

Carbon dioxide (CO2) therapy can be applied to treat a variety of disorders. We previously found that transcutaneous application of CO2 with a hydrogel decreased the tumor volume of several types of tumors and induced apoptosis via the mitochondrial pathway. However, only one condition of treatment intensity has been tested. For widespread application in clinical antitumor therapy, the conditions must be optimized. In the present study, we investigated the relationship between the duration, frequency, and treatment interval of transcutaneous CO2 application and antitumor effects in murine xenograft models. Murine xenograft models of three types of human tumors (breast cancer, osteosarcoma, and malignant fibrous histiocytoma/undifferentiated pleomorphic sarcoma) were used to assess the antitumor effects of transcutaneous CO2 application of varying durations, frequencies, and treatment intervals. In all human tumor xenografts, apoptosis was significantly induced by CO2 treatment for ≥10 min, and a significant decrease in tumor volume was observed with CO2 treatments of >5 min. The effect on tumor volume was not dependent on the frequency of CO2 application, i.e., twice or five times per week. However, treatment using 3- and 4-day intervals was more effective at decreasing tumor volume than treatment using 2- and 5-day intervals. The optimal conditions of transcutaneous CO2 application to obtain the best antitumor effect in various tumors were as follows: greater than 10 min per application, twice per week, with 3- and 4-day intervals, and application to the site of the tumor. The results suggest that this novel transcutaneous CO2 application might be useful to treat primary tumors, while mitigating some side effects, and therefore could be safe for clinical trials.

Stem cells in clinical practice: applications and warnings.

PubMed

Lodi, Daniele; Iannitti, Tommaso; Palmieri, Beniamino

2011-01-17

Stem cells are a relevant source of information about cellular differentiation, molecular processes and tissue homeostasis, but also one of the most putative biological tools to treat degenerative diseases. This review focuses on human stem cells clinical and experimental applications. Our aim is to take a correct view of the available stem cell subtypes and their rational use in the medical area, with a specific focus on their therapeutic benefits and side effects. We have reviewed the main clinical trials dividing them basing on their clinical applications, and taking into account the ethical issue associated with the stem cell therapy. We have searched Pubmed/Medline for clinical trials, involving the use of human stem cells, using the key words "stem cells" combined with the key words "transplantation", "pathology", "guidelines", "properties" and "risks". All the relevant clinical trials have been included. The results have been divided into different categories, basing on the way stem cells have been employed in different pathological conditions.

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.

PubMed

Berendt, Louise; Håkansson, Cecilia; Bach, Karin Friis; Dalhoff, Kim; Andreasen, Per Buch; Petersen, Lene Grejs; Andersen, Elin; Poulsen, Henrik Enghusen

2008-01-05

To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark. Retrospective review of applications for drug trials to the Danish Medicines Agency, 1993-2006. Applications for drug trials for alternate years were classified as academic or commercial trials. A random subset of academic trials was reviewed for number of participants in and intended monitoring of the trials. Academic and commercial drug trials showed an identical steady decline from 1993 to 2006 and no noticeable change after 2004 when good clinical practice became mandatory for academic trials. The Clinical Trials Directive introduced in May 2004 to ensure good clinical practice for academic drug trials was not associated with a decline in research activity in Denmark; presumably because good clinical practice units had already been in place in Danish universities since 1999. With such an infrastructure academic researchers can do drug trials under the same regulations as drug companies.

Clinical laboratory studies of disinfection with Sporicidin.

PubMed Central

Isenberg, H D

1985-01-01

The clinical microbiology laboratory evaluation of disinfectants can serve as a guide for their application to reduce hospital-acquired infections. The use of Sporicidin, a glutaraldehyde-phenol formulation, was evaluated by the application of modified MIC and MBC determinations for standard organisms. In addition, the effect of this formulation on bacteria that may proliferate in water at ambient temperatures was studied. This investigation indicated that such studies can help the clinical microbiologist to guide the use of disinfectants and sterilants for the maintenance of a safe hospital environment. PMID:3932457

The clinical application of teaching people about pain.

PubMed

Louw, Adriaan; Zimney, Kory; O'Hotto, Christine; Hilton, Sandra

2016-07-01

Teaching people about the neurobiology and neurophysiology of their pain experience has a therapeutic effect and has been referred to as pain neuroscience education (PNE). Various high-quality randomized controlled trials and systematic reviews have shown increasing efficacy of PNE decreasing pain, disability, pain catastrophization, movement restrictions, and healthcare utilization. Research studies, however, by virtue of their design, are very controlled environments and, therefore, in contrast to the ever-increasing evidence for PNE, little is known about the clinical application of this emerging therapy. In contrast, case studies, case series, and expert opinion and perspectives by authorities in the world of pain science provide clinicians with a glimpse into potential "real" clinical application of PNE in the face of the ever-increasing chronic pain epidemic. By taking the material from the randomized controlled trials, systematic reviews, case series, case studies, and expert opinion, this article aims to provide a proposed layout of the clinical application of PNE. The article systematically discusses key elements of PNE including examination, educational content, and delivery methods, merging of PNE with movement, goal setting, and progression. This perspectives article concludes with a call for research into the clinical application of PNE.

Development of a Cost-Effective Modular Pixelated NaI(Tl) Detector for Clinical SPECT Applications

PubMed Central

Rozler, Mike; Liang, Haoning; Chang, Wei

2013-01-01

A new pixelated detector for high-resolution clinical SPECT applications was designed and tested. The modular detector is based on a scintillator block comprised of 2.75×2.75×10 mm3 NaI(Tl) pixels and decoded by an array of 51 mm diameter single-anode PMTs. Several configurations, utilizing two types of PMTs, were evaluated using a collimated beam source to measure positioning accuracy directly. Good pixel separation was observed, with correct pixel identification ranging from 60 to 72% averaged over the entire area of the modules, depending on the PMT type and configuration. This translates to a significant improvement in positioning accuracy compared to continuous slab detectors of the same thickness, along with effective reduction of “dead” space at the edges. The observed 10% average energy resolution compares well to continuous slab detectors. The combined performance demonstrates the suitability of pixelated detectors decoded with a relatively small number of medium-sized PMTs as a cost-effective approach for high resolution clinical SPECT applications, in particular those involving curved detector geometries. PMID:24146436

Improving timeliness and efficiency in the referral process for safety net providers: application of the Lean Six Sigma methodology.

PubMed

Deckard, Gloria J; Borkowski, Nancy; Diaz, Deisell; Sanchez, Carlos; Boisette, Serge A

2010-01-01

Designated primary care clinics largely serve low-income and uninsured patients who present a disproportionate number of chronic illnesses and face great difficulty in obtaining the medical care they need, particularly the access to specialty physicians. With limited capacity for providing specialty care, these primary care clinics generally refer patients to safety net hospitals' specialty ambulatory care clinics. A large public safety net health system successfully improved the effectiveness and efficiency of the specialty clinic referral process through application of Lean Six Sigma, an advanced process-improvement methodology and set of tools driven by statistics and engineering concepts.

Telerehabilitation Clinical and Vocational Applications for Assistive Technology: Research, Opportunities, and Challenges

PubMed Central

Schmeler, Mark R.; Schein, Richard M.; McCue, Michael; Betz, Kendra

2009-01-01

Rehabilitation service providers in rural or underserved areas are often challenged in meeting the needs of their complex patients due to limited resources in their geographical area. Recruitment and retention of the rural clinical workforce are beset by the ongoing problems associated with limited continuing education opportunities, professional isolation, and the challenges inherent in coordinating rural community healthcare. People with disabilities who live in rural communities also face challenges accessing healthcare. Traveling long distances to a specialty clinic for necessary expertise may be troublesome due to inadequate or unavailable transportation, disability specific limitations, and financial limitations. Distance and lack of access are just two threats to quality of care that now being addressed by the use of videoconferencing, information exchange, and other telecommunication technologies that facilitate telerehabilitation. This white paper illustrates and summarizes clinical and vocational applications of telerehabilitation. We provide definitions related to the fields of telemedicine, telehealth, and telerehabilitation, and consider the impetus for telerehabilitation. We review the telerehabilitation literature for assistive technology applications; pressure ulcer prevention; virtual reality applications; speech-language pathology applications; seating and wheeled mobility applications; vocational rehabilitation applications; and cost-effectiveness. We then discuss external telerehabilitation influencers, such as the positions of professional organizations. Finally, we summarize clinical and policy issues in a limited context appropriate to the scope of this paper. PMID:25945163

The relaxant effect of Nigella sativa on smooth muscles, its possible mechanisms and clinical applications

PubMed Central

Keyhanmanesh, Rana; Gholamnezhad, Zahra; Boskabady, Mohammad Hossien

2014-01-01

Nigella sativa (N. sativa) is a spice plant which has been traditionally used for culinary and medicinal purposes. Different therapeutic properties including the beneficial effects on asthma and dyspnea, digestive and gynecology disorders have been described for the seeds of N. sativa. There is evidence of the relaxant effects of this plant and some of its constituents on different types of smooth muscle including rabbit aorta, rabbit jejunum and trachea. The relaxant effect of N. sativa could be of therapeutic importance such as bronchodilation in asthma, vasodilation in hypertension and therapeutic effect on digestive or urogenital disorders. Therefore in the present article, the relaxant effects of N. sativa and its constituents on smooth muscles and its possible mechanisms as well as clinical application of this effect were reviewed. PMID:25859297

Engineered pharmabiotics with improved therapeutic potential.

PubMed

Sleator, Roy D; Hill, Colin

2008-01-01

Although described for over a century, scientists and clinicians alike are only now beginning to realize the significant medical applications of probiotic cultures. Given the increasing commercial and clinical relevance of probiotics, improving their stress tolerance profile and ability to overcome the physiochemical defences of the host is an important biological goal. Patho-biotechnology describes the application of pathogen derived (ex vivo and in vivo) stress survival strategies for the design of more technologically robust and effective probiotic cultures with improved biotechnological and clinical applications as well as the development of novel vaccine and drug delivery platforms.

AHRQ series paper 2: principles for developing guidance: AHRQ and the effective health-care program.

PubMed

Helfand, Mark; Balshem, Howard

2010-05-01

This article describes some of the fundamental principles that have been developed to guide the work of producing comparative effectiveness reviews (CERs). We briefly describe the role stakeholders play in providing important insights that inform the evidence-gathering process, and discuss the critical role of analytic frameworks in illuminating the relationship between surrogate measures and health outcomes, providing an understanding of the context in which clinical decisions are made and the uncertainties that underlie clinical controversies. We describe the Effective Health Care program conceptual model for considering different types of evidence that emphasizes minimizing the risk of bias, but places high-quality, highly applicable evidence about effectiveness at the top of the hierarchy. Finally, we briefly describe areas of future methodological research. CERs have become a foundation for decision-making in clinical practice and health policy. To be useful, CERs must approach the evidence from a patient-centered perspective; explore the clinical logic underlying the rationale for a service; cast a broad net with respect to types of evidence, placing a high value on effectiveness and applicability, in addition to internal validity; and, present benefits and harms for treatments and tests in a consistent way.

The effects of black pepper on the intestinal absorption and hepatic metabolism of drugs.

PubMed

Han, Hyo-Kyung

2011-06-01

There is currently a need for a better understanding of the mechanisms of food-drug interaction as well as the clinical implication to maximize the effectiveness and applicability of black pepper or its active component, piperine, as a bioavailability enhancer in the clinical arena. This review deals with the effects of black pepper and piperine on drug metabolizing enzymes as well as on intestinal drug absorption. The review provides the reader with a comprehensive update on the potential mechanisms and pharmacokinetic interactions of black pepper and piperine with co-administered medicines. The article also provides a comprehensive update on the current known issues with black pepper and piperine. The information provided is used to assess the clinical significance of black pepper and piperine and optimize their effectiveness as a bioavailability enhancer. For black pepper or piperine to be widely applicable in current medical practice, as a combination therapy, the clinical significance of food-drug interactions caused by concurrent use of black pepper or piperine should be carefully assessed with consideration for many compounding factors affecting the clinical outcome of pharmacokinetic interactions (e.g., dose, dosing regimen, genetic variation and species). Furthermore, the effective formulation strategy for the optimization of the pharmacokinetic characteristics of dietary components is crucial to improve their in vivo performance and ultimately maximize their effectiveness as a bioavailability enhancer.

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

PubMed

Lansky, Alexandra J; Messé, Steven R; Brickman, Adam M; Dwyer, Michael; Bart van der Worp, H; Lazar, Ronald M; Pietras, Cody G; Abrams, Kevin J; McFadden, Eugene; Petersen, Nils H; Browndyke, Jeffrey; Prendergast, Bernard; Ng, Vivian G; Cutlip, Donald E; Kapadia, Samir; Krucoff, Mitchell W; Linke, Axel; Scala Moy, Claudia; Schofer, Joachim; van Es, Gerrit-Anne; Virmani, Renu; Popma, Jeffrey; Parides, Michael K; Kodali, Susheel; Bilello, Michel; Zivadinov, Robert; Akar, Joseph; Furie, Karen L; Gress, Daryl; Voros, Szilard; Moses, Jeffrey; Greer, David; Forrest, John K; Holmes, David; Kappetein, Arie P; Mack, Michael; Baumbach, Andreas

2018-05-14

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Influence of hyaluronic acid on bacterial and fungal species, including clinically relevant opportunistic pathogens.

PubMed

Ardizzoni, Andrea; Neglia, Rachele G; Baschieri, Maria C; Cermelli, Claudio; Caratozzolo, Manuela; Righi, Elena; Palmieri, Beniamino; Blasi, Elisabetta

2011-10-01

Hyaluronic acid (HA) has several clinical applications (aesthetic surgery, dermatology, orthopaedics and ophtalmology). Following recent evidence, suggesting antimicrobial and antiviral properties for HA, we investigated its effects on 15 ATCC strains, representative of clinically relevant bacterial and fungal species. The in vitro system employed allowed to assess optical density of broth cultures as a measure of microbial load in a time-dependent manner. The results showed that different microbial species and, sometimes, different strains belonging to the same species, are differently affected by HA. In particular, staphylococci, enterococci, Streptococcus mutans, two Escherichia coli strains, Pseudomonas aeruginosa, Candida glabrata and C. parapsilosis displayed a HA dose-dependent growth inhibition; no HA effects were detected in E. coli ATCC 13768 and C. albicans; S. sanguinis was favoured by the highest HA dose. Therefore, the influence of HA on bacteria and fungi warrants further studies aimed at better establishing its relevance in clinical applications.

Clinical utility of measures of breathlessness.

PubMed

Cullen, Deborah L; Rodak, Bernadette

2002-09-01

The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea measurement instruments we studied meet important standards of validity and reliability. Discriminative measures have limited clinical utility and, when used for populations or conditions for which they are not designed or validated, the data collected may not be clinically relevant. Evaluative measures have greater clinical utility and can be applied for outcome purposes. Measures should be applied to the populations and conditions for which they were designed. The relationship between clinical therapies and the measurement of dyspnea as an outcome can develop as respiratory therapists become more comfortable with implementing dyspnea measurement instruments and use the data to improve patient treatment. Dyspnea evaluation should be considered for all clinical practice guidelines and care pathways.

Clinical applications of preimplantation genetic testing.

PubMed

Brezina, Paul R; Kutteh, William H

2015-02-19

Genetic diagnostic technologies are rapidly changing the way medicine is practiced. Preimplantation genetic testing is a well established application of genetic testing within the context of in vitro fertilization cycles. It involves obtaining a cell(s) from a developing embryo in culture, which is then subjected to genetic diagnostic analysis; the resulting information is used to guide which embryos are transferred into the uterus. The potential applications and use of this technology have increased in recent years. Experts agree that preimplantation genetic diagnosis is clinically appropriate for many known genetic disorders. However, some applications of such testing, such as preimplantation genetic screening for aneuploidy, remain controversial. Clinical data suggest that preimplantation genetic screening may be useful, but further studies are needed to quantify the size of the effect and who would benefit most. © BMJ Publishing Group Ltd 2015.

Modeling the value for money of changing clinical practice change: a stochastic application in diabetes care.

PubMed

Hoomans, Ties; Abrams, Keith R; Ament, Andre J H A; Evers, Silvia M A A; Severens, Johan L

2009-10-01

Decision making about resource allocation for guideline implementation to change clinical practice is inevitably undertaken in a context of uncertainty surrounding the cost-effectiveness of both clinical guidelines and implementation strategies. Adopting a total net benefit approach, a model was recently developed to overcome problems with the use of combined ratio statistics when analyzing decision uncertainty. To demonstrate the stochastic application of the model for informing decision making about the adoption of an audit and feedback strategy for implementing a guideline recommending intensive blood glucose control in type 2 diabetes in primary care in the Netherlands. An integrated Bayesian approach to decision modeling and evidence synthesis is adopted, using Markov Chain Monte Carlo simulation in WinBUGs. Data on model parameters is gathered from various sources, with effectiveness of implementation being estimated using pooled, random-effects meta-analysis. Decision uncertainty is illustrated using cost-effectiveness acceptability curves and frontier. Decisions about whether to adopt intensified glycemic control and whether to adopt audit and feedback alter for the maximum values that decision makers are willing to pay for health gain. Through simultaneously incorporating uncertain economic evidence on both guidance and implementation strategy, the cost-effectiveness acceptability curves and cost-effectiveness acceptability frontier show an increase in decision uncertainty concerning guideline implementation. The stochastic application in diabetes care demonstrates that the model provides a simple and useful tool for quantifying and exploring the (combined) uncertainty associated with decision making about adopting guidelines and implementation strategies and, therefore, for informing decisions about efficient resource allocation to change clinical practice.

Music Therapy with Children: A Review of Clinical Utility and Application to Special Populations.

ERIC Educational Resources Information Center

Yeaw, John David Andrew

This paper reviews the effectiveness of music therapy in treating children with psychiatric and developmental problems. The clinical utility of music therapy is first evaluated by examining the foundational effects of music on affect and behavior. Next, the two broad approaches to music therapy, active and passive music therapy, are discussed.…

77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-17

... intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1145... strategies that can be used in clinical trials intended to support effectiveness and safety claims in new...

Rational Design of Improved Pharmabiotics

PubMed Central

Sleator, Roy D.; Hill, Colin

2009-01-01

Herein we review the most recent advances in probiotic research and applications with particular emphasis on the novel concept of patho-biotechnology: the application of pathogen-derived (ex vivo and in vivo) stress survival strategies for the design of more technologically robust and effective probiotic cultures with improved biotechnological and clinical applications. PMID:19753318

Rational design of improved pharmabiotics.

PubMed

Sleator, Roy D; Hill, Colin

2009-01-01

Herein we review the most recent advances in probiotic research and applications with particular emphasis on the novel concept of patho-biotechnology: the application of pathogen-derived (ex vivo and in vivo) stress survival strategies for the design of more technologically robust and effective probiotic cultures with improved biotechnological and clinical applications.

Measuring Workload Demand of Informatics Systems with the Clinical Case Demand Index

PubMed Central

Iyengar, M. Sriram; Rogith, Deevakar; Florez-Arango, Jose F

2017-01-01

Introduction: The increasing use of Health Information Technology (HIT) can add substantially to workload on clinical providers. Current methods for assessing workload do not take into account the nature of clinical cases and the use of HIT tools while solving them. Methods: The Clinical Case Demand Index (CCDI), consisting of a summary score and visual representation, was developed to meet this need. Consistency with current perceived workload measures was evaluated in a Randomized Control Trial of a mobile health system. Results: CCDI is significantly correlated with existing workload measures and inversely related to provider performance. Discussion: CCDI combines subjective and objective characteristics of clinical cases along with cognitive and clinical dimensions. Applications include evaluation of HIT tools, clinician scheduling, medical education. Conclusion: CCDI supports comparative effectiveness research of HIT tools. In addition, CCDI could have numerous applications including training, clinical trials, design of clinical workflows, and others. PMID:29854166

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines

PubMed Central

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-01-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association’s governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research;Improving patient care provided by members by providing focus on quality and evidence;Creating legislative environments that favour effective clinical practice;Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; andIdentifying areas that require further information or research to improve clinical care.The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement. PMID:25314352

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines.

PubMed

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-10-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association's governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research; Improving patient care provided by members by providing focus on quality and evidence; Creating legislative environments that favour effective clinical practice; Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; and Identifying areas that require further information or research to improve clinical care. The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement.

Levobupivacaine: a review of its use in regional anaesthesia and pain management.

PubMed

Sanford, Mark; Keating, Gillian M

2010-04-16

Levobupivacaine (Chirocaine) is a long-acting amide local anaesthetic that is effective when administered as an epidural, spinal, peripheral nerve or ocular block, or by topical application or local infiltration. In comparative trials, its clinical effects were not generally significantly different from those of bupivacaine or ropivacaine, although there was some variability in efficacy findings in different clinical populations. Levobupivacaine was generally well tolerated. Levobupivacaine provides effective anaesthesia and analgesia for a wide range of clinical populations and is a useful alternative to bupivacaine.

An Environment for Guideline-based Decision Support Systems for Outpatients Monitoring.

PubMed

Zini, Elisa M; Lanzola, Giordano; Bossi, Paolo; Quaglini, Silvana

2017-08-11

We propose an architecture for monitoring outpatients that relies on mobile technologies for acquiring data. The goal is to better control the onset of possible side effects between the scheduled visits at the clinic. We analyze the architectural components required to ensure a high level of abstraction from data. Clinical practice guidelines were formalized with Alium, an authoring tool based on the PROforma language, using SNOMED-CT as a terminology standard. The Alium engine is accessible through a set of APIs that may be leveraged for implementing an application based on standard web technologies to be used by doctors at the clinic. Data sent by patients using mobile devices need to be complemented with those already available in the Electronic Health Record to generate personalized recommendations. Thus a middleware pursuing data abstraction is required. To comply with current standards, we adopted the HL7 Virtual Medical Record for Clinical Decision Support Logical Model, Release 2. The developed architecture for monitoring outpatients includes: (1) a guideline-based Decision Support System accessible through a web application that helps the doctors with prevention, diagnosis and treatment of therapy side effects; (2) an application for mobile devices, which allows patients to regularly send data to the clinic. In order to tailor the monitoring procedures to the specific patient, the Decision Support System also helps physicians with the configuration of the mobile application, suggesting the data to be collected and the associated collection frequency that may change over time, according to the individual patient's conditions. A proof of concept has been developed with a system for monitoring the side effects of chemo-radiotherapy in head and neck cancer patients. Our environment introduces two main innovation elements with respect to similar works available in the literature. First, in order to meet the specific patients' needs, in our work the Decision Support System also helps the physicians in properly configuring the mobile application. Then the Decision Support System is also continuously fed by patient-reported outcomes.

The effects of 5% imiquimod cream on high-grade vulval intraepithelial neoplasia.

PubMed

Todd, Richard W; Etherington, Ian J; Luesley, David M

2002-04-01

The aim of this study was to investigate the effects of topical 5% Imiquimod (3M Pharmaceuticals, St. Paul, Minnessota) on high-grade vulval intraepithelial neoplasia (VIN). A prospective uncontrolled observational study was performed. Fifteen patients with histologically confirmed VIN 3 were asked to self-administer 5% Imiquimod cream to their vulval lesions up to three times weekly for 16 weeks. Review was conducted at 1, 2, 3, 4, 6, and 9 months postrecruitment. Lesions were photodocumented and at 4 months any areas demonstrating a clinical response were biopsied. Of 15 patients recruited, 4 demonstrated a clinical improvement in their disease, 3 of whom had negative biopsies posttreatment. Local side effects limited the frequency of application such that 7 patients applied the cream once weekly, 6 twice weekly, and 2 three times weekly. 5% Imiquimod cream appears to have an effect when used on high-grade VIN. The frequency of application was limited by local side effects which may have reduced the clinical responses seen. Measures to alleviate local side effects may allow more aggressive use of Imiquimod and lead to improved responses.

MALDI-TOF-mass spectrometry applications in clinical microbiology.

PubMed

Seng, Piseth; Rolain, Jean-Marc; Fournier, Pierre Edouard; La Scola, Bernard; Drancourt, Michel; Raoult, Didier

2010-11-01

MALDI-TOF-mass spectrometry (MS) has been successfully adapted for the routine identification of microorganisms in clinical microbiology laboratories in the past 10 years. This revolutionary technique allows for easier and faster diagnosis of human pathogens than conventional phenotypic and molecular identification methods, with unquestionable reliability and cost-effectiveness. This article will review the application of MALDI-TOF-MS tools in routine clinical diagnosis, including the identification of bacteria at the species, subspecies, strain and lineage levels, and the identification of bacterial toxins and antibiotic-resistance type. We will also discuss the application of MALDI-TOF-MS tools in the identification of Archaea, eukaryotes and viruses. Pathogenic identification from colony-cultured, blood-cultured, urine and environmental samples is also reviewed.

Smartphone app design for the wireless control of a neuromuscular electrical stimulator device with integrated randomization allocation process for RCT applications.

PubMed

Sweeney, Dean; Quinlan, Leo R; OLaighin, Gearoid

2015-08-01

The use of NMES has evolved over the last five decades. Technological advancements have transformed these once complex systems into user-friendly devices with enhanced control functions, leading to new applications of NMES being investigated. The use of Randomized Control Trial (RCT) methodology in evaluating the effectiveness of new and existing applications of NMES is a demanding process adding time and cost to a translation into clinical practice. Poor quality trials may result in poor evidence of NMES effectiveness. In this paper some of the key challenges encountered in NMES clinical trials are identified with the aim of purposing a solution to address these challenges through the adoption of Smartphone technology. The design and evaluation of a smartphone application to provide automatic blind randomization control and facilitating the wireless temporal control of a portable Bluetooth enabled NMES is presented.

Safety and Feasibility of Topical Application of Limonene as a Massage Oil to the Breast.

PubMed

Miller, Jessica A; Thompson, Patricia A; Hakim, Iman A; Lopez, Ana Maria; Thomson, Cynthia A; Chew, Wade; Hsu, Chiu-Hsieh; Chow, H-H Sherry

2012-10-01

Limonene, a major component in citrus oil, has demonstrated anti-cancer effects in preclinical mammary cancer models. However, the effective oral dose translates to a human dose that may not be feasible for chronic dosing. We proposed to evaluate topical application of limonene to the breast as an alternative dosing strategy. We conducted a mouse disposition study to determine whether limonene would be bio available in the mammary tissue after topical application. SKH-1 mice received topical or oral administration of limonene in the form of orange oil every day for 4 weeks. Plasma and mammary pads were collected 4 hrs after the final dosing. We also conducted an exploratory clinical study to evaluate the safety and feasibility of topically applied limonene in the form of orange oil to the breast. Healthy women were recruited to apply orange oil containing massage oil to their breasts daily for four weeks. Safety and feasibility were assessed by reported adverse events, clinical labs, and usage compliance. Pre and post-intervention nipple aspirate fluid (NAF) and plasma were collected for limonene concentration determination. The mouse disposition study showed that topical and oral orange oil administration resulted in similar mammary tissue disposition of limonene with no clinical signs of toxicity. In the clinical study, the topical application of limonene containing massage oil to the breast was found to be safe with high levels of usage compliance for daily application, although NAF and plasma limonene concentrations were not significantly changed after the massage oil application. Our studies showed that limonene is bio available in mammary tissue after topical orange oil application in mice and this novel route of administration to the breast is safe and feasible in healthy women.

Safety and Feasibility of Topical Application of Limonene as a Massage Oil to the Breast

PubMed Central

Miller, Jessica A.; Thompson, Patricia A.; Hakim, Iman A.; Lopez, Ana Maria; Thomson, Cynthia A.; Chew, Wade; Hsu, Chiu-Hsieh; Chow, H.-H. Sherry

2013-01-01

Background Limonene, a major component in citrus oil, has demonstrated anti-cancer effects in preclinical mammary cancer models. However, the effective oral dose translates to a human dose that may not be feasible for chronic dosing. We proposed to evaluate topical application of limonene to the breast as an alternative dosing strategy. Materials and Methods We conducted a mouse disposition study to determine whether limonene would be bio available in the mammary tissue after topical application. SKH-1 mice received topical or oral administration of limonene in the form of orange oil every day for 4 weeks. Plasma and mammary pads were collected 4 hrs after the final dosing. We also conducted an exploratory clinical study to evaluate the safety and feasibility of topically applied limonene in the form of orange oil to the breast. Healthy women were recruited to apply orange oil containing massage oil to their breasts daily for four weeks. Safety and feasibility were assessed by reported adverse events, clinical labs, and usage compliance. Pre and post-intervention nipple aspirate fluid (NAF) and plasma were collected for limonene concentration determination. Results The mouse disposition study showed that topical and oral orange oil administration resulted in similar mammary tissue disposition of limonene with no clinical signs of toxicity. In the clinical study, the topical application of limonene containing massage oil to the breast was found to be safe with high levels of usage compliance for daily application, although NAF and plasma limonene concentrations were not significantly changed after the massage oil application. Conclusions Our studies showed that limonene is bio available in mammary tissue after topical orange oil application in mice and this novel route of administration to the breast is safe and feasible in healthy women. PMID:24236248

Reliability Stress-Strength Models for Dependent Observations with Applications in Clinical Trials

NASA Technical Reports Server (NTRS)

Kushary, Debashis; Kulkarni, Pandurang M.

1995-01-01

We consider the applications of stress-strength models in studies involving clinical trials. When studying the effects and side effects of certain procedures (treatments), it is often the case that observations are correlated due to subject effect, repeated measurements and observing many characteristics simultaneously. We develop maximum likelihood estimator (MLE) and uniform minimum variance unbiased estimator (UMVUE) of the reliability which in clinical trial studies could be considered as the chances of increased side effects due to a particular procedure compared to another. The results developed apply to both univariate and multivariate situations. Also, for the univariate situations we develop simple to use lower confidence bounds for the reliability. Further, we consider the cases when both stress and strength constitute time dependent processes. We define the future reliability and obtain methods of constructing lower confidence bounds for this reliability. Finally, we conduct simulation studies to evaluate all the procedures developed and also to compare the MLE and the UMVUE.

Transforming community services through the use of a multidimensional model of clinical leadership.

PubMed

Leigh, Jacqueline Anne; Wild, Jill; Hynes, Celia; Wells, Stuart; Kurien, Anish; Rutherford, June; Rosen, Lyn; Ashcroft, Tim; Hartley, Victoria

2015-03-01

To evaluate the application of a Multidimensional Model of Clinical Leadership on the community healthcare leader and on transforming community services. Healthcare policy advocates clinical leadership as the vehicle to transform community and healthcare services. Few studies have identified the key components of an effective clinical leadership development model. The first two stages of Kirkpatrick's (Personnel Administrator 28, 1983, 62) Four/Five Levels of Evaluation were used to evaluate the application of the multidimensional model of clinical leadership. Eighty community healthcare leaders were exposed to this multidimensional clinical leadership development model through attendance of a community clinical leadership development programme. Twenty five leaders participated in focus group interviews. Data from the interviews were analysed utilising thematic content analysis. Three key themes emerged that influenced the development of best practice principles for clinical leadership development: 1. Personal leadership development 2. Organisational leadership 3. The importance of multiprofessional action learning/reflective groups Emergent best practice principles for clinical leadership development include adopting a multidimensional development approach. This approach encompasses: preparing the individual leader in the role and seeking organisational leadership development that promotes the vision and corporate values of the organisation and delivers on service improvement and innovation. Moreover, application of the Multidimensional Model of Clinical Leadership could offer the best platform for embedding the Six C's of Nursing (Compassion in Practice - Our Culture of Compassionate Care, Department of Health, Crown Copyright, 2012) within the culture of the healthcare organisation: care, compassion, courage, commitment, communication, and competency. This is achieved in part through the application of emotional intelligence to understand self and to develop the personal integrity of the healthcare leader and through supporting a culture of lifelong leadership learning. Embedding the best practice principles of clinical leadership development within a multidimensional model of clinical leadership provides a promising approach to: equipping the healthcare leader with those transferable leadership skills required to help them embark on a journey of lifelong leadership learning; and producing the healthcare leader who is caring, compassionate and can confidently and effectively transform community services. © 2014 John Wiley & Sons Ltd.

Assessment of Clinical Effect of Perioperative Comprehensive Nursing Intervention Pattern in 23G Minimally Invasive Vitreous Surgery.

PubMed

Shen, Jie; Li, Su-Yan; Wang, Jian-Yu; Chen, Jing; Wang, Wen

2016-01-01

We observed the clinical effects of comprehensive nursing intervention pattern in 23G minimally invasive vitreous surgery according to the comprehensive nursing intervention table developed by our hospital, which would supply a basis for its clinical application. In this prospective study, we followed 120 patients undergoing 23G minimally invasive vitreous surgery from Xuzhou First People's Hospital from February 2013 to February 2015 and divided them into control and observation groups by a random number table (60 patients in each group). A regular nursing pattern was adopted for the control group, and a comprehensive nursing intervention pattern was adopted for the observation group. After that, a comparative analysis was made to identify the differences between the clinical effects of the two groups. Scores of cognition ratio, patient compliance and comfort level of patients in the observation group were higher than those of the control group were, and there was significant difference between the groups (P< 0.05). Complication incidence of the observation group is significantly lower than that of the control group (P<0.05). The comprehensive nursing intervention pattern developed by our hospital can improve clinical effects notably, which is of application value .We recommend it to be applied in eye diseases.

[Application of the Smoking Scale for Primary Care (ETAP) in clinical practice].

PubMed

González Romero, M P; Cuevas-Fernández, F J; Marcelino-Rodríguez, I; Covas, V J; Rodríguez Pérez, M C; Cabrera de León, A; Aguirre-Jaime, A

2017-08-23

To determine if the ETAP smoking scale, which measures accumulated exposure to tobacco, both actively and passively, is applicable and effective in the clinical practice of Primary Care for the prevention of acute myocardial infarction (AMI). Location Barranco Grande Health Centre in Tenerife, Spain. A study of 61 cases (AMI) and 144 controls. Sampling with random start, without matching. COR-II curves were analysed, and effectiveness was estimated using sensitivity and negative predictive value (NPV). A questionnaire was provided to participating family physicians on the applicability of ETAP in the clinic. The opinion of the participating physicians was unanimously favourable. ETAP was easy to use in the clinic, required less than 3min per patient, and was useful to reinforce the preventive intervention. The ETAP COR-II curve showed that 20years of exposure was the best cut-off point, with an area under the curve of 0.70 (95%CI: 0.62-0.78), and a combination of sensitivity (98%) and NPV (96%) for AMI. When stratifying age and gender, all groups achieved sensitivities and NPVs close to 100%, except for men aged ≥55years, in whom the NPV fell to 75%. The results indicate that ETAP is a valid tool that can be applied and be effective in the clinical practice of Primary Care for the prevention of AMI related to smoking exposure. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

RBE and related modeling in carbon-ion therapy

NASA Astrophysics Data System (ADS)

Karger, Christian P.; Peschke, Peter

2018-01-01

Carbon ion therapy is a promising evolving modality in radiotherapy to treat tumors that are radioresistant against photon treatments. As carbon ions are more effective in normal and tumor tissue, the relative biological effectiveness (RBE) has to be calculated by bio-mathematical models and has to be considered in the dose prescription. This review (i) introduces the concept of the RBE and its most important determinants, (ii) describes the physical and biological causes of the increased RBE for carbon ions, (iii) summarizes available RBE measurements in vitro and in vivo, and (iv) describes the concepts of the clinically applied RBE models (mixed beam model, local effect model, and microdosimetric-kinetic model), and (v) the way they are introduced into clinical application as well as (vi) their status of experimental and clinical validation, and finally (vii) summarizes the current status of the use of the RBE concept in carbon ion therapy and points out clinically relevant conclusions as well as open questions. The RBE concept has proven to be a valuable concept for dose prescription in carbon ion radiotherapy, however, different centers use different RBE models and therefore care has to be taken when transferring results from one center to another. Experimental studies significantly improve the understanding of the dependencies and limitations of RBE models in clinical application. For the future, further studies investigating quantitatively the differential effects between normal tissues and tumors are needed accompanied by clinical studies on effectiveness and toxicity.

Effect of hyaluronic acid in bone formation and its applications in dentistry.

PubMed

Zhao, Ningbo; Wang, Xin; Qin, Lei; Zhai, Min; Yuan, Jing; Chen, Ji; Li, Dehua

2016-06-01

Hyaluronic acid (HA), the simplest glycosaminoglycan, participates in several important biological procedures, including mediation of cellular signaling, regulation of cell adhesion and proliferation, and manipulation of cell differentiation. The effect of HA on cell proliferation and differentiation depends on its molecular weight (MW) and concentration. Moreover, the properties of high viscosity, elasticity, highly negative charge, biocompatibility, biodegradability, and nonimmunogenicity make HA attractive in tissue engineering and disease treatment. This review comprises an overview of the effect of HA on cell proliferation and differentiation in vitro, the role of HA in bone regeneration in vivo, and the clinical applications of HA in dentistry, focusing on the mechanism underlining the effect of MW and concentration of HA on cell proliferation and osteogenic differentiation. It is expected that practical progress of HA both in laboratory-based experiments and clinical applications will be achieved in the next few years. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 1560-1569, 2016. © 2016 Wiley Periodicals, Inc.

Application of virtual reality technology in clinical medicine

PubMed Central

Li, Lan; Yu, Fei; Shi, Dongquan; Shi, Jianping; Tian, Zongjun; Yang, Jiquan; Wang, Xingsong; Jiang, Qing

2017-01-01

The present review discusses the application of virtual reality (VR) technology in clinical medicine, especially in surgical training, pain management and therapeutic treatment of mental illness. We introduce the common types of VR simulators and their operational principles in aforementioned fields. The clinical effects are also discussed. In almost every study that dealt with VR simulators, researchers have arrived at the same conclusion that both doctors and patients could benefit from this novel technology. Moreover, advantages and disadvantages of the utilization of VR technology in each field were discussed, and the future research directions were proposed. PMID:28979666

Application of virtual reality technology in clinical medicine.

PubMed

Li, Lan; Yu, Fei; Shi, Dongquan; Shi, Jianping; Tian, Zongjun; Yang, Jiquan; Wang, Xingsong; Jiang, Qing

2017-01-01

The present review discusses the application of virtual reality (VR) technology in clinical medicine, especially in surgical training, pain management and therapeutic treatment of mental illness. We introduce the common types of VR simulators and their operational principles in aforementioned fields. The clinical effects are also discussed. In almost every study that dealt with VR simulators, researchers have arrived at the same conclusion that both doctors and patients could benefit from this novel technology. Moreover, advantages and disadvantages of the utilization of VR technology in each field were discussed, and the future research directions were proposed.

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol

PubMed Central

2014-01-01

Background New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. Methods/Design A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Discussion Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Trial registration Clinical Trials.gov Identifier: NCT02016014 PMID:24628961

Critical thinking in clinical nurse education: application of Paul's model of critical thinking.

PubMed

Andrea Sullivan, E

2012-11-01

Nurse educators recognize that many nursing students have difficulty in making decisions in clinical practice. The ability to make effective, informed decisions in clinical practice requires that nursing students know and apply the processes of critical thinking. Critical thinking is a skill that develops over time and requires the conscious application of this process. There are a number of models in the nursing literature to assist students in the critical thinking process; however, these models tend to focus solely on decision making in hospital settings and are often complex to actualize. In this paper, Paul's Model of Critical Thinking is examined for its application to nursing education. I will demonstrate how the model can be used by clinical nurse educators to assist students to develop critical thinking skills in all health care settings in a way that makes critical thinking skills accessible to students. Copyright © 2012 Elsevier Ltd. All rights reserved.

[Discussion of the Application of Micro-lecture in the Clinical Training 
of Thoracic Surgery].

PubMed

Li, Xiaofei; Lei, Jie

2018-04-20

Today, with the rapid development of network information technology, the micro-lecture plays a role in the teaching activities is becoming more and more important. The short and efficient teaching content of micro-lecture can be downloaded rapidly, expediently, and repeatedly, which improve the learning efficiency and independent learning capability. The clinical training of thoracic surgery elementarily remains at the scrabble stage. We require continuous reform and introduce new modes of teaching, which compatible with the development of society and the study habits of novice, to enhance the effectiveness of clinical training. In this paper, the concept, characteristic and advantage of micro-lecture was discussed, and the feasibility of application of micro-lecture in thoracic surgery teaching was also discussed. Our aim was to promote the application of micro-lecture in the clinical training of thoracic surgery reasonable and extensive.
.

Yttrium-90 -- current status, expected availability and applications of a high beta energy emitter.

PubMed

Montaña, R Leyva; González, I Hernández; Ramirez, A Alberti; Garaboldi, L; Chinol, M

2012-07-01

Yttrium-90 ((90)Y, T(1/2) 64.14 h) is a key example of a high beta energy-emitting radionuclide which is available from the strontium-90 ((90)Sr)/(90)Y radionuclide generator system. Clinical uses of (90)Y-labeled radiopharmaceutical agents have been pursued for many years and many applications have proven to be clinical effective. These most notably include the application of 90Y-labeled antibodies for a variety of applications such as for effective treatment of non-Hodgkin's lymphoma. One of the major advantages for use of (90)Y is ready availability from the very long-lived (90)Sr parent (T(1/2) 28.78 y). Because of the importance of maintaining generator performance and minimizing parent breakthrough, this paper describes development, use and quality control of both high capacity cation adsorption-type and electrochemical generator systems. In addition, the preparation and targeting to tumors in mice of DOTA-conjugated Nimotuzamab (h-R3) antibody which recognizes the external domain of the EPFR antibody radiolabeled with (90)Y obtained from the electrochemical generator is also described. As a key example for clinical applications of (90)Y, the use of (90)Y-labeled biotin for intra-operative pre-targeting for radionuclide therapy (IART®) of breast cancer is also described.

Inter-professional delirium education and care: a qualitative feasibility study of implementing a delirium Smartphone application.

PubMed

Zhang, Melvyn; Bingham, Kathleen; Kantarovich, Karin; Laidlaw, Jennifer; Urbach, David; Sockalingam, Sanjeev; Ho, Roger

2016-04-30

Delirium is a common medical condition with a high prevalence in hospital settings. Effective delirium management requires a multi-component intervention, including the use of Interprofessional teams and evidence-based interventions at the point of care. One vehicle for increasing access of delirium practice tools at the point of care is E-health. There has been a paucity of studies describing the implementation of delirium related clinical application. The purpose of this current study is to acquire users' perceptions of the utility, feasibility and effectiveness of a smartphone application for delirium care in a general surgery unit. In addition, the authors aimed to elucidate the potential challenges with implementing this application. This quantitative study was conducted between January 2015 and June 2015 at the University Health Network, Toronto General Hospital site. Participants met inclusion criteria if they were clinical staff on the General Surgery Unit at the Toronto General Hospital site and had experience caring for patients with delirium. At the conclusion of the 4 weeks after the implementation of the intervention, participants were invited by email to participate in a focus group to discuss their perspectives related to using the delirium application Our findings identified several themes related to the implementation and use of this smartphone application in an acute care clinical setting. These themes will provide clinicians preparing to use a smartphone application to support delirium care with an implementation framework. This study is one of the first to demonstrate the potential utility of a smartphone application for delirium inter-professional education. While this technology does appeal to healthcare professionals, it is important to note potential implementation challenges. Our findings provide insights into these potential barriers and can be used to assist healthcare professionals considering the development and use of an inter-professional clinical care application in their setting.

The effect of a corticosteroid cream and a barrier-strengthening moisturizer in hand eczema. A double-blind, randomized, prospective, parallel group clinical trial.

PubMed

Lodén, M; Wirén, K; Smerud, K T; Meland, N; Hønnås, H; Mørk, G; Lützow-Holm, C; Funk, J; Meding, B

2012-05-01

Hand eczema is a common and persistent disease with a relapsing course. Clinical data suggest that once daily treatment with corticosteroids is just as effective as twice daily treatment. The aim of this study was to compare once and twice daily applications of a strong corticosteroid cream in addition to maintenance therapy with a moisturizer in patients with a recent relapse of hand eczema. The study was a parallel, double-blind, randomized, clinical trial on 44 patients. Twice daily application of a strong corticosteroid cream (betamethasone valerate 0.1%) was compared with once daily application, where a urea-containing moisturizer was substituted for the corticosteroid cream in the morning. The investigator scored the presence of eczema and the patients judged the health-related quality of life (HRQoL) using the Dermatology Life Quality Index (DLQI), which measures how much the patient's skin problem has affected his/her life over the past week. The patients also judged the severity of their eczema daily on a visual analogue scale. Both groups improved in terms of eczema and DLQI. However, the clinical scoring demonstrated that once daily application of corticosteroid was superior to twice daily application in diminishing eczema, especially in the group of patients with lower eczema scores at inclusion. Twice daily use of corticosteroids was not superior to once daily use in treating eczema. On the contrary, the clinical assessment showed a larger benefit from once daily treatment compared with twice daily, especially in the group of patients with a moderate eczema at inclusion. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

PhotoExam: adoption of an iOS-based clinical image capture application at Mayo Clinic.

PubMed

Wyatt, Kirk D; Willaert, Brian N; Pallagi, Peter J; Uribe, Richard A; Yiannias, James A; Hellmich, Thomas R

2017-12-01

Mayo Clinic developed an internal iOS-based, point-of-care clinical image capture application for clinicians. We aimed to assess the adoption and utilization of the application at Mayo Clinic. Metadata of 22,784 photos of 6417 patients taken by 606 users over 8040 clinical encounters between 3/1/2015 and 10/31/2015 were analyzed. A random sample of photos from 100 clinical encounters was assessed for quality using a five-item rubric. Use of traditional medical photography services before and after application launch were compared. The largest group of users was residents/fellows, accounting for 31% of users but only 18% of all photos. Attending physicians accounted for 29% of users and 30% of photos. Nurses accounted for 14% of users and 28% of photos. Surgical specialties had the most users (36% of users), followed by dermatology (14% of users); however, dermatology accounted for 54% of all photos, and surgery accounted for 26% of photos. Images received an average of 91% of possible points on the quality scoring rubric. Most frequent reasons for missing points were the location on the body not clearly being demonstrated (19% of encounters) and the perspective/scale not being clearly demonstrated (12% of encounters). There was no discernible pre-post effect of the application's launch on use of traditional medical photography services. Point-of-care clinical photography is a growing phenomenon with potential to become the new standard of care. Patient and provider attitudes and the impact on patient outcomes remain unclear. © 2017 The International Society of Dermatology.

Photodynamic therapy (PDT) and photodiagnosis (PD) using endogenous photosensitization induced by 5-aminolevulinic acid (ALA): current clinical and development status

NASA Astrophysics Data System (ADS)

Marcus, Stuart L.; Sobel, Russel S.; Golub, Allyn L.; Carroll, Ronald L.; Lundahl, Scott L.; Shulman, D. Geoffrey

1996-04-01

Exogenous provision of ALA to many tissues results in the accumulation of sufficient quantities of the endogenous photosensitizer protoporphyrin IX, (PpIX), to produce a photodynamic effect. Therefore, ALA may be considered the only current PDT agent in clinical development which is a biochemical precursor of a photosensitizer. Topical ALA application, followed by exposure to activating light (ALA PDT), has been reported effective for the treatment of a variety of dermatologic diseases including cutaneous T-cell lymphoma, superficial basal cell carcinoma, Bowen's disease, and actinic (solar) keratoses, and is also being examined for treatment of acne and hirsutism. PpIX induced by ALA application also may serve as a fluorescence detection marker for photodiagnosis (PD) of malignant and pre- malignant conditions of the urinary bladder and other organs. Local internal application of ALA has also been used for selective endometrial ablation in animal model systems and is beginning to be examined in human clinical studies. Systemic, oral administration of ALA has been used for ALA PDT of superficial head and neck cancer, various gastrointestinal cancers, and the condition known as Barrett's esophagus. This brief paper reviews the current clinical and development status of ALA PDT.

Topical Vitamin C and the Skin: Mechanisms of Action and Clinical Applications

PubMed Central

Al-Niaimi, Firas

2017-01-01

OBJECTIVE: This review article details the main mechanisms of action and clinical applications of topical vitamin C on the skin, including its antioxidative, photoprotective, antiaging, and antipigmentary effects. DESIGN: A PubMed search for the relevant articles on vitamin C and the skin was conducted using the following key words: “vitamin C,” “ascorbic acid,” “ascorbyl-6-palmitate,”and “magnesium ascorbyl phosphate.” RESULTS: As one of the most powerful antioxidants in the skin, vitamin C has been shown to protect against photoaging, ultraviolet-induced immunosuppression, and photocarcinogenesis. It also has an antiaging effect by increasing collagen synthesis, stabilizing collagen fibers, and decreasing collagen degradation. It decreases melanin formation, thereby reducing pigmentation. Vitamin C is the primary replenisher of vitamin E and works synergistically with vitamin E in the protection against oxidative damage. CONCLUSION: Topical vitamin C has a wide range of clinical applications, from antiaging and antipigmentary to photoprotective. Currently, clinical studies on the efficacy of topical formulations of vitamin C remain limited, and the challenge lies in finding the most stable and permeable formulation in achieving the optimal results. PMID:29104718

Design Considerations For A Clinical XeC1 Excimer Laser Angioplasty System

NASA Astrophysics Data System (ADS)

Laudenslager, James B.; Goldenberg, Tsvi; Naghieh, Harry R.; Pham, Andrew A.; Narciso, Hugh L.; Tranis, Art; Pacala, Thomas J.

1989-09-01

Laser ablation and removal of intravascular plaque has long been a goal of physicians and physicists as an alternative treatment for coronary and peripheral artery disease. Early application of cw free light beam visible and infrared lasers such as argon ion or Nd:YAG lasers for this application were plagued by thermal side effects of the ablation process. Specifically, imprecise control of the boundary tissue injury produced by the deep penetration depth of the laser beam gave rise to early reclosure of the vessel due to the thermal nature of the ablation process. Pulsed ultraviolet laser free beam ablation of atherosclerotic plaque, however, does not produce thermal effects, cuts tissue precisely leaving a smooth wall and can ablate hard calcific lesions. We have chosen to develop a XeC1 excimer laser-fiberoptic delivery system for the clinical application of laser angioplasty based on achieving the desired therapeutic results for a laser revascularization procedure. Four major engineering design issues must be considered in order to produce a successful clinical laser angioplasty product. These engineering issues are: 1) Functional clinical engineering, 2) Regulatory design issues, 3) Hospital facility and user requirements, and 4) Economic issues for the manufacturer, the hospital and the patient.

Saffron in phytotherapy: pharmacology and clinical uses.

PubMed

Schmidt, Mathias; Betti, Georges; Hensel, Andreas

2007-01-01

Saffron (stigmata of Crocus sativus L.) has been used for medicinal purposes for millennia. Throughout history, uses against cancer and depressive mood can regularly be identified. These applications have also been in the focus of modern research. Promising and selective anti-cancer effects have been observed in vitro and in vivo, but not yet in clinical trials. Antidepressant effects were found in vivo and in clinical pilot studies. Saffron extracts thus have the potential to make a major contribution to rational phytotherapy.

Honey and contemporary wound care: an overview.

PubMed

Cutting, Keith F

2007-11-01

A growing body of research and empirical evidence have supported the re-discovery of medicinal grade honey as a wound management agent. Pre-clinical study results suggest that honey has therapeutic benefit; clinical study results have shown that honey effectively addresses exudate, inflammation, devitalized tissue, and infection. Honey-containing dressings and gels have been developed to facilitate the application of medicinal-grade honey to the wound. Clinical studies to compare the safety and effectiveness of these products to other moisture-retentive dressings and treatment modalities are warranted.

Information technology and social sciences: how can health IT be used to support the health professional?

PubMed

Wagner-Menghin, Michaela; Pokieser, Peter

2016-10-01

Keeping up to date with the increasing amount of health-related knowledge and managing the increasing numbers of patients with more complex clinical problems is a challenge for healthcare professionals and healthcare systems. Health IT applications, such as electronic health records or decision-support systems, are meant to support both professionals and their support systems. However, for physicians using these applications, the applications often cause new problems, such as the impracticality of their use in clinical practice. This review adopts a social sciences perspective to understand these problems and derive suggestions for further development. Indeed, humans use tools to remediate the brain's weaknesses and enhance thinking. Available health IT tools have been shaped to fit administrative needs rather than physicians' needs. To increase the beneficial effect of health IT applications in health care, clinicians' style of thinking and their learning needs must be considered when designing and implementing such systems. New health IT tools must be shaped to fit health professionals' needs. To further ease the integration of new health IT tools into clinical practice, we must also consider the effects of implementing new tools on the wider social framework. © 2016 New York Academy of Sciences.

Biomarkers in nutrition: new frontiers in research and application.

PubMed

Combs, Gerald F; Trumbo, Paula R; McKinley, Michelle C; Milner, John; Studenski, Stephanie; Kimura, Takeshi; Watkins, Steven M; Raiten, Daniel J

2013-03-01

Nutritional biomarkers--biochemical, functional, or clinical indices of nutrient intake, status, or functional effects--are needed to support evidence-based clinical guidance and effective health programs and policies related to food, nutrition, and health. Such indices can reveal information about biological or physiological responses to dietary behavior or pathogenic processes, and can be used to monitor responses to therapeutic interventions and to provide information on interindividual differences in response to diet and nutrition. Many nutritional biomarkers are available; yet there has been no formal mechanism to establish consensus regarding the optimal biomarkers for particular nutrients and applications. © 2013 New York Academy of Sciences.

[A new approach to the therapy of pyoderma in servicemen: the use of the actoprotector bemitil].

PubMed

Samtsov, A V; Tarasenko, G N; Smirnov, A V

1998-05-01

At 51 men at the age from 20 till 30, sick with pyodermatitis, the clinical-immunological aspects and efficiency of-actoprotector, capable to support motor activity and human performance in the extreme environments. Bemitil has appeared more effective in comparison with conventional therapy: by general and combined application the parameters of immunity have been normalized statistically authentically, and at outside application-the places of damage were cleared faster, disappeared painfulness, hyperemia, edema, terms of staying in the hospital were reduced. The clinical recovery was in 86.3 +/- 4.8% of the patients, while effectiveness from conventional means was 62.1 +/- 6.8%.

[Support of diabetes dietary management and self-management using mobile applications].

PubMed

Szálka, Brigitta; Kósa, István; Vassányi, István; Mák, Erzsébet

2016-07-01

The key components of successful diabetes therapy are pharmacotherapy, hospital care and lifestyle education. Lifestyle education, self-management, and composing the right diet can be effectively supported with mobile applications. In this paper Hungarian mobile applications are reviewed and compared to some international competitors. Besides plenty of useful functions some deficiencies are identified, based on dietary recommendations. The related improvements together with clinical trials validating effectiveness and reliability can strengthen medical evidence as well as the penetration of such mobile applications. Orv. Hetil., 2016, 157(29), 1147-1153.

Allergic effects of the residual monomer used in denture base acrylic resins

PubMed Central

Rashid, Haroon; Sheikh, Zeeshan; Vohra, Fahim

2015-01-01

Denture base resins are extensively used in dentistry for a variety of purposes. These materials can be classified as chemical, heat, light, and microwave polymerization materials depending upon the factor which starts the polymerization reaction. Their applications include use during denture base construction, relining existing dentures, and for fabrication of orthodontic removable appliances. There have been increased concerns regarding the safe clinical application of these materials as their biodegradation in the oral environment leads to harmful effects. Along with local side effects, the materials have certain occupational hazards, and numerous studies can be found in the literature mentioning those. The purpose of this article is to outline the cytotoxic consequences of denture base acrylic resins and clinical recommendations for their use. PMID:26929705

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

SU-C-BRD-02: A Team Focused Clinical Implementation and Failure Mode and Effects Analysis of HDR Skin Brachytherapy Using Valencia and Leipzig Surface Applicators

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sayler, E; Harrison, A; Eldredge-Hindy, H

Purpose: and Leipzig applicators (VLAs) are single-channel brachytherapy surface applicators used to treat skin lesions up to 2cm diameter. Source dwell times can be calculated and entered manually after clinical set-up or ultrasound. This procedure differs dramatically from CT-based planning; the novelty and unfamiliarity could lead to severe errors. To build layers of safety and ensure quality, a multidisciplinary team created a protocol and applied Failure Modes and Effects Analysis (FMEA) to the clinical procedure for HDR VLA skin treatments. Methods: team including physicists, physicians, nurses, therapists, residents, and administration developed a clinical procedure for VLA treatment. The procedure wasmore » evaluated using FMEA. Failure modes were identified and scored by severity, occurrence, and detection. The clinical procedure was revised to address high-scoring process nodes. Results: Several key components were added to the clinical procedure to minimize risk probability numbers (RPN): -Treatments are reviewed at weekly QA rounds, where physicians discuss diagnosis, prescription, applicator selection, and set-up. Peer review reduces the likelihood of an inappropriate treatment regime. -A template for HDR skin treatments was established in the clinical EMR system to standardize treatment instructions. This reduces the chances of miscommunication between the physician and planning physicist, and increases the detectability of an error during the physics second check. -A screen check was implemented during the second check to increase detectability of an error. -To reduce error probability, the treatment plan worksheet was designed to display plan parameters in a format visually similar to the treatment console display. This facilitates data entry and verification. -VLAs are color-coded and labeled to match the EMR prescriptions, which simplifies in-room selection and verification. Conclusion: Multidisciplinary planning and FMEA increased delectability and reduced error probability during VLA HDR Brachytherapy. This clinical model may be useful to institutions implementing similar procedures.« less

Biomarkers in nutrition: new frontiers in research and application

USDA-ARS?s Scientific Manuscript database

Nutritional biomarkers—biochemical, functional, or clinical indices of nutrient intake, status, or functional effects—are needed to support evidence-based clinical guidance and effective health programs and policies related to food, nutrition, and health. Such indices can reveal information about bi...

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review.

PubMed

Fu, Helen; McMahon, Siobhan K; Gross, Cynthia R; Adam, Terrence J; Wyman, Jean F

2017-09-01

To assess the usability and clinical effectiveness of diabetes mobile applications (diabetes apps) developed for adults with type 2 diabetes. A systematic review of the usability and effectiveness of diabetes apps was conducted. Searches were performed using MEDLINE, EMBASE, COMPENDEX, and IEEE XPLORE for articles published from January 1, 2011, to January 17, 2017. Search terms included: diabetes, mobile apps, and mobile health (mHealth). The search yielded 723 abstracts of which seven usability studies and ten clinical effectiveness studies met the inclusion criteria from 20 publications. Usability, as measured by satisfaction ratings from experts and patients, ranged from 38% to 80%. Usability problem ratings ranged from moderate to catastrophic. Top usability problems are multi-steps task, limited functionality and interaction, and difficult system navigation. Clinical effectiveness, measured by reductions in HbA1c, ranged from 0.15% to 1.9%. Despite meager satisfaction ratings and major usability problems, there is some limited evidence supporting the effectiveness of diabetes apps to improve glycemic control for adults with type 2 diabetes. Findings strongly suggest that efforts to improve user satisfaction, incorporate established principles of health behavior change, and match apps to user characteristics will increase the therapeutic impact of diabetes apps. Copyright © 2017 Elsevier B.V. All rights reserved.

[Bone morphogenetic proteins (BMP): clinical application for reconstruction of bone defects].

PubMed

Sierra-García, Gerardo Daniel; Castro-Ríos, Rocío; Gónzalez-Horta, Azucena; Lara-Arias, Jorge; Chávez-Montes, Abelardo

2016-01-01

Since the introduction of bone morphogenetic proteins, their use has become an invaluable ally for the treatment of bone defects. These proteins are potent growth factors, related to angiogenic and osteogenic activity. The osteoinductive capacity of recombinant bone morphogenetic protein (rhBMP) in the formation of bone and cartilage has been confirmed in in vitro studies and evaluated in clinical trials. To obtain a therapeutic effect, administration is systemic, by injection over the physiological dose. Among the disadvantages, ectopic bone formation or high morbidity in cases of spinal fusion is observed. In this review, the roles of bone morphogenetic proteins in bone repair and clinical applications are analyzed. These findings represent advances in the study of bone regeneration and application of growth factors for more predictable results.

Lectins and their application to clinical microbiology.

PubMed Central

Slifkin, M; Doyle, R J

1990-01-01

Lectins are generally associated with plant or animal components, selectively bind carbohydrates, and interact with procaryotic and eucaryotic cells. Lectins have various specificities that are associated with their ability to interact with acetylaminocarbohydrates, aminocarbohydrates, sialic acids, hexoses, pentoses, and as other carbohydrates. Microbial surfaces generally contain many of the sugar residues that react with lectins. Lectins are presently used in the clinical laboratory to type blood cells and are used in a wide spectrum of applications, including, in part, as carriers of chemotherapeutic agents, as mitogens, for fractionation of animal cells, and for investigations of cellular surfaces. Numerous studies have shown that lectins can be used to identify rapidly certain microorganisms isolated from a clinical specimen or directly in a clinical specimen. Lectins have been demonstrated to be important diagnostic reagents in the major realms of clinical microbiology. Thus, they have been applied in bacteriology, mycology, mycobacteriology, and virology for the identification and/or differentiation of various microorganisms. Lectins have been used successfully as epidemiologic as well as taxonomic markers of specific microorganisms. Lectins provide the clinical microbiologist with cost-effective and potential diagnostic reagents. This review describes the applications of lectins in clinical microbiology. Images PMID:2200603

[Drugs for intravenous induction of anesthesia: barbiturates].

PubMed

Dumps, C; Halbeck, E; Bolkenius, D

2018-05-09

The discovery of barbituric acid and research on its derivatives have long been of importance in advancements in modern anesthesia. Decades of clinical use of barbiturates worldwide and their abuse has led to an enormous amount of knowledge. Thiopental and methohexital are ultra-short acting derivatives of barbiturates. Their clinical application has been accompanied by an enormous increase in the knowledge of the pharmacology of cerebrally active drugs, in particular gamma-aminobutyric acid (GABA A ) receptor and GABA-induced effects on nerve cell membranes. Despite the development of newer substances, thiopental still has a firm place in clinical applications. Currently it is mainly used in obstetrics for induction of cesarean sections under general anesthesia. A disadvantage, when properly used to induce anesthesia, is usually only the prolonged elimination kinetics of barbiturates. It is beneficial that barbiturates do not require side effect provoking solubilizers.

A new specimen management system using RFID technology.

PubMed

Shim, Hun; Uh, Young; Lee, Seung Hwan; Yoon, Young Ro

2011-12-01

The specimen management system with barcode needs to be improved in order to solve inherent problems in work performance. This study describes the application of Radio Frequency Identification (RFID) which is the solution for the problems associated with specimen labeling and management. A new specimen management system and architecture with RFID technology for clinical laboratory was designed. The suggested system was tested in various conditions such as durability to temperature and aspect of effective utilization of new work flow under a virtual hospital clinical laboratory environment. This system demonstrates its potential application in clinical laboratories for improving work flow and specimen management. The suggested specimen management system with RFID technology has advantages in comparison to the traditional specimen management system with barcode in the aspect of mass specimen processing, robust durability of temperature, humidity changes, and effective specimen tracking.

Insights into defibrotide: an updated review.

PubMed

Morabito, F; Gentile, M; Gay, F; Bringhen, S; Mazzone, C; Vigna, E; Musto, P; Di Raimondo, F; Palumbo, A

2009-06-01

Defibrotide is a polydisperse oligonucleotide with antiatherosclerotic, anti-inflammatory, anti-ischaemic, pro-fibrinolytic and antithrombotic actions without significant systemic anticoagulant effects. It has been used in the treatment of various cardiovascular disorders, and especially in endothelial complications of allogeneic stem-cell transplantation. We reviewed the published work for the mechanism of action and clinical use of defibrotide to consolidate data and to describe new applications of this drug. We reviewed the most relevant papers on defibrotide published from November 1982 to January 2008. (selected through PubMed), and used recent meeting abstracts as sources for this review. Reports have suggested that defibrotide has clinical efficacy for treatment and prophylaxis of hepatic sinusoidal obstruction syndrome occurring after stem-cell transplantation. Animal models have clearly shown the potential antineoplastic effect of this drug. Further clinical investigations are needed to clarify this new application.

Cardiovascular disease prevention and health promotion with the transcendental meditation program and Maharishi consciousness-based health care.

PubMed

Schneider, Robert H; Walton, Kenneth G; Salerno, John W; Nidich, Sanford I

2006-01-01

This article summarizes the background, rationale, and clinical research on a traditional system of natural health care that may be useful in the prevention of cardiovascular disease (CVD) and promotion of health. Results recently reported include reductions in blood pressure, psychosocial stress, surrogate markers for atherosclerotic CVD, and mortality. The randomized clinical trials conducted so far have involved applications to both primary and secondary prevention as well as to health promotion more generally. The results support the applicability of this approach for reducing ethnic health disparities associated with environmental and psychosocial stress. Proposed mechanisms for the effects of this traditional system include enhanced resistance to physiological and psychological stress and improvements in homeostatic and self-repair processes. This system may offer clinical and cost effectiveness advantages for health care, particularly in preventive cardiology.

[Data Mining-revealed Characteristics of Clinical Application of Scalp Acupuncture].

PubMed

Wang, Qiong; Xing, Hai-Jiao; Bao, Na; Kong, Ling-Juan; Jia, Ye-Juan; Yang, Ke; Sun, Yan-Hui; Wang, Jian-Ling; Shi, Jing; Li, Xiao-Feng; Xu, Jing; Zhang, Xuan-Ping; Zhang, Xin; Jia, Chun-Sheng; Li, Ren-Ling

2018-03-25

To explore the regularity and characteristics of clinical application of scalp acupuncture therapy for different types of clinical conditions so as to provide a reference for clinical practice. In the present study, "head acupuncture" and"scalp acupuncture" were used as the keywords to search papers and academic dissertations having definite standards for diagnosis and therapeutic effect assessment and published in journals and academic conferences collected in database China National Knowledge Internet(CNKI) from January 1 of 1959 to December 31 of 2016, followed by constructing a database after sorting, screening, recording, extracting, and statistical analysis by using a computer. Then, the data mining was conducted for summarizing the indications of disease categories, involved medical departments, needle-insertion methods, needle manipulation techniques, academic schools, and clinical efficacy of scalp acupuncture therapy. As a result, a total of 587 papers met our including criteria were analyzed. The scalp acupuncture therapy was widely employed in the treatment of various clinical conditions of different departments, with the application frequency being the internal medicine (438 times), surgery (75 times), pediatrics (44 times), etc. Of the indicated 102 types of clinical problems, 55 belong to the internal medicine, constituting of 53.92%, particularly the cerebral apoplexy and its sequelae with the top application frequency being 102 and 115 times, respectively. In terms of needle inserting methods mentioned in partial papers (most papers do not mention), fingernail-pressing-aided needle insertion, needle-twirling insertion, fingers-squeezed-needle insertion, particularly the swiftly rotating needle insertion and rapid needle-propelling insertion were most commonly used.Regarding the needle manipulation method, rapid needle twirling technique was frequently employed, usually at a frequency of approximately 200 times per min. In regard to the academic schools, JIAO Shun-fa's scalp acupuncture system was most frequently used, followed by the international standardized scalp acupuncture. The therapeutic effect of scalp acupuncture is effective in the treatment of different conditions of various departments, especially those of the dermatology and gynecology. Scalp acupuncture has superiority in the treatment disorders of the internal medicine and has been demonstrated to have positive effects for many types of problems, particularly for apoplexy and its sequelae. Rapid needle-propelling insertion and rapid needle-twirling technique are often employed.

A machine learning based approach to identify protected health information in Chinese clinical text.

PubMed

Du, Liting; Xia, Chenxi; Deng, Zhaohua; Lu, Gary; Xia, Shuxu; Ma, Jingdong

2018-08-01

With the increasing application of electronic health records (EHRs) in the world, protecting private information in clinical text has drawn extensive attention from healthcare providers to researchers. De-identification, the process of identifying and removing protected health information (PHI) from clinical text, has been central to the discourse on medical privacy since 2006. While de-identification is becoming the global norm for handling medical records, there is a paucity of studies on its application on Chinese clinical text. Without efficient and effective privacy protection algorithms in place, the use of indispensable clinical information would be confined. We aimed to (i) describe the current process for PHI in China, (ii) propose a machine learning based approach to identify PHI in Chinese clinical text, and (iii) validate the effectiveness of the machine learning algorithm for de-identification in Chinese clinical text. Based on 14,719 discharge summaries from regional health centers in Ya'an City, Sichuan province, China, we built a conditional random fields (CRF) model to identify PHI in clinical text, and then used the regular expressions to optimize the recognition results of the PHI categories with fewer samples. We constructed a Chinese clinical text corpus with PHI tags through substantial manual annotation, wherein the descriptive statistics of PHI manifested its wide range and diverse categories. The evaluation showed with a high F-measure of 0.9878 that our CRF-based model had a good performance for identifying PHI in Chinese clinical text. The rapid adoption of EHR in the health sector has created an urgent need for tools that can parse patient specific information from Chinese clinical text. Our application of CRF algorithms for de-identification has shown the potential to meet this need by offering a highly accurate and flexible solution to analyzing Chinese clinical text. Copyright © 2018 Elsevier B.V. All rights reserved.

Clinical software development for the Web: lessons learned from the BOADICEA project

PubMed Central

2012-01-01

Background In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. Results We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web Application version 1 was released for general use in November 2007. By May 2010, we had > 1200 registered users based in the UK, USA, Canada, South America, Europe, Africa, Middle East, SE Asia, Australia and New Zealand. Conclusions We found that an evolutionary software process was effective when we developed the BOADICEA Web Application. The key clinical software development issues identified during the BOADICEA Web Application project were: software reliability, Web security, clinical data protection and user feedback. PMID:22490389

Clinical software development for the Web: lessons learned from the BOADICEA project.

PubMed

Cunningham, Alex P; Antoniou, Antonis C; Easton, Douglas F

2012-04-10

In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web Application version 1 was released for general use in November 2007. By May 2010, we had > 1200 registered users based in the UK, USA, Canada, South America, Europe, Africa, Middle East, SE Asia, Australia and New Zealand. We found that an evolutionary software process was effective when we developed the BOADICEA Web Application. The key clinical software development issues identified during the BOADICEA Web Application project were: software reliability, Web security, clinical data protection and user feedback.

Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial

PubMed Central

DUTRA, Bernardo Carvalho; OLIVEIRA, Alcione Maria Soares Dutra; OLIVEIRA, Peterson Antônio Dutra; MANZI, Flavio Ricardo; CORTELLI, Sheila Cavalca; COTA, Luís Otávio de Miranda; COSTA, Fernando Oliveira

2017-01-01

Abstract Background and objectives Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Material and Methods Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Results Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Conclusions Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy. PMID:28678950

Future Translational Applications From the Contemporary Genomics Era

PubMed Central

Fox, Caroline S.; Hall, Jennifer L.; Arnett, Donna K.; Ashley, Euan A.; Delles, Christian; Engler, Mary B.; Freeman, Mason W.; Johnson, Julie A.; Lanfear, David E.; Liggett, Stephen B.; Lusis, Aldons J.; Loscalzo, Joseph; MacRae, Calum A.; Musunuru, Kiran; Newby, L. Kristin; O’Donnell, Christopher J.; Rich, Stephen S.; Terzic, Andre

2016-01-01

The field of genetics and genomics has advanced considerably with the achievement of recent milestones encompassing the identification of many loci for cardiovascular disease and variable drug responses. Despite this achievement, a gap exists in the understanding and advancement to meaningful translation that directly affects disease prevention and clinical care. The purpose of this scientific statement is to address the gap between genetic discoveries and their practical application to cardiovascular clinical care. In brief, this scientific statement assesses the current timeline for effective translation of basic discoveries to clinical advances, highlighting past successes. Current discoveries in the area of genetics and genomics are covered next, followed by future expectations, tools, and competencies for achieving the goal of improving clinical care. PMID:25882488

Pragmatic Applications of RE-AIM for Health Care Initiatives in Community and Clinical Settings

PubMed Central

Estabrooks, Paul E.

2018-01-01

The RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) planning and evaluation framework has been applied broadly, but users often have difficulty in applying the model because of data collection needs across multiple domains and sources. Questions in the more common “who, what, where, how, when, and why” format may be an effective guide to ensure that individual participants, organization staff, and the perspectives of the setting are considered in planning and evaluation. Such a format can also help users in typical community and clinical settings to identify which outcomes are most valued and to focus limited measurement resources. Translations of RE-AIM that are easy to understand and apply are needed for application in real-world community and clinical settings where research and evaluation resources are limited. The purpose of this article is to provide simplified, pragmatic, user-centered and stakeholder-centered recommendations to increase the use of RE-AIM in community and clinical settings and in translational research. PMID:29300695

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

PubMed

Lansky, Alexandra J; Messé, Steven R; Brickman, Adam M; Dwyer, Michael; van der Worp, H Bart; Lazar, Ronald M; Pietras, Cody G; Abrams, Kevin J; McFadden, Eugene; Petersen, Nils H; Browndyke, Jeffrey; Prendergast, Bernard; Ng, Vivian G; Cutlip, Donald E; Kapadia, Samir; Krucoff, Mitchell W; Linke, Axel; Moy, Claudia Scala; Schofer, Joachim; van Es, Gerrit-Anne; Virmani, Renu; Popma, Jeffrey; Parides, Michael K; Kodali, Susheel; Bilello, Michel; Zivadinov, Robert; Akar, Joseph; Furie, Karen L; Gress, Daryl; Voros, Szilard; Moses, Jeffrey; Greer, David; Forrest, John K; Holmes, David; Kappetein, Arie P; Mack, Michael; Baumbach, Andreas

2017-02-14

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

CER Hub: An informatics platform for conducting comparative effectiveness research using multi-institutional, heterogeneous, electronic clinical data.

PubMed

Hazlehurst, Brian L; Kurtz, Stephen E; Masica, Andrew; Stevens, Victor J; McBurnie, Mary Ann; Puro, Jon E; Vijayadeva, Vinutha; Au, David H; Brannon, Elissa D; Sittig, Dean F

2015-10-01

Comparative effectiveness research (CER) requires the capture and analysis of data from disparate sources, often from a variety of institutions with diverse electronic health record (EHR) implementations. In this paper we describe the CER Hub, a web-based informatics platform for developing and conducting research studies that combine comprehensive electronic clinical data from multiple health care organizations. The CER Hub platform implements a data processing pipeline that employs informatics standards for data representation and web-based tools for developing study-specific data processing applications, providing standardized access to the patient-centric electronic health record (EHR) across organizations. The CER Hub is being used to conduct two CER studies utilizing data from six geographically distributed and demographically diverse health systems. These foundational studies address the effectiveness of medications for controlling asthma and the effectiveness of smoking cessation services delivered in primary care. The CER Hub includes four key capabilities: the ability to process and analyze both free-text and coded clinical data in the EHR; a data processing environment supported by distributed data and study governance processes; a clinical data-interchange format for facilitating standardized extraction of clinical data from EHRs; and a library of shareable clinical data processing applications. CER requires coordinated and scalable methods for extracting, aggregating, and analyzing complex, multi-institutional clinical data. By offering a range of informatics tools integrated into a framework for conducting studies using EHR data, the CER Hub provides a solution to the challenges of multi-institutional research using electronic medical record data. Copyright © 2015. Published by Elsevier Ireland Ltd.

[Muscle relaxants and neuromuscular monitoring - Introduction for a safe clinical application].

PubMed

Döcker, Dennis; Walther, Andreas

2012-05-01

The use of muscle relaxants facilitates endotracheal intubation and ameliorates the conditions of surgery. But, their use should be controlled - otherwise there will be postoperative residual curarisation which can lead to patient discomfort up to severe medical complications. Therefore, an appropriate surveillance via objective neuromuscular monitoring is essential. This article gives a review of the basic principles of muscle relaxants, their clinical application and the surveillance of their effects and degradation. © Georg Thieme Verlag Stuttgart · New York.

Measuring impedance in congestive heart failure: Current options and clinical applications

PubMed Central

Tang, W. H. Wilson; Tong, Wilson

2011-01-01

Measurement of impedance is becoming increasingly available in the clinical setting as a tool for assessing hemodynamics and volume status in patients with heart failure. The 2 major categories of impedance assessment are the band electrode method and the implanted device lead method. The exact sources of the impedance signal are complex and can be influenced by physiologic effects such as blood volume, fluid, and positioning. This article provides a critical review of our current understanding and promises of impedance measurements, the techniques that have evolved, as well as the evidence and limitations regarding their clinical applications in the setting of heart failure management. PMID:19249408

Genomic data into everyday work of a medical practitioner - digital tools for decision-making.

PubMed

Jokiranta, Sakari; Hotakainen, Kristina; Salonen, Iiris; Pöllänen, Pasi; Hänninen, Kai-Petri; Forsström, Jari; Kunnamo, Ilkka

Recent technological development has enabled fast and cost-effective simultaneous analyses of several gene variants or sequence of even the whole genome. For medical practitioners this has created challenges although genomic information may be clinically useful in new applications such as finding out individual risk for diseases influenced by as many as 50,000 variable DNA regions or in detecting pharmacogenetic risks prior to prescribing a medicine. New digital tools have paved the way for utilization of genomic data via easy access and clear clinical interpretation for both doctor and patient. In this review we describe some of these tools and applications for clinical use.

Mechanisms on spasmolytic and anti-inflammatory effects of a herbal medicinal product consisting of myrrh, chamomile flower, and coffee charcoal.

PubMed

Vissiennon, Cica; Goos, Karl-Heinz; Arnhold, Jürgen; Nieber, Karen

2017-05-01

Inflammatory bowel disease or irritable bowel syndrome are chronic gastrointestinal disorders which are associated with a lifelong therapeutic need. The disease results in physical, psychological, and social problems with an impact on partnership, sexuality, education, and career. Thus, the number of patients and health care professionals relying on traditional and complementary medicines and especially phytotherapy for the treatment of these chronic conditions is increasing over recent years. One traditional herbal medicinal product consisting of chamomile flower, myrrh, and coffee charcoal has been widely used in clinical practice within this indication area. Long-term experience and an increasing understanding of the pharmacological mechanisms substantiate its application and clinical effectiveness. Mainly the spasmolytic and anti-inflammatory effects provide a rationale for its therapeutic application. In addition, synergistic effects between the herbal components contribute to the overall effect of this medication.

Functional brain imaging in neuropsychology over the past 25 years.

PubMed

Roalf, David R; Gur, Ruben C

2017-11-01

Outline effects of functional neuroimaging on neuropsychology over the past 25 years. Functional neuroimaging methods and studies will be described that provide a historical context, offer examples of the utility of neuroimaging in specific domains, and discuss the limitations and future directions of neuroimaging in neuropsychology. Tracking the history of publications on functional neuroimaging related to neuropsychology indicates early involvement of neuropsychologists in the development of these methodologies. Initial progress in neuropsychological application of functional neuroimaging has been hampered by costs and the exposure to ionizing radiation. With rapid evolution of functional methods-in particular functional MRI (fMRI)-neuroimaging has profoundly transformed our knowledge of the brain. Its current applications span the spectrum of normative development to clinical applications. The field is moving toward applying sophisticated statistical approaches that will help elucidate distinct neural activation networks associated with specific behavioral domains. The impact of functional neuroimaging on clinical neuropsychology is more circumscribed, but the prospects remain enticing. The theoretical insights and empirical findings of functional neuroimaging have been led by many neuropsychologists and have transformed the field of behavioral neuroscience. Thus far they have had limited effects on the clinical practices of neuropsychologists. Perhaps it is time to add training in functional neuroimaging to the clinical neuropsychologist's toolkit and from there to the clinic or bedside. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Molecular hydrogen in sports medicine: new therapeutic perspectives.

PubMed

Ostojic, S M

2015-04-01

In the past 2 decades, molecular hydrogen emerged as a novel therapeutic agent, with antioxidant, anti-inflammatory and anti-apoptotic effects demonstrated in plethora of animal disease models and human studies. Beneficial effects of molecular hydrogen in clinical environment are observed especially in oxidative stress-mediated diseases, such as diabetes mellitus, brain stem infarction, rheumatoid arthritis, or neurodegenerative diseases. A number of more recent studies have reported that molecular hydrogen affects cell signal transduction and acts as an alkalizing agent, with these newly identified mechanisms of action having the potential to widen its application in clinical medicine even further. In particular, hydrogen therapy may be an effective and specific innovative treatment for exercise-induced oxidative stress and sports injury, with potential for the improvement of exercise performance. This review will summarize recent research findings regarding the clinical aspects of molecular hydrogen use, emphasizing its application in the field of sports medicine. © Georg Thieme Verlag KG Stuttgart · New York.

Advances in Clinical and Biomedical Applications of Photoacoustic Imaging

PubMed Central

Su, Jimmy L.; Wang, Bo; Wilson, Katheryne E.; Bayer, Carolyn L.; Chen, Yun-Sheng; Kim, Seungsoo; Homan, Kimberly A.; Emelianov, Stanislav Y.

2010-01-01

Importance of the field Photoacoustic imaging is an imaging modality that derives image contrast from the optical absorption coefficient of the tissue being imaged. The imaging technique is able to differentiate between healthy and diseased tissue with either deeper penetration or higher resolution than other functional imaging modalities currently available. From a clinical standpoint, photoacoustic imaging has demonstrated safety and effectiveness in diagnosing diseased tissue regions using either endogenous tissue contrast or exogenous contrast agents. Furthermore, the potential of photoacoustic imaging has been demonstrated in various therapeutic interventions ranging from drug delivery and release to image-guided therapy and monitoring. Areas covered in this review This article reviews the current state of photoacoustic imaging in biomedicine from a technological perspective, highlights various biomedical and clinical applications of photoacoustic imaging, and gives insights on future directions. What the reader will gain Readers will learn about the various applications of photoacoustic imaging, as well as the various contrast agents that can be used to assist photoacoustic imaging. This review will highlight both pre-clinical and clinical uses for photoacoustic imaging, as well as discuss some of the challenges that must be addressed to move photoacoustic imaging into the clinical realm. Take home message Photoacoustic imaging offers unique advantages over existing imaging modalities. The imaging field is broad with many exciting applications for detecting and diagnosing diseased tissue or processes. Photoacoustics is also used in therapeutic applications to identify and characterize the pathology and then to monitor the treatment. Although the technology is still in its infancy, much work has been done in the pre-clinical arena, and photoacoustic imaging is fast approaching the clinical setting. PMID:21344060

Understanding synergy.

PubMed

Geary, Nori

2013-02-01

Analysis of the interactive effects of combinations of hormones or other manipulations with qualitatively similar individual effects is an important topic in basic and clinical endocrinology as well as other branches of basic and clinical research related to integrative physiology. Functional, as opposed to mechanistic, analyses of interactions rely on the concept of synergy, which can be defined qualitatively as a cooperative action or quantitatively as a supra-additive effect according to some metric for the addition of different dose-effect curves. Unfortunately, dose-effect curve addition is far from straightforward; rather, it requires the development of an axiomatic mathematical theory. I review the mathematical soundness, face validity, and utility of the most frequently used approaches to supra-additive synergy. These criteria highlight serious problems in the two most common synergy approaches, response additivity and Loewe additivity, which is the basis of the isobole and related response surface approaches. I conclude that there is no adequate, generally applicable, supra-additive synergy metric appropriate for endocrinology or any other field of basic and clinical integrative physiology. I recommend that these metrics be abandoned in favor of the simpler definition of synergy as a cooperative, i.e., nonantagonistic, effect. This simple definition avoids mathematical difficulties, is easily applicable, meets regulatory requirements for combination therapy development, and suffices to advance phenomenological basic research to mechanistic studies of interactions and clinical combination therapy research.

MYPLAN - A Mobile Phone Application for Supporting People at Risk of Suicide.

PubMed

Skovgaard Larsen, Jette L; Frandsen, Hanne; Erlangsen, Annette

2016-05-01

Safety plans have been suggested as an intervention for people at risk of suicide. Given the impulsive character of suicidal ideation, a safety plan in the format of a mobile phone application is likely to be more available and useful than traditional paper versions. The study describes MYPLAN, a mobile phone application designed to support people at risk of suicide by letting them create a safety plan. MYPLAN was developed in collaboration with clinical psychiatric staff at Danish suicide preventive clinics. The mobile application lets the user create an individualized safety plan by filling in templates with strategies, actions, and direct links to contact persons. MYPLAN was developed in 2013 and is freely available in Denmark and Norway. It is designed for iPhone and android platforms. As of December 2015, the application has been downloaded almost 8,000 times. Users at risk of suicide as well as clinical staff have provided positive feedback on the mobile application. Support via mobile phone applications might be particularly useful for younger age groups at risk of suicide as well as in areas or countries where support options are lacking. Yet, it is important to examine the effectiveness of this type of intervention.

Effect of Shock Wave Lithotripsy on Renal Hemodynamics

NASA Astrophysics Data System (ADS)

Handa, Rajash K.; Willis, Lynn R.; Evan, Andrew P.; Connors, Bret A.

2008-09-01

Extracorporeal shock wave lithotripsy (SWL) can injure tissue and decrease blood flow in the SWL-treated kidney, both tissue and functional effects being largely localized to the region targeted with shock waves (SWs). A novel method of limiting SWL-induced tissue injury is to employ the "protection" protocol, where the kidney is pretreated with low-energy SWs prior to the application of a standard clinical dose of high-energy SWs. Resistive index measurements of renal vascular resistance/impedance to blood flow during SWL treatment protocols revealed that a standard clinical dose of high-energy SWs did not alter RI during SW application. However, there was an interaction between low- and high-energy SWL treatment phases of the "protection" protocol such that an increase in RI (vasoconstriction) was observed during the later half of SW application, a time when tissue damage is occurring during the standard high-energy SWL protocol. We suggest that renal vasoconstriction may be responsible for reducing the degree of tissue damage that normally results from a standard clinical dose of high-energy SWs.

Mesoporous composite nanoparticles for dual-modality ultrasound/magnetic resonance imaging and synergistic chemo-/thermotherapy against deep tumors.

PubMed

Zhang, Nan; Wang, Ronghui; Hao, Junnian; Yang, Yang; Zou, Hongmi; Wang, Zhigang

2017-01-01

High-intensity focused ultrasound (HIFU) is a promising and noninvasive treatment for solid tumors, which has been explored for potential clinical applications. However, the clinical applications of HIFU for large and deep tumors such as hepatocellular carcinoma (HCC) are severely limited by unsatisfactory imaging guidance, long therapeutic times, and damage to normal tissue around the tumor due to the high power applied. In this study, we developed doxorubicin/perfluorohexane-encapsulated hollow mesoporous Prussian blue nanoparticles (HMPBs-DOX/PFH) as theranostic agents, which can effectively guide HIFU therapy and enhance its therapeutic effects in combination with chemotherapy, by decreasing the cavitation threshold. We investigated the effects of this agent on ultrasound and magnetic resonance imaging in vitro and in vivo. In addition, we showed a highly efficient HIFU therapeutic effect against HCC tumors, as well as controlled drug release, owing to the phase-transitional performance of the PFH. We therefore conclude that HMPB-DOX/PFH is a safe and efficient nanoplatform, which holds significant promise for cancer theranostics against deep tumors in clinical settings.

Mesoporous composite nanoparticles for dual-modality ultrasound/magnetic resonance imaging and synergistic chemo-/thermotherapy against deep tumors

PubMed Central

Zhang, Nan; Wang, Ronghui; Hao, Junnian; Yang, Yang; Zou, Hongmi; Wang, Zhigang

2017-01-01

High-intensity focused ultrasound (HIFU) is a promising and noninvasive treatment for solid tumors, which has been explored for potential clinical applications. However, the clinical applications of HIFU for large and deep tumors such as hepatocellular carcinoma (HCC) are severely limited by unsatisfactory imaging guidance, long therapeutic times, and damage to normal tissue around the tumor due to the high power applied. In this study, we developed doxorubicin/perfluorohexane-encapsulated hollow mesoporous Prussian blue nanoparticles (HMPBs-DOX/PFH) as theranostic agents, which can effectively guide HIFU therapy and enhance its therapeutic effects in combination with chemotherapy, by decreasing the cavitation threshold. We investigated the effects of this agent on ultrasound and magnetic resonance imaging in vitro and in vivo. In addition, we showed a highly efficient HIFU therapeutic effect against HCC tumors, as well as controlled drug release, owing to the phase-transitional performance of the PFH. We therefore conclude that HMPB-DOX/PFH is a safe and efficient nanoplatform, which holds significant promise for cancer theranostics against deep tumors in clinical settings. PMID:29042775

VISUAL CONTRAST SENSITIVITY: A SENSITIVE INDICATOR OF NEUROTOXICITY FOR RISK ASSESSMENT AND CLINICAL APPLICATIONS.

EPA Science Inventory

Both human-health risk assessments of adverse effects from chronic, environmental exposures to neurotoxics and clinical practice are in need of objective indicators sensitive to the early stages of disruption in neurologic function; risk assessment for the purposes of hazard iden...

A general method to determine sampling windows for nonlinear mixed effects models with an application to population pharmacokinetic studies.

PubMed

Foo, Lee Kien; McGree, James; Duffull, Stephen

2012-01-01

Optimal design methods have been proposed to determine the best sampling times when sparse blood sampling is required in clinical pharmacokinetic studies. However, the optimal blood sampling time points may not be feasible in clinical practice. Sampling windows, a time interval for blood sample collection, have been proposed to provide flexibility in blood sampling times while preserving efficient parameter estimation. Because of the complexity of the population pharmacokinetic models, which are generally nonlinear mixed effects models, there is no analytical solution available to determine sampling windows. We propose a method for determination of sampling windows based on MCMC sampling techniques. The proposed method attains a stationary distribution rapidly and provides time-sensitive windows around the optimal design points. The proposed method is applicable to determine sampling windows for any nonlinear mixed effects model although our work focuses on an application to population pharmacokinetic models. Copyright © 2012 John Wiley & Sons, Ltd.

Engineering growth factors for regenerative medicine applications.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Aaron C.; Briquez, Priscilla S.; Hubbell, Jeffrey A.

Growth factors are important morphogenetic proteins that instruct cell behavior and guide tissue repair and renewal. Although their therapeutic potential holds great promise in regenerative medicine applications, translation of growth factors into clinical treatments has been hindered by limitations including poor protein stability, low recombinant expression yield, and suboptimal efficacy. This review highlights current tools, technologies, and approaches to design integrated and effective growth factor-based therapies for regenerative medicine applications. The first section describes rational and combinatorial protein engineering approaches that have been utilized to improve growth factor stability, expression yield, biodistribution, and serum half-life, or alter their cell traffickingmore » behavior or receptor binding affinity. The second section highlights elegant biomaterial-based systems, inspired by the natural extracellular matrix milieu, that have been developed for effective spatial and temporal delivery of growth factors to cell surface receptors. Although appearing distinct, these two approaches are highly complementary and involve principles of molecular design and engineering to be considered in parallel when developing optimal materials for clinical applications.« less

[Application of three-dimensional digital technology in the diagnosis and treatment planning in orthodontics].

PubMed

Bai, Y X

2016-06-01

Three-dimensional(3D)digital technology has been widely used in the field of orthodontics in clinical examination, diagnosis, treatment and curative effect evaluation. 3D digital technology greatly improves the accuracy of diagnosis and treatment, and provides effective means for personalized orthodontic treatment. This review focuses on the application of 3D digital technology in the field of orthodontics.

The use of stem cells in aesthetic dermatology and plastic surgery procedures. A compact review of experimental and clinical applications

PubMed Central

Nowacki, Maciej; Kloskowski, Tomasz; Pietkun, Katarzyna; Zegarski, Maciej; Pokrywczyńska, Marta; Habib, Samy L.; Drewa, Tomasz

2017-01-01

The aim of this paper was to collect currently available data related to the use of stem cells in aesthetic dermatology and plastic surgery based on a systemic review of experimental and clinical applications. We found that the use of stem cells is very promising but the current state of art is still not effective. This situation is connected with not fully known mechanisms of cell interactions, possible risks and side effects. We think that there is a big need to create and conduct different studies which could resolve problems of stem cells use for implementation into aesthetic dermatology and plastic surgery. PMID:29422816

The use of stem cells in aesthetic dermatology and plastic surgery procedures. A compact review of experimental and clinical applications.

PubMed

Nowacki, Maciej; Kloskowski, Tomasz; Pietkun, Katarzyna; Zegarski, Maciej; Pokrywczyńska, Marta; Habib, Samy L; Drewa, Tomasz; Zegarska, Barbara

2017-12-01

The aim of this paper was to collect currently available data related to the use of stem cells in aesthetic dermatology and plastic surgery based on a systemic review of experimental and clinical applications. We found that the use of stem cells is very promising but the current state of art is still not effective. This situation is connected with not fully known mechanisms of cell interactions, possible risks and side effects. We think that there is a big need to create and conduct different studies which could resolve problems of stem cells use for implementation into aesthetic dermatology and plastic surgery.

Integrating pharmacogenomics into pharmacy practice via medication therapy management.

PubMed

Reiss, Susan M

2011-01-01

To explore the application and integration of pharmacogenomics in pharmacy clinical practice via medication therapy management (MTM) to improve patient care. Department of Health & Human Services (HHS) Personalized Health Care Initiative, Food and Drug Administration (FDA) pharmacogenomics activity, and findings from the Utilizing E-Prescribing Technologies to Integrate Pharmacogenomics into Prescribing and Dispensing Practices Stakeholder Workshop, convened by the American Pharmacists Association (APhA) on March 5, 2009. Participants at the Stakeholder Workshop included diverse representatives from pharmacy, medicine, pathology, health information technology (HIT), standards, science, academia, government, and others with a key interest in the clinical application of pharmacogenomics. In 2006, HHS initiated the Personalized Health Care Initiative with the goal of building the foundation for the delivery of gene-based care, which may prove to be more effective for large patient subpopulations. In the years since the initiative was launched, drug manufacturers and FDA have begun to incorporate pharmacogenomic data and applications of this information into the drug development, labeling, and approval processes. New applications and processes for using this emerging pharmacogenomics data are needed to effectively integrate this information into clinical practice. Building from the findings of a stakeholder workshop convened by APhA and the advancement of the pharmacist's collaborative role in patient care through MTM, emerging roles for pharmacists using pharmacogenomic information to improve patient care are taking hold. Realizing the potential role of the pharmacist in pharmacogenomics through MTM will require connectivity of pharmacists into the electronic health record infrastructure to permit the exchange of pertinent health information among all members of a patient's health care team. Addressing current barriers, concerns, and system limitations and developing an effective infrastructure will be necessary for pharmacogenomics to achieve its true potential. To achieve integration of pharmacogenomics into clinical practice via MTM, the pharmacy profession must define a process for the application of pharmacogenomic data into pharmacy clinical practice that is aligned with MTM service delivery, develop a viable business model for these practices, and encourage and direct the development of HIT solutions that support the pharmacist's role in this emerging field.

Advanced functional polymers for regenerative and therapeutic dentistry.

PubMed

Lai, W-F; Oka, K; Jung, H-S

2015-07-01

Use of ceramics and polymers continues to dominate clinical procedures in modern dentistry. Polymers have provided the basis for adhesives, tissue void fillers, and artificial replacements for whole teeth. They have been remarkably effective in the clinic at restoration of major dental functions after damage or loss of teeth. With the rapid development of polymer science, dental materials science has significantly lagged behind in harnessing these advanced polymer products. What they offer is new and unique properties superior to traditional polymers and crucially a range of properties that more closely match natural biomaterials. Therefore, we should pursue more vigorously the benefits of advanced polymers in dentistry. In this review, we highlight how the latest generation of advanced polymers will enhance the application of materials in the dental clinic using numerous promising examples. Polymers have a broad range of applications in modern dentistry. Some major applications are to construct frameworks that mimic the precise structure of tissues, to restore tooth organ function, and to deliver bioactive agents to influence cell behavior from the inside. The future of polymers in dentistry must include all these new enhancements to increase biological and clinical effectiveness beyond what can be achieved with traditional biomaterials. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Biological effects of electrolyzed water in hemodialysis.

PubMed

Nakayama, Masaaki; Kabayama, Shigeru; Nakano, Hirofumi; Zhu, Wan-Jun; Terawaki, Hiroyuki; Nakayama, Keisuke; Katoh, Kiyoshi; Satoh, Toshinobu; Ito, Sadayoshi

2009-01-01

The application of electrolyzed water (EW) at the cathode side to manufacture reverse osmosis (RO) water and hemodialysis (HD) solution can actually lead to less oxidative capacity in chemical terms. The present study examined the biological actions of this water on human polymorphonuclear leukocytes (PMNs), and the clinical feasibility of applying this technology to HD treatment. RO water using EW (e-RO) exhibited less chemiluminescence in luminol-hydrogen peroxide and higher dissolved hydrogen levels (-99.0 ppb) compared with control RO water. The effects of e-RO on PMN viability were tested. HD using e-RO was performed for 12 consecutive sessions in 8 patients for the feasibility test. Basal cellular viability and function to generate superoxide radicals of PMNs were better preserved by e-RO application. In the clinical trial, reductions of blood pressure were noted, but no adverse events were observed. There were no changes in the blood dialysis parameters, although methylguanidine levels were significantly decreased at the end of study. The present study demonstrated the capacity of e-RO to preserve the viability of PMNs, and the clinical feasibility of applying this water for HD treatment. The clinical application of this technology may improve the bio-compatibility of HD treatment. Copyright 2009 S. Karger AG, Basel.

Liver Rapid Reference Set Application: Hiro Yamada - Wako (2011) — EDRN Public Portal

Cancer.gov

Measure clinical effectiveness of AFP-L3 and DCP for early detection of HCC in patient samples collected prospectively during surveillance. However since such samples are not readily available in the USA the reference set samples are well characterized and studied, gaining access to these samples will allow Wako to quickly measure clinical effectiveness of AFP-L3 and DCP in detecting early HCC.

Application of exercise ECG stress test in the current high cost modern-era healthcare system.

PubMed

Vaidya, Gaurang Nandkishor

Exercise electrocardiogram (ECG) tests boasts of being more widely available, less resource intensive, lower cost and absence of radiation. In the presence of a normal baseline ECG, an exercise ECG test is able to generate a reliable and reproducible result almost comparable to Technitium-99m sestamibi perfusion imaging. Exercise ECG changes when combined with other clinical parameters obtained during the test has the potential to allow effective redistribution of scarce resources by excluding low risk patients with significant accuracy. As we look towards a future of rising healthcare costs, increased prevalence of cardiovascular disease and the need for proper allocation of limited resources; exercise ECG test offers low cost, vital and reliable disease interpretation. This article highlights the physiology of the exercise ECG test, patient selection, effective interpretation, describe previously reported scores and their clinical application in today's clinical practice. Copyright © 2017. Published by Elsevier B.V.

Modulation of Metabolic Detoxification Pathways Using Foods and Food-Derived Components: A Scientific Review with Clinical Application.

PubMed

Hodges, Romilly E; Minich, Deanna M

2015-01-01

Research into human biotransformation and elimination systems continues to evolve. Various clinical and in vivo studies have been undertaken to evaluate the effects of foods and food-derived components on the activity of detoxification pathways, including phase I cytochrome P450 enzymes, phase II conjugation enzymes, Nrf2 signaling, and metallothionein. This review summarizes the research in this area to date, highlighting the potential for foods and nutrients to support and/or modulate detoxification functions. Clinical applications to alter detoxification pathway activity and improve patient outcomes are considered, drawing on the growing understanding of the relationship between detoxification functions and different disease states, genetic polymorphisms, and drug-nutrient interactions. Some caution is recommended, however, due to the limitations of current research as well as indications that many nutrients exert biphasic, dose-dependent effects and that genetic polymorphisms may alter outcomes. A whole-foods approach may, therefore, be prudent.

Renewable Energy for Rural Health Clinics (Energia Removable para Centros de Salud Rurales)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jimenez, A. C.; Olson, K.

This guide provides a broad understanding of the technical, social, and organizational aspects of health clinic electrification, especially through the use of renewable energy sources. It is intended to be used primarily by decision makers within governments or private agencies to accurately assess their health clinic's needs, select appropriate and cost-effective technologies to meet those needs, and to put into place effective infrastructure to install and maintain the hardware. This is the first in a series of rural applications guidebooks that the National Renewable Energy Laboratory (NREL) Village Power Program is commissioning to couple commercial renewable systems with rural applications.more » The guidebooks are complemented by NREL's Village Power Program's development activities, international pilot projects, and visiting professionals program. For more information on the NREL Village Power Program, visit the Renewables for Sustainable Village Power web site at http://www.rsvp.nrel .gov/rsvp/.« less

Cardiovascular Disease Prevention and Health Promotion with the Transcendental Meditation Program and Maharishi Consciousness-Based Health Care

PubMed Central

Schneider, Robert H.; Walton, Kenneth G.; Salerno, John W.; Nidich, Sanford I.

2008-01-01

This article summarizes the background, rationale, and clinical research on a traditional system of natural health care that may be useful in the prevention of cardiovascular disease (CVD) and promotion of health. Results recently reported indude reductions in blood pressure, psychosocial stress, surrogate markers for atherosclerotic CVD, and mortality. The randomized clinical trials conducted so far have involved applications to both primary and secondary prevention as well as to health promotion more generally. The results support the applicability of this approach for reducing ethnic health disparities associated with environmental and psychosocial stress. Proposed mechanisms for the effects of this traditional system include enhanced resistance to physiological and psychological stress and improvements in homeostatic and self-repair processes. This system may offer clinical and cost effectiveness advantages for health care, particularly in preventive cardiology. PMID:16938913

Modulation of Metabolic Detoxification Pathways Using Foods and Food-Derived Components: A Scientific Review with Clinical Application

PubMed Central

Hodges, Romilly E.; Minich, Deanna M.

2015-01-01

Research into human biotransformation and elimination systems continues to evolve. Various clinical and in vivo studies have been undertaken to evaluate the effects of foods and food-derived components on the activity of detoxification pathways, including phase I cytochrome P450 enzymes, phase II conjugation enzymes, Nrf2 signaling, and metallothionein. This review summarizes the research in this area to date, highlighting the potential for foods and nutrients to support and/or modulate detoxification functions. Clinical applications to alter detoxification pathway activity and improve patient outcomes are considered, drawing on the growing understanding of the relationship between detoxification functions and different disease states, genetic polymorphisms, and drug-nutrient interactions. Some caution is recommended, however, due to the limitations of current research as well as indications that many nutrients exert biphasic, dose-dependent effects and that genetic polymorphisms may alter outcomes. A whole-foods approach may, therefore, be prudent. PMID:26167297

Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial.

PubMed

Ledford, Christy J W; Womack, Jasmyne J; Rider, Heather A; Seehusen, Angela B; Conner, Stephen J; Lauters, Rebecca A; Hodge, Joshua A

2018-06-01

As pregnant mothers increasingly engage in shared decision making regarding prenatal decisions, such as induction of labor, the patient's level of activation may influence pregnancy outcomes. One potential tool to increase patient activation in the clinical setting is mobile applications. However, research is limited in comparing mobile apps with other modalities of patient education and engagement tools. This study was designed to test the effectiveness of a mobile app as a replacement for a spiral notebook guide as a patient education and engagement tool in the prenatal clinical setting. This randomized controlled trial was conducted in the Women's Health Clinic and Family Health Clinic of three hospitals. Repeated-measures analysis of covariance was used to test intervention effects in the study sample of 205 patients. Mothers used a mobile app interface to more frequently record information about their pregnancy; however, across time, mothers using a mobile app reported a significant decrease in patient activation. The unexpected negative effects in the group of patients randomized to the mobile app prompt these authors to recommend that health systems pause before distributing their own version of mobile apps that may decrease patient activation. Mobile apps can be inherently empowering and engaging, but how a system encourages their use may ultimately determine their adoption and success.

[The application of the modern phototherapeutic technologies for the medical rehabilitation of the children].

PubMed

Khan, M A; Chubarova, А I; Pogonchenkova, I V; Rassulova, M A; Sergeenko, E Y; Vakhova, E L; Lyan, N A; Mikitchenko, N A

2017-12-28

This literature review is focused on the application of polychromatic and monochromatic polarized light for the treatment of various diseases of the childhood including those in the newborns and the premature babies. The analysis of the data of scientific research gives evidence of the beneficial effect of polychromatic polarized light on the clinical course of various skin diseases in the newborn children. Moreover, the improved immunological and reparative processes were revealed after the surgical interventions for congenital heart defects in the newborns. The light-induced changes in the skin contribute to the realization of therapeutic effects of polarized polychromatic light in such children's diseases as atopic dermatitis, bronchitis, bronchial asthma, neurogenic urinary bladder dysfunction, and the traumatic injuries of the limbs. The biologically positive physiological effects of monochromatic polarized light are known to contribute to the improvement of the clinical and functional status in the children presenting with bronchial asthma and in the patients frequently suffering from acute respiratory diseases. The versatility of the biological effects of polarized light taken together with the possibility of its application from the first days of the child's life, the short duration of the procedure, the absence of unpleasant sensations and contact between the damaged surface and the device as well as the simplicity of using the equipment determine the promising prospects for the use of the proposed method in the clinical pediatric practice.

Applying a soft-robotic glove as assistive device and training tool with games to support hand function after stroke: Preliminary results on feasibility and potential clinical impact.

PubMed

Prange-Lasonder, Gerdienke B; Radder, Bob; Kottink, Anke I R; Melendez-Calderon, Alejandro; Buurke, Jaap H; Rietman, Johan S

2017-07-01

Recent technological developments regarding wearable soft-robotic devices extend beyond the current application of rehabilitation robotics and enable unobtrusive support of the arms and hands during daily activities. In this light, the HandinMind (HiM) system was developed, comprising a soft-robotic, grip supporting glove with an added computer gaming environment. The present study aims to gain first insight into the feasibility of clinical application of the HiM system and its potential impact. In order to do so, both the direct influence of the HiM system on hand function as assistive device and its therapeutic potential, of either assistive or therapeutic use, were explored. A pilot randomized clinical trial was combined with a cross-sectional measurement (comparing performance with and without glove) at baseline in 5 chronic stroke patients, to investigate both the direct assistive and potential therapeutic effects of the HiM system. Extended use of the soft-robotic glove as assistive device at home or with dedicated gaming exercises in a clinical setting was applicable and feasible. A positive assistive effect of the soft-robotic glove was proposed for pinch strength and functional task performance 'lifting full cans' in most of the five participants. A potential therapeutic impact was suggested with predominantly improved hand strength in both participants with assistive use, and faster functional task performance in both participants with therapeutic application.

Initial Clinical Trial of Robot of Endovascular Treatment with Force Feedback and Cooperating of Catheter and Guidewire.

PubMed

Jiang, Yuhua; Liu, Keyun; Li, Youxiang

2018-01-01

To evaluate the feasibility and safety of the robot of endovascular treatment (RobEnt) in clinical practice, we carried out a cerebral angiography using this robot system. We evaluated the performance of application of the robot system to clinical practice through using this robotic system to perform the digital subtraction angiography for a patient who was suspected of suffering intracranial aneurysm. At the same time, through comparing the postoperative head nuclear magnetic and blood routine with the preoperative examination, we evaluated the safety of application of the robot system to clinical practice. We performed the robot system to complete the bilateral carotid artery and bilateral vertebral arteriography. The results indicate that there was no obvious abnormality in the patient's cerebral artery. No obvious abnormality was observed in the examination of patients' check-up, head nuclear magnetism, and blood routine after the digital subtraction angiography. From this clinical trial, it can be observed that the robot system can perform the operation of cerebral angiography. The robot system can basically complete the related observation indexes, and its accuracy, effectiveness, stability, and safety basically meet the requirements of clinical application in neurointerventional surgery.

'Televaluation' of clinical information systems: an integrative approach to assessing Web-based systems.

PubMed

Kushniruk, A W; Patel, C; Patel, V L; Cimino, J J

2001-04-01

The World Wide Web provides an unprecedented opportunity for widespread access to health-care applications by both patients and providers. The development of new methods for assessing the effectiveness and usability of these systems is becoming a critical issue. This paper describes the distance evaluation (i.e. 'televaluation') of emerging Web-based information technologies. In health informatics evaluation, there is a need for application of new ideas and methods from the fields of cognitive science and usability engineering. A framework is presented for conducting evaluations of health-care information technologies that integrates a number of methods, ranging from deployment of on-line questionnaires (and Web-based forms) to remote video-based usability testing of user interactions with clinical information systems. Examples illustrating application of these techniques are presented for the assessment of a patient clinical information system (PatCIS), as well as an evaluation of use of Web-based clinical guidelines. Issues in designing, prototyping and iteratively refining evaluation components are discussed, along with description of a 'virtual' usability laboratory.

Fundamentals of Clinical Pharmacology With Application for Pregnant Women.

PubMed

Patil, Avinash S; Sheng, Jessica; Dotters-Katz, Sarah K; Schmoll, Maria S; Onslow, Mitchell; Pierson, Rebecca C

2017-05-01

Medication use is common in pregnancy, yet for most medications the optimal formulation and dosage have not been described specifically for pregnant women. Often, adverse effects are only discovered anecdotally or after extensive off-label use occurs. Since pharmacologic research that includes pregnant women is sparse and animal studies are often not applicable to the human fetus, providers must use knowledge of drug behavior and normal physiologic changes of pregnancy to personalize treatment for pregnant women. In this review, we present an overview of the basic concepts of clinical pharmacology: pharmacokinetics, pharmacodynamics, and pharmacogenomics. The normal physiologic changes of pregnancy are presented as a framework to understand alterations in drug behavior. A clinical vignette that addresses 4 pregnancy scenarios involving medications-preterm birth, vaccination, herpes simplex virus infection, and codeine toxicity-is provided to illustrate application of core clinical pharmacologic concepts. Discussion of relevant literature illustrates the challenges of offering individualized pharmacologic therapy in pregnancy. © 2017 by the American College of Nurse-Midwives.

[Technical specification for clinical application of critical ultrasonography].

PubMed

Yin, M G; Wang, X T; Liu, D W; Chao, Y G; Guan, X D; Kang, Y; Yan, J; Ma, X C; Tang, Y Q; Hu, Z J; Yu, K J; Chen, D C; Ai, Y H; Zhang, L N; Zhang, H M; Wu, J; Liu, L X; Zhu, R; He, W; Zhang, Q; Ding, X; Li, L; Li, Y; Liu, H T; Zeng, Q B; Si, X; Chen, H; Zhang, J W; Xu, Q H; Chen, W J; Chen, X K; Huang, D Z; Cai, S H; Shang, X L; Guan, J; Du, J; Zhao, L; Wang, M J; Cui, S; Wang, X M; Zhou, R; Zeng, X Y; Wang, Y P; Lyu, L W; Zhu, W H; Zhu, Y; Duan, J; Yang, J; Yang, H

2018-06-01

Critical ultrasonography(CUS) is different from the traditional diagnostic ultrasound, the examiner and interpreter of the image are critical care medicine physicians. The core content of CUS is to evaluate the pathophysiological changes of organs and systems and etiology changes. With the idea of critical care medicine as the soul, it can integrate the above information and clinical information, bedside real-time diagnosis and titration treatment, and evaluate the therapeutic effect so as to improve the outcome. CUS is a traditional technique which is applied as a new application method. The consensus of experts on critical ultrasonography in China released in 2016 put forward consensus suggestions on the concept, implementation and application of CUS. It should be further emphasized that the accurate and objective assessment and implementation of CUS requires the standardization of ultrasound image acquisition and the need to establish a CUS procedure. At the same time, the standardized training for CUS accepted by critical care medicine physicians requires the application of technical specifications, and the establishment of technical specifications is the basis for the quality control and continuous improvement of CUS. Chinese Critical Ultrasound Study Group and Critical Hemodynamic Therapy Collabration Group, based on the rich experience of clinical practice in critical care and research, combined with the essence of CUS, to learn the traditional ultrasonic essence, established the clinical application technical specifications of CUS, including in five parts: basic view and relevant indicators to obtain in CUS; basic norms for viscera organ assessment and special assessment; standardized processes and systematic inspection programs; examples of CUS applications; CUS training and the application of qualification certification. The establishment of applied technology standard is helpful for standardized training and clinical correct implementation. It is helpful for clinical evaluation and correct guidance treatment, and is also helpful for quality control and continuous improvement of CUS application.

Assessment of statistical significance and clinical relevance.

PubMed

Kieser, Meinhard; Friede, Tim; Gondan, Matthias

2013-05-10

In drug development, it is well accepted that a successful study will demonstrate not only a statistically significant result but also a clinically relevant effect size. Whereas standard hypothesis tests are used to demonstrate the former, it is less clear how the latter should be established. In the first part of this paper, we consider the responder analysis approach and study the performance of locally optimal rank tests when the outcome distribution is a mixture of responder and non-responder distributions. We find that these tests are quite sensitive to their planning assumptions and have therefore not really any advantage over standard tests such as the t-test and the Wilcoxon-Mann-Whitney test, which perform overall well and can be recommended for applications. In the second part, we present a new approach to the assessment of clinical relevance based on the so-called relative effect (or probabilistic index) and derive appropriate sample size formulae for the design of studies aiming at demonstrating both a statistically significant and clinically relevant effect. Referring to recent studies in multiple sclerosis, we discuss potential issues in the application of this approach. Copyright © 2012 John Wiley & Sons, Ltd.

Mobile-Assisted Grammar Exercises: Effects on Self-Editing in L2 Writing

ERIC Educational Resources Information Center

Li, Zhi; Hegelheimer, Volker

2013-01-01

In this paper, we report on the development and implementation of a web-based mobile application, "Grammar Clinic," for an ESL writing class. Drawing on insights from the interactionist approach to Second Language Acquisition (SLA), the Noticing Hypothesis, and mobile-assisted language learning (MALL), "Grammar Clinic" was…

Meta-Analysis: Application to Clinical Dentistry and Dental Education.

ERIC Educational Resources Information Center

Cohen, Peter A.

1992-01-01

Meta-analysis is proposed as an effective alternative to conventional narrative review for extracting trends from research findings. This type of analysis is explained, advantages over more traditional review techniques are discussed, basic procedures and limitations are outlined, and potential applications in dental education and clinical…

I-Maculaweb: A Tool to Support Data Reuse in Ophthalmology

PubMed Central

Bonetto, Monica; Nicolò, Massimo; Gazzarata, Roberta; Fraccaro, Paolo; Rosa, Raffaella; Musetti, Donatella; Musolino, Maria; Traverso, Carlo E.

2016-01-01

This paper intends to present a Web-based application to collect and manage clinical data and clinical trials together in a unique tool. I-maculaweb is a user-friendly Web-application designed to manage, share, and analyze clinical data from patients affected by degenerative and vascular diseases of the macula. The unique and innovative scientific and technological elements of this project are the integration with individual and population data, relevant for degenerative and vascular diseases of the macula. Clinical records can also be extracted for statistical purposes and used for clinical decision support systems. I-maculaweb is based on an existing multilevel and multiscale data management model, which includes general principles that are suitable for several different clinical domains. The database structure has been specifically built to respect laterality, a key aspect in ophthalmology. Users can add and manage patient records, follow-up visits, treatment, diagnoses, and clinical history. There are two different modalities to extract records: one for the patient’s own center, in which personal details are shown and the other for statistical purposes, where all center’s anonymized data are visible. The Web-platform allows effective management, sharing, and reuse of information within primary care and clinical research. Clear and precise clinical data will improve understanding of real-life management of degenerative and vascular diseases of the macula as well as increasing precise epidemiologic and statistical data. Furthermore, this Web-based application can be easily employed as an electronic clinical research file in clinical studies. PMID:27170913

Evaluation of hyaluronan gel (Gengigel(®) ) as a topical applicant in the treatment of gingivitis.

PubMed

Sapna, Nadiger; Vandana, Kharidi Laxman

2011-08-01

  To clinically and histopathologically evaluate the anti-inflammatory effect of 0.2% hyaluronan gel alone and with mechanical therapy on gingivitis. The argyrophilic nucleolar organizer region staining technique was attempted to routinely determine its diagnostic and prognostic dependability for periodontal lesions.   In each of the 28 gingivitis patients, the four quadrants were subjected to different treatments: scaling, scaling + topical hyaluronan gel, only topical hyaluronan gel, and topical + intrasulcular hyaluronan gel. Clinical parameters were recorded at baseline, and on days 7, 14, and 21. Biopsies were taken from each quadrant, inflammatory infiltrates were graded, and the argyrophilic nucleolar organizer region count was measured before and after treatment.   A significant reduction was seen in clinical parameters, inflammatory infiltrates, and the argyrophilic nucleolar organizer region count within the groups. The effect of topical + intrasulcular gel was equivalent to scaling (P > 0.05). Topical + intrasulcular hyaluronan gel application demonstrated a better reduction than topical hyaluronan gel alone.   Hyaluronan gel is an effective topical agent for treating gingivitis, along with scaling and intrasulcular application. The argyrophilic nucleolar organizer region count can be used as a histopathological indicator in cases of non-responsive gingivitis to assess the severity of gingival inflammation. © 2011 Blackwell Publishing Asia Pty Ltd.

Mind-body interventions: applications in neurology.

PubMed

Wahbeh, Helané; Elsas, Siegward-M; Oken, Barry S

2008-06-10

Half of the adults in the United States use complementary and alternative medicine with mind-body therapy being the most commonly used form. Neurology patients often turn to their physicians for insight into the effectiveness of the therapies and resources to integrate them into their care. The objective of this article is to give a clinical overview of mind-body interventions and their applications in neurology. Medline and PsychInfo were searched on mind-body therapies and neurologic disease search terms for clinical trials and reviews and published evidence was graded. Meditation, relaxation, and breathing techniques, yoga, tai chi, and qigong, hypnosis, and biofeedback are described. Mind-body therapy application to general pain, back and neck pain, carpal tunnel syndrome, headaches, fibromyalgia, multiple sclerosis, epilepsy, muscular dysfunction, stroke, aging, Parkinson disease, stroke, and attention deficit-hyperactivity disorder are reviewed. There are several conditions where the evidence for mind-body therapies is quite strong such as migraine headache. Mind-body therapies for other neurology applications have limited evidence due mostly to small clinical trials and inadequate control groups.

Future translational applications from the contemporary genomics era: a scientific statement from the American Heart Association.

PubMed

Fox, Caroline S; Hall, Jennifer L; Arnett, Donna K; Ashley, Euan A; Delles, Christian; Engler, Mary B; Freeman, Mason W; Johnson, Julie A; Lanfear, David E; Liggett, Stephen B; Lusis, Aldons J; Loscalzo, Joseph; MacRae, Calum A; Musunuru, Kiran; Newby, L Kristin; O'Donnell, Christopher J; Rich, Stephen S; Terzic, Andre

2015-05-12

The field of genetics and genomics has advanced considerably with the achievement of recent milestones encompassing the identification of many loci for cardiovascular disease and variable drug responses. Despite this achievement, a gap exists in the understanding and advancement to meaningful translation that directly affects disease prevention and clinical care. The purpose of this scientific statement is to address the gap between genetic discoveries and their practical application to cardiovascular clinical care. In brief, this scientific statement assesses the current timeline for effective translation of basic discoveries to clinical advances, highlighting past successes. Current discoveries in the area of genetics and genomics are covered next, followed by future expectations, tools, and competencies for achieving the goal of improving clinical care. © 2015 American Heart Association, Inc.

Effect of application of an external teat sealant and/or oral treatment with a monensin capsule pre-calving on the prevalence and incidence of subclinical and clinical mastitis in dairy heifers.

PubMed

McDougall, S; Parker, K I; Weir, A M; Compton, C W R

2008-06-01

To assess the effect of applying an external teat sealant or a slow-release intraruminal monensin capsule pre-calving on the prevalence and incidence of subclinical or clinical mastitis in dairy heifers post-calving. The studies were undertaken in 13 herds. In two herds application of an external teat sealant was compared with a negative control; in nine herds treatment with monensin was compared with controls, and in two herds treatments were applied in a 2 x 2 factorial design. Heifers were randomly assigned within herd to be treated with a slow-release intraruminal device containing 32 g monensin (n=383), or left as untreated controls (n=389), approximately 30 days before the start of the spring calving period; or to be treated with a latex external teat sealant (n=206) when calving was impending, or be left as untreated controls (n=205). Milk samples were collected from each gland between 0 and 5 days after calving and from any gland diagnosed with clinical mastitis. The effect of the treatments on the prevalence of intramammary infection (IMI), i.e. subclinical mastitis, and clinical mastitis were initially analysed at the univariate level, with associated variables (p<0.2) being used in construction of multivariable models. The prevalence of IMI was 18.4% at the gland level, and coagulase-negative staphylococci followed by Streptococcus uberis were the most common isolates. Treatment with an external teat sealant reduced the prevalence, compared with controls, of any IMI (12.1 (SE 1.7)% vs 16.5 (SE 2.1)%, respectively; p=0.05) or IMI caused by a major pathogen (3.8 (SE 0.8)% vs 6.0 (SE 1.1)%, respectively; p=0.05). Monensin treatment did not affect the prevalence of any IMI (p=0.68) or IMI due to a major pathogen (p=0.11). The cumulative incidence of clinical mastitis was 14.2%. Neither monensin treatment (p=0.47) nor application of an external teat sealant (p=0.71) altered the risk of clinical mastitis. There was no interaction between the monensin and external teat sealant in the two herds where the treatments were applied in a 2 x 2 factorial design. Application of an external teat sealant resulted in a lower prevalence of any IMI and of an IMI caused by a major pathogen. Despite monensin reducing the mobilisation of body tissue and the risk of subclinical ketosis, it had no effect on the prevalence or incidence of IMI or clinical mastitis. Application of an external teat sealant is an option for reducing the prevalence of IMI in pasture fed dairy heifers.

Prospects and applications of nanobiotechnology: a medical perspective.

PubMed

Fakruddin, Md; Hossain, Zakir; Afroz, Hafsa

2012-07-20

Nanobiotechnology is the application of nanotechnology in biological fields. Nanotechnology is a multidisciplinary field that currently recruits approach, technology and facility available in conventional as well as advanced avenues of engineering, physics, chemistry and biology. A comprehensive review of the literature on the principles, limitations, challenges, improvements and applications of nanotechnology in medical science was performed. Nanobiotechnology has multitude of potentials for advancing medical science thereby improving health care practices around the world. Many novel nanoparticles and nanodevices are expected to be used, with an enormous positive impact on human health. While true clinical applications of nanotechnology are still practically inexistent, a significant number of promising medical projects are in an advanced experimental stage. Implementation of nanotechnology in medicine and physiology means that mechanisms and devices are so technically designed that they can interact with sub-cellular (i.e. molecular) levels of the body with a high degree of specificity. Thus therapeutic efficacy can be achieved to maximum with minimal side effects by means of the targeted cell or tissue-specific clinical intervention. More detailed research and careful clinical trials are still required to introduce diverse components of nanobiotechnology in random clinical applications with success. Ethical and moral concerns also need to be addressed in parallel with the new developments.

Prospects and applications of nanobiotechnology: a medical perspective

PubMed Central

2012-01-01

Background Nanobiotechnology is the application of nanotechnology in biological fields. Nanotechnology is a multidisciplinary field that currently recruits approach, technology and facility available in conventional as well as advanced avenues of engineering, physics, chemistry and biology. Method A comprehensive review of the literature on the principles, limitations, challenges, improvements and applications of nanotechnology in medical science was performed. Results Nanobiotechnology has multitude of potentials for advancing medical science thereby improving health care practices around the world. Many novel nanoparticles and nanodevices are expected to be used, with an enormous positive impact on human health. While true clinical applications of nanotechnology are still practically inexistent, a significant number of promising medical projects are in an advanced experimental stage. Implementation of nanotechnology in medicine and physiology means that mechanisms and devices are so technically designed that they can interact with sub-cellular (i.e. molecular) levels of the body with a high degree of specificity. Thus therapeutic efficacy can be achieved to maximum with minimal side effects by means of the targeted cell or tissue-specific clinical intervention. Conclusion More detailed research and careful clinical trials are still required to introduce diverse components of nanobiotechnology in random clinical applications with success. Ethical and moral concerns also need to be addressed in parallel with the new developments. PMID:22817658

Considerations for automated machine learning in clinical metabolic profiling: Altered homocysteine plasma concentration associated with metformin exposure.

PubMed

Orlenko, Alena; Moore, Jason H; Orzechowski, Patryk; Olson, Randal S; Cairns, Junmei; Caraballo, Pedro J; Weinshilboum, Richard M; Wang, Liewei; Breitenstein, Matthew K

2018-01-01

With the maturation of metabolomics science and proliferation of biobanks, clinical metabolic profiling is an increasingly opportunistic frontier for advancing translational clinical research. Automated Machine Learning (AutoML) approaches provide exciting opportunity to guide feature selection in agnostic metabolic profiling endeavors, where potentially thousands of independent data points must be evaluated. In previous research, AutoML using high-dimensional data of varying types has been demonstrably robust, outperforming traditional approaches. However, considerations for application in clinical metabolic profiling remain to be evaluated. Particularly, regarding the robustness of AutoML to identify and adjust for common clinical confounders. In this study, we present a focused case study regarding AutoML considerations for using the Tree-Based Optimization Tool (TPOT) in metabolic profiling of exposure to metformin in a biobank cohort. First, we propose a tandem rank-accuracy measure to guide agnostic feature selection and corresponding threshold determination in clinical metabolic profiling endeavors. Second, while AutoML, using default parameters, demonstrated potential to lack sensitivity to low-effect confounding clinical covariates, we demonstrated residual training and adjustment of metabolite features as an easily applicable approach to ensure AutoML adjustment for potential confounding characteristics. Finally, we present increased homocysteine with long-term exposure to metformin as a potentially novel, non-replicated metabolite association suggested by TPOT; an association not identified in parallel clinical metabolic profiling endeavors. While warranting independent replication, our tandem rank-accuracy measure suggests homocysteine to be the metabolite feature with largest effect, and corresponding priority for further translational clinical research. Residual training and adjustment for a potential confounding effect by BMI only slightly modified the suggested association. Increased homocysteine is thought to be associated with vitamin B12 deficiency - evaluation for potential clinical relevance is suggested. While considerations for clinical metabolic profiling are recommended, including adjustment approaches for clinical confounders, AutoML presents an exciting tool to enhance clinical metabolic profiling and advance translational research endeavors.

Prospective randomized clinical trial: single and weekly viscosupplementation

PubMed Central

Zóboli, Alejandro Agustin Carri; de Rezende, Márcia Uchôa; de Campos, Gustavo Constantino; Pasqualin, Thiago; Frucchi, Renato; de Camargo, Olavo Pires

2013-01-01

OBJECTIVE: To compare two different dosages of an intermediate molecular weight sodium hyaluronate (HA) (Osteonil®-TRB Pharma) assessing whether a single 6 ml application of this HA has the same effectiveness as the classical three-weekly 2 ml dose. METHODS: 108 patients with knee osteoarthritis were randomized into two groups of 54 patients each. The groups were designated "single" (S) and "weekly" (W). Patients in group S underwent a viscosupplementation procedure by application of only 6 ml of sodium hyaluronate and 1 ml triamcinolone hexacetonide. Patients in group W underwent the procedure of viscosupplementation through three applications with 2 ml sodium hyaluronate with a week interval between them, and the first application was also performed with the infiltration of 1 ml (20 mg) of Triamcinolone Hexacetonide. Both groups were assessed before, at one month and three months after application, by responding to the WOMAC, Lequesne, IKDC and VAS questionnaires. RESULTS: There was no statistical difference between the single application of 6 ml of sodium hyaluronate and classic application with three weekly injections. However, only the classical regime showed statistically significant improvement in baseline pain (WOMAC pain and VAS). CONCLUSION: Our results suggest that both application schemes improve application function, but the three-weekly regimen of 2 ml was more effective in reducing pain. Level of Evidence I, Prospective Randomized, Clinical Trial. PMID:24453681

[Clinical application of professor MA Rou's experience in treating hematological disease by arsenic-containing Chinese herbal medicine].

PubMed

Li, Liu; Ma, Rou

2011-08-01

Professor MA Rou has been engaged in clinical and basic research of hematology for more than 40 years. He is excel in the treatment of refractory hematological diseases under the guidance of holism and syndrome differentiation in Chinese medicine. Application of arsenic-containing Chinese herbal medicine in treating myelodysplastic syndrome (MDS), primary polycythemia vera (CMPD-PV), primary thrombocythemia (CMPD-ET), MDS-U, myeloproliferative disease, acute non lymphocytic leukemia except for promyelocytic leukemia, Prof. MA has made great innovation and exploration. For some diseases, he has obtained much mature experiences. Although some are still in the stage of exploration, ideal clinical effects has been shown primarily.

Applications of PET CT in clinical practice: Present and future

NASA Astrophysics Data System (ADS)

Costa, Durval Campos

2007-02-01

Radionuclide imaging and specially positron emission tomography (PET) has already demonstrated its benefits in three major medical subjects, i.e. neurology, cardiology and particularly clinical oncology. More recently the combination of PET and X-ray computed tomography (CT) as PET-CT led to a significant increment of the already large number of clinical applications of this imaging modality. This "anatomy-metabolic fusion" also known as Metabolic Imaging has its future assured if we can: (1) improve resolution reducing partial volume effect, (2) achieve very fast whole body imaging, (3) obtain accurate quantification of specific functions with higher contrast resolution and, if possible, (4) reduce exposure rates due to the unavoidable use of ionizing radiation.

Intratumoural interleukin-2 therapy can induce regression of non-resectable mastocytoma in dogs.

PubMed

Ziekman, Paul G P M; Otter, Willem D E N; Tan, Jurgen F V; Teske, Erik; Kirpensteijn, Jolle; Koten, Jan-Willem; Jacobs, John J L

2013-01-01

Mast cell tumours (MCT) are common skin tumours in dogs. If complete surgical removal of the tumours is not possible, then another therapy is needed. In the current study we tested the therapeutic effect of intratumoural injection of interleukin-2 (IL-2). Seven dogs had non-resectable cutaneous MCT. The tumours were injected with 4.5×10(6) IU IL-2. The early clinical effects in the seven dogs with cutaneous MCT were: complete regression (CR) in two dogs; partial regression (PR) in four, and stable disease (SD) in one dog. The final clinical effects were CR in three dogs, PR in two dogs, and PD in two dogs. This pilot study shows that intratumoural IL-2 application can exert an anti-MCT effect. A larger study would be required to precisely establish the magnitude of the therapeutic effect against MCT. A single application of IL-2 in cases of non-resectable MCT has no observable side-effects.

The Role of Platelet Rich Plasma (PRP) and Other Biologics for Rotator Cuff Repair.

PubMed

Greenspoon, Joshua A; Moulton, Samuel G; Millett, Peter J; Petri, Maximilian

2016-01-01

Surgical treatment of rotator cuff tears has consistently demonstrated good clinical and functional outcomes. However, in some cases, the rotator cuff fails to heal. While improvements in rotator cuff constructs and biomechanics have been made, the role of biologics to aid healing is currently being investigated. A selective literature search was performed and personal surgical experiences are reported. Biologic augmentation of rotator cuff repairs can for example be performed wtableith platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs). Clinical results on PRP application have been controversial. Application of MSCs has shown promise in animal studies, but clinical data on its effectiveness is presently lacking. The role of Matrix Metalloproteinase (MMP) inhibitors is another interesting field for potential targeted drug therapy after rotator cuff repair. Large randomized clinical studies need to confirm the benefit of these approaches, in order to eventually lower retear rates and improve clinical outcomes after rotator cuff repair.

Toxicogenomics and clinical toxicology: an example of the connection between basic and applied sciences.

PubMed

Ferrer-Dufol, Ana; Menao-Guillen, Sebastian

2009-04-10

The relationship between basic research and its potential clinical applications is often a difficult subject. Clinical toxicology has always been very dependent on experimental research whose usefulness has been impaired by the existence of huge differences in the toxicity expression of different substances, inter- and intra-species which make it difficult to predict clinical effects in humans. The new methods in molecular biology developed in the last decades are furnishing very useful tools to study some of the more relevant molecules implied in toxicokinetic and toxicodynamic processes. We aim to show some meaningful examples of how recent research developments with genes and proteins have clear applications to understand significant clinical matters, such as inter-individual variations in susceptibility to chemicals, and other phenomena related to the way some substances act to induce variations in the expression and functionality of these targets.

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

[Comparative analysis between origin of cooked traditional Chinese medicine powder and modern formula granules].

PubMed

Li, Rui; Zhai, Hua-Qiang; Tian, Wei-Lan; Hou, Ji-Ru; Jin, Shi-Yuan; Wang, Yong-Yan

2016-03-01

In this study, the origin and causes of cooked traditional Chinese medicine powder were reviewed, and a comprehensive analysis was made for the time background of modern traditional Chinese medicine formula granules and the future development trend, in order to provide reference for application and promotion of traditional Chinese medicine formula granules. By reference to ancient medical books of previous dynasties, a system review was conducted for infancy, formation, maturity and transition of cooked traditional Chinese medicine powder, and a comprehensive analysis was made for the six factors of cooked traditional Chinese medicine powder's maturity in the Song Dynasty. Efforts were made to collect domestic and foreign research literatures of modern formula granules, understand the detailed development, and conduct an objective analysis of the current clinical application of modern formula granules. According to the comparative analysis for the application characteristics of cooked traditional Chinese medicine powder and modern formula granules, ①the popularity of cooked traditional Chinese medicine powder in the Song Dynasty has six factors: soaring numbers of medical students and medical practitioners, high medical expenses due to huge army, rapid population growth, frequent epidemics and increasing diseases, and insufficient finances of central and local governments. ②On the basis of clinical application characteristics of traditional Chinese medicine formula granules, traditional Chinese medicine formula granules contain extracted and concentrated effective components, which guarantee the curative effect, meet modern people's demands for "quick, simple and convenience" traditional Chinese medicine decoctions, show a relatively high cost performance; however, formula granules are restricted by their varieties and lack unified quality control standards, and single-extract formula granules have not synergy and attenuation effects of combined traditional Chinese medicine decoctions, which also restricts its clinical application and promotion. ③Both have advantages in the process of clinical application, and shall be used based on syndromes. In conclusion, traditional Chinese medicine formula granules do not have disadvantages of "difficult, complicated, turbid and disorderly" cooked traditional Chinese medicine powder, and solve such problems as "inflexibility, expensiveness, restriction, disorder and inefficacy", which is the important basis for promoting traditional Chinese medicine formula granules. Copyright© by the Chinese Pharmaceutical Association.

'Bioengineered Bugs' - a patho-biotechnology approach to probiotic research and applications.

PubMed

Sleator, Roy D; Hill, Colin

2008-01-01

Given the increasing commercial and clinical relevance of probiotic cultures, improving their stress tolerance profile and ability to overcome the physiochemical defences of the host is an important biological goal. Pathogenic bacteria have evolved sophisticated strategies to overcome host defences, interact with the immune system and modulate essential host systems. The 'Patho-biotechnology' concept promotes the exploitation of these valuable traits for the design of more technologically robust and effective probiotic cultures with potentially improved biotechnological and clinical applications, as well as the development of novel vaccine and drug delivery platforms.

Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.

PubMed

Khin, N A; Yang, P; Hung, H M J; Maung-U, K; Chen, Y-F; Meeker-O'Connell, A; Okwesili, P; Yasuda, S U; Ball, L K; Huang, S-M; O'Neill, R T; Temple, R

2013-08-01

Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to the US Food and Drug Administration (FDA) in new drug applications. This article discusses the FDA's experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between the effectiveness and safety outcomes of studies conducted inside and outside the United States, and the FDA's approach to acceptance of these trials.

[Progress of midfacial fat compartments and related clinical applications].

PubMed

Wen, Lihong; Wang, Jinhuang; Li, Yang; Liu, Dalie

2018-02-01

To review the research progress of midfacial fat compartments, and to thoroughly understand its current state of the anatomy and the aging morphologic characters of midfacial fat compartments, as well as the current status of clinical applications. The recent literature concerning the midfacial fat compartments and related clinical applications were extensively reviewed and analyzed. Midfacial fat layer has been considered as a fusion and a continuous layer, experiencing a global atrophy when aging. As more anatomical researches have done, recent studies have shown that midfacial fat layer is broadly divided into superficial and deep layers, which are both divided into different fat compartments by fascia, ligaments, or muscles. Midfacial fat compartments tend to atrophy with age, specifically in the deep fat compartments while hypertrophy in the superficial fat compartments. Clinical applications show that fat volumetric restoration with deep medial cheek fat and Ristow's space can restore the appearance of midface effectively. In recent years, the researches of midfacial fat compartments have achieved obvious progress, which will provide new ideas and basis for fat volumetric restoration. Corresponding treatments are selected based on different sites and different layers with different aging changes, reshaping a more youthful midface.

Lower Body Negative Pressure: Historical Perspective, Research Findings, and Clinical Applications.

PubMed

Crystal, George J; Salem, M Ramez

2015-04-01

Lower body negative pressure (LBNP) is a technique that redistributes blood from the upper body to the dependent regions of the pelvis and legs, thus reducing central venous pressure and venous return. The subject is placed in a cylindrical air-tight metal tank, which is sealed at the level of the iliac crests, and subatmospheric pressure is produced using a vacuum pump. This article reviews the historical background, physiological effects, research findings, and clinical applications of LBNP. LBNP is found in both the basic science and clinical literature, encompassing its diverse investigational and clinical applications. The first references to LBNP were in 1952 describing its effectiveness in inducing hypotensive anesthesia. Major interest in LBNP began in the mid 1960s when it was used to characterize the cardiovascular responses to hemorrhage and orthostatic stress, especially that associated with the weightlessness of space flight; these studies have continued to the present day. Advantages of LBNP for such experimental studies include the following: (1) The degree of central hypovolemia is easily controlled and has a rapid onset and reversal. (2) The technique is repeatable, reproducible, and noninvasive. (3) No exogenous pharmacologic agent is required to produce venous pooling. (4) The findings are independent of gravity. In recent years, a few institutions have applied LBNP clinically to diagnose abnormalities in cardiovascular autonomic function and, when combined with echocardiography, to uncover changes in cardiac performance through analysis of Starling curves. Copyright © 2015 Anesthesia History Association. Published by Elsevier Inc. All rights reserved.

Resilient Systemics to Telehealth Support for Clinical Psychiatry and Psychology.

PubMed

Fiorini, Rodolfo A; De Giacomo, Piero; L'Abate, Luciano

2015-01-01

Reliably expanding our clinical practice and lowering our overhead with telepsychiatry, telepsychology, distance counseling and online therapy, requires resilient and antifragile system and tools. When utilized appropriately these technologies may provide greater access to needed services to include more reliable treatment, consultation, supervision, and training. The wise and proper use of technology is fundamental to create and boost outstanding social results. We present, as an example, the main steps to achieve application resilience and antifragility at system level, for diagnostic and therapeutic telepractice and telehealth support, devoted to psychiatry and psychology application. This article presents a number of innovations that can take psychotherapy treatment, supervision, training, and research forward, towards increased effectiveness application.

Meta-analysis of the clinical application on gasless laparoscopic cholecystectomy in China

PubMed Central

Liu, Qian; Zhang, Guangyong; Zhong, Yong; Duan, Chongyang; Hu, Sanyuan

2015-01-01

Objective: We aim to perform systematic reviews of the clinical effects of the abdominal wall suspension technique in laparoscopic cholecystectomy in China. Methods: We retrieved databases of literature on randomized controlled trials involving abdominal wall suspension laparoscopic cholecystectomy. Then, we conducted screenings, extracted data, and performed quality assessment and meta-analysis. Results: We analyzed 611 patients. Our analysis showed that the abdominal wall suspension group compared to the traditional group had reduced length of hospital stay (SMD = -0.91, 95% CI = -1.76~-0.06, P = 0.04), had shortened postoperative first exhaust time (SMD = -0.65, 95% CI = -1.11~-0.20, P = 0.005), and had diminished incidence of postoperative complications (P < 0.001), which decreased the cost of hospitalization. Conclusions: Application of abdominal wall suspension endoscopic technique can significantly speed up the rehabilitation of laparoscopic cholecystectomy patients; therefore, it is worthy of further research and clinical application. PMID:25932097

Molecular classification and molecular forecasting of breast cancer: ready for clinical application?

PubMed

Brenton, James D; Carey, Lisa A; Ahmed, Ahmed Ashour; Caldas, Carlos

2005-10-10

Profiling breast cancer with expression arrays has become common, and it has been suggested that the results from early studies will lead to understanding of the molecular differences between clinical cases and allow individualization of care. We critically review two main applications of expression profiling; studies unraveling novel breast cancer classifications and those that aim to identify novel markers for prediction of clinical outcome. Breast cancer may now be subclassified into luminal, basal, and HER2 subtypes with distinct differences in prognosis and response to therapy. However, profiling studies to identify predictive markers have suffered from methodologic problems that prevent general application of their results. Future work will need to reanalyze existing microarray data sets to identify more representative sets of candidate genes for use as prognostic signatures and will need to take into account the new knowledge of molecular subtypes of breast cancer when assessing predictive effects.

Preclinical evaluation of injectable sirolimus formulated with polymeric nanoparticle for cancer therapy

PubMed Central

Woo, Ha Na; Chung, Hye Kyung; Ju, Eun Jin; Jung, Joohee; Kang, Hye-Won; Lee, Sa-Won; Seo, Min-Hyo; Lee, Jin Seong; Lee, Jung Shin; Park, Heon Joo; Song, Si Yeol; Jeong, Seong-Yun; Choi, Eun Kyung

2012-01-01

Nanoparticles are useful delivery vehicles for promising drug candidates that face obstacles for clinical applicability. Sirolimus, an inhibitor of mammalian target of rapamycin has gained attention for targeted anticancer therapy, but its clinical application has been limited by its poor solubility. This study was designed to enhance the feasibility of sirolimus for human cancer treatment. Polymeric nanoparticle (PNP)–sirolimus was developed as an injectable formulation and has been characterized by transmission electron microscopy and dynamic light scattering. Pharmacokinetic analysis revealed that PNP–sirolimus has prolonged circulation in the blood. In addition, PNP–sirolimus preserved the in vitro killing effect of free sirolimus against cancer cells, and intravenous administration displayed its potent in vivo anticancer efficacy in xenograft tumor mice. In addition, PNP–sirolimus enhanced the radiotherapeutic efficacy of sirolimus both in vitro and in vivo. Clinical application of PNP–sirolimus is a promising strategy for human cancer treatment. PMID:22619555

LIMS and Clinical Data Management.

PubMed

Chen, Yalan; Lin, Yuxin; Yuan, Xuye; Shen, Bairong

2016-01-01

In order to achieve more accurate disease prevention, diagnosis, and treatment, clinical and genetic data need extensive and systematically associated study. As one way to achieve precision medicine, a laboratory information management system (LIMS) can effectively associate clinical data in a macrocosmic aspect and genomic data in a microcosmic aspect. This chapter summarizes the application of the LIMS in a clinical data management and implementation mode. It also discusses the principles of a LIMS in clinical data management, as well as the opportunities and challenges in the context of medical informatics.

Combining novel technologies with improved logistics to reduce hemodialysis vascular access dysfunction.

PubMed

Roy-Chaudhury, P; Lee, T; Duncan, H; El-Khatib, M

2009-01-01

Hemodialysis (HD) vascular access dysfunction is currently a huge clinical problem for which there are no effective therapies. There are, however, a number of promising technologies that are currently at the experimental or clinical trial stage. We believe that the application of these novel technologies in combination with better clinical protocols for vascular access care could significantly reduce the current problems associated with HD vascular access.

Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster.

PubMed

Liedert, B; Bassus, S; Schneider, C K; Kalinke, U; Löwer, J

2007-01-01

This review summarizes scientific, ethical and regulatory aspects of Phase I clinical trials with monoclonal antibodies. The current standard requirements for pre-clinical testing and for clinical study design are presented. The scientific considerations discussed herein are generally applicable, the view on legal requirements for clinical trials refer to the German jurisdiction only. The adverse effects associated with the TGN1412 Phase I trial indicate that the predictive value of pre-clinical animal models requires reevaluation and that, in certain cases, some issues of clinical trial protocols such as dose fixing may need refinement or redesign. Concrete safety measures, which have been proposed as a consequence of the TGN1412 event include introduction of criteria for high-risk antibodies, sequential inclusion of trial participants and implementation of pre-Phase I studies where dose calculation is based on the pre-clinical No Effect Level instead of the No Observed Adverse Effect Level. The recently established European clinical trials database (EUDRACT Database) is a further safety tool to expedite the sharing of relevant information between scientific authorities.

[Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

PubMed

Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

2015-06-01

The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

Concise Review: The Clinical Application of Mesenchymal Stem Cells for Musculoskeletal Regeneration: Current Status and Perspectives

PubMed Central

Steinert, Andre F.; Rackwitz, Lars; Gilbert, Fabian; Nöth, Ulrich

2012-01-01

Regenerative therapies in the musculoskeletal system are based on the suitable application of cells, biomaterials, and/or factors. For an effective approach, numerous aspects have to be taken into consideration, including age, disease, target tissue, and several environmental factors. Significant research efforts have been undertaken in the last decade to develop specific cell-based therapies, and in particular adult multipotent mesenchymal stem cells hold great promise for such regenerative strategies. Clinical translation of such therapies, however, remains a work in progress. In the clinical arena, autologous cells have been harvested, processed, and readministered according to protocols distinct for the target application. As outlined in this review, such applications range from simple single-step approaches, such as direct injection of unprocessed or concentrated blood or bone marrow aspirates, to fabrication of engineered constructs by seeding of natural or synthetic scaffolds with cells, which were released from autologous tissues and propagated under good manufacturing practice conditions (for example, autologous chondrocyte implantation). However, only relatively few of these cell-based approaches have entered the clinic, and none of these treatments has become a “standard of care” treatment for an orthopaedic disease to date. The multifaceted reasons for the current status from the medical, research, and regulatory perspectives are discussed here. In summary, this review presents the scientific background, current state, and implications of clinical mesenchymal stem cell application in the musculoskeletal system and provides perspectives for future developments. PMID:23197783

CRC Clinical Trials Management System (CTMS): An Integrated Information Management Solution for Collaborative Clinical Research

PubMed Central

Payne, Philip R.O.; Greaves, Andrew W.; Kipps, Thomas J.

2003-01-01

The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) consists of 9 geographically distributed sites conducting a program of research including both basic science and clinical components. To enable the CRC’s clinical research efforts, a system providing for real-time collaboration was required. CTMS provides such functionality, and demonstrates that the use of novel data modeling, web-application platforms, and management strategies provides for the deployment of an extensible, cost effective solution in such an environment. PMID:14728471

Potential role of bromelain in clinical and therapeutic applications

PubMed Central

Rathnavelu, Vidhya; Alitheen, Noorjahan Banu; Sohila, Subramaniam; Kanagesan, Samikannu; Ramesh, Rajendran

2016-01-01

Pineapple has been used as part of traditional folk medicine since ancient times and it continues to be present in various herbal preparations. Bromelain is a complex mixture of protease extracted from the fruit or stem of the pineapple plant. Although the complete molecular mechanism of action of bromelain has not been completely identified, bromelain gained universal acceptability as a phytotherapeutic agent due to its history of safe use and lack of side effects. Bromelain is widely administered for its well-recognized properties, such as its anti-inflammatory, antithrombotic and fibrinolytic affects, anticancer activity and immunomodulatory effects, in addition to being a wound healing and circulatory improvement agent. The current review describes the promising clinical applications and therapeutic properties of bromelain. PMID:27602208

Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence

PubMed Central

Ud-Din, Sara; Bayat, Ardeshir

2014-01-01

Electrical stimulation (ES) has been shown to have beneficial effects in wound healing. It is important to assess the effects of ES on cutaneous wound healing in order to ensure optimization for clinical practice. Several different applications as well as modalities of ES have been described, including direct current (DC), alternating current (AC), high-voltage pulsed current (HVPC), low-intensity direct current (LIDC) and electrobiofeedback ES. However, no one method has been advocated as the most optimal for the treatment of cutaneous wound healing. Therefore, this review aims to examine the level of evidence (LOE) for the application of different types of ES to enhance cutaneous wound healing in the skin. An extensive search was conducted to identify relevant clinical studies utilising ES for cutaneous wound healing since 1980 using PubMed, Medline and EMBASE. A total of 48 studies were evaluated and assigned LOE. All types of ES demonstrated positive effects on cutaneous wound healing in the majority of studies. However, the reported studies demonstrate contrasting differences in the parameters and types of ES application, leading to an inability to generate sufficient evidence to support any one standard therapeutic approach. Despite variations in the type of current, duration, and dosing of ES, the majority of studies showed a significant improvement in wound area reduction or accelerated wound healing compared to the standard of care or sham therapy as well as improved local perfusion. The limited number of LOE-1 trials for investigating the effects of ES in wound healing make critical evaluation and assessment somewhat difficult. Further, better-designed clinical trials are needed to improve our understanding of the optimal dosing, timing and type of ES to be used. PMID:27429287

Refining Video Game Use Questionnaires for Research and Clinical Application: Detection of Problematic Response Sets

ERIC Educational Resources Information Center

Faust, Kyle A.; Faust, David; Baker, Aaron M.; Meyer, Joseph F.

2012-01-01

Even when relatively infrequent, deviant response sets, such as defensive and careless responding, can have remarkably robust effects on individual and group data and thereby distort clinical evaluations and research outcomes. Given such potential adverse impacts and the widespread use of self-report measures when appraising addictions and…

Clinical applicability of inorganic phosphate measurements.

PubMed

Larner, A J

Many articles have warned of the dangers of too much and/or too little potassium, calcium or sodium in the blood, but phosphate has not received similar attention. Yet, because of its pivotal role in intermediary metabolism and its close solubility product relationship with ionized calcium, disordered phosphate homeostasis can have profound clinical effects.

42 CFR 498.3 - Scope and applicability.

Code of Federal Regulations, 2010 CFR

2010-10-01

... section 1910(b) of the Act. (iii) CMS's determination, under the Clinical Laboratory Improvement Act (CLIA... health clinic agreement in accordance with § 405.2404 of this chapter, or the termination of a Federally... for a SNF or NF of its nurse aide training program. (15) The effective date of a Medicare provider...

Antibacterial effect of bioactive glasses on clinically important anaerobic bacteria in vitro.

PubMed

Leppäranta, Outi; Vaahtio, Minna; Peltola, Timo; Zhang, Di; Hupa, Leena; Hupa, Mikko; Ylänen, Heimo; Salonen, Jukka I; Viljanen, Matti K; Eerola, Erkki

2008-02-01

Bioactive glasses (BAGs) of different compositions have been studied for decades for clinical use and they have found many dental and orthopaedic applications. Particulate BAGs have also been shown to have antibacterial properties. This large-scale study shows that two bioactive glass powders (S53P4 and 13-93) and a sol-gel derived material (CaPSiO II) have an antibacterial effect on 17 clinically important anaerobic bacterial species. All the materials tested demonstrated growth inhibition, although the concentration and time needed for the effect varied depending on the BAG. Glass S53P4 had a strong growth-inhibitory effect on all pathogens tested. Glass 13-93 and sol-gel derived material CaPSiO II showed moderate antibacterial properties.

Application of stereo x-ray photogrammetry (SRM) in the determination of absorbed dose values during intracavitary radiation therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

van Kleffens, H.J.; Star, W.M.

1979-04-01

The method of stereo x-ray photogrammetry is described, using a stereo x-ray comparator, as well as some clinical applications. The x-ray equipment consists of two x-ray tubes and a pneumatically driven cassette changer, developed to reduce effects of patient or organ motion between stero radiographs. The accuracy of the set-up is demonstated with measurements on a geometrical model and on a gelatine phantom containing radium needles. The clinical use is reported in determining dose rates to points of the intestinal wall during intracavitary radiotherapy of gynecological cancer. In a number of cases the stereo measurements have resulted in a changemore » in the application time or in the charge or position of the applicator, possibly preventing later complications, as a result of a high dose. Future applications for implant dosimetry (/sup 192/Ir, /sup 125/I) are suggested.« less

Developing and delivering clinical pharmacology in pharmaceutical companies.

PubMed

Richards, Duncan

2012-06-01

The challenges of developing new medicines are well known. Effective application of clinical pharmacology expertise is vital to the successful evaluation of potential new medicines. In drug development, this depends on effective integration of diverse skills. Many of these are currently in short supply, but through innovative partnerships between industry and academia there is an opportunity to reinvigorate the discipline by nurturing these key skills to the benefit of both partners. Specific areas of focus should be experimental medicine, modelling and simulation, and translational skills. © 2012 The Author. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.

The SALOME study: recruitment experiences in a clinical trial offering injectable diacetylmorphine and hydromorphone for opioid dependency.

PubMed

Oviedo-Joekes, Eugenia; Marchand, Kirsten; Lock, Kurt; MacDonald, Scott; Guh, Daphne; Schechter, Martin T

2015-01-26

The Study to Assess Long-term Opioid Medication Effectiveness (SALOME) is a two-stage phase III, single site (Vancouver, Canada), randomized, double blind controlled trial designed to test if hydromorphone is as effective as diacetylmorphine for the treatment of long-term illicit opioid injection. Recruiting participants for clinical trials continues to be a challenge in medical and addiction research, with many studies not being able to reach the planned sample size in a timely manner. The aim of this study is to describe the recruitment strategies in SALOME, which offered appealing treatments but had limited clinic capacity and no guaranteed post-trial continuation of the treatments. SALOME included chronic opioid-dependent, current illicit injection opioid users who had at least one previous episode of opioid maintenance treatment. Regulatory approvals were received in June 2011 and recruitment strategies were implemented over the next 5 months. Recruitment strategies included ongoing open communication with the community, a consistent and accessible team and participant-centered screening. All applicants completed a pre-screening checklist to assess prerequisites. Applicants meeting these prerequisites were later contacted to commence the screening process. A total of 598 applications were received over the two-year recruitment period; 130 were received on the first day of recruitment. Of these applicants, 485 met prerequisites; however, many could not be found or were not reached before recruitment ended. For the 253 candidates who initiated the screening process, the average time lapse between application and screening date was 8.3 months (standard deviation [SD] = 4.44) and for the 202 randomized to the study, the average processing time from initial screen to randomization was 25.9 days (SD = 37.48; Median = 15.0). As in prior trials offering injectable diacetylmorphine within a supervised model, recruiting participants for this study took longer than planned. The recruitment challenges overcome in SALOME were due to the high number of applicants compared with the limited number that could be randomized and treated. Our study emphasizes the value of integrating these strategies into clinical addiction research to overcome study-specific barriers. ClinicalTrials.gov: NCT01447212.

Gambogic acid-loaded biomimetic nanoparticles in colorectal cancer treatment

PubMed Central

Zhang, Zhen; Qian, Hanqing; Yang, Mi; Li, Rutian; Hu, Jing; Li, Li; Yu, Lixia; Liu, Baorui; Qian, Xiaoping

2017-01-01

Gambogic acid (GA) is expected to be a potential new antitumor drug, but its poor aqueous solubility and inevitable side effects limit its clinical application. Despite these inhe rent defects, various nanocarriers can be used to promote the solubility and tumor targeting of GA, improving antitumor efficiency. In addition, a cell membrane-coated nanoparticle platform that was reported recently, unites the customizability and flexibility of a synthetic copolymer, as well as the functionality and complexity of natural membrane, and is a new synthetic biomimetic nanocarrier with improved stability and biocompatibility. Here, we combined poly(lactic-co-glycolic acid) (PLGA) with red blood-cell membrane (RBCm), and evaluated whether GA-loaded RBCm nanoparticles can retain and improve the antitumor efficacy of GA with relatively lower toxicity in colorectal cancer treatment compared with free GA. We also confirmed the stability, biocompatibility, passive targeting, and few side effects of RBCm-GA/PLGA nanoparticles. We expect to provide a new drug carrier in the treatment of colorectal cancer, which has strong clinical application prospects. In addition, the potential antitumor drug GA and other similar drugs could achieve broader clinical applications via this biomimetic nanocarrier. PMID:28280328

Fatherhood and depression: a review of risks, effects, and clinical application.

PubMed

Spector, Aaron Z

2006-10-01

This literature review attempted to compile a complete evaluation of the presentation, risks, and subsequent effects upon a family in relation to paternal depression. Clinical applications are reviewed as well. As with women, fathers will present with a dysphoric mood, but unlike their female counterparts, depressed men often experience a change in social behavior. Withdrawal from social situations, indecisiveness, cynicism, and an irritable mood are often found as hallmark signs of depression in the adult male. Life stress, or family stress and low social support, are risk factors associated with depression among fathers. Marital difficulties may be the most common trigger for first-time depression in husbands just as divorce amplifies depressive episodes, especially when children are involved. A variety of treatments have proven effective for depressed fathers including traditional psycho-dynamic, CBT, and group therapy. Therapy is effective when it can be initiated and continued but research repeatedly showed that men seek it out far less than women. Effective outreach programs to encourage treatment among depressed fathers are recommended.

Finite element modelling of the foot for clinical application: A systematic review.

PubMed

Behforootan, Sara; Chatzistergos, Panagiotis; Naemi, Roozbeh; Chockalingam, Nachiappan

2017-01-01

Over the last two decades finite element modelling has been widely used to give new insight on foot and footwear biomechanics. However its actual contribution for the improvement of the therapeutic outcome of different pathological conditions of the foot, such as the diabetic foot, remains relatively limited. This is mainly because finite element modelling has only been used within the research domain. Clinically applicable finite element modelling can open the way for novel diagnostic techniques and novel methods for treatment planning/optimisation which would significantly enhance clinical practice. In this context this review aims to provide an overview of modelling techniques in the field of foot and footwear biomechanics and to investigate their applicability in a clinical setting. Even though no integrated modelling system exists that could be directly used in the clinic and considerable progress is still required, current literature includes a comprehensive toolbox for future work towards clinically applicable finite element modelling. The key challenges include collecting the information that is needed for geometry design, the assignment of material properties and loading on a patient-specific basis and in a cost-effective and non-invasive way. The ultimate challenge for the implementation of any computational system into clinical practice is to ensure that it can produce reliable results for any person that belongs in the population for which it was developed. Consequently this highlights the need for thorough and extensive validation of each individual step of the modelling process as well as for the overall validation of the final integrated system. Copyright © 2016 IPEM. Published by Elsevier Ltd. All rights reserved.

Learning for clinical leadership.

PubMed

Cook, Michael J; Leathard, Helen L

2004-11-01

Clinical leadership has been acclaimed widely as a major factor influencing the quality of patient care but research has revealed a paucity of preparation for this significant role. Leadership literature has rarely addressed clinical leadership specifically or referred to the difficulties in characterizing effective clinical leaders. The research informing this paper focused on clinical leadership and identified five attributes of effective clinical leaders: creativity, highlighting, influencing, respecting, and supporting. Effective clinical leaders adopted a transformational leadership style and improved care, through others, by including transformational (soft) knowledge as an integral part of their effective practice repertoire. Phronesis is introduced as practical wisdom that is gained through immersion in relevant experience, and as an essential element of preparation for clinical nursing leadership practice. It is argued, that learning to transform care requires opportunities to work within an environment that engenders and supports aspiring leaders. The paper describes the research process, elucidates the attributes through illustrative examples from the research data, and discusses an emergent educational strategy for the development of these attributes by clinicians in their practice environments. The paper also describes the application of this research through an interdisciplinary programme for staff leading teams in both health and social services sectors.

What's the Evidence: A Review of the One-Minute Preceptor Model of Clinical Teaching and Implications for Teaching in the Emergency Department.

PubMed

Farrell, Susan E; Hopson, Laura R; Wolff, Margaret; Hemphill, Robin R; Santen, Sally A

2016-09-01

The 2012 Academic Emergency Medicine Consensus Conference, "Education Research in Emergency Medicine: Opportunities, Challenges, and Strategies for Success" noted that emergency medicine (EM) educators often rely on theory and tradition in molding their approaches to teaching and learning, and called on the EM education community to advance the teaching of our specialty through the performance and application of research in teaching and assessment methods, cognitive function, and the effects of education interventions. The purpose of this article is to review the research-based evidence for the effectiveness of the one-minute preceptor (OMP) teaching method, and to provide suggestions for its use in clinical teaching and learning in EM. This article reviews hypothesis-testing education research related to the use of the OMP as a pedagogical method applicable to clinical teaching. Evidence indicates that the OMP prompts the teaching of higher level concepts, facilitates the assessment of students' knowledge, and prompts the provision of feedback. Students indicate satisfaction with this method of clinical case-based discussion teaching. Advancing EM education will require that high quality education research results be translated into actual curricular, pedagogical, assessment, and professional development changes. The OMP is a pedagogical method that is applicable to teaching in the emergency department. Copyright © 2016 Elsevier Inc. All rights reserved.

Dentin Biomodification: Strategies, Renewable Resources and Clinical Applications

PubMed Central

Bedran-Russo, Ana K.; Pauli, Guido F.; Chen, Shao-Nong; McAlpine, James; Castellan, Carina S.; Phansalkar, Rasika S; Aguiar, Thaiane R.; Vidal, Cristina M.P.; Napotilano, José; Nam, Joo-Won; Leme, Ariene A.

2014-01-01

Objectives The biomodification of dentin is a biomimetic approach, mediated by bioactive agents, to enhance and reinforce the dentin by locally altering the biochemistry and biomechanical properties. This review provides an overview of key dentin matrix components, targeting effects of biomodification strategies, the chemistry of renewable natural sources, and current research on their potential clinical applications. Methods The PubMed database and collected literature were used as a resource for peer-reviewed articles to highlight the topics of dentin hierarchical structure, biomodification agents, and laboratorial investigations of their clinical applications. In addition, new data is presented on laboratorial methods for the standardization of proanthocyanidin-rich preparations as a renewable source of plant-derived biomodification agents. Results Biomodification agents can be categorized as physical methods and chemical agents. Synthetic and naturally occurring chemical strategies present distinctive mechanism of interaction with the tissue. Initially thought to be driven only by inter- or intra-molecular collagen induced non-enzymatic collagen cross-linking, multiple interactions with other dentin components are fundamental for the long-term biomechanics and biostability of the tissue. Oligomeric proanthocyanidins show promising bioactivity, and their chemical complexity requires systematic evaluation of the active compounds to produce a fully standardized intervention material from renewable resource, prior to their detailed clinical evaluation. Significance Understanding the hierarchical structure of dentin and the targeting effect of the bioactive compounds will establish their use in both dentin-biomaterials interface and caries management. PMID:24309436

Development of Bioethics and Clinical Ethics in Bulgaria.

PubMed

Aleksandrova-Yankulovska, Silviya S

2017-03-01

Bioethics and clinical ethics emerged from the classical medical ethics in the 1970s of the 20th century. Both fields are new for the Bulgarian academic tradition. The aims of this paper were to demarcate the subject fields of medical ethics, bioethics, and clinical ethics, to present the developments in the field of medical ethics in Bulgaria, to delineate the obstacles to effective ethics education of medical professionals, and to present the results of the application of an adapted bottom-up methodology for clinical ethics consultation in several clinical units in Bulgaria. Extended literature review and application of an adapted METAP methodology for clinical ethics consultation in six clinical units in the Northern Bulgaria between May 2013 and December 2014. Teaching of medical ethics in Bulgaria was introduced in the 1990s and still stands mainly as theoretical expertise without sufficient dilemma training in clinical settings. Earlier studies revealed need of clinical ethics consultation services in our country. METAP methodology was applied in 69 ethics meetings. In 31.9% of them non-medical considerations affected the choice of treatment and 34.8% resulted in reaching consensus between the team and the patient. Participants' opinion about the meetings was highly positive with 87.7% overall satisfaction. Development of bioethics in Bulgaria follows recent worldwide trends. Several ideas could be applied towards increasing the effectiveness of ethics education. Results of the ethics meetings lead to the conclusion that it is a successful and well accepted approach for clinical ethics consultation with a potential for wider introduction in our medical practice.

Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib.

PubMed

Parrott, Neil J; Yu, Li J; Takano, Ryusuke; Nakamura, Mikiko; Morcos, Peter N

2016-11-01

Alectinib, a lipophilic, basic, anaplastic lymphoma kinase (ALK) inhibitor with very low aqueous solubility, has received Food and Drug Administration-accelerated approval for the treatment of patients with ALK+ non-small-cell lung cancer. This paper describes the application of physiologically based absorption modeling during clinical development to predict and understand the impact of food and gastric pH changes on alectinib absorption. The GastroPlus ™ software was used to develop an absorption model integrating in vitro and in silico data on drug substance properties. Oral pharmacokinetics was simulated by linking the absorption model to a disposition model fit to pharmacokinetic data obtained after an intravenous infusion. Simulations were compared to clinical data from a food effect study and a drug-drug interaction study with esomeprazole, a gastric acid-reducing agent. Prospective predictions of a positive food effect and negligible impact of gastric pH elevation were confirmed with clinical data, although the exact magnitude of the food effect could not be predicted with confidence. After optimization of the absorption model with clinical food effect data, a refined model was further applied to derive recommendations on the timing of dose administration with respect to a meal. The application of biopharmaceutical absorption modeling is an area with great potential to further streamline late stage drug development and with impact on regulatory questions.

Concise Review: Endothelial Progenitor Cells in Regenerative Medicine: Applications and Challenges

PubMed Central

Chong, Mark Seow Khoon; Ng, Wei Kai

2016-01-01

Endothelial progenitor cells (EPCs) are currently being studied as candidate cell sources for revascularization strategies. Significant advances have been made in understanding the biology of EPCs, and preclinical studies have demonstrated the vasculogenic, angiogenic, and beneficial paracrine effects of transplanted EPCs in the treatment of ischemic diseases. Despite these promising results, widespread clinical acceptance of EPCs for clinical therapies remains hampered by several challenges. The present study provides a concise summary of the different EPC populations being studied for ischemic therapies and their known roles in the healing of ischemic tissues. The challenges and issues surrounding the use of EPCs and the current strategies being developed to improve the harvest efficiency and functionality of EPCs for application in regenerative medicine are discussed. Significance Endothelial progenitor cells (EPCs) have immense clinical value for cardiovascular therapies. The present study provides a concise description of the EPC subpopulations being evaluated for clinical applications. The current major lines of investigation involving preclinical and clinical evaluations of EPCs are discussed, and significant gaps limiting the translation of EPCs are highlighted. The present report could be useful for clinicians and clinical researchers with interests in ischemic therapy and for basic scientists working in the related fields of tissue engineering and regenerative medicine. PMID:26956207

Evolving technologies drive the new roles of Biomedical Engineering.

PubMed

Frisch, P H; St Germain, J; Lui, W

2008-01-01

Rapidly changing technology coupled with the financial impact of organized health care, has required hospital Biomedical Engineering organizations to augment their traditional operational and business models to increase their role in developing enhanced clinical applications utilizing new and evolving technologies. The deployment of these technology based applications has required Biomedical Engineering organizations to re-organize to optimize the manner in which they provide and manage services. Memorial Sloan-Kettering Cancer Center has implemented a strategy to explore evolving technologies integrating them into enhanced clinical applications while optimally utilizing the expertise of the traditional Biomedical Engineering component (Clinical Engineering) to provide expanded support in technology / equipment management, device repair, preventive maintenance and integration with legacy clinical systems. Specifically, Biomedical Engineering is an integral component of the Medical Physics Department which provides comprehensive and integrated support to the Center in advanced physical, technical and engineering technology. This organizational structure emphasizes the integration and collaboration between a spectrum of technical expertise for clinical support and equipment management roles. The high cost of clinical equipment purchases coupled with the increasing cost of service has driven equipment management responsibilities to include significant business and financial aspects to provide a cost effective service model. This case study details the dynamics of these expanded roles, future initiatives and benefits for Biomedical Engineering and Memorial Sloan Kettering Cancer Center.

Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Ledford, Christy J. W.; Womack, Jasmyne J.; Rider, Heather A.; Seehusen, Angela B.; Conner, Stephen J.; Lauters, Rebecca A.; Hodge, Joshua A.

2018-01-01

Background: As pregnant mothers increasingly engage in shared decision making regarding prenatal decisions, such as induction of labor, the patient's level of activation may influence pregnancy outcomes. One potential tool to increase patient activation in the clinical setting is mobile applications. However, research is limited in comparing…

76 FR 81508 - Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... derived from clinical investigations and presented as part of a marketing application. The marketing... product is safe and effective for its intended uses, as reflected in the marketing application, it... general principles underlying the IND submission and the general requirements for an IND's content and...

78 FR 71555 - Medicare Program; Town Hall Meeting on FY 2015 Applications for New Medical Services and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... FY 2015 new medical services and technologies applications meet the substantial clinical improvement... new medical services and technologies under Medicare. Effective for discharges beginning on or after... specifies that a medical service or technology will be considered ``new'' if it meets criteria established...

Clinical use of Skype: a review of the evidence base.

PubMed

Armfield, Nigel R; Gray, Leonard C; Smith, Anthony C

2012-04-01

Skype is a popular and free software application that allows PCs and mobile devices to be used for video communication over the Internet. We reviewed the literature to determine whether the clinical use of Skype is supported by evidence. One small (n = 7) controlled clinical trial had assessed the effect of nursing communication using Skype on elderly patients with dementia and their carers. However, we were unable to identify any large, well-designed studies which had formally evaluated the safety, clinical effectiveness, security and privacy of Skype for the routine delivery of patient care. While there were many case reports and small studies, no firm evidence either in favour of, or against the use of Skype for clinical telehealth was found. The risks and benefits of using Skype for clinical purposes are not known.

[The application of laser therapy for the medical rehabilitation of the children presenting with chronic osteomyelitis].

PubMed

Trunova, O V; Mashkov, A E; Khan, M A; Prikuls, V F; Nazarenko, N N; Supova, M V; Smirnova, S N; Larionov, K S

2015-01-01

The objective of the present study was to develop a scientifically sound rationale for the application of infrared laser radiation (IRLR) either separately or in the combination with fluctuation magnetic therapy in the medical rehabilitation of the children presenting with chronic hematogenous osteomyelitis. Another objective was to evaluate the clinical effectiveness of this therapeutic modality. Two achieve these goals, the clinical observations and special research studies were conducted in two directions with the participation of 95 patients at the age varying from 1 to 15 years. The study has demonstrated the effectiveness of the inclusion of IRLR in the medical rehabilitation program for the children with chronic hematogenous osteomyelitis in different periods of the disease. It was shown that the transcutaneous infrared irradiation of the affected area during the exacerbation of chronic osteomyelitis had a well apparent immunostimulatory effect and reduced the activity of the inflammatory process. The application of IRLR in combination with fluctuation magnetic therapy during the period of partial remission, had a more pronounced influence on the microcirculation and stimulated the regenerative and trophic processes.

Clinical pharmacokinetics: perceptions of hospital pharmacists in Qatar about how it was taught and how it is applied.

PubMed

Kheir, Nadir; Awaisu, Ahmed; Gad, Hoda; Elazzazy, Shereen; Jibril, Farah; Gajam, Mawadda

2015-12-01

The application of clinical pharmacokinetics (PK) is essential when providing pharmaceutical care. Appropriate application of PK monitoring results in improved patient outcomes including decreased mortality, length of treatment, length of hospital stay, and adverse effects of drug therapy. Despite the well-documented evidence of benefits of clinical PK services, many pharmacists find it challenging to apply PK in clinical practice. To evaluate pharmacists' training backgrounds, attitude, practices, and perceived barriers pertaining to the application of PK in clinical practice in Qatar. All hospitals under Hamad Medical Corporation, the main healthcare provider in Qatar. This was a cross-sectional, descriptive study that was conducted between October 2012 and January 2013, using a self-administered web-based survey. Pharmacists were eligible to participate if they: (1) were working as full-time hospital pharmacists and; (2) have been in practice for at least 1 year. PK contents learned in undergraduate curriculum; perception towards the PK contents and instructions received in the undergraduate curriculum and; application of PK in current clinical practice. A total of 112 pharmacists responded to the questionnaire. The majority of the respondents (n = 91; 81.3 %) reported that they had received PK course(s) in their undergraduate curriculum. Similarly, the majority (70-80 %) of them agreed that the undergraduate PK courses or contents they received were important and relevant to their current practice. The pharmacists identified spending more time on dispensing and inventory issues rather than clinical practice, scarce resources, and manual rather than computerized PK calculations as some of the barriers they encountered in learning about PK and its application. The characteristics of the surveyed pharmacists such as gender, age, highest academic degree, and country of graduation did not influence the pharmacists' perception and attitudes towards PK teaching and application (p > 0.05). PK course contents were perceived to lack depth and relevance to practice, and pharmacist had no experiential training that included aspects of PK. These, and other issues, result in poor application of PK in practice.

A hospital-wide transition from paper to digital problem-oriented clinical notes. A descriptive history and cross-sectional survey of use, usability, and satisfaction.

PubMed

Cillessen, Felix H J M; de Vries Robbé, Pieter F; Biermans, Marion C J

2017-05-17

To evaluate the use, usability, and physician satisfaction of a locally developed problem-oriented clinical notes application that replaced paper-based records in a large Dutch university medical center. Using a clinical notes database and an application event log file and a cross-sectional survey of usability, authors retrospectively analyzed system usage for medical specialties, users, and patients over 4 years. A standardized questionnaire measured usability. Authors analyzed the effects of sex, age, professional experience, training hours, and medical specialty on user satisfaction via univariate analysis of variance. Authors also examined the correlation between user satisfaction in relation to users' intensity of use of the application. In total 1,793 physicians used the application to record progress notes for 219,755 patients. The overall satisfaction score was 3.2 on a scale from 1 (highly dissatisfied) to 5 (highly satisfied). A statistically significant difference occurred in satisfaction by medical specialty, but no statistically significant differences in satisfaction took place by sex, age, professional experience, or training hours. Intensity of system use did not correlate with physician satisfaction. By two years after the start of the implementation, all medical specialties utilized the clinical notes application. User satisfaction was neutral (3.2 on a 1-5 scale). Authors believe that the significant factors facilitating this transition mirrored success factors reported by other groups: a generic, consistent, and transparent design of the application; intensive collaboration; continuous monitoring; and an incremental rollout.

Clinical applications of image-based airway computational fluid dynamics: assessment of inhalation medication and endobronchial devices

NASA Astrophysics Data System (ADS)

De Backer, Jan W.; Vos, Wim G.; Germonpré, Paul; Salgado, Rodrigo; Parizel, Paul M.; De Backer, Wilfried

2009-02-01

Computational fluid dynamics (CFD) is a technique that is used increasingly in the biomedical field. Solving the flow equations numerically provides a convenient way to assess the efficiency of therapies and devices, ranging from cardiovascular stents and heart valves to hemodialysis workflows. Also in the respiratory field CFD has gained increasing interest, especially through the combination of three dimensional image reconstruction which results in highend patient-specific models. This paper provides an overview of clinical applications of CFD through image based modeling, resulting from recent studies performed in our center. We focused on two applications: assessment of the efficiency of inhalation medication and analysis of endobronchial valve placement. In the first application we assessed the mode of action of a novel bronchodilator in 10 treated patients and 4 controls. We assessed the local volume increase and resistance change based on the combination of imaging and CFD. We found a good correlation between the changes in volume and resistance coming from the CFD results and the clinical tests. In the second application we assessed the placement and effect of one way endobronchial valves on respiratory function in 6 patients. We found a strong patientspecific result of the therapy where in some patients the therapy resulted in complete atelectasis of the target lobe while in others the lobe remained inflated. We concluded from these applications that CFD can provide a better insight into clinically relevant therapies.

Development of a Clinical Framework for Mirror Therapy in Patients with Phantom Limb Pain: An Evidence-based Practice Approach.

PubMed

Rothgangel, Andreas; Braun, Susy; de Witte, Luc; Beurskens, Anna; Smeets, Rob

2016-04-01

To describe the development and content of a clinical framework for mirror therapy (MT) in patients with phantom limb pain (PLP) following amputation. Based on an a priori formulated theoretical model, 3 sources of data collection were used to develop the clinical framework. First, a review of the literature took place on important clinical aspects and the evidence on the effectiveness of MT in patients with phantom limb pain. In addition, questionnaires and semi-structured interviews were used to analyze clinical experiences and preferences of physical and occupational therapists and patients suffering from PLP regarding the application of MT. All data were finally clustered into main and subcategories and were used to complement and refine the theoretical model. For every main category of the a priori formulated theoretical model, several subcategories emerged from the literature search, patient, and therapist interviews. Based on these categories, we developed a clinical flowchart that incorporates the main and subcategories in a logical way according to the phases in methodical intervention defined by the Royal Dutch Society for Physical Therapy. In addition, we developed a comprehensive booklet that illustrates the individual steps of the clinical flowchart. In this study, a structured clinical framework for the application of MT in patients with PLP was developed. This framework is currently being tested for its effectiveness in a multicenter randomized controlled trial. © 2015 World Institute of Pain.

Application of Bayesian Approach in Cancer Clinical Trial

PubMed Central

Bhattacharjee, Atanu

2014-01-01

The application of Bayesian approach in clinical trials becomes more useful over classical method. It is beneficial from design to analysis phase. The straight forward statement is possible to obtain through Bayesian about the drug treatment effect. Complex computational problems are simple to handle with Bayesian techniques. The technique is only feasible to performing presence of prior information of the data. The inference is possible to establish through posterior estimates. However, some limitations are present in this method. The objective of this work was to explore the several merits and demerits of Bayesian approach in cancer research. The review of the technique will be helpful for the clinical researcher involved in the oncology to explore the limitation and power of Bayesian techniques. PMID:29147387

An optical microfluidic platform for spatiotemporal biofilm treatment monitoring

NASA Astrophysics Data System (ADS)

Kim, Young Wook; Mosteller, Matthew P.; Subramanian, Sowmya; Meyer, Mariana T.; Bentley, William E.; Ghodssi, Reza

2016-01-01

Bacterial biofilms constitute in excess of 65% of clinical microbial infections, with the antibiotic treatment of biofilm infections posing a unique challenge due to their high antibiotic tolerance. Recent studies performed in our group have demonstrated that a bioelectric effect featuring low-intensity electric signals combined with antibiotics can significantly improve the efficacy of biofilm treatment. In this work, we demonstrate the bioelectric effect using sub-micron thick planar electrodes in a microfluidic device. This is critical in efforts to develop microsystems for clinical biofilm infection management, including both in vivo and in vitro applications. Adaptation of the method to the microscale, for example, can enable the development of localized biofilm infection treatment using microfabricated medical devices, while augmenting existing capabilities to perform biofilm management beyond the clinical realm. Furthermore, due to scale-down of the system, the voltage requirement for inducing the electric field is reduced further below the media electrolysis threshold. Enhanced biofilm treatment using the bioelectric effect in the developed microfluidic device elicited a 56% greater reduction in viable cell density and 26% further decrease in biomass growth compared to traditional antibiotic therapy. This biofilm treatment efficacy, demonstrated in a micro-scale device and utilizing biocompatible voltage ranges, encourages the use of this method for future clinical biofilm treatment applications.

Building the Evidence Base for Decision-making in Cancer Genomic Medicine Using Comparative Effectiveness Research

PubMed Central

Goddard, Katrina A.B.; Knaus, William A.; Whitlock, Evelyn; Lyman, Gary H.; Feigelson, Heather Spencer; Schully, Sheri D.; Ramsey, Scott; Tunis, Sean; Freedman, Andrew N.; Khoury, Muin J.; Veenstra, David L.

2013-01-01

Background The clinical utility is uncertain for many cancer genomic applications. Comparative effectiveness research (CER) can provide evidence to clarify this uncertainty. Objectives To identify approaches to help stakeholders make evidence-based decisions, and to describe potential challenges and opportunities using CER to produce evidence-based guidance. Methods We identified general CER approaches for genomic applications through literature review, the authors’ experiences, and lessons learned from a recent, seven-site CER initiative in cancer genomic medicine. Case studies illustrate the use of CER approaches. Results Evidence generation and synthesis approaches include comparative observational and randomized trials, patient reported outcomes, decision modeling, and economic analysis. We identified significant challenges to conducting CER in cancer genomics: the rapid pace of innovation, the lack of regulation, the limited evidence for clinical utility, and the beliefs that genomic tests could have personal utility without having clinical utility. Opportunities to capitalize on CER methods in cancer genomics include improvements in the conduct of evidence synthesis, stakeholder engagement, increasing the number of comparative studies, and developing approaches to inform clinical guidelines and research prioritization. Conclusions CER offers a variety of methodological approaches to address stakeholders’ needs. Innovative approaches are needed to ensure an effective translation of genomic discoveries. PMID:22516979

Oximetry: a new non-invasive method to detect metabolic effects induced by a local application of mechanical vibration

NASA Astrophysics Data System (ADS)

Felici, A.; Trombetta, C.; Abundo, P.; Foti, C.; Rosato, N.

2012-10-01

Mechanical vibrations application is increasingly common in clinical practice due to the effectiveness induced by these stimuli on the human body. Local vibration (LV) application allows to apply and act only where needed, focusing the treatment on the selected body segment. An experimental device for LV application was used to generate the vibrations. The aim of this study was to detect and analyze the metabolic effects induced by LV on the brachial bicep muscle by means of an oximeter. This device monitors tissue and muscle oxygenation using NIRS (Near Infrared Spectroscopy) and is able to determine the concentration of haemoglobin and oxygen saturation in the tissue. In a preliminary stage we also investigated the effects induced by LV application, by measuring blood pressure, heart rate, oxygen saturation and temperature. These data confirmed that the effects induced by LV application are actually localized. The results of the measurements obtained using the oximeter during the vibration application, have shown a variation of the concentrations. In particular an increase of oxygenate haemoglobin was shown, probably caused by an increased muscle activity and/or a rise in local temperature detected during the application.

Dental student attitudes towards communication skills instruction and clinical application.

PubMed

McKenzie, Carly T

2014-10-01

This study investigated dental students' attitudes towards communication skills instruction and clinical application and explored the impact of a one-semester course and year in school on students' attitudes, measured by the Communication Skills Attitude Scale. Demographic characteristics and self-assessment of communication skills were also analyzed. The study employed a pretest-posttest survey design combined with cross-sectional data. Participants were first- and fourth-year students at a U.S. dental school. Out of a possible 120 students, 106 (fifty-seven D1 and forty-nine D4) participated in the pretest, an 88 percent response rate; out of a possible 121 students, 115 (fifty-seven D1 and fifty-eight D4) participated in the posttest, a 95 percent response rate. In the results, D4 students consistently demonstrated less positive attitudes towards communication skills instruction and more negative attitudes regarding the importance of interpersonal skills in clinical encounters than did their D1 counterparts. A single communications course had no discernible effect on attitudes or self-assessments for either cohort. Females reported more positive attitudes towards clinical application of interpersonal skills than did males. Gender significantly interacted with two demographic variables: primary language and parent as health care professional. Female children of health care professionals reported poorer attitudes towards clinical communication skills training and application than did their male counterparts. Generally, parental occupation in health care moderated the decrease in positive attitudes over time towards clinical usefulness of communication skills. The D4 students rated their communication skills higher than did the D1 students. Students who demonstrated more positive attitudes towards communication skills training and application were more likely to say their own skills needed improvement.

Current evidence of percutaneous nucleoplasty for the cervical herniated disk: a systematic review.

PubMed

Wullems, Jorgen A; Halim, Willy; van der Weegen, Walter

2014-07-01

Although percutaneous cervical nucleoplasty (PCN) has been shown to be both safe and effective, its application is still debated. PCN applied in disk herniation has not been systematically reviewed before, resulting in a limited insight into its effectiveness and safety, and the quality of available evidence. Therefore, we systematically reviewed the evidence on the efficacy and safety of PCN in patients with a (contained) herniated disk. MEDLINE, EMBASE, and the Cochrane Library (Central Register of Controlled Trials) were searched for randomized controlled trials (RCTs) and nonrandomized studies using the following keywords: "Nucleoplasty," "Cervical," "Hernia," "Herniation," "Prolapse," "Protrusion," "Intervertebral disk," and "Percutaneous disk decompression." First, all articles were appraised for methodological quality, and then, RCTs were graded for the level of evidence according a best-evidence synthesis, because a meta-analysis was not possible. Finally, the RCTs' applicability and clinical relevance also was assessed. Of 75 identified abstracts, 10 full-text articles were included (3 RCTs and 7 nonrandomized studies). These studies represented a total of 1021 patients: 823 patients (≥ 892 disks) were treated by PCN. All studies showed low methodological quality, except for two. The level of evidence of the RCTs was graded as moderate, with low to moderate applicability and clinical relevance. All included studies showed PCN to be an effective and safe procedure in the treatment of (contained) herniated disks at short-, mid-, and long-term follow-up. However, the level of evidence is moderate and shows only low to moderate applicability and clinical relevance. © 2013 World Institute of Pain.

Clinical Data Warehouse: An Effective Tool to Create Intelligence in Disease Management.

PubMed

Karami, Mahtab; Rahimi, Azin; Shahmirzadi, Ali Hosseini

Clinical business intelligence tools such as clinical data warehouse enable health care organizations to objectively assess the disease management programs that affect the quality of patients' life and well-being in public. The purpose of these programs is to reduce disease occurrence, improve patient care, and decrease health care costs. Therefore, applying clinical data warehouse can be effective in generating useful information about aspects of patient care to facilitate budgeting, planning, research, process improvement, external reporting, benchmarking, and trend analysis, as well as to enable the decisions needed to prevent the progression or appearance of the illness aligning with maintaining the health of the population. The aim of this review article is to describe the benefits of clinical data warehouse applications in creating intelligence for disease management programs.

Development of a smartphone application for eating disorder self-monitoring.

PubMed

Tregarthen, Jenna P; Lock, James; Darcy, Alison M

2015-11-01

This case report aims to (1) describe the development and refinement of a smartphone application for eating disorder self-monitoring; (2) characterize its users in terms of demographic and clinical characteristics; and (3) explore its feasibility and utilization as a self-monitoring tool. We developed a mobile phone application through which people with eating disorders can self-monitor meals, emotions, behaviors, and thoughts. The application also included positive reinforcement, coping skill suggestions, social support, and feedback components. The app was made available on two Internet app stores. Data include number of downloads and subsequent usage statistics, consumer ratings on app-stores are used as indicators of satisfaction, anonymous aggregate demographic data and Eating Disorder Examination Questionnaire scores from 57,940 individuals collected over a two-year period. The app demonstrated population-level utilization with over 100,000 users over a two-year period. Almost 50% percent of users stated that they are not currently receiving clinical treatment and 33% reported they had not told anyone about their eating disorder. A surprising number of people with severe problems are using the app. Smartphone apps have the capacity to reach and engage traditionally underserved individuals with eating disorders at a large scale. Additional work is indicated for the evaluation of the clinical effectiveness of applications for specific user groups and in clinical treatment contexts. © 2015 Wiley Periodicals, Inc.

A quality risk management model approach for cell therapy manufacturing.

PubMed

Lopez, Fabio; Di Bartolo, Chiara; Piazza, Tommaso; Passannanti, Antonino; Gerlach, Jörg C; Gridelli, Bruno; Triolo, Fabio

2010-12-01

International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell-based therapies in regenerative medicine. The available risk management guidelines, however, provide little guidance on specific risk analysis approaches and procedures applicable in clinical cell therapy manufacturing. This raises a number of problems. Cell manufacturing is a poorly automated process, prone to operator-introduced variations, and affected by heterogeneity of the processed organs/tissues and lot-dependent variability of reagent (e.g., collagenase) efficiency. In this study, the principal challenges faced in a cell-based product manufacturing context (i.e., high dependence on human intervention and absence of reference standards for acceptable risk levels) are identified and addressed, and a risk management model approach applicable to manufacturing of cells for clinical use is described for the first time. The use of the heuristic and pseudo-quantitative failure mode and effect analysis/failure mode and critical effect analysis risk analysis technique associated with direct estimation of severity, occurrence, and detection is, in this specific context, as effective as, but more efficient than, the analytic hierarchy process. Moreover, a severity/occurrence matrix and Pareto analysis can be successfully adopted to identify priority failure modes on which to act to mitigate risks. The application of this approach to clinical cell therapy manufacturing in regenerative medicine is also discussed. © 2010 Society for Risk Analysis.

Utilising the Intel RealSense Camera for Measuring Health Outcomes in Clinical Research.

PubMed

Siena, Francesco Luke; Byrom, Bill; Watts, Paul; Breedon, Philip

2018-02-05

Applications utilising 3D Camera technologies for the measurement of health outcomes in the health and wellness sector continues to expand. The Intel® RealSense™ is one of the leading 3D depth sensing cameras currently available on the market and aligns itself for use in many applications, including robotics, automation, and medical systems. One of the most prominent areas is the production of interactive solutions for rehabilitation which includes gait analysis and facial tracking. Advancements in depth camera technology has resulted in a noticeable increase in the integration of these technologies into portable platforms, suggesting significant future potential for pervasive in-clinic and field based health assessment solutions. This paper reviews the Intel RealSense technology's technical capabilities and discusses its application to clinical research and includes examples where the Intel RealSense camera range has been used for the measurement of health outcomes. This review supports the use of the technology to develop robust, objective movement and mobility-based endpoints to enable accurate tracking of the effects of treatment interventions in clinical trials.

Pharmacogenetic studies of antidepressant response: how far from the clinic?

PubMed

Perlis, Roy H

2007-03-01

Because the US FDA has begun to focus on disclosure of pharmacogenetic testing results in applications for new drug approval and review of existing drugs (see, eg, http://www.fda.gov/OHRMS/DOCKETS/AC/05/slides/2005-4194S1_Slide-Index.htm), the application of such testing in a clinical setting is likely to increase substantially. Instead of small cohorts of patients, potentially nearly every participant in the large pivotal trials required for drug approval could help inform the future application of that drug. Psychiatry as a whole, and antidepressant prescribing ni particular, stands to benefit in the near term from the identification of newer treatment targets that may overcome some of the limitations of current therapeutics. On the other hand, despite the excitement about the rapid pace of development in psychiatric pharmacogenetics, a number of key issues remain to be addressed before these discoveries are applied in a clinical setting. Close coordination will be required between those who study treatment efficacy and effectiveness and those who study genetic variation in populations to ensure that studies yield results that have scientific importance and clinical importance as well.

Impact of the economic downturn on nursing schools.

PubMed

Terry, Allison J; Whitman, Marilyn V

2011-01-01

The challenges posed by the economic downturn on baccalaureate nursing schools in the southeast as it relates to their perceptions of changes in the number of applicants, acceptance rates, employer recruitment efforts, and student clinical and job placement were explored. Responses from deans and program directors indicated nursing schools are experiencing negative effects of the economic downturn in the form of graduates having difficulty finding employment, decreased recruitment efforts from prospective employers, difficulty locating clinical placements for students, and no change in faculty applicants despite an increase in undergraduate student applicants as well as graduate student applicants. These multiple factors combined could signal the death knell for programs that are ill-prepared to deal with such a crisis. Programs need to be aggressive in their efforts to draw health care recruiters as well as qualified faculty applicants to their campuses. Nursing schools must be able to clearly show why their graduates are superior to other programs' graduates when competing for both highly qualified faculty applicants and prospective student employers.

Clinical applications of low-intensity pulsed ultrasound and its potential role in urology

PubMed Central

Lin, Guiting; Lei, Hongen; Lue, Tom F.; Guo, Yinglu

2016-01-01

Low-intensity pulsed ultrasound (LIPUS) is a form of ultrasound that delivered at a much lower intensity (<3 W/cm2) than traditional ultrasound energy and output in the mode of pulse wave, and it is typically used for therapeutic purpose in rehabilitation medicine. LIPUS has minimal thermal effects due to its low intensity and pulsed output mode, and its non-thermal effects which is normally claimed to induce therapeutic changes in tissues attract most researchers’ attentions. LIPUS have been demonstrated to have a rage of biological effects on tissues, including promoting bone-fracture healing, accelerating soft-tissue regeneration, inhibiting inflammatory responses and so on. Recent studies showed that biological effects of LIPUS in healing morbid body tissues may be mainly associated with the upregulation of cell proliferation through activation of integrin receptors and Rho/ROCK/Src/ERK signaling pathway, and with promoting multilineage differentiation of mesenchyme stem/progenitor cell lines through ROCK-Cot/Tpl2-MEK-ERK signaling pathway. Hopefully, LIPUS may become an effective clinical procedure for the treatment of urological diseases, such as chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), erectile dysfunction (ED), and stress urinary incontinence (SUI) in the field of urology. It still needs an intense effort for basic-science and clinical investigators to explore the biomedical applications of ultrasound. PMID:27141455

Application of failure mode and effect analysis in a radiology department.

PubMed

Thornton, Eavan; Brook, Olga R; Mendiratta-Lala, Mishal; Hallett, Donna T; Kruskal, Jonathan B

2011-01-01

With increasing deployment, complexity, and sophistication of equipment and related processes within the clinical imaging environment, system failures are more likely to occur. These failures may have varying effects on the patient, ranging from no harm to devastating harm. Failure mode and effect analysis (FMEA) is a tool that permits the proactive identification of possible failures in complex processes and provides a basis for continuous improvement. This overview of the basic principles and methodology of FMEA provides an explanation of how FMEA can be applied to clinical operations in a radiology department to reduce, predict, or prevent errors. The six sequential steps in the FMEA process are explained, and clinical magnetic resonance imaging services are used as an example for which FMEA is particularly applicable. A modified version of traditional FMEA called Healthcare Failure Mode and Effect Analysis, which was introduced by the U.S. Department of Veterans Affairs National Center for Patient Safety, is briefly reviewed. In conclusion, FMEA is an effective and reliable method to proactively examine complex processes in the radiology department. FMEA can be used to highlight the high-risk subprocesses and allows these to be targeted to minimize the future occurrence of failures, thus improving patient safety and streamlining the efficiency of the radiology department. RSNA, 2010

Application of empirically supported treatments to clinical settings. In: Jelalian, E., Steele, R.G., editors. Handbook of Childhood and Adolescent Obesity

USDA-ARS?s Scientific Manuscript database

This book chapter identifies treatments for pediatric obesity that have been shown to be effective in research settings and discusses how these treatments can be implemented in an applied clinical setting. Behavior-based treatments have demonstrated the best outcomes. Commonly used behavioral strate...

Implementing a low-cost web-based clinical trial management system for community studies: a case study.

PubMed

Geyer, John; Myers, Kathleen; Vander Stoep, Ann; McCarty, Carolyn; Palmer, Nancy; DeSalvo, Amy

2011-10-01

Clinical trials with multiple intervention locations and a single research coordinating center can be logistically difficult to implement. Increasingly, web-based systems are used to provide clinical trial support with many commercial, open source, and proprietary systems in use. New web-based tools are available which can be customized without programming expertise to deliver web-based clinical trial management and data collection functions. To demonstrate the feasibility of utilizing low-cost configurable applications to create a customized web-based data collection and study management system for a five intervention site randomized clinical trial establishing the efficacy of providing evidence-based treatment via teleconferencing to children with attention-deficit hyperactivity disorder. The sites are small communities that would not usually be included in traditional randomized trials. A major goal was to develop database that participants could access from computers in their home communities for direct data entry. Discussed is the selection process leading to the identification and utilization of a cost-effective and user-friendly set of tools capable of customization for data collection and study management tasks. An online assessment collection application, template-based web portal creation application, and web-accessible Access 2007 database were selected and customized to provide the following features: schedule appointments, administer and monitor online secure assessments, issue subject incentives, and securely transmit electronic documents between sites. Each tool was configured by users with limited programming expertise. As of June 2011, the system has successfully been used with 125 participants in 5 communities, who have completed 536 sets of assessment questionnaires, 8 community therapists, and 11 research staff at the research coordinating center. Total automation of processes is not possible with the current set of tools as each is loosely affiliated, creating some inefficiency. This system is best suited to investigations with a single data source e.g., psychosocial questionnaires. New web-based applications can be used by investigators with limited programming experience to implement user-friendly, efficient, and cost-effective tools for multi-site clinical trials with small distant communities. Such systems allow the inclusion in research of populations that are not usually involved in clinical trials.

Transcranial magnetic stimulation: physics, electrophysiology, and applications.

PubMed

Fatemi-Ardekani, Ali

2008-01-01

Transcranial magnetic stimulation (TMS) is a noninvasive technique used to stimulate the brain. This review will examine the fundamental principles of physics upon which magnetic stimulation is based, the design considerations of the TMS device, and hypotheses about its electrophysiological effects resulting in neuromodulation. TMS is valuable in neurophysiology research and has significant therapeutic potential in clinical neurology and psychiatry. While TMS can modify neuronal currents in the brain, its underlying mechanism remains unknown. Salient applications are included and some suggestions are outlined for future development of magnetic stimulators that could lead to more effective neuronal stimulation and therefore better therapeutic and diagnostic applications.

The present and future of nanotechnology in human health care.

PubMed

Sahoo, S K; Parveen, S; Panda, J J

2007-03-01

Nanotechnology is a multidisciplinary field that covers a vast and diverse array of devices derived from engineering, physics, chemistry, and biology. The burgeoning new field of nanotechnology, opened up by rapid advances in science and technology, creates myriad new opportunities for advancing medical science and disease treatment in human health care. Applications of nanotechnology to medicine and physiology imply materials and devices designed to interact with the body at subcellular (i.e., molecular) scales with a high degree of specificity. This can be potentially translated into targeted cellular and tissue-specific clinical applications designed to achieve maximal therapeutic efficacy with minimal side effects. In this review the chief scientific and technical aspects of nanotechnology are introduced, and some of its potential clinical applications are discussed.

Combination of Fluorescence-Guided Surgery With Photodynamic Therapy for the Treatment of Cancer

PubMed Central

He, Jun; Yang, Leping; Yi, Wenjun; Fan, Wentao; Wen, Yu; Miao, Xiongying; Xiong, Li

2017-01-01

Specific visualization of body parts is needed during surgery. Fluorescence-guided surgery (FGS) uses a fluorescence contrast agent for in vivo tumor imaging to detect and identify both malignant and normal tissues. There are several advantages and clinical benefits of FGS over other conventional medical imaging modalities, such as its safety, effectiveness, and suitability for real-time imaging in the operating room. Recent advancements in contrast agents and intraoperative fluorescence imaging devices have led to a greater potential for intraoperative fluorescence imaging in clinical applications. Photodynamic therapy (PDT) is an alternative modality to treat tumors, which uses a light-sensitive drug (photosensitizers) and special light to destroy the targeted tissues. In this review, we discuss the fluorescent contrast agents, some newly developed imaging devices, and the successful clinical application of FGS. Additionally, we present the combined strategy of FGS with PDT to further improve the therapeutic effect for patients with cancer. Taken together, this review provides a unique perspective and summarization of FGS. PMID:28849712

Luminol-Based Chemiluminescent Signals: Clinical and Non-clinical Application and Future Uses

PubMed Central

Khan, Parvez; Idrees, Danish; Moxley, Michael A.; Corbett, John A.; Ahmad, Faizan; von Figura, Guido; Sly, William S.; Waheed, Abdul

2015-01-01

Chemiluminescence (CL) is an important method for quantification and analysis of various macromolecules. A wide range of CL agents such as luminol, hydrogen peroxide, fluorescein, dioxetanes and derivatives of oxalate, and acridinium dyes are used according to their biological specificity and utility. This review describes the application of luminol chemiluminescence (LCL) in forensic, biomedical, and clinical sciences. LCL is a very useful detection method due to its selectivity, simplicity, low cost, and high sensitivity. LCL has a dynamic range of applications, including quantification and detection of macro and micromolecules such as proteins, carbohydrates, DNA, and RNA. Luminol-based methods are used in environmental monitoring as biosensors, in the pharmaceutical industry for cellular localization and as biological tracers, and in reporter gene-based assays and several other immunoassays. Here, we also provide information about different compounds that may enhance or inhibit the LCL along with the effect of pH and concentration on LCL. This review covers most of the significant information related to the applications of luminol in different fields. PMID:24752935

Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

PubMed

Bogenschutz, Michael P

2013-03-01

Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials.

Defibrotide: a review on clinical use and future development.

PubMed

Larocca, A; Cavallo, F; Magarotto, V; Rossi, D; Patriarca, F; Boccadoro, M; Palumbo, A

2008-08-01

Defibrotide is a deoxyribonucleic acid derivative that has been developed for the treatment of different vascular disorders. The authors reviewed the literature to give due representation to the spectrum of pharmacological properties and clinical application of this drug, evaluating consolidate and innovative application. The authors used PubMed from November 1982 to December 2007 and meeting abstracts (form American Society of Hematology Annual Meeting) with updated data as the sources for this review and selecting the most relevant papers when two or more articles covered the same point of interest. Defibrotide has been used effectively in the treatment of endothelial complications of allogeneic stem cell transplantation and recent preclinical evidences suggest an antiangiogenic effect and an anticancer activity. Further in vivo and in vitro investigations are needed.

[Application of variable magnetic fields in medicine--15 years experience].

PubMed

Sieroń, Aleksander; Cieślar, Grzegorz

2003-01-01

The results of 15-year own experimental and clinical research on application of variable magnetic fields in medicine were presented. In experimental studies analgesic effect (related to endogenous opioid system and nitrogen oxide activity) and regenerative effect of variable magnetic fields with therapeutical parameters was observed. The influence of this fields on enzymatic and hormonal activity, free oxygen radicals, carbohydrates, protein and lipid metabolism, dielectric and rheological properties of blood as well as behavioural reactions and activity of central dopamine receptor in experimental animals was proved. In clinical studies high therapeutic efficacy of magnetotherapy and magnetostimulation in the treatment of osteoarthrosis, abnormal ossification, osteoporosis, nasosinusitis, multiple sclerosis, Parkinson's disease, spastic paresis, diabetic polyneuropathy and retinopathy, vegetative neurosis, peptic ulcers, colon irritable and trophic ulcers was confirmed.

An Ontology-based Architecture for Integration of Clinical Trials Management Applications

PubMed Central

Shankar, Ravi D.; Martins, Susana B.; O’Connor, Martin; Parrish, David B.; Das, Amar K.

2007-01-01

Management of complex clinical trials involves coordinated-use of a myriad of software applications by trial personnel. The applications typically use distinct knowledge representations and generate enormous amount of information during the course of a trial. It becomes vital that the applications exchange trial semantics in order for efficient management of the trials and subsequent analysis of clinical trial data. Existing model-based frameworks do not address the requirements of semantic integration of heterogeneous applications. We have built an ontology-based architecture to support interoperation of clinical trial software applications. Central to our approach is a suite of clinical trial ontologies, which we call Epoch, that define the vocabulary and semantics necessary to represent information on clinical trials. We are continuing to demonstrate and validate our approach with different clinical trials management applications and with growing number of clinical trials. PMID:18693919

Clinical application of the cardioprotective effects of volatile anaesthetics: PRO--get an extra benefit from a proven anaesthetic free of charge.

PubMed

Bein, Berthold

2011-09-01

Volatile anaesthetic agents have been used in millions of patients around the world and have proved to be both well tolerated and efficient. In recent years, cardioprotective properties of these drugs have been demonstrated unequivocally in numerous experimental investigations, but the beneficial effects of volatile anaesthetics in daily clinical practice are still under debate. In order to elucidate their cardioprotective properties in an unbiased way, the STAIR (Stroke Therapy Academic Industry Roundtable Preclinical Recommendation) criteria proposed as a framework for researchers in the field of neuroprotection can be applied to research conducted in the field of cardioprotection by volatile anaesthetics. All STAIR criteria have already been clearly fulfilled when all experimental and clinical studies are considered. Specifically, a dose-response pattern has been found with a minimal alveolar concentration value and a ceiling effect; volatile anaesthetics show two distinct therapeutic windows after application; important outcome measures such as hospital length of stay have been addressed; and multiple species have been studied by different independent groups of researchers who were largely able to reproduce their findings. Given the numerous confounding factors capable of attenuating or even abolishing the cardioprotective properties of volatile anaesthetics in laboratory investigations, the positive effects found in the majority of clinical trials point to the fact that the cardioprotective effects exerted by volatile anaesthetics are robust and triggered by interactions with several distinct cellular and subcellular targets, thereby providing multiplication and reiteration. The available evidence indicates that volatile anaesthetic agents should be used routinely in clinical practice in order to claim an extra benefit for our patients 'free of charge'.

Smartphone Application WeChat for Clinical Follow-up of Discharged Patients with Head and Neck Tumors: A Randomized Controlled Trial.

PubMed

Lyu, Ke-Xing; Zhao, Jing; Wang, Bin; Xiong, Guan-Xia; Yang, Wei-Qiang; Liu, Qi-Hong; Zhu, Xiao-Lin; Sun, Wei; Jiang, Ai-Yun; Wen, Wei-Ping; Lei, Wen-Bin

2016-12-05

Nowadays, social media tools such as short message service, Twitter, video, and web-based systems are more and more used in clinical follow-up, making clinical follow-up much more time- and cost-effective than ever before. However, as the most popular social media in China, little is known about the utility of smartphone WeChat application in follow-up. In this study, we aimed to investigate the feasibility and superiority of WeChat application in clinical follow-up. A total of 108 patients diagnosed with head and neck tumor were randomized to WeChat follow-up (WFU) group or telephone follow-up (TFU) group for 6-month follow-up. The follow-ups were delivered by WeChat or telephone at 2 weeks, 1, 2, 3, and 6 months to the patients after being discharged. The study measurements were time consumption for follow-up delivery, total economic cost, lost-to-follow-up rate, and overall satisfaction for the follow-up method. Time consumption in WFU group for each patient (23.36 ± 6.16 min) was significantly shorter than that in TFU group (42.89 ± 7.15 min) (P < 0.001); total economic cost in WFU group (RMB 90 Yuan) was much lower than that in TFU group (RMB 196 Yuan). Lost-to-follow-up rate in the WFU group was 7.02% (4/57) compared with TFU group, 9.80% (5/51), while no significance was observed (95% confidence interval [CI]: 0.176-2.740; P = 0.732). The overall satisfaction rate in WFU group was 94.34% (50/53) compared with 80.43% (37/46) in TFU group (95% CI: 0.057-0.067; P = 0.034). The smartphone WeChat application was found to be a viable option for follow-up in discharged patients with head and neck tumors. WFU was time-effective, cost-effective, and convenient in communication. This doctor-led follow-up model has the potential to establish a good physician-patient relationship by enhancing dynamic communications and providing individual health instructions. Chinese Clinical Trial Registry, ChiCTR-IOR-15007498; http://www.chictr.org.cn/ showproj.aspx?proj=12613.

Delays in new drug applications in Japan and industrial R&D strategies.

PubMed

Hirai, Y; Kinoshita, H; Kusama, M; Yasuda, K; Sugiyama, Y; Ono, S

2010-02-01

The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.

The clinical application of research utilization: amphotericin B.

PubMed

Reedy, A M; Shivnan, J C; Hanson, J L; Haisfield, M E; Gregory, R E

1994-05-01

To describe the first application of the research utilization process by clinical nurses using the Stetler-Marram Model of Research Utilization to the practice of amphotericin B administration; to share the findings; and to discuss issues encountered in the process and their solutions. Published articles identified through computerized literature searches, published abstracts and books, personal communication with one author, and an informal survey of other cancer centers' amphotericin B infusion practices; research articles were selected for review if studies included settings and patient populations similar to those of the authors and if they used experimental designs. Studies were reviewed for scientific merit and clinical applicability according to the Stetler-Marram model; findings were used to develop a specific nursing protocol for infusion times of amphotericin B based on clinical criteria. The Stetler-Marram model helped staff nurses decide how to apply research findings to practice, although using it was difficult and required mentorship. A research base exists for amphotericin B administration time but not for test doses or premedications to prevent or minimize side effects. Staff nurses can use the Stetler-Marram model but need resources and support from individuals, committees, and administration. A specific protocol representing a practice change was implemented and may be applicable to other settings.

What Is the International Classification of Functioning, Disability and Health and Why Is It Relevant to Audiology?

PubMed Central

Meyer, Carly; Grenness, Caitlin; Scarinci, Nerina; Hickson, Louise

2016-01-01

The World Health Organization's International Classification of Functioning, Disability and Health (ICF) is widely used in disability and health sectors as a framework to describe the far-reaching effects of a range of health conditions on individuals. This biopsychosocial framework can be used to describe the experience of an individual in the components of body functions, body structures, and activities and participation, and it considers the influence of contextual factors (environmental and personal) on these components. Application of the ICF in audiology allows the use of a common language between health care professionals in both clinical and research settings. Furthermore, the ICF is promoted as a means of facilitating patient-centered care. In this article, the relevance and application of the ICF to audiology is described, along with clinical examples of its application in the assessment and management of children and adults with hearing loss. Importantly, the skills necessary for clinicians to apply the ICF effectively are discussed. PMID:27489397

Discovery, development, and clinical application of sugammadex sodium, a selective relaxant binding agent

PubMed Central

Welliver, Mark; McDonough, John; Kalynych, Nicholas; Redfern, Robert

2008-01-01

Neuromuscular blockade, induced by neuromuscular blocking agents, has allowed prescribed immobility, improved surgical exposure, optimal airway management conditions, and facilitated mechanical ventilation. However, termination of the effects of neuromuscular blocking agents has, until now, remained limited. A novel cyclodextrin encapsulation process offers improved termination of the paralytic effects of aminosteroidal non-depolarizing neuromuscular blocking agents. Sugammadex sodium is the first in a new class of drug called selective relaxant binding agents. Currently, in clinical trials, sugammadex, a modified gamma cyclodextrin, has shown consistent and rapid termination of neuromuscular blockade with few side effects. The pharmacology of cyclodextrins in general and sugammadex in particular, together with the results of current clinical research are reviewed. The ability of sugammadex to terminate the action of neuromuscular blocking agents by direct encapsulation is compared to the indirect competitive antagonism of their effects by cholinesterase inhibitors. Also discussed are the clinical implications that extend beyond fast, effective reversal, including numerous potential perioperative benefits. PMID:19920893

Spinal Tissue Loading Created by Different Methods of Spinal Manipulative Therapy Application

PubMed Central

Funabashi, Martha; Nougarou, François; Descarreaux, Martin; Prasad, Narasimha; Kawchuk, Gregory N.

2017-01-01

Study Design. Comparative study using robotic replication of spinal manipulative therapy (SMT) vertebral kinematics together with serial dissection. Objective. The aim of this study was to quantify loads created in cadaveric spinal tissues arising from three different forms of SMT application. Summary of Background Data. There exist many distinct methods by which to apply SMT. It is not known presently whether different forms of SMT application have different effects on spinal tissues. Should the method of SMT application modulate spinal tissue loading, quantifying this relation may help explain the varied outcomes of SMT in terms of effect and safety. Methods. SMT was applied to the third lumbar vertebra in 12 porcine cadavers using three SMT techniques: a clinical device that applies forces through a hand-held instrument (INST), a manual technique of applying SMT clinically (MAN) and a research device that applies parameters of manual SMT through a servo-controlled linear actuator motor (SERVO). The resulting kinematics from each SMT application were tracked optically via indwelling bone pins. The L3/L4 segment was then removed, mounted in a parallel robot and the resulting kinematics from SMT replayed for each SMT application technique. Serial dissection of spinal structures was conducted to quantify loading characteristics of discrete spinal tissues. Results. In terms of load magnitude, SMT application with MAN and SERVO created greater forces than INST in all conditions (P < 0.05). Additionally, MAN and SERVO created comparable posterior forces in the intact specimen, but MAN created greater posterior forces on IVD structures compared to SERVO (P < 0.05). Conclusion. Specific methods of SMT application create unique vertebral loading characteristics, which may help explain the varied outcomes of SMT in terms of effect and safety. Level of Evidence: N/A PMID:28146021

Describing the clinical reasoning process: application of a model of enablement to a pediatric case.

PubMed

Furze, Jennifer; Nelson, Kelly; O'Hare, Megan; Ortner, Amanda; Threlkeld, A Joseph; Jensen, Gail M

2013-04-01

Clinical reasoning is a core tenet of physical therapy practice leading to optimal patient care. The purpose of this case was to describe the outcomes, subjective experience, and reflective clinical reasoning process for a child with cerebral palsy using the International Classification of Functioning, Disability, and Health (ICF) model. Application of the ICF framework to a 9-year-old boy with spastic triplegic cerebral palsy was utilized to capture the interwoven factors present in this case. Interventions in the pool occurred twice weekly for 1 h over a 10-week period. Immediately post and 4 months post-intervention, the child made functional and meaningful gains. The family unit also developed an enjoyment of exercising together. Each individual family member described psychological, emotional, or physical health improvements. Reflection using the ICF model as a framework to discuss clinical reasoning can highlight important factors contributing to effective patient management.

A semi-automated, field-portable microscopy platform for clinical diagnostic applications

NASA Astrophysics Data System (ADS)

Jagannadh, Veerendra Kalyan; Srinivasan, Rajesh; Gorthi, Sai Siva

2015-08-01

Clinical microscopy is a versatile diagnostic platform used for diagnosis of a multitude of diseases. In the recent past, many microfluidics based point-of-care diagnostic devices have been developed, which serve as alternatives to microscopy. However, these point-of-care devices are not as multi-functional and versatile as clinical microscopy. With the use of custom designed optics and microfluidics, we have developed a versatile microscopy-based cellular diagnostic platform, which can be used at the point of care. The microscopy platform presented here is capable of detecting infections of very low parasitemia level (in a very small quantity of sample), without the use of any additional computational hardware. Such a cost-effective and portable diagnostic device, would greatly impact the quality of health care available to people living in rural locations of the world. Apart from clinical diagnostics, it's applicability to field research in environmental microbiology has also been outlined.

Micropulsed diode laser therapy: evolution and clinical applications.

PubMed

Sivaprasad, Sobha; Elagouz, Mohammed; McHugh, Dominic; Shona, Olajumoke; Dorin, Giorgio

2010-01-01

Many clinical trials have demonstrated the clinical efficacy of laser photocoagulation in the treatment of retinal vascular diseases, including diabetic retinopathy. There is, however, collateral iatrogenic retinal damage and functional loss after conventional laser treatment. Such side effects may occur even when the treatment is appropriately performed because of morphological damage caused by the visible endpoint, typically a whitening burn. The development of the diode laser with micropulsed emission has allowed subthreshold therapy without a visible burn endpoint. This greatly reduces the risk of structural and functional retinal damage, while retaining the therapeutic efficacy of conventional laser treatment. Studies using subthreshold micropulse laser protocols have reported successful outcomes for diabetic macular edema, central serous chorioretinopathy, macular edema secondary to retinal vein occlusion, and primary open angle glaucoma. The report includes the rationale and basic principles underlying micropulse diode laser therapy, together with a review of its current clinical applications. Copyright © 2010 Elsevier Inc. All rights reserved.

The impact of inclusion criteria in health economic assessments.

PubMed

Richter, Anke; Thieda, Patricia; Thaler, Kylie; Gartlehner, Gerald

2011-05-01

The debate surrounding whether the findings of efficacy studies are applicable to real-world treatment situations is ongoing. The issue of lack of applicability due to a lack of clinical heterogeneity could be addressed by employing less restrictive inclusion criteria. Given that health economic assessments based on cost-effectiveness measures are required by many governments and insurance providers, the impact of this choice may be far reaching. The objective of this article was to explore the use of a pilot study to examine the impact of inclusion criteria on cost-effectiveness results and clinical heterogeneity. A health economic assessment was conducted using QRISK®2 and simulation modelling of different population groups within the pilot study in Lower Austria. Patients were referred by their family physicians to 'Active Prevention' (Vorsorge Aktiv), a community-based lifestyle intervention focused on exercise and nutritional programmes. Cardiovascular risk factors were recorded before and after the intervention and translated to cardiovascular events. As expected, enforcing restrictive inclusion criteria produced stronger and more irrefutable computations - in the expected number of events, the number of deaths, the incremental cost per life-year saved and in the 95% confidence interval. These findings provide insight into the issues surrounding clinical heterogeneity and the need for restrictive inclusion criteria. This is not a full health economic assessment of the intervention. While inclusion criteria provide stronger results by limiting populations to those who would benefit the most, they must be enforced, both within and outside the clinical trial setting. Enforcement has costs, both monetary and arising from unintended negative consequences of enforcement mechanisms. All these considerations will affect the results realized by the payer organization. A pilot study can reveal whether an intervention may be cost effective 'enough' without restrictive inclusion criteria and can enable researchers to search for population subgroups in which the intervention remains cost effective. When the pilot study does not indicate sufficiently strong cost-effectiveness results, the broader trade-offs between clinical heterogeneity and the strength of the submission package to the reimbursement agency can be discussed by all parties. Payer concerns about the ability to generalize the results beyond the clinical trial can also be discussed at this time. Applicability then depends on the ability to enforce inclusion criteria similar to those used in the trials in the real world.

Placebos in clinical practice and research.

PubMed Central

De Deyn, P P; D'Hooge, R

1996-01-01

The main current application of placebo is in clinical research. The term placebo effect refers to diverse non-specific, desired or non-desired effects of substances or procedures and interactions between patient and therapist. Unpredictability of the placebo effect necessitates placebo-controlled designs for most trials. Therapeutic and diagnostic use of placebo is ethically acceptable only in few well-defined cases. While "therapeutic" application of placebo almost invariably implies deception, this is not the case for its use in research. Conflicts may exist between the therapist's Hippocratic and scientific obligations. The authors provide examples in neuropsychiatry, illustrating that objective scientific data and well-considered guidelines may solve the ethical dilemma. Placebo control might even be considered an ethical obligation but some provisos should be kept in mind: (a) no adequate therapy for the disease should exist and/or (presumed) active therapy should have serious side-effects; (b) placebo treatment should not last too long; (c) placebo treatment should not inflict unacceptable risks, and (d) the experimental subject should be adequately informed and informed consent given. PMID:8798935

Advances in the Studies of Ginkgo Biloba Leaves Extract on Aging-Related Diseases

PubMed Central

Zuo, Wei; Yan, Feng; Zhang, Bo; Li, Jiantao; Mei, Dan

2017-01-01

The prevalence of degenerative disorders in public health has promoted in-depth investigations of the underlying pathogenesis and the development of new treatment drugs. Ginkgo biloba leaves extract (EGb) is obtained from Ginkgo biloba leaves and has been used for thousands of years. In recent decades, both basic and clinical studies have established the effects of EGb. It is widely used in various degenerative diseases such as cerebrovascular disease, Alzheimer’s disease, macroangiopathy and more. Here, we reviewed several pharmacological mechanisms of EGb, including its antioxidant properties, prevention of mitochondrial dysfunctions, and effect on apoptosis. We also described some clinical applications of EGb, such as its effect on neuro and cardiovascular protection, and anticancer properties. The above biological functions of EGb are mainly focused on aging-related disorders, but its effect on other diseases remains unclear. Thus, through this review, we aim to encourage further studies on EGb and discover more potential applications PMID:29344418

Herbal Products: Benefits, Limits, and Applications in Chronic Liver Disease

PubMed Central

Del Prete, Anna; Scalera, Antonella; Iadevaia, Maddalena Diana; Miranda, Agnese; Zulli, Claudio; Gaeta, Laura; Tuccillo, Concetta; Federico, Alessandro; Loguercio, Carmelina

2012-01-01

Complementary and alternative medicine soughts and encompasses a wide range of approaches; its use begun in ancient China at the time of Xia dynasty and in India during the Vedic period, but thanks to its long-lasting curative effect, easy availability, natural way of healing, and poor side-effects it is gaining importance throughout the world in clinical practice. We conducted a review describing the effects and the limits of using herbal products in chronic liver disease, focusing our attention on those most known, such as quercetin or curcumin. We tried to describe their pharmacokinetics, biological properties, and their beneficial effects (as antioxidant role) in metabolic, alcoholic, and viral hepatitis (considering that oxidative stress is the common pathway of chronic liver diseases of different etiology). The main limit of applicability of CAM comes from the lacking of randomized, placebo-controlled clinical trials giving a real proof of efficacy of those products, so that anecdotal success and personal experience are frequently the driving force for acceptance of CAM in the population. PMID:22991573

The Effectiveness of Transcranial Brain Stimulation in Improving Clinical Signs of Hyperkinetic Movement Disorders.

PubMed

Obeso, Ignacio; Cerasa, Antonio; Quattrone, Aldo

2015-01-01

Repetitive transcranial magnetic stimulation (rTMS) is a safe and painless method for stimulating cortical neurons. In neurological realm, rTMS has prevalently been applied to understand pathophysiological mechanisms underlying movement disorders. However, this tool has also the potential to be translated into a clinically applicable therapeutic use. Several available studies supported this hypothesis, but differences in protocols, clinical enrollment, and variability of rTMS effects across individuals complicate better understanding of efficient clinical protocols. The aim of this present review is to discuss to what extent the evidence provided by the therapeutic use of rTMS may be generalized. In particular, we attempted to define optimal cortical regions and stimulation protocols that have been demonstrated to maximize the effectiveness seen in the actual literature for the three most prevalent hyperkinetic movement disorders: Parkinson's disease (PD) with levodopa-induced dyskinesias (LIDs), essential tremor (ET) and dystonia. A total of 28 rTMS studies met our search criteria. Despite clinical and methodological differences, overall these studies demonstrated that therapeutic applications of rTMS to "normalize" pathologically decreased or increased levels of cortical activity have given moderate progress in patient's quality of life. Moreover, the present literature suggests that altered pathophysiology in hyperkinetic movement disorders establishes motor, premotor or cerebellar structures as candidate regions to reset cortico-subcortical pathways back to normal. Although rTMS has the potential to become a powerful tool for ameliorating the clinical outcome of hyperkinetic neurological patients, until now there is not a clear consensus on optimal protocols for these motor disorders. Well-controlled multicenter randomized clinical trials with high numbers of patients are urgently required.

Gold-Containing Indoles as Anti-Cancer Agents that Potentiate the Cytotoxic Effects of Ionizing Radiation

PubMed Central

Craig, Sandra; Gao, Lei; Lee, Irene; Gray, Thomas; Berdis, Anthony J.

2012-01-01

This report describes the design and application of several distinct gold-containing indoles as anti-cancer agents. When used individually, all gold-bearing compounds display cytostatic effects against leukemia and adherent cancer cell lines. However, two gold-bearing indoles show unique behavior by increasing the cytotoxic effects of clinically relevant levels of ionizing radiation. Quantifying the amount of DNA damage demonstrates that each gold-indole enhances apoptosis by inhibiting DNA repair. Both Au(I)-indoles were tested for inhibitory effects against various cellular targets including thioredoxin reductase, a known target of several gold compounds, and various ATP-dependent kinases. While neither compound significantly inhibits the activity of thioreoxin reductase, both showed inhibitory effects against several kinases associated with cancer initiation and progression. The inhibition of these kinases provides a possible mechanism for the ability of these Au(I)-indoles potentiate the cytotoxic effects of ionizing radiation. Clinical applications of combining Au(I)-indoles with ionizing radiation are discussed as a new strategy to achieve chemosensitization of cancer cells. PMID:22289037

DNA enzymes as potential therapeutics: towards clinical application of 10-23 DNAzymes.

PubMed

Fokina, Alesya A; Stetsenko, Dmitry A; François, Jean-Christophe

2015-05-01

Ongoing studies on the inhibition of gene expression at the mRNA level have identified several types of specific inhibitors such as antisense oligonucleotides, small interfering RNA, ribozymes and DNAzymes (Dz). After its discovery in 1997, the 10-23 Dz (which can cleave RNA efficiently and site-specifically, has flexible design, is independent from cell mechanisms, does not require expensive chemical modifications for effective use in vivo) has been employed to downregulate a range of therapeutically important genes. Recently, 10-23 Dzs have taken their first steps into clinical trials. This review focuses predominantly on Dz applications as potential antiviral, antibacterial, anti-cancer and anti-inflammatory agents as well as for the treatment of cardiovascular disease and diseases of CNS, summarizing results of their clinical trials up to the present day. In comparison with antisense oligonucleotides and small interfering RNAs, Dzs do not usually show off-target effects due to their high specificity and lack of immunogenicity in vivo. As more results of clinical trials carried out so far are gradually becoming available, Dzs may turn out to be safe and well-tolerated therapeutics in humans. Therefore, there is a good chance that we may witness a deoxyribozyme drug reaching the clinic in the near future.

[Application of case-based learning in clinical internship teaching of conservative dentistry and endodontics].

PubMed

Liu, Sheng-bo; Peng, Bin; Song, Ya-ling; Xu, Qing-an

2013-12-01

To investigate the education effect of case-based learning (CBL) pattern on clinical internship of conservative dentistry and endodontics. Forty-one undergraduates were randomly assigned into CBL group and traditional teaching group. After clinical internship in the department of conservative dentistry and endodontics for 11 weeks, each student in the 2 groups underwent comprehensive examinations including medical record writing, case analysis, academic knowledge, professional skills and the ability of winning the trust of the patients. The scores were compared between the 2 groups using SPSS 13.0 software package. There was no significant difference between the 2 groups with regard to the scores of academic knowledge and profession skills (P>0.05). However, the results of medical record writing, case analysis and the ability of winning the trust of the patients showed significant difference between the 2 groups(P<0.05). Proper application of CBL in clinical internship of conservative dentistry and endodontics contributes to improve students' ability of clinical thinking, synthetical analysis and adaptability to different patients.

Latest status of the clinical and industrial applications of cell sheet engineering and regenerative medicine.

PubMed

Egami, Mime; Haraguchi, Yuji; Shimizu, Tatsuya; Yamato, Masayuki; Okano, Teruo

2014-01-01

Cell sheet engineering, which allows tissue engineering to be realized without the use of biodegradable scaffolds as an original approach, using a temperature-responsive intelligent surface, has been applied in regenerative medicine for various tissues, and a number of clinical studies have been already performed for life-threatening diseases. By using the results and findings obtained from the initial clinical studies, additional investigative clinical studies in several tissues with cell sheet engineering are currently in preparation stage. For treating many patients effectively by cell sheet engineering, an automated system integrating cell culture, cell-sheet fabrication, and layering is essential, and the system should include an advanced three-dimensional suspension cell culture system and an in vitro bioreactor system to scale up the production of cultured cells and fabricate thicker vascularized tissues. In this paper, cell sheet engineering, its clinical application, and further the authors' challenge to develop innovative cell culture systems under newly legislated regulatory platform in Japan are summarized and discussed.

Practice-Based Knowledge Discovery for Comparative Effectiveness Research: An Organizing Framework

PubMed Central

Lucero, Robert J.; Bakken, Suzanne

2014-01-01

Electronic health information systems can increase the ability of health-care organizations to investigate the effects of clinical interventions. The authors present an organizing framework that integrates outcomes and informatics research paradigms to guide knowledge discovery in electronic clinical databases. They illustrate its application using the example of hospital acquired pressure ulcers (HAPU). The Knowledge Discovery through Informatics for Comparative Effectiveness Research (KDI-CER) framework was conceived as a heuristic to conceptualize study designs and address potential methodological limitations imposed by using a single research perspective. Advances in informatics research can play a complementary role in advancing the field of outcomes research including CER. The KDI-CER framework can be used to facilitate knowledge discovery from routinely collected electronic clinical data. PMID:25278645

[Progress in methodological characteristics of clinical practice guideline for osteoarthritis].

PubMed

Xing, D; Wang, B; Lin, J H

2017-06-01

At present, several clinical practice guidelines for the treatment of osteoarthritis have been developed by institutes or societies. The ultimate purpose of developing clinical practice guidelines is to formulate the process in the treatment of osteoarthritis effectively. However, the methodologies used in developing clinical practice guidelines may place an influence on the transformation and application of that in treating osteoarthritis. The present study summarized the methodological features of individual clinical practice guideline and presented the tools for quality evaluation of clinical practice guideline. The limitations of current osteoarthritis guidelines of China are also indicated. The review article might help relevant institutions improve the quality in developing guide and clinical transformation.

[Pharmacogenomics of the first-line treatment for gastric cancer: advances in the identification of genomic biomarkers for clinical response to chemotherapy].

PubMed

Castro-Rojas, Carlos; Ortiz-Lópezj, Rocío; Rojas-Martínez, Augusto

2014-06-01

Gastric cancer (GC) is often diagnosed at later stages due to the lack of specificity of symptoms associated with the neoplasm, causing high mortality rates worldwide. The first line of adjuvant and neoadjuvant treatment includes cytotoxic fluoropyrimidines and platin-containing compounds which cause the formation of DNA adducts. The clinical outcome with these antineoplastic agents depends mainly on tumor sensitivity, which is conditioned by the expression level of the drug targets and the DNA-repair system enzymes. In addition, some germ line polymorphisms, in genes linked to drug metabolism and response to chemotherapy, have been associated with poor responses and the development of adverse effects, even with fatal outcomes in GC patients. The identification of genomic biomarkers, such as individual gene polymorphisms or differential expression patterns of specific genes, in a patient-by-patient context with potential clinical application is the main focus of current pharmacogenomic research, which aims at developing a rational and personalized therapy (i.e., a therapy that ensures maximum efficacy with no predictable side effects). However, because of the future application of genomic technologies in the clinical setting, it is necessary to establish the prognostic value of these genomic biomarkers with genotype-phenotype association studies and to evaluate their prevalence in the population under treatment. These issues are important for their cost-effectiveness evaluation, which determines the feasibility of using these medical genomic research products for GC treatment in the clinical setting.

Using wireless handheld computers to seek information at the point of care: an evaluation by clinicians.

PubMed

Hauser, Susan E; Demner-Fushman, Dina; Jacobs, Joshua L; Humphrey, Susanne M; Ford, Glenn; Thoma, George R

2007-01-01

To evaluate: (1) the effectiveness of wireless handheld computers for online information retrieval in clinical settings; (2) the role of MEDLINE in answering clinical questions raised at the point of care. A prospective single-cohort study: accompanying medical teams on teaching rounds, five internal medicine residents used and evaluated MD on Tap, an application for handheld computers, to seek answers in real time to clinical questions arising at the point of care. All transactions were stored by an intermediate server. Evaluators recorded clinical scenarios and questions, identified MEDLINE citations that answered the questions, and submitted daily and summative reports of their experience. A senior medical librarian corroborated the relevance of the selected citation to each scenario and question. Evaluators answered 68% of 363 background and foreground clinical questions during rounding sessions using a variety of MD on Tap features in an average session length of less than four minutes. The evaluator, the number and quality of query terms, the total number of citations found for a query, and the use of auto-spellcheck significantly contributed to the probability of query success. Handheld computers with Internet access are useful tools for healthcare providers to access MEDLINE in real time. MEDLINE citations can answer specific clinical questions when several medical terms are used to form a query. The MD on Tap application is an effective interface to MEDLINE in clinical settings, allowing clinicians to quickly find relevant citations.

Using Wireless Handheld Computers to Seek Information at the Point of Care: An Evaluation by Clinicians

PubMed Central

Hauser, Susan E.; Demner-Fushman, Dina; Jacobs, Joshua L.; Humphrey, Susanne M.; Ford, Glenn; Thoma, George R.

2007-01-01

Objective To evaluate: (1) the effectiveness of wireless handheld computers for online information retrieval in clinical settings; (2) the role of MEDLINE® in answering clinical questions raised at the point of care. Design A prospective single-cohort study: accompanying medical teams on teaching rounds, five internal medicine residents used and evaluated MD on Tap, an application for handheld computers, to seek answers in real time to clinical questions arising at the point of care. Measurements All transactions were stored by an intermediate server. Evaluators recorded clinical scenarios and questions, identified MEDLINE citations that answered the questions, and submitted daily and summative reports of their experience. A senior medical librarian corroborated the relevance of the selected citation to each scenario and question. Results Evaluators answered 68% of 363 background and foreground clinical questions during rounding sessions using a variety of MD on Tap features in an average session length of less than four minutes. The evaluator, the number and quality of query terms, the total number of citations found for a query, and the use of auto-spellcheck significantly contributed to the probability of query success. Conclusion Handheld computers with Internet access are useful tools for healthcare providers to access MEDLINE in real time. MEDLINE citations can answer specific clinical questions when several medical terms are used to form a query. The MD on Tap application is an effective interface to MEDLINE in clinical settings, allowing clinicians to quickly find relevant citations. PMID:17712085

The effect of Laser and taping on pain, functional status and quality of life in patients with fibromyalgia syndrome: A placebo- randomized controlled clinical trial.

PubMed

Vayvay, Emre Serdar; Tok, Damla; Turgut, Elif; Tunay, Volga Bayrakci

2016-01-01

Conservative treatments have been proved to be effective to control pain and optimize function in fibromyalgia, however there is need for scientific evidence to make better clinical application across various physiotherapy applications. The aim of this study was to investigate the effects of Laser and taping applications on pain, flexibility, anxiety, depression, functional status and quality of life in patients with fibromyalgia syndrome. Forty-five female patients with fibromyalgia syndrome were included to the study and randomly allocated into three treatment groups; Laser (n= 15), placebo Laser (n= 15), and taping applications (n= 15). Visual analogue scale for pain intensity, trunk flexibility, Fibromyalgia Impact Questionnaire for functional status, Short Form 36 Questionnaire for quality of life and health status, and Beck Depression Inventory for anxiety level were evaluated before and after three weeks interventions. There were decreased pain severity in activity (p= 0.028), anxiety level (p= 0.01) and improved general health status, quality of life (p= 0.01) found at Laser group, whereas there were increased trunk flexibility, flexion (p= 0.03), extension (p= 0.02) found at taping group. After interventions, there were decreased pain severity for whole groups at night for Laser group (p= 0.04), placebo Laser group (p= 0.001), taping group (p= 0.01) and improved functional status found for Laser group (p= 0.001), placebo Laser group (p= 0.001), taping group (p= 0.01). Kinesiotape application had a similar effect on parameters in FMS patient, so this method could be preferred instead of Laser application for rehabilitation program.

Importance of placebo effect in cough clinical trials.

PubMed

Eccles, Ron

2010-01-01

Cough is a unique symptom because, unlike sneeze and other symptoms, it can be under voluntary control and this complicates clinical trials on cough medicines. All over-the-counter cough medicines (OTC) are very effective treatments because of their placebo effect. The placebo effect is enhanced by expectancy related to advertising, brand, packaging, and formulation. This placebo effect creates a problem for the conduct of clinical trials on OTC cough medicines that attempt to demonstrate the efficacy of a pharmacological agent above that of any placebo effect. Up to 85% of the efficacy of some cough medicines can be attributed to a placebo effect. The placebo effect apparent in clinical trials consists of several components: natural recovery, regression of cough response toward mean, demulcent effect, effect of sweetness, voluntary control, and effects related to expectancy and meaning of the treatment. The placebo effect has been studied most in the pain model, and placebo analgesia is reported to depend on the activation of endogenous opioid systems in the brain; this model may be applicable to cough. A balanced placebo design may help to control for the placebo effect, but this trial design may not be acceptable due to deception of patients. The placebo effect in clinical trials may be controlled by use of a crossover design, where feasible, and the changes in the magnitude of the placebo effect in this study design are discussed.

Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

PubMed

Riley, Isaretta L; Boulware, L Ebony; Sun, Jie-Lena; Chiswell, Karen; Que, Loretta G; Kraft, Monica; Todd, Jamie L; Palmer, Scott M; Anderson, Monique L

2018-02-01

Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0.51-0.83)). Conclusion A total of 15% of pulmonary clinical highly likely applicable clinical trials report basic summary results to ClinicalTrials.gov within 1 year of trial completion. Strategies to improve reporting are needed within the pulmonary community.

Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression.

PubMed

McClintock, Shawn M; Reti, Irving M; Carpenter, Linda L; McDonald, William M; Dubin, Marc; Taylor, Stephan F; Cook, Ian A; O'Reardon, John; Husain, Mustafa M; Wall, Christopher; Krystal, Andrew D; Sampson, Shirlene M; Morales, Oscar; Nelson, Brent G; Latoussakis, Vassilios; George, Mark S; Lisanby, Sarah H

To provide expert recommendations for the safe and effective application of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depressive disorder (MDD). Participants included a group of 17 expert clinicians and researchers with expertise in the clinical application of rTMS, representing both the National Network of Depression Centers (NNDC) rTMS Task Group and the American Psychiatric Association Council on Research (APA CoR) Task Force on Novel Biomarkers and Treatments. The consensus statement is based on a review of extensive literature from 2 databases (OvidSP MEDLINE and PsycINFO) searched from 1990 through 2016. The search terms included variants of major depressive disorder and transcranial magnetic stimulation. The results were limited to articles written in English that focused on adult populations. Of the approximately 1,500 retrieved studies, a total of 118 publications were included in the consensus statement and were supplemented with expert opinion to achieve consensus recommendations on key issues surrounding the administration of rTMS for MDD in clinical practice settings. In cases in which the research evidence was equivocal or unclear, a consensus decision on how rTMS should be administered was reached by the authors of this article and is denoted in the article as "expert opinion." Multiple randomized controlled trials and published literature have supported the safety and efficacy of rTMS antidepressant therapy. These consensus recommendations, developed by the NNDC rTMS Task Group and APA CoR Task Force on Novel Biomarkers and Treatments, provide comprehensive information for the safe and effective clinical application of rTMS in the treatment of MDD. © Copyright 2017 Physicians Postgraduate Press, Inc.

A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children.

PubMed

Eichenfield, Lawrence F; Funk, Ann; Fallon-Friedlander, Sheila; Cunningham, Bari B

2002-06-01

A double-randomized, blinded crossover trial was performed to assess the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics (EMLA) for pain relief during pediatric venipuncture procedures. Safety was assessed by evaluation for topical or systemic effects and measurement of serum lidocaine concentrations. A total of 120 children who were scheduled for repeat venipuncture for non-study-related reasons at 2 sites participated in the study. Patients were doubly randomized to treatment regimen (study medication application time of either 30 or 60 minutes) and to the order of application of the topical anesthetics for each venipuncture. The primary outcome measures were the child's rating of pain immediately after the venipuncture procedures using a 100-mm visual analog scale (VAS) tool and the parent's and blinded research observer's Observed Behavioral Distress scores. Both ELA-Max and EMLA seemed to alleviate venipuncture pain. There was no clinically or statistically significant difference in the patient VAS scores within the 30-minute or 60-minute treatment groups, and there was no clinical or statistical difference in VAS scores between the 30-minute ELA-Max treatment without occlusion and the 60-minute EMLA treatment with occlusion. There were no clinically or statistically significant differences between treatment with ELA-Max and EMLA in parental or blinded researcher Observed Behavioral Distress scores, the most frequent response at any observation time being "no distress." This study demonstrates that a 30-minute application of ELA-Max without occlusion is as safe and as effective for ameliorating pain associated with venipuncture as a 60-minute application of the prescription product EMLA requiring occlusion.

Countertransference in working with victims of political repression.

PubMed

Comas-Díaz, L; Padilla, A M

1990-01-01

The countertransferential reactions of psychotherapists working in a threatening environment with victims of political repression are described. Via case studies based on clinical consultation and direct testimony, this paper examines the effects on Chilean therapists living and working in that country. It is suggested that these clinical observations may have application to therapeutic work with victims in other stressful settings.

Epilepsy informatics and an ontology-driven infrastructure for large database research and patient care in epilepsy.

PubMed

Sahoo, Satya S; Zhang, Guo-Qiang; Lhatoo, Samden D

2013-08-01

The epilepsy community increasingly recognizes the need for a modern classification system that can also be easily integrated with effective informatics tools. The 2010 reports by the United States President's Council of Advisors on Science and Technology (PCAST) identified informatics as a critical resource to improve quality of patient care, drive clinical research, and reduce the cost of health services. An effective informatics infrastructure for epilepsy, which is underpinned by a formal knowledge model or ontology, can leverage an ever increasing amount of multimodal data to improve (1) clinical decision support, (2) access to information for patients and their families, (3) easier data sharing, and (4) accelerate secondary use of clinical data. Modeling the recommendations of the International League Against Epilepsy (ILAE) classification system in the form of an epilepsy domain ontology is essential for consistent use of terminology in a variety of applications, including electronic health records systems and clinical applications. In this review, we discuss the data management issues in epilepsy and explore the benefits of an ontology-driven informatics infrastructure and its role in adoption of a "data-driven" paradigm in epilepsy research. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

Epilepsy informatics and an ontology-driven infrastructure for large database research and patient care in epilepsy

PubMed Central

Sahoo, Satya S.; Zhang, Guo-Qiang; Lhatoo, Samden D.

2013-01-01

Summary The epilepsy community increasingly recognizes the need for a modern classification system that can also be easily integrated with effective informatics tools. The 2010 reports by the United States President's Council of Advisors on Science and Technology (PCAST) identified informatics as a critical resource to improve quality of patient care, drive clinical research, and reduce the cost of health services. An effective informatics infrastructure for epilepsy, which is underpinned by a formal knowledge model or ontology, can leverage an ever increasing amount of multimodal data to improve (1) clinical decision support, (2) access to information for patients and their families, (3) easier data sharing, and (4) accelerate secondary use of clinical data. Modeling the recommendations of the International League Against Epilepsy (ILAE) classification system in the form of an epilepsy domain ontology is essential for consistent use of terminology in a variety of applications, including electronic health records systems and clinical applications. In this review, we discuss the data management issues in epilepsy and explore the benefits of an ontology-driven informatics infrastructure and its role in adoption of a “data-driven” paradigm in epilepsy research. PMID:23647220

Use of dyes in cariology.

PubMed

van de Rijke, J W

1991-04-01

The property of dyes to enhance contrast by their colour can be used in clinical dentistry and in investigations in vitro or in vivo. They have been used for indication of affected dental tissues, improvement of diagnostic methods, enhancement of patient awareness and information about specific processes. The development of particular dye systems, aimed at clinical application, is often laborious because of toxic effects, lack of specificity, irreversible staining or difficulties with removal of the dye. Clinically used dyes are often visually observed, which means a qualitative assessment of the staining, while quantification of the staining, if performed at all, is confined mostly to laboratory experiments. In this paper the application of dyes, arranged according to their specific purpose in cariology, is discussed, and a brief historical overview is given of the development of two particular dye applications for which commercial dye systems are now available. If certain requirements are met, dyes can be of great help in detection and quantification when used with several diagnostic methods.

A conceptual model of transference and its psychotherapeutic application.

PubMed

Corradi, Richard B

2006-01-01

The tendency to repeat formative human relationships in later life, a universal developmental characteristic, is referred to as transference when it occurs in the doctor-patient relationship. Its systematic therapeutic application in psychiatry has historically been associated with classical psychoanalysis. As psychoanalysis has lost its cachet, and as drug treatment has replaced psychotherapy as psychiatry's major treatment modality, the therapeutic potential of transference risks being neglected. This is to the great detriment of psychiatric patients. Knowledge of the power of transference and expertise in its clinical use in psychotherapy should be the most powerful tool in the psychiatric therapeutic armamentarium. This article discusses a concept of transference that the author has found effective, both in clinical practice and in teaching about transference to psychiatric residents. The article delineates a psychology of transference, discusses its universal applicability to the whole of the psychotherapeutic process, and utilizes case material to illustrate principles of its application.

Clinical Effectiveness of a Resin-modified Glass Ionomer Cement and a Mild One-step Self-etch Adhesive Applied Actively and Passively in Noncarious Cervical Lesions: An 18-Month Clinical Trial.

PubMed

Jassal, M; Mittal, S; Tewari, S

2018-05-21

To evaluate the clinical effectiveness of two methods of application of a mild one-step self-etch adhesive and composite resin as compared with a resin-modified glass ionomer cement (RMGIC) control restoration in noncarious cervical lesions (NCCLs). A total of 294 restorations were placed in 56 patients, 98 in each one of the following groups: 1) G-Bond active application combined with Solare-X composite resin (A-1SEA), 2) G-Bond passive application combined with Solare-X composite resin (P-1SEA), and 3) GC II LC RMGIC. The restorations were evaluated at baseline and after six, 12, and 18 months according to the FDI criteria for fractures/retention, marginal adaptation, marginal staining, postoperative sensitivity, and secondary caries. Cumulative failure rates were calculated for each criterion at each recall period. The effect of adhesive, method of application, and recall period were assessed. The Kruskal-Wallis test for intergroup comparison and Friedman and Wilcoxon signed ranks tests for intragroup comparison were used for each criterion ( α=0.05). The retention rates at 18 months were 93.26% for the A-1SEA group, 86.21% for the P-1SEA group, and 90.91% for the RMGIC group. The active application improved the retention rates compared with the passive application of mild one-step self-etch adhesive; however, no statistically significant difference was observed between the groups. Marginal staining was observed in 13 restorations (1 in A-1SEA, 4 in P-1SEA, and 8 in RMGIC) with no significant difference between the groups. The RMGIC group showed a significant increase in marginal staining at 12 and 18 months from the baseline. There was no significant difference between the groups for marginal adaptation, secondary caries, or postoperative sensitivity. Within the limitations of the study, we can conclude that mild one-step self-etch adhesive followed by a resin composite restoration can be an alternative to RMGIC with similar retention and improved esthetics in restoration of NCCLs. Agitation could possibly benefit the clinical performance of mild one-step self-etch adhesives, but this study did not confirm that the observed benefit was statistically significant.

The effect of pre- and after-treatment of sevoflurane on central ischemia tolerance and the underlying mechanisms

PubMed Central

2018-01-01

In recent years, with continuous research efforts targeted at studying the effects of pre- and after-treatment of inhaled anesthetics, significant progress has been made regarding the common clinical use of low concentrations of inhaled sevoflurane and its effect on induced central ischemia tolerance by pre- and post-treatment. In this study, we collected, analyzed, classified, and summarized recent literature regarding the effect of sevoflurane on central ischemia tolerance and its related mechanisms. In addition, we provide a theoretical basis for the clinical application of sevoflurane to protect the central nervous system and other important organs against ischemic injury. PMID:29556553

[Reasonable and safe application of Shuxuetong injection and intravenous medication's combined application in acute cerebral infarction's therapy].

PubMed

Li, Ming-Quan; Xie, Yan-Ming; Zhao, Jian-Jun

2012-09-01

Shuxuetong injection is a kind of compound injection which is made from traditional Chinese medicine Hirudo and Pheretime, which has a clear anticoagulant, fibrinolytic promoting, blood rheology improving, blood lipids regulating and cell protecting effect, and the injection has been widely used in clinical. Especially, the injection has often been combined with other Chinese and modern medicine in the treatment of cerebral infarction disease. However, there are still many non-standard and irrational aspects in clinical practice so as to make a more reasonable and safer use of Shuxuetong injection. In order to avoid the occurrence of adverse reactions to provide a reference for regulating the use of the injection,the paper systematically expounds the Shuxuetong injection's main clinical problems and the reasonable combination.

Current Concepts in Gastrointestinal Photodynamic Therapy

PubMed Central

Webber, John; Herman, Mark; Kessel, David; Fromm, David

1999-01-01

Objective To review current concepts of photodynamic therapy (PDT) applied to the treatment of tumors of the gastrointestinal tract. Summary Background Data PDT initially involves the uptake or production of a photosensitive compound by tumor cells. Subsequent activation of the photoreactive compound by a specific wavelength of light results in cell death, either directly or as a result of vascular compromise and/or apoptosis. Methods The authors selectively review current concepts relating to photosensitization, photoactivation, time of PDT application, tissue selectivity, sites of photodynamic action, PDT effects on normal tissue, limitations of PDT, toxicity of photosensitizers, application of principles of PDT to tumor detection, and current applications of PDT to tumors of the gastrointestinal tract. Results PDT is clearly effective for small cancers, but it is not yet clear in which cases such treatment is more effective than other currently acceptable approaches. The major side effect of PDT is cutaneous photosensitization. The major limitation of PDT is depth of tumor kill. As data from current and future clinical trials become available, a clearer perspective of where PDT fits in the treatment of cancers will be gained. Many issues regarding pharmacokinetic data of photosensitizers, newer technology involved in light sources, optimal treatment regimens that take advantage of the pharmacophysiology of photoablation, and light dosimetry still require solution. One can foresee application of differing sensitizers and light sources depending on the specific clinical situation. As technologic advances occur, interstitial PDT may have significant application. Conclusions PDT has a potentially important role either as a primary or adjuvant mode of treatment of tumors of the gastrointestinal tract. PMID:10400031

Comprehensive, powerful, efficient, intuitive: a new software framework for clinical imaging applications

NASA Astrophysics Data System (ADS)

Augustine, Kurt E.; Holmes, David R., III; Hanson, Dennis P.; Robb, Richard A.

2006-03-01

One of the greatest challenges for a software engineer is to create a complex application that is comprehensive enough to be useful to a diverse set of users, yet focused enough for individual tasks to be carried out efficiently with minimal training. This "powerful yet simple" paradox is particularly prevalent in advanced medical imaging applications. Recent research in the Biomedical Imaging Resource (BIR) at Mayo Clinic has been directed toward development of an imaging application framework that provides powerful image visualization/analysis tools in an intuitive, easy-to-use interface. It is based on two concepts very familiar to physicians - Cases and Workflows. Each case is associated with a unique patient and a specific set of routine clinical tasks, or a workflow. Each workflow is comprised of an ordered set of general-purpose modules which can be re-used for each unique workflow. Clinicians help describe and design the workflows, and then are provided with an intuitive interface to both patient data and analysis tools. Since most of the individual steps are common to many different workflows, the use of general-purpose modules reduces development time and results in applications that are consistent, stable, and robust. While the development of individual modules may reflect years of research by imaging scientists, new customized workflows based on the new modules can be developed extremely fast. If a powerful, comprehensive application is difficult to learn and complicated to use, it will be unacceptable to most clinicians. Clinical image analysis tools must be intuitive and effective or they simply will not be used.

Simple and effective exercise design for assessing in vivo mitochondrial function in clinical applications using (31)P magnetic resonance spectroscopy.

PubMed

Sleigh, Alison; Lupson, Victoria; Thankamony, Ajay; Dunger, David B; Savage, David B; Carpenter, T Adrian; Kemp, Graham J

2016-01-11

The growing recognition of diseases associated with dysfunction of mitochondria poses an urgent need for simple measures of mitochondrial function. Assessment of the kinetics of replenishment of the phosphocreatine pool after exercise using (31)P magnetic resonance spectroscopy can provide an in vivo measure of mitochondrial function; however, the wider application of this technique appears limited by complex or expensive MR-compatible exercise equipment and protocols not easily tolerated by frail participants or those with reduced mental capacity. Here we describe a novel in-scanner exercise method which is patient-focused, inexpensive, remarkably simple and highly portable. The device exploits an MR-compatible high-density material (BaSO4) to form a weight which is attached directly to the ankle, and a one-minute dynamic knee extension protocol produced highly reproducible measurements of post-exercise PCr recovery kinetics in both healthy subjects and patients. As sophisticated exercise equipment is unnecessary for this measurement, our extremely simple design provides an effective and easy-to-implement apparatus that is readily translatable across sites. Its design, being tailored to the needs of the patient, makes it particularly well suited to clinical applications, and we argue the potential of this method for investigating in vivo mitochondrial function in new cohorts of growing clinical interest.

Effect of brief training on reliability and applicability of Global Assessment of functioning scale by Psychiatric clinical officers in Uganda.

PubMed

Abbo, C; Okello, E S; Nakku, J

2013-03-01

The Global Assessment of Functioning (GAF) is the standard method and an essential tool for representing a clinician's judgment of a patient's overall level of psychological, social and occupational functioning. As such, it is probably the single most widely used method for assessing impairment among the patients with psychiatric illnesses. To assess the effects of one-hour training on application of the GAF by Psychiatric Clinical Officers' in a Ugandan setting. Five Psychiatrists and five Psychiatric Clinical Officers (PCOs) or Assistant Medical Officers who hold a 2 year diploma in Clinical Psychiatry were randomly selected to independently rate a video-recorded psychiatric interview according to the DSM IV-TR. The PCOs were then offered a one-hour training on how to rate the GAF scale and asked to rate the video case interview again. All ratings were assigned on the basis of past one year, at admission and current functioning. Interclass correlations (ICC) were computed using two-way mixed models. The ICC between the psychiatrists and the PCOs before training in the past one year, at admission and current functioning were +0.48, +0.51 and +0.59 respectively. After training, the ICC coefficients were +0.60, +0.82 and +0.83. Brief training given to PCOs improved the applications of their ratings of GAF scale to acceptable levels. There is need for formal training to this cadre of psychiatric practitioners in the use of the GAF.

Colon cleansing protocol in children: research conditions vs. clinical practice.

PubMed

Elitsur, Yoram; Balfaqih, Yaslam; Preston, Deborah

2018-04-01

 Colon preparation rates are the limiting factor for a successful diagnostic colonoscopy in children. Different colon cleansing protocols have been published for use in children. Unfortunately, the applicability of those published research protocols has not been formally evaluated in routine clinical practice. We investigated the success rate of our previously published colon cleansing protocol as utilized in our clinical practice.  This was a retrospective study. In the clinical practice, the colon cleansing protocol included PEG-3350 at a dose of 2 g/kg/day plus Dulcolax (Bisacodyl, Boehringer Ingelheim, TX USA) 5 mg/day for 2 days. Adequate colon preparation was graded between 1 - 5, as previously described, and grade ≥ 4.0 was considered an adequate preparation. Patients were instructed to complete a questionnaire that included PEG-3350 dose, number of stools per day, consistency of each stool, and side effects (vomiting, abdominal pain). Clinical and endoscopic results were compared between the protocol under research conditions and routine practice.  The success rate of the colon preparation in our clinical practice was similar to the results observed under our research protocol (75 % vs. 73.6 %). Moreover, the total number of stools, stool consistency, and the intubation rate of the terminal ileum were also similar. We concluded, that in our experience, the colon cleansing protocol used under research conditions was effective and appropriate for use in routine clinical practice.  We recommend testing each new protocol under the routine conditions of clinical practice to confirm its applicability for general practitioners.

Topical PDT in the Treatment of Benign Skin Diseases: Principles and New Applications.

PubMed

Kim, Miri; Jung, Haw Young; Park, Hyun Jeong

2015-09-25

Photodynamic therapy (PDT) uses a photosensitizer, light energy, and molecular oxygen to cause cell damage. Cells exposed to the photosensitizer are susceptible to destruction upon light absorption because excitation of the photosensitizing agents leads to the production of reactive oxygen species and, subsequently, direct cytotoxicity. Using the intrinsic cellular heme biosynthetic pathway, topical PDT selectively targets abnormal cells, while preserving normal surrounding tissues. This selective cytotoxic effect is the basis for the use of PDT in antitumor treatment. Clinically, PDT is a widely used therapeutic regimen for oncologic skin conditions such as actinic keratosis, squamous cell carcinoma in situ, and basal cell carcinoma. PDT has been shown, under certain circumstances, to stimulate the immune system and produce antibacterial, and/or regenerative effects while protecting cell viability. Thus, it may be useful for treating benign skin conditions. An increasing number of studies support the idea that PDT may be effective for treating acne vulgaris and several other inflammatory/infective skin diseases, including psoriasis, rosacea, viral warts, and aging-related changes. This review provides an overview of the clinical investigations of PDT and discusses each of the essential aspects of the sequence: its mechanism of action, common photosensitizers, light sources, and clinical applications in dermatology. Of the numerous clinical trials of PDT in dermatology, this review focuses on those studies that have reported remarkable therapeutic benefits following topical PDT for benign skin conditions such as acne vulgaris, viral warts, and photorejuvenation without causing severe side effects.

Potential applications of Erbium:YAG laser in periodontics.

PubMed

Ishikawa, Isao; Aoki, Akira; Takasaki, Aristeo Atsushi

2004-08-01

Since lasers were introduced for the treatment of oral diseases, there has been considerable advancement in technology. As a result, numerous laser systems are currently available for oral use. Neodymium:Yttrium-Aluminum:Garnet (Nd:YAG), carbon dioxide (CO(2)) laser and the semiconductor Diode lasers have already been approved by the US Food and Drug Administration for soft tissue treatment in oral cavity. The Erbium:YAG (Er:YAG) laser was approved in 1997 for hard tissue treatment in dentistry and recent studies have reported positive results. This suggests that the Er:YAG laser system is a promising apparatus, which will be able to revolutionize and improve dental practice, in particular periodontal treatment. In this mini-review, we would like to describe the positive characteristics of the Er:YAG laser which indicate its potential as a new treatment modality in periodontics. Recent findings are summarized briefly to evaluate the potential of the Er:YAG laser for clinical application in periodontics. The Er:YAG laser possesses suitable characteristics for oral soft and hard tissue ablation. Recently, it has been applied for effective elimination of granulation tissue, gingival melanin pigmentation and gingival discoloration. Contouring and cutting of bone with minimal damage and even or faster healing can also be performed with this laser. In addition, irradiation with the Er:YAG laser has a bactericidal effect with reduction of lipopolysaccharide, high ability of plaque and calculus removal, with the effect limited to a very thin layer of the surface and is effective for implant maintenance. The Er:YAG laser seems to be an effective tool for periodontal therapy, however, further clinical and basic investigations are required to confirm its clinical application. Copyright Blackwell Munksgaard, 2004

Developing performance indicators for clinical governance in dimensions of risk management and clinical effectiveness.

PubMed

Azami-Aghdash, Saber; Tabrizi, Jafar Sadegh; Sadeghi-Bazargani, Homayoun; Hajebrahimi, Sakineh; Naghavi-Behzad, Mohammad

2015-04-01

This study has been designed and conducted to develop domestic indicators for evaluating the performance of clinical governance in dimensions of risk management and clinical effectiveness. This study implemented a 5-stage process including conducting a comprehensive literature review, expert panel (∼ 1000 h per person per session, 11 experts), semi-structured interviews, a 2-round Delphi study (33 experts were in attendance) and a final expert panel (8 experts were in attendance). East Azerbaijan-Iran Province. Fifty-six specialists and experts in different fields of medical sciences. Importance and applicability of indicators. Using a thorough literature review, 361 indicators (129 risk management indicators in 4 dimensions and 232 clinical effectiveness indicators in 18 dimensions) were found. After conducting expert panels and interviews, the number of indicators decreased to 168 cases (65 risk management indicators in 4 dimensions and 103 clinical effectiveness indicators in 12 dimensions). Two rounds of Delphi identified four indicators that were omitted. The members of the final expert panel agreed on 113 indicators (43 risk management indicators in 4 dimensions and 70 clinical effectiveness indicators in 11 dimensions). In this study, indicators for assessing clinical governance in domains of risk management and clinical effectiveness were designed that can be used by policy-makers and other authorities for improving the quality of services and evaluating the performance of clinical governance. Those indicators can be used with slight modifications in other countries having healthcare systems similar to that of Iran. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Improvement in latent variable indirect response modeling of multiple categorical clinical endpoints: application to modeling of guselkumab treatment effects in psoriatic patients.

PubMed

Hu, Chuanpu; Randazzo, Bruce; Sharma, Amarnath; Zhou, Honghui

2017-10-01

Exposure-response modeling plays an important role in optimizing dose and dosing regimens during clinical drug development. The modeling of multiple endpoints is made possible in part by recent progress in latent variable indirect response (IDR) modeling for ordered categorical endpoints. This manuscript aims to investigate the level of improvement achievable by jointly modeling two such endpoints in the latent variable IDR modeling framework through the sharing of model parameters. This is illustrated with an application to the exposure-response of guselkumab, a human IgG1 monoclonal antibody in clinical development that blocks IL-23. A Phase 2b study was conducted in 238 patients with psoriasis for which disease severity was assessed using Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA) scores. A latent variable Type I IDR model was developed to evaluate the therapeutic effect of guselkumab dosing on 75, 90 and 100% improvement of PASI scores from baseline and PGA scores, with placebo effect empirically modeled. The results showed that the joint model is able to describe the observed data better with fewer parameters compared with the common approach of separately modeling the endpoints.

Iterative integral parameter identification of a respiratory mechanics model.

PubMed

Schranz, Christoph; Docherty, Paul D; Chiew, Yeong Shiong; Möller, Knut; Chase, J Geoffrey

2012-07-18

Patient-specific respiratory mechanics models can support the evaluation of optimal lung protective ventilator settings during ventilation therapy. Clinical application requires that the individual's model parameter values must be identified with information available at the bedside. Multiple linear regression or gradient-based parameter identification methods are highly sensitive to noise and initial parameter estimates. Thus, they are difficult to apply at the bedside to support therapeutic decisions. An iterative integral parameter identification method is applied to a second order respiratory mechanics model. The method is compared to the commonly used regression methods and error-mapping approaches using simulated and clinical data. The clinical potential of the method was evaluated on data from 13 Acute Respiratory Distress Syndrome (ARDS) patients. The iterative integral method converged to error minima 350 times faster than the Simplex Search Method using simulation data sets and 50 times faster using clinical data sets. Established regression methods reported erroneous results due to sensitivity to noise. In contrast, the iterative integral method was effective independent of initial parameter estimations, and converged successfully in each case tested. These investigations reveal that the iterative integral method is beneficial with respect to computing time, operator independence and robustness, and thus applicable at the bedside for this clinical application.

Resveratrol and cancer: Challenges for clinical translation

PubMed Central

Singh, Chandra K.; Ndiaye, Mary A.; Ahmad, Nihal

2014-01-01

Significant work has been done towards identifying the health-beneficial effects of the grape antioxidant resveratrol in a variety of bioassay- and disease- models, with much research being focused on its possible application to cancer management. Despite the large number of preclinical studies dealing with different aspects of the biological effects of resveratrol, it’s translation to clinics is far from reality due to a variety of challenges. In this review, we discuss the issues and questions associated with resveratrol becoming an effective in vivo anticancer drug, from basic metabolic issues to the problems faced by incomplete understanding of the mechanism(s) of action in the body. We also explore efforts taken by researchers, both public and private, to contend with some of these issues. By examining the published data and previous clinical trials, we have attempted to identify the problems and issues that hinder the clinical translation of resveratrol for cancer management. PMID:25446990

Application of Gelatin Sponge Impregnated with a Mixture of 3 Drugs to Intraoperative Nerve Root Block Combined with Robot-Assisted Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgery in the Treatment of Adult Degenerative Scoliosis: A Clinical Observation Including 96 Patients.

PubMed

Du, Jin Peng; Fan, Yong; Liu, Ji Jun; Zhang, Jia Nan; Chang Liu, Shi; Hao, Dingjun

2017-12-01

Application of nerve root block is mainly for diagnosis with less application in intraoperative treatment. The aim of this study was to observe clinical and imaging outcomes of application of gelatin sponge impregnated with a mixture of 3 drugs to intraoperative nerve root block combined with robot-assisted minimally invasive transforaminal lumbar interbody fusion surgery in to treat adult degenerative lumbar scoliosis. From January 2012 to November 2014, 108 patients with adult degenerative lumbar scoliosis were treated with robot-assisted minimally invasive transforaminal lumbar interbody fusion surgery combined with intraoperative gelatin sponge impregnated with a mixture of 3 drugs. Visual analog scale and Oswestry Disability Index scores were used to evaluate postoperative improvement of back and leg pain, and clinical effects were assessed according to the 36-Item Short-Form Health Survey. Imaging was obtained preoperatively, 1 week and 3 months postoperatively, and at the last follow-up. Fusion status, complications, and other outcomes were assessed. Follow-up was complete for 96 patients. Visual analog scale scores of leg and back pain on postoperative days 1-7 were decreased compared with preoperatively. At 1 week postoperatively, 3 months postoperatively, and last follow-up, visual analog scale score, Oswestry Disability Index score, coronal Cobb angle, and coronal and sagittal deviated distance decreased significantly (P = 0.000) and lumbar lordosis angle increased (P = 0.000) compared with preoperatively. Improvement rate of Oswestry Disability Index was 81.8% ± 7.4. Fusion rate between vertebral bodies was 92.7%. Application of gelatin sponge impregnated with 3 drugs combined with robot-assisted minimally invasive transforaminal lumbar interbody fusion for treatment of adult degenerative lumbar scoliosis is safe and feasible with advantages of good short-term analgesia effect, minimal invasiveness, short length of stay, and good long-term clinical outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

[Otomycosis and topical application of thimerosal: study of 152 cases].

PubMed

Tisner, J; Millán, J; Rivas, P; Adiego, I; Castellote, A; Valles, H

1995-01-01

To evaluate the effectiveness of the topical application of Timerosal (merthilate tintura) in mycosis involving the external auditory canal. The study includes 152 patients with the clinical, otoscopic and microscopic diagnosis of otomycosis. Results were assessed 72 hours and 10 days after the application. Bacteriological study was performed in 83 patients, finding Aspergilly niger in 54.0% of the cases, Candida albicans in 25.4%, Aspergillus fumigatus in 15.8% and Penicillium in 4.8%. Improvement at 72 h. was found in 66.4% and at 10 days in 93.4% of the patients. Bacteriological contamination was found in 6.6% of the total. In most of the patients, the otomycosis healed after cleaning of the external auditory canal and topical application of timerosal. This method is easy to apply, fast, effective, of low cost and few side effects.

Clinical application prospect of umbilical cord-derived mesenchymal stem cells on clearance of advanced glycation end products through autophagy on diabetic wound.

PubMed

Han, Yanfu; Sun, Tianjun; Tao, Ran; Han, Yanqing; Liu, Jing

2017-03-24

Nowadays, wound healing delay due to diabetes is considered to be closely related to the accumulation of advanced glycation end products (AGEs). Although mesenchymal stem cells (MSCs) exhibit positive effects on diabetic wound healing, related mechanisms are still not fully elucidated. It has been reported that MSCs can improve the activity of autophagy in injured tissues, thereby playing an important role in wound healing. The autophagy induced by MSCs may be beneficial to diabetic wound healing via removing AGEs, which provide new ideas for clinical treatment of diabetic wounds with the potential of broad application prospects. In this study, the current research situation and application prospect of umbilical cord-derived MSCs on the clearance of AGEs in diabetic wound were reviewed.

Clinical application of neurotrophic factors: the potential for primary auditory neuron protection

PubMed Central

Gillespie, Lisa N.; Shepherd, Robert K.

2007-01-01

Sensorineural hearing loss, as a result of damage to or destruction of the sensory epithelia within the cochlea, is a common cause of deafness. The subsequent degeneration of the neural elements within the inner ear may impinge upon the efficacy of the cochlear implant. Experimental studies have demonstrated that neurotrophic factors can prevent this degeneration in animal models of deafness, and can even provide functional benefits. Neurotrophic factor therapy may, therefore, provide similar protective effects in humans, resulting in improved speech perception outcomes among cochlear implant patients. There are, however, numerous issues pertaining to delivery techniques and treatment regimes which need to be addressed prior to any clinical application. This review considers these issues in view of the potential therapeutic application of neurotrophic factors within the auditory system. PMID:16262651

[R-ALERGO. Allergy-healthy routes in Valencia].

PubMed

Temes Cordovez, Rafael R; Moya Fuero, Alfonso; Martí Garrido, Jaume; Perales Chordá, Carolina; Díaz Palacios, Miguel; Hernández Fernández de Rojas, Dolores

2016-01-01

R-ALERGO is a project developed by researchers from the Universitat Politècnica de València and the Hospital Universitario La Fe (Valencia, Spain). The main objective of the project is to create a mobile application identifying, within the city of Valencia, the most favorable routes for allergic individuals. The application is developed using nine environmental variables with a potential effect on the development of clinical manifestations in allergic individuals. The application combines the use of spatial analysis based on network technology and implemented with a geographic information system software. The first 01 version is under evaluation for a Healthy app hallmark. The next step in this project is to design a clinical validation process to test its usefulness in allergic individuals. Copyright © 2015 SESPAS. Published by Elsevier Espana. All rights reserved.

The Application of a Three-Dimensional Printed Product to Fill the Space After Organ Removal.

PubMed

Weng, Jui-Yu; Wang, Che-Chuna; Chen, Pei-Jar; Lim, Sher-Wei; Kuo, Jinn-Rung

2017-11-01

Maintaining body integrity, especially in Asian societies, is an independent predictor of organ donation. Herein, we report the case of an 18-year-old man who suffered a traumatic brain injury with ensuing brain death caused by a car accident. According to the family's wishes, we used a 3-dimensional printer to create simulated heart, kidneys, and liver to fill the spaces after the patient's organs were removed. This is the first case report to introduce this new clinical application of 3-dimensional printed products during transplantation surgery. This new clinical application may have supportive psychological effects on the family and caregivers; however, given the varied responses to our procedure, this ethical issue is worth discussing. Copyright © 2017 Elsevier Inc. All rights reserved.

Review of quantitative ultrasound: envelope statistics and backscatter coefficient imaging and contributions to diagnostic ultrasound

PubMed Central

Oelze, Michael L.; Mamou, Jonathan

2017-01-01

Conventional medical imaging technologies, including ultrasound, have continued to improve over the years. For example, in oncology, medical imaging is characterized by high sensitivity, i.e., the ability to detect anomalous tissue features, but the ability to classify these tissue features from images often lacks specificity. As a result, a large number of biopsies of tissues with suspicious image findings are performed each year with a vast majority of these biopsies resulting in a negative finding. To improve specificity of cancer imaging, quantitative imaging techniques can play an important role. Conventional ultrasound B-mode imaging is mainly qualitative in nature. However, quantitative ultrasound (QUS) imaging can provide specific numbers related to tissue features that can increase the specificity of image findings leading to improvements in diagnostic ultrasound. QUS imaging techniques can encompass a wide variety of techniques including spectral-based parameterization, elastography, shear wave imaging, flow estimation and envelope statistics. Currently, spectral-based parameterization and envelope statistics are not available on most conventional clinical ultrasound machines. However, in recent years QUS techniques involving spectral-based parameterization and envelope statistics have demonstrated success in many applications, providing additional diagnostic capabilities. Spectral-based techniques include the estimation of the backscatter coefficient, estimation of attenuation, and estimation of scatterer properties such as the correlation length associated with an effective scatterer diameter and the effective acoustic concentration of scatterers. Envelope statistics include the estimation of the number density of scatterers and quantification of coherent to incoherent signals produced from the tissue. Challenges for clinical application include correctly accounting for attenuation effects and transmission losses and implementation of QUS on clinical devices. Successful clinical and pre-clinical applications demonstrating the ability of QUS to improve medical diagnostics include characterization of the myocardium during the cardiac cycle, cancer detection, classification of solid tumors and lymph nodes, detection and quantification of fatty liver disease, and monitoring and assessment of therapy. PMID:26761606

Is light-emitting diode phototherapy (LED-LLLT) really effective?

PubMed Central

Kim, Won-Serk; Calderhead, R Glen

2011-01-01

Background: Low level light therapy (LLLT) has attracted attention in many clinical fields with a new generation of light-emitting diodes (LEDs) which can irradiate large targets. To pain control, the first main application of LLLT, have been added LED-LLLT in the accelerated healing of wounds, both traumatic and iatrogenic, inflammatory acne and the patient-driven application of skin rejuvenation. Rationale and Applications: The rationale behind LED-LLLT is underpinned by the reported efficacy of LED-LLLT at a cellular and subcellular level, particularly for the 633 nm and 830 nm wavelengths, and evidence for this is presented. Improved blood flow and neovascularization are associated with 830 nm. A large variety of cytokines, chemokines and macromolecules can be induced by LED phototherapy. Among the clinical applications, non-healing wounds can be healed through restoring the collagenesis/collagenase imbalance in such examples, and ‘normal’ wounds heal faster and better. Pain, including postoperative pain, postoperative edema and many types of inflammation can be significantly reduced. Experimental and clinical evidence: Some personal examples of evidence are offered by the first author, including controlled animal models demonstrating the systemic effect of 830 nm LED-LLLT on wound healing and on induced inflammation. Human patients are presented to illustrate the efficacy of LED phototherapy on treatment-resistant inflammatory disorders. Conclusions: Provided an LED phototherapy system has the correct wavelength for the target cells, delivers an appropriate power density and an adequate energy density, then it will be at least partly, if not significantly, effective. The use of LED-LLLT as an adjunct to conventional surgical or nonsurgical indications is an even more exciting prospect. LED-LLLT is here to stay. PMID:24155530

Web-based multimedia information retrieval for clinical application research

NASA Astrophysics Data System (ADS)

Cao, Xinhua; Hoo, Kent S., Jr.; Zhang, Hong; Ching, Wan; Zhang, Ming; Wong, Stephen T. C.

2001-08-01

We described a web-based data warehousing method for retrieving and analyzing neurological multimedia information. The web-based method supports convenient access, effective search and retrieval of clinical textual and image data, and on-line analysis. To improve the flexibility and efficiency of multimedia information query and analysis, a three-tier, multimedia data warehouse for epilepsy research has been built. The data warehouse integrates clinical multimedia data related to epilepsy from disparate sources and archives them into a well-defined data model.

Magnetic resonance imaging criteria for thrombolysis in hyperacute cerebral infarction.

PubMed

Ahmetgjekaj, Ilir; Kabashi-Muçaj, Serbeze; Lascu, Luana Corina; Kabashi, Antigona; Bondari, A; Bondari, Simona; Dedushi-Hoti, Kreshnike; Biçaku, Ardian; Shatri, Jeton

2014-01-01

Selection of patients with cerebral infarction for MRI that is suitable for thrombolytic therapy as an emerging application. Although the efficiency of the therapy with i.v. tissue plasminogen activator (tPA) within 3 hours after onset of symptoms has been proven in selected patients with CT, now these criteria are determined by MRI, as the data we gather are fast and accurate in the first hours. MRI screening in patients with acute cerebral infarction before application of thrombolytic therapy was done in a UCC Mannheim in Germany. Unlike trials with CT, MRI studies demonstrated the benefits of therapy up to 6 hours after the onset of symptoms. We studied 21 patients hospitalized in Clinic of Neuroradiology at University Clinical Centre in Mannheim-Germany. They all undergo brain MRI evaluation for stroke. This article reviews literature that has followed application of thrombolysis in patients with cerebral infarction based on MRI. We have analyzed the MRI criteria for i.v. application of tPA at this University Centre. Alongside the personal viewpoints of clinicians, survey reveals a variety of clinical aspects and MRI features that are opened for further more exploration: therapeutic effects, the use of the MRI angiography, dynamics, and other. MRI is a tested imaging method for rapid evaluation of patients with hyperacute cerebral infarction, replacing the use of CT imaging and clinical features. MRI criteria for thrombolytic therapy are being applied in some cerebral vascular centres. In Kosovo, the application of thrombolytic therapy has not started yet.

Examining the use of comparative and cost-effectiveness analyses in radiology.

PubMed

Goehler, Alexander; Gazelle, G Scott

2014-11-01

This article explores key principles of comparative effectiveness analysis--in particular, how radiologic comparative and cost-effectiveness studies differ from other clinical trials. Exemplary studies are reviewed to show how comparative effectiveness has been implemented in radiology and how future studies might be conducted. Finally, the article closes with a discussion of several additional key themes relevant to quality and value in clinical radiology going forward. Comparative effectiveness is likely to require a paradigm shift in thinking within the discipline. For new radiologic applications to be accepted, we will need to show at least a significant change in treatment planning and at best a meaningful change in patient outcomes. This shift will require a forward-thinking approach to robust evidence generation for new imaging modalities or indications and the inclusion of other modes of value demonstration such as clinical decision support and intelligent data mining.

The Impact of eHealth on the Quality and Safety of Healthcare

NASA Astrophysics Data System (ADS)

Majeed, Azeem; Black, Ashly; Car, Josip; Anandan, Chantelle; Cresswell, Kathrin; McKinstry, Brian; Pagliari, Claudia; Procter, Rob; Sheikh, Aziz

There is considerable interest in using information technology (IT) to enhance the quality and safety of healthcare. We undertook a systematic literature review to assess the impact of eHealth applications on the quality and safety of healthcare. We retrieved 46,349 potentially relevant publications, from which we selected 67 relevant systematic reviews for inclusion. The literature was found to be poorly collated and of variable quality in its methodology, reporting and utility. We categorised eHealth applications into three main areas: i). storing, managing and transmission of data; ii). supporting clinical decision-making; and iii). facilitating care from a distance. We found that relative to the potential benefits noted within the literature, little empirical evidence exists in support of these applications. Of the few studies revealing the clearest evidence of benefits, many are from academic clinical centres where developers of new applications have also been directly associated with their evaluation. It is therefore unclear how effective these applications would be if deployed outside the environment in which they were developed. Our review of the impact of eHealth applications on quality and safety of healthcare demonstrated a vast gap between the postulated and empirically demonstrated benefits. In addition, there is a lack of robust research on risks and costs. Consequently, the cost-effectiveness of these interventions has yet to be demonstrated.

Correction factors for ionization chamber measurements with the ‘Valencia’ and ‘large field Valencia’ brachytherapy applicators

NASA Astrophysics Data System (ADS)

Gimenez-Alventosa, V.; Gimenez, V.; Ballester, F.; Vijande, J.; Andreo, P.

2018-06-01

Treatment of small skin lesions using HDR brachytherapy applicators is a widely used technique. The shielded applicators currently available in clinical practice are based on a tungsten-alloy cup that collimates the source-emitted radiation into a small region, hence protecting nearby tissues. The goal of this manuscript is to evaluate the correction factors required for dose measurements with a plane-parallel ionization chamber typically used in clinical brachytherapy for the ‘Valencia’ and ‘large field Valencia’ shielded applicators. Monte Carlo simulations have been performed using the PENELOPE-2014 system to determine the absorbed dose deposited in a water phantom and in the chamber active volume with a Type A uncertainty of the order of 0.1%. The average energies of the photon spectra arriving at the surface of the water phantom differ by approximately 10%, being 384 keV for the ‘Valencia’ and 343 keV for the ‘large field Valencia’. The ionization chamber correction factors have been obtained for both applicators using three methods, their values depending on the applicator being considered. Using a depth-independent global chamber perturbation correction factor and no shift of the effective point of measurement yields depth-dose differences of up to 1% for the ‘Valencia’ applicator. Calculations using a depth-dependent global perturbation factor, or a shift of the effective point of measurement combined with a constant partial perturbation factor, result in differences of about 0.1% for both applicators. The results emphasize the relevance of carrying out detailed Monte Carlo studies for each shielded brachytherapy applicator and ionization chamber.

Synergistic activity between Echinophora platyloba DC ethanolic extract and azole drugs against clinical isolates of Candida albicans from women suffering chronic recurrent vaginitis.

PubMed

Avijgan, M; Mahboubi, M; Moheb Nasab, M; Ahmadi Nia, E; Yousefi, H

2014-06-01

Candida albicans is one of the main causes of vaginitis, especially in women with recurrent episodes. The appearance of drug resistant C. albicans and adverse effects of chemical agents have raised interest in Echinophora platyloba as one of four native species in Traditional Persian-Iranian medicine. This study evaluates the antifungal activity of ethanolic extract from dried aerial parts of E. platyloba against 27 clinical isolates of C. albicans from women suffering chronic recurrent vaginitis by micro-broth dilution assay. The synergistic effect of azole drugs and E. platyloba ethanolic extract were also determined by disc diffusion method after determining the MIC90. The results of this study showed a potent synergistic effect of E. platyloba ethanolic extract and itraconazole (P<0.01) and fluconazole (P<0.001) but an antagonistic effect between E. platyloba ethanolic extract and clotrimazole and miconazole against clinical isolates of C. albicans. These results must be confirmed by clinical application and by further clinical studies. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Lasers in Medicine.

ERIC Educational Resources Information Center

Hill, P. D.

1989-01-01

Described are the characteristics of the laser and its effects on the body. Discussed are examples of laser treatments, including angioplasty, ophthalmology, and dermatology. A discussion of lasers of clinical interest and their applications is presented. (YP)

Implementation of a Multiplex and Quantitative Proteomics Platform for Assessing Protein Lysates Using DNA-Barcoded Antibodies.

PubMed

Lee, Jinho; Geiss, Gary K; Demirkan, Gokhan; Vellano, Christopher P; Filanoski, Brian; Lu, Yiling; Ju, Zhenlin; Yu, Shuangxing; Guo, Huifang; Bogatzki, Lisa Y; Carter, Warren; Meredith, Rhonda K; Krishnamurthy, Savitri; Ding, Zhiyong; Beechem, Joseph M; Mills, Gordon B

2018-06-01

Molecular analysis of tumors forms the basis for personalized cancer medicine and increasingly guides patient selection for targeted therapy. Future opportunities for personalized medicine are highlighted by the measurement of protein expression levels via immunohistochemistry, protein arrays, and other approaches; however, sample type, sample quantity, batch effects, and "time to result" are limiting factors for clinical application. Here, we present a development pipeline for a novel multiplexed DNA-labeled antibody platform which digitally quantifies protein expression from lysate samples. We implemented a rigorous validation process for each antibody and show that the platform is amenable to multiple protocols covering nitrocellulose and plate-based methods. Results are highly reproducible across technical and biological replicates, and there are no observed "batch effects" which are common for most multiplex molecular assays. Tests from basal and perturbed cancer cell lines indicate that this platform is comparable to orthogonal proteomic assays such as Reverse-Phase Protein Array, and applicable to measuring the pharmacodynamic effects of clinically-relevant cancer therapeutics. Furthermore, we demonstrate the potential clinical utility of the platform with protein profiling from breast cancer patient samples to identify molecular subtypes. Together, these findings highlight the potential of this platform for enhancing our understanding of cancer biology in a clinical translation setting. © 2018 by The American Society for Biochemistry and Molecular Biology, Inc.

Plasma medicine—current state of research and medical application

NASA Astrophysics Data System (ADS)

Weltmann, K.-D.; von Woedtke, Th

2017-01-01

Plasma medicine means the direct application of cold atmospheric plasma (CAP) on or in the human body for therapeutic purposes. Further, the field interacts strongly with results gained for biological decontamination. Experimental research as well as first practical application is realized using two basic principles of CAP sources: dielectric barrier discharges (DBD) and atmospheric pressure plasma jets (APPJ). Originating from the fundamental insights that the biological effects of CAP are most probably caused by changes of the liquid environment of cells, and are dominated by reactive oxygen and nitrogen species (ROS, RNS), basic mechanisms of biological plasma activity are identified. It was demonstrated that there is no increased risk of cold plasma application and, above all, there are no indications for genotoxic effects. The most important biological effects of cold atmospheric pressure plasma were identified: (1) inactivation of a broad spectrum of microorganisms including multidrug resistant ones; (2) stimulation of cell proliferation and tissue regeneration with lower plasma treatment intensity (treatment time); (3) inactivation of cells by initialization of programmed cell death (apoptosis) with higher plasma treatment intensity (treatment time). In recent years, the main focus of clinical applications was in the field of wound healing and treatment of infective skin diseases. First CAP sources are CE-certified as medical devices now which is the main precondition to start the introduction of plasma medicine into clinical reality. Plasma application in dentistry and, above all, CAP use for cancer treatment are becoming more and more important research fields in plasma medicine. A further in-depth knowledge of control and adaptation of plasma parameters and plasma geometries is needed to obtain suitable and reliable plasma sources for the different therapeutic indications and to open up new fields of medical application.

Contact flexible microstrip applicators (CFMA) in a range from microwaves up to short waves.

PubMed

Gelvich, Edward A; Mazokhin, Vladimir N

2002-09-01

Contact flexible microstrip applicator (CFMA) is a new light-weight microstrip applicator type for superficial and deep local hyperthermia. Typical specimens are developed for operation at frequencies of 434, 70, 40, and 27 MHz. The main common features of CFMA, namely, their flexibility and light weight, as well as their aperture dimensions slightly depend on the operating frequency. Two antenna types are used in CFMAs: inductive antennas with a radiating plane electrical dipole at microwaves, and coplanar capacitive antennas, providing depression of the normal component of the electrical field in the very high-frequency (VHF) and high-frequency (HF) range. The flexibility of the applicators enables one to conform them with curved surfaces. In a bent state of the applicators there arises a focusing effect of energy deposition in deeper located tissues due to linear polarization of the irradiated electromagnetic (EM) field, inherent in CFMA. All CFMA are integrated with silicon water boluses which serve as a matching element, so as a skin cooling agent. Due to this and to the predominance of the tangential electrical component in the radiated EM field, no fat overheating effects are noticed, as a rule. The aperture of the developed applicators overlap the range 160-630 cm2 providing effective heating field sizes (EFSs) 64-400 cm2, respectively. The most bulky CFMAs with an aperture of (21 x 29) cm2 operating at the frequency of 434 MHz weigh 0.8 kg and 2.5 kg at 27 MHz. Phenomenological analysis of the radiating systems, as well as experimental evaluation of the applicators are presented. CFMAs operating at frequencies of 434 and 40 MHz are used in clinical practice. CFMA at 70 and 27 MHz are subjected to laboratory clinical investigations.

[Acupoint catgut-embedding therapy: superiorities and principles of application].

PubMed

Zhang, Xuan-Ping; Jia, Chun-Sheng; Wang, Jian-Ling; Shi, Jing; Zhang, Xin; Li, Xiao-Feng; Xu, Xiao-Kang; Qin, Liang; Zhang, Mei-Ling; Kang, Su-Gang; Duan, Xiao-Dong

2012-10-01

To analyze the superiorities of acupoint catgut-embedding therapy, discuss its law of clinical application and provide scientific decision-making for clinical treatment. Literatures on acupoint catgut-embedding therapy in the recent 40 years were selected, input, examined and verified, picked up and analyzed by establishing database with the modern computer technology. (1) One thousand and seventy-five literatures were input. It shows that the acupoint catgut-embedding therapy has an extensive application in all departments, especially in the internal department, accounting for 48.54% (50/103) of the total disease category. It has the most extensive application on treatment of epigastric pain, with the frequency of 102 times, and obesity of 74 times. The next is surgery, accounting for 14.56% (15/103). The major application is on low back pain and leg pain with the frequency of 79 times. Psoriasis, with the frequency of 30 times, holds the major application in dermatological department. And blepharoplasty, with the frequency of 30 times, gains the most application in department of ophthalmology and otorhinolaryngology. (2) In the included literatures, selection of adjacent acupoints and distal acupoints are held as the major method of acupoint selection. The adjusted lumbar puncture needle is taken as the major tool for the acupoint catgut-embedding therapy. And catguts of different sizes are adopted for the operation. (3) Analysis of the therapeutic effect shows that acupoint catgut-embedding therapy has obvious effect in all departments, especially in surgery and dermatology, with the total effective rate over 90%. Epigastric pain, obesity, epilepsy, asthma, abdominal pain, facial paralysis and constipation of the internal medicine, low back pain and leg pain of the surgical department, psoriasis of the dermatological department and blepharoplasty of the department of ophthalmology and otorhinolaryngology are considered as the dominant diseases for acupoint catgut-embedding therapy.

[The peculiarities of the application of transcranial magnetic therapy and electrical stimulation for the treatment of the patients presenting with various types of stroke].

PubMed

Melnikova, E A

2015-01-01

In this article, the results of the authors' research, including analysis of the clinical and instrumental data concerning 203 patients with, stroke are presented. It is shown that the clinical effectiveness of the transcranial methods incorporated in the combined rehabilitation programs depends on the type of stroke and localization of the lesions. Specifically, the patients presenting with ischemic stroke of hemispheric localization experienced a neurophysiologically confirmed significant clinical improvement that became apparent after the consistent application of transcranial magnetic therapy and micropolarization. In the patients with ischemic stroke of stem localization, the positive influence on psychomotor recovery was achieved with the application of transcranial magnetic therapy, but transcranial micropolarization did not have an appreciable effect on the recovery of such patients. The patients presenting with hemorrhagic stroke did not experience any significant improvement of psychomotor parameters from transcranial magnetic therapy and transcranial micropolarization. The likely mechanism underlying the recovery of psychomotor processes under effect of transcranial magnetic therapy in the patients with ischemic stroke is the normalization of the frequency of interaction between brain structures. In addition, in the patients with ischemic stroke of hemispheric localization and in the patients with hemorrhagic stroke electrical myostimulation has a marked impact on the psychomotor recovery only in case of functional treatment. In the patients suffering from ischemic stroke of stem localization non-functional electromyostimulation significantly improves motor functions and cognitive motor control.

[Prescription rules of preparations containing Crataegi Fructus in Chinese patent drug].

PubMed

Geng, Ya; Ma, Yue-Xiang; Xu, Hai-Yu; Li, Jun-Fang; Tang, Shi-Huan; Yang, Hong-Jun

2016-08-01

To analyze the prescription rules of preparations containing Crataegi Fructus in the drug standards of the People's Republic of China Ministry of Public Health-Chinese Patent Drug(hereinafter referred to as Chinese patent drug), and provide some references for clinical application and the research and development of new medicines. Based on TCMISS(V2.5), the prescriptions containing Crataegi Fructus in Chinese patent drug were collected to build the database; association rules, frequency statistics and other data mining methods were used to analyze the disease syndrome, common drug compatibility and prescription rules. There were a total of 308 prescriptions containing Crataegi Fructus, involving 499 kinds of Chinese medicines, 34 commonly used drug combinations, and mainly for 18 kinds of diseases. Drug combination analysis was done with "Crataegi Fructus-Citri Reticulatae Pericarpium" and "Crataegi Fructus-Poria" as the high-frequency herb pairs and with "stagnation" and "diarrhea" as the high-frequency diseases. The results indicated that the Crataegi Fructus in different herb pairs had a roughly same function, and its therapy effect was different in different diseases. The prescriptions containing Crataegi Fructus in Chinese patent drug had the effect of digestion, and they were widely used in clinical application, often used together with spleen-strengthening medicines to achieve different treatment effects; the prescription rules reflected the prescription characteristics of Crataegi Fructus for different diseases, providing a basis for its clinically scientific application and the research and development of new medicines. Copyright© by the Chinese Pharmaceutical Association.

[Cost-effectiveness of the deep vein thrombosis diagnosis process in primary care].

PubMed

Fuentes Camps, Eva; Luis del Val García, José; Bellmunt Montoya, Sergi; Hmimina Hmimina, Sara; Gómez Jabalera, Efren; Muñoz Pérez, Miguel Ángel

2016-04-01

To analyse the cost effectiveness of the application of diagnostic algorithms in patients with a first episode of suspected deep vein thrombosis (DVT) in Primary Care compared with systematic referral to specialised centres. Observational, cross-sectional, analytical study. Patients from hospital emergency rooms referred from Primary Care to complete clinical evaluation and diagnosis. A total of 138 patients with symptoms of a first episode of DVT were recruited; 22 were excluded (no Primary Care report, symptoms for more than 30 days, anticoagulant treatment, and previous DVT). Of the 116 patients finally included, 61% women and the mean age was 71 years. Variables from the Wells and Oudega clinical probability scales, D-dimer (portable and hospital), Doppler ultrasound, and direct costs generated by the three algorithms analysed: all patients were referred systematically, referral according to Wells and Oudega scale. DVT was confirmed in 18.9%. The two clinical probability scales showed a sensitivity of 100% (95% CI: 85.1 to 100) and a specificity of about 40%. With the application of the scales, one third of all referrals to hospital emergency rooms could have been avoided (P<.001). The diagnostic cost could have been reduced by € 8,620 according to Oudega and € 9,741 according to Wells, per 100 patients visited. The application of diagnostic algorithms when a DVT is suspected could lead to better diagnostic management by physicians, and a more cost effective process. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Mobile application as a prenatal education and engagement tool: A randomized controlled pilot.

PubMed

Ledford, Christy J W; Canzona, Mollie Rose; Cafferty, Lauren A; Hodge, Joshua A

2016-04-01

Research has shown that mobile applications provide a powerful alternative to traditional paper diaries; however, little data exists in comparing apps to the traditional mode of paper as a patient education and engagement tool in the clinical setting. This study was designed to compare the effectiveness of a mobile app versus a spiral-notebook guide throughout prenatal care. This randomized (n=173) controlled pilot was conducted at an East Coast community hospital. Chi-square and repeated-measures analysis of variance was used to test intervention effects in the sample of 127 pregnant mothers who completed their prenatal care in the healthcare system. Patients who were distributed the mobile application used the tool to record information about pregnancy more frequently (p=.04) and developed greater patient activation (p=.02) than patients who were distributed notebooks. No difference was detected on interpersonal clinical communication. A mobile application successfully activated a patient population in which self-management is a critical factor. This study shows that mobile apps can prompt greater use and result in more activated patients. Findings may be translated to other patient populations who receive recurring care for chronic disease. Published by Elsevier Ireland Ltd.

Evaluation of treatment effects in obese children with co-morbid medical or psychiatric conditions

USDA-ARS?s Scientific Manuscript database

The need for effective treatments for pediatric overweight is well known. We evaluated the applicability of an evidence-based treatment in an applied clinic setting that includes children with severe obesity and comorbid medical or psychiatric conditions. Forty-eight overweight children and their fa...

Design and development of a computer-based clinical referral system for use within a physician hospital organization.

PubMed

Sittig, D F; Franklin, M; Turetsky, M; Sussman, A J; Bates, D W; Komaroff, A L; Teich, J M

1998-01-01

The process of creating a clinical referral for a patient and the transfer of information from the primary care physician to the specialist and back again is a key component in the struggle to deliver less costly and more effective clinical care. We have created a computer-based clinical referral application which facilitates 1) identifying an appropriate specialist; 2) collecting the clinical, demographic, and financial data required to generate a referral; and 3) transferring the information between the specialist and the primary care physician. Preliminary results indicate that the new computer-based process is faster.

Treatment of chronic recurrent juvenile parotitis using sialendoscopy.

PubMed

Mikolajczak, Stefanie; Meyer, Moritz Friedo; Beutner, Dirk; Luers, Jan Christoffer

2014-05-01

The combination of sialendoscopy and an intraductal application of corticosteroids can be recommended for children with chronic recurrent juvenile parotitis (CRJP) as there is growing evidence for a positive effect in the absence of side effects. CRJP is a disorder with painful, episodic swelling of the parotid gland in children. The majority of cases have a self-limiting character within 5-10 years, but the disease may also continue into adulthood. CRJP can occur on one or both sides and up to now the etiology has been unclear. The aim of this study was to analyze the therapeutic effect of a sialendoscopic application of corticosteroids on the clinical course of patients with CRJP. We retrospectively analyzed the clinical course of 9 children with 10 parotid glands affected by CRJP, who all underwent sialendoscopy and intraductal application of corticosteroids. In all cases the procedure was conducted under general anesthesia. The average follow-up period was 15 months. There were no side effects associated with the sialendoscopy. All duct systems showed signs of chronic inflammation with an atrophic or thickened epithelium. At the follow-up visit, CRJP symptoms had completely resolved in eight children. One child still showed slight parotid swellings without the need for antibiotics. None of the parents reported that symptoms had continued at an equal level or worsened after sialendoscopy.

Clinical study of a retinoic acid-loaded microneedle patch for seborrheic keratosis or senile lentigo.

PubMed

Hirobe, Sachiko; Otsuka, Risa; Iioka, Hiroshi; Quan, Ying-Shu; Kamiyama, Fumio; Asada, Hideo; Okada, Naoki; Nakagawa, Shinsaku

2017-01-01

Pigmented lesions such as of seborrheic keratosis and senile lentigo, which are commonly seen on skin of people>50years of age, are considered unattractive and disfiguring because of their negative psychological impact. Drug therapy using all-trans retinoic acid (ATRA) is an attractive option for self-treatment at home. We have developed an ATRA-loaded microneedle patch (ATRA-MN) and confirmed the pharmacological effects of ATRA-MN application in mice. Here, we describe a clinical study to evaluate the safety and efficacy of ATRA-MN in subjects with seborrheic keratosis or senile lentigo. ATRA-MN was applied to the lesion site of each subject for 6h once per week for 4weeks. The skin irritation reaction was scored to assess adverse reactions and blood tests were performed to evaluate the presence of systemic adverse reactions. To assess the treatment effect using ATRA-MN, the desquamation and whitening ability of the investigational skin was observed. Desquamation of the stratum corneum was observed following four ATRA-MN applications at 1-week intervals, but ATRA-MN applications did not induce severe local or systemic adverse effects. These results showed that ATRA-MN treatment is promising as a safe and effective therapy for seborrheic keratosis and senile lentigo. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical Computer Applications in Mental Health

PubMed Central

Greist, John H.; Klein, Marjorie H.; Erdman, Harold P.; Jefferson, James W.

1982-01-01

Direct patient-computer interviews were among the earliest applications of computing in medicine. Yet patient interviewing and other clinical applications have lagged behind fiscal/administrative uses. Several reasons for delays in the development and implementation of clinical computing programs and their resolution are discussed. Patient interviewing, clinician consultation and other applications of clinical computing in mental health are reviewed.

Therapeutic applications of curcumin for patients with pancreatic cancer

PubMed Central

Kanai, Masashi

2014-01-01

A number of preclinical studies have demonstrated anticancer effects for curcumin in various types of tumors, including pancreatic cancer. Curcumin has anticancer effects both alone and in combination with other anticancer drugs (e.g., gemcitabine, 5-fluorouracil, and oxaliplatin), and it has been shown to modulate a variety of molecular targets in preclinical models, with more than 30 molecular targets identified to date. Of these various molecules, NF-κB is thought to be one of the primary targets of curcumin activity. Based on these promising preclinical results, several research groups, including our own, have progressed to testing the anticancer effects of curcumin in clinical trials; however, the poor bioavailability of this agent has been the major challenge for its clinical application. Despite the ingestion of gram-level doses of curcumin, plasma curcumin levels remain at low (ng/mL) levels in patients, which is insufficient to yield the anticancer benefits of curcumin. This problem has been solved by the development of highly bioavailable forms of curcumin (THERACURMIN®), and higher plasma curcumin levels can now be achieved without increased toxicity in patients with pancreatic cancer. In this article, we review possible therapeutic applications of curcumin in patients with pancreatic cancer. PMID:25071333

Rater reliability and construct validity of a mobile application for posture analysis

PubMed Central

Szucs, Kimberly A.; Brown, Elena V. Donoso

2018-01-01

[Purpose] Measurement of posture is important for those with a clinical diagnosis as well as researchers aiming to understand the impact of faulty postures on the development of musculoskeletal disorders. A reliable, cost-effective and low tech posture measure may be beneficial for research and clinical applications. The purpose of this study was to determine rater reliability and construct validity of a posture screening mobile application in healthy young adults. [Subjects and Methods] Pictures of subjects were taken in three standing positions. Two raters independently digitized the static standing posture image twice. The app calculated posture variables, including sagittal and coronal plane translations and angulations. Intra- and inter-rater reliability were calculated using the appropriate ICC models for complete agreement. Construct validity was determined through comparison of known groups using repeated measures ANOVA. [Results] Intra-rater reliability ranged from 0.71 to 0.99. Inter-rater reliability was good to excellent for all translations. ICCs were stronger for translations versus angulations. The construct validity analysis found that the app was able to detect the change in the four variables selected. [Conclusion] The posture mobile application has demonstrated strong rater reliability and preliminary evidence of construct validity. This application may have utility in clinical and research settings. PMID:29410561

Rater reliability and construct validity of a mobile application for posture analysis.

PubMed

Szucs, Kimberly A; Brown, Elena V Donoso

2018-01-01

[Purpose] Measurement of posture is important for those with a clinical diagnosis as well as researchers aiming to understand the impact of faulty postures on the development of musculoskeletal disorders. A reliable, cost-effective and low tech posture measure may be beneficial for research and clinical applications. The purpose of this study was to determine rater reliability and construct validity of a posture screening mobile application in healthy young adults. [Subjects and Methods] Pictures of subjects were taken in three standing positions. Two raters independently digitized the static standing posture image twice. The app calculated posture variables, including sagittal and coronal plane translations and angulations. Intra- and inter-rater reliability were calculated using the appropriate ICC models for complete agreement. Construct validity was determined through comparison of known groups using repeated measures ANOVA. [Results] Intra-rater reliability ranged from 0.71 to 0.99. Inter-rater reliability was good to excellent for all translations. ICCs were stronger for translations versus angulations. The construct validity analysis found that the app was able to detect the change in the four variables selected. [Conclusion] The posture mobile application has demonstrated strong rater reliability and preliminary evidence of construct validity. This application may have utility in clinical and research settings.

Environmental pollution and DNA methylation: carcinogenesis, clinical significance, and practical applications.

PubMed

Cao, Yi

2015-09-01

Environmental pollution is one of the main causes of human cancer. Exposures to environmental carcinogens result in genetic and epigenetic alterations which induce cell transformation. Epigenetic changes caused by environmental pollution play important roles in the development and progression of environmental pollution-related cancers. Studies on DNA methylation are among the earliest and most conducted epigenetic research linked to cancer. In this review, the roles of DNA methylation in carcinogenesis and their significance in clinical medicine were summarized, and the effects of environmental pollutants, particularly air pollutants, on DNA methylation were introduced. Furthermore, prospective applications of DNA methylation to environmental pollution detection and cancer prevention were discussed.

Clinical Application of Genome and Exome Sequencing as a Diagnostic Tool for Pediatric Patients: a Scoping Review of the Literature.

PubMed

Smith, Hadley Stevens; Swint, J Michael; Lalani, Seema R; Yamal, Jose-Miguel; de Oliveira Otto, Marcia C; Castellanos, Stephan; Taylor, Amy; Lee, Brendan H; Russell, Heidi V

2018-05-14

Availability of clinical genomic sequencing (CGS) has generated questions about the value of genome and exome sequencing as a diagnostic tool. Analysis of reported CGS application can inform uptake and direct further research. This scoping literature review aims to synthesize evidence on the clinical and economic impact of CGS. PubMed, Embase, and Cochrane were searched for peer-reviewed articles published between 2009 and 2017 on diagnostic CGS for infant and pediatric patients. Articles were classified according to sample size and whether economic evaluation was a primary research objective. Data on patient characteristics, clinical setting, and outcomes were extracted and narratively synthesized. Of 171 included articles, 131 were case reports, 40 were aggregate analyses, and 4 had a primary economic evaluation aim. Diagnostic yield was the only consistently reported outcome. Median diagnostic yield in aggregate analyses was 33.2% but varied by broad clinical categories and test type. Reported CGS use has rapidly increased and spans diverse clinical settings and patient phenotypes. Economic evaluations support the cost-saving potential of diagnostic CGS. Multidisciplinary implementation research, including more robust outcome measurement and economic evaluation, is needed to demonstrate clinical utility and cost-effectiveness of CGS.

Application of Quality Assurance Strategies in Diagnostics and Clinical Support Services in Iranian Hospitals

PubMed Central

Aghaei Hashjin, Asgar; Kringos, Dionne; Ravaghi, Hamid; Manoochehri, Jila; Gorji, Hassan Abolghasem; Klazinga, Niek S.

2015-01-01

Background: Iran has a widespread diagnostics and clinical support services (DCSS) network that plays a crucial role in providing diagnostic and clinical support services to both inpatient and outpatient care. However, very little is known on the application of quality assurance (QA) policies in DCSS units. This study explores the extent of application of eleven QA strategies in DCSS units within Iranian hospitals and its association with hospital characteristics. Methods: A descriptive cross-sectional study was conducted in 2009/2010. Data were collected from 554 DCSS units among 84 hospitals. Results: The average reported application rate for the QA strategies ranged from 57%-94% in the DCSS units. Most frequently reported were checking drugs expiration dates (94%), pharmacopoeia availability (92%), equipment calibration (87%) and identifying responsibilities (86%). Least reported was external auditing of the DCSS (57%). The clinical chemistry and microbiology laboratories (84%), pharmacies, blood bank services (83%) reported highest average application rates across all questioned QA strategies. Lowest application rates were reported in human tissue banks (50%). There was no significant difference between the reported application rates in DCSS in the general/specialized, teaching/research, nonteaching/research hospitals with the exception of pharmacies and radiology departments. They reported availability of a written QA plan significantly more often in research hospitals. Nearly all QA strategies were reported to be applied significantly more often in the DCSS of Social Security Organization (SSO) and private-for-profit hospitals than in governmental hospitals. Conclusion: There is still room for strengthening the managerial cycle of QA systems and accountability in the DCSS in Iranian hospitals. Getting feedback, change and learning through application of specific QA strategies (eg, external/internal audits) can be improved. Both the effectiveness of QA strategies in practice, and the application of these strategies in outpatient DCSS units require further policy attention. PMID:26673175

Application of Quality Assurance Strategies in Diagnostics and Clinical Support Services in Iranian Hospitals.

PubMed

Aghaei Hashjin, Asgar; Kringos, Dionne; Ravaghi, Hamid; Manoochehri, Jila; Gorji, Hassan Abolghasem; Klazinga, Niek S

2015-05-20

Iran has a widespread diagnostics and clinical support services (DCSS) network that plays a crucial role in providing diagnostic and clinical support services to both inpatient and outpatient care. However, very little is known on the application of quality assurance (QA) policies in DCSS units. This study explores the extent of application of eleven QA strategies in DCSS units within Iranian hospitals and its association with hospital characteristics. A descriptive cross-sectional study was conducted in 2009/2010. Data were collected from 554 DCSS units among 84 hospitals. The average reported application rate for the QA strategies ranged from 57%-94% in the DCSS units. Most frequently reported were checking drugs expiration dates (94%), pharmacopoeia availability (92%), equipment calibration (87%) and identifying responsibilities (86%). Least reported was external auditing of the DCSS (57%). The clinical chemistry and microbiology laboratories (84%), pharmacies, blood bank services (83%) reported highest average application rates across all questioned QA strategies. Lowest application rates were reported in human tissue banks (50%). There was no significant difference between the reported application rates in DCSS in the general/specialized, teaching/research, nonteaching/research hospitals with the exception of pharmacies and radiology departments. They reported availability of a written QA plan significantly more often in research hospitals. Nearly all QA strategies were reported to be applied significantly more often in the DCSS of Social Security Organization (SSO) and private-for-profit hospitals than in governmental hospitals. There is still room for strengthening the managerial cycle of QA systems and accountability in the DCSS in Iranian hospitals. Getting feedback, change and learning through application of specific QA strategies (eg, external/internal audits) can be improved. Both the effectiveness of QA strategies in practice, and the application of these strategies in outpatient DCSS units require further policy attention. © 2015 by Kerman University of Medical Sciences.

Translating self-persuasion into an adolescent HPV vaccine promotion intervention for parents attending safety-net clinics.

PubMed

Baldwin, Austin S; Denman, Deanna C; Sala, Margarita; Marks, Emily G; Shay, L Aubree; Fuller, Sobha; Persaud, Donna; Lee, Simon Craddock; Skinner, Celette Sugg; Wiebe, Deborah J; Tiro, Jasmin A

2017-04-01

Self-persuasion is an effective behavior change strategy, but has not been translated for low-income, less educated, uninsured populations attending safety-net clinics or to promote human papillomavirus (HPV) vaccination. We developed a tablet-based application (in English and Spanish) to elicit parental self-persuasion for adolescent HPV vaccination and evaluated its feasibility in a safety-net population. Parents (N=45) of age-eligible adolescents used the self-persuasion application. Then, during cognitive interviews, staff gathered quantitative and qualitative feedback on the self-persuasion tasks including parental decision stage. The self-persuasion tasks were rated as easy to complete and helpful. We identified six question prompts rated as uniformly helpful, not difficult to answer, and generated non-redundant responses from participants. Among the 33 parents with unvaccinated adolescents, 27 (81.8%) reported deciding to get their adolescent vaccinated after completing the self-persuasion tasks. The self-persuasion application was feasible and resulted in a change in parents' decision stage. Future studies can now test the efficacy of the tablet-based application on HPV vaccination. The self-persuasion application facilitates verbalization of reasons for HPV vaccination in low literacy, safety-net settings. This self-administered application has the potential to be more easily incorporated into clinical practice than other patient education approaches. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The clinical use of Skype--For which patients, with which problems and in which settings? A snapshot review of the literature.

PubMed

Armfield, Nigel R; Bradford, Madeleine; Bradford, Natalie K

2015-10-01

Low-cost and no-cost software-based video tools may be a feasible and effective way to provide some telemedicine services, particularly in low-resource settings. One of the most popular tools is Skype; it is freely available, may be installed on many types of devices, and is easy to use by clinicians and patients. While a previous review found no evidence in favor of, or against the clinical use of Skype, anecdotally it is believed to be widely used in healthcare for providing clinical services. However, the range of clinical applications in which Skype has been used has not been described. We aimed to identify and summarize the clinical applications of Skype. We reviewed the literature to identify studies that reported the use of Skype in clinical care or clinical education. We searched three electronic databases using the single search term "Skype". We found 239 unique articles. Twenty seven of the articles met our criteria for further review. The use of Skype was most prevalent in the management of chronic diseases such as cardiovascular diseases and diabetes, followed by educational and speech and language pathology applications. Most reported uses were in developed countries. In all but one case, Skype was reported by the authors to be feasible and to have benefit. However, while Skype may be a pragmatic approach to providing telemedicine services, in the absence of formal studies, the clinical and economic benefits remain unclear. Copyright © 2015. Published by Elsevier Ireland Ltd.

Personal digital assistant use by nurse practitioners: a descriptive study.

PubMed

Stroud, Sally D; Smith, Carol A; Erkel, Elizabeth A

2009-01-01

We sought to describe the prevalence and patterns of use of personal digital assistants (PDAs) among active nurse practitioners (NPs). A descriptive correlational survey was conducted among NPs in the United States (N = 126). Participants were randomly selected from members of the American Academy of Nurse Practitioners who had listed a practice site on their application. Sixty-four percent of participants used PDAs. A drug reference was reported to be the most useful and frequently installed application. A large majority of PDA users believed that PDA use supported clinical decision making (91%), promoted patient safety (89%), and increased productivity (75%). Sixty-two percent predicted that PDA use would change their practice within the next 5 years. As innovative PDA applications with potential to improve patient outcomes become increasingly available, handheld computer skills will be a fundamental practice competency. To prevent errors in clinical decision making with quick access to PDA reference materials, NPs must critically evaluate the legitimacy and worth of PDA software programs. There is a critical need to evaluate the effectiveness of PDA use in clinical settings and develop an evidence base to guide use of the PDA in solving clinical problems.

Frontiers of monoclonal antibodies: Applications in medical practices.

PubMed

Ghagane, Shridhar C; Puranik, Sridevi I; Gan, Siew Hua; Hiremath, Murigendra B; Nerli, R B; Ravishankar, M V

2017-01-01

With the flourishing of innovation in drug discovery into a new era of personalized therapy, the use of monoclonal antibodies (mAbs) in the treatment of various ailments lies at the forefront. Major improvements in genetic sequencing and biomedical techniques as well as research into mAbs emphasize on determining new targets for advanced therapy while maximizing efficacy for clinical application. However, a balance has to be achieved concerning developing a target with low toxicity combined with high specificity and versatility, to allow a specific antibody to facilitate several biotic effects, ranging from neutralization of virus mechanisms to modulation of immune response and maintaining low global economic cost. Presently, there are approximately 30 mAbs' permitted for therapeutic use with many more being tested in clinical trials. Nevertheless, the heavy cost of mAbs' production, stowage and management as well as the subsequent hindrances to their development are outweighed by mAbs' clinical advantages. Compared to conventional drugs, since mAbs use as pharmacologic iotas have specific physical features and modes of action, they should be considered as a discrete therapeutic category. In this review, the history of mAb generation and the innovative technological applications of mAbs that has advanced in clinical practices is reviewed.

Federating heterogeneous datasets to enhance data sharing and experiment reproducibility

NASA Astrophysics Data System (ADS)

Prieto, Juan C.; Paniagua, Beatriz; Yatabe, Marilia S.; Ruellas, Antonio C. O.; Fattori, Liana; Muniz, Luciana; Styner, Martin; Cevidanes, Lucia

2017-03-01

Recent studies have demonstrated the difficulties to replicate scientific findings and/or experiments published in past.1 The effects seen in the replicated experiments were smaller than previously reported. Some of the explanations for these findings include the complexity of the experimental design and the pressure on researches to report positive findings. The International Committee of Medical Journal Editors (ICMJE) suggests that every study considered for publication must submit a plan to share the de-identified patient data no later than 6 months after publication. There is a growing demand to enhance the management of clinical data, facilitate data sharing across institutions and also to keep track of the data from previous experiments. The ultimate goal is to assure the reproducibility of experiments in the future. This paper describes Shiny-tooth, a web based application created to improve clinical data acquisition during the clinical trial; data federation of such data as well as morphological data derived from medical images; Currently, this application is being used to store clinical data from an osteoarthritis (OA) study. This work is submitted to the SPIE Biomedical Applications in Molecular, Structural, and Functional Imaging conference.

Reversal of rocuronium-induced neuromuscular blockade by sugammadex allows for optimization of neural monitoring of the recurrent laryngeal nerve.

PubMed

Lu, I-Cheng; Wu, Che-Wei; Chang, Pi-Ying; Chen, Hsiu-Ya; Tseng, Kuang-Yi; Randolph, Gregory W; Cheng, Kuang-I; Chiang, Feng-Yu

2016-04-01

The use of neuromuscular blocking agent may effect intraoperative neuromonitoring (IONM) during thyroid surgery. An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a porcine model and subsequently clinically applied during human thyroid neural monitoring surgery. Prospective animal and retrospective clinical study. In the animal experiment, 12 piglets were injected with rocuronium 0.6 mg/kg and randomly allocated to receive normal saline, sugammadex 2 mg/kg, or sugammadex 4 mg/kg to compare the recovery of laryngeal electromyography (EMG). In a subsequent clinical application study, 50 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol-rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at the operation start. The train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission. In our porcine model, it took 49 ± 15, 13.2 ± 5.6, and 4.2 ± 1.5 minutes for the 80% recovery of laryngeal EMG after injection of saline, sugammadex 2 mg/kg, and sugammadex 4 mg/kg, respectively. In subsequent clinical human application, the TOF ratio recovered from 0 to >0.9 within 5 minutes after administration of sugammadex 2 mg/kg at the operation start. All patients had positive and high EMG amplitude at the early stage of the operation, and intubation was without difficulty in 96% of patients. Both porcine modeling and clinical human application demonstrated that sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium. Implementation of this enhanced NMB recovery protocol assures optimal conditions for tracheal intubation as well as IONM in thyroid surgery. NA. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Hydrogen Gas Inhalation Treatment in Acute Cerebral Infarction: A Randomized Controlled Clinical Study on Safety and Neuroprotection.

PubMed

Ono, Hirohisa; Nishijima, Yoji; Ohta, Shigeo; Sakamoto, Masaki; Kinone, Kazunori; Horikosi, Tohru; Tamaki, Mituyuki; Takeshita, Hirosi; Futatuki, Tomoko; Ohishi, Wataru; Ishiguro, Taichi; Okamoto, Saori; Ishii, Shou; Takanami, Hiroko

2017-11-01

Molecular hydrogen (H 2 ) acts as a therapeutic antioxidant. Inhalation of H 2 gas (1-4%) was effective for the improvement of cerebral infarction in multiple animal experiments. Thus, for actual applications, a randomized controlled clinical study is desired to evaluate the effects of inhalation of H 2 gas. Here, we evaluate the H 2 treatment on acute cerebral infarction. Through this randomized controlled clinical study, we assessed the safety and effectiveness of H 2 treatment in patients with cerebral infarction in an acute stage with mild- to moderate-severity National Institute of Health Stroke Scale (NIHSS) scores (NIHSS = 2-6). We enrolled 50 patients (25 each in the H 2 group and the control group) with a therapeutic time window of 6 to 24 hours. The H 2 group inhaled 3% H 2 gas (1 hour twice a day), and the control group received conventional intravenous medications for the initial 7 days. The evaluations included daily vital signs, NIHSS scores, physical therapy indices, weekly blood chemistry, and brain magnetic resonance imaging (MRI) scans over the 2-week study period. The H 2 group showed no significant adverse effects with improvements in oxygen saturation. The following significant effects were found: the relative signal intensity of MRI, which indicated the severity of the infarction site, NIHSS scores for clinically quantifying stroke severity, and physical therapy evaluation, as judged by the Barthel Index. H 2 treatment was safe and effective in patients with acute cerebral infarction. These results suggested a potential for widespread and general application of H 2 gas. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Modelling and performance analysis of clinical pathways using the stochastic process algebra PEPA.

PubMed

Yang, Xian; Han, Rui; Guo, Yike; Bradley, Jeremy; Cox, Benita; Dickinson, Robert; Kitney, Richard

2012-01-01

Hospitals nowadays have to serve numerous patients with limited medical staff and equipment while maintaining healthcare quality. Clinical pathway informatics is regarded as an efficient way to solve a series of hospital challenges. To date, conventional research lacks a mathematical model to describe clinical pathways. Existing vague descriptions cannot fully capture the complexities accurately in clinical pathways and hinders the effective management and further optimization of clinical pathways. Given this motivation, this paper presents a clinical pathway management platform, the Imperial Clinical Pathway Analyzer (ICPA). By extending the stochastic model performance evaluation process algebra (PEPA), ICPA introduces a clinical-pathway-specific model: clinical pathway PEPA (CPP). ICPA can simulate stochastic behaviours of a clinical pathway by extracting information from public clinical databases and other related documents using CPP. Thus, the performance of this clinical pathway, including its throughput, resource utilisation and passage time can be quantitatively analysed. A typical clinical pathway on stroke extracted from a UK hospital is used to illustrate the effectiveness of ICPA. Three application scenarios are tested using ICPA: 1) redundant resources are identified and removed, thus the number of patients being served is maintained with less cost; 2) the patient passage time is estimated, providing the likelihood that patients can leave hospital within a specific period; 3) the maximum number of input patients are found, helping hospitals to decide whether they can serve more patients with the existing resource allocation. ICPA is an effective platform for clinical pathway management: 1) ICPA can describe a variety of components (state, activity, resource and constraints) in a clinical pathway, thus facilitating the proper understanding of complexities involved in it; 2) ICPA supports the performance analysis of clinical pathway, thereby assisting hospitals to effectively manage time and resources in clinical pathway.

[Research on the Clinical Alarm Management Mechanism Based on Closed-loop Control Theory].

PubMed

Lin, Zhongkuan; Zheng, Kun; Shen, Yunming; Wu, Yunyun

2018-05-30

This paper proposes a clinical alarm management system based on the theory of the closed loop control. The alarm management mechanism can be divided into the expected standard, improving execution rule, rule execution, medical devices with alarm functions, results analysis strategy and the output link. And, we make relevant application and discussion. Results showed that the mechanism can be operable and effective.

The Computer-Based Writing Program: A Clinical Teaching Experience for Education Interns to Develop Professional Knowledge and Skills in Effective Instructional Writing Practices

ERIC Educational Resources Information Center

Painter, Diane D.

2016-01-01

The four-week university-sponsored summer Computer-based Writing (CBW) Program directed by the head of a special education initial teacher licensure program gave teaching interns opportunities to work with young struggling writers in a supervised clinical setting to address keyboarding skills, writing conventions and knowledge and application of…

Microwave-induced thermoacoustic computed tomography with a clinical contrast agent of NMG2[Gd(DTPA)

NASA Astrophysics Data System (ADS)

Qin, Huan; Yang, Sihua; Xing, Da

2012-01-01

NMG2[Gd(DTPA)], a clinical contrast agent, was investigated for microwave-induced thermoacoustic computed tomography (CT). Due to ionic conduction and magnetic dipole rotation in the presence of microwave field, microwave energy absorbed by NMG2[Gd(DTPA)] would be transformed to thermoacoustic signals based on the thermoelastic effect. The experimental results demonstrated that NMG2[Gd(DTPA)] at a concentration of 10 mM provided effective enhancement compared with water. The enhancement of NMG2[Gd(DTPA)] for thermoacoustic CT was further demonstrated in invivo tumor-bearing mouse. The theory and experimental results indicate that the clinically available NMG2[Gd(DTPA)] will promote the medical applications of thermoacoustic CT.

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Hyperbaric oxygen therapy and preconditioning for ischemic and hemorrhagic stroke.

PubMed

Hu, Sheng-Li; Feng, Hua; Xi, Guo-Hua

2016-01-01

To date, the therapeutic methods for ischemic and hemorrhagic stroke are still limited. The lack of oxygen supply is critical for brain injury following stroke. Hyperbaric oxygen (HBO), an approach through a process in which patients breathe in 100% pure oxygen at over 101 kPa, has been shown to facilitate oxygen delivery and increase oxygen supply. Hence, HBO possesses the potentials to produce beneficial effects on stroke. Actually, accumulated basic and clinical evidences have demonstrated that HBO therapy and preconditioning could induce neuroprotective functions via different mechanisms. Nevertheless, the lack of clinical translational study limits the application of HBO. More translational studies and clinical trials are needed in the future to develop effective HBO protocols.

Big data analytics to improve cardiovascular care: promise and challenges.

PubMed

Rumsfeld, John S; Joynt, Karen E; Maddox, Thomas M

2016-06-01

The potential for big data analytics to improve cardiovascular quality of care and patient outcomes is tremendous. However, the application of big data in health care is at a nascent stage, and the evidence to date demonstrating that big data analytics will improve care and outcomes is scant. This Review provides an overview of the data sources and methods that comprise big data analytics, and describes eight areas of application of big data analytics to improve cardiovascular care, including predictive modelling for risk and resource use, population management, drug and medical device safety surveillance, disease and treatment heterogeneity, precision medicine and clinical decision support, quality of care and performance measurement, and public health and research applications. We also delineate the important challenges for big data applications in cardiovascular care, including the need for evidence of effectiveness and safety, the methodological issues such as data quality and validation, and the critical importance of clinical integration and proof of clinical utility. If big data analytics are shown to improve quality of care and patient outcomes, and can be successfully implemented in cardiovascular practice, big data will fulfil its potential as an important component of a learning health-care system.

The nightmare of FDA clearance/approval to market: perception or reality?

PubMed

Tylenda, C A

1996-09-01

Over the last few years the Center for Device Evaluation and Research (CDRH) at the Food and Drug Administration (FDA) has received annually over 16 thousand submissions related to medical devices. Over 10,000 of these are major submissions which include applications to conduct clinical trials and applications to market medical devices for a specified indication for use. Each application is carefully considered. FDA personnel work closely with applicants to ensure that clinical trial design minimizes risk to the patients and maximizes benefit with respect to addressing the safety and effectiveness of the device being tested. Applicants are given every opportunity to provide additional information when necessary to assure that applications to market medical devices are complete. Applicants have the opportunity to meet with FDA staff prior to submitting applications in cases where the application is other than a straight forward, uncomplicated submission. In addition, FDA assists applicants through the development of guidance documents, which discuss the type of information that would be beneficial to include in a submission. The Division of Small Manufacturers Assistance at FDA is dedicated to helping interested persons understand the clearance/approval process. This paper will discuss the role of FDA in the regulation of medical devices, with an emphasis on the pathway to obtaining permission to market medical devices in the United States.

International models of investigator-initiated trials: implications for Japan

PubMed Central

Trimble, E. L.; Ledermann, J.; Law, K.; Miyata, T.; Imamura, C. K.; Nam, B.-H.; Kim, Y.H.; Bang, Y.-J.; Michaels, M.; Ardron, D.; Amano, S.; Ando, Y.; Tominaga, T.; Kurokawa, K.; Takebe, N.

2012-01-01

Background Academic/institutional investigator-initiated clinical trials benefit individuals and society by supplementing gaps in industry-sponsored clinical trials. Materials In May 2010, experts from Japan, the Republic of Korea, the UK, and the United States, met at a symposium in Tokyo, Japan, to discuss how policies related to the conduct of clinical trials, which have been shown to be effective, may be applied to other regions of the world. Results In order to increase the availability of anticancer drugs world-wide, nations including Japan should examine the benefits of increasing the number of investigator-initiated clinical trials. These trials represent one of the most effective ways to translate basic scientific knowledge into clinical practice. These trials should be conducted under GCP guidelines and include Investigational New Drug application submissions with the ultimate goal of future drug approval. Conclusions To maximize the effectiveness of these trials, a policy to educate health care professionals, cancer patients and their families, and the public in general on the benefits of clinical trials should be strengthened. Finally, policies that expedite the clinical development of novel cancer drugs which have already been shown to be effective in other countries are needed in many nations including Japan to accelerate drug approval. PMID:22843420

Estimates of cost-effectiveness of prehospital continuous positive airway pressure in the management of acute pulmonary edema.

PubMed

Hubble, Michael W; Richards, Michael E; Wilfong, Denise A

2008-01-01

To estimate the cost-effectiveness of continuous positive airway pressure (CPAP) in managing prehospital acute pulmonary edema in an urban EMS system. Using estimates from published reports on prehospital and emergency department CPAP, a cost-effectiveness model of implementing CPAP in a typical urban EMS system was derived from the societal perspective as well as the perspective of the implementing EMS system. To assess the robustness of the model, a series of univariate and multivariate sensitivity analyses was performed on the input variables. The cost of consumables, equipment, and training yielded a total cost of $89 per CPAP application. The theoretical system would be expected to use CPAP 4 times per 1000 EMS patients and is expected to save 0.75 additional lives per 1000 EMS patients at a cost of $490 per life saved. CPAP is also expected to result in approximately one less intubation per 6 CPAP applications and reduce hospitalization costs by $4075 per year for each CPAP application. Through sensitivity analyses the model was verified to be robust across a wide range of input variable assumptions. Previous studies have demonstrated the clinical effectiveness of CPAP in the management of acute pulmonary edema. Through a theoretical analysis which modeled the costs and clinical benefits of implementing CPAP in an urban EMS system, prehospital CPAP appears to be a cost-effective treatment.

Design and Development of a Sharable Clinical Decision Support System Based on a Semantic Web Service Framework.

PubMed

Zhang, Yi-Fan; Gou, Ling; Tian, Yu; Li, Tian-Chang; Zhang, Mao; Li, Jing-Song

2016-05-01

Clinical decision support (CDS) systems provide clinicians and other health care stakeholders with patient-specific assessments or recommendations to aid in the clinical decision-making process. Despite their demonstrated potential for improving health care quality, the widespread availability of CDS systems has been limited mainly by the difficulty and cost of sharing CDS knowledge among heterogeneous healthcare information systems. The purpose of this study was to design and develop a sharable clinical decision support (S-CDS) system that meets this challenge. The fundamental knowledge base consists of independent and reusable knowledge modules (KMs) to meet core CDS needs, wherein each KM is semantically well defined based on the standard information model, terminologies, and representation formalisms. A semantic web service framework was developed to identify, access, and leverage these KMs across diverse CDS applications and care settings. The S-CDS system has been validated in two distinct client CDS applications. Model-level evaluation results confirmed coherent knowledge representation. Application-level evaluation results reached an overall accuracy of 98.66 % and a completeness of 96.98 %. The evaluation results demonstrated the technical feasibility and application prospect of our approach. Compared with other CDS engineering efforts, our approach facilitates system development and implementation and improves system maintainability, scalability and efficiency, which contribute to the widespread adoption of effective CDS within the healthcare domain.

Mkit: A Cell Migration Assay Based on Microfluidic Device and Smartphone

PubMed Central

Yang, Ke; Wu, Jiandong; Peretz-Soroka, Hagit; Zhu, Ling; Li, Zhigang; Sang, Yaoshuo; Hipolito, Jolly; Zhang, Michael; Santos, Susy; Hillier, Craig; de Faria, Ricardo Lobato; Liu, Yong; Lin, Francis

2017-01-01

Mobile sensing based on the integration of microfluidic device and smartphone, so-called MS2 technology, has enabled many applications over recent years, and continues to stimulate growing interest in both research communities and industries. In particular, it has been envisioned that MS2 technology can be developed for various cell functional assays to enable basic research and clinical applications. Toward this direction, in this paper, we describe the development of a MS2-based cell functional assay for testing cell migration (the Mkit). The system is constructed as an integrated test kit, which includes microfluidic chips, a smartphone-based imaging platform, the phone apps for image capturing and data analysis, and a set of reagent and accessories for performing the cell migration assay. We demonstrated that the Mkit can effectively measure purified neutrophil and cancer cell chemotaxis. Furthermore, neutrophil chemotaxis can be tested from a drop of whole blood using the Mkit with red blood cell (RBC) lysis. The effects of chemoattractant dose and gradient profile on neutrophil chemotaxis were also tested using the Mkit. In addition to research applications, we demonstrated the effective use of the Mkit for on-site test at the hospital and for testing clinical samples from chronic obstructive pulmonary disease patient. Thus, this developed Mkit provides an easy and integrated experimental platform for cell migration related research and potential medical diagnostic applications. PMID:28772229

Combined application of alginate dressing and human granulocyte-macrophage colony stimulating factor promotes healing in refractory chronic skin ulcers.

PubMed

Huang, Guobao; Sun, Tangqing; Zhang, Lei; Wu, Qiuhe; Zhang, Keyan; Tian, Qingfen; Huo, Ran

2014-06-01

The aim of the present study was to evaluate the clinical therapeutic effect of the combined application of alginate and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) on the healing of refractory chronic skin ulcers. A single center, three arm, randomized study was performed at Jinan Central Hospital (Jinan, Shandong, China). A total of 60 patients with refractory chronic skin ulcers, which persisted for >1 month, were enrolled and randomly assigned into one of the following three groups: alginate dressing/rhGM-CSF group (group A), rhGM-CSF only group (group B) and conventional (vaseline dressing) group (group C). The wound area rate was measured, granulation and color were observed and pain was evaluated. The data were summarized and statistical analysis was performed. The results demonstrated that group A exhibited a significantly faster wound healing rate and lower pain score compared with the other groups (P<0.01). In conclusion, the combined application of alginate dressing and rhGM-CSF for the treatment of refractory chronic skin ulcers demonstrated significant advantages. It promoted the growth of granulation tissue, accelerated re-epithelialization and also effectively reduced wound pain, and thus improved the quality of life for the patient. This suggests that the combined application of alginate and rhGM-CSF may be an effective therapeutic strategy for the clinical treatment of refractory chronic skin ulcers.

Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference.

PubMed

Kilmer, Suzanne L

2017-01-01

Cryolipolysis is a safe, effective non-surgical procedure to reduce fat. For most cryolipolysis treatments, tissue is pulled between parallel cooling plates with a treatment duration of 60 minutes. A novel contoured cup, medium-sized applicator was developed to increase tissue contact with reduced skin tension and reduced treatment time. This prototype contoured cup was investigated with a standard cryolipolysis applicator to evaluate safety, efficacy, and patient preference. A prototype CoolCup medium-sized vacuum applicator (CoolSculpting System, ZELTIQ Aesthetics) was used to treat n = 19 subjects in the flanks. Randomly assigned, one flank received standard treatment with the CoolCore applicator (-10°C for 60 minutes). The contralateral flank received treatment from the CoolCup (-11°C for 35 minutes). The clinical study primary efficacy endpoint was 70% correct identification of baseline photographs by independent physician review. Incidence of adverse device effects was monitored. Fat layer reduction was measured by ultrasound and subject surveys were administered 12 weeks post-treatment. Equivalent efficacy was demonstrated between the CoolCore standard treatment and the prototype CoolCup. Independent review from three blinded physicians found 81% correct identification of baseline photographs for the standard treatment and 79% for the CoolCup. Ultrasound measurements indicated mean fat layer reduction of 4.38 mm for the standard treatment and 4.40 mm for the CoolCup; no statistically significant difference was found when comparing treatment efficacy of the two applicators (P = 0.96). Patient questionnaires revealed 85% preferred CoolCup because of shorter treatment duration and greater comfort. Procedural assessments revealed 45% lower pain scores for CoolCup. Immediate post-treatment clinical assessments revealed 82% less bruising. Typical side effects, such as numbness and erythema, were similar. There were no adverse events. This clinical study of a prototype medium-sized vacuum applicator with a cooled contoured surface indicates that the CoolCup produces equivalent safety and efficacy to the standard CoolCore cryolipolysis applicator. With a 42% reduction in treatment time, the procedure was found to be more comfortable because of lower vacuum skin tension and shorter treatment duration. Lasers Surg. Med. 49:63-68, 2017. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Features of ciguatera fish poisoning cases in Hong Kong 2004-2007.

PubMed

Wong, Chun-Kwan; Hung, Patricia; Lee, Kellie L H; Mok, Tina; Chung, Thomas; Kam, Kai-Man

2008-12-01

To review the clinical features and laboratory investigations of ciguatera patients in Hong Kong between 2004 and 2007 in order to show the timely sampling of implicated fish from ciguatera victims and application of validated mouse bioassay for confirming suspected clinical cases of ciguatera. Diagnosis of the ciguatera victims was based on history of coral fish consumption and clinical presentations stated in official guidelines for clinical diagnosis of ciguatera fish poisoning in Hong Kong. Food remnants of coral fish samples were collected swiftly from ciguatera victims between 2004 and 2007 for ciguatoxins (CTXs) analysis. Major clinical symptoms in ciguatera patients included gastrointestinal and neurological effects including limb numbness and diarrhoea, which developed at 0.5 to 15 hours after consumption of fish. In most cases, neurological symptoms were more common than gastrointestinal symptoms. A broad range of attack rate (10%-100%) was observed in each ciguatera outbreak. Validated mouse bioassay on ether extracts of the food remnant samples confirmed that all were CTXs-positive (<0.5 - 4.3 MU/20 mg ether extract) and directly linked to the corresponding ciguatera cases. Consistency between clinical and laboratory analysis for ciguatera poisoning illustrates the application of laboratory mouse bioassay in a timely fashion for confirming ciguatera poisoning cases and implementing effective public health measures. With further improvement in laboratory techniques, features of ciguatera fish poisoning cases can be better defined. Further studies are needed to determine the risk of each class of CTXs (Pacific-, Indian- and Caribbean-CTXs) in Hong Kong.

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research☆

PubMed Central

Rossi, Simone; Hallett, Mark; Rossini, Paolo M.; Pascual-Leone, Alvaro

2011-01-01

This article is based on a consensus conference, which took place in Certosa di Pontignano, Siena (Italy) on March 7–9, 2008, intended to update the previous safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical settings. Over the past decade the scientific and medical community has had the opportunity to evaluate the safety record of research studies and clinical applications of TMS and repetitive TMS (rTMS). In these years the number of applications of conventional TMS has grown impressively, new paradigms of stimulation have been developed (e.g., patterned repetitive TMS) and technical advances have led to new device designs and to the real-time integration of TMS with electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Thousands of healthy subjects and patients with various neurological and psychiatric diseases have undergone TMS allowing a better assessment of relative risks. The occurrence of seizures (i.e., the most serious TMS-related acute adverse effect) has been extremely rare, with most of the few new cases receiving rTMS exceeding previous guidelines, often in patients under treatment with drugs which potentially lower the seizure threshold. The present updated guidelines review issues of risk and safety of conventional TMS protocols, address the undesired effects and risks of emerging TMS interventions, the applications of TMS in patients with implanted electrodes in the central nervous system, and safety aspects of TMS in neuroimaging environments. We cover recommended limits of stimulation parameters and other important precautions, monitoring of subjects, expertise of the rTMS team, and ethical issues. While all the recommendations here are expert based, they utilize published data to the extent possible. PMID:19833552

Research and application of absorbable screw in orthopedics: a clinical review comparing PDLLA screw with metal screw in patients with simple medial malleolus fracture.

PubMed

Tang, Jin; Hu, Jin-feng; Guo, Wei-chun; Yu, Ling; Zhao, Sheng-hao

2013-01-01

To observe the therapeutic effect of absorbable screw in medial malleolus fracture and discuss its clinical application in orthopedics. A total of 129 patients with simple medial malleolus fracture were studied. Among them, 64 patients were treated with poly-D, L-lactic acid (PDLLA) absorbable screws, while the others were treated with metal screws. All the patients were followed up for 12-20 months (averaged 18.4 months) and the therapeutic effect was evaluated according to the American Orthopaedic Foot and Ankle Society clinical rating systems. In absorbable screw group, we obtained excellent and good results in 62 cases (96.88%); in steel screw group, 61 cases (93.85%) achieved excellent and good results. There was no significant difference between the two groups. In the treatment of malleolus fracture, absorbable screw can achieve the same result compared with metal screw fixation. Absorbable screw is preferred due to its advantages of safety, cleanliness and avoiding the removal procedure associated with metallic implants.

Honey in wound care: effects, clinical application and patient benefit.

PubMed

Lay-flurrie, Karen

The use of honey in wound management has enjoyed a resurgence. This is largely due to the growing clinical problem of antibiotic-resistant bacteria and the combined difficulties for the practitioner in managing chronic wound types, such as burns, leg ulcers or surgical wounds, that may become infected, for example, with methicillin-resistant Staphylococcus aureus or Pseudomonas. The associated costs of treating such wounds are escalating as a result. While the use of honey as a wound dressing has been recognized, at least since Egyptian times circa 2000 BC, it is only more recently, due to the development and licensing of modern honey wound dressings, that such dressings have become more widely available and used in wound management. This article focuses on the use of honey in the treatment of infected wounds and burns. It will examine the effects of honey at the wound bed and its clinical applications, along with the current dressings available. Also discussed are the practical considerations, if, like any wound dressing, honey is to be used safely, appropriately and for the benefit of the patient.

Shedding light: laser physics and mechanism of action.

PubMed

De Felice, E

2010-02-01

Lasers have affected health care in many ways. Clinical applications have been found in a number of medical and surgical specialities. In particular, applications of laser technology in phlebology has made it essential for vein physicians to obtain a fundamental knowledge of laser physics, laser operation and also to be well versed in laser safety procedures. This article reviews recommended text books and current literature to detail the basics of laser physics and its application to venous disease. Laser safety and laser side effects are also discussed.

A combined approach of enamel matrix derivative gel and autogenous bone grafts in treatment of intrabony periodontal defects. A case report.

PubMed

Leung, George; Jin, Lijian

2003-04-01

Enamel matrix derivative (EMD) has recently been introduced as a new modality in regenerative periodontal therapy. This case report demonstrates a combined approach in topical application of EMD gel (Emdogain) and autogenous bone grafts for treatment of intrabony defects and furcation involvement defects in a patient with chronic periodontitis. The seven-month post-surgery clinical and radiographic results were presented. The combined application of EMD gel with autogenous bone grafts in intrabony osseous defects resulted in clinically significant gain of attachment on diseased root surfaces and bone fill on radiographs. Further controlled clinical studies are required to confirm the long-term effectiveness of the combination of EMD gel and autogenous bone grafts in treatment of various osseous defects in subjects with chronic periodontitis.

Clinical Application of High-intensity Focused Ultrasound in Cancer Therapy

PubMed Central

Hsiao, Yi-Hsuan; Kuo, Shou-Jen; Tsai, Horng-Der; Chou, Ming-Chih; Yeh, Guang-Perng

2016-01-01

The treatment of cancer is an important issue in both developing and developed countries. Clinical use of ultrasound in cancer is not only for the diagnosis but also for the treatment. Focused ultrasound surgery (FUS) is a noninvasive technique. By using the combination of high-intensity focused ultrasound (HIFU) and imaging method, FUS has the potential to ablate tumor lesions precisely. The main mechanisms of HIFU ablation involve mechanical and thermal effects. Recent advances in HIFU have increased its popularity. Some promising results were achieved in managing various malignancies, including pancreas, prostate, liver, kidney, breast and bone. Other applications include brain tumor ablation and disruption of the blood-brain barrier. We aim at briefly outlining the clinical utility of FUS as a noninvasive technique for a variety of types of cancer treatment. PMID:26918034

Mediation analysis in nursing research: a methodological review.

PubMed

Liu, Jianghong; Ulrich, Connie

2016-12-01

Mediation statistical models help clarify the relationship between independent predictor variables and dependent outcomes of interest by assessing the impact of third variables. This type of statistical analysis is applicable for many clinical nursing research questions, yet its use within nursing remains low. Indeed, mediational analyses may help nurse researchers develop more effective and accurate prevention and treatment programs as well as help bridge the gap between scientific knowledge and clinical practice. In addition, this statistical approach allows nurse researchers to ask - and answer - more meaningful and nuanced questions that extend beyond merely determining whether an outcome occurs. Therefore, the goal of this paper is to provide a brief tutorial on the use of mediational analyses in clinical nursing research by briefly introducing the technique and, through selected empirical examples from the nursing literature, demonstrating its applicability in advancing nursing science.

Review of U.S. registries for psoriasis.

PubMed

Amin, Mina; No, Daniel J; Wu, Jashin J

2017-12-01

Patient registries are databases comprised of standardized clinical data for a specific population of patients with a particular disease or medical condition. Information from patient registries allows clinicians to assess long-lasting outcomes in patients with a specific disease, such as psoriasis. Our primary objective was to identify available psoriasis registries in the United States (U.S.) and evaluate the application of patient registries compared to clinical trials. We searched Google, the Registry of Patient Registries, Orphanet and ClinicalTrials.gov to create a list of U.S. psoriasis registries. We also performed a literature review on the application of psoriasis registries using PubMed. We identified 6 psoriasis patient registries in the United States. Patient registries are frequently used for psoriasis in the U.S. and provide important information about the safety, efficacy and long-term effects of systemic therapies.

Application of dermoscopy image analysis technique in diagnosing urethral condylomata acuminata.

PubMed

Zhang, Yunjie; Jiang, Shuang; Lin, Hui; Guo, Xiaojuan; Zou, Xianbiao

2018-01-01

In this study, cases with suspected urethral condylomata acuminata were examined by dermoscopy, in order to explore an effective method for clinical. To study the application of dermoscopy image analysis technique in clinical diagnosis of urethral condylomata acuminata. A total of 220 suspected urethral condylomata acuminata were clinically diagnosed first with the naked eyes, and then by using dermoscopy image analysis technique. Afterwards, a comparative analysis was made for the two diagnostic methods. Among the 220 suspected urethral condylomata acuminata, there was a higher positive rate by dermoscopy examination than visual observation. Dermoscopy examination technique is still restricted by its inapplicability in deep urethral orifice and skin wrinkles, and concordance between different clinicians may also vary. Dermoscopy image analysis technique features a high sensitivity, quick and accurate diagnosis and is non-invasive, and we recommend its use.

The PsyLOG mobile application: development of a tool for the assessment and monitoring of side effects of psychotropic medication.

PubMed

Kuzman, Martina Rojnic; Andlauer, Olivier; Burmeister, Kai; Dvoracek, Boris; Lencer, Rebekka; Koelkebeck, Katja; Nawka, Alexander; Riese, Florian

2017-06-01

Mobile health interventions are regarded as affordable and accessible tools that can enhance standard psychiatric care. As part of the mHealth Psycho-Educational Intervention Versus Antipsychotic-Induced Side Effects (mPIVAS) project (www.psylog.eu), we developed the mobile application "PsyLOG" based on mobile "smartphone" technology to monitor antipsychotic-induced side effects. The aim of this paper is to describe the rationale and development of the PsyLOG and its clinical use. The PsyLOG application runs on smartphones with Android operating system. The application is currently available in seven languages (Croatian, Czech, English, French, German, Japanese and Serbian). It consists of several categories: "My Drug Effects", "My Life Styles", "My Charts", "My Medication", "My Strategies", "My Supporters", "Settings" and "About". The main category "My Drug Effects" includes a list of 30 side effects with the possibility to add three additional side effects. Side effects are each accompanied by an appropriate description and the possibility to rate its severity on a visual analogue scale from 0-100%. The PsyLOG application is intended to enhance the link between patients and mental health professionals, serving as a tool that more objectively monitors side-effects over certain periods of time. To the best of our knowledge, no such applications have so far been developed for patients taking antipsychotic medication or for their therapists.

Progress in the capture, manipulation, and delivery of medical media and its impact on education, clinical care, and research.

PubMed

Bernardo, Theresa M; Malinowski, Robert P

2005-01-01

In this article, advances in the application of medical media to education, clinical care, and research are explored and illustrated with examples, and their future potential is discussed. Impact is framed in terms of the Sloan Consortium's five pillars of quality education: access; student and faculty satisfaction; learning effectiveness; and cost effectiveness. (Hiltz SR, Zhang Y, Turoff M. Studies of effectiveness of learning networks. In Bourne J, Moore J, ed. Elements of Quality Online Education. Needham, MA: Sloan-Consortium, 2002:15-45). The alternatives for converting analog media (text, photos, graphics, sound, video, animations, radiographs) to digital media and direct digital capture are covered, as are options for storing, manipulating, retrieving, and sharing digital collections. Diagnostic imaging is given particular attention, clarifying the difference between computerized radiography and digital radiography and explaining the accepted standard (DICOM) and the advantages of Web PACS. Some novel research applications of medical media are presented.

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research.

PubMed

Phillips, Kathryn A; Deverka, Patricia A; Sox, Harold C; Khoury, Muin J; Sandy, Lewis G; Ginsburg, Geoffrey S; Tunis, Sean R; Orlando, Lori A; Douglas, Michael P

2017-10-01

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address.Genet Med advance online publication 13 April 2017.

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research

PubMed Central

Phillips, Kathryn A.; Deverka, Patricia A.; Sox, Harold C.; Khoury, Muin J.; Sandy, Lewis G.; Ginsburg, Geoffrey S.; Tunis, Sean R.; Orlando, Lori A.; Douglas, Michael P.

2017-01-01

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address. Genet Med advance online publication 13 April 2017 PMID:28406488

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l=515) and the intervention group received lecture plus a simulation exercise (n l+s=1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

Background The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. Purpose To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. Methods This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l =515) and the intervention group received lecture plus a simulation exercise (n l+s =1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Results Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Discussion Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

Dual-energy CT revisited with multidetector CT: review of principles and clinical applications.

PubMed

Karçaaltıncaba, Muşturay; Aktaş, Aykut

2011-09-01

Although dual-energy CT (DECT) was first conceived in the 1970s, it was not widely used for CT indications. Recently, the simultaneous acquisition of volumetric dual-energy data has been introduced using multidetector CT (MDCT) with two X-ray tubes and rapid kVp switching (gemstone spectral imaging). Two major advantages of DECT are material decomposition by acquiring two image series with different kVp and the elimination of misregistration artifacts. Hounsfield unit measurements by DECT are not absolute and can change depending on the kVp used for an acquisition. Typically, a combination of 80/140 kVp is used for DECT, but for some applications, 100/140 kVp is preferred. In this study, we summarized the clinical applications of DECT and included images that were acquired using the dual-source CT and rapid kVp switching. In general, unenhanced images can be avoided by using DECT for body and neurological applications; iodine can be removed from the image, and a virtual, non-contrast (water) image can be obtained. Neuroradiological applications allow for the removal of bone and calcium from the carotid and brain CT angiography. Thorax applications include perfusion imaging in patients with pulmonary thromboemboli and other chest diseases, xenon ventilation-perfusion imaging and solitary nodule characterization. Cardiac applications include dual-energy cardiac perfusion, viability and cardiac iron detection. The removal of calcific plaques from arteries, bone removal and aortic stent graft evaluation may be achieved in the vascular system. Abdominal applications include the detection and characterization of liver and pancreas masses, the diagnosis of steatosis and iron overload, DECT colonoscopy and CT cholangiography. Urinary system applications are urinary calculi characterization (uric acid vs. non-uric acid), renal cyst characterization and mass characterization. Musculoskeletal applications permit the differentiation of gout from pseudogout and a reduction of metal artifacts. Recent introduction of iterative reconstruction techniques can increase the use of DECT techniques; the use of dual energy in patients with a high BMI is limited due to noise and the radiation dose. DECT may be a good alternative to PET-CT. Iodine map images can quantify iodine uptake, and this approach may be more effective than obtaining non-contrast and post-contrast images for the diagnosis of a solid mass. Thus, computer-aided detection may be used more effectively in CT applications. DECT is a promising technique with potential clinical applications.

Knee Ligament Injury and the Clinical Application of Tissue Engineering Techniques: A Systematic Review.

PubMed

Riley, Thomas C; Mafi, Reza; Mafi, Pouya; Khan, Wasim S

2018-02-23

The incidence of knee ligament injury is increasing and represents a significant cost to healthcare providers. Current interventions include tissue grafts, suture repair and non-surgical management. These techniques have demonstrated good patient outcomes but have been associated graft rejection, infection, long term immobilization and reduced joint function. The limitations of traditional management strategies have prompted research into tissue engineering of knee ligaments. This paper aims to evaluate whether tissue engineering of knee ligaments offers a viable alternative in the clinical management of knee ligament injuries. A search of existing literature was performed using OVID Medline, Embase, AMED, PubMed and Google Scholar, and a manual review of citations identified within these papers. Silk, polymer and extracellular matrix based scaffolds can all improve graft healing and collagen production. Fibroblasts and stem cells demonstrate compatibility with scaffolds, and have been shown to increase organized collagen production. These effects can be augmented using growth factors and extracellular matrix derivatives. Animal studies have shown tissue engineered ligaments can provide the biomechanical characteristics required for effective treatment of knee ligament injuries. There is a growing clinical demand for a tissue engineered alternative to traditional management strategies. Currently, there is limited consensus regarding material selection for use in tissue engineered ligaments. Further research is required to optimize tissue engineered ligament production before clinical application. Controlled clinical trials comparing the use of tissue engineered ligaments and traditional management in patients with knee ligament injury could determine whether they can provide a cost-effective alternative. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A unified procedure for meta-analytic evaluation of surrogate end points in randomized clinical trials

PubMed Central

Dai, James Y.; Hughes, James P.

2012-01-01

The meta-analytic approach to evaluating surrogate end points assesses the predictiveness of treatment effect on the surrogate toward treatment effect on the clinical end point based on multiple clinical trials. Definition and estimation of the correlation of treatment effects were developed in linear mixed models and later extended to binary or failure time outcomes on a case-by-case basis. In a general regression setting that covers nonnormal outcomes, we discuss in this paper several metrics that are useful in the meta-analytic evaluation of surrogacy. We propose a unified 3-step procedure to assess these metrics in settings with binary end points, time-to-event outcomes, or repeated measures. First, the joint distribution of estimated treatment effects is ascertained by an estimating equation approach; second, the restricted maximum likelihood method is used to estimate the means and the variance components of the random treatment effects; finally, confidence intervals are constructed by a parametric bootstrap procedure. The proposed method is evaluated by simulations and applications to 2 clinical trials. PMID:22394448

TU-A-210-00: HIFU Therapies - A Primer

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

2015-06-15

High-intensity focused ultrasound (HIFU) has developed rapidly in recent years and is used frequently for clinical treatments in Asia and Europe with increasing clinical use and clinical trial activity in the US, making it an important medical technology with which the medical physics community must become familiar. Akin to medical devices that deliver treatments using ionizing radiation, HIFU relies on emitter geometry to non-invasively form a tight focus that can be used to affect diseased tissue while leaving healthy tissue intact. HIFU is unique in that it does not involve the use of ionizing radiation, it causes thermal necrosis inmore » 100% of the treated tissue volume, and it has an immediate treatment effect. However, because it is an application of ultrasound energy, HIFU interacts strongly with tissue interfaces, which makes treatment planning challenging. In order to appreciate the advantages and disadvantages of HIFU as a thermal therapy, it is important to understand the underlying physics of ultrasound tissue interactions. The first lecture in the session will provide an overview of the physics of ultrasound wave propagation; the mechanism for the accumulation of heat in soft-tissue; image-guidance modalities including temperature monitoring; current clinical applications and commercial devices; active clinical trials; alternate mechanisms of action (future of FUS). The second part of the session will compare HIFU to existing ionization radiation techniques. The difficulties in defining a clear concept of absorbed dose for HIFU will be discussed. Some of the technical challenges that HIFU faces will be described, with an emphasis on how the experience of radiation oncology physicists could benefit the field. Learning Objectives: Describe the basic physics and biology of HIFU, including treatment delivery and image guidance techniques. Summarize existing and emerging clinical applications and manufacturers for HIFU. Understand that thermal ablation with HIFU is likely the first of several applications of the technology Learn about some similarities and differences between HIFU and ionizing radiation in terms of physics and biological effects. Learn about some of the technical challenges HIFU faces that might benefit from the experience of radiation oncology physicists including treatment planning improvements, quality assurance procedures, and treatment risk analysis. David Schlesinger receives research support from Elekta Instruments, AB. Matt Eames is an employee of the Focused Ultrasound Foundation which supports research and clinical trials. Dr. Eames conducts research which is supported by the Focused Ultrasound Foundation.« less

TU-A-210-01: HIFU Physics and Delivery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Eames, M.

2015-06-15

High-intensity focused ultrasound (HIFU) has developed rapidly in recent years and is used frequently for clinical treatments in Asia and Europe with increasing clinical use and clinical trial activity in the US, making it an important medical technology with which the medical physics community must become familiar. Akin to medical devices that deliver treatments using ionizing radiation, HIFU relies on emitter geometry to non-invasively form a tight focus that can be used to affect diseased tissue while leaving healthy tissue intact. HIFU is unique in that it does not involve the use of ionizing radiation, it causes thermal necrosis inmore » 100% of the treated tissue volume, and it has an immediate treatment effect. However, because it is an application of ultrasound energy, HIFU interacts strongly with tissue interfaces, which makes treatment planning challenging. In order to appreciate the advantages and disadvantages of HIFU as a thermal therapy, it is important to understand the underlying physics of ultrasound tissue interactions. The first lecture in the session will provide an overview of the physics of ultrasound wave propagation; the mechanism for the accumulation of heat in soft-tissue; image-guidance modalities including temperature monitoring; current clinical applications and commercial devices; active clinical trials; alternate mechanisms of action (future of FUS). The second part of the session will compare HIFU to existing ionization radiation techniques. The difficulties in defining a clear concept of absorbed dose for HIFU will be discussed. Some of the technical challenges that HIFU faces will be described, with an emphasis on how the experience of radiation oncology physicists could benefit the field. Learning Objectives: Describe the basic physics and biology of HIFU, including treatment delivery and image guidance techniques. Summarize existing and emerging clinical applications and manufacturers for HIFU. Understand that thermal ablation with HIFU is likely the first of several applications of the technology Learn about some similarities and differences between HIFU and ionizing radiation in terms of physics and biological effects. Learn about some of the technical challenges HIFU faces that might benefit from the experience of radiation oncology physicists including treatment planning improvements, quality assurance procedures, and treatment risk analysis. David Schlesinger receives research support from Elekta Instruments, AB. Matt Eames is an employee of the Focused Ultrasound Foundation which supports research and clinical trials. Dr. Eames conducts research which is supported by the Focused Ultrasound Foundation.« less

77 FR 13513 - Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-07

...The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input from interested persons on FDA's scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products. Clinical trials are a critical source of evidence to inform medical policy and practice, and effective regulatory oversight is needed to ensure that human subjects are protected and resulting clinical trial data are credible and accurate. FDA is aware of concerns within the clinical trial community that certain regulations and policies applicable to the conduct of clinical trials may result in inefficiencies or increased cost and may not facilitate the use of innovative methods and technological advances to improve clinical trial quality. The Agency is involved in an effort to modernize the regulatory framework that governs clinical trials and approaches to good clinical practice (GCP). The purpose of this hearing is to solicit public input from a broad group of stakeholders on the scope and direction of this effort, including encouraging the use of innovative models that may enhance the effectiveness and efficiency of the clinical trial enterprise.

Documenting clinical pharmacist intervention before and after the introduction of a web-based tool.

PubMed

Nurgat, Zubeir A; Al-Jazairi, Abdulrazaq S; Abu-Shraie, Nada; Al-Jedai, Ahmed

2011-04-01

To develop a database for documenting pharmacist intervention through a web-based application. The secondary endpoint was to determine if the new, web-based application provides any benefits with regards to documentation compliance by clinical pharmacists and ease of calculating cost savings compared with our previous method of documenting pharmacist interventions. A tertiary care hospital in Saudi Arabia. The documentation of interventions using a web-based documentation application was retrospectively compared with previous methods of documentation of clinical pharmacists' interventions (multi-user PC software). The number and types of interventions recorded by pharmacists, data mining of archived data, efficiency, cost savings, and the accuracy of the data generated. The number of documented clinical interventions increased from 4,926, using the multi-user PC software, to 6,840 for the web-based application. On average, we observed 653 interventions per clinical pharmacist using the web-based application, which showed an increase compared to an average of 493 interventions using the old multi-user PC software. However, using a paired Student's t-test there was no statistical significance difference between the two means (P = 0.201). Using a χ² test, which captured management level and the type of system used, we found a strong effect of management level (P < 2.2 × 10⁻¹⁶) on the number of documented interventions. We also found a moderately significant relationship between educational level and the number of interventions documented (P = 0.045). The mean ± SD time required to document an intervention using the web-based application was 66.55 ± 8.98 s. Using the web-based application, 29.06% of documented interventions resulted in cost-savings, while using the multi-user PC software only 4.75% of interventions did so. The majority of cost savings across both platforms resulted from the discontinuation of unnecessary drugs and a change in dosage regimen. Data collection using the web-based application was consistently more complete when compared to the multi-user PC software. The web-based application is an efficient system for documenting pharmacist interventions. Its flexibility and accessibility, as well as its detailed report functionality is a useful tool that will hopefully encourage other primary and secondary care facilities to adopt similar applications.

Analysis and Application of Antagonism Compound Prescription Compatibility

NASA Astrophysics Data System (ADS)

Li, Mengyan; Wang, Can; Bai, Ming; Miao, Mingsan

2018-01-01

Deer horn glue is deer family animals deer or red deer horn made of solid plastic animal medicine, according to Chinese medicine “seven emotions together” theory, the antler and other Chinese herbal medicines compatibility can be better play its Medicinal value. In this paper, the chemical composition, pharmacological effects, compatibility analysis, clinical application and classic ancient prescriptions of antler are reviewed in recent years.

The effects of body position on distortion-product otoacoustic emission testing.

PubMed

Driscoll, Carlie; Kei, Joseph; Shyu, Jenny; Fukai, Natasha

2004-09-01

Otoacoustic emissions are frequently acquired from patients in a variety of body positions aside from the standard, seated orientation. Yet little knowledge is available regarding whether these deviations will produce nonpathological changes to the clinical results obtained. The present study aimed to describe the effects of body position on the distortion-product otoacoustic emissions of 60 normal-hearing adults. With particular attention given to common clinical practice, the Otodynamics ILO292, and the measurement parameters of amplitude, signal-to-noise ratio, and noise were utilized. Significant position-related effects and interactions were revealed for all parameters. Specifically, stronger emissions in the mid frequencies and higher noise levels at the extreme low and high frequencies were produced by testing subjects while lying on their side compared with the seated position. Further analysis of body position effects on emissions is warranted, in order to determine the need for clinical application of position-dependent normative data.

Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes.

PubMed

Testa, Marco; Rossettini, Giacomo

2016-08-01

Placebo and nocebo represent complex and distinct psychoneurobiological phenomena in which behavioural and neurophysiological modifications occur together with the application of a treatment. Despite a better understanding of this topic in the medical field, little is known about their role in physiotherapy. The aim of this review is: a) to elucidate the neurobiology behind placebo and nocebo effects, b) to describe the role of the contextual factors as modulators of the clinical outcomes in rehabilitation and c) to provide clinical and research guidelines on their uses. The physiotherapist's features, the patient's features, the patient-physiotherapist relationship, the characteristics of the treatment and the overall healthcare setting are all contextual factors influencing clinical outcomes. Since every physiotherapy treatment determines a specific and a contextual effect, physiotherapists should manage the contextual factors as a boosting element of any manual therapy to improve placebo effects and avoid detrimental nocebo effects. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Clinical application of IPS-empress 2 pressable all-ceramic crowns].

PubMed

Wang, Ai-jun; He, Xiao-ming; Liu, Li-xia; Zhang, Chao-biao; Zhang, Min; Shen, Bei-yong

2007-02-01

To evaluate the clinical prosthetic effect of IPS-Empress 2 pressahie ceramic crowns. 198 teeth of 70 patients were restored with IPS-Empress 2 pressahie ceramic crowns. The patients were asked to return in one week and every half year. The clinical prosthetic effect was evaluated. Through follow-up of 3-38 months, the veneer porcelain crowns of 3 teeth were broken. 2 crowns fall off due to teeth fracture, gingivitis occurred in 2 teeth, pulpitis or periapical periodontitis occurred in 3 teeth. The shades of 3 crowns were darkening. The prosthetic effect of 185 teeth was satisfied. The rate of satisfaction was 93.4%. IPS-Empress 2 pressable all-ceramic crown has the advantages of aesthetic effect, good hiocompatihility and simple fabrication. But its strength is not enough for posterior teeth and it can not cover the deep color of non-vital teeth and metal materials.

Development and evaluation of a web-based application for digital findings and documentation in physiotherapy education.

PubMed

Spieler, Bernadette; Burgsteiner, Harald; Messer-Misak, Karin; Gödl-Purrer, Barbara; Salchinger, Beate

2015-01-01

Findings in physiotherapy have standardized approaches in treatment, but there is also a significant margin of differences in how to implement these standards. Clinical decisions require experience and continuous learning processes to consolidate personal values and opinions and studies suggest that lecturers can influence students positively. Recently, the study course of Physiotherapy at the University of Applied Science in Graz has offered a paper based finding document. This document supported decisions through the adaption of the clinical reasoning process. The document was the starting point for our learning application called "EasyAssess", a Java based web-application for a digital findings documentation. A central point of our work was to ensure efficiency, effectiveness and usability of the web-application through usability tests utilized by both students and lecturers. Results show that our application fulfills the previously defined requirements and can be efficiently used in daily routine largely because of its simple user interface and its modest design. Due to the close cooperation with the study course Physiotherapy, the application has incorporated the various needs of the target audiences and confirmed the usefulness of our application.

The impact of health information technology adoption by outpatient facilities on pregnancy outcomes.

PubMed

Deily, Mary E; Hu, Tianyan; Terrizzi, Sabrina; Chou, Shin-Yi; Meyerhoefer, Chad D

2013-02-01

Examine whether health information technology (HIT) at nonhospital facilities (NHFs) improves health outcomes and decreases resource use at hospitals within the same heath care network, and whether the impact of HIT varies as providers gain experience using the technologies. Administrative claims data on 491,832 births in Pennsylvania during 1998-2004 from the Pennsylvania Health Care Cost Containment Council and HIT applications data from the Dorenfest Institute. Fixed-effects regression analysis of the impact of HIT at NHFs on adverse birth outcomes and resource use. Greater use of clinical HIT applications by NHFs is associated with reduced incidence of obstetric trauma and preventable complications, as well as longer lengths of stay. In addition, the beneficial effects of HIT increase the longer that technologies have been in use. However, we find no consistent evidence on whether or how nonclinical HIT in NHFs affects either resource use or health outcomes. Clinical HIT applications at NHFs may reduce the likelihood of adverse birth outcomes, particularly after physicians and staff gain experience using the technologies. © Health Research and Educational Trust.

The Impact of Health Information Technology Adoption by Outpatient Facilities on Pregnancy Outcomes

PubMed Central

Deily, Mary E; Hu, Tianyan; Terrizzi, Sabrina; Chou, Shin-Yi; Meyerhoefer, Chad D

2013-01-01

Objective Examine whether health information technology (HIT) at nonhospital facilities (NHFs) improves health outcomes and decreases resource use at hospitals within the same heath care network, and whether the impact of HIT varies as providers gain experience using the technologies. Data Sources Administrative claims data on 491,832 births in Pennsylvania during 1998–2004 from the Pennsylvania Health Care Cost Containment Council and HIT applications data from the Dorenfest Institute. Study Design Fixed-effects regression analysis of the impact of HIT at NHFs on adverse birth outcomes and resource use. Principal Findings Greater use of clinical HIT applications by NHFs is associated with reduced incidence of obstetric trauma and preventable complications, as well as longer lengths of stay. In addition, the beneficial effects of HIT increase the longer that technologies have been in use. However, we find no consistent evidence on whether or how nonclinical HIT in NHFs affects either resource use or health outcomes. Conclusions Clinical HIT applications at NHFs may reduce the likelihood of adverse birth outcomes, particularly after physicians and staff gain experience using the technologies. PMID:22742682

Point-of-care testing: applications of 3D printing.

PubMed

Chan, Ho Nam; Tan, Ming Jun Andrew; Wu, Hongkai

2017-08-08

Point-of-care testing (POCT) devices fulfil a critical need in the modern healthcare ecosystem, enabling the decentralized delivery of imperative clinical strategies in both developed and developing worlds. To achieve diagnostic utility and clinical impact, POCT technologies are immensely dependent on effective translation from academic laboratories out to real-world deployment. However, the current research and development pipeline is highly bottlenecked owing to multiple restraints in material, cost, and complexity of conventionally available fabrication techniques. Recently, 3D printing technology has emerged as a revolutionary, industry-compatible method enabling cost-effective, facile, and rapid manufacturing of objects. This has allowed iterative design-build-test cycles of various things, from microfluidic chips to smartphone interfaces, that are geared towards point-of-care applications. In this review, we focus on highlighting recent works that exploit 3D printing in developing POCT devices, underscoring its utility in all analytical steps. Moreover, we also discuss key advantages of adopting 3D printing in the device development pipeline and identify promising opportunities in 3D printing technology that can benefit global health applications.

Therapeutic Applications of Herbal Medicines for Cancer Patients

PubMed Central

Yin, Shu-Yi; Wei, Wen-Chi; Jian, Feng-Yin; Yang, Ning-Sun

2013-01-01

Medicinal herbs and their derivative phytocompounds are being increasingly recognized as useful complementary treatments for cancer. A large volume of clinical studies have reported the beneficial effects of herbal medicines on the survival, immune modulation, and quality of life (QOL) of cancer patients, when these herbal medicines are used in combination with conventional therapeutics. Here, we briefly review some examples of clinical studies that investigated the use of herbal medicines for various cancers and the development of randomized controlled trials (RCTs) in this emerging research area. In addition, we also report recent studies on the biochemical and cellular mechanisms of herbal medicines in specific tumor microenvironments and the potential application of specific phytochemicals in cell-based cancer vaccine systems. This review should provide useful technological support for evidence-based application of herbal medicines in cancer therapy. PMID:23956768

Endotoxemia: methods of detection and clinical correlates.

PubMed Central

Hurley, J C

1995-01-01

As an assay for endotoxin, the Limulus amebocyte lysate assay has several desirable properties: sensitivity, specificity, and potential for adaptation to a quantitative format. Several modifications have been developed to enhance its potential for clinical application. The modifications that allow quantitative measurement of endotoxin and also improve its application to blood samples are described in this review. In fluids other than blood, the detection of endotoxin with the Limulus amebocyte lysate assay can be used as an aid to identify the presence of gram-negative bacteria, and the assay has established utility. With blood, however, there are a range of factors that interfere with the detection of endotoxemia and there are disparate views with respect to the diagnostic and prognostic significance of the test results. In general, the clinical significance of the finding of endotoxemia broadly parallels the frequency and importance of gram-negative sepsis in the patient groups studied and a decline in endotoxin levels accompanies clinical improvement. However, with therapies designed to reduce levels of endotoxin, or to antagonize its effects, it is unclear whether clinical improvement occurs as a consequence of changes in the levels of endotoxemia. PMID:7621402

The road ahead: working towards effective clinical translation of myocardial gene therapies

PubMed Central

Katz, Michael G; Fargnoli, Anthony S; Williams, Richard D; Bridges, Charles R

2014-01-01

During the last two decades the fields of molecular and cellular cardiology, and more recently molecular cardiac surgery, have developed rapidly. The concept of delivering cDNA encoding a therapeutic gene to cardiomyocytes using a vector system with substantial cardiac tropism, allowing for long-term expression of a therapeutic protein, has moved from hypothesis to bench to clinical application. However, the clinical results to date are still disappointing. The ideal gene transfer method should be explored in clinically relevant animal models of heart disease to evaluate the relative roles of specific molecular pathways in disease pathogenesis, helping to validate the potential targets for therapeutic intervention. Successful clinical cardiovascular gene therapy also requires the use of nonimmunogenic cardiotropic vectors capable of expressing the requisite amount of therapeutic protein in vivo and in situ. Depending on the desired application either regional or global myocardial gene delivery is required. Cardiac-specific delivery techniques incorporating mapping technologies for regional delivery and highly efficient methodologies for global delivery should improve the precision and specificity of gene transfer to the areas of interest and minimize collateral organ gene expression. PMID:24341816

Application of ultrasound in periodontics: Part I

PubMed Central

Bains, Vive K.; Mohan, Ranjana; Bains, Rhythm

2008-01-01

Ultrasonic is a branch of acoustics concerned with sound vibrations in frequency ranges above audible level. Ultrasound uses the transmission and reflection of acoustic energy. A pulse is propagated and its reflection is received, both by the transducer. For clinical purposes ultrasound is generated by transducers, which converts electrical energy into ultrasonic waves. This is usually achieved by magnetostriction or piezoelectricity. Primary effects of ultrasound are thermal, mechanical (cavitation and microstreaming), and chemical (sonochemicals). Knowledge of the basic and other secondary effects of ultrasound is essential for the development of techniques of application. PMID:20142941

Pimecrolimus 1% cream for anogenital lichen sclerosus in childhood

PubMed Central

Boms, Stefanie; Gambichler, Thilo; Freitag, Marcus; Altmeyer, Peter; Kreuter, Alexander

2004-01-01

Background Lichen sclerosus is a chronic inflammatory disease with a predilection of the anogenital region. Because of the potential side effects of repeated local application of potent glucocorticosteroids, equally-effective, safer therapeutic options are required, especially in the treatment of children. Case presentations We report on the efficacy of twice-daily application of pimecrolimus 1% cream in four prepubertal girls (range of age: 4 to 9 years) who suffered from anogenital lichen sclerosus. After three to four-month treatment, all patients had almost complete clinical remission including relief from itch, pain and inflammation. Only minor improvement was observed for the white sclerotic lesions. No significant side effects have been observed. Conclusions Topical pimecrolimus appears to be an effective and safe treatment for children with anogenital lichen sclerosus. The clinical benefits observed in the four patient presented particularly include relief of pruritus, pain and inflammation. Vehicle-controlled studies on a larger number of patients are now warranted to substantiate our promising findings, and to investigate long-term efficacy and safety of topical pimecrolimus in anogenital lichen sclerosus. PMID:15485581

Effects of Ionizing Radiation on DNA Methylation: From Experimental Biology to Clinical Applications

PubMed Central

Miousse, Isabelle R.; Kutanzi, Kristy R.; Koturbash, Igor

2017-01-01

Purpose Ionizing radiation (IR) is a ubiquitous environmental stressor with genotoxic and epigenotoxic capabilities. Terrestrial IR, predominantly a low-linear energy transfer (LET) radiation, is being widely utilized in medicine, as well as in multiple industrial applications. Additionally, an interest in understanding the effects of high-LET irradiation is emerging due to the potential of exposure during space missions and the growing utilization of LET radiation in medicine. Conclusions In this review, we summarize the current knowledge of the effects of IR on DNA methylation, a key epigenetic mechanism regulating the expression of genetic information. We discuss global, repetitive elements and gene-specific DNA methylation in light of exposure to high and low doses of high- or low-LET IR, fractionated IR exposure, and bystander effects. Finally, we describe the mechanisms of IR-induced alterations to DNA methylation and discuss ways in which that understanding can be applied clinically, including utilization of DNA methylation as a predictor of response to radiotherapy and in the manipulation of DNA methylation patterns for tumor radiosensitization. PMID:28134023

Effects of ionizing radiation on DNA methylation: from experimental biology to clinical applications.

PubMed

Miousse, Isabelle R; Kutanzi, Kristy R; Koturbash, Igor

2017-05-01

Ionizing radiation (IR) is a ubiquitous environmental stressor with genotoxic and epigenotoxic capabilities. Terrestrial IR, predominantly a low-linear energy transfer (LET) radiation, is being widely utilized in medicine, as well as in multiple industrial applications. Additionally, an interest in understanding the effects of high-LET irradiation is emerging due to the potential of exposure during space missions and the growing utilization of high-LET radiation in medicine. In this review, we summarize the current knowledge of the effects of IR on DNA methylation, a key epigenetic mechanism regulating the expression of genetic information. We discuss global, repetitive elements and gene-specific DNA methylation in light of exposure to high and low doses of high- or low-LET IR, fractionated IR exposure, and bystander effects. Finally, we describe the mechanisms of IR-induced alterations to DNA methylation and discuss ways in which that understanding can be applied clinically, including utilization of DNA methylation as a predictor of response to radiotherapy and in the manipulation of DNA methylation patterns for tumor radiosensitization.

Complement inhibition in pre-clinical models of periodontitis and prospects for clinical application.

PubMed

Hajishengallis, George; Hajishengallis, Evlambia; Kajikawa, Tetsuhiro; Wang, Baomei; Yancopoulou, Despina; Ricklin, Daniel; Lambris, John D

2016-06-01

Periodontitis is a dysbiotic inflammatory disease leading to the destruction of the tooth-supporting tissues. Current therapies are not always effective and this prevalent oral disease continues to be a significant health and economic burden. Early clinical studies have associated periodontitis with elevated complement activity. Consistently, subsequent genetic and pharmacological studies in rodents have implicated the central complement component C3 and downstream signaling pathways in periodontal host-microbe interactions that promote dysbiosis and inflammatory bone loss. This review discusses these mechanistic advances and moreover focuses on the compstatin family of C3 inhibitors as a novel approach to treat periodontitis. In this regard, local application of the current lead analog Cp40 was recently shown to block both inducible and naturally occurring periodontitis in non-human primates. These promising results from non-human primate studies and the parallel development of Cp40 for clinical use highlight the feasibility for developing an adjunctive, C3-targeted therapy for human periodontitis. Copyright © 2016 Elsevier Ltd. All rights reserved.

Collective intelligence for translational medicine: Crowdsourcing insights and innovation from an interdisciplinary biomedical research community.

PubMed

Budge, Eleanor Jane; Tsoti, Sandra Maria; Howgate, Daniel James; Sivakumar, Shivan; Jalali, Morteza

2015-01-01

Translational medicine bridges the gap between discoveries in biomedical science and their safe and effective clinical application. Despite the gross opportunity afforded by modern research for unparalleled advances in this field, the process of translation remains protracted. Efforts to expedite science translation have included the facilitation of interdisciplinary collaboration within both academic and clinical environments in order to generate integrated working platforms fuelling the sharing of knowledge, expertise, and tools to align biomedical research with clinical need. However, barriers to scientific translation remain, and further progress is urgently required. Collective intelligence and crowdsourcing applications offer the potential for global online networks, allowing connection and collaboration between a wide variety of fields. This would drive the alignment of biomedical science with biotechnology, clinical need, and patient experience, in order to deliver evidence-based innovation which can revolutionize medical care worldwide. Here we discuss the critical steps towards implementing collective intelligence in translational medicine using the experience of those in other fields of science and public health.

Next-generation sequencing in the clinic: promises and challenges.

PubMed

Xuan, Jiekun; Yu, Ying; Qing, Tao; Guo, Lei; Shi, Leming

2013-11-01

The advent of next generation sequencing (NGS) technologies has revolutionized the field of genomics, enabling fast and cost-effective generation of genome-scale sequence data with exquisite resolution and accuracy. Over the past years, rapid technological advances led by academic institutions and companies have continued to broaden NGS applications from research to the clinic. A recent crop of discoveries have highlighted the medical impact of NGS technologies on Mendelian and complex diseases, particularly cancer. However, the ever-increasing pace of NGS adoption presents enormous challenges in terms of data processing, storage, management and interpretation as well as sequencing quality control, which hinder the translation from sequence data into clinical practice. In this review, we first summarize the technical characteristics and performance of current NGS platforms. We further highlight advances in the applications of NGS technologies towards the development of clinical diagnostics and therapeutics. Common issues in NGS workflows are also discussed to guide the selection of NGS platforms and pipelines for specific research purposes. Published by Elsevier Ireland Ltd.

Treatment selection in a randomized clinical trial via covariate-specific treatment effect curves.

PubMed

Ma, Yunbei; Zhou, Xiao-Hua

2017-02-01

For time-to-event data in a randomized clinical trial, we proposed two new methods for selecting an optimal treatment for a patient based on the covariate-specific treatment effect curve, which is used to represent the clinical utility of a predictive biomarker. To select an optimal treatment for a patient with a specific biomarker value, we proposed pointwise confidence intervals for each covariate-specific treatment effect curve and the difference between covariate-specific treatment effect curves of two treatments. Furthermore, to select an optimal treatment for a future biomarker-defined subpopulation of patients, we proposed confidence bands for each covariate-specific treatment effect curve and the difference between each pair of covariate-specific treatment effect curve over a fixed interval of biomarker values. We constructed the confidence bands based on a resampling technique. We also conducted simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrated the application of the proposed method in a real-world data set.

The applicability of Lean and Six Sigma techniques to clinical and translational research.

PubMed

Schweikhart, Sharon A; Dembe, Allard E

2009-10-01

Lean and Six Sigma are business management strategies commonly used in production industries to improve process efficiency and quality. During the past decade, these process improvement techniques increasingly have been applied outside the manufacturing sector, for example, in health care and in software development. This article concerns the potential use of Lean and Six Sigma in improving the processes involved in clinical and translational research. Improving quality, avoiding delays and errors, and speeding up the time to implementation of biomedical discoveries are prime objectives of the National Institutes of Health (NIH) Roadmap for Medical Research and the NIH's Clinical and Translational Science Award program. This article presents a description of the main principles, practices, and methods used in Lean and Six Sigma. Available literature involving applications of Lean and Six Sigma to health care, laboratory science, and clinical and translational research is reviewed. Specific issues concerning the use of these techniques in different phases of translational research are identified. Examples of Lean and Six Sigma applications that are being planned at a current Clinical and Translational Science Award site are provided, which could potentially be replicated elsewhere. We describe how different process improvement approaches are best adapted for particular translational research phases. Lean and Six Sigma process improvement methods are well suited to help achieve NIH's goal of making clinical and translational research more efficient and cost-effective, enhancing the quality of the research, and facilitating the successful adoption of biomedical research findings into practice.

Curcuma as a functional food in the control of cancer and inflammation.

PubMed

Schaffer, Moshe; Schaffer, Pamela M; Zidan, Jamal; Bar Sela, Gil

2011-11-01

Several nutritional compounds are the focus of public attention because of their potential beneficial health effects. Turmeric is a spice that comes from the root Curcuma longa. Extensive research over the past half century and especially in recent years has revealed important functions of curcumin and a timely review of clinical state-of-the-art using curcumin. In-vitro and in-vivo research has shown various activities, such as anti-inflammatory, antiviral, antifungal, cytokines release, antioxidant, immunomodulatory, enhancing of the apoptotic process, and antiangiogenic properties. Curcumin also have been shown to be a mediator of chemo-resistance and radio-resistance. Various in-vitro and in-vivo and scarce number of clinical studies on curcumin were identified. The various effects and properties of curcumin are summarized in this review, including preclinical and especially clinical studies. This review concentrates on recent knowledge and research with curcumin clinical applications, and clinical studies, focusing on studies published between 2008 and 2011 demonstrating the gap between preclinical and clinical research.

Antibacterial activity in adhesive dentistry: a literature review.

PubMed

Shafiei, Fereshteh; Memarpour, Mahtab

2012-01-01

This literature review summarizes the published research regarding the antibacterial agents used in adhesive dentistry. This article provides information about the clinical applications, beneficial effects, and possible disadvantages of antibacterials when used in various bonding situations.

Interrupted time series design: a useful approach for studying interventions targeting participation.

PubMed

Anaby, Dana; Lal, Shalini; Huszczynski, Justine; Maich, Jana; Rogers, Jade; Law, Mary

2014-11-01

Comparative effectiveness research (CER) strives for evidence to inform clinical decisions for specific clients in typical health care settings. While the randomized controlled trial (RCT) is well-aligned with the objectives of CER, this design may not be feasible or applicable to all research questions, particularly those pertaining to clinical decision making and individually based change. It is important, therefore, to consider alternative approaches, especially when studying complex and subjective outcomes such as children's participation. We propose the use of interrupted time series (ITS) quasi-experimental design for its potential application in determining the effectiveness of participation-focused interventions. In this perspective, ITS design is described, ascertaining its advantages and limitations, and suggestions are provided to overcome challenges to implementation. Results of a case study using the ITS approach to evaluate changes in participation of an adolescent with physical disabilities are described. Finally, strategies to implement this design in practice are suggested.

The Long Path of Human Placenta, and Its Derivatives, in Regenerative Medicine

PubMed Central

Silini, Antonietta R.; Cargnoni, Anna; Magatti, Marta; Pianta, Stefano; Parolini, Ornella

2015-01-01

In the 1800s, a baby born with a caul, a remnant of the amniotic sack or fetal membranes, was thought to be lucky, special, or protected. Over time, fetal membranes lost their legendary power and were soon considered nothing more than biological waste after birth. However, placenta tissues have reclaimed their potential and since the early 1900s an increasing body of evidence has shown that these tissues have clinical benefits in a wide range of wound repair and surgical applications. Nowadays, there is a concerted effort to understand the mechanisms underlying the beneficial effects of placental tissues, and, more recently, cells derived thereof. This review will summarize the historical and current clinical applications of human placental tissues, and cells isolated from these tissues, and discuss some mechanisms thought to be responsible for the therapeutic effects observed after tissue and/or cell transplantation. PMID:26539433

Review of Anemone raddeana Rhizome and its pharmacological effects.

PubMed

Wang, Shu-Ling; Zhao, Zhen-Kun; Sun, Jian-Feng; Sun, Yun-Ting; Pang, Xiao-Qing; Zeng, Zhao-Wu; Xie, Tian

2018-01-01

The chemical compositions of Anemone raddeana Rhizome, a kind of traditional Chinese medicine, were reviewed, along with its bioactivity and pharmacological properties and method improvements of extracting and detecting triterpenoid saponins. A. raddeana Rhizome is used to treat neuralgia and rheumatism, and is rich in triterpenoid saponins, most of which are pentacyclic, with oleanane as the nucleus. So far, 37 triterpenoid saponins have been determined from the herb. Its reported bioactivity and pharmacological properties have been described as anticancerous, antimicrobial, anti-inflammatory, analgesic, antipyretic, anticonvulsive, antihistaminic, and sedative. It has also been used for the induction of the humoral immune response and treatment of liver fibrosis in chronic hepatitis. However, the herb also has hemolytic effects and can be toxic, which limits its clinical application. Further studies are needed on the pharmaceutical functions, mechanisms, and immunological responses to contribute to the herb's clinical applications.

A novel melittin nano-liposome exerted excellent anti-hepatocellular carcinoma efficacy with better biological safety.

PubMed

Mao, Jie; Liu, Shujun; Ai, Min; Wang, Zhuo; Wang, Duowei; Li, Xianjing; Hu, Kaiyong; Gao, Xinghua; Yang, Yong

2017-03-20

Melittin is the main effective component of bee venom and has extensive biological functions; however, serious side effects have restricted its clinical application. Preclinical and clinical studies showed that the main adverse events were allergic reaction and pain at the administration site. To decrease the toxicity, we prepared melittin nano-liposomes by encapsulating melittin with poloxamer 188 and explored the inhibitory activities on liver cancer together with biological safety. Here, we showed that melittin nano-liposomes significantly inhibited the survival of hepatocellular carcinoma (HCC) cells in vitro and prominently suppressed the growth of subcutaneous and orthotopic HCC transplantation tumors in vivo. It was important that it induced less inflammation and allergy in mice compared with melittin. Overall, melittin nano-liposomes would have a better application in HCC therapy due to its significant anti-tumor activity and better biological safety.

The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world.

PubMed

Dronkers, T M G; Krist, L; Van Overveld, F J; Rijkers, G T

2018-05-25

The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.

Ethical and Safety Issues of Stem Cell-Based Therapy.

PubMed

Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

2018-01-01

Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells.

Ethical and Safety Issues of Stem Cell-Based Therapy

PubMed Central

Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

2018-01-01

Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells. PMID:29333086

Applications of Telemedicine and Telecommunications to Disaster Medicine

PubMed Central

Garshnek, Victoria; Burkle, Frederick M.

1999-01-01

Disaster management utilizes diverse technologies to accomplish a complex set of tasks. Despite a decade of experience, few published reports have reviewed application of telemedicine (clinical care at a distance enabled by telecommunication) in disaster situations. Appropriate new telemedicine applications can improve future disaster medicine outcomes, based on lessons learned from a decade of civilian and military disaster (wide-area) telemedicine deployments. This manuscript reviews the history of telemedicine activities in actual disasters and similar scenarios as well as ongoing telemedicine innovations that may be applicable to disaster situations. Emergency care providers must begin to plan effectively to utilize disaster-specific telemedicine applications to improve future outcomes. PMID:9925226

Smartphone Application WeChat for Clinical Follow-up of Discharged Patients with Head and Neck Tumors: A Randomized Controlled Trial

PubMed Central

Lyu, Ke-Xing; Zhao, Jing; Wang, Bin; Xiong, Guan-Xia; Yang, Wei-Qiang; Liu, Qi-Hong; Zhu, Xiao-Lin; Sun, Wei; Jiang, Ai-Yun; Wen, Wei-Ping; Lei, Wen-Bin

2016-01-01

Background: Nowadays, social media tools such as short message service, Twitter, video, and web-based systems are more and more used in clinical follow-up, making clinical follow-up much more time- and cost-effective than ever before. However, as the most popular social media in China, little is known about the utility of smartphone WeChat application in follow-up. In this study, we aimed to investigate the feasibility and superiority of WeChat application in clinical follow-up. Methods: A total of 108 patients diagnosed with head and neck tumor were randomized to WeChat follow-up (WFU) group or telephone follow-up (TFU) group for 6-month follow-up. The follow-ups were delivered by WeChat or telephone at 2 weeks, 1, 2, 3, and 6 months to the patients after being discharged. The study measurements were time consumption for follow-up delivery, total economic cost, lost-to-follow-up rate, and overall satisfaction for the follow-up method. Results: Time consumption in WFU group for each patient (23.36 ± 6.16 min) was significantly shorter than that in TFU group (42.89 ± 7.15 min) (P < 0.001); total economic cost in WFU group (RMB 90 Yuan) was much lower than that in TFU group (RMB 196 Yuan). Lost-to-follow-up rate in the WFU group was 7.02% (4/57) compared with TFU group, 9.80% (5/51), while no significance was observed (95% confidence interval [CI]: 0.176–2.740; P = 0.732). The overall satisfaction rate in WFU group was 94.34% (50/53) compared with 80.43% (37/46) in TFU group (95% CI: 0.057–0.067; P = 0.034). Conclusions: The smartphone WeChat application was found to be a viable option for follow-up in discharged patients with head and neck tumors. WFU was time-effective, cost-effective, and convenient in communication. This doctor-led follow-up model has the potential to establish a good physician-patient relationship by enhancing dynamic communications and providing individual health instructions. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-IOR-15007498; http://www.chictr.org.cn/ showproj.aspx?proj=12613. PMID:27900995

Simple Preparation of Timolol 0.5% Gel from Eye Drop Solution for Superficial Infantile Hemangiomas.

PubMed

Choo, Winnie

2017-01-01

The discovery of beta-adrenergic blocker effects on infantile hemangiomas has affected the choice of treatment in recent years. Oral propranolol is effective in treating infantile hemangiomas, but the risk of systemic side effects remains a concern. Data from literature review reported positive clinical outcomes with no major adverse effects observed in children using topical beta-blocker such as timolol maleate. Topical application of timolol eye drop has been mentioned in few studies, most of which reported that the solution cannot stay on the site of application due to its fluidity. Adding hydroxyethyl cellulose into a timolol solution increased its viscosity by forming a hydrogel and thus changed the rheology property. The compounded timolol gel exhibited thixotropy property allowing better and longer contact at sites of application. Experimental data from literature review showed desirable characteristics and measurable flux of timolol across human stratum corneum. Gel dosage form allows easy and precise application and maximizes timolol's therapeutic efficacy at the sites of application. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Magnetic Resonance Imaging Criteria for Thrombolysis in Hyperacute Cerebral Infarction

PubMed Central

AHMETGJEKAJ, ILIR; KABASHI-MUÇAJ, SERBEZE; LASCU, LUANA CORINA; KABASHI, ANTIGONA; BONDARI, A.; BONDARI, SIMONA; DEDUSHI-HOTI, KRESHNIKE; BIÇAKU, ARDIAN; SHATRI, JETON

2014-01-01

Purpose: Selection of patients with cerebral infarction for MRI that is suitable for thrombolytic therapy as an emerging application. Although the efficiency of the therapy with i.v. tissue plasminogen activator (tPA) within 3 hours after onset of symptoms has been proven in selected patients with CT, now these criteria are determined by MRI, as the data we gather are fast and accurate in the first hours. Material and methods: MRI screening in patients with acute cerebral infarction before application of thrombolytic therapy was done in a UCC Mannheim in Germany. Unlike trials with CT, MRI studies demonstrated the benefits of therapy up to 6 hours after the onset of symptoms. We studied 21 patients hospitalized in Clinic of Neuroradiology at University Clinical Centre in Mannheim-Germany. They all undergo brain MRI evaluation for stroke. This article reviews literature that has followed application of thrombolysis in patients with cerebral infarction based on MRI. Results: We have analyzed the MRI criteria for i.v. application of tPA at this University Centre. Alongside the personal viewpoints of clinicians, survey reveals a variety of clinical aspects and MRI features that are opened for further more exploration: therapeutic effects, the use of the MRI angiography, dynamics, and other. Conclusions: MRI is a tested imaging method for rapid evaluation of patients with hyperacute cerebral infarction, replacing the use of CT imaging and clinical features. MRI criteria for thrombolytic therapy are being applied in some cerebral vascular centres. In Kosovo, the application of thrombolytic therapy has not started yet. PMID:25729591

Considerations in the development of circulating tumor cell technology for clinical use

PubMed Central

2012-01-01

This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC) technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development–analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA) and the US National Cancer Institute (NCI). PMID:22747748

Concise Review: Process Development Considerations for Cell Therapy

PubMed Central

Brieva, Thomas; Raviv, Lior; Rowley, Jon; Niss, Knut; Brandwein, Harvey; Oh, Steve; Karnieli, Ohad

2015-01-01

The development of robust and well-characterized methods of production of cell therapies has become increasingly important as therapies advance through clinical trials toward approval. A successful cell therapy will be a consistent, safe, and effective cell product, regardless of the cell type or application. Process development strategies can be developed to gain efficiency while maintaining or improving safety and quality profiles. This review presents an introduction to the process development challenges of cell therapies and describes some of the tools available to address production issues. This article will provide a summary of what should be considered to efficiently advance a cellular therapy from the research stage through clinical trials and finally toward commercialization. The identification of the basic questions that affect process development is summarized in the target product profile, and considerations for process optimization are discussed. The goal is to identify potential manufacturing concerns early in the process so they may be addressed effectively and thus increase the probability that a therapy will be successful. Significance The present study contributes to the field of cell therapy by providing a resource for those transitioning a potential therapy from the research stage to clinical and commercial applications. It provides the necessary steps that, when followed, can result in successful therapies from both a clinical and commercial perspective. PMID:26315572

Clinical Relevance of Coronary Fractional Flow Reserve: Art-of-state.

PubMed

Adiputra, Yohanes; Chen, Shao-Liang

2015-05-20

The objective was to delineate the current knowledge of fractional flow reserve (FFR) in terms of definition, features, clinical applications, and pitfalls of measurement of FFR. We searched database for primary studies published in English. The database of National Library of Medicine (NLM), MEDLINE, and PubMed up to July 2014 was used to conduct a search using the keyword term "FFR". The articles about the definition, features, clinical application, and pitfalls of measurement of FFR were identified, retrieved, and reviewed. Coronary pressure-derived FFR rapidly assesses the hemodynamic significance of individual coronary artery lesions and can readily be performed in the catheterization laboratory. The use of FFR has been shown to effectively guide coronary revascularization procedures leading to improved patient outcomes. FFR is a valuable tool to determine the functional significance of coronary stenosis. It combines physiological and anatomical information, and can be followed immediately by percutaneous coronary intervention (PCI) if necessary. The technique of FFR measurement can be performed easily, rapidly, and safely in the catheterization laboratory. By systematic use of FFR in dubious stenosis and multi-vessel disease, PCI can be made an even more effective and better treatment than it is currently. The current clinical evidence for FFR should encourage cardiologists to use this tool in the catheterization laboratory.

Cryopreservation and Revival of Human Mesenchymal Stromal Cells.

PubMed

Haack-Sørensen, Mandana; Ekblond, Annette; Kastrup, Jens

2016-01-01

Cell-based therapy is a promising and innovative new treatment for different degenerative and autoimmune diseases, and mesenchymal stromal cells (MSCs) from the bone marrow have demonstrated great therapeutic potential due to their immunosuppressive and regenerative capacities.The establishment of methods for large-scale expansion of clinical-grade MSCs in vitro has paved the way for their therapeutic use in clinical trials. However, the clinical application of MSCs also requires cryopreservation and banking of the cell products. To preserve autologous or allogeneic MSCs for future clinical applications, a reliable and effective cryopreservation method is required.Developing a successful cryopreservation protocol for clinical stem cell products, cryopreservation media, cryoprotectant agents (CPAs), the freezing container, the freezing temperature, and the cooling and warming rate are all aspects which should be considered.A major challenge is the selection of a suitable cryoprotectant which is able to penetrate the cells and yet has low toxicity.This chapter focuses on recent technological developments relevant for the cryopreservation of MSCs using the most commonly used cryopreservation medium containing DMSO and animal serum or human-derived products for research use and the animal protein-free cryopreservation media CryoStor (BioLife Solutions) for clinical use.

Ultrasound Molecular Imaging: Moving Towards Clinical Translation

PubMed Central

Abou-Elkacem, Lotfi; Bachawal, Sunitha V.; Willmann, Jürgen K.

2015-01-01

Ultrasound is a widely available, cost-effective, real-time, non-invasive and safe imaging modality widely used in the clinic for anatomical and functional imaging. With the introduction of novel molecularly-targeted ultrasound contrast agents, another dimension of ultrasound has become a reality: diagnosing and monitoring pathological processes at the molecular level. Most commonly used ultrasound molecular imaging contrast agents are micron sized, gas-containing microbubbles functionalized to recognize and attach to molecules expressed on inflamed or angiogenic vascular endothelial cells. There are several potential clinical applications currently being explored including earlier detection, molecular profiling, and monitoring of cancer, as well as visualization of ischemic memory in transient myocardial ischemia, monitoring of disease activity in inflammatory bowel disease, and assessment of arteriosclerosis. Recently, a first clinical grade ultrasound contrast agent (BR55), targeted at a molecule expressed in neoangiogenesis (vascular endothelial growth factor receptor type 2; VEGFR2) has been introduced and safety and feasibility of VEGFR2-targeted ultrasound imaging is being explored in first inhuman clinical trials in various cancer types. This review describes the design of ultrasound molecular imaging contrast agents, imaging techniques, and potential future clinical applications of ultrasound molecular imaging. PMID:25851932

Ultrasound molecular imaging: Moving toward clinical translation.

PubMed

Abou-Elkacem, Lotfi; Bachawal, Sunitha V; Willmann, Jürgen K

2015-09-01

Ultrasound is a widely available, cost-effective, real-time, non-invasive and safe imaging modality widely used in the clinic for anatomical and functional imaging. With the introduction of novel molecularly-targeted ultrasound contrast agents, another dimension of ultrasound has become a reality: diagnosing and monitoring pathological processes at the molecular level. Most commonly used ultrasound molecular imaging contrast agents are micron sized, gas-containing microbubbles functionalized to recognize and attach to molecules expressed on inflamed or angiogenic vascular endothelial cells. There are several potential clinical applications currently being explored including earlier detection, molecular profiling, and monitoring of cancer, as well as visualization of ischemic memory in transient myocardial ischemia, monitoring of disease activity in inflammatory bowel disease, and assessment of arteriosclerosis. Recently, a first clinical grade ultrasound contrast agent (BR55), targeted at a molecule expressed in neoangiogenesis (vascular endothelial growth factor receptor type 2; VEGFR2) has been introduced and safety and feasibility of VEGFR2-targeted ultrasound imaging is being explored in first inhuman clinical trials in various cancer types. This review describes the design of ultrasound molecular imaging contrast agents, imaging techniques, and potential future clinical applications of ultrasound molecular imaging. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Sclerostin Antibody Therapy for the Treatment of Osteoporosis: Clinical Prospects and Challenges

PubMed Central

MacNabb, Claire; Patton, D.; Hayes, J. S.

2016-01-01

It is estimated that over 200 million adults worldwide have osteoporosis, a disease that has increasing socioeconomic impact reflected by unsustainable costs associated with disability, fracture management, hospital stays, and treatment. Existing therapeutic treatments for osteoporosis are associated with a variety of issues relating to use, clinical predictability, and health risks. Consequently, additional novel therapeutic targets are increasingly sought. A promising therapeutic candidate is sclerostin, a Wnt pathway antagonist and, as such, a negative regulator of bone formation. Sclerostin antibody treatment has demonstrated efficacy and superiority compared to other anabolic treatments for increasing bone formation in both preclinical and clinical settings. Accordingly, it has been suggested that sclerostin antibody treatment is set to achieve market approval by 2017 and aggressively compete as the gold standard for osteoporotic treatment by 2021. In anticipation of phase III trial results which may potentially signify a significant step in achieving market approval here, we review the preclinical and clinical emergence of sclerostin antibody therapies for both osteoporosis and alternative applications. Potential clinical challenges are also explored as well as ongoing developments that may impact on the eventual clinical application of sclerostin antibodies as an effective treatment of osteoporosis. PMID:27313945

Monomeric DR2/MOG-35-55 recombinant TCR ligand treats relapses of experimental encephalomyelitis in DR2 transgenic mice.

PubMed

Link, Jason M; Rich, Cathleen M; Korat, Maya; Burrows, Gregory G; Offner, Halina; Vandenbark, Arthur A

2007-04-01

Treatment of human autoimmune diseases such as multiple sclerosis (MS) will likely require agents that can prevent or reverse the inflammatory process that results in clinical relapses and disease progression. We evaluated the ability of a newly designed monomeric recombinant TCR ligand (RTL342M) containing HLA-DR2 peptide-binding domains covalently linked to MOG-35-55 peptide to prevent and treat both the initial episode and subsequent relapses of experimental autoimmune encephalomyelitis (EAE) in HLA-DR2 transgenic mice. Single doses of RTL342M given either i.v. or s.c. to HLA-DR2 mice produced a rapid (within 24 h) and dose-dependent reversal of clinical signs of paralytic EAE, and even a single dose < or = 2 microg could produce a significant treatment effect. Multiple daily doses were even more effective than the same total amount of RTL given as a single dose. By establishing the minimal effective dose, we determined that RTLs may be 50 times more potent than molar equivalent doses of myelin peptide alone. RTL342M given prior to induction of EAE prevented disease in most mice, and the remainder could be successfully retreated with RTL. Most important for clinical application, RTL342M was highly effective for treating EAE relapses when given periodically prior to the relapse or even after relapses had occurred. These data demonstrate the rapid and potent clinical effects of RTL342M at disease onset and during relapses in EAE and establish important principles governing the application of this novel approach as a possible therapy for patients with MS.

An Automated Medical Information Management System (OpScan-MIMS) in a Clinical Setting

PubMed Central

Margolis, S.; Baker, T.G.; Ritchey, M.G.; Alterescu, S.; Friedman, C.

1981-01-01

This paper describes an automated medical information management system within a clinic setting. The system includes an optically scanned data entry system (OpScan), a generalized, interactive retrieval and storage software system(Medical Information Management System, MIMS) and the use of time-sharing. The system has the advantages of minimal hardware purchase and maintenance, rapid data entry and retrieval, user-created programs, no need for user knowledge of computer language or technology and is cost effective. The OpScan-MIMS system has been operational for approximately 16 months in a sexually transmitted disease clinic. The system's application to medical audit, quality assurance, clinic management and clinical training are demonstrated.

Recent advances in the biomedical applications of fumaric acid and its ester derivatives: The multifaceted alternative therapeutics.

PubMed

Das, Ratul Kumar; Brar, Satinder Kaur; Verma, Mausam

2016-04-01

Several lines of evidence have demonstrated the potential biomedical applications of fumaric acid (FA) and its ester derivatives against many human disease conditions. Fumaric acid esters (FAEs) have been licensed for the systemic treatment of the immune-mediated disease psoriasis. Biogen Idec Inc. announced about the safety and efficacy of the formulation FAE (BG-12) for treating RRMS (relapsing-remitting multiple sclerosis). Another FAE formulation DMF (dimethyl fumarate) was found to be capable of reduction in inflammatory cardiac conditions, such as autoimmune myocarditis and ischemia and reperfusion. DMF has also been reported to be effective as a potential neuroprotectant against the HIV-associated neurocognitive disorders (HAND). Many in vivo studies carried out on rat and mice models indicated inhibitory effects of fumaric acid on carcinogenesis of different origins. Moreover, FAEs has emerged as an important matrix ingredient in the fabrication of biodegradable scaffolds for tissue engineering applications. Drug delivery vehicles composed of FAEs have shown promising results in delivering some leading drug molecules. Apart from these specific applications and findings, many more studies on FAEs have revealed new therapeutic potentials with the scope of clinical applications. However, until now, this scattered vital information has not been written into a collective account and analyzed for minute details. The aim of this paper is to review the advancement made in the biomedical application of FA and FAEs and to focus on the clinical investigation and molecular interpretation of the beneficial effects of FA and FAEs. Copyright © 2015 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Preventing pressure sores of the nasal ala after nasotracheal tube intubation: from animal model to clinical application.

PubMed

Huang, Tze-Ta; Tseng, Chih-En; Lee, Tsan-Mu; Yeh, Jen-Ying; Lai, Yu-Yung

2009-03-01

Nasal-ala pressure sores induced by nasotracheal intubation are common complications of oral and maxillofacial surgery, but are easily ignored. To determine whether such sores could be prevented, we studied the effects of a combination of cushioning material in an animal model, and then analyzed the efficacy of this combination clinically. Four pigs received nasotracheal intubation. Each pig received intubation for 4, 8, 12, or 16 hours. Outcomes from pigs undergoing 500-gram-weight compression on each nostril were compared: one nostril received an application of cushioning materials, and the contralateral nostril did not. After the required study period, clinical assessment and further evaluation were performed by measuring pressure-sore dimensions and performing incisional biopsies. Clinical applications of this protective technique were then undertaken. Eight patients who underwent intubation without Soft Liner (GC Co, Tokyo, Japan) and DuoDERM CGF (ConvaTec, Inc, Princeton, NJ) protection, and 10 patients with Soft Liner and DuoDERM protection, were evaluated. The protective efficacy of the cushioning materials was significant in the animal model as well as in clinical practice. Pressure sores were avoided on the protected side, with severe tissue necrosis documented on the control side. We found that the combined use of Soft Liner and DuoDERM reduced the size and severity of nasal-ala pressure sores attributable to nasotracheal intubation during oral and maxillofacial surgery.

Does medical students' clinical performance affect their actual performance during medical internship?

PubMed

Han, Eui-Ryoung; Chung, Eun-Kyung

2016-02-01

This study examines the relationship between the clinical performance of medical students and their performance as doctors during their internships. This retrospective study involved 63 applicants to a residency programme conducted at the Chonnam National University Hospital, South Korea, in November 2012. We compared the performance of the applicants during their internship with the clinical performance of the applicants during their fourth year of medical school. The performance of the applicants as interns was periodically evaluated by the faculty of each department, while the clinical performance of the applicants as fourth year medical students was assessed using the Clinical Performance Examination (CPX) and the Objective Structured Clinical Examination (OSCE). The performance of the applicants as interns was positively correlated with their clinical performance as fourth year medical students, as measured by CPX and OSCE. The performance of the applicants as interns was moderately correlated with the patient-physician interactions items addressing communication and interpersonal skills in the CPX. The clinical performance of medical students during their fourth year in medical school was related to their performance as medical interns. Medical students should be trained to develop good clinical skills, through actual encounters with patients or simulated encounters using manikins, so that they are able to become competent doctors. Copyright © Singapore Medical Association.

Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

PubMed

Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

2017-11-01

Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

How to apply clinical cases and medical literature in the framework of a modified "failure mode and effects analysis" as a clinical reasoning tool--an illustration using the human biliary system.

PubMed

Wong, Kam Cheong

2016-04-06

Clinicians use various clinical reasoning tools such as Ishikawa diagram to enhance their clinical experience and reasoning skills. Failure mode and effects analysis, which is an engineering methodology in origin, can be modified and applied to provide inputs into an Ishikawa diagram. The human biliary system is used to illustrate a modified failure mode and effects analysis. The anatomical and physiological processes of the biliary system are reviewed. Failure is defined as an abnormality caused by infective, inflammatory, obstructive, malignancy, autoimmune and other pathological processes. The potential failures, their effect(s), main clinical features, and investigation that can help a clinician to diagnose at each anatomical part and physiological process are reviewed and documented in a modified failure mode and effects analysis table. Relevant medical and surgical cases are retrieved from the medical literature and weaved into the table. A total of 80 clinical cases which are relevant to the modified failure mode and effects analysis for the human biliary system have been reviewed and weaved into a designated table. The table is the backbone and framework for further expansion. Reviewing and updating the table is an iterative and continual process. The relevant clinical features in the modified failure mode and effects analysis are then extracted and included in the relevant Ishikawa diagram. This article illustrates an application of engineering methodology in medicine, and it sows the seeds of potential cross-pollination between engineering and medicine. Establishing a modified failure mode and effects analysis can be a teamwork project or self-directed learning process, or a mix of both. Modified failure mode and effects analysis can be deployed to obtain inputs for an Ishikawa diagram which in turn can be used to enhance clinical experiences and clinical reasoning skills for clinicians, medical educators, and students.

The effect of music video exposure on students' perceived clinical applications of popular music in the field of music therapy: a pilot study.

PubMed

Gooding, Lori F; Mori-Inoue, Satoko

2011-01-01

The purpose of this study was to examine the effect of video exposure on music therapy students' perceptions of clinical applications of popular music in the field of music therapy. Fifty-one participants were randomly divided into two groups and exposed to a popular song in either audio-only or music video format. Participants were asked to indicate clinical applications; specifically, participants chose: (a) possible population(s), (b) most appropriate population(s), (c) possible age range(s), (d) most appropriate age ranges, (e) possible goal area(s) and (f) most appropriate goal area. Data for each of these categories were compiled and analyzed, with no significant differences found in the choices made by the audio-only and video groups. Three items, (a) selection of the bereavement population, (b) selection of bereavement as the most appropriate population and (c) selection of the age ranges of pre teen/mature adult, were additionally selected for further analysis due to their relationship to the video content. Analysis results revealed a significant difference between the video and audio-only groups for the selection of these specific items, with the video group's selections more closely aligned to the video content. Results of this pilot study suggest that music video exposure to popular music can impact how students choose to implement popular songs in the field of music therapy.

Alternative treatments for adults with attention-deficit hyperactivity disorder (ADHD).

PubMed

Arnold, L E

2001-06-01

A previous review of alternative treatments (Tx) of ADHD--those other than psychoactive medication and behavioral/psychosocial Tx--was supplemented with an additional literature search focused on adults with ADHD. Twenty-four alternative Tx were identified, ranging in scientific documentation from discrediting controlled studies through mere hypotheses to positive controlled double-blind clinical trials. Many of them are applicable only to a specific subgroup. Although oligoantigenic (few-foods) diets have convincing double-blind evidence of efficacy for a properly selected subgroup of children, they do not appear promising for adults. Enzyme-potentiated desensitization, relaxation/EMG biofeedback, and deleading also have controlled evidence of efficacy. Iron supplementation, magnesium supplementation, Chinese herbals, EEG biofeedback, massage, meditation, mirror feedback, channel-specific perceptual training, and vestibular stimulation all have promising prospective pilot data, many of these tests reasonably controlled. Single-vitamin megadosage has some intriguing pilot trial data. Zinc supplementation is hypothetically supported by systematic case-control data, but no systematic clinical trial. Laser acupuncture has promising unpublished pilot data and may be more applicable to adults than children. Essential fatty acid supplementation has promising systematic case-control data, but clinical trials are equivocal. RDA vitamin supplementation, non-Chinese herbals, homeopathic remedies, and antifungal therapy have no systematic data in ADHD. Megadose multivitamin combinations are probably ineffective for most patients and are possibly dangerous. Simple sugar restriction seems ineffective. Amino acid supplementation is mildly effective in the short term, but not beyond 2-3 months. Thyroid treatment is effective in the presence of documented thyroid abnormality. Some alternative Tx of ADHD are effective or probably effective, but mainly for certain patients. In some cases, they are the Tx of choice, and initial evaluation should consider the relevant etiologies. A few have failed to prove effective in controlled trials. Most need research to determine whether they are effective and/or to define the applicable subgroup. Some of them, although not safer than standard Tx, may be preferable for an etiologic subgroup.

A continuous-time adaptive particle filter for estimations under measurement time uncertainties with an application to a plasma-leucine mixed effects model

PubMed Central

2013-01-01

Background When mathematical modelling is applied to many different application areas, a common task is the estimation of states and parameters based on measurements. With this kind of inference making, uncertainties in the time when the measurements have been taken are often neglected, but especially in applications taken from the life sciences, this kind of errors can considerably influence the estimation results. As an example in the context of personalized medicine, the model-based assessment of the effectiveness of drugs is becoming to play an important role. Systems biology may help here by providing good pharmacokinetic and pharmacodynamic (PK/PD) models. Inference on these systems based on data gained from clinical studies with several patient groups becomes a major challenge. Particle filters are a promising approach to tackle these difficulties but are by itself not ready to handle uncertainties in measurement times. Results In this article, we describe a variant of the standard particle filter (PF) algorithm which allows state and parameter estimation with the inclusion of measurement time uncertainties (MTU). The modified particle filter, which we call MTU-PF, also allows the application of an adaptive stepsize choice in the time-continuous case to avoid degeneracy problems. The modification is based on the model assumption of uncertain measurement times. While the assumption of randomness in the measurements themselves is common, the corresponding measurement times are generally taken as deterministic and exactly known. Especially in cases where the data are gained from measurements on blood or tissue samples, a relatively high uncertainty in the true measurement time seems to be a natural assumption. Our method is appropriate in cases where relatively few data are used from a relatively large number of groups or individuals, which introduce mixed effects in the model. This is a typical setting of clinical studies. We demonstrate the method on a small artificial example and apply it to a mixed effects model of plasma-leucine kinetics with data from a clinical study which included 34 patients. Conclusions Comparisons of our MTU-PF with the standard PF and with an alternative Maximum Likelihood estimation method on the small artificial example clearly show that the MTU-PF obtains better estimations. Considering the application to the data from the clinical study, the MTU-PF shows a similar performance with respect to the quality of estimated parameters compared with the standard particle filter, but besides that, the MTU algorithm shows to be less prone to degeneration than the standard particle filter. PMID:23331521

A novel cardiac extracorporeal shock wave for enhancing the efficacy of cell therapy

NASA Astrophysics Data System (ADS)

Khaled, Walaa; Assmus, Birgit; Lutz, Andreas; Walter, Dirk; Leistner, David; Dimmeler, Stefanie; Zeiher, Andreas

2012-11-01

Targeted therapy can maximize therapeutic efficiency and minimize the side effects of drug treatments, especially for cancer and cardiovascular disease. In previous in-vitro experiments, it was shown that shock wave (SW) application can change the permeability of cell membranes for tumor therapy. Similarly, in animal studies, extracorporeal SWs were proven to increase expression of growth and homing factors like SDF-1 and vascular endothelial growth factor (VEGF) within a targeted ischemic tissue. This pretreatment increased the homing and neovascularization following application of bone marrow-derived mononuclear cells (BMC). In a randomized, double blinded, placebo-controlled clinical trial, 103 patients were recruited with stable chronic post-infarction heart failure (CHF). The goal of this work was to demonstrate improved recovery of left ventricular contractile function (LVEF) by combining targeted SW application with subsequent BMC administration. Results showed that the shock wavefacilitated intracoronary BMC administration in patients with chronic post-infarction heart failure is associated with significant persistent improvements in LVEF contractile function, NYHA class, and reduction of major adverse clinical events during extended clinical follow-up. (clinicaltrials.gov: NCT00326989).

Personalized skincare: from molecular basis to clinical and commercial applications.

PubMed

Markiewicz, Ewa; Idowu, Olusola Clement

2018-01-01

Individual responses of human skin to the environmental stress are determined by differences in the anatomy and physiology that are closely linked to the genetic characteristics such as pigmentation. Ethnic skin phenotypes can be distinguished based on defined genotypic traits, structural organization and compartmentalized sensitivity to distinct extrinsic aging factors. These differences are not only responsible for the variation in skin performance after exposure to damaging conditions, but can also affect the mechanisms of drug absorption, sensitization and other longer term effects. The unique characteristics of the individual skin function and, particularly, of the ethnic skin type are currently considered to shape the future of clinical and pharmacologic interventions as a basis for personalized skincare. Individual approaches to skincare render a novel and actively growing area with a range of biomedical and commercial applications within cosmetics industry. In this review, we summarize the aspects of the molecular and clinical manifestations of the environmental stress on human skin and proposed protective mechanisms that are linked to ethnic differences and pathophysiology of extrinsic skin aging. We subsequently discuss the possible applications and translation of this knowledge into personalized skincare.

Personalized skincare: from molecular basis to clinical and commercial applications

PubMed Central

Markiewicz, Ewa; Idowu, Olusola Clement

2018-01-01

Individual responses of human skin to the environmental stress are determined by differences in the anatomy and physiology that are closely linked to the genetic characteristics such as pigmentation. Ethnic skin phenotypes can be distinguished based on defined genotypic traits, structural organization and compartmentalized sensitivity to distinct extrinsic aging factors. These differences are not only responsible for the variation in skin performance after exposure to damaging conditions, but can also affect the mechanisms of drug absorption, sensitization and other longer term effects. The unique characteristics of the individual skin function and, particularly, of the ethnic skin type are currently considered to shape the future of clinical and pharmacologic interventions as a basis for personalized skincare. Individual approaches to skincare render a novel and actively growing area with a range of biomedical and commercial applications within cosmetics industry. In this review, we summarize the aspects of the molecular and clinical manifestations of the environmental stress on human skin and proposed protective mechanisms that are linked to ethnic differences and pathophysiology of extrinsic skin aging. We subsequently discuss the possible applications and translation of this knowledge into personalized skincare. PMID:29692619

Mind–body interventions

PubMed Central

Wahbeh, Helané; Elsas, Siegward-M.; Oken, Barry S.

2010-01-01

Objective Half of the adults in the United States use complementary and alternative medicine with mind–body therapy being the most commonly used form. Neurology patients often turn to their physicians for insight into the effectiveness of the therapies and resources to integrate them into their care. The objective of this article is to give a clinical overview of mind–body interventions and their applications in neurology. Methods Medline and PsychInfo were searched on mind–body therapies and neurologic disease search terms for clinical trials and reviews and published evidence was graded. Results Meditation, relaxation, and breathing techniques, yoga, tai chi, and qigong, hypnosis, and biofeedback are described. Mind–body therapy application to general pain, back and neck pain, carpal tunnel syndrome, headaches, fibromyalgia, multiple sclerosis, epilepsy, muscular dysfunction, stroke, aging, Parkinson disease, stroke, and attention deficit–hyperactivity disorder are reviewed. Conclusions There are several conditions where the evidence for mind–body therapies is quite strong such as migraine headache. Mind–body therapies for other neurology applications have limited evidence due mostly to small clinical trials and inadequate control groups. PMID:18541886

High doses of corticosteroid suppress resistance to Ichthyophonus in starry flounder

USGS Publications Warehouse

Perry, J.A.; Kocan, R.M.; Winton, J.R.; Hershberger, P.K.

2004-01-01

Application of pharmacological doses of the corticosteroid dexamethasone phosphate to starry flounder Platichthys stellatus resulted in a predisposition to clinical ichthyophoniasis and a progression from latent Ichthyophonus infections to patent, histologically identifiable infections. Among Ichthyophonus-challenged starry flounder, the prevalences of clinical infections and histologically identifiable infections were significantly greater in two groups that received dexamethasone (100% and 31%, respectively) than in the respective control groups (8% and 0%). Proliferation of Ichthyophonus infections in corticosteroid-treated groups may have resulted from suppression of the cellular immune response that typically follows corticosteroid application; however, further studies are needed to determine whether these effects occur at lower, physiological concentrations of corticosteroids.

The role of lasers and intense pulsed light technology in dermatology

PubMed Central

Husain, Zain; Alster, Tina S

2016-01-01

The role of light-based technologies in dermatology has expanded dramatically in recent years. Lasers and intense pulsed light have been used to safely and effectively treat a diverse array of cutaneous conditions, including vascular and pigmented lesions, tattoos, scars, and undesired hair, while also providing extensive therapeutic options for cosmetic rejuvenation and other dermatologic conditions. Dermatologic laser procedures are becoming increasingly popular worldwide, and demand for them has fueled new innovations and clinical applications. These systems continue to evolve and provide enhanced therapeutic outcomes with improved safety profiles. This review highlights the important roles and varied clinical applications that lasers and intense pulsed light play in the dermatologic practice. PMID:26893574

Effects of medical school selection on student motivation: a PhD thesis report.

PubMed

Wouters, Anouk

2018-02-01

High stakes are involved in student selection, for both medical schools and applicants. This thesis investigated the effects of selection on the medical student population and applicant pool in the Dutch setting. This thesis consists of six papers: two quantitative studies, one qualitative study, two mixed methods studies and one perspective paper based on a review of the literature. (1) Compared with a lottery, selection does not result in a student population with better motivation, engagement and performance, both in the clinical and pre-clinical phases of the study. (2) Selection seems to have a temporary stimulating effect on student motivation through enhancing perceived autonomy, competence and relatedness. (3) Applicants adopt a strategic approach, based on the selection procedure, in their choice of medical school. (4) The description of an applicant's motivation is not a reliable and valid tool to assess motivation during selection. (5) Gaining healthcare experience is crucial for applicants' motivation, but inequalities in access to such experiences can demotivate certain student groups from applying to medical school. (6) The gains yielded from selection compared with a lottery seem to be small. Unintentionally induced self-selection among certain groups of students and biased selection procedures may compromise student diversity. The added value of selection procedures compared with a weighted lottery for admitting students to medical school is questionable. Students are generally motivated and perform well, irrespective of how they enrolled in medical school. Selection yields only small gains, while student diversity may be hampered.

42 CFR 447.321 - Outpatient hospital and clinic services: Application of upper payment limits.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Outpatient hospital and clinic services: Application of upper payment limits. 447.321 Section 447.321 Public Health CENTERS FOR MEDICARE & MEDICAID... Clinic Services § 447.321 Outpatient hospital and clinic services: Application of upper payment limits...

Balancing the Need for Clinical Photography With Patient Privacy Issues: The Search for a Secure SmartPhone Application to Take and Store Clinical Photographs.

PubMed

Dumestre, Danielle O; Fraulin, Frankie O G

2017-11-01

Physicians are increasingly using smartphones to take clinical photographs. This study evaluates a smartphone application for clinical photography that prioritizes and facilitates patient security. Ethics approval was obtained to trial a smartphone clinical photography application, PicSafe Medi. Calgary plastic surgeons and residents used the application to obtain informed consent and photograph patients. Surveys gauging the application's usability, consent process, and photograph storage/sharing were then sent to surgeons and patients. Over a 6-month trial period, 15 plastic surgeons and residents used the application to photograph 86 patients. Over half of the patients (57%) completed the survey. The majority of patients (96%) were satisfied with the application's consent process, and all felt their photographs were secure. The majority (93%) of surgeons/residents completed the survey. The application was felt to overcome issues with current photography practices: inadequate consent and storage of photographs (100%), risk to patient confidentiality (92%), and unsecure photograph sharing (93%). Barriers to regular use of the application included need for cellphone service/Internet (54%), sanitary concerns due to the need for patients to sign directly on the phone (46%), inability to obtain proactive/retroactive consent (85%), and difficulty viewing photographs (80%). The majority of surgeons (85%) believe a smartphone application would be suitable for clinical patient photography, but due to its limitations, only 23% would use the trialed application. A smartphone clinical photography application addresses the patient confidentiality risks of current photography methods; however, limitations of the trialed application prevent its broad implementation.

[Implementation of transgingival antibacterial photodynamic therapy (PDT) supplementary to scaling and root planing. A controlled clinical proof-of-principle study].

PubMed

Mettraux, Gérald; Hüsler, Jürg

2011-01-01

The antibacterial photodynamic therapy (PDT) has been effective in the periodontal therapy. The laser light application reported in the literature so far is the subgingival placement of a light fibre. To study the effect of PDT with a transgingival laser application. In 19 patients with untreated periodontitis 1 test and 1 control site were selected. Both pockets were treated by scaling, root planing. the Test site received additional PDT (LASOTRONIC MED 701 by ORCOS MEDICAL, Switzerland) at baseline, after 2 and 6 months. The control sites were rinsed with ringer solution. Clinical parameters (ST, BOP, CAL) and bacterial monitoring (PADO, IAI, Switzerland) at baseline, 2 and 6 months were recorded. Mean pocket reduction was after 6 months 2.1 mm (+/-1.4) in the test group, 1.5 mm (+/-1.6) in the control group significantly different. The 95% confidence interval for the difference of the mean reductions of the test and control group after 6 months is (1.5, 3). Mean CAL gain after 6 months was 1.5 mm (+/-1.3) in the test, 0.9 mm (+/-1.7) in the control group. T. denticola showed lower number after 2 and 6 months in the test versus the control. The total bacterial load (TBL) showed significantly better reduction in the test group at 6 months. The transgingival application of PDT with the MED 701 showed clinical and bacteriological effects which are comparable to those reported in the literature with the subgingival method. The transgingival method is convenient, harmless and easy to perform.

Data for Cancer Comparative Effectiveness Research: Past, Present, and Future Potential

PubMed Central

Meyer, Anne-Marie; Carpenter, William R; Abernethy, Amy P.; Stürmer, Til; Kosorok, Michael R.

2012-01-01

Background Comparative effectiveness research (CER) can efficiently and rapidly generate new scientific evidence and address knowledge gaps, reduce clinical uncertainty, and guide health care choices. Much of the potential in CER is driven by the application of novel methods to analyze existing data. Despite its potential, several challenges must be identified and overcome so that CER may be improved, accelerated, and expeditiously implemented into the broad spectrum of cancer care and clinical practice. Methods To identify and characterize the challenges to cancer CER, we reviewed the literature and conducted semi-structured interviews with 41 cancer CER researchers at the Agency for Healthcare Research and Quality (AHRQ)'s Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Cancer CER Consortium. Results A number of datasets for cancer CER were identified and differentiated into an ontology of eight categories, and characterized in terms of strengths, weaknesses, and utility. Several themes emerged during development of this ontology and discussions with CER researchers. Dominant among them was accelerating cancer CER and promoting the acceptance of findings, which will necessitate transcending disciplinary silos to incorporate diverse perspectives and expertise. Multidisciplinary collaboration is required including those with expertise in non-experimental data, outcomes research, clinical trials, epidemiology, generalist and specialty medicine, survivorship, informatics, data, and methods, among others. Conclusions Recommendations highlight the systematic, collaborative identification of critical measures; application of more rigorous study design and sampling methods; policy-level resolution of issues in data ownership, governance, access, and cost; and development and application of consistent standards for data security, privacy, and confidentiality. PMID:22517505

Data for cancer comparative effectiveness research: past, present, and future potential.

PubMed

Meyer, Anne-Marie; Carpenter, William R; Abernethy, Amy P; Stürmer, Til; Kosorok, Michael R

2012-11-01

Comparative effectiveness research (CER) can efficiently and rapidly generate new scientific evidence and address knowledge gaps, reduce clinical uncertainty, and guide health care choices. Much of the potential in CER is driven by the application of novel methods to analyze existing data. Despite its potential, several challenges must be identified and overcome so that CER may be improved, accelerated, and expeditiously implemented into the broad spectrum of cancer care and clinical practice. To identify and characterize the challenges to cancer CER, the authors reviewed the literature and conducted semistructured interviews with 41 cancer CER researchers at the Agency for Healthcare Research and Quality's Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Cancer CER Consortium. Several data sets for cancer CER were identified and differentiated into an ontology of 8 categories and were characterized in terms of strengths, weaknesses, and utility. Several themes emerged during the development of this ontology and discussions with CER researchers. Dominant among them was accelerating cancer CER and promoting the acceptance of findings, which will necessitate transcending disciplinary silos to incorporate diverse perspectives and expertise. Multidisciplinary collaboration is required, including those with expertise in nonexperimental data, statistics, outcomes research, clinical trials, epidemiology, generalist and specialty medicine, survivorship, informatics, data, and methods, among others. Recommendations highlight the systematic, collaborative identification of critical measures; application of more rigorous study design and sampling methods; policy-level resolution of issues in data ownership, governance, access, and cost; and development and application of consistent standards for data security, privacy, and confidentiality. Copyright © 2012 American Cancer Society.

The Role of Ursodeoxycholic Acid in Acute Viral Hepatitis: an Evidence-based Case Report.

PubMed

Wijaya, Indra

2015-10-01

to review the role of ursodeoxycholic acid in acute viral hepatitis. following literature searching according to the clinical question on Pubmed and Cochrane Library. After filtered with our inclusion and exclusion criteria, one meta-analysis and two randomized clinical trials are obtained. Through critical appraisal, it was concluded that the articles meet the criteria for validity and relevance. the article found that there is a positive effect of ursodeoxycholic acid on the activity of serum transaminases and cholestasis indexes. However, there is insufficient evidence to support or to refute effects of ursodeoxycholic acid on disease's course as well as the viral load. better method of clinical trials are needed to obtain a valid and applicable result for daily practice.

Overview of Experimental and Clinical Findings regarding the Neuroprotective Effects of Cerebral Ischemic Postconditioning.

PubMed

Ma, Di; Feng, Liangshu; Deng, Fang; Feng, Jia-Chun

2017-01-01

Research on attenuating the structural and functional deficits observed following ischemia-reperfusion has become increasingly focused on the therapeutic potential of ischemic postconditioning. In recent years, various methods and animal models of ischemic postconditioning have been utilized. The results of these numerous studies have indicated that the mechanisms underlying the neuroprotective effects of ischemic postconditioning may involve reductions in the generation of free radicals and inhibition of calcium overload, as well as the release of endogenous active substances, alterations in membrane channel function, and activation of protein kinases. Here we review the novel discovery, mechanism, key factors, and clinical application of ischemic postconditioning and discuss its implications for future research and problem of clinical practice.

Understanding the 'Silver Book' - An important reference for standardised nomenclature in clinical laboratory sciences.

PubMed

Flatman, Robert; Férard, Georges; Dybkaer, René

2017-04-01

Clinical laboratories perform a wide menu of testing (examinations). Successful requesting, examination, and ordering in this environment requires clear standardised nomenclature. The Silver Book (SB) is an IUPAC (International Union of Pure and Applied Chemistry) publication, produced with the support of both IUPAC and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), that makes recommendations on logical standardised nomenclature, symbols, properties, and units in many disciplines of the clinical laboratory sciences. These recommendations are founded on and in agreement with the principles and work of the International Organization for Standardization (ISO), Bureau International des Poids et Mesures (BIPM), IUPAC, and the IFCC. Practical applications described are based on those scientific principles. The SB recommendations apply to all types of examination, not only to measurement of quantities but also examination of nominal properties where no magnitude is involved. The SB is applicable not only to clinical chemistry, but to many other clinical laboratory disciplines. For examples, reports regarding haemostasis, toxicology, clinical microbiology, reproduction and fertility, clinical pharmacology, clinical allergology, clinical molecular biology, and clinical immunohaematology have been published by the IUPAC and the IFCC. Peak scientific bodies such as the IUPAC and the IFCC have important roles in the development of sound international standards for nomenclature of examinations. Such standards support safe and effective representation of patient health information, foster portability, and empower future decision support systems. Copyright © 2016. Published by Elsevier B.V.

Combination of photodynamic therapy and immunomodulation — current status and future trends

PubMed Central

Qiang, Yong-Gang; Yow, Christine M.N.; Huang, Zheng

2008-01-01

Photodynamic therapy (PDT) has been used for the treatment of non-malignant and malignant diseases from head to toe. Over the last decade its clinical application has gained increasing acceptance around the world. Pre-clinical studies demonstrate that, in addition to the direct local cytotoxicity and vascular effects, PDT can induce various host immune responses. Recent clinical data also show that improved clinical outcomes are obtained through the combination of PDT and immunomodulation. This review will summarize and discuss recent progress in developing innovative regimen of PDT combined with immunomodulation for the treatment of both non-malignant and malignant diseases. PMID:18161883

Microcomputer Calculated Diagnostic X-Ray Exposure Factors: Clinical Evaluation

PubMed Central

Markivee, C. R.; Edwards, F. Marc; Leonard, Patricia

1981-01-01

Calculation of correct settings for the controls of a diagnostic x-ray machine was established as feasible in a microcomputer with 4K memory. The cost effectiveness and other findings in the application of this method are discussed.

May spa therapy be a valid opportunity to treat hand osteoarthritis? A review of clinical trials and mechanisms of action

NASA Astrophysics Data System (ADS)

Fortunati, Nicola Angelo; Fioravanti, Antonella; Seri, Gina; Cinelli, Simone; Tenti, Sara

2016-01-01

Osteoarthritis (OA) is the most common form of arthritis and its current treatment includes non-pharmacological and pharmacological modalities. Spa therapy represents a popular treatment for many rheumatic diseases. The aim of this review was to summarize the currently available information on clinical effects and mechanisms of action of spa therapy in OA of the hand. We conducted a search of the literature to extract articles describing randomized clinical trials (RCTs) in hand OA published in the period 1952-2015. We identified three assessable articles reporting RCTs on spa therapy in hand OA. Data from these clinical trials support a beneficial effect of spa therapy on pain, function and quality of life in hand OA. Spa therapy seems to have a role in the treatment of hand OA. However, additional RCTs are necessary to clarify the mechanisms of action and the effects of the application of thermal treatments.

Comparing the effect of topical application of human milk and dry cord care on umbilical cord separation time in healthy newborn infants.

PubMed

Aghamohammadi, Azar; Zafari, Mandana; Moslemi, Leila

2012-06-01

Comparing the effect of topical human milk application and dry cord care on cord separation time. This research was a randomized clinical trial study on 130 singleton and mature newborns. Newborns were placed randomly in groups of topical application of human milk and dry cord care. The umbilical separation time was compared in the two groups. Data was analyzed by SPSS software. Independent Samples t-Test, χ(2), Fisher were used in this study. Median time of cord separation in human milk application group (150.95±28.68 hours) was significantly shorter than dry cord care group (180.93±37.42 hours) (P<0.001). Topical application of human milk on the remaining part of the cord reduces the cord separation time and it can be used as an easy, cheap and non invasive way for cord care.

Use of Flowchart for Automation of Clinical Protocols in mHealth.

PubMed

Dias, Karine Nóra; Welfer, Daniel; Cordeiro d'Ornellas, Marcos; Pereira Haygert, Carlos Jesus; Dotto, Gustavo Nogara

2017-01-01

For healthcare professionals to use mobile applications we need someone who knows software development, provide them. In healthcare institutions, health professionals use clinical protocols to govern care, and sometimes these documents are computerized through mobile applications to assist them. This work aims to present a proposal of an application of flow as a way of describing clinical protocols for automatic generation of mobile applications to assist health professionals. The purpose of this research is to enable health professionals to develop applications from the description of their own clinical protocols. As a result, we developed a web system that automates clinical protocols for an Android platform, and we validated with two clinical protocols used in a Brazilian hospital. Preliminary results of the developed architecture demonstrate the feasibility of this study.

Low Energy Laser Biostimulation: New Prospects For Medical Applications

NASA Astrophysics Data System (ADS)

Castel, John C.; Abergel, R. Patrick; Willner, Robert E.; Baumann, James G.

1987-03-01

The therapeutic benefits of light-energy is not a new concept to the modern world. Documented applications from ancient times tell of the therapeutic effects of ordinary sun-light to treat such common ailments as painful body joints, wounds, compound fractures and tetanus. The discovery of laser light in the 1960's, opened up new prospects for the medical use of light. Laser light differs from other forms of electromagnetic spectrum in that a single wavelength rather than a spectrum of wavelengths is emitted. Since the early 1970's, low-energy laser radiation has been reported to enhance wound healing rates, reduce edema, and relieve musculoskeletal pain. There is no detectable thermal effect of this laser on the tissue being treated. The effects are considered to occur as a result of photochemical, non thermal effects of the laser beam. Photons are absorbed by the tissue being treated and, in turn, produce positive therapeutic effects such as reduction of pain and edema. Pre-clinical and clinical evaluations are, presently, underway to document the safety and efficacy of low energy laser therapy, which represents a significant advance in the non-invasive treatment of pain.

Dosimetric evaluation of a MOSFET detector for clinical application in photon therapy.

PubMed

Kohno, Ryosuke; Hirano, Eriko; Nishio, Teiji; Miyagishi, Tomoko; Goka, Tomonori; Kawashima, Mitsuhiko; Ogino, Takashi

2008-01-01

Dosimetric characteristics of a metal oxide-silicon semiconductor field effect transistor (MOSFET) detector are studied with megavoltage photon beams for patient dose verification. The major advantages of this detector are its size, which makes it a point dosimeter, and its ease of use. In order to use the MOSFET detector for dose verification of intensity-modulated radiation therapy (IMRT) and in-vivo dosimetry for radiation therapy, we need to evaluate the dosimetric properties of the MOSFET detector. Therefore, we investigated the reproducibility, dose-rate effect, accumulated-dose effect, angular dependence, and accuracy in tissue-maximum ratio measurements. Then, as it takes about 20 min in actual IMRT for the patient, we evaluated fading effect of MOSFET response. When the MOSFETs were read-out 20 min after irradiation, we observed a fading effect of 0.9% with 0.9% standard error of the mean. Further, we applied the MOSFET to the measurement of small field total scatter factor. The MOSFET for dose measurements of small field sizes was better than the reference pinpoint chamber with vertical direction. In conclusion, we assessed the accuracy, reliability, and usefulness of the MOSFET detector in clinical applications such as pinpoint absolute dosimetry for small fields.

Induced pluripotent stem cells in hematology: current and future applications

PubMed Central

Focosi, D; Amabile, G; Di Ruscio, A; Quaranta, P; Tenen, D G; Pistello, M

2014-01-01

Reprogramming somatic cells into induced pluripotent stem (iPS) cells is nowadays approaching effectiveness and clinical grade. Potential uses of this technology include predictive toxicology, drug screening, pathogenetic studies and transplantation. Here, we review the basis of current iPS cell technology and potential applications in hematology, ranging from disease modeling of congenital and acquired hemopathies to hematopoietic stem and other blood cell transplantation. PMID:24813079

JPRS Report, Science & Technology, Europe & Latin America.

DTIC Science & Technology

1988-01-21

this way we can analyze the elements that control the 27 cell-specific and temporal expression of genes, and study the effects of genie expression... effects of new genetic diversity that a scientific basis will be created for the establishment of efficient regulation. 5) Feasibility studies for...which I am involved inatituted a multi- centric study to evaluate the real clinical applicability and diagnostic effectiveness of associating

Systematic analysis of the scatter environment in clinical intra-operative high dose rate (IOHDR) brachytherapy

NASA Astrophysics Data System (ADS)

Oh, Moonseong

Most brachytherapy planning systems are based on a dose calculation algorithm that assumes an infinite scatter environment surrounding the target volume and applicator. In intra-operative high dose rate brachytherapy (IOHDR) where treatment catheters are typically laid either directly on a tumor bed or within applicators that may have little or no scatter material above them, the lack of scatter from one side of the applicator can result in serious underdosage during treatment. Therefore, full analyses of the physical processes such as the photoelectric effect, Rayleigh, and Compton scattering that contribute to dosimetric errors have to be investigated and documented to result in more accurate treatment delivery to patients undergoing IOHDR procedures. Monte Carlo simulation results showed the Compton scattering effect is about 40 times more probable than photoelectric effect for the treated areas of single source, 4 x 4, and 2 x 4 cm2. Also, the dose variations with and without photoelectric effect were 0.3 ˜ 0.7%, which are within the uncertainty in Monte Carlo simulations. Also, Monte Carlo simulation studies were done to verify the following experimental results for quantification of dosimetric errors in clinical IOHDR brachytherapy. The first experimental study was performed to quantify the inaccuracy in clinical dose delivery due to the incomplete scatter conditions inherent in IOHDR brachytherapy. Treatment plans were developed for 3 different treatment surface areas (4 x 4, 7 x 7, 12 x 12 cm2), each with prescription points located at 3 distances (0.5 cm, 1.0 cm, and 1.5 cm) from the source dwell positions. Measurements showed that the magnitude of the underdosage varies from about 8% to 13% of the prescription dose as the prescription depth is increased from 0.5 cm to 1.5 cm. This treatment error was found to be independent of the irradiated area and strongly dependent on the prescription distance. The study was extended to confirm the underdosage for various shape of treated area (especially, irregular shape), which can be applied in clinical cases. Treatment plans of 10 patients previously treated at Roswell Park Cancer Institute in Buffalo, which had irregular shapes of treated areas, were used. In IOHDR brachytherapy, a 2-dimensional (2-D) planar geometry is typically used without considering the curved shape of target surfaces. In clinical cases, this assumption of the planar geometry may cause the serious dose delivery errors to target volumes. The second study was performed to investigate the dose errors to curved surfaces. Seven rectangular shaped plans (five for 1.0 cm and two for 0.5 cm prescription depth) and archived irregular shaped plans of 2 patients were analyzed. Cylindrical phantoms with six radii (ranged 1.35 to 12.5 cm) were used to simulate the treatment planning geometries, which were calculated in 2-D plans. Actual doses delivered to prescription points were over-estimated up to 15% on the concave side of curved applicators for all cylindrical phantoms with 1.0 cm prescription depth. Also, delivered doses decreased by up to 10% on the convex side of curved applicators for small treated areas (≤ 5catheters), but interestingly, any dose dependence was not shown with large treated areas. Our measurements have shown inaccuracy in dose delivery when the original planar treatment plan was delivered in a curved applicator setting. Dose errors arising due to the tumor curvature may be significant in a clinical set up and merit attention during planning.

Recent Developments in Cellular Immunotherapy for HSCT-Associated Complications

PubMed Central

Reis, Monica; Ogonek, Justyna; Qesari, Marsela; Borges, Nuno M.; Nicholson, Lindsay; Preußner, Liane; Dickinson, Anne Mary; Wang, Xiao-nong; Weissinger, Eva M.; Richter, Anne

2016-01-01

Allogeneic hematopoietic stem cell transplantation is associated with serious complications, and improvement of the overall clinical outcome of patients with hematological malignancies is necessary. During the last decades, posttransplant donor-derived adoptive cellular immunotherapeutic strategies have been progressively developed for the treatment of graft-versus-host disease (GvHD), infectious complications, and tumor relapses. To date, the common challenge of all these cell-based approaches is their implementation for clinical application. Establishing an appropriate manufacturing process, to guarantee safe and effective therapeutics with simultaneous consideration of economic requirements is one of the most critical hurdles. In this review, we will discuss the recent scientific findings, clinical experiences, and technological advances for cell processing toward the application of mesenchymal stromal cells as a therapy for treatment of severe GvHD, virus-specific T cells for targeting life-threating infections, and of chimeric antigen receptors-engineered T cells to treat relapsed leukemia. PMID:27895644

[Controlled weight bearing after osteosynthesis].

PubMed

Perren, T; Matter, P

1993-01-01

Patient compliance with postoperative partial weight bearing can be a difficult management problem. The problem may be intentional or unintentional. There is no objective way to assess the amount of weight placed on the lower extremity by the patient. It is our clinical suspicion that patients place more weight than is desirable on the effected limb. There are few reports in the literature on this topic. One study has confirmed our suspicion of poor patient compliance with postoperative weight bearing. Our goal is to develop a system to accurately assess weight bearing and to improve this aspect of postoperative fracture care. Through an active feedback device we hope to improve patient education and understanding. We plan to study the clinical applications of using a pressure sensitive shoe insert device. Our ultimate goal is to improve upon the present device and to study the clinical application of there use.

Femtosecond lasers in ophthalmology: clinical applications in anterior segment surgery

NASA Astrophysics Data System (ADS)

Juhasz, Tibor; Nagy, Zoltan; Sarayba, Melvin; Kurtz, Ronald M.

2010-02-01

The human eye is a favored target for laser surgery due to its accessibility via the optically transparent ocular tissue. Femtosecond lasers with confined tissue effects and minimized collateral tissue damage are primary candidates for high precision intraocular surgery. The advent of compact diode-pumped femtosecond lasers, coupled with computer controlled beam delivery devices, enabled the development of high precision femtosecond laser for ophthalmic surgery. In this article, anterior segment femtosecond laser applications currently in clinical practice and investigation are reviewed. Corneal procedures evolved first and remain dominant due to easy targeting referenced from a contact surface, such as applanation lenses placed on the eye. Adding a high precision imaging technique, such as optical coherence tomography (OCT), can enable accurate targeting of tissue beyond the cornea, such as the crystalline lens. Initial clinical results of femtosecond laser cataract surgery are discussed in detail in the latter portion part of the article.

Mediation analysis in nursing research: a methodological review

PubMed Central

Liu, Jianghong; Ulrich, Connie

2017-01-01

Mediation statistical models help clarify the relationship between independent predictor variables and dependent outcomes of interest by assessing the impact of third variables. This type of statistical analysis is applicable for many clinical nursing research questions, yet its use within nursing remains low. Indeed, mediational analyses may help nurse researchers develop more effective and accurate prevention and treatment programs as well as help bridge the gap between scientific knowledge and clinical practice. In addition, this statistical approach allows nurse researchers to ask – and answer – more meaningful and nuanced questions that extend beyond merely determining whether an outcome occurs. Therefore, the goal of this paper is to provide a brief tutorial on the use of mediational analyses in clinical nursing research by briefly introducing the technique and, through selected empirical examples from the nursing literature, demonstrating its applicability in advancing nursing science. PMID:26176804

Formal Representations of Eligibility Criteria: A Literature Review

PubMed Central

Weng, Chunhua; Tu, Samson W.; Sim, Ida; Richesson, Rachel

2010-01-01

Standards-based, computable knowledge representations for eligibility criteria are increasingly needed to provide computer-based decision support for automated research participant screening, clinical evidence application, and clinical research knowledge management. We surveyed the literature and identified five aspects of eligibility criteria knowledge representations that contribute to the various research and clinical applications: the intended use of computable eligibility criteria, the classification of eligibility criteria, the expression language for representing eligibility rules, the encoding of eligibility concepts, and the modeling of patient data. We consider three of them (expression language, codification of eligibility concepts, and patient data modeling), to be essential constructs of a formal knowledge representation for eligibility criteria. The requirements for each of the three knowledge constructs vary for different use cases, which therefore should inform the development and choice of the constructs toward cost-effective knowledge representation efforts. We discuss the implications of our findings for standardization efforts toward sharable knowledge representation of eligibility criteria. PMID:20034594

The Biological Effects of Quadripolar Radiofrequency Sequential Application: A Human Experimental Study

PubMed Central

Cornaglia, Antonia Icaro; Faga, Angela; Scevola, Silvia

2014-01-01

Abstract Objective: An experimental study was conducted to assess the effectiveness and safety of an innovative quadripolar variable electrode configuration radiofrequency device with objective measurements in an ex vivo and in vivo human experimental model. Background data: Nonablative radiofrequency applications are well-established anti-ageing procedures for cosmetic skin tightening. Methods: The study was performed in two steps: ex vivo and in vivo assessments. In the ex vivo assessments the radiofrequency applications were performed on human full-thickness skin and subcutaneous tissue specimens harvested during surgery for body contouring. In the in vivo assessments the applications were performed on two volunteer patients scheduled for body contouring surgery at the end of the study. The assessment methods were: clinical examination and medical photography, temperature measurement with thermal imaging scan, and light microscopy histological examination. Results: The ex vivo assessments allowed for identification of the effective safety range for human application. The in vivo assessments allowed for demonstration of the biological effects of sequential radiofrequency applications. After a course of radiofrequency applications, the collagen fibers underwent an immediate heat-induced rearrangement and were partially denaturated and progressively metabolized by the macrophages. An overall thickening and spatial rearrangement was appreciated both in the collagen and elastic fibers, the latter displaying a juvenile reticular pattern. A late onset in the macrophage activation after sequential radiofrequency applications was appreciated. Conclusions: Our data confirm the effectiveness of sequential radiofrequency applications in obtaining attenuation of the skin wrinkles by an overall skin tightening. PMID:25244081

The biological effects of quadripolar radiofrequency sequential application: a human experimental study.

PubMed

Nicoletti, Giovanni; Cornaglia, Antonia Icaro; Faga, Angela; Scevola, Silvia

2014-10-01

An experimental study was conducted to assess the effectiveness and safety of an innovative quadripolar variable electrode configuration radiofrequency device with objective measurements in an ex vivo and in vivo human experimental model. Nonablative radiofrequency applications are well-established anti-ageing procedures for cosmetic skin tightening. The study was performed in two steps: ex vivo and in vivo assessments. In the ex vivo assessments the radiofrequency applications were performed on human full-thickness skin and subcutaneous tissue specimens harvested during surgery for body contouring. In the in vivo assessments the applications were performed on two volunteer patients scheduled for body contouring surgery at the end of the study. The assessment methods were: clinical examination and medical photography, temperature measurement with thermal imaging scan, and light microscopy histological examination. The ex vivo assessments allowed for identification of the effective safety range for human application. The in vivo assessments allowed for demonstration of the biological effects of sequential radiofrequency applications. After a course of radiofrequency applications, the collagen fibers underwent an immediate heat-induced rearrangement and were partially denaturated and progressively metabolized by the macrophages. An overall thickening and spatial rearrangement was appreciated both in the collagen and elastic fibers, the latter displaying a juvenile reticular pattern. A late onset in the macrophage activation after sequential radiofrequency applications was appreciated. Our data confirm the effectiveness of sequential radiofrequency applications in obtaining attenuation of the skin wrinkles by an overall skin tightening.

Applying risk adjusted cost-effectiveness (RAC-E) analysis to hospitals: estimating the costs and consequences of variation in clinical practice.

PubMed

Karnon, Jonathan; Caffrey, Orla; Pham, Clarabelle; Grieve, Richard; Ben-Tovim, David; Hakendorf, Paul; Crotty, Maria

2013-06-01

Cost-effectiveness analysis is well established for pharmaceuticals and medical technologies but not for evaluating variations in clinical practice. This paper describes a novel methodology--risk adjusted cost-effectiveness (RAC-E)--that facilitates the comparative evaluation of applied clinical practice processes. In this application, risk adjustment is undertaken with a multivariate matching algorithm that balances the baseline characteristics of patients attending different settings (e.g., hospitals). Linked, routinely collected data are used to analyse patient-level costs and outcomes over a 2-year period, as well as to extrapolate costs and survival over patient lifetimes. The study reports the relative cost-effectiveness of alternative forms of clinical practice, including a full representation of the statistical uncertainty around the mean estimates. The methodology is illustrated by a case study that evaluates the relative cost-effectiveness of services for patients presenting with acute chest pain across the four main public hospitals in South Australia. The evaluation finds that services provided at two hospitals were dominated, and of the remaining services, the more effective hospital gained life years at a low mean additional cost and had an 80% probability of being the most cost-effective hospital at realistic cost-effectiveness thresholds. Potential determinants of the estimated variation in costs and effects were identified, although more detailed analyses to identify specific areas of variation in clinical practice are required to inform improvements at the less cost-effective institutions. Copyright © 2012 John Wiley & Sons, Ltd.

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

PubMed

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 < 0.004) in the 3 years following introduction of the European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p < 0.001; 15% Europe, 29% United Kingdom). The introduction of the Clinical Trials Directive has therefore coincided with a decline in 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.

Time course of clinical change following neurofeedback.

PubMed

Rance, Mariela; Walsh, Christopher; Sukhodolsky, Denis G; Pittman, Brian; Qiu, Maolin; Kichuk, Stephen A; Wasylink, Suzanne; Koller, William N; Bloch, Michael; Gruner, Patricia; Scheinost, Dustin; Pittenger, Christopher; Hampson, Michelle

2018-05-02

Neurofeedback - learning to modulate brain function through real-time monitoring of current brain state - is both a powerful method to perturb and probe brain function and an exciting potential clinical tool. For neurofeedback effects to be useful clinically, they must persist. Here we examine the time course of symptom change following neurofeedback in two clinical populations, combining data from two ongoing neurofeedback studies. This analysis reveals a shared pattern of symptom change, in which symptoms continue to improve for weeks after neurofeedback. This time course has several implications for future neurofeedback studies. Most neurofeedback studies are not designed to test an intervention with this temporal pattern of response. We recommend that new studies incorporate regular follow-up of subjects for weeks or months after the intervention to ensure that the time point of greatest effect is sampled. Furthermore, this time course of continuing clinical change has implications for crossover designs, which may attribute long-term, ongoing effects of real neurofeedback to the control intervention that follows. Finally, interleaving neurofeedback sessions with assessments and examining when clinical improvement peaks may not be an appropriate approach to determine the optimal number of sessions for an application. Copyright © 2018 Elsevier Inc. All rights reserved.

Studies on the disposable obstetrical dressings sterilized by radiation and the effect of its application

NASA Astrophysics Data System (ADS)

Haiqiao, Wang; Sujing, Sun

1993-10-01

In order to attain an optimum sterilization treatment to obstetric dressings, a new product made by us, with 60Coγ-ray, the effects of radiation on standard bacteria pseudomonas aeruginosa ATcc27853, Escherichia coli ATcc25922, Staphylococcus aureus ATcc25923, Clostridium PB6KA, short Bacillus E60163202 and HBSAg were studied. Results showed that at the absorbed dose of 10 kGy, all the bacteria, bacillus and HBSAg were killed off, and sterilized with the dose, the dressings can completely accord with the demands of hygiene, which was further confirmed by microbiological and poisonous tests and the effects of clinical application. In Nov. 1988, the dressings was awarded the excellent prize in the 1st international exhibition of patent, new technique and new equipment in Guangzhou; its effective application is also reported in the paper.

New Functions and Potential Applications of Amino Acids.

PubMed

Uneyama, Hisayuki; Kobayashi, Hisamine; Tonouchi, Naoto

Currently, several types of amino acids are being produced and used worldwide. Nevertheless, several new functions of amino acids have been recently discovered that could result in other applications. For example, oral stimulation by glutamate triggers the cephalic phase response to prepare for food digestion. Further, the stomach and intestines have specific glutamate-recognizing systems in their epithelial mucosa. Regarding clinical applications, addition of monosodium glutamate to the medicinal diet has been shown to markedly enhance gastric secretion in a vagus-dependent manner. Branched-chain amino acids (BCAAs) are the major components of muscles, and ingestion of BCAAs has been found to be effective for decreasing muscle pain. BCAAs are expected to be a solution for the serious issue of aging. Further, ingestion of specific amino acids could be beneficial. Glycine can be ingested for good night's sleep: glycine ingestion before bedtime significantly improved subjective sleep quality. Ingestion of alanine and glutamine effectively accelerates alcohol metabolism, and ingestion of cystine and theanine effectively prevents colds. Finally, amino acids could be used in a novel clinical diagnostic method: the balance of amino acids in the blood could be an indicator of the risk of diseases such as cancer. These newly discovered functions of amino acids are expected to contribute to the resolution of various issues.

Cryopreservation of Human Stem Cells for Clinical Application: A Review

PubMed Central

Hunt, Charles J.

2011-01-01

Summary Stem cells have been used in a clinical setting for many years. Haematopoietic stem cells have been used for the treatment of both haematological and non-haematological disease; while more recently mesenchymal stem cells derived from bone marrow have been the subject of both laboratory and early clinical studies. Whilst these cells show both multipotency and expansion potential, they nonetheless do not form stable cell lines in culture which is likely to limit the breadth of their application in the field of regenerative medicine. Human embryonic stem cells are pluripotent cells, capable of forming stable cell lines which retain the capacity to differentiate into cells from all three germ layers. This makes them of special significance in both regenerative medicine and toxicology. Induced pluripotent stem (iPS) cells may also provide a similar breadth of utility without some of the confounding ethical issues surrounding embryonic stem cells. An essential pre-requisite to the commercial and clinical application of stem cells are suitable cryopreservation protocols for long-term storage. Whilst effective methods for cryopreservation and storage have been developed for haematopoietic and mesenchymal stem cells, embryonic cells and iPS cells have proved more refractory. This paper reviews the current state of cryopreservation as it pertains to stem cells and in particular the embryonic and iPS cell. PMID:21566712

Cryopreservation of Human Stem Cells for Clinical Application: A Review.

PubMed

Hunt, Charles J

2011-01-01

SUMMARY: Stem cells have been used in a clinical setting for many years. Haematopoietic stem cells have been used for the treatment of both haematological and non-haematological disease; while more recently mesenchymal stem cells derived from bone marrow have been the subject of both laboratory and early clinical studies. Whilst these cells show both multipotency and expansion potential, they nonetheless do not form stable cell lines in culture which is likely to limit the breadth of their application in the field of regenerative medicine. Human embryonic stem cells are pluripotent cells, capable of forming stable cell lines which retain the capacity to differentiate into cells from all three germ layers. This makes them of special significance in both regenerative medicine and toxicology. Induced pluripotent stem (iPS) cells may also provide a similar breadth of utility without some of the confounding ethical issues surrounding embryonic stem cells. An essential pre-requisite to the commercial and clinical application of stem cells are suitable cryopreservation protocols for long-term storage. Whilst effective methods for cryopreservation and storage have been developed for haematopoietic and mesenchymal stem cells, embryonic cells and iPS cells have proved more refractory. This paper reviews the current state of cryopreservation as it pertains to stem cells and in particular the embryonic and iPS cell.

Myocardial T2* Mapping at Ultrahigh Field: Physics and Frontier Applications

NASA Astrophysics Data System (ADS)

Huelnhagen, Till; Paul, Katharina; Ku, Min-Chi; Serradas Duarte, Teresa; Niendorf, Thoralf

2017-06-01

Cardiovascular magnetic resonance imaging (CMR) has become an indispensable clinical tool for the assessment of morphology, function and structure of the heart muscle. By exploiting quantification of the effective transverse relaxation time (T2*) CMR also affords myocardial tissue characterization and probing of cardiac physiology, both being in the focus of ongoing research. These developments are fueled by the move to ultrahigh magnetic field strengths, which permits enhanced sensitivity and spatial resolution that help to overcome limitations of current clinical MR systems with the goal to contribute to a better understanding of myocardial (patho)physiology in vivo. In this context, the aim of this report is to introduce myocardial T2* mapping at ultrahigh magnetic fields as a promising technique to non-invasively assess myocardial (patho)physiology. For this purpose the basic principles of T2* assessment, the biophysical mechanisms determining T2* and (pre)clinical applications of myocardial T2* mapping are presented. Technological challenges and solutions for T2* sensitized CMR at ultrahigh magnetic field strengths are discussed followed by a review of acquisition techniques and post processing approaches. Preliminary results derived from myocardial T2* mapping in healthy subjects and cardiac patients at 7.0 Tesla are presented. A concluding section discusses remaining questions and challenges and provides an outlook on future developments and potential clinical applications.

Brief Analysis of Application of Objective Structured Clinical Examination (OSCE) in Graduation Exams of Clinical Medical Students

ERIC Educational Resources Information Center

Du, Yihua; Yu, Ke; Li, Xiaohong; Wang, Feng; Wang, Tingting

2011-01-01

This article gives a brief introduction to the Objective Structured Clinical Examination (OSCE) and analyzes developmental progress of OSCE at both home and abroad and standardized patients' application in OSCE. Also, this article expounds application of OSCE in graduation exam of clinical medical students. Finally, this article summarizes…

Levosimendan beyond inotropy and acute heart failure: Evidence of pleiotropic effects on the heart and other organs: An expert panel position paper.

PubMed

Farmakis, Dimitrios; Alvarez, Julian; Gal, Tuvia Ben; Brito, Dulce; Fedele, Francesco; Fonseca, Candida; Gordon, Anthony C; Gotsman, Israel; Grossini, Elena; Guarracino, Fabio; Harjola, Veli-Pekka; Hellman, Yaron; Heunks, Leo; Ivancan, Visnja; Karavidas, Apostolos; Kivikko, Matti; Lomivorotov, Vladimir; Longrois, Dan; Masip, Josep; Metra, Marco; Morelli, Andrea; Nikolaou, Maria; Papp, Zoltán; Parkhomenko, Alexander; Poelzl, Gerhard; Pollesello, Piero; Ravn, Hanne Berg; Rex, Steffen; Riha, Hynek; Ricksten, Sven-Erik; Schwinger, Robert H G; Vrtovec, Bojan; Yilmaz, M Birhan; Zielinska, Marzenna; Parissis, John

2016-11-01

Levosimendan is a positive inotrope with vasodilating properties (inodilator) indicated for decompensated heart failure (HF) patients with low cardiac output. Accumulated evidence supports several pleiotropic effects of levosimendan beyond inotropy, the heart and decompensated HF. Those effects are not readily explained by cardiac function enhancement and seem to be related to additional properties of the drug such as anti-inflammatory, anti-oxidative and anti-apoptotic ones. Mechanistic and proof-of-concept studies are still required to clarify the underlying mechanisms involved, while properly designed clinical trials are warranted to translate preclinical or early-phase clinical data into more robust clinical evidence. The present position paper, derived by a panel of 35 experts in the field of cardiology, cardiac anesthesiology, intensive care medicine, cardiac physiology, and cardiovascular pharmacology from 22 European countries, compiles the existing evidence on the pleiotropic effects of levosimendan, identifies potential novel areas of clinical application and defines the corresponding gaps in evidence and the required research efforts to address those gaps. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Mobile application to induce lifestyle modifications in type 2 diabetic patients: prototype based on international guidelines

NASA Astrophysics Data System (ADS)

García-Jaramillo, M.; Delgado, J. S.; León-Vargas, F.

2015-12-01

This paper describes a prototype app to induce lifestyle modifications in newly diagnosed type 2 diabetic patients. The app design is based on International Diabetes Federation guidelines and recommendations from clinical studies related to diabetes health-care. Two main approaches, lifestyle modification and self-management education are used owing to significant benefits reported. The method used is based on setting goals under medical support related to physical activity, nutritional habits and weight loss, in addition to educational messages. This is specially implemented to address the main challenges that have limited the success of similar mobile applications already validated on diabetic patients. A traffic light is used to show the overall state of the goals compliance. This state could be understood as excellent (green), there are aspects to improve (yellow), or some individual goals are not carrying out (red). An example of how works this method is presented in results. Furthermore, the app provides recommendations to the user in case the overall state was in yellow or red. The recommendations pretend to induce the user to make changes in their eating habits and physical activity. According to international guidelines and clinical studies, a prototype of mobile application to induce a lifestyle modification in order to prevent adverse risk factors related to diabetes was presented. The resulting application is apparently consistent with clinical judgments, but a formal clinical validation is required. The effectiveness of this app is currently under consideration for the Colombian population with type 2 diabetes.

[Analysis of Applying Chinese Medical Clinical Pathway for Treating Attention-deficit Hyperactivity Disorder].

PubMed

Guo, Yu-qing; Han, Xin-min; Zhu, Xian-kang; Zhou, Zheng; Ma, Bing-xiang; Zhang, Bao-qing; Li, Yan-ning; Feng, Yu-lin; Xue, Zheng; Wang, Yong-hong; Li, Yi-min; Jiang, Zhi-mei; Xu, Jin-xing; Yue, Wei-zhen; Xiang, Xi-xiong

2015-12-01

To evaluate the application effect of Chinese medical clinical pathway for treating attention-deficit hyperactivity disorder (ADHD), and to provide evidence for further improving clinical pathways. Totally 270 ADHD children patients were recruited and treated at pediatrics clinics of 9 cooperative hospitals from December 2011 to December 2012. The treatment course for all was 3 months. Scores of attention deficit and hyperactivity rating scale, scores of behavior, Conners index of hyperactivity (CIH), and Chinese medical syndrome scores were compared between before and after treatment. The efficacy difference in various sexes, ages, and disease courses were evaluated by judging standards for Chinese medical syndrome and ADHD. Fifteen children patients who entered clinical pathway dropped out, and the rest 255 completed this trial. Compared with before treatment, total scores of attention deficit and hyperactivity rating scale, scores of attention deficit and hyperactivity rating scale, CIH, and Chinese medical syndrome scores obviously decreased (all P < 0.01). The total effective rate in disease efficacy was 87.8% (224/255 cases), and the total effective rate in Chinese medical syndrome curative effect was 87.5% (223/255 cases). The clinical curative effect was not influenced by age, gender, or course of disease when statistically analyzed from judging standards for Chinese medical syndrome or for disease efficacy. Intervention by Chinese medical clinical pathway could improve ADHD patients' symptoms, and its efficacy was not influenced by sex, age, or course of disease.

Addressing the Research-to-Practice Gap in Autism Treatments: Applying an Effectiveness Research Model to the Picture Exchange Communication System

ERIC Educational Resources Information Center

Greenberg, Alissa L.

2011-01-01

Despite expansive improvements in both treatments and research, the majority of persons with autism use non-empirically supported interventions. One way to decrease the research-to-practice gap involves increasing the direct applicability of research findings to clinical settings. Effectiveness research achieves this goal by identifying treatments…

FDA: Evidentiary Standards for Drug Development and Approval

PubMed Central

Katz, Russell

2004-01-01

Summary: The United States Food and Drug Administration is charged with approving drug treatments that have been shown to be safe and effective. Relevant statutes and regulations provide a legal framework for establishing safety and effectiveness that is sufficiently flexible to ensure that appropriate scientific data are collected for specific treatments targeted to particular diseases. Nonetheless, all clinical trials proposed to establish effectiveness must incorporate common elements in order for the appropriate legal and scientific standards of drug approval to be met. This article will discuss the relevant laws and regulations pertaining to the current effectiveness standard and will discuss the most important clinical trial design elements currently considered acceptable for applications for treatments of neurologic and psychiatric illness. PMID:15717032