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Sample records for e2br clinical safety

  1. Patient safety in clinical research articles.

    Science.gov (United States)

    Vintzileos, Anthony M; Finamore, Peter S; Sicuranza, Genevieve B; Ananth, Cande V

    2013-11-01

    Patient safety has remained one of the most important priorities over the past decade, particularly in hospital settings. Implementation of patient safety measures has focused not only on reducing medication and surgical errors but also on the development of a culture of safety, including enhanced communication among all healthcare stakeholders. Academic medicine may further contribute to the culture of safety if all relevant clinical article submissions address patient safety. In order to improve communication between the authors of clinical research articles and practicing physicians, we propose that each clinical research article may be accompanied by a clear statement from the authors regarding practice implications and patient safety. © 2013.

  2. GOLIMUMAB SAFETY ACCORDING TO CLINICAL FINDINGS

    Directory of Open Access Journals (Sweden)

    G. V. Lukina

    2015-01-01

    Full Text Available                                                      The review analyzes trials dealing with the safety of golimumab (GLM  used in rheumatology.  This drug was the latest Contact: Galina Lukina;gvl3@yandex.ru Поступила 12.05.14tumor necrosis factor α (TNF-α inhibitor introduced  into clinical practice and therefore the estimation of its tolerability is particularly relevant. The data obtained in large-scale clinical trials suggest that GLM has a good safety profile. The most common  adverse events (AE were infections, more often mild. The rate of infections was higher with the use of GLM 100 mg than with that of 50 mg. The overall cancer rate did not increase during a follow-up of less than 160 weeks. However, the rate of lymphomas in patients receiving GLM 100 mg proved to be higher than in those taking GLM 50 mg, in the general population, and in the placebo group in particular. AE were evenly distributed among patients with rheumatoid  arthritis, psoriatic arthritis, or ankylosing spondylitis. Overall, the findings are in agreement with the data on the safety of previously used TNF-α inhibitors. No fundamentally new AE have been encountered. It is necessary to accumulate  data on the use of GLM in real clinical practice, which will be able to more objectively define its place in the current therapy of rheumatic diseases.

  3. Chemotherapy safety in clinical veterinary oncology.

    Science.gov (United States)

    Klahn, Shawna

    2014-09-01

    Exposure to chemotherapy is a health hazard for all personnel in facilities that store, prepare, or administer antineoplastic agents. Contamination levels have been measured as much as 15 times higher in the veterinary medicine sector than in human facilities. Recent publications in human and veterinary medicine indicate that exposure extends beyond the clinic walls to affect the patient's home and family. This article provides an update on the advances in chemotherapy safety, the current issues, and the impact on cancer management in veterinary medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Clinical Trial of a Home Safety Toolkit for Alzheimer's Disease

    OpenAIRE

    Horvath, Kathy J.; Trudeau, Scott A.; Rudolph, James L.; Trudeau, Paulette A.; Duffy, Mary E.; Berlowitz, Dan

    2013-01-01

    This randomized clinical trial tested a new self-directed educational intervention to improve caregiver competence to create a safer home environment for persons with dementia living in the community. The sample included 108 patient/caregiver dyads: the intervention group (n = 60) received the Home Safety Toolkit (HST), including a new booklet based on health literacy principles, and sample safety items to enhance self-efficacy to make home safety modifications. The control group (n = 48) rec...

  5. Safety behaviours in eating disorders: factor structure and clinical validation of the brief safety behaviours scale.

    Science.gov (United States)

    Waller, Glenn; Kyriacou Marcoulides, Olivia

    2013-05-01

    This study examined the utility of a transdiagnostic measure of safety behaviours [Brief Safety Behaviours Scale (BSBS)] in eating disorders. Prior to treatment, a group of 102 women with eating disorders completed the BSBS and well-validated measures of eating pathology, anxiety and intolerance of uncertainty. The BSBS had three factors, suggesting that avoidant, checking and social safety behaviours are distinct constructs in the eating disorders. This three-scale scoring system showed greater clinical precision in correlations with eating pathology than the original two-scale version. The pattern of safety behaviours in the eating disorders is more specific than had previously been shown in other clinical samples. While it is important to consider eating-related safety behaviours in the eating disorders (e.g. restriction, body checking), it is also necessary to consider the role of generic safety behaviours when assessing, formulating and treating eating disorders. Copyright © 2012 John Wiley & Sons, Ltd and Eating Disorders Association.

  6. Clinical pharmacology: special safety considerations in drug development and pharmacovigilance.

    Science.gov (United States)

    Atuah, Kwame N; Hughes, Dyfrig; Pirmohamed, Munir

    2004-01-01

    The dose of a drug is a major determinant of its safety, and establishing a safe dose of a novel drug is a prime objective during clinical development. The design of pre-marketing clinical trials precludes the representation of important subpopulations such as children, the elderly and people with co-morbidities. Therefore, postmarketing surveillance (PMS) activities are required to monitor the safety profile of drugs in real clinical practice. Furthermore, individual variations in pharmacogenetic profiles, the immune system, drug metabolic pathways and drug-drug interactions are also important factors in the occurrence of adverse drug reactions. Thus, the safety of a drug is a major clinical consideration before and after it is marketed. A multidisciplinary approach is required to enhance the safety profile of drugs at all stages of development, including PMS activities. Clinical pharmacology encompasses a range of disciplines and forms the backbone of drug safety consideration during clinical drug development. In this review we give an overview of the clinical drug development process and consider its limitations. We present a discussion of several aspects of clinical pharmacology and their application to enhancing drug safety. Pharmacokinetic-pharmacodynamic modelling provides a method of predicting a clinically safe dose; consideration of drug pharmacokinetics in special populations may enhance safe therapeutics in a wider spectrum of patients, while pharmacogenetics provides the possibility of genotype-specific therapeutics. Pharmacovigilance activities are also discussed. Given the complex nature and unpredictability of type B reactions, PMS activities are crucial in managing the risks drugs pose to the general population. The various aspects of clinical pharmacology discussed make a strong case for this field as the backbone of optimising and promoting safe development and use of drugs.

  7. D-Limonene: safety and clinical applications.

    Science.gov (United States)

    Sun, Jidong

    2007-09-01

    D-limonene is one of the most common terpenes in nature. It is a major constituent in several citrus oils (orange, lemon, mandarin, lime, and grapefruit). D-limonene is listed in the Code of Federal Regulations as generally recognized as safe (GRAS) for a flavoring agent and can be found in common food items such as fruit juices, soft drinks, baked goods, ice cream, and pudding. D-limonene is considered to have fairly low toxicity. It has been tested for carcinogenicity in mice and rats. Although initial results showed d-limonene increased the incidence of renal tubular tumors in male rats, female rats and mice in both genders showed no evidence of any tumor. Subsequent studies have determined how these tumors occur and established that d-limonene does not pose a mutagenic, carcinogenic, or nephrotoxic risk to humans. In humans, d-limonene has demonstrated low toxicity after single and repeated dosing for up to one year. Being a solvent of cholesterol, d-limonene has been used clinically to dissolve cholesterol-containing gallstones. Because of its gastric acid neutralizing effect and its support of normal peristalsis, it has also been used for relief of heartburn and gastroesophageal reflux (GERD). D-limonene has well-established chemopreventive activity against many types of cancer. Evidence from a phase I clinical trial demonstrated a partial response in a patient with breast cancer and stable disease for more than six months in three patients with colorectal cancer.

  8. Double blind clinical trail comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Background: Osteoarthritis of the hip or knees is a very disabling condition in both Caucasians and Africans. A lot of medical drugs have been in use with their corresponding side effects, hence the search for newer drugs with fewer side effects. Study design: A double blind clinical trial comparing the safety and efficacy of ...

  9. Clinical efficacy and safety of edaravone therapy in acute cerebral ...

    African Journals Online (AJOL)

    Purpose: To evaluate the clinical efficacy and safety of edaravone in the treatment of acute cerebral haemorrhage (ACH). Methods: This study recruited 120 patients who developed ACH. The patients were divided into control and treatment groups with 60 patients per group. The control group underwent conventional ...

  10. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  11. Safety and usefulness of outreach clinic conducted by pediatric echosonographers

    International Nuclear Information System (INIS)

    Al Harbi, Badr; Al Akhfash, Ali A.; Al Ghamdi, Abdullah; Al-Mesned, Abdulrahman

    2012-01-01

    Outreach echocardiographic services led by cardiac sonographers may help district level hospitals in the management of patients suspected to have cardiac anomalies. However, the safety and utility of such an approach is not tested. We retrospectively reviewed our experience of patients seen in the outreach visits by the echocardiographers alone and subsequently reviewed in the pediatric cardiology clinic. Comparison between the diagnosis made by the echocardiographer and the consultant pediatric cardiologist were done. We defined safety as no change in patient management plan between the outreach evaluation and the pediatric cardiology clinic evaluation, and we defined usefulness as being beneficial, serviceable and of practical use. Two senior echocardiographic technicians did 41 clinic visits and over a period of 17 months, 623 patients were seen. Patients less than 3 months of age constitute 63% of the total patients seen. Normal echocardiographic examinations were found in 342 (55%) of patients. These patients were not seen in our cardiology clinic. Abnormal echocardiographic examinations were found in 281 (45%) of patients. Among the 281 patients with abnormal echos in the outreach visits, 251 patients (89.3%) were seen in the pediatric cardiology clinic. Comparing the results of the outreach clinic evaluation to that of the pediatric cardiology clinic, 73 patients (29%) diagnosed to have a minor CHD turned to have normal echocardiographic examinations. In all patients seen in both the outreach clinics and the pediatric tertiary cardiac clinics there was no change in patient's management plan. Outreach clinic conducted by pediatric echo sonographers could be useful and safe. It may help in reducing unnecessary visits to pediatric cardiology clinics, provide parental reassurance, and help in narrowing the differential diagnosis in critically ill patient unable to be transferred to tertiary cardiac centers provided it is done by experienced echosonographers

  12. 7T: Physics, safety, and potential clinical applications.

    Science.gov (United States)

    Kraff, Oliver; Quick, Harald H

    2017-12-01

    With more than 60 installed magnetic resonance imaging (MRI) systems worldwide operating at a magnetic field strength of 7T or higher, ultrahigh-field (UHF) MRI has been established as a platform for clinically oriented research in recent years. Profound technical and methodological developments have helped overcome the inherent physical challenges of UHF radiofrequency (RF) signal homogenization in the human body. The ongoing development of dedicated RF coil arrays was pivotal in realizing UHF body MRI, beyond mere brain imaging applications. Another precondition to clinical application of 7T MRI is the safety testing of implants and the establishment of safety concepts. Against this backdrop, 7T MRI and MR spectroscopy (MRS) recently have demonstrated capabilities and potentials for clinical diagnostics in a variety of studies. This article provides an overview of the immanent physical challenges of 7T UHF MRI and discusses recent technical solutions and safety concepts. Furthermore, recent clinically oriented studies are highlighted that span a broad application spectrum from 7T UHF brain to body MRI. 4 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2017;46:1573-1589. © 2017 International Society for Magnetic Resonance in Medicine.

  13. Electronic clinical safety reporting system: a benefits evaluation.

    Science.gov (United States)

    Elliott, Pamela; Martin, Desmond; Neville, Doreen

    2014-06-11

    Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

  14. Clinical alarm hazards: a "top ten" health technology safety concern.

    Science.gov (United States)

    Keller, James P

    2012-01-01

    For the past several years ECRI Institute has published a list of Top Ten Health Technology Hazards. This list is based on ECRI's extensive research in health technology safety and on data provided to its problemreporting systems. For every year that the Top Ten list has been published, Alarm Hazards have been at or near the top of the list. Improving alarm safety requires a systematic review of a hospital's alarm-based technologies and analysis of alarm management policies like alarm escalation strategies and staffing patterns. It also requires careful selection of alarm setting criteria for each clinical care area. This article will overview the clinical alarm problems that have been identified through ECRI Institute's research and analysis of various problem reporting databases, including those operated by ECRI Institute. It will also highlight suggestions for improvement, particularly from a technology design and technology management perspective. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. Advancing medication infusion safety through the clinical integration of technology.

    Science.gov (United States)

    Gerhart, Donald; O'Shea, Kristen; Muller, Sharon

    2013-01-01

    Adverse drug events resulting from errors in prescribing or administering medications are preventable. Within a hospital system, numerous technologies are employed to address the common sources of medication error, including the use of electronic medical records, physician order entry, smart infusion pumps, and barcode medication administration systems. Infusion safety is inherently risky because of the high-risk medications administered and the lack of integration among the stand-alone systems in most institutions. Intravenous clinical integration (IVCI) is a technology that connects electronic medical records, physician order entry, smart infusion pumps, and barcode medication administration systems. It combines the safety features of an automatically programmed infusion pump (drug, concentration, infusion rate, and patient weight, all auto-programmed into the device) with software that provides visibility to real-time clinical infusion data. Our article describes the characteristics of IVCI at WellSpan Health and its impact on patient safety. The integrated infusion system has the capability of reducing medication errors, improving patient care, reducing in-facility costs, and supporting asset management. It can enhance continuous quality improvement efforts and efficiency of clinical work flow. After implementing IVCI, the institution realized a safer patient environment and a more streamlined work flow for pharmacy and nursing.

  16. Clinical safety and professional liability claims in Ophthalmology.

    Science.gov (United States)

    Dolz-Güerri, F; Gómez-Durán, E L; Martínez-Palmer, A; Castilla Céspedes, M; Arimany-Manso, J

    2017-11-01

    Patient safety is an international public health priority. Ophthalmology scientific societies and organisations have intensified their efforts in this field. As a tool to learn from errors, these efforts have been linked to the management of medical professional liability insurance through the analysis of claims. A review is performed on the improvements in patient safety, as well as professional liability issues in Ophthalmology. There is a high frequency of claims and risk of economic reparation of damage in the event of a claim in Ophthalmology. Special complaints, such as wrong surgery or lack of information, have a high risk of financial compensation and need strong efforts to prevent these potentially avoidable events. Studies focused on pathologies or specific procedures provide information of special interest to sub-specialists. The specialist in Ophthalmology, like any other doctor, is subject to the current legal provisions and appropriate mandatory training in the medical-legal aspects of health care is essential. Professionals must be aware of the fundamental aspects of medical professional liability, as well as specific aspects, such as defensive medicine and clinical safety. The understanding of these medical-legal aspects in the routine clinical practice can help to pave the way towards a satisfactory and safe professional career, and help in increasing patient safety. The aim of this review is to contribute to this training, for the benefit of professionals and patients. Copyright © 2017 Sociedad Española de Oftalmología. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Moving and handling and patient safety: analysis of clinical incidents.

    Science.gov (United States)

    Cornish, Jocelyn; Jones, Anne

    The aim of this study is to identify the potential contribution of moving and handling practice to clinical incidents through an analysis of incident data. Previous studies focusing on moving and handling have highlighted potential harm to patients through poor practice, and have suggested that this might be an issue for patient safety. However, this has not been identified in studies analysing clinical incident reports, where the potential contribution of moving and handling has not been recognized. This study reports an analysis of clinical incident data from the specific perspective of moving and handling. Survey of clinical incident reports in hospital in-patient care settings Method: A random sample of 500 incident reports was analysed using descriptive statistics and thematic analysis of qualitative data. There is an indication that some staff are not following recommended moving and handling policy through a lack of risk assessment; for example, in the selection of appropriate actions to assist patients, and in the prevention of further occurrences of incidents where patients had fallen. The limited detail within the reports affected consideration of the causes of the incidents and actions that could be taken to prevent a further occurrence. Some of the reported staff actions may contravene policy guidelines. Missing detail in the incident reports inhibited investigation of incidents that could lead to appropriate and safe systems of work being identified.

  18. Local Health Departments as Clinical Safety Net in Rural Communities.

    Science.gov (United States)

    Hale, Nathan L; Klaiman, Tamar; Beatty, Kate E; Meit, Michael B

    2016-11-01

    The appropriate role of local health departments (LHDs) as a clinical service provider remains a salient issue. This study examines differences in clinical service provision among rural/urban LHDs for early periodic screening, diagnosis, and treatment (EPSDT) and prenatal care services. Data collected from the 2013 National Association of County and City Health Officials Profile of Local Health Departments Survey was used to conduct a cross-sectional analysis of rural/urban differences in clinical service provision by LHDs. Profile data were linked with the 2013 Area Health Resource File to derive other county-level measures. Data analysis was conducted in 2015. Approximately 35% of LHDs in the analysis provided EPSDT services directly and 26% provided prenatal care. LHDs reporting no others providing these services in the community were four times more likely to report providing EPSDT services directly and six times more likely to provide prenatal care services directly. Rural LHDs were more likely to provide EPSDT (OR=1.46, 95% CI=1.07, 2.00) and prenatal care (OR=2.43, 95% CI=1.70, 3.47) services than urban LHDs. The presence of a Federally Qualified Health Center in the county was associated with reduced clinical service provision by LHDs for EPSDT and prenatal care. Findings suggest that many LHDs in rural communities remain a clinical service provider and a critical component of the healthcare safety net. The unique position of rural LHDs should be considered in national policy discussions around the organization and delivery of public health services, particularly as they relate to clinical services. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  19. Safety Culture and Senior Leadership Behavior: Using Negative Safety Ratings to Align Clinical Staff and Senior Leadership.

    Science.gov (United States)

    O'Connor, Shawn; Carlson, Elizabeth

    2016-04-01

    This report describes how staff-designed behavior changes among senior leaders can have a positive impact on clinical nursing staff and enhance the culture of safety in a community hospital. A positive culture of safety in a hospital improves outcomes for patients and staff. Senior leaders are accountable for developing an environment that supports a culture of safety. At 1 community hospital, surveys demonstrated that staff members did not view senior leaders as supportive of or competent in creating a culture of safety. After approval from the hospital's institutional review board was obtained, clinical nurses generated and selected ideas for senior leader behavior change. The new behaviors were assessed by a convenience sample survey of clinical nurses. In addition, culture of safety survey results were compared. Risk reports and harm events were also measured before and after behavior changes. The volume of risk and near-miss reports increased, showing that clinical staff were more inclined to report events after senior leader communication, access, and visibility increased. Harm events went down. The culture of safety survey demonstrated an improvement in the senior leadership domain in 4 of 6 units. The anonymous convenience survey demonstrated that staff members recognized changes that senior leaders had made and felt that these changes positively impacted the culture of safety. By developing skills in communication, advocacy, visibility, and access, senior leaders can enhance a hospital's culture of safety and create stronger ties with clinical staff.

  20. Automated validation of patient safety clinical incident classification: macro analysis.

    Science.gov (United States)

    Gupta, Jaiprakash; Patrick, Jon

    2013-01-01

    Patient safety is the buzz word in healthcare. Incident Information Management System (IIMS) is electronic software that stores clinical mishaps narratives in places where patients are treated. It is estimated that in one state alone over one million electronic text documents are available in IIMS. In this paper we investigate the data density available in the fields entered to notify an incident and the validity of the built in classification used by clinician to categories the incidents. Waikato Environment for Knowledge Analysis (WEKA) software was used to test the classes. Four statistical classifier based on J48, Naïve Bayes (NB), Naïve Bayes Multinominal (NBM) and Support Vector Machine using radial basis function (SVM_RBF) algorithms were used to validate the classes. The data pool was 10,000 clinical incidents drawn from 7 hospitals in one state in Australia. In first part of the study 1000 clinical incidents were selected to determine type and number of fields worth investigating and in the second part another 5448 clinical incidents were randomly selected to validate 13 clinical incident types. Result shows 74.6% of the cells were empty and only 23 fields had content over 70% of the time. The percentage correctly classified classes on four algorithms using categorical dataset ranged from 42 to 49%, using free-text datasets from 65% to 77% and using both datasets from 72% to 79%. Kappa statistic ranged from 0.36 to 0.4. for categorical data, from 0.61 to 0.74. for free-text and from 0.67 to 0.77 for both datasets. Similar increases in performance in the 3 experiments was noted on true positive rate, precision, F-measure and area under curve (AUC) of receiver operating characteristics (ROC) scores. The study demonstrates only 14 of 73 fields in IIMS have data that is usable for machine learning experiments. Irrespective of the type of algorithms used when all datasets are used performance was better. Classifier NBM showed best performance. We think the

  1. [Clinical governance and patient safety culture in clinical laboratories in the Spanish National Health System].

    Science.gov (United States)

    Giménez-Marín, Á; Rivas-Ruiz, F

    To conduct a situational analysis of patient safety culture in public laboratories in the Spanish National Health System and to determine the clinical governance variables that most strongly influence patient safety. A descriptive cross-sectional study was carried out, in which a Survey of Patient Safety in Clinical Laboratories was addressed to workers in 26 participating laboratories. In this survey, which consisted of 45 items grouped into 6 areas, scores were assigned on a scale from 0 to 100 (where 0 is the lowest perception of patient safety). Laboratory managers were asked specific questions about quality management systems and technology. The mean scores for the 26 participating hospitals were evaluated, and the following results observed: in 4of the 6areas, the mean score was higher than 70 points. In the third area (equipment and resources) and the fourth area (working conditions), the scores were lower than 60 points. Every hospital had a digital medical record system. This 100% level of provision was followed by that of an electronic request management system, which was implemented in 82.6% of the hospitals. The results obtained show that the culture of security is homogeneous and of high quality in health service laboratories, probably due to the steady improvement observed. However, in terms of clinical governance, there is still some way to go, as shown by the presence of weaknesses in crucial dimensions of safety culture, together with variable levels of implementation of fail-safe technologies and quality management systems. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. Ethics of safety reporting of a clinical trial

    Directory of Open Access Journals (Sweden)

    Amrita Sil

    2017-01-01

    Full Text Available Clinical trial related injury and serious adverse events (SAE are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR whereas if causal association is not yet established it is termed adverse event (AE. An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI, sponsor and Chairperson of the Ethics Committee (EC within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.

  3. Non-clinical safety evaluation of intranasal iota-carrageenan.

    Directory of Open Access Journals (Sweden)

    Alexandra Hebar

    Full Text Available Carrageenan has been widely used as food additive for decades and therefore, an extended oral data set is available in the public domain. Less data are available for other routes of administration, especially intranasal administration. The current publication describes the non-clinical safety and toxicity of native (non-degraded iota-carrageenan when applied intranasally or via inhalation. Intranasally applied iota-carrageenan is a topically applied, locally acting compound with no need of systemic bioavailability for the drug's action. Animal experiments included repeated dose local tolerance and toxicity studies with intranasally applied 0.12% iota-carrageenan for 7 or 28 days in New Zealand White rabbits and nebulized 0.12% iota-carrageenan administered to F344 rats for 7 days. Permeation studies revealed no penetration of iota-carrageenan across nasal mucosa, demonstrating that iota-carrageenan does not reach the blood stream. Consistent with this, no relevant toxic or secondary pharmacological effects due to systemic exposure were observed in the rabbit or rat repeated dose toxicity studies. Data do not provide any evidence for local intolerance or toxicity, when carrageenan is applied intranasally or by inhalation. No signs for immunogenicity or immunotoxicity have been observed in the in vivo studies. This is substantiated by in vitro assays showing no stimulation of a panel of pro-inflammatory cytokines by iota-carrageenan. In conclusion, 0.12% iota-carrageenan is safe for clinical use via intranasal application.

  4. [Innovation in healthcare processes and patient safety using clinical simulation].

    Science.gov (United States)

    Rojo, E; Maestre, J M; Díaz-Mendi, A R; Ansorena, L; Del Moral, I

    2016-01-01

    Many excellent ideas are never implemented or generalised by healthcare organisations. There are two related paradigms: thinking that individuals primarily change through accumulating knowledge, and believing that the dissemination of that knowledge within the organisation is the key element to facilitate change. As an alternative, a description and evaluation of a simulation-based inter-professional team training program conducted in a Regional Health Service to promote and facilitate change is presented. The Department of Continuing Education completed the needs assessment using the proposals presented by clinical units and management. Skills and behaviors that could be learned using simulation were selected, and all personnel from the units participating were included. Experiential learning principles based on clinical simulation and debriefing, were used for the instructional design. The Kirkpatrick model was used to evaluate the program. Objectives included: a) decision-making and teamwork skills training in high prevalence diseases with a high rate of preventable complications; b) care processes reorganisation to improve efficiency, while maintaining patient safety; and, c) implementation of new complex techniques with a long learning curve, and high preventable complications rate. Thirty clinical units organised 39 training programs in the 3 public hospitals, and primary care of the Regional Health Service during 2013-2014. Over 1,559 healthcare professionals participated, including nursing assistants, nurses and physicians. Simulation in healthcare to train inter-professional teams can promote and facilitate change in patient care, and organisational re-engineering. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  5. Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

    Science.gov (United States)

    de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

    2018-01-01

    Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical

  6. Patients' perceptions of safety and quality of maternity clinical handover

    Directory of Open Access Journals (Sweden)

    Chin Georgiana SM

    2011-08-01

    Full Text Available Abstract Background Maternity clinical handover serves to address the gaps in knowledge existing when transitions between individuals or groups of clinicians occur throughout the antenatal, intra-partum and postnatal period. There are limited published studies on maternity handover and a paucity of information about patients' perceptions of the same. This paper reports postnatal patients' perceptions of how maternity handover contributes to the quality and safety of maternity care. Methods This paper reports on a mixed-methods study consisting of qualitative interviews and quantitative medical record analysis. Thirty English-speaking postnatal patients who gave birth at an Australian tertiary maternity hospital participated in a semi-structured interview prior to discharge from hospital. Interview data were coded thematically using the constant comparative method and managed via NVivo software; this data set was supplemented by medical record data analysed using STATA. Results Almost half of the women were aware of a handover process. Clinician awareness of patient information was seen as evidence that handover had taken place and was seen as representing positive aspects of teamwork, care and communication by participants, all important factors in the perception of quality health care. Collaborative cross-checking, including the use of cognitive artefacts such as hand held antenatal records and patient-authored birth plans, and the involvement of patients and their support people in handover were behaviours described by participants to be protective mechanisms that enhanced quality and safety of care. These human factors also facilitated team situational awareness (TSA, shared decision making and patient motivation in labour. Conclusions This study illustrates that many patients are aware of handover processes. For some patients, evidence of handover, through clinician awareness of information, represented positive aspects of teamwork, care and

  7. Worldwide clinical safety assessment of gadoteridol injection: an update

    Energy Technology Data Exchange (ETDEWEB)

    Runge, V.M. [Department of Diagnostic Radiology, University of Kentucky, Lexington, KY 40536 (United States); Parker, J.R. [Department of Medical and Scientific Affairs, Bracco Diagnostics, Inc., P. O. Box 5225, Princeton, NJ 08543 (United States)

    1997-12-31

    Gadoteridol injection is a low molecular weight chelate complex of gadolinium (III) which is useful as a contrast agent for magnetic resonance imaging. A total of 2481 adult and pediatric subjects were studied with gadoteridol at doses from 0.025 to 0.3 mmol/kg in phase I-IIIb clinical trials in Europe and the United States. The study population had a mean age of 49 years, and included 119 patients under 18 years of age and 747 patients over 60 years of age. After 2656 administered injections of gadoteridol a total of 233 adverse events were recorded in 176 exposures, an incidence rate of 6.6 % irrespective of relationship to drug administration. The most frequently reported adverse events were nausea (1.5 %), taste perversion (0.9 %), and headache (0.6 %). All other adverse events occurred with an incidence of 0.5 % or less. This report confirms the excellent safety profile of gadoteridol in healthy subjects and patients with a variety of known or suspected pathologies. (orig.) With 3 tabs., 10 refs.

  8. Safety culture perceptions of pharmacists in Malaysian hospitals and health clinics: a multicentre assessment using the Safety Attitudes Questionnaire.

    Science.gov (United States)

    Samsuri, Srima Elina; Pei Lin, Lua; Fahrni, Mathumalar Loganathan

    2015-11-26

    To assess the safety attitudes of pharmacists, provide a profile of their domains of safety attitude and correlate their attitudes with self-reported rates of medication errors. A cross-sectional study utilising the Safety Attitudes Questionnaire (SAQ). 3 public hospitals and 27 health clinics. 117 pharmacists. Safety culture mean scores, variation in scores across working units and between hospitals versus health clinics, predictors of safety culture, and medication errors and their correlation. Response rate was 83.6% (117 valid questionnaires returned). Stress recognition (73.0±20.4) and working condition (54.8±17.4) received the highest and lowest mean scores, respectively. Pharmacists exhibited positive attitudes towards: stress recognition (58.1%), job satisfaction (46.2%), teamwork climate (38.5%), safety climate (33.3%), perception of management (29.9%) and working condition (15.4%). With the exception of stress recognition, those who worked in health clinics scored higher than those in hospitals (pculture. As perceptions improved, the number of medication errors reported decreased. Group-specific interventions that target specific domains are necessary to improve the safety culture. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

    Science.gov (United States)

    Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

    2014-10-01

    Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

  10. Deriving meaningful insights from clinical trial and postmarketing safety data: Perspectives from India

    Directory of Open Access Journals (Sweden)

    Anand Harugeri

    2017-01-01

    Full Text Available Today, drug safety data collection in India is both manual and electronic with reporting of potential overlapping and duplicate data, which is likely incomplete for further review and analysis. Furthermore, standardized data collection and timelines are not aligned with international standards. Complete coverage of safety data from all sources throughout the life of the drug cannot be ensured. There is no requirement to submit periodic safety data in clinical trials to regulatory authority. There is clearly a lack of emphasis on deriving meaningful safety data insights for ensuring patient safety. Efforts toward the early detection of drug safety issues are minimal. There is no mandate to publicly disclose drug safety findings. Benefit-risk evaluation of investigational and marketed products cannot be assured merely through annual status reports and periodic safety update reports, respectively. Focused initiatives involving stakeholders from regulatory, health-care, and pharmaceutical industries are required to change the current situation and enable derivation of meaningful insights from safety data. Equal emphasis on assessing real-time safety of the drugs and protection of patients' rights, safety, and well-being is required. Periodic safety data reporting in clinical trials, proactive safety data collection related to potential safety concerns, electronic medical records, electronic expedited reporting, collection of targeted data from stakeholders, and standardized and harmonized data collection aligned to the International Council for Harmonization guidelines are required. The Central Drugs Standard Control Organization should implement requirements to submit Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and Risk Management Plans. Access to clinical trials and postmarketing safety data through central repository would enable researchers to explore the data for application in clinical practice.

  11. Learning to ensure patient safety in clinical settings: comparing Finnish and British nursing students' perceptions.

    Science.gov (United States)

    Tella, Susanna; Smith, Nancy-Jane; Partanen, Pirjo; Jamookeeah, David; Lamidi, Marja-Leena; Turunen, Hannele

    2015-10-01

    To explore and compare Finnish and British nursing students' perceptions of their learning about patient safety in clinical settings. Patient safety culture and practices in different health care organisations and clinical units varies, posing challenges for nursing students' learning about patient safety during their clinical placements. Patient safety as a growing international concern has challenged health care professionals globally requiring a comprehensive review. International studies comparing nursing education about patient safety are lacking. A cross-sectional comparative study. The participants were final year preregistration nursing students from two universities of applied sciences in Finland (n = 195) and from two universities in England, UK (n = 158). The data were collected with the Patient Safety in Nursing Education Questionnaire and analysed with principal component analysis, Pearson Chi-Square and Mann-Whitney U tests and logistic regression. Finnish nursing students had significantly more critical perceptions on their learning about patient safety in clinical settings than their British peers. A strong predictor for differences was supportive and systems-based approaches in learning to ensure patient safety. Notably, fewer Finnish students had practiced reporting of incidents in clinical settings compared to British students. In both countries, the students held learning about patient safety in higher esteem compared to their learning experiences in clinical settings. Nursing students appear to want more learning opportunities related to patient safety compared to the reality in clinical settings. Learning systematically from errors in a supportive environment and having systems-based approaches to ensure patient safety are essential elements for nursing students' learning about safe practice. Finnish students seem to experience more barriers in learning about safe practices and to report errors than the British students. Health care

  12. Passiflora incarnata L.: ethnopharmacology, clinical application, safety and evaluation of clinical trials.

    Science.gov (United States)

    Miroddi, M; Calapai, G; Navarra, M; Minciullo, P L; Gangemi, S

    2013-12-12

    The genus Passiflora incarnata Linnaeus comprises approximately 520 species belonging to the Passifloraceae family. The majority of these species are vines found in Central or South America, with rare occurrence in North America, Southeast Asia and Australia. The genus Passiflora incarnata has long been used in traditional herbal medicine for the treatment of insomnia and anxiety in Europe, and it has been used as a sedative tea in North America. Furthermore, this plant has been used for analgesic, anti-spasmodic, anti-asthmatic, wormicidal and sedative purposes in Brazil; as a sedative and narcotic in Iraq; and for the treatment of disorders such as dysmenorrhoea, epilepsy, insomnia, neurosis and neuralgia in Turkey. In Poland, this plant has been used to treat hysteria and neurasthenia; in America, it has been used to treat diarrhoea, dysmenorrhoea, neuralgia, burns, haemorrhoids and insomnia. Passiflora incarnata L. has also been used to cure subjects affected by opiate dependence in India. This review aims to provide up-to-date information about the pharmacology, clinical efficacy and clinical safety of Passiflora incarnata L. based on the scientific literature. In particular, the methodological accuracy of clinical trials is analysed in accordance with current consolidated guidelines on reporting the clinical efficacy of herbal medicine, offering new insight into opportunities for future research and development. A bibliographic investigation was performed by examining the available data on Passiflora incarnata L. from globally accepted scientific databases and search engines (Pubmed, Scopus and Web of Science, SciFinder and Google Scholar). We selected studies, case reports, and reviews addressing the pharmacology and safety of Passiflora incarnata. Although numerous Passiflora incarnata L. derivative products have been commercialised as alternative anxiolytic and sedative remedies based on their long tradition of use, their supposed efficacy does not appear

  13. Injection safety knowledge and practices among clinical health care ...

    African Journals Online (AJOL)

    Background: The World Health Organization estimates that approximately 16 billion injections are administered in developing countries annually. Injection safety is therefore critical in preventing occupational exposure and infection from blood borne pathogens, hence prevention is a vital part of any comprehensive plan for ...

  14. Contracting for safety with patients: clinical practice and forensic implications.

    Science.gov (United States)

    Garvey, Keelin A; Penn, Joseph V; Campbell, Angela L; Esposito-Smythers, Christianne; Spirito, Anthony

    2009-01-01

    The contract for safety is a procedure used in the management of suicidal patients and has significant patient care, risk management, and medicolegal implications. We conducted a literature review to assess empirical support for this procedure and reviewed legal cases in which this practice was employed, to examine its effect on outcome. Studies obtained from a PubMed search were reviewed and consisted mainly of opinion-based surveys of clinicians and patients and retrospective reviews. Overall, empirically based evidence to support the use of the contract for safety in any population is very limited, particularly in adolescent populations. A legal review revealed that contracting for safety is never enough to protect against legal liability and may lead to adverse consequences for the clinician and the patient. Contracts should be considered for use only in patients who are deemed capable of giving informed consent and, even in these circumstances, should be used with caution. A contract should never replace a thorough assessment of a patient's suicide risk factors. Further empirical research is needed to determine whether contracting for safety merits consideration as a future component of the suicide risk assessment.

  15. Safety measurement and monitoring in healthcare: a framework to guide clinical teams and healthcare organisations in maintaining safety

    Science.gov (United States)

    Vincent, Charles; Burnett, Susan; Carthey, Jane

    2014-01-01

    Patients, clinicians and managers all want to be reassured that their healthcare organisation is safe. But there is no consensus about what we mean when we ask whether a healthcare organisation is safe or how this is achieved. In the UK, the measurement of harm, so important in the evolution of patient safety, has been neglected in favour of incident reporting. The use of softer intelligence for monitoring and anticipation of problems receives little mention in official policy. The Francis Inquiry report into patient treatment at the Mid Staffordshire NHS Foundation Trust set out 29 recommendations on measurement, more than on any other topic, and set the measurement of safety an absolute priority for healthcare organisations. The Berwick review found that most healthcare organisations at present have very little capacity to analyse, monitor or learn from safety and quality information. This paper summarises the findings of a more extensive report and proposes a framework which can guide clinical teams and healthcare organisations in the measurement and monitoring of safety and in reviewing progress against safety objectives. The framework has been used so far to promote self-reflection at both board and clinical team level, to stimulate an organisational check or analysis in the gaps of information and to promote discussion of ‘what could we do differently’. PMID:24764136

  16. Efficacy and Safety of Rituximab in Children with Refractory Nephrotic Syndrome; A Multicenter Clinical Trial

    Directory of Open Access Journals (Sweden)

    Yo Han Ahn

    2014-06-01

    Conclusions: In this interim analysis of clinical trial to evaluate the efficacy and safety of RTX in children with refractory NS, RTX treatment for refractory NS was safe and effective, especially in patients with DNS.

  17. Quality and safety based management of radiological and clinical equipment

    International Nuclear Information System (INIS)

    Arora, S.; Saini, P.S.

    2001-01-01

    TQM (Total quality management) is the 'buzz' acronym expected in almost every aspect of industrial manufacturing, product development and services solicited by the outside agencies. The correct management of the many technological resources in health institutions in terms of efficiency, effectiveness and safety is a necessity in view of the criteria on which modern medicine is based. Almost all activities -be they diagnostic, therapeutic and rehabilitative - carried out within a modern hospital are based on widespread application of equipment and technology, the efficiency of which can directly influence the quality of service offered to the patient

  18. US stem cell clinics, patient safety, and the FDA.

    Science.gov (United States)

    Turner, Leigh

    2015-05-01

    Scholarship on patients accessing unproven stem cell interventions is dominated by research addressing 'stem cell tourism' to such countries as China, India, Mexico, and the Ukraine. However, clinics marketing 'adipose-derived mesenchymal stem cell treatments' are proliferating across the USA. These businesses typically claim to operate in compliance with federal regulations, but careful review of their commercial practices suggests that such clinics are marketing unapproved and noncompliant biological drugs. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Safety

    International Nuclear Information System (INIS)

    1998-01-01

    A brief account of activities carried out by the Nuclear power plants Jaslovske Bohunice in 1997 is presented. These activities are reported under the headings: (1) Nuclear safety; (2) Industrial and health safety; (3) Radiation safety; and Fire protection

  20. Safety and effectiveness considerations for clinical studies of visual prosthetic devices

    Science.gov (United States)

    Cohen, Ethan D.

    2007-03-01

    With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.

  1. Preclinical and clinical safety studies on DNA vaccines.

    NARCIS (Netherlands)

    Schalk, Johanna A C; Mooi, Frits R; Berbers, Guy A M; Aerts, Leon A G J M van; Ovelgönne, Hans; Kimman, Tjeerd G

    2007-01-01

    DNA vaccines are based on the transfer of genetic material, encoding an antigen, to the cells of the vaccine recipient. Despite high expectations of DNA vaccines as a result of promising preclinical data their clinical utility remains unproven. However, much data is gathered in preclinical and

  2. Evaluating predictive modeling's potential to improve teleretinal screening participation in urban safety net clinics.

    Science.gov (United States)

    Ogunyemi, Omolola; Teklehaimanot, Senait; Patty, Lauren; Moran, Erin; George, Sheba

    2013-01-01

    Screening guidelines for diabetic patients recommend yearly eye examinations to detect diabetic retinopathy and other forms of diabetic eye disease. However, annual screening rates for retinopathy in US urban safety net settings remain low. Using data gathered from a study of teleretinal screening in six urban safety net clinics, we assessed whether predictive modeling could be of value in identifying patients at risk of developing retinopathy. We developed and examined the accuracy of two predictive modeling approaches for diabetic retinopathy in a sample of 513 diabetic individuals, using routinely available clinical variables from retrospective medical record reviews. Bayesian networks and radial basis function (neural) networks were learned using ten-fold cross-validation. The predictive models were modestly predictive with the best model having an AUC of 0.71. Using routinely available clinical variables to predict patients at risk of developing retinopathy and to target them for annual eye screenings may be of some usefulness to safety net clinics.

  3. Clinical Outcome and Safety of Multilevel Vertebroplasty: Clinical Experience and Results

    Energy Technology Data Exchange (ETDEWEB)

    Mailli, Leto, E-mail: lmailli@hotmail.com; Filippiadis, Dimitrios K.; Brountzos, Elias N.; Alexopoulou, Efthymia; Kelekis, Nikolaos; Kelekis, Alexios [Attikon University Hospital, Second Department of Radiology, Athens University School of Medicine (Greece)

    2013-02-15

    To compare safety and efficacy of percutaneous vertebroplasty (PVP) when treating up to three vertebrae or more than three vertebrae per session. We prospectively compared two groups of patients with symptomatic vertebral fractures who had no significant response to conservative therapy. Pathologic substrate included osteoporosis (n = 77), metastasis (n = 24), multiple myeloma (n = 13), hemangioma (n = 15), and lymphoma (n = 1). Group A patients (n = 94) underwent PVP of up to three treated vertebrae (n = 188). Group B patients (n = 36) underwent PVP with more than three treated vertebrae per session (n = 220). Decreased pain and improved mobility were recorded the day after surgery and at 12 and 24 months after surgery per clinical evaluation and the use of numeric visual scales (NVS): the Greek Brief Pain Inventory, a linear analogue self-assessment questionnaire, and a World Health Organization questionnaire. Group A presented with a mean pain score of 7.9 {+-} 1.1 NVS units before PVP, which decreased to 2.1 {+-} 1.6, 2.0 {+-} 1.5 and 2.0 {+-} 1.5 NVS units the day after surgery and at 12 and 24 months after surgery, respectively. Group B presented with a mean pain score of 8.1 {+-} 1.3 NVS units before PVP, which decreased to 2.2 {+-} 1.3, 2.0 {+-} 1.5, and 2.1 {+-} 1.6 NVS units the day after surgery and at 12 and 24 months after surgery, respectively. Overall pain decrease and mobility improvement throughout the follow-up period presented no statistical significance neither between the two groups nor between different underlying aetiology. Reported cement leakages presented no statistical significance between the two groups (p = 0.365). PVP is an efficient and safe technique for symptomatic vertebral fractures independently of the vertebrae number treated per session.

  4. Clinical Outcome and Safety of Multilevel Vertebroplasty: Clinical Experience and Results

    International Nuclear Information System (INIS)

    Mailli, Leto; Filippiadis, Dimitrios K.; Brountzos, Elias N.; Alexopoulou, Efthymia; Kelekis, Nikolaos; Kelekis, Alexios

    2013-01-01

    To compare safety and efficacy of percutaneous vertebroplasty (PVP) when treating up to three vertebrae or more than three vertebrae per session. We prospectively compared two groups of patients with symptomatic vertebral fractures who had no significant response to conservative therapy. Pathologic substrate included osteoporosis (n = 77), metastasis (n = 24), multiple myeloma (n = 13), hemangioma (n = 15), and lymphoma (n = 1). Group A patients (n = 94) underwent PVP of up to three treated vertebrae (n = 188). Group B patients (n = 36) underwent PVP with more than three treated vertebrae per session (n = 220). Decreased pain and improved mobility were recorded the day after surgery and at 12 and 24 months after surgery per clinical evaluation and the use of numeric visual scales (NVS): the Greek Brief Pain Inventory, a linear analogue self-assessment questionnaire, and a World Health Organization questionnaire. Group A presented with a mean pain score of 7.9 ± 1.1 NVS units before PVP, which decreased to 2.1 ± 1.6, 2.0 ± 1.5 and 2.0 ± 1.5 NVS units the day after surgery and at 12 and 24 months after surgery, respectively. Group B presented with a mean pain score of 8.1 ± 1.3 NVS units before PVP, which decreased to 2.2 ± 1.3, 2.0 ± 1.5, and 2.1 ± 1.6 NVS units the day after surgery and at 12 and 24 months after surgery, respectively. Overall pain decrease and mobility improvement throughout the follow-up period presented no statistical significance neither between the two groups nor between different underlying aetiology. Reported cement leakages presented no statistical significance between the two groups (p = 0.365). PVP is an efficient and safe technique for symptomatic vertebral fractures independently of the vertebrae number treated per session.

  5. Nurses' Use of Computerized Clinical Guidelines to Improve Patient Safety in Hospitals.

    Science.gov (United States)

    Hovde, Birgit; Jensen, Kari H; Alexander, Gregory L; Fossum, Mariann

    2015-07-01

    Computerized clinical guidelines are frequently used to translate research into evidence-based behavioral practices and to improve patient outcomes. The purpose of this integrative review is to summarize the factors influencing nurses' use of computerized clinical guidelines and the effects of nurses' use of computerized clinical guidelines on patient safety improvements in hospitals. The Embase, Medline Complete, and Cochrane databases were searched for relevant literature published from 2000 to January 2013. The matrix method was used, and a total of 16 papers were included in the final review. The studies were assessed for quality with the Critical Appraisal Skills Program. The studies focused on nurses' adherence to guidelines and on improved patient care and patient outcomes as benefits of using computerized clinical guidelines. The nurses' use of computerized clinical guidelines demonstrated improvements in care processes; however, the evidence for an effect of computerized clinical guidelines on patient safety remains limited. © The Author(s) 2015.

  6. Prediction of Clinically Relevant Safety Signals of Nephrotoxicity through Plasma Metabolite Profiling

    Directory of Open Access Journals (Sweden)

    W. B. Mattes

    2013-01-01

    Full Text Available Addressing safety concerns such as drug-induced kidney injury (DIKI early in the drug pharmaceutical development process ensures both patient safety and efficient clinical development. We describe a unique adjunct to standard safety assessment wherein the metabolite profile of treated animals is compared with the MetaMap Tox metabolomics database in order to predict the potential for a wide variety of adverse events, including DIKI. To examine this approach, a study of five compounds (phenytoin, cyclosporin A, doxorubicin, captopril, and lisinopril was initiated by the Technology Evaluation Consortium under the auspices of the Drug Safety Executive Council (DSEC. The metabolite profiles for rats treated with these compounds matched established reference patterns in the MetaMap Tox metabolomics database indicative of each compound’s well-described clinical toxicities. For example, the DIKI associated with cyclosporine A and doxorubicin was correctly predicted by metabolite profiling, while no evidence for DIKI was found for phenytoin, consistent with its clinical picture. In some cases the clinical toxicity (hepatotoxicity, not generally seen in animal studies, was detected with MetaMap Tox. Thus metabolite profiling coupled with the MetaMap Tox metabolomics database offers a unique and powerful approach for augmenting safety assessment and avoiding clinical adverse events such as DIKI.

  7. [Clinical analysis of safety and effectiveness of electroconvulsive therapy].

    Science.gov (United States)

    Dabrowski, Marek; Parnowski, Tadeusz

    2012-01-01

    The aim of the study was to assess efficacy and safety of electroconvulsive therapy. 43 patients included into the study were hospitalised in The Institute of Psychiatry and Neurology and received all together over 400 bilateral electroconvulsive procedures. Most of the patients (N = 25) were qualified for electroconvulsive therapy due to treatment resistant depression (58.1%). Six patients: 2 with catatonia and 4 with depression had life saving indications for electroconvulsive therapy. Three patients (7%) were excluded from electroconvulsive therapy, following 1 or 2 electroconvulsive procedures. Forty patients continued electroconvulsive therapy. There were no complications and serious adverse events in patients who continued electroconvulsive therapy. Generally, electroconvulsive therapy was well tolerated and treatment had been cut down in only one case due to adverse events and high risk related to the procedure. Transient cardiac arrhythmias (10% of patients) were the most often occurring adverse events and patients (35%) mostly reported headaches. We observed remission in 22 patients (58%) and improvement in 14 patients (35%) following electroconvulsive treatment. Only 4 patients (10%) had no benefit after a series of electroconvulsive procedures. Electroconvulsive treatment was most effective in patients with catatonia (80% patients had full recovery) and in depressive patients with bipolar disorder (73% patients had full recovery). Electroconvulsive procedures were safe and effective. Electroconvulsive treatment was most effective in catatonic patients with schizophrenia and in depressive patients with bipolar disorder.

  8. Improving Patient Safety in Clinical Oncology: Applying Lessons From Normal Accident Theory.

    Science.gov (United States)

    Chera, Bhishamjit S; Mazur, Lukasz; Buchanan, Ian; Kim, Hong Jin; Rockwell, John; Milowsky, Matthew I; Marks, Lawrence B

    2015-10-01

    Concerns for patient safety persist in clinical oncology. Within several nonmedical areas (eg, aviation, nuclear power), concepts from Normal Accident Theory (NAT), a framework for analyzing failure potential within and between systems, have been successfully applied to better understand system performance and improve system safety. Clinical oncology practice is interprofessional and interdisciplinary, and our therapies often have narrow therapeutic windows. Thus, many of our processes are, in NAT terms, interactively complex and tightly coupled within and across systems and are therefore prone to unexpected behaviors that can result in substantial patient harm. To improve safety at the University of North Carolina, we have applied the concepts of NAT to our practice to better understand our systems' behavior and adopted strategies to reduce complexity and coupling. Furthermore, recognizing that we cannot eliminate all risks, we have stressed safety mindfulness among our staff to further promote safety. Many specific examples are provided herein. The lessons from NAT are translatable to clinical oncology and may help to promote safety.

  9. Assessment of patient safety culture in clinical laboratories in the Spanish National Health System.

    Science.gov (United States)

    Giménez-Marín, Angeles; Rivas-Ruiz, Francisco; García-Raja, Ana M; Venta-Obaya, Rafael; Fusté-Ventosa, Margarita; Caballé-Martín, Inmaculada; Benítez-Estevez, Alfonso; Quinteiro-García, Ana I; Bedini, José Luis; León-Justel, Antonio; Torra-Puig, Montserrat

    2015-01-01

    There is increasing awareness of the importance of transforming organisational culture in order to raise safety standards. This paper describes the results obtained from an evaluation of patient safety culture in a sample of clinical laboratories in public hospitals in the Spanish National Health System. A descriptive cross-sectional study was conducted among health workers employed in the clinical laboratories of 27 public hospitals in 2012. The participants were recruited by the heads of service at each of the participating centers. Stratified analyses were performed to assess the mean score, standardized to a base of 100, of the six survey factors, together with the overall patient safety score. 740 completed questionnaires were received (88% of the 840 issued). The highest standardized scores were obtained in Area 1 (individual, social and cultural) with a mean value of 77 (95%CI: 76-78), and the lowest ones, in Area 3 (equipment and resources), with a mean value of 58 (95%CI: 57-59). In all areas, a greater perception of patient safety was reported by the heads of service than by other staff. We present the first multicentre study to evaluate the culture of clinical safety in public hospital laboratories in Spain. The results obtained evidence a culture in which high regard is paid to safety, probably due to the pattern of continuous quality improvement. Nevertheless, much remains to be done, as reflected by the weaknesses detected, which identify areas and strategies for improvement.

  10. Multilevel correlates for human papillomavirus vaccination of adolescent girls attending safety net clinics.

    Science.gov (United States)

    Tiro, Jasmin A; Pruitt, Sandi L; Bruce, Corinne M; Persaud, Donna; Lau, May; Vernon, Sally W; Morrow, Jay; Skinner, Celette Sugg

    2012-03-16

    Adolescent HPV vaccination in minority and low income populations with high cervical cancer incidence and mortality could reduce disparities. Safety-net primary care clinics are a key delivery site for improving vaccination rates in these populations. To examine prevalence of HPV initiation (≥ 1 dose), completion (receipt of dose 3 within 12 months of initiation), and receipt of 3 doses in four safety-net clinics as well as individual-, household-, and clinic-level correlates of initiation. We used multilevel modeling to investigate HPV initiation among 700 adolescent females who sought primary care in four safety-net clinics in Dallas, Texas from March 2007 to December 2009. Data were abstracted from patients' paper and electronic medical records. HPV vaccine uptake varied significantly by clinic. Across clinics, initiation was 36.6% and completion was 39.7% among those who initiated. In the total study population, only 15.7% received all three doses. In multivariate, two-level logistic regression analyses, initiation was associated with receipt of other adolescent vaccines, influenza vaccination in the year prior to data abstraction, being sexually active, and having more chart documentation (presence of health maintenance questionnaire and/or immunization record). There was no association between initiation and age, race/ethnicity, or insurance status. In four urban safety-net clinics, HPV initiation rates paralleled 2008 national rates. The correlation of HPV initiation with other adolescent vaccines underscores the importance of reviewing vaccination status at every health care visit. HPV vaccine uptake in safety-net clinics should continue to be monitored to understand impact on cervical cancer disparities. Copyright © 2011 Elsevier Ltd. All rights reserved.

  11. Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network.

    Science.gov (United States)

    LaRussa, Philip S; Edwards, Kathryn M; Dekker, Cornelia L; Klein, Nicola P; Halsey, Neal A; Marchant, Colin; Baxter, Roger; Engler, Renata J M; Kissner, Jennifer; Slade, Barbara A

    2011-05-01

    The Clinical Immunization Safety Assessment (CISA) Network is a collaboration between the Centers for Disease Control and Prevention (CDC) and 6 academic medical centers to provide support for immunization safety assessment and research. The CISA Network was established by the CDC in 2001 with 4 primary goals: (1) develop research protocols for clinical evaluation, diagnosis, and management of adverse events following immunization (AEFI); (2) improve the understanding of AEFI at the individual level, including determining possible genetic and other risk factors for predisposed people and subpopulations at high risk; (3) develop evidence-based algorithms for vaccination of people at risk of serious AEFI; and (4) serve as subject-matter experts for clinical vaccine-safety inquiries. CISA Network investigators bring in-depth clinical, pathophysiologic, and epidemiologic expertise to assessing causal relationships between vaccines and adverse events and to understanding the pathogenesis of AEFI. CISA Network researchers conduct expert reviews of clinically significant adverse events and determine the validity of the recorded diagnoses on the basis of clinical and laboratory criteria. They also conduct special studies to investigate the possible pathogenesis of adverse events, assess relationships between vaccines and adverse events, and maintain a centralized repository for clinical specimens. The CISA Network provides specific clinical guidance to both health care providers who administer vaccines and those who evaluate and treat patients with possible AEFI. The CISA Network plays an important role in providing critical immunization-safety data and expertise to inform vaccine policy-makers. The CISA Network serves as a unique resource for vaccine-safety monitoring efforts conducted at the CDC.

  12. Patient safety and quality of care: How may clinical simulation contribute?

    Directory of Open Access Journals (Sweden)

    Sanne Jensen

    2015-09-01

    Full Text Available The usability of health information technology (IT is increasingly recognized as critically important to the development of systems that ensure patient safety and quality of care. The substantial complexity of organizations, work practice and physical environments within the healthcare sector influences the development and application of health IT. When health IT is introduced in local clinical work practices, potential patient safety hazards and insufficient support of work practices need to be examined. Qualitative methods, such as clinical simulation, may be used to evaluate new technology in correlation with the clinical context and to study the interaction between users, technology and work practice. Compared with the “classic” methods, such as heuristic inspection and usability testing, clinical simulation takes the clinical context into account. Clinical simulation can be useful in many processes in the human-centred design cycle. In the requirement specification, clinical simulation can be useful to analyze user requirements and work practice as well to evaluate requirements. In the design of health IT, clinical simulation can be used to evaluate clinical information systems and serve as common ground to help to achieve a shared understanding between various communities of practice. In a public procurement process, a clinical simulation-based assessment can help give insight into different solutions and how they support work practice. Before organizational implementation, clinical simulation is a very suitable means, by which to assess an application in connection with work practice.

  13. SAFETY

    CERN Document Server

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  14. Non-clinical models: validation, study design and statistical consideration in safety pharmacology.

    Science.gov (United States)

    Pugsley, M K; Towart, R; Authier, S; Gallacher, D J; Curtis, M J

    2010-01-01

    The current issue of the Journal of Pharmacological and Toxicological Methods (JPTM) focuses exclusively on safety pharmacology methods. This is the 7th year the Journal has published on this topic. Methods and models that specifically relate to methods relating to the assessment of the safety profile of a new chemical entity (NCE) prior to first in human (FIH) studies are described. Since the Journal started publishing on this topic there has been a major effort by safety pharmacologists, toxicologists and regulatory scientists within Industry (both large and small Pharma as well as Biotechnology companies) and also from Contract Research Organizations (CRO) to publish the surgical details of the non-clinical methods utilized but also provide important details related to standard and non-standard (or integrated) study models and designs. These details from core battery and secondary (or ancillary) drug safety assessment methods used in drug development programs have been the focus of these special issues and have been an attempt to provide validation of methods. Similarly, the safety pharmacology issues of the Journal provide the most relevant forum for scientists to present novel and modified methods with direct applicability to determination of drug safety-directly to the safety pharmacology scientific community. The content of the manuscripts in this issue includes the introduction of additional important surgical methods, novel data capture and data analysis methods, improved study design and effects of positive control compounds with known activity in the model. Copyright 2010 Elsevier Inc. All rights reserved.

  15. Factors shaping effective utilization of health information technology in urban safety-net clinics.

    Science.gov (United States)

    George, Sheba; Garth, Belinda; Fish, Allison; Baker, Richard

    2013-09-01

    Urban safety-net clinics are considered prime targets for the adoption of health information technology innovations; however, little is known about their utilization in such safety-net settings. Current scholarship provides limited guidance on the implementation of health information technology into safety-net settings as it typically assumes that adopting institutions have sufficient basic resources. This study addresses this gap by exploring the unique challenges urban resource-poor safety-net clinics must consider when adopting and utilizing health information technology. In-depth interviews (N = 15) were used with key stakeholders (clinic chief executive officers, medical directors, nursing directors, chief financial officers, and information technology directors) from staff at four clinics to explore (a) nonhealth information technology-related clinic needs, (b) how health information technology may provide solutions, and (c) perceptions of and experiences with health information technology. Participants identified several challenges, some of which appear amenable to health information technology solutions. Also identified were requirements for effective utilization of health information technology including physical infrastructural improvements, funding for equipment/training, creation of user groups to share health information technology knowledge/experiences, and specially tailored electronic billing guidelines. We found that despite the potential benefit that can be derived from health information technologies, the unplanned and uninformed introduction of these tools into these settings might actually create more problems than are solved. From these data, we were able to identify a set of factors that should be considered when integrating health information technology into the existing workflows of low-resourced urban safety-net clinics in order to maximize their utilization and enhance the quality of health care in such settings.

  16. Sound understanding of environmental, health and safety, clinical, and market aspects is imperative to clinical translation of nanomedicines.

    Science.gov (United States)

    Rösslein, Matthias; Liptrott, Neill J; Owen, Andrew; Boisseau, Patrick; Wick, Peter; Herrmann, Inge K

    2017-03-01

    Nanotechnology has transformed materials engineering. However, despite much excitement in the scientific community, translation of nanotechnology-based developments has suffered from significant translational gaps, particularly in the field of biomedicine. Of the many concepts investigated, very few have entered routine clinical application. Safety concerns and associated socioeconomic uncertainties, together with the lack of incentives for technology transfer, are undoubtedly imposing significant hurdles to effective clinical translation of potentially game-changing developments. Commercialisation aspects are only rarely considered in the early stages and in many cases, the market is not identified early on in the process, hence precluding market-oriented development. However, methodologies and in-depth understanding of mechanistic processes existing in the environmental, health and safety (EHS) community could be leveraged to accelerate translation. Here, we discuss the most important stepping stones for (nano)medicine development along with a number of suggestions to facilitate future translation.

  17. Patient safety and quality of care: how may clinical simulation contribute?

    DEFF Research Database (Denmark)

    Jensen, Sanne

    2015-01-01

    The usability of health information technology (IT) is increasingly recognized as critically important to the development of systems that ensure patient safety and quality of care. The substantial complexity of organizations, work practice and physical environments within the healthcare sector...... in correlation with the clinical context and to study the interaction between users, technology and work practice. Compared with the “classic” methods, such as heuristic inspection and usability testing, clinical simulation takes the clinical context into account. Clinical simulation can be useful in many...... processes in the human-centred design cycle. In the requirement specification, clinical simulation can be useful to analyze user requirements and work practice as well to evaluate requirements. In the design of health IT, clinical simulation can be used to evaluate clinical information systems and serve...

  18. Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

    Science.gov (United States)

    Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

    2018-01-01

    Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

  19. Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

    Science.gov (United States)

    Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

    2018-01-01

    Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

  20. Template protocol for clinical trials investigating vaccines—Focus on safety elements☆

    Science.gov (United States)

    Bonhoeffer, Jan; Imoukhuede, Egeruan B.; Aldrovandi, Grace; Bachtiar, Novilia S.; Chan, Eng-Soon; Chang, Soju; Chen, Robert T.; Fernandopulle, Rohini; Goldenthal, Karen L.; Heffelfinger, James D.; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B.; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

    2015-01-01

    This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I–IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. PMID:23499603

  1. A multidisciplinary three-phase approach to improve the clinical utility of patient safety indicators.

    Science.gov (United States)

    Najjar, Peter; Kachalia, Allen; Sutherland, Tori; Beloff, Jennifer; David-Kasdan, Jo Ann; Bates, David W; Urman, Richard D

    2015-01-01

    The AHRQ Patient Safety Indicators (PSIs) are used for calculation of risk-adjusted postoperative rates for adverse events. The payers and quality consortiums are increasingly requiring public reporting of hospital performance on these metrics. We discuss processes designed to improve the accuracy and clinical utility of PSI reporting in practice. The study was conducted at a 793-bed tertiary care academic medical center where PSI processes have been aggressively implemented to track patient safety events at discharge. A three-phased approach to improving administrative data quality was implemented. The initiative consisted of clinical review of all PSIs, documentation improvement, and provider outreach including active querying for patient safety events. This multidisciplinary effort to develop a streamlined process for PSI calculation reduced the reporting of miscoded PSIs and increased the clinical utility of PSI monitoring. Over 4 quarters, 4 of 41 (10%) PSI-11 and 9 of 138 (7%) PSI-15 errors were identified on review of clinical documentation and appropriate adjustments were made. A multidisciplinary, phased approach leveraging existing billing infrastructure for robust metric coding, ongoing clinical review, and frontline provider outreach is a novel and effective way to reduce the reporting of false-positive outcomes and improve the clinical utility of PSIs.

  2. Endoscope-assisted frenotomy approach to median upper neck masses: clinical outcomes and safety (from a phase II clinical trial).

    Science.gov (United States)

    Woo, Seung Hoon; Jeong, Han-Sin; Kim, Jin Pyeong; Park, Jung Je; Baek, Chung-Hwan

    2014-07-01

    An endoscope-assisted frenotomy approach (EFA) to resection of the median upper neck mass has been introduced to clinical practice. However, its technical feasibility, indications, and safety have not been fully studied. Here, we report the results of a prospective phase II clinical trial to evaluate the clinical outcomes. Twenty patients were enrolled in this trial. The masses were divided into 3 subtypes. We implemented EFA to remove the masses after receiving informed patient consent. We evaluated the clinical outcomes and complications related to this procedure for more than a 2-year period. EFA successfully removed the masses in all cases without any injuries to adjacent nerves or ducts. During the more than 2-year follow-up period, recurrence or revision surgeries were not required. EFA can be a very effective and safe approach for median upper neck masses, and can also lead to excellent cosmetic and functional results. Copyright © 2013 Wiley Periodicals, Inc.

  3. Safety

    International Nuclear Information System (INIS)

    2001-01-01

    This annual report of the Senior Inspector for the Nuclear Safety, analyses the nuclear safety at EDF for the year 1999 and proposes twelve subjects of consideration to progress. Five technical documents are also provided and discussed concerning the nuclear power plants maintenance and safety (thermal fatigue, vibration fatigue, assisted control and instrumentation of the N4 bearing, 1300 MW reactors containment and time of life of power plants). (A.L.B.)

  4. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  5. Have the Findings from Clinical Risk Prediction and Trials Any Key Messages for Safety Pharmacology?

    Directory of Open Access Journals (Sweden)

    Jem D. Lane

    2017-11-01

    Full Text Available Anti-arrhythmic drugs are a mainstay in the management of symptoms related to arrhythmias, and are adjuncts in prevention and treatment of life-threatening ventricular arrhythmias. However, they also have the potential for pro-arrhythmia and thus the prediction of arrhythmia predisposition and drug response are critical issues. Clinical trials are the latter stages in the safety testing and efficacy process prior to market release, and as such serve as a critical safeguard. In this review, we look at some of the lessons to be learned from approaches to arrhythmia prediction in patients, clinical trials of drugs used in the treatment of arrhythmias, and the implications for the design of pre-clinical safety pharmacology testing.

  6. [A preliminary clinical safety evaluation of parvovirus H-1 on cancer therapy].

    Science.gov (United States)

    Lin, W; Ling, W; Guo, L

    1999-12-01

    To make a preliminary evaluation of parvovirus H-1 for its safety in clinical use. In this study, clinical safety of H-1 in cancer therapy was examined using the Ames test, the mammalian cell chromosome aberration test, the micronucleus calculation of mouse bone marrow cells, the allergy test and the pyrogenicity test. Negative results were observed in all the tests. The mouse tolerance test showed that the tolerance limit was at least 5 x 10(11) plaque-forming units/kg weight, which was 2500 times higher than the supposed clinical dose. The H-1 host NB-324K cells were also tested using the anchorage-independent assay and the tumour formation in nude mice. Both of the assays gave negative results. All these results preliminarily showed that the H-1 was safe in cancer therapy.

  7. Safety and tolerability of dienogest in endometriosis: pooled analysis from the European clinical study program.

    Science.gov (United States)

    Strowitzki, Thomas; Faustmann, Thomas; Gerlinger, Christoph; Schumacher, Ulrike; Ahlers, Christiane; Seitz, Christian

    2015-01-01

    In four randomized, controlled, European trials, dienogest 2 mg once daily demonstrated significant efficacy for lesion reduction and reduction in pain intensity in endometriosis. We describe a pooled analysis of the safety and tolerability data from these trials to confirm and further characterize the safety profile of dienogest in the treatment of endometriosis. All 332 women treated with dienogest 2 mg who participated in the four clinical trials were included in the pooled analyses for safety assessments, including adverse events, laboratory tests, vital signs, body weight, and bleeding patterns. Safety variables were analyzed using descriptive statistics. Pooled analyses of this large patient population confirmed that dienogest 2 mg is well tolerated, with a favorable safety profile extending over a period up to 65 weeks in women with endometriosis. The most common adverse drug reactions were headache, breast discomfort, depressed mood, and acne, each occurring in dienogest 2 mg was well tolerated, and only two women (0.6%) reported bleeding events as the primary reason for premature discontinuation. Laboratory and vital sign assessments indicated no safety concerns for dienogest. Estradiol levels were maintained within the low-physiological range, in support of previous evidence indicating that dienogest 2 mg demonstrates therapeutic efficacy without inducing estradiol deficiency. In this pooled analysis of 332 women with endometriosis, dienogest was well tolerated with a favorable safety profile extending over a period of up to 65 weeks. There is a paucity of randomized trial evidence to support the use of many treatments in endometriosis. These pooled analyses from four clinical trials of dienogest 2 mg represent a contribution to evidence-based medicine in endometriosis, providing outcomes of potential relevance to daily practice.

  8. Evaluation of features to support safety and quality in general practice clinical software

    Directory of Open Access Journals (Sweden)

    Schattner Peter

    2011-05-01

    Full Text Available Abstract Background Electronic prescribing is now the norm in many countries. We wished to find out if clinical software systems used by general practitioners in Australia include features (functional capabilities and other characteristics that facilitate improved patient safety and care, with a focus on quality use of medicines. Methods Seven clinical software systems used in general practice were evaluated. Fifty software features that were previously rated as likely to have a high impact on safety and/or quality of care in general practice were tested and are reported here. Results The range of results for the implementation of 50 features across the 7 clinical software systems was as follows: 17-31 features (34-62% were fully implemented, 9-13 (18-26% partially implemented, and 9-20 (18-40% not implemented. Key findings included: Access to evidence based drug and therapeutic information was limited. Decision support for prescribing was available but varied markedly between systems. During prescribing there was potential for medicine mis-selection in some systems, and linking a medicine with its indication was optional. The definition of 'current medicines' versus 'past medicines' was not always clear. There were limited resources for patients, and some medicines lists for patients were suboptimal. Results were provided to the software vendors, who were keen to improve their systems. Conclusions The clinical systems tested lack some of the features expected to support patient safety and quality of care. Standards and certification for clinical software would ensure that safety features are present and that there is a minimum level of clinical functionality that clinicians could expect to find in any system.

  9. Evaluation of features to support safety and quality in general practice clinical software

    Science.gov (United States)

    2011-01-01

    Background Electronic prescribing is now the norm in many countries. We wished to find out if clinical software systems used by general practitioners in Australia include features (functional capabilities and other characteristics) that facilitate improved patient safety and care, with a focus on quality use of medicines. Methods Seven clinical software systems used in general practice were evaluated. Fifty software features that were previously rated as likely to have a high impact on safety and/or quality of care in general practice were tested and are reported here. Results The range of results for the implementation of 50 features across the 7 clinical software systems was as follows: 17-31 features (34-62%) were fully implemented, 9-13 (18-26%) partially implemented, and 9-20 (18-40%) not implemented. Key findings included: Access to evidence based drug and therapeutic information was limited. Decision support for prescribing was available but varied markedly between systems. During prescribing there was potential for medicine mis-selection in some systems, and linking a medicine with its indication was optional. The definition of 'current medicines' versus 'past medicines' was not always clear. There were limited resources for patients, and some medicines lists for patients were suboptimal. Results were provided to the software vendors, who were keen to improve their systems. Conclusions The clinical systems tested lack some of the features expected to support patient safety and quality of care. Standards and certification for clinical software would ensure that safety features are present and that there is a minimum level of clinical functionality that clinicians could expect to find in any system.

  10. Clinically relevant safety issues associated with St. John's wort product labels

    Directory of Open Access Journals (Sweden)

    Rutledge Jennifer C

    2008-07-01

    Full Text Available Abstract Background St. John's wort (SJW, used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin, contraindications (bipolar disorder, therapeutic duplication (antidepressants, and general considerations (phototoxicity and advice to consult a healthcare professional (HCP. A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1% provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%, SJW-immunosupressants (5.4%, SJW-OCPs (8.1%, SJW-warfarin (5.4%, bipolar (1.4%, antidepressants (23.0%, phototoxicity (51.4%, and consult HCP (87.8%. Other safety-related information on labels included warnings about pregnancy (74.3%, lactation (64.9%, discontinue if adverse reaction (23.0%, and not for use in patients under 18 years old (13.5%. The average number of a priori safety issues included on a product label was 1.91 (range 0–8 for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety

  11. Clinical impact, safety, and efficacy of single- versus Dual-Coil ICD leads in MADIT-CRT

    DEFF Research Database (Denmark)

    Kutyifa, Valentina; Huth Ruwald, Anne Christine; Aktas, Mehmet K.

    2013-01-01

    Current data on efficacy, safety and impact on clinical outcome of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads are limited and contradictory.......Current data on efficacy, safety and impact on clinical outcome of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads are limited and contradictory....

  12. Clinical safety, quality and effect of resin infiltration for proximal caries.

    Science.gov (United States)

    Altarabulsi, M B; Alkilzy, M; Petrou, M A; Splieth, C

    2014-03-01

    Resin infiltration of proximal lesions is a new approach to stop caries progression. The aim of this clinical trial was to assess its safety and quality, as well as the therapeutic effect. In 47 children, adolescents and young adults, ten dentists applied the infiltration material ICON (DMG, Germany) on initial proximal lesions according to the manufacturer's instruction. One lesion with radiographic extension into enamel or the outer third of dentin per participant was allocated for the treatment. The clinical safety and quality of resin infiltration were assessed 1 week, 6 months and 12 months after the treatment and the evaluation of the therapeutic effect was analysed by pair-wise radiographs. The clinical safety and quality of the infiltration were assessed in 45 individuals after 12 months. The test surfaces showed no relevant changes in clinical status, plaque accumulation or gingival status (p > 0.05). A high quality of infiltration was found for the marginal adaptation. In contrast to the improvement of colour at the one-week recall (p = 0.005), the infiltrated surfaces showed a statistically significant increase in the discoloration within the following year (p = 0.014). Out of the 43 lesions which could be assessed radiographically, only two lesions showed progression to a different score (4.7%). Resin infiltration can be considered a safe and effective treatment to reduce progression of initial proximal caries.

  13. Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda

    Directory of Open Access Journals (Sweden)

    Mpimbaza Arthur

    2008-06-01

    Full Text Available Abstract Background New antimalarial regimens, including artemisinin-based combination therapies (ACTs, have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed. Here the reporting system is described, and difficulties faced in analysing and interpreting the safety results are illustrated, using data from the trials. Case description Between 2002 and 2007, eleven randomized, controlled clinical trials were conducted to compare the efficacy, safety, and tolerability of different antimalarial regimens for treatment of uncomplicated malaria in Uganda. The approach to adverse event monitoring was similar in all studies. A total of 5,614 treatments were evaluated in 4,876 patients. Differences in baseline characteristics and patterns of adverse event reporting were noted between the sites, which limited the ability to pool and analyse data. Clinical failure following antimalarial treatment confounded associations between treatment and adverse events that were also common symptoms of malaria, particularly in areas of lower transmission intensity. Discussion and evaluation Despite prospectively evaluating for adverse events, limitations in the monitoring system were identified. New standardized guidelines for monitoring safety and tolerability in antimalarial trials are needed, which should address how to detect events of greatest importance, including serious events, those with a causal relationship to the treatment, those which impact on adherence, and events not previously reported. Conclusion Although the World Health Organization has supported the development of

  14. Clinical Trial of a Home Safety Toolkit for Alzheimer’s Disease

    Directory of Open Access Journals (Sweden)

    Kathy J. Horvath

    2013-01-01

    Full Text Available This randomized clinical trial tested a new self-directed educational intervention to improve caregiver competence to create a safer home environment for persons with dementia living in the community. The sample included 108 patient/caregiver dyads: the intervention group (n=60 received the Home Safety Toolkit (HST, including a new booklet based on health literacy principles, and sample safety items to enhance self-efficacy to make home safety modifications. The control group (n=48 received customary care. Participants completed measures at baseline and at twelve-week follow-up. Multivariate Analysis of Covariance (MANCOVA was used to test for significant group differences. All caregiver outcome variables improved in the intervention group more than in the control. Home safety was significant at P≤0.001, caregiver strain at P≤0.001, and caregiver self-efficacy at P=0.002. Similarly, the care receiver outcome of risky behaviors and accidents was lower in the intervention group (P≤0.001. The self-directed use of this Home Safety Toolkit activated the primary family caregiver to make the home safer for the person with dementia of Alzheimer's type (DAT or related disorder. Improving the competence of informal caregivers is especially important for patients with DAT in light of all stakeholders reliance on their unpaid care.

  15. Adapting Cognitive Task Analysis to Investigate Clinical Decision Making and Medication Safety Incidents.

    Science.gov (United States)

    Russ, Alissa L; Militello, Laura G; Glassman, Peter A; Arthur, Karen J; Zillich, Alan J; Weiner, Michael

    2017-05-03

    Cognitive task analysis (CTA) can yield valuable insights into healthcare professionals' cognition and inform system design to promote safe, quality care. Our objective was to adapt CTA-the critical decision method, specifically-to investigate patient safety incidents, overcome barriers to implementing this method, and facilitate more widespread use of cognitive task analysis in healthcare. We adapted CTA to facilitate recruitment of healthcare professionals and developed a data collection tool to capture incidents as they occurred. We also leveraged the electronic health record (EHR) to expand data capture and used EHR-stimulated recall to aid reconstruction of safety incidents. We investigated 3 categories of medication-related incidents: adverse drug reactions, drug-drug interactions, and drug-disease interactions. Healthcare professionals submitted incidents, and a subset of incidents was selected for CTA. We analyzed several outcomes to characterize incident capture and completed CTA interviews. We captured 101 incidents. Eighty incidents (79%) met eligibility criteria. We completed 60 CTA interviews, 20 for each incident category. Capturing incidents before interviews allowed us to shorten the interview duration and reduced reliance on healthcare professionals' recall. Incorporating the EHR into CTA enriched data collection. The adapted CTA technique was successful in capturing specific categories of safety incidents. Our approach may be especially useful for investigating safety incidents that healthcare professionals "fix and forget." Our innovations to CTA are expected to expand the application of this method in healthcare and inform a wide range of studies on clinical decision making and patient safety.

  16. Impact of safety-related regulatory action on clinical practice: a systematic review.

    Science.gov (United States)

    Piening, Sigrid; Haaijer-Ruskamp, Flora M; de Vries, Jonie T N; van der Elst, Menno E; de Graeff, Pieter A; Straus, Sabine M J M; Mol, Peter G M

    2012-05-01

    After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of the effects of these drug safety warnings on clinical practice to resolve the debate about their effectiveness. The aim of this systematic review is to provide an overview of studies that assessed the impact of safety warnings. A systematic search was performed for articles assessing the impact of Direct Healthcare Professional Communications or 'Dear Doctor' letters, Black Box Warnings and Public Health Advisories on clinical behaviour published between January 1996 and January 2010. The following variables were extracted: publication year, country, name of the drug, safety issue, specific safety warning (Direct Healthcare Professional Communication/Black Box Warning/Public Health Advisory), effect (intended/unintended) of the safety warning, outcome measure and study design. Papers were checked for several quality aspects. Study data were summarized using descriptive analyses. A total of 50 articles were identified. Two articles assessed two different drugs and were therefore counted twice (n = 52). Thirty-three articles described the impact of safety warnings issued for three drugs and drug groups, i.e. third-generation oral contraceptives, cisapride and selective serotonin reuptake inhibitors. The remaining 19 articles described a broad variety of 14 drugs and drug groups. Twenty-five studies applied an interrupted time series design, 23 a controlled or uncontrolled before/after design, and four articles applied both. None of the articles could rule out the influence of confounding factors. The intended effects were reported in 18 (72%) of the 25 before/after analyses, whereas only 11 (41%) of the 27 interrupted time series analyses reported an impact. Only two (8%) of the

  17. Development of innovative competitive amperometric immunosensors as promising tools in clinical diagnosis and food safety applications

    OpenAIRE

    Costantini, Monica

    2017-01-01

    The aim of the research project was the development of competitive amperometric biosensors for clinical diagnostics and food safety applications, as a part of a research activity focused on innovations in sensing systems investigated in our laboratories of analytical chemistry. In particular, the project purpose was the development of innovative sensors for detection of serum biomarkers for HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) and the development of competitive immun...

  18. Clinical efficacy and safety of a water-soluble micellar paclitaxel (Paccal Vet) in canine mastocytomas.

    Science.gov (United States)

    Rivera, P; Akerlund-Denneberg, N; Bergvall, K; Kessler, M; Rowe, A; Willmann, M; Persson, G; Kastengren Fröberg, G; Westberg, S; von Euler, H

    2013-01-01

    To determine the clinical efficacy and safety of a cremophor-free formulation of paclitaxel (Paccal Vet, Oasmia Pharmaceuticals) in dogs with mast cell tumours. Paccal Vet was administered at a median dose of 145 (range, 135 to 150) mg/m(2) intravenously once every 21 days for three cycles to 29 dogs with macroscopic grade 2 or 3 mast cell tumour. Efficacy was assessed by tumour response (Response Evaluation Criteria in Solid Tumours version 1.0) and performance status score. Progression-free survival, quality of life and safety/adverse events were also evaluated. Clinical safety was assessed by clinicopathological analyses and recording of adverse events. Complete or partial response was observed in 59% of dogs. Performance status score remained constant or improved for 20 dogs and decreased by one grade for 9 dogs. Median time to progression was 247 (range, 42 to 268) days. Expected, transient frequently subclinical adverse events (primarily grade 3/4 neutropenia and grade 1/2 leukopenia) were observed in the majority of dogs. Nine dogs were euthanased and one dog died due to disease progression. Paccal Vet appears to be a clinically safe and effective treatment for canine mast cell tumours. Further controlled confirmatory investigation is warranted. © 2012 British Small Animal Veterinary Association.

  19. Medication safety: using incident data analysis and clinical focus groups to inform educational needs.

    Science.gov (United States)

    Hesselgreaves, Hannah; Watson, Anne; Crawford, Andy; Lough, Murray; Bowie, Paul

    2013-02-01

    Medication-related safety incidents are a source of concern to patients, policy makers and clinicians. The role of education in improving safety-critical practices in health care is poorly appreciated. This pilot study aimed to initiate collective discussion among professional groups of clinical staff about a range of medicine-related patient safety issues which were identified from a local incident reporting system. In engaging staff to collectively reflect on reported medication incidents we attempted to uncover a deeper understanding of local contextual issues and potential educational needs. A mixed method study was conducted involving categorical analysis of 1058 medication incident reports (Phase 1) and the use of three mixed focus groups of clinical staff (Phase 2) in three acute hospitals in one locality in NHS Scotland. Focus group transcript analysis produced four main themes (e.g. the medical role) and 12 related sub-themes (e.g. pharmacological education and skill mix for administration of medicines) concerning medication-related practices and possible educational interventions. While it is necessary to review reported incident data and disseminate the educational messages for the improvement of quality, this traditional risk management process is inadequate on its own. Reporting systems can be enhanced by collective examination of reported information about medicines by local clinical teams. We identified a strong message from the focus groups for learning about each other and from each other, and that the method piloted may be an important inter-professional mechanism for improvement. © 2011 Blackwell Publishing Ltd.

  20. Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic.

    Science.gov (United States)

    Hübner, N-O; Kramer, A

    2010-01-01

    Infected wounds are still one of the great challenges in medicine. In the last decade, it has become increasingly clear that antimicrobial chemotherapy is limited by the spread of antimicrobial resistance. Fortunately, new, highly effective antiseptic substances with a broad antimicrobial spectrum are available, so local treatment is expected to get increasingly more important in wound therapy. This paper reviews the antiseptic agent polihexanide (polyhexamethylene biguanide, PHMB), one of the most promising substances available today, from a clinical point of view, focusing on efficacy, safety and clinical applications. Copyright © 2010 S. Karger AG, Basel.

  1. CEDRIC: a computerized chronic disease management system for urban, safety net clinics.

    Science.gov (United States)

    Ogunyemi, Omolola; Mukherjee, Sukrit; Ani, Chizobam; Hindman, David; George, Sheba; Ilapakurthi, Ramarao; Verma, Mary; Dayrit, Melvin

    2010-01-01

    To meet the challenge of improving health care quality in urban, medically underserved areas of the US that have a predominance of chronic diseases such as diabetes, we have developed a new information system called CEDRIC for managing chronic diseases. CEDRIC was developed in collaboration with clinicians at an urban safety net clinic, using a community-participatory partnered research approach, with a view to addressing the particular needs of urban clinics with a high physician turnover and large uninsured/underinsured patient population. The pilot implementation focuses on diabetes management. In this paper, we describe the system's architecture and features.

  2. Patient safety in the clinical laboratory: a longitudinal analysis of specimen identification errors.

    Science.gov (United States)

    Wagar, Elizabeth A; Tamashiro, Lorraine; Yasin, Bushra; Hilborne, Lee; Bruckner, David A

    2006-11-01

    Patient safety is an increasingly visible and important mission for clinical laboratories. Attention to improving processes related to patient identification and specimen labeling is being paid by accreditation and regulatory organizations because errors in these areas that jeopardize patient safety are common and avoidable through improvement in the total testing process. To assess patient identification and specimen labeling improvement after multiple implementation projects using longitudinal statistical tools. Specimen errors were categorized by a multidisciplinary health care team. Patient identification errors were grouped into 3 categories: (1) specimen/requisition mismatch, (2) unlabeled specimens, and (3) mislabeled specimens. Specimens with these types of identification errors were compared preimplementation and postimplementation for 3 patient safety projects: (1) reorganization of phlebotomy (4 months); (2) introduction of an electronic event reporting system (10 months); and (3) activation of an automated processing system (14 months) for a 24-month period, using trend analysis and Student t test statistics. Of 16,632 total specimen errors, mislabeled specimens, requisition mismatches, and unlabeled specimens represented 1.0%, 6.3%, and 4.6% of errors, respectively. Student t test showed a significant decrease in the most serious error, mislabeled specimens (P < .001) when compared to before implementation of the 3 patient safety projects. Trend analysis demonstrated decreases in all 3 error types for 26 months. Applying performance-improvement strategies that focus longitudinally on specimen labeling errors can significantly reduce errors, therefore improving patient safety. This is an important area in which laboratory professionals, working in interdisciplinary teams, can improve safety and outcomes of care.

  3. The Relationship of Financial Pressures and Community Characteristics to Closure of Private Safety Net Clinics.

    Science.gov (United States)

    Li, Suhui; Dor, Avi; Pines, Jesse M; Zocchi, Mark S; Hsia, Renee Y

    2016-10-01

    In order to better understand what threatens vulnerable populations' access to primary care, it is important to understand the factors associated with closing safety net clinics. This article examines how a clinic's financial position, productivity, and community characteristics are associated with its risk of closure. We examine patterns of closures among private-run primary care clinics (PCCs) in California between 2006 and 2012. We use a discrete-time proportional hazard model to assess relative hazard ratios of covariates, and a random-effect hazard model to adjust for unobserved heterogeneity among PCCs. We find that lower net income from patient care, smaller amount of government grants, and lower productivity were associated with significantly higher risk of PCC closure. We also find that federally qualified health centers and nonfederally qualified health centers generally faced the same risk factors of closure. These results underscore the critical role of financial incentives in the long-term viability of safety net clinics. © The Author(s) 2015.

  4. Safety and tolerability of dienogest in endometriosis: pooled analysis from the European clinical study program

    Directory of Open Access Journals (Sweden)

    Strowitzki T

    2015-04-01

    Full Text Available Thomas Strowitzki,1 Thomas Faustmann,2 Christoph Gerlinger,3,4 Ulrike Schumacher,5,6 Christiane Ahlers,7 Christian Seitz8 1Department of Gynecological Endocrinology and Reproductive Medicine, University of Heidelberg, Heidelberg, Germany; 2Bayer Pharma AG, Global Medical Affairs Women’s Healthcare, Berlin, Germany; 3Bayer Pharma AG, Global Research and Development Statistics, Berlin, Germany; 4Department of Gynecology, Obstetrics, and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany; 5Jenapharm GmbH & Co KG, Medical Affairs Support, Jena, Germany; 6Center for Clinical Studies, Universitätsklinikum Jena, Jena, Germany; 7Bayer Pharma AG, Global Integrated Analysis and Lifecycle Management Statistics, Wuppertal, Germany; 8Bayer Pharma AG, Global Clinical Development Therapeutic Area Primary Care and Women’s Healthcare, Berlin, Germany Background: In four randomized, controlled, European trials, dienogest 2 mg once daily demonstrated significant efficacy for lesion reduction and reduction in pain intensity in endometriosis. We describe a pooled analysis of the safety and tolerability data from these trials to confirm and further characterize the safety profile of dienogest in the treatment of endometriosis.Methods: All 332 women treated with dienogest 2 mg who participated in the four clinical trials were included in the pooled analyses for safety assessments, including adverse events, laboratory tests, vital signs, body weight, and bleeding patterns. Safety variables were analyzed using descriptive statistics.Results: Pooled analyses of this large patient population confirmed that dienogest 2 mg is well tolerated, with a favorable safety profile extending over a period up to 65 weeks in women with endometriosis. The most common adverse drug reactions were headache, breast discomfort, depressed mood, and acne, each occurring in <10% of women. All these adverse events were generally of mild

  5. Safety Analysis of Panax Ginseng in Randomized Clinical Trials: A Systematic Review

    Science.gov (United States)

    Kim, Young-Sook; Woo, Jung-Yoon; Han, Chang-Kyun; Chang, Il-Moo

    2015-01-01

    Background: Panax ginseng C.A. Meyer is one of the most frequently used herbs in the world. The roots of Panax ginseng have been used as a traditional tonic and medicine for thousands of years in Korea and China. Today, ginseng root is used as a dietary supplement and complementary medicine and for adjuvant therapeutics worldwide. The efficacy of ginseng has been studied in a wide range of basic research and clinical studies. However, it has been reported that the results from clinical studies are conflicting, and they depend on the parameters of the protocol design including the conditions of the participants and the types of ginseng used such as red ginseng, white ginseng, fermented ginseng and cultured ginseng. Meanwhile, in addition to clinical efficacy, the safety of ginseng is a highly important matter for customers. With globally increasing demand for Panax ginseng as a dietary supplement or complementary medicine, it is necessary to provide information on its safe use to customers to improve their health conditions. Although the safety of Panax ginseng in pre-clinical studies is well known, the evaluation of safety in clinical studies has so far been insufficient. This systematic review was conducted to assess the safety of ginseng in randomized controlled clinical trials (RCT) over the last 10 years. We chose the last 10 years because many clinical trials have been conducted in the past 10 years, and it will help to understand the recent trends in RCTs of ginseng. Methods: Articles on ginseng studies were searched with keywords in MEDLINE and four other Korean online database sites. Studies with ginseng as a monopreparation were selected while studies with single administration, preparations combined with other herbs or drug combinations were excluded from the selected studies. Data from the selected studies meeting the criteria were extracted and reviewed in terms of study design, condition and number of participants, type of ginseng, dosage, duration

  6. Benzodiazepine use during buprenorphine treatment for opioid dependence: clinical and safety outcomes.

    Science.gov (United States)

    Schuman-Olivier, Zev; Hoeppner, Bettina B; Weiss, Roger D; Borodovsky, Jacob; Shaffer, Howard J; Albanese, Mark J

    2013-10-01

    Prescribing benzodiazepines during buprenorphine treatment is a topic of active discussion. Clinical benefit is unclear. Overdose, accidental injury, and benzodiazepine misuse remain concerns. We examine the relationship between benzodiazepine misuse history, benzodiazepine prescription, and both clinical and safety outcomes during buprenorphine treatment. We retrospectively examined outpatient buprenorphine treatment records, classifying patients by past-year benzodiazepine misuse history and approved benzodiazepine prescription at intake. Primary clinical outcomes included 12-month treatment retention and urine toxicology for illicit opioids. Primary safety outcomes included total emergency department (ED) visits and odds of an ED visit related to overdose or accidental injury during treatment. The 12-month treatment retention rate for the sample (N=328) was 40%. Neither benzodiazepine misuse history nor benzodiazepine prescription was associated with treatment retention or illicit opioid use. Poisson regressions of ED visits during buprenorphine treatment revealed more ED visits among those with a benzodiazepine prescription versus those without (phistory had no effect. The odds of an accidental injury-related ED visit during treatment were greater among those with a benzodiazepine prescription (OR: 3.7, phistory or prescription. We found no effect of benzodiazepine prescriptions on opioid treatment outcomes; however, benzodiazepine prescription was associated with more frequent ED visits and accidental injuries, especially among females. When prescribing benzodiazepines during buprenorphine treatment, patients need more education about accidental injury risk. Alternative treatments for anxiety should be considered when possible, especially among females. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  7. [Analysis of patient complaints in Primary Care: An opportunity to improve clinical safety].

    Science.gov (United States)

    Añel-Rodríguez, R M; Cambero-Serrano, M I; Irurzun-Zuazabal, E

    2015-01-01

    To determine the prevalence and type of the clinical safety problems contained in the complaints made by patients and users in Primary Care. An observational, descriptive, cross-sectional study was conducted by analysing both the complaint forms and the responses given to them in the period of one year. At least 4.6% of all claims analysed in this study contained clinical safety problems. The family physician is the professional who received the majority of the complaints (53.6%), and the main reason was the problems related to diagnosis (43%), mainly the delay in diagnosis. Other variables analysed were the severity of adverse events experienced by patients (in 68% of cases the patient suffered some harm), the subsequent impact on patient care, which was affected in 39% of cases (7% of cases even requiring hospital admission), and the level of preventability of adverse events (96% avoidable) described in the claims. Finally the type of response issued to each complaint was analysed, being purely bureaucratic in 64% of all cases. Complaints are a valuable source of information about the deficiencies identified by patients and healthcare users. There is considerable scope for improvement in the analysis and management of claims in general, and those containing clinical safety issues in particular. To date, in our area, there is a lack of appropriate procedures for processing these claims. Likewise, we believe that other pathways or channels should be opened to enable communication by patients and healthcare users. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  8. FDA drug safety communications: a narrative review and clinical considerations for older adults.

    Science.gov (United States)

    Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

    2012-08-01

    The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

  9. Resident Cosmetic Clinic: Practice Patterns, Safety, and Outcomes at an Academic Plastic Surgery Institution.

    Science.gov (United States)

    Qureshi, Ali A; Parikh, Rajiv P; Myckatyn, Terence M; Tenenbaum, Marissa M

    2016-10-01

    Comprehensive aesthetic surgery education is an integral part of plastic surgery residency training. Recently, the ACGME increased minimum requirements for aesthetic procedures in residency. To expand aesthetic education and prepare residents for independent practice, our institution has supported a resident cosmetic clinic for over 25 years. To evaluate the safety of procedures performed through a resident clinic by comparing outcomes to benchmarked national aesthetic surgery outcomes and to provide a model for resident clinics in academic plastic surgery institutions. We identified a consecutive cohort of patients who underwent procedures through our resident cosmetic clinic between 2010 and 2015. Major complications, as defined by CosmetAssure database, were recorded and compared to published aesthetic surgery complication rates from the CosmetAssure database for outcomes benchmarking. Fisher's exact test was used to compare sample proportions. Two hundred and seventy-one new patients were evaluated and 112 patients (41.3%) booked surgery for 175 different aesthetic procedures. There were 55 breast, 19 head and neck, and 101 trunk or extremity aesthetic procedures performed. The median number of preoperative and postoperative visits was 2 and 4 respectively with a mean follow-up time of 35 weeks. There were 3 major complications (2 hematomas and 1 infection requiring IV antibiotics) with an overall complication rate of 1.7% compared to 2.0% for patients in the CosmetAssure database (P = .45). Surgical outcomes for procedures performed through a resident cosmetic clinic are comparable to national outcomes for aesthetic surgery procedures, suggesting this experience can enhance comprehensive aesthetic surgery education without compromising patient safety or quality of care. 4 Risk. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  10. Assessing the Safety of Human Pluripotent Stem Cells and Their Derivatives for Clinical Applications

    Directory of Open Access Journals (Sweden)

    Peter W. Andrews

    2017-07-01

    Full Text Available Pluripotent stem cells may acquire genetic and epigenetic variants during culture following their derivation. At a conference organized by the International Stem Cell Initiative, and held at The Jackson Laboratory, Bar Harbor, Maine, October 2016, participants discussed how the appearance of such variants can be monitored and minimized and, crucially, how their significance for the safety of therapeutic applications of these cells can be assessed. A strong recommendation from the meeting was that an international advisory group should be set up to review the genetic and epigenetic changes observed in human pluripotent stem cell lines and establish a framework for evaluating the risks that they may pose for clinical use.

  11. Safety and clinical efficacy of golimumab in the treatment of arthritides

    Directory of Open Access Journals (Sweden)

    Ismail Simsek

    2010-09-01

    Full Text Available Ismail Simsek, Yusuf YaziciNew York University School of Medicine, NYU Hospital for Joint Diseases, New York, USAAbstract: Golimumab is a human anti-tumor necrosis factor (TNF-alpha monoclonal antibody that was recently approved for the treatment of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This review covers the published clinical trial data on the use of golimumab for the approved indications mentioned above with respect to efficacy and safety. The various ongoing trials for golimumab have yielded promising results in terms of efficacy and safety in methotrexate-naive and -resistant patients with rheumatoid arthritis, as well as in patients who were previously treated with other anti-TNF agents. In addition, the efficacy of golimumab in psoriatic arthritis and ankylosing spondylitis has also been demonstrated. The real safety information will be available only once the drug has been used in many more patients, who frequently have comorbid conditions.Keywords: arthritis, rheumatoid, psoriatic arthritis, ankylosing spondylitis

  12. [Clinical safety and professional liability claims in Orthopaedic Surgery and Traumatology].

    Science.gov (United States)

    Bori, G; Gómez-Durán, E L; Combalia, A; Trilla, A; Prat, A; Bruguera, M; Arimany-Manso, J

    2016-01-01

    The specialist in orthopaedic and traumatological surgery, like any other doctor, is subject to the current legal provisions while exercising their profession. Mandatory training in the medical-legal aspects of health care is essential. Claims against doctors are a reality, and orthopaedic and traumatological surgery holds first place in terms of frequency of claims according to the data from the General Council of Official Colleges of Doctors of Catalonia. Professionals must be aware of the fundamental aspects of medical professional liability, as well as specific aspects, such as defensive medicine and clinical safety. The understanding of these medical-legal aspects in the routine clinical practice can help to pave the way towards a satisfactory and safe professional career. The aim of this review is to contribute to this training, for the benefit of professionals and patients. Copyright © 2015 SECOT. Published by Elsevier Espana. All rights reserved.

  13. Autologous stromal vascular fraction therapy for rheumatoid arthritis: rationale and clinical safety

    Directory of Open Access Journals (Sweden)

    Rodriguez Jorge

    2012-02-01

    Full Text Available Abstract Advancements in rheumatoid arthritis (RA treatment protocols and introduction of targeted biological therapies have markedly improved patient outcomes, despite this, up to 50% of patients still fail to achieve a significant clinical response. In veterinary medicine, stem cell therapy in the form of autologous stromal vascular fraction (SVF is an accepted therapeutic modality for degenerative conditions with 80% improvement and no serious treatment associated adverse events reported. Clinical translation of SVF therapy relies on confirmation of veterinary findings in targeted patient populations. Here we describe the rationale and preclinical data supporting the use of autologous SVF in treatment of RA, as well as provide 1, 3, 6, and 13 month safety outcomes in 13 RA patients treated with this approach.

  14. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  15. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  16. Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

    Science.gov (United States)

    Leeper, Nicholas J; Bauer-Mehren, Anna; Iyer, Srinivasan V; Lependu, Paea; Olson, Cliff; Shah, Nigam H

    2013-01-01

    Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

  17. Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

    Directory of Open Access Journals (Sweden)

    Nicholas J Leeper

    Full Text Available Peripheral arterial disease (PAD is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF.We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55], myocardial infarction (OR = 1.00, CI [0.71, 1.39], or death (OR = 0.86, CI [0.63, 1.18]. Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients.This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

  18. Safety evaluation of "retina implant alpha IMS"--a prospective clinical trial.

    Science.gov (United States)

    Kitiratschky, Veronique B D; Stingl, Katarina; Wilhelm, Barbara; Peters, Tobias; Besch, Dorothea; Sachs, Helmut; Gekeler, Florian; Bartz-Schmidt, Karl Ulrich; Zrenner, Eberhart

    2015-03-01

    To restore vision in patients with retinitis pigmentosa, several types of electronic devices have been developed to stimulate neurons at different levels along the visual pathway. Subretinal stimulation of the retina with the Retina Implant Alpha IMS (Retina Implant AG, Reutlingen, Germany) has been demonstrated to provide useful vision in daily life. Here we evaluated the safety of this device. An interventional, prospective, multi-center, single-arm study was conducted in patients with retinitis pigmentosa with the Retina Implant Alpha IMS. The results from the first nine patients of a single center regarding safety of the device are reported. Any untoward medical occurrence related or unrelated to the tested device was documented and evaluated. Nine adult subjects were included in the study at the Tübingen site. Seventy-five adverse events occurred in total, and 53 affected the eye and its adnexa. Thirty-one ocular adverse events had a relationship to the implant that was classified as "certain" while 19 had a probable or possible relationship; three had no relationship to the implant. Thirty-nine ocular adverse events resolved without sequelae, two resolved with sequelae, 11 remained unresolved, and in one the status was unknown. The intensity of ocular adverse events was mild in the majority of cases (n = 45), while six were of moderate and two of severe intensity. There was no non-ocular adverse event with certain relationship to the device. One subject lost light perception (without light localization) in her study eye. In conclusion, this prospective study, "Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients," shows that the Retina Implant Alpha IMS is an option for restoring vision using a subretinal stimulation device with a clinically acceptable safety profile.

  19. Patient Experience of Chronic Illness Care and Medical Home Transformation in Safety Net Clinics.

    Science.gov (United States)

    Tung, Elizabeth L; Gao, Yue; Peek, Monica E; Nocon, Robert S; Gunter, Kathryn E; Lee, Sang Mee; Chin, Marshall H

    2018-02-01

    To examine the relationship between medical home transformation and patient experience of chronic illness care. Thirteen safety net clinics located in five states enrolled in the Safety Net Medical Home Initiative. Repeated cross-sectional surveys of randomly selected adult patients were completed at baseline (n = 303) and postintervention (n = 271). Questions from the Patient Assessment of Chronic Illness Care (PACIC) (100-point scale) were used to capture patient experience of chronic illness care. Generalized estimating equation methods were used to (i) estimate how differential improvement in patient-centered medical home (PCMH) capability affected differences in modified PACIC scores between baseline and postintervention, and (ii) to examine cross-sectional associations between PCMH capability and modified PACIC scores for patients at completion of the intervention. In adjusted analyses, high PCMH improvement (above median) was only marginally associated with a larger increase in total modified PACIC score (adjusted β = 7.7, 95 percent confidence interval [CI]: -1.1 to 16.5). At completion of the intervention, a 10-point higher PCMH capability score was associated with an 8.9-point higher total modified PACIC score (95 percent CI: 3.1-14.7) and higher scores in four of five subdomains (patient activation, delivery system design, contextual care, and follow-up/coordination). We report that sustained, 5-year medical home transformation may be associated with modest improvement in patient experience of chronic illness care for vulnerable populations in safety net clinics. © Health Research and Educational Trust.

  20. Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

    Science.gov (United States)

    da Cruz, Lyndon; Dorn, Jessy D; Humayun, Mark S; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E; Hafezi, Farhad; Safran, Avinoam B; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V; de Juan, Eugene; Duncan, Jacque L; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C; Ho, Allen C; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V; Arditi, Aries; Greenberg, Robert J

    2016-10-01

    The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. Thirty participants in 10 centers in the United States and Europe. The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  1. Drug Safety

    Science.gov (United States)

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  2. Clinic-based screening for domestic violence: use of a child safety questionnaire

    Directory of Open Access Journals (Sweden)

    Sisk Doris J

    2004-06-01

    Full Text Available Abstract Background Domestic violence affects many women during their lifetime. Children living in homes where they are or have been exposed to violence are at increased risk for adverse outcomes. The American Academy of Pediatrics, the American Academy of Family Practice, and the American College of Obstetrics/Gynecology have recently joined in recommending routine screening of all families for the presence of domestic violence. We present our experience with an office-based domestic violence screening questionnaire. Methods A series of four child safety questionnaires (designed for parents of infant, preschool-age, school-age, and adolescent patients, which included specific questions about domestic violence, was given to all mothers presenting to a university out-patient general pediatric clinic. The questionnaires, offered in both English and Spanish, were reviewed for the presence of domestic violence exposure, usually at the time of the clinic visit. The number of women who reported either current or past exposure to domestic violence as disclosed by this active screening process was compared to the number discovered prior to the use of these questionnaires. Results Prior to the use of active screening with a child safety questionnaire, five cases of domestic violence were identified in our clinic population of approximately 5000 children over a 3 month period. Active screening of this population with a parent questionnaire resulted in the identification of 69 cases of current domestic violence exposure (2% of those screened during each of 2 years of screening. Use of the child safety questionnaire was associated with a significantly increased odds of detecting current domestic violence (OR = 3.6, 95% CI [1.4, 9.1], P = 0.007, with 72% [26–84%] of the cases identified being attributable to the use of the questionnaire. Of children screened, 2% were currently exposed to domestic violence, and 13% had been exposed to past domestic violence

  3. Safety of bevacizumab in clinical practice for recurrent ovarian cancer: A retrospective cohort study

    Science.gov (United States)

    SELLE, FRÉDÉRIC; EMILE, GEORGE; PAUTIER, PATRICIA; ASMANE, IRÈNE; SOARES, DANIELE G.; KHALIL, AHMED; ALEXANDRE, JEROME; LHOMMÉ, CATHERINE; RAY-COQUARD, ISABELLE; LOTZ, JEAN-PIERRE; GOLDWASSER, FRANÇOIS; TAZI, YOUSSEF; HEUDEL, PIERRE; PUJADE-LAURAINE, ERIC; GOUY, SÉBASTIEN; TREDAN, OLIVIER; BARBAZA, MARIE O.; ADY-VAGO, NORA; DUBOT, CORALINE

    2016-01-01

    The poor outcome of patients with recurrent ovarian cancer constitutes a continuous challenge for decision-making in clinical practice. In this setting, molecular targets have recently been identified, and novel compounds are now available. Bevacizumab has been introduced for the treatment of patients with ovarian cancer and is, to date, the most extensively investigated targeted therapy in this setting. However, potential toxicities are associated with the use of this monoclonal antibody. These toxicities have been reported in clinical trials, and can also be observed outside of trials. As limited data is currently available regarding the safety of bevacizumab treatment in daily clinical practice, the current retrospective study was designed to evaluate this. Data from 156 patients with recurrent ovarian cancer who had received bevacizumab treatment between January 2006 and June 2009 were retrospectively identified from the institutional records of five French centers. In contrast to clinical trials, the patients in the present study were not selected and had a heterogeneous profile according to their prior medical history, lines of treatment prior to bevacizumab introduction and number of relapses. The results first confirm the effect of heavy pretreatment on the occurrence of serious and fatal adverse events in clinical practice, as previously reported for clinical trials and for other retrospective cohort studies. Importantly, the data also demonstrates, for the first time, that medical history of hypertension is an independent predictive risk factor for the development of high-grade hypertension during bevacizumab treatment. These results thus suggest that treating physicians must consider all risk factors for managing bevacizumab toxicity prior to its introduction. Such risk factors include the time of bevacizumab introduction, a patient's history of hypertension and a low incidence of pre-existing obstructive disease. PMID:26998090

  4. Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases.

    Science.gov (United States)

    Brennan, Frank R; Cauvin, Annick; Tibbitts, Jay; Wolfreys, Alison

    2014-05-01

    An increasing number of immunomodulatory monoclonal antibodies (mAbs) and IgG Fc fusion proteins are either approved or in early-to-late stage clinical trials for the treatment of chronic inflammatory conditions, autoimmune diseases and organ transplant rejection. The exquisite specificity of mAbs, in combination with their multi-functional properties, high potency, long half-life (permitting intermittent dosing and prolonged pharamcological effects), and general lack of off-target toxicity makes them ideal therapeutics. Dosing with mAbs for these severe and debilitating but often non life-threatening diseases is usually prolonged, for several months or years, and not only affects adults, including sensitive populations such as woman of child-bearing potential (WoCBP) and the elderly, but also children. Immunosuppression is usually a therapeutic goal of these mAbs and when administered to patients whose treatment program often involves other immunosuppressive therapies, there is an inherent risk for frank immunosuppression and reduced host defence which when prolonged increases the risk of infection and cancer. In addition when mAbs interact with the immune system they can induce other adverse immune-mediated drug reactions such as infusion reactions, cytokine release syndrome, anaphylaxis, immune-complex-mediated pathology and autoimmunity. An overview of the nonclinical safety assessment and risk mitigation strategies utilized to characterize these immunomodulatory mAbs and Fc fusion proteins to support first-in human (FIH) studies and futher clinical development in inflammatory disease indications is provided. Specific emphasis is placed on the design of studies to qualify animal species for toxicology studies, early studies to investigate safety and define PK/PD relationships, FIH-enabling and chronic toxicology studies, immunotoxicity, developmental, reproductive and juvenile toxicity studies and studies to determine the potential for immunosuppression and

  5. A meta-model for computer executable dynamic clinical safety checklists.

    Science.gov (United States)

    Nan, Shan; Van Gorp, Pieter; Lu, Xudong; Kaymak, Uzay; Korsten, Hendrikus; Vdovjak, Richard; Duan, Huilong

    2017-12-12

    Safety checklist is a type of cognitive tool enforcing short term memory of medical workers with the purpose of reducing medical errors caused by overlook and ignorance. To facilitate the daily use of safety checklists, computerized systems embedded in the clinical workflow and adapted to patient-context are increasingly developed. However, the current hard-coded approach of implementing checklists in these systems increase the cognitive efforts of clinical experts and coding efforts for informaticists. This is due to the lack of a formal representation format that is both understandable by clinical experts and executable by computer programs. We developed a dynamic checklist meta-model with a three-step approach. Dynamic checklist modeling requirements were extracted by performing a domain analysis. Then, existing modeling approaches and tools were investigated with the purpose of reusing these languages. Finally, the meta-model was developed by eliciting domain concepts and their hierarchies. The feasibility of using the meta-model was validated by two case studies. The meta-model was mapped to specific modeling languages according to the requirements of hospitals. Using the proposed meta-model, a comprehensive coronary artery bypass graft peri-operative checklist set and a percutaneous coronary intervention peri-operative checklist set have been developed in a Dutch hospital and a Chinese hospital, respectively. The result shows that it is feasible to use the meta-model to facilitate the modeling and execution of dynamic checklists. We proposed a novel meta-model for the dynamic checklist with the purpose of facilitating creating dynamic checklists. The meta-model is a framework of reusing existing modeling languages and tools to model dynamic checklists. The feasibility of using the meta-model is validated by implementing a use case in the system.

  6. Using quality and safety education for nurses to guide clinical teaching on a new dedicated education unit.

    Science.gov (United States)

    McKown, Terri; McKeon, Leslie; McKown, Leslie; Webb, Sherry

    2011-12-01

    Gaps exist in health professional education versus the demands of current practice. Leveraging front-line nurses to teach students exemplary practice in a Dedicated Education Unit (DEU) may narrow this gap. The DEU is an innovative model for experiential learning, capitalizing on the expertise of staff nurses as clinical teachers. This study evaluated the effectiveness of a new academic-practice DEU in facilitating quality and safety competency achievement among students. Six clinical teachers received education in clinical teaching and use of Quality and Safety Education for Nurses (QSEN) competencies to guide acquisition of essential knowledge, skills, and attitudes for continuous health care improvement. Twelve students assigned to the six teachers completed daily logs for the 10-week practicum. Findings suggest that DEU students achieved QSEN competencies through clinical teacher mentoring in interdisciplinary collaboration, using electronic information for best practice and patient teaching, patient/family decision making, quality improvement, and resolution of safety issues.

  7. Using clinical supervision to improve the quality and safety of patient care: a response to Berwick and Francis.

    Science.gov (United States)

    Tomlinson, Jonathon

    2015-06-11

    After widely publicised investigations into excess patient deaths at Mid Staffordshire hospital the UK government commissioned reports from Robert Francis QC and Professor Don Berwick. Among their recommendations to improve the quality and safety of patient care were lifelong learning, professional support and 'just culture'. Clinical supervision is in an excellent position to support these activities but opportunities are in danger of being squeezed out by regulatory and managerial demands. Doctors who have completed their training are responsible for complex professional judgements for which narrative supervision is particularly helpful. With reference to the literature and my own practice I propose that all practicing clinicians should have regular clinical supervision. Clinical supervision has patient-safety and the quality of patient care as its primary purposes. After training is completed, doctors may practice for the rest of their career without any clinical supervision, the implication being that the difficulties dealt with in clinical supervision are no longer difficulties, or are better dealt with some other way. Clinical supervision is sufficiently flexible to be adapted to the needs of experienced clinicians as its forms can be varied, though its functions remain focused on patient safety, good quality clinical care and professional wellbeing. The evidence linking clinical supervision to the quality and safety of patient care reveals that supervision is most effective when its educational and supportive functions are separated from its managerial and evaluative functions. Among supervision's different forms, narrative-based-supervision is particularly useful as it has been developed for clinicians who have completed their training. It provides ways to explore the complexity of clinical judgements and encourages doctors to question one another's authority in a supportive culture. To be successful, supervision should also be professionally led and

  8. PCA safety data review after clinical decision support and smart pump technology implementation.

    Science.gov (United States)

    Prewitt, Judy; Schneider, Susan; Horvath, Monica; Hammond, Julia; Jackson, Jason; Ginsberg, Brian

    2013-06-01

    Medication errors account for 20% of medical errors in the United States with the largest risk at prescribing and administration. Analgesics or opioids are frequently used medications that can be associated with patient harm when prescribed or administered improperly. In an effort to decrease medication errors, Duke University Hospital implemented clinical decision support via computer provider order entry (CPOE) and "smart pump" technology, 2/2008, with the goal to decrease patient-controlled analgesia (PCA) adverse events. This project evaluated PCA safety events, reviewing voluntary report system and adverse drug events via surveillance (ADE-S), on intermediate and step-down units preimplementation and postimplementation of clinical decision support via CPOE and PCA smart pumps for the prescribing and administration of opioids therapy in the adult patient requiring analgesia for acute pain. Voluntary report system and ADE-S PCA events decreased based upon 1000 PCA days; ADE-S PCA events per 1000 PCA days decreased 22%, from 5.3 (pre) to 4.2 (post) (P = 0.09). Voluntary report system events decreased 72%, from 2.4/1000 PCA days (pre) to 0.66/1000 PCA days (post) and was statistically significant (P PCA events between time periods in both the ADE-S and voluntary report system data, thus supporting the recommendation of clinical decision support via CPOE and PCA smart pump technology.

  9. The clinical benefit and safety of current and future assisted reproductive technology.

    Science.gov (United States)

    Brown, Rachel; Harper, Joyce

    2012-08-01

    Since the first birth by IVF was achieved in 1978, the techniques involved in assisted reproductive technology have grown at an enormous rate. However, new technology has rarely been robustly validated before clinical use and developing scientific understanding of the available techniques has done little to alter their use. Furthermore, there are inconsistencies in the available clinical studies and endpoints. The benefits of some technologies already established for routine use are currently dubious and there are clear ethical concerns with providing them to patients when their scientific basis is not clear. As the uptake of assisted reproductive technology increases and newer technologies continue to push the boundaries of science, it is important to consider the clinical benefits and safety of all assisted reproductive technologies. This review will discuss aspects of some of the more recent techniques, including sperm DNA-damage tests, intracytoplasmic morphologically selected sperm injection, amino acid and metabolomics profiling, preimplantation genetic screening and time-lapse imaging, and those that may have substantial impacts on the field of reproductive medicine in the future including artificial gametes, ovarian transplantation and gene therapy. Copyright © 2012 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  10. The Clinical Efficacy and Safety of Tulsi in Humans: A Systematic Review of the Literature

    Directory of Open Access Journals (Sweden)

    Negar Jamshidi

    2017-01-01

    Full Text Available Tulsi, also known as holy basil, is indigenous to the Indian continent and highly revered for its medicinal uses within the Ayurvedic and Siddha medical systems. Many in vitro, animal and human studies attest to tulsi having multiple therapeutic actions including adaptogenic, antimicrobial, anti-inflammatory, cardioprotective, and immunomodulatory effects, yet to date there are no systematic reviews of human research on tulsi’s clinical efficacy and safety. We conducted a comprehensive literature review of human studies that reported on a clinical outcome after ingestion of tulsi. We searched for studies published in books, theses, conference proceedings, and electronic databases including Cochrane Library, Google Scholar, Embase, Medline, PubMed, Science Direct, and Indian Medical databases. A total of 24 studies were identified that reported therapeutic effects on metabolic disorders, cardiovascular disease, immunity, and neurocognition. All studies reported favourable clinical outcomes with no studies reporting any significant adverse events. The reviewed studies reinforce traditional uses and suggest tulsi is an effective treatment for lifestyle-related chronic diseases including diabetes, metabolic syndrome, and psychological stress. Further studies are required to explore mechanisms of action, clarify the dosage and dose form, and determine the populations most likely to benefit from tulsi’s therapeutic effects.

  11. Design and implementation of a radiotherapy programme: Clinical, medical physics, radiation protection and safety aspects

    International Nuclear Information System (INIS)

    1998-09-01

    It is widely acknowledged that the clinical aspects (diagnosis, decision, indication for treatment, follow-up) as well as the procedures related to the physical and technical aspects of patient treatment must be subjected to careful control and planning in order to ensure safe, high quality radiotherapy. Whilst it has long been recognized that the physical aspects of quality assurance in radiotherapy are vital to achieve and effective and safe treatment, it has been increasingly acknowledged only recently that a systematic approach is absolutely necessary to all steps within clinical and technical aspects of a radiotherapy programme as well. The need to establish general guidelines at the IAEA, taking into account clinical medical physics, radiation protection and safety considerations, for designing and implementing radiotherapy programmes in Member States has been identified through the Member States' increased interest in the efficient and safe application of radiation in health care. Several consultants and advisory group meetings were convened to prepare a report providing a basis for establishing a programme in radiotherapy. The present TECDOC is addressed to all professionals and administrators involved in the development, implementation and management of a radiotherapy programme in order to establish a common and consistent framework where all steps and procedures in radiotherapy are taken into account

  12. Safety and tolerability of 5-grass pollen tablet sublingual immunotherapy: pooled analysis and clinical review.

    Science.gov (United States)

    Didier, Alain; Bons, Brigitte

    2015-05-01

    The 5-grass pollen tablet (Oralair®, Stallergenes, Antony, France) is a once-daily preseasonal and coseasonal sublingual immunotherapy (SLIT) that is effective in controlling the symptoms of allergic rhinoconjunctivitis and in reducing the need for symptomatic medication. The body of safety data gathered from the 5-grass pollen tablet clinical development program, post-approval studies, and more than 6 years of real-life experience demonstrates the safety and tolerability profile of the 5-grass pollen tablet across all age groups. Adverse events (AEs) are generally mild or moderate in severity, and rarely lead to treatment discontinuation. AEs also tend to decline in frequency and severity over time and with repeated treatment. The most frequent treatment-emergent AEs are local-site oropharyngeal reactions (e.g., oral pruritus, throat irritation, tongue pruritus, mouth edema, ear pruritus), which are consistent with the sublingual route of administration. The first dose of the 5-grass pollen tablet should be administered under the supervision of an experienced physician, to allow for optimal monitoring and timely management of AEs, should they occur. The 5-grass pollen tablet can be administered at home after the first dose, and patients and carers should be educated on how to manage adverse reactions, unplanned treatment interruptions and situations in which SLIT should be withheld.

  13. RESTORING SAFETY: AN ATTACHMENT-BASED APPROACH TO CLINICAL WORK WITH A TRAUMATIZED TODDLER.

    Science.gov (United States)

    Ribaudo, Julie

    2016-01-01

    This clinical case study explores the integration of infancy research, brain development, attachment theory, and models of infant-parent/child-parent psychotherapy to address the needs of abused and neglected young children placed in foster or adoptive homes. Traumatized children employ defensive strategies to survive when there is no "good enough" caregiver (D.W. Winnicott, 1953, p. 94), and helping professionals can provide therapeutic experiences to develop or restore a child's sense of safety. With the case example of Anthony and his foster/adoptive parents, I illustrate how to manage and contain a traumatized child's terror, rage, and grief through therapeutic sessions with the parent and child together, and supportive parental guidance. I promote attention to the child's ability to self-integrate and to regulate his own affect, and encourages secure-base parental responses that facilitate a child's shift toward secure attachment behavior. © 2015 Michigan Association for Infant Mental Health.

  14. Efficacy and safety of midazolam for sedation in pediatric dentistry: a controlled clinical trial.

    Science.gov (United States)

    Azevedo, Isabelita Duarte; Ferreira, Maria Angela Fernandes; da Costa, Anna Paula Serejo; Bosco, Vera Lúcia; Moritz, Rachel Duarte

    2013-01-01

    Pharmacological management of uncooperative children is becoming increasingly common in the dental setting. The purpose of this study was to determine the efficacy and safety of 3 different doses of midazolam for sedation in 2- to 4- year-old children with multiple dental needs and negative behavior. Ten children participated in this crossover, controlled, double-blinded clinical trial, which evaluated their behavior, appointment length and patient response after administration of 3 different doses of midazolam or placebo. Oxygen saturation, heart rate, respiratory rate, and blood pressure were monitored in all sessions. Sedated children exhibited a more positive behavior compared to the placebo group, both at the beginning of the appointment (sitting in the chair) and during administration of local anesthesia (P=.008 and Pbehavior overall. No changes in oxygen saturation, heart rate, respiratory rate, and blood pressure were observed. Midazolam was effective and safe for pediatric sedation in the dosages studied.

  15. Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study

    OpenAIRE

    Kamo, Toshiko; Maeda, Masaharu; Oe, Misari; Kato, Hiroshi; Shigemura, Jun; Kuribayashi, Kazuhiko; Hoshino, Yuko

    2016-01-01

    Background Many of the posttraumatic stress disorder (PTSD) treatment guidelines recognize the use of selective serotonin reuptake inhibitors as first-line pharmacological treatment. In Japan, there were no published studies investigating the effectiveness and safety of sertraline for PTSD in a clinical setting. Methods We conducted a retrospective medical chart review of the dosage, effectiveness, and safety of sertraline for the PTSD treatment in Japan. Data were collected from medical char...

  16. An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies

    OpenAIRE

    Iffland, Kerstin; Grotenhermen, Franjo

    2017-01-01

    Abstract Introduction: This literature survey aims to extend the comprehensive survey performed by Bergamaschi et al. in 2011 on cannabidiol (CBD) safety and side effects. Apart from updating the literature, this article focuses on clinical studies and CBD potential interactions with other drugs. Results: In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epileps...

  17. The disparity of frontline clinical staff and managers' perceptions of a quality and patient safety initiative.

    Science.gov (United States)

    Parand, Anam; Burnett, Susan; Benn, Jonathan; Pinto, Anna; Iskander, Sandra; Vincent, Charles

    2011-12-01

    Arguably, a shared perspective between managers and their clinical staff on an improvement initiative would allow for most effective implementation and increase programme success. However, it has been reported that research has failed to differentiate between managers and line employees on quality management implementation and examine their differences in perceptions of quality and safety initiatives. The aim of this study was to compare clinical frontline staff and senior managers' perceptions on the importance of an organization-wide quality and safety collaborative: the Safer Patients Initiative (SPI). A quantitative study obtained 635 surveys at 20 trusts participating in SPI. Participants included the teams and frontline staff involved within the programme at each organization. Independent T-tests were carried out between frontline staff and senior managers' perceptions of SPI programme elements, success factors and impact & sustainability. Statistically significant differences were found between the perceptions of frontline staff and senior managers on a wide number of issues, including the frontline perceiving a significantly larger improvement on the timeliness of care delivery (t = 2.943, P = 0.004), while managers perceived larger improvement on the culture within the organization for safe, effective and reliable care (t = -2.454, P = 0.014). This study has identified statistically significant disparities in perceptions of an organization-wide improvement initiative between frontline staff and senior managers. This holds valuable implications for the importance of getting both frontline and management perspectives when designing such interventions, in monitoring their performance, and in evaluating their impact. © 2010 Blackwell Publishing Ltd.

  18. An integrated analysis of liver safety data from orlistat clinical trials.

    Science.gov (United States)

    Morris, Marc; Lane, Peter; Lee, Kwan; Parks, Daniel

    2012-01-01

    Orlistat is an oral gastrointestinal lipase inhibitor and is indicated for treatment of obesity in combination with a hypocaloric diet. Post-marketing reports of adverse reactions revealed hints for possible drug-induced liver injury which has prompted changes to the product information. Orlistat's development program, involving over 30,000 patients, did not indicate a hepatic safety issue. We analyzed liver function test data from randomized clinical trials of orlistat, using i) meta-analysis of published study safety data, ii) time-to-event analysis for individual patients, and iii) a novel and more sensitive method derived from the U.S. Food and Drug Administration's (FDA) evaluation of drug-induced serious hepatotoxicity (eDISH) technique. Over 10,000 subjects were included. The combined odds ratio from a simple summary-level fixed-effects meta-analysis of treatment-emergent abnormalities in serum alanine aminotransferase (ALT) (defined as greater than the upper level of normal for 2 successive measurements) was 1.09 (95% CI 0.93-1.28), and in total bilirubin 1.24 (95% CI 1.03-1.49). Part of the small apparent effect was due to longer exposure to orlistat than to placebo, on average. A patient-level display, adjusting for regression towards the mean, and Kaplan-Meier analysis of changes in ALT and bilirubin, taking account of different exposure, showed no significant difference between orlistat and placebo. This shows that there is no signal for hepatic damage in clinical studies of orlistat. While idiosyncratic liver injury following exposure to orlistat cannot be excluded, it is likely to be extremely rare.

  19. Internet access and online cancer information seeking among Latino immigrants from safety net clinics.

    Science.gov (United States)

    Selsky, Claire; Luta, George; Noone, Anne-Michelle; Huerta, Elmer E; Mandelblatt, Jeanne S

    2013-01-01

    Internet use is widespread, but little is known about Internet use for cancer information among Latinos, especially those who rely on safety net clinics. The authors investigated access to and intended use of the Internet for cancer information among low income, immigrant Latinos predominately from Central and South America. A cross-sectional study of 1,273 Latinos 21 years and older attending safety net clinics or health fairs was conducted from June 2007 to November 2008. The authors used logistic regression models to evaluate associations of age, acculturation, psychosocial factors and other covariates with Internet access and intended use of the Internet for cancer information among those with access. Of the sample, 44% reported Internet access. Higher information self-efficacy and greater trust in the Internet were independently associated with Internet access (p = .05 and p Internet use for cancer information, considering covariates. In addition, those with high (vs. low) perceived risk of cancer (OR = 1.76; 95% CI [1.14, 2.73]; p = .01) and higher levels of trust in online health information (OR = 1.47 per one-point increase; 95% [CI 1.19, 1.82]; p = .0004) were more likely to intend to seek cancer information online. These findings that Internet access is fairly high in the immigrant Latino population and that the Internet is a trusted source of cancer information suggest that the Internet may be a channel for cancer control interventions.

  20. Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women.

    Science.gov (United States)

    Villarreal Pérez, Jesús Zacarías; Ramírez Aranda, José Manuel; de la O Cavazos, Manuel; Zamudio Osuna, Michelle de J; Perales Dávila, José; Ballesteros Elizondo, María Romelia; Gómez Meza, Marco Vinicio; García Elizondo, Francisco Javier; Rodríguez González, Azucena M

    2017-01-02

    Immunization with the tetanus, diphtheria, and pertussis (Tdap) vaccine raises controversies on immunogenicity and possible antibody interference. We performed an experimental, double-blind, parallel group controlled clinical trial to evaluate the safety and immunogenicity of the Tdap vaccine in 204 pregnant women and their children and to determine its interference in antibody production. Pregnant women 18 to 38 y of age with 12 to 24 weeks gestation, a low obstetric risk, and without serious disease were randomly selected. The experimental group received 0.5 mL IM of Tdap and the control group normal saline. Six blood samples were drawn before and after solution application, and from the umbilical cord of the infants and at 2, 4, and 6 months of age. Pertactin and Pertussis toxin antibodies and possible interference of maternal antibodies with the vaccine were determined. In the experimental group, antibodies against Bordetella pertussis pertactin (anti-PRN) (112 E/mL 95% CI 89.9-139.9) and antibodies against pertussis toxin (anti-PT) (24.0 E/mL, 95% CI 18.3-31.4) were elevated in the mother before vaccination. These were higher in the umbilical cord and descended in the infant at 2 months (71.4 (95% CI 56.8-89.7 and 10.9; 95% CI 8.7-13.7, respectively). Anti-PT showed a delay in production. Tdap safety was confirmed with only mild local pain at 24 and 48 hours. Anti-PRN and anti-PT antibodies in the infant descend at 2 months of age. There is a delay in anti-PT in children of immunized mothers. Further studies are needed to elucidate its clinical significance.

  1. [Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

    Science.gov (United States)

    Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

    2015-06-01

    To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P BSG group (P BSG group was lower than that of the control group. BSG based on Shen supplementing, Du-channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

  2. Development and testing of an objective structured clinical exam (OSCE) to assess socio-cultural dimensions of patient safety competency.

    Science.gov (United States)

    Ginsburg, Liane R; Tregunno, Deborah; Norton, Peter G; Smee, Sydney; de Vries, Ingrid; Sebok, Stefanie S; VanDenKerkhof, Elizabeth G; Luctkar-Flude, Marian; Medves, Jennifer

    2015-03-01

    Patient safety (PS) receives limited attention in health professional curricula. We developed and pilot tested four Objective Structured Clinical Examination (OSCE) stations intended to reflect socio-cultural dimensions in the Canadian Patient Safety Institute's Safety Competency Framework. 18 third year undergraduate medical and nursing students at a Canadian University. OSCE cases were developed by faculty with clinical and PS expertise with assistance from expert facilitators from the Medical Council of Canada. Stations reflect domains in the Safety Competency Framework (ie, managing safety risks, culture of safety, communication). Stations were assessed by two clinical faculty members. Inter-rater reliability was examined using weighted κ values. Additional aspects of reliability and OSCE performance are reported. Assessors exhibited excellent agreement (weighted κ scores ranged from 0.74 to 0.82 for the four OSCE stations). Learners' scores varied across the four stations. Nursing students scored significantly lower (pOSCE stations evaluating socio-cultural dimensions of PS achieved variation in scores and (2) performance on this OSCE can be evaluated with high reliability, suggesting a single assessor per station would be sufficient. Differences between nursing and medical student performance are interesting; however, it is unclear what factors explain these differences. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  3. Efficacy, Safety and Cost of Regorafenib in Patients with Metastatic Colorectal Cancer in French Clinical Practice.

    Science.gov (United States)

    Calcagno, Fabien; Lenoble, Sabrina; Lakkis, Zaher; Nguyen, Thierry; Limat, Samuel; Borg, Christophe; Jary, Marine; Kim, Stefano; Nerich, Virginie

    2016-01-01

    Regorafenib is an orally administered multikinase inhibitor that has been approved for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). Even though regorafenib significantly improved survival in two international phase 3 trials (CORRECT and CONCUR), a high rate of treatment-related toxic effects and dose modifications were observed with a modest benefit. The aim of this study was to provide information concerning the efficacy, safety, and cost of regorafenib in patients with mCRC in clinical practice. We retrospectively reviewed patients treated with regorafenib monotherapy for unresectable mCRC in five Franche-Comté cancer hospitals (France). The primary end point was overall survival. Secondary end points were safety and descriptive cost analyses of patients treated with regorafenib in clinical practice. Another aim of this study was to assess the impact of regorafenib prescription on the risk of hospitalization in real-life practice. From January 2014 to August 2014, 29 consecutive patients were enrolled. Patients were heavily pretreated and were refractory to standard chemotherapies. The primary tumor sites were the colon and the rectum for 55% and 45% of patients, respectively. Fifteen patients (51%) harbored an RAS mutation. Eastern Cooperative Oncology Group - Performance Status (PS) was 0-1 for 86% of patients and 2 for 14% of patients. Nineteen patients (66%) initially received reduced doses of 120 or 80 mg/day. The median duration of treatment was 2.5 months (range, 0.13-11.4 months). Treatment-related adverse events occurred in 86% of patients. The most frequent adverse events of any grade were fatigue (35%), diarrhea (20%), and hand-foot skin reaction (20%). Grade 3 or 4 treatment-related adverse events occurred in 10 patients (35%). Three patients (10%) were admitted to hospital due to drug-related severe adverse events. The mean cost of patient management with regorafenib for the duration of treatment was 9908 ± 8191

  4. Effects of an integrated clinical information system on medication safety in a multi-hospital setting.

    Science.gov (United States)

    Mahoney, Charles D; Berard-Collins, Christine M; Coleman, Reid; Amaral, Joseph F; Cotter, Carole M

    2007-09-15

    The implementation of vendor-based integrated clinical information technology was studied, and its effect on medication errors throughout the medication-use process in a health care system was evaluated. The integrated systems selected for implementation included computerized physician order entry, pharmacy and laboratory information systems, clinical decision-support systems (CDSSs), electronic drug dispensing systems (EDDSs), and a bar-code point-of-care medication administration system. The primary endpoint was the reduction in related medication errors. Secondary endpoints included the reductions in medication order turnaround time and EDDS override transactions. Integrated clinical information system technology was implemented in a multihospital health care system with a phased-in approach. A positive effect of this integration on medication errors throughout the medication-use process was demonstrated. Most prescribing errors decreased significantly in the selected categories monitored, specifically drug allergy detection, excessive dosing, and incomplete or unclear orders. Pharmacists were also twice as likely to identify dosages requiring adjustment for renal insufficiency when the integrated technology was in place and more than six times as likely for drug levels outside of the therapeutic range. A positive effect on medication administration safety was also demonstrated: 73 administration-related errors were intercepted through electronic bar-code scanning for every 100,000 doses charted. Integration of clinical information system technology decreased selected types of medication errors throughout the medication-use process in a health care system and improved therapeutic drug monitoring in patients with renal insufficiency and in patients receiving drugs with narrow therapeutic ranges through the use of CDSS alerts.

  5. Safety, Clinical Response, and Microbiome Findings Following Fecal Microbiota Transplant in Children With Inflammatory Bowel Disease.

    Science.gov (United States)

    Goyal, Alka; Yeh, Andrew; Bush, Brian R; Firek, Brian A; Siebold, Leah M; Rogers, Matthew Brian; Kufen, Adam D; Morowitz, Michael J

    2018-01-18

    The role of fecal microbiota transplant (FMT) in the treatment of pediatric inflammatory bowel disease (IBD) is unknown. The aims of this study were to assess safety, clinical response, and gut microbiome alterations in children with Crohn's disease (CD), ulcerative colitis (UC), or indeterminate colitis (IC). In this open-label, single-center prospective trial, patients with IBD refractory to medical therapy underwent a single FMT by upper and lower endoscopy. Adverse events, clinical response, gut microbiome, and biomarkers were assessed at baseline, 1 week, 1 month, and 6 months following FMT. Twenty-one subjects were analyzed, with a median age of 12 years, of whom 57% and 28% demonstrated clinical response at 1 and 6 months post-FMT, respectively. Two CD patients were in remission at 6 months. Adverse events attributable to FMT were mild to moderate and self-limited. Patients prior to FMT showed decreased species diversity and significant microbiome compositional differences characterized by increased Enterobacteriaceae, Enterococcus, Haemophilus, and Fusobacterium compared with donors and demonstrated increased species diversity at 30 days post-FMT. At 6 months, these changes shifted toward baseline. Clinical responders had a higher relative abundance of Fusobacterium and a lower diversity at baseline, as well as a greater shift toward donor-like microbiome after FMT compared with nonresponders. A single FMT is relatively safe and can result in a short-term response in young patients with active IBD. Responders possessed increased Fusobacterium prior to FMT and demonstrated more significant microbiome changes compared with nonresponders after FMT. Microbiome characteristics may help in predicting response. © 2018 Crohn’s & Colitis Foundation of America. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  6. Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics

    Directory of Open Access Journals (Sweden)

    Maureen Sanderson

    2017-02-01

    Full Text Available Abstract Background Human papillomavirus (HPV infection has been causally linked to six cancers, and many disproportionately affect minorties. This study reports on the development and effectiveness of an intervention aimed at increasing HPV vaccine uptake among African American and Hispanic pediatric patients in safety-net clinics. Methods Formative research, community engagement, and theory guided development of the intervention. A clustered, non-randomized controlled pragmatic trial was conducted in four clinics providing healthcare for the underserved in Tennessee, U.S., with two intervention sites and two usual care sites. Patients aged 9-18 years (N = 408 and their mothers (N = 305 enrolled, with children clustered within families. The intervention consisted of two provider/staff training sessions and provision of patient education materials, consisting of a video/flyer promoting HPV vaccine. Medical records were reviewed before/after the initial visit and after 12 months. Results At the initial visit, provision of patient education materials and provider recommendation were higher at intervention sites versus usual care sites, and receipt of HPV vaccine was higher at intervention sites (45.4% versus 32.9% but not significantly after adjusting for patient’s age and mother’s education. Provider recommendation, but not education materials, increased the likelihood of vaccine receipt at the initial visit, although over one-third of intervention mothers cited the flyer/video as motivating vaccination. Completion of the 3-dose series at follow-up was lower in the intervention arm. Conclusions Future interventions should combine patient education, intensive provider/staff education, and patient reminders. Research should compare patient education focusing on HPV vaccine only versus all adolescent vaccines. Trial registration Retrospectively registered with ClinicalTrials.gov NCT02808832 , 9/12/16

  7. Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia

    Directory of Open Access Journals (Sweden)

    Bhusal S

    2016-02-01

    Full Text Available Santosh Bhusal,1 Sherilyn Diomampo,1 Marina N Magrey2 1Division of Rheumatology, Metrohealth Medical Center, 2Case Western Reserve University School of Medicine at Metrohealth Medical Center, Cleveland OH, USA Abstract: Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Administration for the treatment of fibromyalgia. The drug has shown clinically meaningful benefits across multiple symptom domains of fibromyalgia. Efficacy of pregabalin in fibromyalgia pain has been evaluated in at least five high-quality randomized trials, two long-term extension studies, a meta-analysis, a Cochrane database systematic review, and several post hoc analyses. These studies also hint towards a meaningful benefit on sleep, functioning, quality of life, and work productivity. Side effects of pregabalin, although common, are mild to moderate in intensity. They are noted early during therapy, improve or disappear with dose reduction, and are not usually life- or organ threatening. In most patients, tolerance develops to the most common side effects, dizziness, and somnolence, with time. With close clinical monitoring at initiation or dose titration, pregabalin can be effectively used in primary care setting. Pregabalin is cost saving with long-term use and its cost-effectiveness profile is comparable, if not better, to that of other drugs used in fibromyalgia. In the present era of limited therapeutic options, pregabalin undoubtedly retains its role as one of cardinal drugs used in the treatment of fibromyalgia. This review intends to discuss the clinical utility of pregabalin in the management of fibromyalgia with a focus on efficacy, safety, and cost-effectiveness. Keywords: fibrositis, myofascial pain, diffuse pain syndrome, lyrica

  8. Pre-Clinical Study of a Novel Recombinant Botulinum Neurotoxin Derivative Engineered for Improved Safety.

    Science.gov (United States)

    Vazquez-Cintron, Edwin; Tenezaca, Luis; Angeles, Christopher; Syngkon, Aurelia; Liublinska, Victoria; Ichtchenko, Konstantin; Band, Philip

    2016-08-03

    Cyto-012 is a recombinant derivative of Botulinum neurotoxin Type A (BoNT/A). It primarily differs from wild type (wt) BoNT/A1 in that it incorporates two amino acid substitutions in the catalytic domain of the light chain (LC) metalloprotease (E224 > A and Y366 > A), designed to provide a safer clinical profile. Cyto-012 is specifically internalized into rat cortical and hippocampal neurons, and cleaves Synaptosomal-Associated Protein 25 (SNAP-25), the substrate of wt BoNT/A, but exhibits slower cleavage kinetics and therefore requires a higher absolute dose to exhibit pharmacologic activity. The pharmacodynamics of Cyto-012 and wt BoNT/A have similar onset and duration of action using the Digital Abduction Assay (DAS). Intramuscular LD50 values for Cyto-012 and wt BoNT/A respectively, were 0.63 ug (95% CI = 0.61, 0.66) and 6.22 pg (95% CI = 5.42, 7.02). ED50 values for Cyto-012 and wt BoNT/A were respectively, 0.030 ug (95% CI = 0.026, 0.034) and 0.592 pg (95% CI = 0.488, 0.696). The safety margin (intramuscular LD50/ED50 ratio) for Cyto-012 was found to be improved 2-fold relative to wt BoNT/A (p < 0.001). The DAS response to Cyto-012 was diminished when a second injection was administered 32 days after the first. These data suggest that the safety margin of BoNT/A can be improved by modulating their activity towards SNAP-25.

  9. Monoclonal purified F VIII for continuous infusion: stability, microbiological safety and clinical experience.

    Science.gov (United States)

    Schulman, S; Varon, D; Keller, N; Gitel, S; Martinowitz, U

    1994-09-01

    Replacement therapy for patients with hemophilia A postoperatively or for major hemorrhage, administered as a continuous infusion, is efficient and reduces the requirement for factor VIII (F VIII). The convenience of the method is increased by using a minipump and not diluting the concentrate further after reconstitution. A monoclonally purified F VIII concentrate (Monoclate-P), was evaluated for its stability after reconstitution in different infusion systems, for its microbiological safety as well as clinical safety and efficacy in continuous infusion. The F VIII activity was unaffected by 2 of the 3 infusion systems at room temperature during 15 days, whereas in the third (CADD-1) it decreased below 80% of initial value after 3-7 days. Addition of heparin (1 U/ml) or low molecular weight heparin (1 anti-Xa U/ml), which are used to prevent thrombophlebitis at the site of infusion, did not affect the stability. Nine out of 9 samples taken from the infusion systems after 3 days and again after 7 days were sterile. After inoculation with Staphylococcus aureus or Escherichia coli the bacterial growth in samples of the reconstituted concentrate was not different from that in lidocaine in saline or heparin in saline. F VIII was given in continuous infusion with a minipump (Infu-Med) to 12 patients undergoing major surgery and 8 patients with major hemorrhage for a total of 157 days. A progressive decrease of the clearance was seen during the first 5 days of infusion from 3.0 to 1.7 ml/kg/h. Hemostasis was effectively achieved, and no infectious complications were registered.(ABSTRACT TRUNCATED AT 250 WORDS)

  10. A Real-Time Safety and Quality Reporting System: Assessment of Clinical Data and Staff Participation

    Energy Technology Data Exchange (ETDEWEB)

    Rahn, Douglas A.; Kim, Gwe-Ya; Mundt, Arno J.; Pawlicki, Todd, E-mail: tpawlicki@ucsd.edu

    2014-12-01

    Purpose: To report on the use of an incident learning system in a radiation oncology clinic, along with a review of staff participation. Methods and Materials: On September 24, 2010, our department initiated an online real-time voluntary reporting system for safety issues, called the Radiation Oncology Quality Reporting System (ROQRS). We reviewed these reports from the program's inception through January 18, 2013 (2 years, 3 months, 25 days) to assess error reports (defined as both near-misses and incidents of inaccurate treatment). Results: During the study interval, there were 60,168 fractions of external beam radiation therapy and 955 brachytherapy procedures. There were 298 entries in the ROQRS system, among which 108 errors were reported. There were 31 patients with near-misses reported and 27 patients with incidents of inaccurate treatment reported. These incidents of inaccurate treatment occurred in 68 total treatment fractions (0.11% of treatments delivered during the study interval). None of these incidents of inaccurate treatment resulted in deviation from the prescription by 5% or more. A solution to the errors was documented in ROQRS in 65% of the cases. Errors occurred as repeated errors in 22% of the cases. A disproportionate number of the incidents of inaccurate treatment were due to improper patient setup at the linear accelerator (P<.001). Physician participation in ROQRS was nonexistent initially, but improved after an education program. Conclusions: Incident learning systems are a useful and practical means of improving safety and quality in patient care.

  11. A Real-Time Safety and Quality Reporting System: Assessment of Clinical Data and Staff Participation

    International Nuclear Information System (INIS)

    Rahn, Douglas A.; Kim, Gwe-Ya; Mundt, Arno J.; Pawlicki, Todd

    2014-01-01

    Purpose: To report on the use of an incident learning system in a radiation oncology clinic, along with a review of staff participation. Methods and Materials: On September 24, 2010, our department initiated an online real-time voluntary reporting system for safety issues, called the Radiation Oncology Quality Reporting System (ROQRS). We reviewed these reports from the program's inception through January 18, 2013 (2 years, 3 months, 25 days) to assess error reports (defined as both near-misses and incidents of inaccurate treatment). Results: During the study interval, there were 60,168 fractions of external beam radiation therapy and 955 brachytherapy procedures. There were 298 entries in the ROQRS system, among which 108 errors were reported. There were 31 patients with near-misses reported and 27 patients with incidents of inaccurate treatment reported. These incidents of inaccurate treatment occurred in 68 total treatment fractions (0.11% of treatments delivered during the study interval). None of these incidents of inaccurate treatment resulted in deviation from the prescription by 5% or more. A solution to the errors was documented in ROQRS in 65% of the cases. Errors occurred as repeated errors in 22% of the cases. A disproportionate number of the incidents of inaccurate treatment were due to improper patient setup at the linear accelerator (P<.001). Physician participation in ROQRS was nonexistent initially, but improved after an education program. Conclusions: Incident learning systems are a useful and practical means of improving safety and quality in patient care

  12. Clinical evaluation of the efficacy and safety of a constant rate infusion of dexmedetomidine for postoperative pain management in dogs

    NARCIS (Netherlands)

    Valtolina, C.|info:eu-repo/dai/nl/412503034; Robben, J.H.|info:eu-repo/dai/nl/266740790; Uilenreef, J.J.|info:eu-repo/dai/nl/30483095X; Murrell, J.C.; Aspegrén, J.; McKusick, B.C.; Hellebrekers, L.J.|info:eu-repo/dai/nl/073499234

    2009-01-01

    Vet Anaesth Analg. 2009 Jul;36(4):369-83. Epub 2009 May 12. Clinical evaluation of the efficacy and safety of a constant rate infusion of dexmedetomidine for postoperative pain management in dogs. Valtolina C, Robben JH, Uilenreef J, Murrell JC, Aspegrén J, McKusick BC, Hellebrekers LJ. Department

  13. 75 FR 53701 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01...

    Science.gov (United States)

    2010-09-01

    ... [Federal Register Volume 75, Number 169 (Wednesday, September 1, 2010)] [Notices] [Page 53701] [FR Doc No: 2010-21795] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0394] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project...

  14. Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: a randomized control trial.

    Science.gov (United States)

    Jones, Mitchell L; Martoni, Christopher J; Di Pietro, E; Simon, Ryan R; Prakash, Satya

    2012-07-01

    A significant number of human clinical trials have reported no adverse effects associated with consumption of Lactobacillus reuteri (L. reuteri). In the present study, the clinical safety and toxicology of oral ingestion of supplement capsules containing L. reuteri NCIMB 30242 was investigated. A randomized group of 131 subjects received a dose of 2.9×10⁹ CFU L. reuteri NCIMB 30242 capsules (n=67) or placebo capsules (n=64) twice daily for 9 weeks. Clinical chemistry and hematological parameters of safety were analyzed. The frequency, duration and intensity of adverse events (AE)s and clinical significance of safety parameters were recorded for both groups. No clinically significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results. The frequency and intensity of AEs was similar in the two groups. These results demonstrate that administration of a twice daily dose of 2.9×10⁹ CFU was safe and well tolerated in the population evaluated over 9 weeks. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

  15. Preclinical and phase 1 clinical safety of Setarud (IMOD™, a novel immunomodulator

    Directory of Open Access Journals (Sweden)

    P Khairandish

    2009-10-01

    Full Text Available "n "n  Background: A new herbal drug, Setarud (IMODTM that has been shown to have beneficial immune effects was tested to determine its acute and chronic toxicity in animals and to establish its intravenous form maximum tolerated dose (MTD in an open-labeled phase I clinical trial. Methods: BALB/c and C57BL/6 mice and Wistar rats were monitored for general state and biochemical markers for chronic test. At the end of chronic test, animals examined macroscopically and histologically. HIV-infected asymptomatic male patients with CD4 counts more than 200, were enrolled in the trial. Baseline dose was calculated from the 10% lethal dose (LD10 established in laboratory animal studies. Dose escalation was performed in four cohorts of 3 patients receiving IMODTM intravenously at a cohort-specific dose of 2, 4, 6.7, and 10 ml daily for 4 weeks. Patients were clinically examined at days of 1, 2, 3 and then weekly; and the safety was assessed on the basis of reports of adverse events, laboratory-test data and toxicity signs. Results: LD50 values in acute toxicity test were 42-66 and 50-56 ml/kg in i.m. and i.p. injections, respectively. Total scores of embryotoxicity during pregnancy were significantly lower in the Setarud group (p < 0.05. Pre-implantational deaths in the Setarud group were significantly higher, but post-implantational deaths level was lower than those in the control group. Inhibition of ossification in the skeletons of the fetuses and incidence of still birth were significantly higher while body weight of new-born rats of treatment group in the first month of their lifes were lower than those of the control group.In all four cohorts, there were no major side effects or dose-limiting toxicity, except for a mild sweating and weight loss in two patients from the first group that was reversed without discontinuation of the treatment. No clinically relevant trends in laboratory test results or ECG changes were noted. No adverse effect due to

  16. Setting up a radiotherapy programme: Clinical, medical physics, radiation protection and safety aspects

    International Nuclear Information System (INIS)

    2008-02-01

    quality, radiotherapy. While it has long been recognized that the physical aspects of quality assurance in radiotherapy are vital to achieving effective and safe treatment, it has been increasingly acknowledged that a systematic approach is necessary for all the steps within the clinical and technical aspects of radiotherapy programmes as well. The need to establish general guidelines at the IAEA, taking into account the clinical, medical physics, radiation protection and safety considerations for designing and implementing radiotherapy programmes in Member States, has been identified through the increased interest of Member States in the efficient and safe application of radiation in health care. To satisfy this need, the IAEA has convened several consultant and advisory group meetings to prepare a publication providing a basis for establishing a programme in radiotherapy. The external expertise has been substantially complemented by the contributions of a large number of IAEA staff members. The present publication supersedes IAEA-TECDOC-1040 (Design and Implementation of a Radiotherapy Programme: Clinical, Medical Physics, Radiation Protection and Safety Aspects) published in 1998. It is addressed to professionals and administrators involved in the development, implementation and management of a radiotherapy programme, in order to establish a common and consistent framework in which all the steps and procedures in radiotherapy are taken into account. The present publication has been expanded to include orthovoltage X rays and linear accelerators

  17. A Bayesian meta-analytic approach for safety signal detection in randomized clinical trials.

    Science.gov (United States)

    Odani, Motoi; Fukimbara, Satoru; Sato, Tosiya

    2017-04-01

    Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials. To develop our meta-analysis model, we extended an existing three-stage Bayesian hierarchical model by including an additional stage of the clinical trial level in the hierarchical model; this generated a four-stage Bayesian hierarchical model. We applied the proposed Bayesian meta-analysis models to published adverse event data from three premarketing randomized clinical trials of tadalafil and to a simulation study motivated by the case example to evaluate the characteristics of three alternative models. Comparison of the results from the Bayesian meta-analysis model with those from Fisher's exact test after simple pooling showed that 6 out of 10 adverse events were the same within a top 10 ranking of individual adverse events with regard to association with treatment. However, more individual adverse events were detected in the Bayesian meta-analysis model than in Fisher's exact test under the body system "Musculoskeletal and connective tissue disorders." Moreover, comparison of the overall trend of estimates between the Bayesian model and the standard approach (odds ratios after simple pooling methods) revealed that the posterior median odds ratios for the Bayesian model for most adverse events shrank toward values for no association. Based on the simulation results, the Bayesian meta-analysis model could balance the false detection rate and power to a better extent than Fisher's exact test. For example, when the threshold value of the posterior probability for

  18. Clinical Experience of Insulin Detemir in Turkey: Efficacy and Safety Data From the PREDICTIVE™ Study

    Directory of Open Access Journals (Sweden)

    Gaye Akoz

    2008-12-01

    Full Text Available Objective: To assess outcomes in Turkish type 1 and 2 diabetic patients given insulin detemir in the multinational PREDICTIVE™ study. Materials and Methods: PREDICTIVE™ was a large, open-label, prospective, observational study examining the efficacy and safety of insulin detemir in routine clinical practice. Data from the Turkish cohort (2786 patients were analysed following a 12-week treatment period. Results: Following treatment, HbA1c significantly decreased by-1.81% (from 9.66% in type 1 diabetics and by-1.77% (from 9.54% in type 2 diabetics (P<0.0001. Mean fasting blood glucose (FBG reduced from 12.35 mmol/L (222.3 mg/dL to 8.10 mmol/L (145.8 mg/dL in type 1 diabetics and from 13.46 mmol/L (242.3 mg/dL to 8.05 mmol/L (144.9 mg/dL in type 2 diabetics (P<0.0001. Mean within-patient variability of FBG was also reduced (P<0.0001. Serious adverse drug reactions occurred in four patients, 38 if including major hypoglycaemia. Total, major and nocturnal hypoglycaemic events all reduced in frequency after 12 weeks (P<0.0001. Conclusions: Insulin detemir treatment for 12 weeks resulted in improved, more predictable glycaemic control, modest weight loss or minimal weight gain, and reduced incidence of hypoglycaemia in a large cohort of Turkish patients with diabetes treated according to local clinical practice.

  19. Post-Reteplase Evaluation of Clinical Safety & Efficacy in Indian Patients (Precise-In Study).

    Science.gov (United States)

    Singh, R K; Trailokya, A; Naik, M M

    2015-04-01

    ST elevated myocardial infarction is a serious and life-threatening condition. In patients suitable for thrombolytic treatment, time is critical and reperfusion should be initiated as soon as possible. Reteplase is commonly used in the management of ST elevated myocardial infarction. To assess the safety and efficacy of intravenous Retelex (Reteplase) injection in management of patients with ST elevated myocardial infarction in clinical practice. An open label, non-comparative, multicentric, post-marketing observational study was conducted in > 18 years of patients with ST elevated myocardial infarction (STEMI) receiving Retelex. All patients received 20 units Retelex within 6 hours after the onset of acute myocardial infarction (AMI) symptoms. The dose was given as two 10 unit Intravenous injections each over two minutes 30 minutes apart. Evaluation criteria: Patients were followed on day 1, 3, 5/7 and 30. The primary evaluation criteria was total number of patients showing clinically successful thrombolysis based on 50% resolution of ST-elevation in the maximum affected (adjacent) leads within 90-120 minutes of initiation of Reteplase and resolution of chest pain. Secondary evaluation criteria included percentage of patient requiring rescue percutaneous coronary intervention (PCI), percentage of patient underwent angioplasty or CABG after thrombolysis. Door to needle time was also recorded in patients receiving the study drug. Global assessment of efficacy and safety was done by patient as well as investigator. All adverse events were recorded for safety assessment. Statistical analysis: Mean and percentage were calculated for primary efficacy parameters i.e. 50% resolution of ST elevation and resolution of chest pain. Chi square test was used for comparing the difference between diabetes versus non-diabetes patients for primary efficacy variables as well as for comparing the number of patients requiring rescue PCI, angioplasty and CABG between these two groups

  20. A clinical comparison of safety and efficacy in phacoemulsification with versus without ophthalmic viscoelastic device.

    Science.gov (United States)

    Kugu, Suleyman; Erdogan, Gurkan; Sahin Sevim, M; Ozerturk, Yusuf

    2015-03-01

    To evaluate in a comparative manner the safety and efficacy of 1.0% sodium-Hyaluronate used during capsulorhexis and intraocular lens (IOL) implantation in phacoemulsification surgery. 1.0% sodium-Hyaluronate, which is commonly used as one of the ophthalmic viscoelastic devices, was compared to intraocular irrigating solution, which can bring up these effects. In addition, the effect of both methods on occurring corneal endothelial cell (CEC) loss was investigated. Each group comprised 19 eyes. The mean preoperative CEC density was 2525.68 ± 181.85 in Group H and 2514.16 ± 174.59 in Group V; no statistically significant difference was found between the groups (p > 0.05). Preoperative and postoperative first and twelfth week CEC densities were 2438.21 ± 198.12 (p  0.05). Although it was found that there was no statistically difference in terms of preventing CEC loss between 1.0% sodium-Hyaluronate and the irrigation method during phacoemulsification, it was observed clinically that 1.0% sodium-hyaluronate can make the procedure easy, safer, very helpful, especially for understanding phacoemulsification.

  1. Improving patient safety through a clinical audit spiral: prevention of wrong tooth extraction in orthodontics.

    Science.gov (United States)

    Anwar, H; Waring, D

    2017-07-07

    Introduction With an increasing demand to improve patient safety within the NHS, it is important to ensure that measures are undertaken to continually improve patient care. Wrong site surgery has been defined as a 'never event'. This article highlights the importance of preventing wrong tooth extraction within orthodontics through an audit spiral over five years investigating the accuracy and clarity of orthodontic extraction letters at the University Dental Hospital of Manchester.Aims To examine compliance with the standards for accuracy and clarity of extraction letters and the incidence of wrong tooth extractions, and to increase awareness of the errors that can occur with extraction letters and of the current guidelines.Method A retrospective audit was conducted examining extraction letters sent to clinicians outside the department.Results It can be seen there has been no occurrence of a wrong site tooth extraction. The initial audit highlighted issues in conformity, with it falling below expected standards. Cycle two generally demonstrated a further reduction in compliance. Cycle three appeared to result in an increase in levels of compliance. Cycles 4 and 5 have demonstrated gradual improvements. However, it is noteworthy that in all cycles the audit standards were still not achieved, with the exception of no incidences of the incorrect tooth being extracted.Conclusion This audit spiral demonstrates the importance of long term re-audit to aim to achieve excellence in clinical care. There has been a gradual increase in standards through each audit.

  2. Clinical efficacy and safety of topical versus oral ivermectin in treatment of uncomplicated scabies.

    Science.gov (United States)

    Ahmad, Hesham M; Abdel-Azim, Eman S; Abdel-Aziz, Rasha T

    2016-01-01

    Many medications are available for scabies treatment including oral and topical ivermectin. However, studies comparing these two forms as a scabies treatment are few. This study compares efficacy and safety of topical versus oral ivermectin as scabies treatment. The study included 62 confirmed uncomplicated scabies patients, divided into: Group I (32 patients, received topical ivermectin) and Group II (30 patients, received oral ivermectin). Patients were assessed, clinically and by KOH smear at 1, 2 and 4 weeks. Treatment was repeated after one week in patients with persistent infection. Adverse events were recorded. Most patients (87.5% and 73.5% in group I and group II respectively) were symptom free after a single treatment. A second treatment was required in 4 patients of group I and 8 patients of group II. However, 2 weeks after treatment symptoms and signs completely resolved in all cases with no recurrence at 4 weeks. This study suggests that both topical and oral ivermectin are safe and equally effective in treatment of uncomplicated scabies. Single treatment, whether topical or oral, is associated with high cure rate in a week post treatment. However, repeating treatment after one week may be required to achieve 100% cure. © 2015 Wiley Periodicals, Inc.

  3. Scleral fixation of intraocular lenses using Gore-Tex suture: clinical outcomes and safety profile.

    Science.gov (United States)

    Khan, M Ali; Gupta, Omesh P; Smith, Ryan G; Ayres, Brandon D; Raber, Irving M; Bailey, Robert S; Hsu, Jason; Spirn, Marc J

    2016-05-01

    To report the short-term safety profile and clinical outcomes of scleral fixation of intraocular lenses (IOLs) using Gore-Tex suture. Retrospective, interventional case series. 85 eyes of 84 patients undergoing ab externo scleral fixation of a Bausch and Lomb Akreos AO60 or Alcon CZ70BD IOL using Gore-Tex suture. Primary outcome measures were change in visual acuity and occurrence of intraoperative and postoperative complications with minimum follow-up of 90 days. 85 eyes of 84 patients were identified. Mean logarithm of the minimum angle of resolution visual acuity improved from 1.43±0.72 (20/538 Snellen equivalent) preoperatively to 0.64±0.61 (20/87 Snellen equivalent) postoperatively (pGore-Tex suture was well tolerated in all cases. No suture-related complications were encountered. This procedure led to improvement in visual acuity and was not associated with significant intraoperative or postoperative complications. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. Efficacy and safety of far infrared radiation in lymphedema treatment: clinical evaluation and laboratory analysis.

    Science.gov (United States)

    Li, Ke; Zhang, Zheng; Liu, Ning Fei; Feng, Shao Qing; Tong, Yun; Zhang, Ju Fang; Constantinides, Joannis; Lazzeri, Davide; Grassetti, Luca; Nicoli, Fabio; Zhang, Yi Xin

    2017-04-01

    Swelling is the most common symptom of extremities lymphedema. Clinical evaluation and laboratory analysis were conducted after far infrared radiation (FIR) treatment on the main four components of lymphedema: fluid, fat, protein, and hyaluronan. Far infrared radiation is a kind of hyperthermia therapy with several and additional benefits as well as promoting microcirculation flow and improving collateral lymph circumfluence. Although FIR therapy has been applied for several years on thousands of lymphedema patients, there are still few studies that have reported the biological effects of FIR on lymphatic tissue. In this research, we investigate the effects of far infrared rays on the major components of lymphatic tissue. Then, we explore the effectiveness and safety of FIR as a promising treatment modality of lymphedema. A total of 32 patients affected by lymphedema in stage II and III were treated between January 2015 and January 2016 at our department. After therapy, a significant decrease of limb circumference measurements was noted and improving of quality of life was registered. Laboratory examination showed the treatment can also decrease the deposition of fluid, fat, hyaluronan, and protein, improving the swelling condition. We believe FIR treatment could be considered as both an alternative monotherapy and a useful adjunctive to the conservative or surgical lymphedema procedures. Furthermore, the real and significant biological effects of FIR represent possible future applications in wide range of the medical field.

  5. The laboratory and clinical safety evaluation of a dentifrice containing hydrogen peroxide and baking soda.

    Science.gov (United States)

    Fischman, S L; Truelove, R B; Hart, R; Cancro, L P

    1992-01-01

    This study reports the laboratory, clinical, and microbiological finding of the safety testing and daily use of a dentifrice delivering 0.75% hydrogen peroxide and 5% baking soda. Laboratory studies using Ca45 labeled teeth and biologically stained teeth confirmed that the dentifrice did not decalcify enamel or bleach teeth. Over the course of a six-month period, 62 subjects using a hydrogen peroxide-baking soda dentifrice and 21 subjects using a control dentifrice were examined for oral soft tissue change and hard tissue alterations. No soft tissue changes attributable to the use of either dentifrice were noted. Experienced clinicians using Trubyte shade guide teeth observed no significant changes to the subjects' anterior teeth following 6 months use of the test dentifrice. Paired discrimination tests revealed that the examiners could distinguish color differences in the shade guide teeth at 0.7%. Microbiological monitoring of the subjects for six months use of their assigned dentifrice and for the following months on the control dentifrice, revealed neither an increased incidence of candida nor increased candida counts.

  6. Case report of a pustular dermatitis outbreak in sheep: Clinical and food safety considerations

    Directory of Open Access Journals (Sweden)

    Mariana Roccaro

    2018-04-01

    Full Text Available The objective of this report is to describe an outbreak of pustular dermatitis in a flock of about 200 sheep, its clinical evolution and food safety implications. The onset of the symptoms was sudden and the lesions spread very quickly from ewe to ewe, so that in about 3 days almost all of the lactating sheep were stricken. Pustules from 5 different animals, six milk samples, two cheese samples, teat cup samples from the milking machine and farmer’s hands were analysed. A pure culture of Staphylococcus aureus, producing staphylococcal enterotoxin (SE C, was isolated from pustules. Milk and cheese showed a contamination by coagulase positive staphylococci <15 and 30 colony forming units respectively and the absence of SE. Farmer’s hands and teat cups samples resulted negative for coagulase positive staphylococci. Therapy with daily topical medicaments was prescribed and a prophylactic intervention was suggested by the administration of an autovaccine. The low level of milk and cheese contamination and the absence of SE in cheese supported the decision to not advise the farmer to recall cheese produced with milk from affected animals.

  7. Promoting Safety in Hypnosis: A Clinical Instrument for the Assessment of Alertness.

    Science.gov (United States)

    Howard, Hedy A

    2017-04-01

    Hypnosis has long demonstrated its power to facilitate various approaches to psychotherapy. Like other potent modalities, hypnosis may produce unwanted effects. Although its negative sequelae are usually mild and transient, more serious complications may occur. Recently, attention has been drawn to the powerful role of failures of dehypnosis or alerting/realerting in producing unwanted effects. Traditionally, alerting has been viewed as a relatively uncomplicated process that requires little more than the simple suggestion that the subject will return or awaken from trance, and exiting from trance has generally been considered the cessation of the phenomena suggested during induction and thereafter. Newer findings challenge these assumptions and suggest that restoring the subject to a prehypnotic baseline level of alertness is of equal or greater importance. Here, I describe the Howard Alertness Scale (HAS), with which subjects can be made aware of their baseline levels of alertness to help them understand the unique ways that their trance states differ from their normal alert states, and assess and measure their subjective perception of alertness before and after hypnosis. Furthermore, regular use of the HAS holds potential to enhance both the therapeutic alliance and the patient's sense of safety and mastery. The development and use of the HAS is discussed along with three vignettes illustrating its clinical application.

  8. The effect object paradigm--a means to support medication safety with clinical decision support.

    Science.gov (United States)

    Patapovas, Andrius; Pfistermeister, Barbara; Tarkhov, Aleksey; Terfloth, Lothar; Maas, Renke; Fromm, Martin F; Kornhuber, Johannes; Prokosch, Hans-Ulrich; Bürkle, Thomas

    2014-01-01

    In many countries, officially approved drug information known as summary of product characteristics (SPC) is mostly available in text form, which cannot be used for Clinical Decision Support Systems (CDSS). It may be essential however to substantiate CDSS advice with such legally binding text snippets. In an attempt to link various drug data sources including SPC towards a CDSS to support medication safety in psychiatric patients we arrived at the notion of an effect object. A requirements analysis revealed data items and data structure which are needed from the patient and from the drug information source for the CDSS functionality. Published drug data modelling approaches were analyzed and found unsuitable. A conceptional database modeling approach using top down and bottom up modeling was performed. The schema based data model implemented within the django framework centered on SPC "effect objects" which comprise all SPC data required for the respective CDSS function such as search for contraindications in the proposed medication. Today six effect objects have been defined for contraindications and warnings, missing indications, adverse effects, drug-drug interactions, dosing and pharmacokinetics. The transformation of SPC data to a database-driven "effect objects" structure permits decoupling between the CDSS functions and different underlying data sources and supports the design of reusable, stable and verified CDSS functions.

  9. Clinical evaluation of the safety of repetitive intraoperative defibrillation threshold testing.

    Science.gov (United States)

    Frame, R; Brodman, R; Furman, S; Kim, S G; Roth, J; Ferrick, K; Hollinger, I; Gross, J; Fisher, J D

    1992-06-01

    One goal of the initial implantation procedure for a cardioverter defibrillator is determination of the configuration and patch location with the lowest defibrillation threshold (DFT). To determine the safety of multiple defibrillation tests, an analysis of the intraoperative defibrillation threshold tests (DFTT) in our patients was performed. In 84 patients, the mean number of DFT trials was 5.27; the mean number of joules received was 275.0. The maximum number of shocks in one implant procedure was 50 for a total of 4,895 joules without complications. Four patients received 30 or more DFT shocks without complication. There were two complications related directly to the DFTT: one patient with severe noninflammatory cardiomyopathy developed electromechanical dissociation and was subsequently resuscitated and survived; the second patient with severe triple vessel coronary artery disease suffered an intraoperative myocardial infarction during testing and eventually died 22 days postoperatively. All patients received an ICD unit; six patients had DFTs of greater than 20 joules. Based on our experience, we followed the clinical status (heart rate, blood pressure, ECG changes, fluid status, total anesthesia time) during the DFTT to determine the extent and duration of our testing protocol. Multiple shocks due to repositioning of the leads in a stable patient should not prohibit extensive testing as adverse consequences do not appear to be cumulative.

  10. Development and testing of an objective structured clinical exam (OSCE) to assess socio-cultural dimensions of patient safety competency

    Science.gov (United States)

    Ginsburg, Liane R; Tregunno, Deborah; Norton, Peter G; Smee, Sydney; de Vries, Ingrid; Sebok, Stefanie S; VanDenKerkhof, Elizabeth G; Luctkar-Flude, Marian; Medves, Jennifer

    2015-01-01

    Background Patient safety (PS) receives limited attention in health professional curricula. We developed and pilot tested four Objective Structured Clinical Examination (OSCE) stations intended to reflect socio-cultural dimensions in the Canadian Patient Safety Institute's Safety Competency Framework. Setting and participants 18 third year undergraduate medical and nursing students at a Canadian University. Methods OSCE cases were developed by faculty with clinical and PS expertise with assistance from expert facilitators from the Medical Council of Canada. Stations reflect domains in the Safety Competency Framework (ie, managing safety risks, culture of safety, communication). Stations were assessed by two clinical faculty members. Inter-rater reliability was examined using weighted κ values. Additional aspects of reliability and OSCE performance are reported. Results Assessors exhibited excellent agreement (weighted κ scores ranged from 0.74 to 0.82 for the four OSCE stations). Learners’ scores varied across the four stations. Nursing students scored significantly lower (p<0.05) than medical students on three stations (nursing student mean scores=1.9, 1.9 and 2.7; medical student mean scores=2.8, 2.9 and 3.5 for stations 1, 2 and 3, respectively where 1=borderline unsatisfactory, 2=borderline satisfactory and 3=competence demonstrated). 7/18 students (39%) scored below ‘borderline satisfactory’ on one or more stations. Conclusions Results show (1) four OSCE stations evaluating socio-cultural dimensions of PS achieved variation in scores and (2) performance on this OSCE can be evaluated with high reliability, suggesting a single assessor per station would be sufficient. Differences between nursing and medical student performance are interesting; however, it is unclear what factors explain these differences. PMID:25398630

  11. Does clinical supervision of health professionals improve patient safety? A systematic review and meta-analysis.

    Science.gov (United States)

    Snowdon, David A; Hau, Raphael; Leggat, Sandra G; Taylor, Nicholas F

    2016-09-01

    To determine whether clinical supervision (CS) of health professionals improves patient safety. Databases MEDLINE, PsychINFO, CINAHL, EMBASE and AMED were searched from earliest date available. Additional studies were identified by searching of reference lists and citation tracking. Two reviewers independently applied inclusion and exclusion criteria. Thirty-two studies across three health professions [medicine (n = 29), nursing (n = 2) and paramedicine (n = 1)] were selected. The quality of each study was rated using the Medical Education Research Study Quality Instrument. Risk ratios (RR) were calculated for patient safety outcomes of mortality, complications, adverse events, reoperation following initial surgery, conversion to more invasive surgery and readmission to hospital. Results of meta-analyses provided low-quality evidence that supervision of medical professionals reduced the risk of mortality (RR 0.76, 95% CI 0.60-0.95, I(2) = 76%) and supervision of medical professionals and paramedics reduced the risk of complications (RR 0.69, 95% CI 0.53-0.89, I(2) = 76%). Due to a high level of statistical heterogeneity, sub-group analyses were performed. Sub-group analyses provided moderate-quality evidence that direct supervision of surgery significantly reduced the risk of mortality (RR 0.68, 95% CI 0.50-0.93, I(2) = 33%) and direct supervision of medical professionals conducting non-surgical invasive procedures significantly reduced the risk of complications (RR 0.33, 95% CI 0.24-0.46, I(2) = 0%). CS was associated with safer surgery and other invasive procedures for medical practitioners. There was a lack of evidence about the relationship between CS and safer patient care for non-medical health professionals. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Antiremodelling Efficacy and Clinical Safety of Zofenopril in Patients with Grade 1and 2 Hypertension

    Directory of Open Access Journals (Sweden)

    Guzal J. Abdullaeva

    2015-12-01

    Full Text Available Objective: to estimate the antihypertensive, antiremodelling efficacy and clinical tolerability of the monotherapy with Zofenopril in patients with Grade 1 and 2 hypertension (HT 1 and 2 Materials and Methods: The study included 30 patients aged from 30 to 60 years with HT 1 and 2 (ESH/ESC, 2013 without severe comorbidities and cardiovascular complications. Zofenopril was prescribed as monotherapy to HT patients who had never been treated before or patients after one week of lavage from previous antihypertensive therapy, who did not reach target levels of BP. Before and during treatment all patients were checked on office BP using Korotkov’s method and ambulatory blood pressure monitoring (ABPM. Echocardiography and Doppler sonography were carried out by standard methods using the recommendations of the American Society of Echocardiography. Intima-media thickness (IMT of the carotid artery and brachial artery was measured by a 7.5MHz high-resolution ultrasound. Assessment of flow-mediated dilation (FMD of the brachial artery was used as a method of determining endothelial function. Results: A 12-week monotherapy with Zofenopril in average daily dose of 36.0±19.54 mg showed a high antihypertensive efficacy and a good safety profile without side effects. We noted a reliable decrease in systolic BP (SBP, diastolic BP (DBP, mean BP, and pulse pressure (PP by -19.53±5.93%, -18.64±7.18%, BP -19.05±6.14%, and -20.65±12.07%, respectively. Target SBP, DBP, and SBP+DBP were reached in 90%, 86.6%, and 83.3% of patients, respectively. We found a significant regression of LVH, significant improvement in volume indicators of LV echogeometry and parameters of FMD of the brachial artery, as well as a decrease in IMT of carotid and brachial arteries. Monotherapy with Zofenopril showed metabolic neutrality regarding the lipid and carbohydrate metabolism, a good safety profile without the side effects and undesired events.

  13. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Safety Standards

    OpenAIRE

    Gullatte, Mary

    2013-01-01

    Oncology nurses have used chemotherapy standards to develop educational materials and guidelines for standardization and safety and anticipate future opportunities to partner in translating evidence into practice.

  14. [Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Galicia].

    Science.gov (United States)

    Pato-Pato, A; Midaglia, L; Costa-Arpin, E; Rodriguez-Regal, A; Puy-Nunez, A; Rodriguez-Rodriguez, M; Lopez-Real, A; Llaneza-Gonzalez, M A; Garcia-Estevez, D A; Moreno-Carretero, M J; Escriche-Jaime, D; Aguado-Valcarcel, M L; Munoz, D; Prieto, J M; Lorenzo-Gonzalez, J R; Amigo-Jorrin, M C

    2016-09-05

    The effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) have been proven in clinical trials. Yet, due to their limitations, it is important to know how it behaves under everyday clinical practice conditions. Hence, the aim of this study is to evaluate the effectiveness and safety of fingolimod after 12 months' usage in clinical practice in Galicia. We conducted a retrospective, multi-centre study (n = 8) of patients with RRMS who were treated with one or more doses of fingolimod, 0.5 mg/day. Effectiveness was assessed -annualised relapse rate (ARR), changes in the score on the Expanded Disability Status Scale (EDSS), percentage of patients free from relapses, free from progression of disability and free from activity in resonance- for the total number of patients and according to previous treatment. Safety was assessed based on the percentage of patients who withdrew and presented adverse side effects. After 12 months' use, fingolimod reduced the ARR by 87% (1.7 to 0.23; p < 0.0001) and, consequently, 81% of patients were free from relapses. The score was reduced by 9%. In all, 91% of patients were free from progression of disability and 72% were free from resonance activity. No signs of disease activity were found in 43% of the patients. Most of the benefits of fingolimod differed depending on previous treatment. About a third of the patients reported adverse side effects, but only 2% of them withdrew for this reason. In clinical practice, most of the results on the effectiveness of the clinical trials conducted with fingolimod were observed during the first 12 months of treatment. A better safety profile was observed than that reported in the clinical trials.

  15. Frontline experiences of a practice redesign to improve self-management of obesity in safety net clinics.

    Science.gov (United States)

    AuYoung, Mona; Duru, O Kenrik; Ponce, Ninez A; Mangione, Carol M; Rodriguez, Hector P

    2015-01-01

    Teamlets of physicians and medical assistants may help improve obesity management in primary care settings. We aimed to understand the barriers and facilitators of implementing a teamlet approach to managing obesity in 3 safety net clinics. Key stakeholder interviews (n = 21) were conducted both during early implementation of practice change and 6 months later. Patient surveys (n = 393) examined obese patient activation and health status. Insufficient program resources and limited patient engagement due to external factors were implementation barriers despite fairly high patient activation. Staff members need time and resources to execute new responsibilities to support obesity management in safety net settings. Because of high turnover, multiple supporters may improve sustainability.

  16. Computerised clinical decision support systems to improve medication safety in long-term care homes: a systematic review.

    Science.gov (United States)

    Marasinghe, Keshini Madara

    2015-05-12

    Computerised clinical decision support systems (CCDSS) are used to improve the quality of care in various healthcare settings. This systematic review evaluated the impact of CCDSS on improving medication safety in long-term care homes (LTC). Medication safety in older populations is an important health concern as inappropriate medication use can elevate the risk of potentially severe outcomes (ie, adverse drug reactions, ADR). With an increasing ageing population, greater use of LTC by the growing ageing population and increasing number of medication-related health issues in LTC, strategies to improve medication safety are essential. Databases searched included MEDLINE, EMBASE, Scopus and Cochrane Library. Three groups of keywords were combined: those relating to LTC, medication safety and CCDSS. One reviewer undertook screening and quality assessment. Overall findings suggest that CCDSS in LTC improved the quality of prescribing decisions (ie, appropriate medication orders), detected ADR, triggered warning messages (ie, related to central nervous system side effects, drug-associated constipation, renal insufficiency) and reduced injury risk among older adults. CCDSS have received little attention in LTC, as attested by the limited published literature. With an increasing ageing population, greater use of LTC by the ageing population and increased workload for health professionals, merely relying on physicians' judgement on medication safety would not be sufficient. CCDSS to improve medication safety and enhance the quality of prescribing decisions are essential. Analysis of review findings indicates that CCDSS are beneficial, effective and have potential to improve medication safety in LTC; however, the use of CCDSS in LTC is scarce. Careful assessment on the impact of CCDSS on medication safety and further modifications to existing CCDSS are recommended for wider acceptance. Due to scant evidence in the current literature, further research on implementation and

  17. Efficacy and Safety of Basimglurant as Adjunctive Therapy for Major Depression: A Randomized Clinical Trial.

    Science.gov (United States)

    Quiroz, Jorge A; Tamburri, Paul; Deptula, Dennis; Banken, Ludger; Beyer, Ulrich; Rabbia, Michael; Parkar, Nikhat; Fontoura, Paulo; Santarelli, Luca

    2016-07-01

    Antagonism of the postsynaptic metabotropic glutamate subtype 5 receptor is a novel approach to modulate glutamatergic function and has proven efficacy in a number of preclinical behavioral models of depression. To evaluate the safety and efficacy of basimglurant modified-release (MR) vs placebo as adjunctive therapy to ongoing antidepressant medication therapy in patients with MDD who had inadequate response within the current episode. In this phase 2b, double blind, randomized clinical trial of 333 adult patients with a DSM-IV-TR diagnosis of MDD across 59 research clinics globally, patients were assigned to 1 of 2 doses of basimglurant MR (0.5 or 1.5 mg) or placebo once daily, adjunctive to ongoing antidepressant medication therapy (selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor). Patients were enrolled from October 5, 2011, through July 26, 2013. Six-week treatment with 0.5 mg of basimglurant MR, 1.5-mg basimglurant MR, or placebo once daily, adjunctive to ongoing antidepressant medication therapy. The primary end point was the mean change from baseline score on the Montgomery-Åsberg Depression Rating Scale (MADRS), as rated by the clinician at week 6. Other measures included patient-rated MADRS, Quick Inventory of Depressive Symptomatology-Self-Report, Clinical Global Impression-Improvement, Patient Global Impression-Improvement, and Clinical Global Impression-Severity Scales and adverse events. A total of 596 patients were screened, and 333 were randomized into the study (mean [SD] age, 47 [11.2] years; 216 female [65.1%]). The primary end point (mean change in clinician-rated MADRS score from baseline to end of treatment) was not met (effect size [ES] = 0.16, P = .42; intent-to-treat [ITT] mixed-effects model for repeated measures [MMRM] analysis for comparing 1.5-mg basimglurant MR and placebo). Across secondary and exploratory end points, 1.5-mg basimglurant MR revealed larger improvements vs placebo on

  18. Safety and function of a new clinical intracerebral microinjection instrument for stem cells and therapeutics examined in the Göttingen minipig

    DEFF Research Database (Denmark)

    Bjarkam, Carsten R; GLUD, AN; Margolin, Lee

    2010-01-01

    Safety and function of a new clinical intracerebral microinjection instrument for stem cells and therapeutics examined in the Göttingen minipig......Safety and function of a new clinical intracerebral microinjection instrument for stem cells and therapeutics examined in the Göttingen minipig...

  19. Patient safety during anaesthesia: incorporation of the WHO safe surgery guidelines into clinical practice

    NARCIS (Netherlands)

    Schlack, Wolfgang S.; Boermeester, Marja A.

    2010-01-01

    Purpose of review WHO makes clear recommendations on how to improve patient safety during surgical procedures by using the WHO Surgical Safety Checklist. We will review the scientific basis of these recommendations and the practical problems encountered during introduction. Recent findings

  20. Cardiovascular Safety of One-Year Escitalopram Therapy in Clinically Nondepressed Patients With Acute Coronary Syndrome

    DEFF Research Database (Denmark)

    Hanash, Jamal A; Hansen, Baiba H; Hansen, Jørgen F

    2012-01-01

    : Selective serotonin reuptake inhibitors are commonly used for treatment of depression in patients with cardiac diseases. However, evidence of cardiovascular (CV) safety from randomized trials is based on studies of no longer than 6-month duration. We examined the CV safety of 1-year treatment w...... with Selective serotonin reuptake inhibitor escitalopram compared with placebo in patients with recent acute coronary syndrome (ACS)....

  1. Impact of safety-related regulatory action on clinical practice : a systematic review

    NARCIS (Netherlands)

    Piening, S.; Haaijer-Ruskamp, F.M.; de Vries, J.T.; van der Elst, M.E.; de Graeff, P.A.; Straus, S.M.; Mol, P.G.

    2012-01-01

    Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of

  2. Impact of Safety-Related Regulatory Action on Clinical Practice A Systematic Review

    NARCIS (Netherlands)

    Piening, Sigrid; Haaijer-Ruskamp, Flora M.; de Vries, Jonie T. N.; van der Elst, Menno E.; de Graeff, Pieter A.; Straus, Sabine M. J. M.; Mol, Peter G. M.

    2012-01-01

    Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of

  3. Promoting HPV Vaccination in Safety-Net Clinics: A Randomized Trial.

    Science.gov (United States)

    Tiro, Jasmin A; Sanders, Joanne M; Pruitt, Sandi L; Stevens, Clare Frey; Skinner, Celette Sugg; Bishop, Wendy P; Fuller, Sobha; Persaud, Donna

    2015-11-01

    Evaluate effects of a multicomponent intervention (human papillomavirus [HPV] vaccine-specific brochure and recalls) on HPV vaccination and secondarily examine if race/ethnicity moderates effects. Unvaccinated girls aged 11 to 18 years attending 4 safety-net pediatric clinics and their parent/guardian (n = 814 dyads) were randomized to (1) active comparison (general adolescent vaccine brochure), or (2) intervention consisting of a HPV vaccine-specific brochure, telephone recalls to parents who declined, and recalls to patients overdue for doses 2 and 3. HPV 1-dose and 3-dose coverages were assessed via electronic health records 12 months after randomization. Multivariate logistic regressions estimated adjusted odds and marginal predicted vaccine coverage by study arm and race/ethnicity. Intent-to-treat analyses found no main effect of the HPV vaccine-specific brochure on 1-dose coverage (42.0% vs 40.6%); however, secondary analyses found race/ethnicity was a significant moderator such that the intervention was effective only for Hispanic individuals (adjusted odds ratio [AOR] 1.43; 95% confidence interval [CI] 1.02-2.02), and not effective for black individuals (AOR 0.64; 95% CI 0.41-1.13). Recalls to parents who declined the vaccine during the index visit were not effective, but recalls to patients overdue for doses 2 and 3 were effective at increasing 3-dose coverage regardless of race/ethnicity (AOR 1.99; 95% CI 1.16-3.45). Educational materials describing only the HPV vaccine were effective for Hispanic but not black individuals. Future research should test mechanisms that may mediate intervention effects for different racial/ethnic groups, such as different informational needs or vaccine schemas (experiences, beliefs, norms). Copyright © 2015 by the American Academy of Pediatrics.

  4. A phase II clinical trial to assess the safety of clonidine in acute organophosphorus pesticide poisoning

    Directory of Open Access Journals (Sweden)

    Karunatilake Harindra

    2009-08-01

    Full Text Available Abstract Background An estimated 2–3 million people are acutely poisoned by organophosphorus pesticides each year, mostly in the developing world. There is a pressing need for new affordable antidotes and clonidine has been shown to be effective in animal studies. Our aim was to determine the safety of clonidine given as an antidote in adult patients presenting with signs or symptoms of acute organophosphate ingestion. Methods This study was a dose finding, open-label, multicentre, phase II trial. Forty eight patients with acute organophosphate poisoning were randomized to receive either clonidine or placebo: Four to receive placebo and twelve to receive clonidine at each dose level. The first dose level was an initial loading dose of 0.15 mg followed by an infusion of 0.5 mg of clonidine over 24 hours. The initial loading dose was increased to 0.3 mg, 0.45 and 0.6 mg. at all dosing levels however the subsequent infusion remained at 0.5 mg of clonidine over 24 hours. Results The baseline characteristics of both groups were similar. The trial was stopped after completion of the 3rd dosing level. At the 1st and 2nd dosing level there were no reported adverse drug reactions. At the 3rd dosing level 5 patients (42% developed significant hypotension during clonidine treatment that responded to intravenous fluids. There were no statistical differences in ventilation rate, pre and post GCS, and mortality rates over all levels. Conclusion Our findings suggest use of moderate doses of clonidine in acute organophosphate poisoning can be used without causing frequent clinical problems but that higher doses are associated with a high incidence of hypotension requiring intervention. Further studies are needed to study the efficacy of clonidine as an antidote in organophosphate poisoning. Trial registration Current Controlled Trial ISRCTN89917816.

  5. Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer's disease clinical trials.

    Science.gov (United States)

    Grill, Joshua D; Raman, Rema; Ernstrom, Karin; Aisen, Paul; Dowsett, Sherie A; Chen, Yun-Fei; Liu-Seifert, Hong; Hake, Ann Marie; Miller, David S; Doody, Rachelle S; Henley, David B; Cummings, Jeffrey L

    2015-01-01

    Most Alzheimer's disease (AD) clinical trials enroll participants multinationally. Yet, few data exist to guide investigators and sponsors regarding the types of patients enrolled in these studies and whether participant characteristics vary by region. We used data derived from four multinational phase III trials in mild to moderate AD to examine whether regional differences exist with regard to participant demographics, safety reporting, and baseline scores on the Mini Mental State Examination (MMSE), the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog11), the Clinical Dementia Rating scale Sum of Boxes (CDR-SB), the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), and the Neuropsychiatric Inventory (NPI). We assigned 31 participating nations to 7 geographic regions: North America, South America/Mexico, Western Europe/Israel, Eastern Europe/Russia, Australia/South Africa, Asia, and Japan. North America, Western Europe/Israel, and Australia/South Africa enrolled similar proportions of men, apolipoprotein E ε4 carriers, and participants with spouse study partners, whereas Asia, Eastern Europe/Russia, and South America/Mexico had lower proportions for these variables. North America and South America/Mexico enrolled older subjects, whereas Asia and South America/Mexico enrolled less-educated participants than the remaining regions. Approved AD therapy use differed among regions (range: 73% to 92%) and was highest in North America, Western Europe/Israel, and Japan. Dual therapy was most frequent in North America (48%). On the MMSE, North America, Western Europe/Israel, Japan, and Australia/South Africa had higher (better) scores, and Asia, South America/Mexico, and Eastern Europe/Russia had lower scores. Eastern Europe/Russia had more impaired ADAS-cog11 scores than all other regions. Eastern Europe/Russia and South America/Mexico had more impaired scores for the ADCS-ADL and the CDR-SB. Mean scores for

  6. A Clinical Audit of Escorts' Awareness And Patients' Safety Following Intravenous Sedation In Adult Oral Surgery.

    Science.gov (United States)

    Licheri, Luca; Erriu, Matteo; Bryant, Vincenzo; Piras, Vincenzo

    2016-01-01

    To evaluate current level of safety under the care of an escort following intravenous sedation, post-sedation arrangements and to identify potential risk levels. Information and post-sedation arrangements are important to patients'safety following surgery but although there is a general consensus over what is recommended for patients and their escorts, there is little, if any, literature on the escorts' awareness of sedation and accordance to post-sedation arrangement and recommendations. Escorts of 113 consecutive patients treated in oral surgery under sedation (midazolam) completed a questionnaire composed of 27 questions divided into seven sections including demographics, awareness of sedation, source of information and post-operative arrangement. From the data collected, two scores were calculated representative of the escorts' Safety and Reliability. Data were then analysed by ANOVA. Safety scores were statistically correlated with instruction source while Reliability correlated to a wider variety of parameters including gender, age as well as information source. Provision of clear written information to escorts is recommended as likely to improve patients' safety. Assessment of escorts' Safety and Reliability could provide a means for improving quality and safety of sedation service.

  7. Preclinical safety of human embryonic stem cell-derived oligodendrocyte progenitors supporting clinical trials in spinal cord injury.

    Science.gov (United States)

    Priest, Catherine A; Manley, Nathan C; Denham, Jerrod; Wirth, Edward D; Lebkowski, Jane S

    2015-11-01

    To characterize the preclinical safety profile of a human embryonic stem cell-derived oligodendrocyte progenitor cell therapy product (AST-OPC1) in support of its use as a treatment for spinal cord injury (SCI). The phenotype and functional capacity of AST-OPC1 was characterized in vitro and in vivo. Safety and toxicology of AST-OPC1 administration was assessed in rodent models of thoracic SCI. These results identify AST-OPC1 as an early-stage oligodendrocyte progenitor population capable of promoting neurite outgrowth in vitro and myelination in vivo. AST-OPC1 administration did not cause any adverse clinical observations, toxicities, allodynia or tumors. These results supported initiation of a Phase I clinical trial in patients with sensorimotor complete thoracic SCI.

  8. Clinical Utility and Safety of a Model-Based Patient-Tailored Dose of Vancomycin in Neonates.

    Science.gov (United States)

    Leroux, Stéphanie; Jacqz-Aigrain, Evelyne; Biran, Valérie; Lopez, Emmanuel; Madeleneau, Doriane; Wallon, Camille; Zana-Taïeb, Elodie; Virlouvet, Anne-Laure; Rioualen, Stéphane; Zhao, Wei

    2016-04-01

    Pharmacokinetic modeling has often been applied to evaluate vancomycin pharmacokinetics in neonates. However, clinical application of the model-based personalized vancomycin therapy is still limited. The objective of the present study was to evaluate the clinical utility and safety of a model-based patient-tailored dose of vancomycin in neonates. A model-based vancomycin dosing calculator, developed from a population pharmacokinetic study, has been integrated into the routine clinical care in 3 neonatal intensive care units (Robert Debré, Cochin Port Royal, and Clocheville hospitals) between 2012 and 2014. The target attainment rate, defined as the percentage of patients with a first therapeutic drug monitoring serum vancomycin concentration achieving the target window of 15 to 25 mg/liter, was selected as an endpoint for evaluating the clinical utility. The safety evaluation was focused on nephrotoxicity. The clinical application of the model-based patient-tailored dose of vancomycin has been demonstrated in 190 neonates. The mean (standard deviation) gestational and postnatal ages of the study population were 31.1 (4.9) weeks and 16.7 (21.7) days, respectively. The target attainment rate increased from 41% to 72% without any case of vancomycin-related nephrotoxicity. This proof-of-concept study provides evidence for integrating model-based antimicrobial therapy in neonatal routine care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  9. Undergraduate baccalaureate nursing students' self-reported confidence in learning about patient safety in the classroom and clinical settings: an annual cross-sectional study (2010-2013).

    Science.gov (United States)

    Lukewich, Julia; Edge, Dana S; Tranmer, Joan; Raymond, June; Miron, Jennifer; Ginsburg, Liane; VanDenKerkhof, Elizabeth

    2015-05-01

    Given the increasing incidence of adverse events and medication errors in healthcare settings, a greater emphasis is being placed on the integration of patient safety competencies into health professional education. Nurses play an important role in preventing and minimizing harm in the healthcare setting. Although patient safety concepts are generally incorporated within many undergraduate nursing programs, the level of students' confidence in learning about patient safety remains unclear. Self-reported patient safety competence has been operationalized as confidence in learning about various dimensions of patient safety. The present study explores nursing students' self-reported confidence in learning about patient safety during their undergraduate baccalaureate nursing program. Cross-sectional study with a nested cohort component conducted annually from 2010 to 2013. Participants were recruited from one Canadian university with a four-year baccalaureate of nursing science program. All students enrolled in the program were eligible to participate. The Health Professional Education in Patient Safety Survey was administered annually. The Health Professional Education in Patient Safety Survey captures how the six dimensions of the Canadian Patient Safety Institute Safety Competencies Framework and broader patient safety issues are addressed in health professional education, as well as respondents' self-reported comfort in speaking up about patient safety issues. In general, nursing students were relatively confident in what they were learning about the clinical dimensions of patient safety, but they were less confident about the sociocultural aspects of patient safety. Confidence in what they were learning in the clinical setting about working in teams, managing adverse events and responding to adverse events declined in upper years. The majority of students did not feel comfortable speaking up about patient safety issues. The nested cohort analysis confirmed these

  10. The algorithmic performance of J-Tpeak for drug safety clinical trial.

    Science.gov (United States)

    Chien, Simon C; Gregg, Richard E

    The interval from J-point to T-wave peak (JTp) in ECG is a new biomarker able to identify drugs that prolong the QT interval but have different ion channel effects. If JTp is not prolonged, the prolonged QT may be associated with multi ion channel block that may have low torsade de pointes risk. From the automatic ECG measurement perspective, accurate and repeatable measurement of JTp involves different challenges than QT. We evaluated algorithm performance and JTp challenges using the Philips DXL diagnostic 12/16/18-lead algorithm. Measurement of JTp represents a different use model. Standard use of corrected QT interval is clinical risk assessment on patients with cardiac disease or suspicion of heart disease. Drug safety trials involve a very different population - young healthy subjects - who commonly have J-waves, notches and slurs. Drug effects include difficult and unusual morphology such as flat T-waves, gentle notches, and multiple T-wave peaks. The JTp initiative study provided ECGs collected from 22 young subjects (11 males and females) in randomized testing of dofetilide, quinidine, ranolazine, verapamil and placebo. We compare the JTp intervals between DXL algorithm and the FDA published measurements. The lead wise, vector-magnitude (VM), root-mean-square (RMS) and principal-component-analysis (PCA) representative beats were used to measure JTp and QT intervals. We also implemented four different methods for T peak detection for comparison. We found that JTp measurements were closer to the reference for combined leads RMS and PCA than individual leads. Differences in J-point location led to part of the JTp measurement difference because of the high prevalence of J-waves, notches and slurs. Larger differences were noted for drug effect causing multiple distinct T-wave peaks (Tp). The automated algorithm chooses the later peak while the reference was the earlier peak. Choosing among different algorithmic strategies in T peak measurement results in the

  11. [Clinical efficacy and safety of uterine artery chemoembolization in abnormal placental implantation complicated with postpartum hemorrhage].

    Science.gov (United States)

    Chen, Yao-ting; Xu, Lin-feng; Sun, Hong-liang; Li, Hui-qing; Hu, Ren-mei; Tan, Qi-yin

    2010-04-01

    To investigate the safety and clinical efficacy of uterime artery chemoembolization in postpartum hemorrhage (PPH) caused by abnormal placental implantation. Between December 2006 and September 2009, there were 23 cases of abnormal placental implantation with PPH in our hospital, among which 9 presented with continuous small amount of vaginal bleeding and 14 with acute excessive bleeding. The average bleeding time was (8+/-6) d and the mean blood loss was (980+/-660) ml. Abnormal placental implantation was confirmed by color Doppler ultrasound (CD-US) in all cases, the internal iliac artery angiography was performed to identify the uterine artery and bilateral uterine artery chemoembolization (UACE) with methotrexate (MTX) and gelfoam particles to the distal end of uterine artery was conducted after. CD-US rechecked all patients within 48 h after UACE and those patients with blurred margins between placenta and uterus and abnormal blood flow (>1 cmx1 cm) received ultrasonic-guided per vagina MTX multipoint injections. All cases were followed up for 3-26 months (average 12 months) to observe vaginal bleeding, placenta tissue discharge, serum human chorionic gonadotropin (hCG), uterine involution, menses, and side-effects or complications. (1) Curative effect: These 23 cases underwent 24 procedures of UACE successfully and vaginal bleeding ceased at an average of (3.5+/-1.3) min after UACE. Reduced blood flow in the placental implantation area was detected under CD-US after UACE. Among the 23 patients, wterine curettage was required in 16 cases due to retained placenta tissues with the mean blood loss of (40+/-28) ml during the operation, 2 underwent subtotal hysterectomy and confirmed to be placenta percreta by pathology examination, and placenta tissues were spontaneously discharged completely in 5 cases. Totally, 91% of the patients (21/23) reserved their uterus. (2) FOLLOW-UP: the serum hCG reduced to normal within 1-13 d after the placenta tissue were evacuated

  12. Effectiveness and Safety of Dementia Care Management in Primary Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Thyrian, Jochen René; Hertel, Johannes; Wucherer, Diana; Eichler, Tilly; Michalowsky, Bernhard; Dreier-Wolfgramm, Adina; Zwingmann, Ina; Kilimann, Ingo; Teipel, Stefan; Hoffmann, Wolfgang

    2017-10-01

    Dementia care management (DCM) can increase the quality of care for people with dementia. Methodologically rigorous clinical trials on DCM are lacking. To test the effectiveness and safety of DCM in the treatment and care of people with dementia living at home and caregiver burden (when available). This pragmatic, general practitioner-based, cluster-randomized intervention trial compared the intervention with care as usual at baseline and at 12-month follow-up. Simple 1:1 randomization of general practices in Germany was used. Analyses were intent to treat and per protocol. In total, 6838 patients were screened for dementia (eligibility: 70 years and older and living at home) from January 1, 2012, to March 31, 2016. Overall, 1167 (17.1%) were diagnosed as having dementia, and 634 (9.3%) provided written informed consent to participate. Dementia care management was provided for 6 months at the homes of patients with dementia. Dementia care management is a model of collaborative care, defined as a complex intervention aiming to provide optimal treatment and care for patients with dementia and support caregivers using a computer-assisted assessment determining a personalized array of intervention modules and subsequent success monitoring. Dementia care management was targeted at the individual patient level and was conducted by 6 study nurses with dementia care-specific qualifications. Quality of life, caregiver burden, behavioral and psychological symptoms of dementia, pharmacotherapy with antidementia drugs, and use of potentially inappropriate medication. The mean age of 634 patients was 80 years. A total of 407 patients received the intended treatment and were available for primary outcome measurement. Of these patients, 248 (60.9%) were women, and 204 (50.1%) lived alone. Dementia care management significantly decreased behavioral and psychological symptoms of dementia (b = -7.45; 95% CI, -11.08 to -3.81; P nurses is an effective collaborative care model

  13. A Department of Medicine Infrastructure for Patient Safety and Clinical Quality Improvement.

    Science.gov (United States)

    Mathews, Simon C; Pronovost, Peter J; Daugherty Biddison, E Lee; Petty, Brent G; Anderson, Mark E; Nelson, Terry S; Outten, Katie; Langlotz, Ronald; Duda, Denice; Herzke, Carrie A; Peairs, Kimberly S; Golden, Sherita H; Lautzenheiser, Matthew B; James, Hailey J; Desai, Sanjay V; Keller, Sara C; Feldman, Leonard S; Pahwa, Amit K; Berry, Stephen A

    2017-11-01

    Payers, providers, and patients increasingly recognize the importance of quality and safety in health care. Academic Departments of Medicine can advance quality and safety given the large populations they serve and the broad spectrum of diseases they treat. However, there are only few detailed examples of how quality and safety can be organized. This article describes a practical model at The Johns Hopkins Hospital Department of Medicine and details its structure and operation within a large academic health system. It is based on a fractal model that integrates multiple smaller units similar in structure (composition of faculty/staff), process (use of similar tools), and approach (using a common framework to address issues). This organization stresses local, multidisciplinary leadership, facilitates horizontal connections for peer learning, and maintains vertical connections for broader accountability.

  14. Clinical safety and tolerability of tedizolid phosphate in the treatment of acute bacterial skin and skin structure infections.

    Science.gov (United States)

    Hardalo, Cathy; Lodise, Thomas P; Bidell, Monique; Flanagan, Shawn; De Anda, Carisa; Anuskiewicz, Steven; Prokocimer, Philippe

    2018-03-12

    We evaluated safety and tolerability of tedizolid phosphate at the 200-mg once-daily dose approved for 6-day treatment of skin and skin-structure infections. Clinical adverse event (AE) and laboratory data were pooled across completed clinical studies (13 phase 1, two phase 2, and two phase 3), for all participants who received ≥1 dose of tedizolid 200 mg, linezolid 600 mg (phase 3 only), or placebo (phase 1 only). 1280 participants received tedizolid (phase 1: n = 355; phase 2/3: n = 925). In total, 13% received >6 doses of tedizolid (range: 7-21); in phase 2/3, 94% of participants received ≥5 doses (range: 5-10). Drug-related AEs occurred in 27% of participants (most commonly gastrointestinal reactions in 13% of participants and headache in 4%). Most AEs were mild-moderate in severity; Tedizolid and linezolid had similar frequency, severity, and types of drug-related AEs. Tolerability in clinically important subpopulations (obese, n = 346; elderly, n = 99; renal impairment, n = 40; hepatic disease/impairment, n = 294) appeared comparable to the overall population. Tedizolid, given orally or intravenously at 200 mg, has a favorable safety profile. Clinical trial and postmarketing experience with treatment ≥7 days is limited.

  15. [Post-marketing study on clinical safety of ginkgo diterpene lactone meglumine injection in 6 300 patients with ischemic stroke].

    Science.gov (United States)

    Zhou, Li; Gao, Ying; Lai, Xin-Xing; Xu, Tian-Shu; Yu, Ming; Wang, Yan; Zhao, Jian-Jun; Tan, Zi-Hu

    2017-12-01

    To further evaluate the safety of ginkgo diterpene lactone meglumine injection in the clinical use in ischemic stroke patients. Clinical safety study was conducted in 82 clinical units and 6 300 cases were completed and included from June 2013 to December 2014 by using multicenter, prospective, open and uncontrolled design methods for clinical research. A total of 29 cases of adverse reactions were observed in the experiment. Adverse reaction ratio (ADR) was 0.46%, and about 86.21% (25 cases) of them was mild with transient response which could be alleviated or disappeared without intervention; about 13.79% (4 cases) was moderate, including 2 cases of headache, 1 case of dizziness and 1 case of rash; no serious adverse reactions were found. The adverse reactions occurred in this study were pre-known adverse reactions or common adverse reactions of Chinese medicine injection. The overall incidence of adverse reactions was low, and the risk was controllable. Copyright© by the Chinese Pharmaceutical Association.

  16. Urban and rural safety net health care system clinics: no disparity in HPV4 vaccine completion rates.

    Directory of Open Access Journals (Sweden)

    Kelly Jo Sandri

    Full Text Available OBJECTIVE: Safety net health care centers in the US serve vulnerable and underinsured females. The primary aim of this work was to determine if HPV4 dosing compliance differs between females who receive doses at rural vs. urban core safety net health care locations. METHODS: Females exclusively receiving health care in the Truman Medical Center (TMC safety net system at the urban core and rural locations were identified by their HPV4 vaccine records. Dates and number of HPV4 doses as well as age, gravidity, parity and race/ethnicity were recorded from the electronic medical record (EMR. Appropriate HPV4 dosing intervals were referenced from the literature. RESULTS: 1259 females, 10-26 years of age, received HPV4 vaccination at either the rural (23% or urban core location (77%. At the rural location, 23% received three doses on time, equal to the 24% at the urban core. Females seen in the urban core were more likely to receive on-time doublet dosing than on-time triplet dosing (82% vs. 67%, p<0.001. Mistimed doses occurred equally often among females receiving only two doses, as well as those receiving three doses. CONCLUSIONS: Compliance with on-time HPV4 triplet dose completion was low at rural and urban core safety net health clinics, but did not differ by location.

  17. Urban and rural safety net health care system clinics: no disparity in HPV4 vaccine completion rates.

    Science.gov (United States)

    Sandri, Kelly Jo; Verdenius, Inge; Bartley, Mitchell J; Else, Britney M; Paynter, Christopher A; Rosemergey, Beth E; Harris, George D; Malnar, Gerard J; Harper, Sean M; Griffith, R Stephen; Bonham, Aaron J; Harper, Diane M

    2014-01-01

    Safety net health care centers in the US serve vulnerable and underinsured females. The primary aim of this work was to determine if HPV4 dosing compliance differs between females who receive doses at rural vs. urban core safety net health care locations. Females exclusively receiving health care in the Truman Medical Center (TMC) safety net system at the urban core and rural locations were identified by their HPV4 vaccine records. Dates and number of HPV4 doses as well as age, gravidity, parity and race/ethnicity were recorded from the electronic medical record (EMR). Appropriate HPV4 dosing intervals were referenced from the literature. 1259 females, 10-26 years of age, received HPV4 vaccination at either the rural (23%) or urban core location (77%). At the rural location, 23% received three doses on time, equal to the 24% at the urban core. Females seen in the urban core were more likely to receive on-time doublet dosing than on-time triplet dosing (82% vs. 67%, prural and urban core safety net health clinics, but did not differ by location.

  18. Translating self-persuasion into an adolescent HPV vaccine promotion intervention for parents attending safety-net clinics.

    Science.gov (United States)

    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.

  19. Catalyzing Implementation of Evidence-Based Interventions in Safety Net Settings: A Clinical-Community Partnership in South Los Angeles.

    Science.gov (United States)

    Payán, Denise D; Sloane, David C; Illum, Jacqueline; Vargas, Roberto B; Lee, Donzella; Galloway-Gilliam, Lark; Lewis, LaVonna B

    2017-07-01

    This study is a process evaluation of a clinical-community partnership that implemented evidence-based interventions in clinical safety net settings. Adoption and implementation of evidence-based interventions in these settings can help reduce health disparities by improving the quality of clinical preventive services in health care settings with underserved populations. A clinical-community partnership model is a possible avenue to catalyze adoption and implementation of interventions amid organizational barriers to change. Three Federally Qualified Health Centers in South Los Angeles participated in a partnership led by a local community-based organization (CBO) to implement hypertension interventions. Qualitative research methods were used to evaluate intervention selection and implementation processes between January 2014 and June 2015. Data collection tools included a key participant interview guide, health care provider interview guide, and protocol for taking meeting minutes. This case study demonstrates how a CBO acted as an external facilitator and employed a collaborative partnership model to catalyze implementation of evidence-based interventions in safety net settings. The study phases observed included initiation, planning, and implementation. Three emergent categories of organizational facilitators and barriers were identified (personnel capacity, professional development capacity, and technological capacity). Key participants and health care providers expressed a high level of satisfaction with the collaborative and the interventions, respectively. The CBO's role as a facilitator and catalyst is a replicable model to promote intervention adoption and implementation in safety net settings. Key lessons learned are provided for researchers and practitioners interested in partnering with Federally Qualified Health Centers to implement health promotion interventions.

  20. Non-clinical and Pre-clinical Testing to Demonstrate Safety of the Barostim Neo Electrode for Activation of Carotid Baroreceptors in Chronic Human Implants.

    Science.gov (United States)

    Wilks, Seth J; Hara, Seth A; Ross, Erika K; Nicolai, Evan N; Pignato, Paul A; Cates, Adam W; Ludwig, Kip A

    2017-01-01

    The Barostim neo™ electrode was developed by CVRx, Inc.to deliver baroreflex activation therapy (BAT)™ to treat hypertension and heart failure. The neo electrode concept was designed to deliver electrical stimulation to the baroreceptors within the carotid sinus bulb, while minimizing invasiveness of the implant procedure. This device is currently CE marked in Europe, and in a Pivotal (akin to Phase III) Trial in the United States. Here we present the in vitro and in vivo safety testing that was completed in order to obtain necessary regulatory approval prior to conducting human studies in Europe, as well as an FDA Investigational Device Exemption (IDE) to conduct a Pivotal Trial in the United States. Stimulated electrodes (10 mA, 500 μs, 100 Hz) were compared to unstimulated electrodes using optical microscopy and several electrochemical techniques over the course of 27 weeks. Electrode dissolution was evaluated by analyzing trace metal content of solutions in which electrodes were stimulated. Lastly, safety testing under Good Laboratory Practice guidelines was conducted in an ovine animal model over a 12 and 24 week time period, with results processed and evaluated by an independent histopathologist. Long-term stimulation testing indicated that the neo electrode with a sputtered iridium oxide coating can be stimulated at maximal levels for the lifetime of the implant without clinically significant dissolution of platinum or iridium, and without increasing the potential at the electrode interface to cause hydrolysis or significant tissue damage. Histological examination of tissue that was adjacent to the neo electrodes indicated no clinically significant signs of increased inflammation and no arterial stenosis as a result of 6 months of continuous stimulation. The work presented here involved rigorous characterization and evaluation testing of the neo electrode, which was used to support its safety for chronic implantation. The testing strategies discussed

  1. Clinical Pharmacist Team-Based Care in a Safety Net Medical Home: Facilitators and Barriers to Chronic Care Management.

    Science.gov (United States)

    Price-Haywood, Eboni G; Amering, Sarah; Luo, Qingyang; Lefante, John J

    2017-04-01

    Collaborative care models incorporating pharmacists have been shown to improve quality of care for patients with hypertension and/or diabetes. Little is known about how to integrate such services outside of clinical trials. The authors implemented a 22-month observational study to evaluate pharmacy collaborative care for hypertension and diabetes in a safety net medical home that incorporated population risk stratification, clinical decision support, and medication dose adjustment protocols. Patients in the pharmacy group saw their primary care provider (PCP) more often and had higher baseline systolic blood pressure (SBP) and diastolic blood pressure (DBP) and A1c levels compared to patients who only received care from their PCPs. There were no significant differences in the proportion of patients achieving treatment goals (SBP work best in specific settings to optimize the benefits of team-based care with clinical pharmacists.

  2. Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

    Science.gov (United States)

    Jones, Christine E.; Munoz, Flor M.; Spiegel, Hans M.L.; Heininger, Ulrich; Zuber, Patrick L.F.; Edwards, Kathryn M.; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S.; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M.; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O.; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T.

    2017-01-01

    Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. PMID:27481360

  3. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  4. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  5. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  6. A web-based medical safety reporting system for a large multicenter clinical trial: the ALIAS experience.

    Science.gov (United States)

    Zhao, Wenle; Waldman, Bonnie D; Dillon, Catherine; Pauls, Keith; Kim, Jaemyung; Patterson, Lynn; Ginsberg, Myron D; Hill, Michael D; Palesch, Yuko

    2010-11-01

    An electronic safety reporting (ESR) module was developed and integrated into a home-grown web-based clinical trial management system (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Second, safety and efficacy data were managed within the same relational database. Relevant data captured on efficacy case report forms, such as demographics, medical history, lab data and concomitant medications, were directly retrievable for MedWatch report composition without requiring redundant data entry. Finally, the ESR module shared the same generic user interfaces and data processing functions with other modules in the CTMS. These generic components include data editing, data retrieving, data reporting, dictionary-based automatic and interactive coding, event-driven and calendar-driven automatic email notifications, and user privilege management. This integrated ESR module was implemented in the Albumin in Acute Stroke (ALIAS) Trial-Part 1. A total of 397 serious adverse event reports were processed and 33 FDA MedWatch reports, 28 initial reports, and 5 follow-up reports were submitted to FDA and Health Canada using this system. Experiences and lessons learned from the development and implementation of this system are presented in this paper. Copyright © 2010 Elsevier Inc. All rights reserved.

  7. Curbing the urge to care : A Bourdieusian analysis of the effect of the caring disposition on nurse middle managers’ clinical leadership in patient safety practices

    NARCIS (Netherlands)

    Lalleman, P. C B; Smid, G. A C; Lagerwey, M. D.; Shortridge-Baggett, L. M.; Schuurmans, M. J.

    2016-01-01

    Background Nurse managers play an important role in implementing patient safety practices in hospitals. However, the influence of their professional background on their clinical leadership behaviour remains unclear. Research has demonstrated that concepts of Bourdieu (dispositions of habitus,

  8. Curbing the urge to care : a Bourdieusian analysis of the effect of the caring disposition on nurse middle managers’ clinical leadership in patient safety practices

    NARCIS (Netherlands)

    Pieterbas Lalleman; Mary Lagerwey; L.M. Shortridge-Baggett; Prof. Dr. M.J. Schuurmans; Gerhard Smid

    2016-01-01

    Nurse managers play an important role in implementing patient safety practices in hospitals. However, the influence of their professional background on their clinical leadership behaviour remains unclear. Research has demonstrated that concepts of Bourdieu (dispositions of habitus, capital and

  9. Development of the SaFETy Score: A Clinical Screening Tool for Predicting Future Firearm Violence Risk.

    Science.gov (United States)

    Goldstick, Jason E; Carter, Patrick M; Walton, Maureen A; Dahlberg, Linda L; Sumner, Steven A; Zimmerman, Marc A; Cunningham, Rebecca M

    2017-05-16

    Interpersonal firearm violence among youth is a substantial public health problem, and emergency department (ED) physicians require a clinical screening tool to identify high-risk youth. To derive a clinically feasible risk index for firearm violence. 24-month prospective cohort study. Urban, level 1 ED. Substance-using youths, aged 14 to 24 years, seeking ED care for an assault-related injury and a proportionately sampled group of non-assault-injured youth enrolled from September 2009 through December 2011. Firearm violence (victimization/perpetration) and validated questionnaire items. A total of 599 youths were enrolled, and presence/absence of future firearm violence during follow-up could be ascertained in 483 (52.2% were positive). The sample was randomly split into training (75%) and post-score-construction validation (25%) sets. Using elastic-net penalized logistic regression, 118 baseline predictors were jointly analyzed; the most predictive variables fell predominantly into 4 domains: violence victimization, community exposure, peer influences, and fighting. By selection of 1 item from each domain, the 10-point SaFETy (Serious fighting, Friend weapon carrying, community Environment, and firearm Threats) score was derived. SaFETy was associated with firearm violence in the validation set (odds ratio [OR], 1.47 [95% CI, 1.23 to 1.79]); this association remained (OR, 1.44 [CI, 1.20 to 1.76]) after adjustment for reason for ED visit. In 5 risk strata observed in the training data, firearm violence rates in the validation set were 18.2% (2 of 11), 40.0% (18 of 45), 55.8% (24 of 43), 81.3% (13 of 16), and 100.0% (6 of 6), respectively. The study was conducted in a single ED and involved substance-using youths. SaFETy was not externally validated. The SaFETy score is a 4-item score based on clinically feasible questionnaire items and is associated with firearm violence. Although broader validation is required, SaFETy shows potential to guide resource allocation

  10. An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies.

    Science.gov (United States)

    Iffland, Kerstin; Grotenhermen, Franjo

    2017-01-01

    Introduction: This literature survey aims to extend the comprehensive survey performed by Bergamaschi et al. in 2011 on cannabidiol (CBD) safety and side effects. Apart from updating the literature, this article focuses on clinical studies and CBD potential interactions with other drugs. Results: In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epilepsy and psychotic disorders. Here, the most commonly reported side effects were tiredness, diarrhea, and changes of appetite/weight. In comparison with other drugs, used for the treatment of these medical conditions, CBD has a better side effect profile. This could improve patients' compliance and adherence to treatment. CBD is often used as adjunct therapy. Therefore, more clinical research is warranted on CBD action on hepatic enzymes, drug transporters, and interactions with other drugs and to see if this mainly leads to positive or negative effects, for example, reducing the needed clobazam doses in epilepsy and therefore clobazam's side effects. Conclusion: This review also illustrates that some important toxicological parameters are yet to be studied, for example, if CBD has an effect on hormones. Additionally, more clinical trials with a greater number of participants and longer chronic CBD administration are still lacking.

  11. A novel peptide-based pan-influenza A vaccine: a double blind, randomised clinical trial of immunogenicity and safety.

    Science.gov (United States)

    Francis, James N; Bunce, Campbell J; Horlock, Claire; Watson, Jeannette M; Warrington, Steven J; Georges, Bertrand; Brown, Carlton B

    2015-01-03

    FP-01.1 is a novel synthetic influenza A vaccine consisting of six fluorocarbon-modified 35-mer peptides that encapsulate multiple CD4+ and CD8+ T-cell epitopes and is designed to induce an immune response across a broad population. FP-01.1 was evaluated for safety and immunogenicity in a randomised, double-blind, placebo-controlled, dose-escalation, phase I clinical study in healthy adult volunteers (n=49). IFNγ ELISpot assays and multicolour flow cytometry were used to characterise the immune response. FP-01.1 was safe and well tolerated at all doses tested with a similar adverse event profile in actively vaccinated subjects compared with controls. Maximum immunogenicity was in the 150 μg/peptide dose group where a robust response (243 spots/million PBMC) was demonstrated in 75% subjects compared with 0% in placebo controls. All six peptides were immunogenic. FP-01.1 induced dual CD4+ and CD8+ T cell responses and vaccine-specific T cells cross-recognise divergent influenza strains. This first-in-human study showed that FP-01.1 has an acceptable safety and tolerability profile and generated robust anti-viral T cell responses in a high proportion of subjects tested. The results support the further clinical testing of FP-01.1 prior to clinical, proof-of-concept, live viral challenge studies. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Simulated settings; powerful arenas for learning patient safety practices and facilitating transference to clinical practice. A mixed method study.

    Science.gov (United States)

    Reime, Marit Hegg; Johnsgaard, Tone; Kvam, Fred Ivan; Aarflot, Morten; Breivik, Marit; Engeberg, Janecke Merethe; Brattebø, Guttorm

    2016-11-01

    Poor teamwork is an important factor in the occurrence of critical incidents because of a lack of non-technical skills. Team training can be a key to prevent these incidents. The purpose of this study was to explore the experience of nursing and medical students after a simulation-based interprofessional team training (SBITT) course and its impact on professional and patient safety practices, using a concurrent mixed-method design. The participants (n = 262) were organized into 44 interprofessional teams. The results showed that two training sequences the same day improved overall team performance. Making mistakes during SBITT appeared to improve the quality of patient care once the students returned to clinical practice as it made the students more vigilant. Furthermore, the video-assisted oral debriefing provided an opportunity to strengthen interprofessional teamwork and share situational awareness. SBITT gave the students an opportunity to practice clinical reasoning skills and to share professional knowledge. The students conveyed the importance of learning to speak up to ensure safe patient practices. Simulated settings seem to be powerful arenas for learning patient safety practices and facilitating transference of this awareness to clinical practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials.

    Science.gov (United States)

    Darney, Philip; Patel, Ashlesha; Rosen, Kimberly; Shapiro, Lena S; Kaunitz, Andrew M

    2009-05-01

    To present efficacy, safety, and bleeding profile results from the clinical trials that supported the U.S. Food and Drug Administration filing for the approval of a single-rod etonogestrel (ENG) contraceptive implant (Implanon). Integrated analysis of 11 international clinical trials. Contraceptive clinics in U.S., Chile, Asia, and Europe. A total of 942 healthy women, aged 18 to 40 years. Insertion of an ENG implant. Most women were enrolled in studies lasting either 2 or 3 years. Efficacy was measured by the cumulative Pearl Index in women Safety was primarily assessed by incidence of adverse events. Bleeding profiles were analyzed via reference period analyses. No pregnancies were reported while the ENG implants were in place. Six pregnancies occurred during the first 14 days after ENG implant removal. Including these six pregnancies, the cumulative Pearl Index was 0.38 (year 1 and 2 Pearl Indexes were 0.27 and 0.30, respectively). Common drug-related adverse events were headache, weight gain, acne, breast tenderness, emotional lability, and abdominal pain. Bleeding pattern changes were observed, but no one pattern predominated. The ENG implant is an efficacious and safe method of contraception which does not require patients' consistent action.

  14. Prevalence of Substance Use in an HIV Primary Care Safety Net Clinic: A Call for Screening

    Science.gov (United States)

    Dawson-Rose, Carol; Draughon, Jessica E.; Zepf, Roland; Cuca, Yvette P.; Huang, Emily; Freeborn, Kellie; Lum, Paula J.

    2015-01-01

    Substance use complicates HIV care and prevention. Primary care clinics are an ideal setting to screen for and offer interventions for unhealthy alcohol and drug use; however, few HIV clinics routinely screen for substance use. We enrolled 208 clinic patients at an urban underserved HIV primary care clinic. We screened the patients for substance use with the Alcohol, Smoking, and Substance Involvement Score Test (ASSIST) and measured urine toxicology. Of the 168 participants who completed screening, the majority reported tobacco or non-prescribed substance use in the previous 3 months. White men reported significantly more amphetamine-type stimulant use compared to African American and Latino men (p < 0.001). Implementing standard clinic practice for screening and assessing substance use in HIV primary care clinics is needed. PMID:26763795

  15. Safety Overview of a Recombinant Live-Attenuated Tetravalent Dengue Vaccine: Pooled Analysis of Data from 18 Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Sophia Gailhardou

    2016-07-01

    Full Text Available A recombinant live attenuated tetravalent dengue vaccine (CYD-TDV has been shown to be efficacious in preventing virologically-confirmed dengue disease, severe dengue disease and dengue hospitalization in children aged 2-16 years in Asia and Latin America. We analyzed pooled safety data from 18 phase I, II and III clinical trials in which the dengue vaccine was administered to participants aged 2-60 years, including long-term safety follow-up in three efficacy trials. The participants were analyzed according to their age at enrollment. The percentage of participants aged 2-60 years reporting ≥1 solicited injection-site or systemic reactions was slightly higher in the CYD-TDV group than in the placebo group. The most common solicited injection-site reactions were pain. Headache and malaise were the most common solicited systemic reactions. In both groups 0.3% of participants discontinued for safety reasons. The most common unsolicited adverse events were injection-site reactions, gastrointestinal disorders, and infections. Reactogenicity did not increase with successive doses of CYD-TDV. The frequency and nature of SAEs occurring within 28 days of any dose were similar in the CYD-TDV and placebo groups and were common medical conditions that could be expected as a function of age. Baseline dengue virus serostatus did not appear to influence the safety profile. No vaccine-related anaphylactic reactions, neurotropic events or viscerotropic events were reported. In year 3 after dose 1, an imbalance for dengue hospitalization, including for severe dengue, observed in participants aged <9 years in the CYD-TDV group compared with the placebo group was not observed for participants aged ≥9 years. In Year 4, this imbalance in participants aged <9 years was less marked, giving an overall lower risk of dengue hospitalization or severe dengue from dose 1 to Year 4 in the CYD-TDV group. These results have contributed to the definition of the target

  16. Safety Overview of a Recombinant Live-Attenuated Tetravalent Dengue Vaccine: Pooled Analysis of Data from 18 Clinical Trials

    Science.gov (United States)

    Gailhardou, Sophia; Skipetrova, Anna; Dayan, Gustavo H.; Jezorwski, John; Saville, Melanie; Van der Vliet, Diane; Wartel, T. Anh

    2016-01-01

    A recombinant live attenuated tetravalent dengue vaccine (CYD-TDV) has been shown to be efficacious in preventing virologically-confirmed dengue disease, severe dengue disease and dengue hospitalization in children aged 2–16 years in Asia and Latin America. We analyzed pooled safety data from 18 phase I, II and III clinical trials in which the dengue vaccine was administered to participants aged 2–60 years, including long-term safety follow-up in three efficacy trials. The participants were analyzed according to their age at enrollment. The percentage of participants aged 2–60 years reporting ≥1 solicited injection-site or systemic reactions was slightly higher in the CYD-TDV group than in the placebo group. The most common solicited injection-site reactions were pain. Headache and malaise were the most common solicited systemic reactions. In both groups 0.3% of participants discontinued for safety reasons. The most common unsolicited adverse events were injection-site reactions, gastrointestinal disorders, and infections. Reactogenicity did not increase with successive doses of CYD-TDV. The frequency and nature of SAEs occurring within 28 days of any dose were similar in the CYD-TDV and placebo groups and were common medical conditions that could be expected as a function of age. Baseline dengue virus serostatus did not appear to influence the safety profile. No vaccine-related anaphylactic reactions, neurotropic events or viscerotropic events were reported. In year 3 after dose 1, an imbalance for dengue hospitalization, including for severe dengue, observed in participants aged dengue hospitalization or severe dengue from dose 1 to Year 4 in the CYD-TDV group. These results have contributed to the definition of the target population for vaccination (≥9 years old) for which CYD-TDV has a satisfactory safety profile. Long-term safety will continue to be monitored in the ongoing follow-up of efficacy trials. Safety and effectiveness in real-life settings

  17. Safety Overview of a Recombinant Live-Attenuated Tetravalent Dengue Vaccine: Pooled Analysis of Data from 18 Clinical Trials.

    Science.gov (United States)

    Gailhardou, Sophia; Skipetrova, Anna; Dayan, Gustavo H; Jezorwski, John; Saville, Melanie; Van der Vliet, Diane; Wartel, T Anh

    2016-07-01

    A recombinant live attenuated tetravalent dengue vaccine (CYD-TDV) has been shown to be efficacious in preventing virologically-confirmed dengue disease, severe dengue disease and dengue hospitalization in children aged 2-16 years in Asia and Latin America. We analyzed pooled safety data from 18 phase I, II and III clinical trials in which the dengue vaccine was administered to participants aged 2-60 years, including long-term safety follow-up in three efficacy trials. The participants were analyzed according to their age at enrollment. The percentage of participants aged 2-60 years reporting ≥1 solicited injection-site or systemic reactions was slightly higher in the CYD-TDV group than in the placebo group. The most common solicited injection-site reactions were pain. Headache and malaise were the most common solicited systemic reactions. In both groups 0.3% of participants discontinued for safety reasons. The most common unsolicited adverse events were injection-site reactions, gastrointestinal disorders, and infections. Reactogenicity did not increase with successive doses of CYD-TDV. The frequency and nature of SAEs occurring within 28 days of any dose were similar in the CYD-TDV and placebo groups and were common medical conditions that could be expected as a function of age. Baseline dengue virus serostatus did not appear to influence the safety profile. No vaccine-related anaphylactic reactions, neurotropic events or viscerotropic events were reported. In year 3 after dose 1, an imbalance for dengue hospitalization, including for severe dengue, observed in participants aged dengue hospitalization or severe dengue from dose 1 to Year 4 in the CYD-TDV group. These results have contributed to the definition of the target population for vaccination (≥9 years old) for which CYD-TDV has a satisfactory safety profile. Long-term safety will continue to be monitored in the ongoing follow-up of efficacy trials. Safety and effectiveness in real-life settings will

  18. Survey of the Patient Safety Culture in the Clinics and Hospitals of Chabahar, Iran

    Directory of Open Access Journals (Sweden)

    Fereydoon Laal

    2017-07-01

    Results:In total, 255.85 subjects were enrolled in the study and equally divided into three groups (33.3%. The minimum and maximum work experience was one and 27 years, respectively. Among the participants, 116 cases (45.49% were female, and 139 cases (54.50% were male. Mean total score of the patient safety culture was 149.87±25.20. The lowest and highest scores were observed in the dimensions of ‘non-punitive response to errors’ (3.23±9.11 and ‘teamwork within units’ (3.86±15.41, respectively. The results indicated a significant difference between the three study groups in terms of the patient safety culture (P

  19. Safety and Clinical Efficiency of Using Combined Preparation of Metformin Extended-Release and Glimepiride

    Directory of Open Access Journals (Sweden)

    V.I. Pankiv

    2013-04-01

    Conclusions. Administration of a combined anti-diabetic therapy with Duglimax for 24 weeks results in a significant reduction in HbA1c and the achievement of the targets of carbohydrate metabolism in patients with DM type 2. On the background of normalization of carbohydrate metabolism using combination therapy helps moderate decrease in body weight and WC value, to reduce serum LDL. Good tolerability and high degree of safety of Duglimax throughout the observation period were noted.

  20. The Clinical Efficacy, Safety and Functionality of Anion Textile in the Treatment of Atopic Dermatitis

    OpenAIRE

    Kim, Sang Hyun; Hwang, Sung Hwan; Hong, Soon Kwon; Seo, Jong Keun; Sung, Ho Suk; Park, Sung Wook; Shin, Jeong Hwan

    2012-01-01

    Background Several previous studies have suggested the improvement of atopic dermatitis (AD) in response to special fabrics. In particular, beneficial effects have been reported, following the use of anion textiles. Objective The purpose of this study is to evaluate the effectiveness and safety of an anion textile in patients suffering from AD. Methods We compared an anion textile with a pure cotton textile. Fifty-two atopic patients (n=52) were enrolled and divided into two groups. The patie...

  1. Safety Profile of Good Manufacturing Practice Manufactured Interferon γ-Primed Mesenchymal Stem/Stromal Cells for Clinical Trials.

    Science.gov (United States)

    Guess, Adam J; Daneault, Beth; Wang, Rongzhang; Bradbury, Hillary; La Perle, Krista M D; Fitch, James; Hedrick, Sheri L; Hamelberg, Elizabeth; Astbury, Caroline; White, Peter; Overolt, Kathleen; Rangarajan, Hemalatha; Abu-Arja, Rolla; Devine, Steven M; Otsuru, Satoru; Dominici, Massimo; O'Donnell, Lynn; Horwitz, Edwin M

    2017-10-01

    Mesenchymal stem/stromal cells (MSCs) are widely studied by both academia and industry for a broad array of clinical indications. The collective body of data provides compelling evidence of the clinical safety of MSC therapy. However, generally accepted proof of therapeutic efficacy has not yet been reported. In an effort to generate a more effective therapeutic cell product, investigators are focused on modifying MSC processing protocols to enhance the intrinsic biologic activity. Here, we report a Good Manufacturing Practice-compliant two-step MSC manufacturing protocol to generate MSCs or interferon γ (IFNγ) primed MSCs which allows freshly expanded cells to be infused in patients on a predetermined schedule. This protocol eliminates the need to infuse cryopreserved, just thawed cells which may reduce the immune modulatory activity. Moreover, using (IFNγ) as a prototypic cytokine, we demonstrate the feasibility of priming the cells with any biologic agent. We then characterized MSCs and IFNγ primed MSCs prepared with our protocol, by karyotype, in vitro potential for malignant transformation, biodistribution, effect on engraftment of transplanted hematopoietic cells, and in vivo toxicity in immune deficient mice including a complete post-mortem examination. We found no evidence of toxicity attributable to the MSC or IFNγ primed MSCs. Our data suggest that the clinical risk of infusing MSCs or IFNγ primed MSCs produced by our two-step protocol is not greater than MSCs currently in practice. While actual proof of safety requires phase I clinical trials, our data support the use of either cell product in new clinical studies. Stem Cells Translational Medicine 2017;6:1868-1879. © 2017 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  2. Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

    Directory of Open Access Journals (Sweden)

    E Salehifar

    2011-05-01

    Full Text Available "nBackground and the purpose of the study: Functional constipation is prevalent in children. Recently has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009. "nMethods: Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. "nResults and major conclusion: Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7 compared with the patients in paraffin group (mean: 87.2%±7.1 (p=0.087. Administration of PEG 3350 was associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation , regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

  3. Cross matching observations on toxicological and clinical data for the assessment of tolerability and safety of Ginkgo biloba leaf extract

    International Nuclear Information System (INIS)

    Heinonen, Tuula; Gaus, Wilhelm

    2015-01-01

    Highlights: • Cross-matching of toxicological, clinical and other data improves risk analysis. • Induction of drug metabolism is linked to increased cell proliferation. • Rodents and man have differences in metabolism of Ginkgo biloba. • Controlled clinical data did not reveal any serious or specific adverse drug reaction. • Cross-matching of various sources gives strong evidence that G. biloba is safe. - Abstract: Ginkgo biloba is one of the most widely used herbal remedies in Europe and the US. It may be purchased in different types of formulations, but most of the clinical studies have been performed with the controlled G. biloba extract EGb761 ® . Indications include Alzheimers disease, cardiovascular disease, dementia, memory loss, and cerebral ischemia. The pharmacological modes of action cover antioxidant effects, radical scavenging, inhibition of platelet activating factor, alterations in membrane fluidity (signal transduction), and inhibition of glucocorticoid synthesis. Due to the widespread and long-term use of G. biloba – about a million doses of EGb761 ® are sold per day – tolerability and safety are a crucial issue. Based on broad and long-term clinical use of G. biloba extracts, it is regarded as well tolerated in man. Cross matching, a tool we introduced, combines different fields of knowledge and types of data to a consolidated result. In this article, we combine toxicological and clinical data and utilize other sources of information to assess tolerability and safety of G. biloba. It is well known that because of biological differences between animals and man or even between animal species, animal experiments do not necessarily mimic the effects in humans. Therefore, for adequate risk assessment, the relevance of non-clinical toxicological findings should be correlated with human data. The cross matching of toxicological data and results from clinical studies is possible because many toxicological and clinical studies are available

  4. The experience of primary care providers with an integrated mental health care program in safety-net clinics.

    Science.gov (United States)

    Bentham, Wayne D; Ratzliff, Anna; Harrison, David; Chan, Ya-Fen; Vannoy, Steven; Unützer, Jürgen

    2015-01-01

    Primary care providers participating in a statewide implementation of an integrated mental health care program for "safety-net" patients in primary care clinics were surveyed to elicit their experiences and level of satisfaction. Quantitative analyses were performed to identify respondent characteristics and satisfaction with the program. Qualitative analyses were done to identify common themes in response to the question "How could psychiatric consultation [in the program] be improved?" Primary care providers were generally satisfied with the integrated mental health care program and raised several concerns that suggest important principles for successful future implementations of these types of programs.

  5. Clinical efficacy and safety of imatinib in the management of Ph+ chronic myeloid or acute lymphoblastic leukemia in Chinese patients

    Science.gov (United States)

    Zhu, Yu; Qian, Si-Xuan

    2014-01-01

    Imatinib mesylate is considered the standard first-line systemic treatment for patients with chronic myeloid leukemia (CML) and functions by targeting BCR-ABL tyrosine kinases. Imatinib has substantially changed the clinical management and improved the prognosis of CML and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL). Here, we review the pharmacology, mode of action, and pharmacokinetics of imatinib; Chinese efficacy studies in CML and Ph+ ALL; safety and tolerability; patient-focused perspectives, such as quality of life, patient satisfaction, acceptability, and adherence; and uptake of imatinib. PMID:24623982

  6. Nutritional Content and a Phase - I Safety Clinical Trial of a Herbal ...

    African Journals Online (AJOL)

    The phase I study was conducted at the MRC clinic in Botha's hill and the study lasted 5 weeks from date of participant dosing. The study was a randomised blinded placebocontrolled phase I clinical trial conducted on 48 healthy males. The participants were randomly divided into 4 groups of 12. The 3 groups received ...

  7. Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

    Science.gov (United States)

    Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

    2018-02-02

    We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  8. Clinical safety of a polyvalent F(ab')2 equine antivenom in 223 African snake envenomations : a field trial in Cameroon

    OpenAIRE

    Chippaux, Jean-Philippe; Lang, J.; Amadi Eddine, S; Fagot, P.; Rage, V.; Peyrieux, J.C.; Le Mener, V.

    1998-01-01

    A large-scale clinical trial was conducted, according to World Health Organization Good Clinical Practice guidelines, in 7 centres in North Cameroon to determine the safety and efficacy of a polyvalent antivenom composed of purified F(ab')2. This study included 223 patients presenting clinically with an obvious snake bite, predominantly due to #Echis ocellatus$ (viper), the most abundant species in this savannah region. Clinical surveillance was maintained for 5 d in all patients and until th...

  9. Many-to-one comparisons after safety selection in multi-arm clinical trials

    OpenAIRE

    Hlavin, Gerald; Hampson, Lisa V.; Koenig, Franz

    2017-01-01

    In phase II platform trials, 'many-to-one' comparisons are performed when K experimental treatments are compared with a common control to identify the most promising treatment(s) to be selected for Phase III trials. However, when sample sizes are limited, such as when the disease of interest is rare, only a single Phase II/III trial addressing both treatment selection and confirmatory efficacy testing may be feasible. In this paper, we suggest a two-step safety selection and testing procedure...

  10. Clinical value, cost-effectiveness, and safety of myocardial perfusion scintigraphy: a position statement

    DEFF Research Database (Denmark)

    Marcassa, C.; Bax, J.J.; Bengel, F.

    2008-01-01

    scintigraphy (MPS) provides a highly cost-effective tool for the early detection of obstructive CAD in symptomatic individuals and contributes substantially to stratification of patients according to their risk of cardiac death or nonfatal myocardial infarction. MPS also provides valuable information...... that assists clinical decision-making with regard to medical treatment and intervention. A large body of evidence supports the current applications of MPS, which has become integral to several guidelines for clinical practice Udgivelsesdato: 2008/2...

  11. Clinical value, cost-effectiveness, and safety of myocardial perfusion scintigraphy: a position statement

    DEFF Research Database (Denmark)

    Marcassa, C.; Bax, J.J.; Bengel, F.

    2008-01-01

    Mortality rates due to coronary artery disease (CAD) have declined in recent years as result of improved prevention, diagnosis, and management. Nonetheless, CAD remains the leading cause of death worldwide with most casualties expected to occur in developing nations. Myocardial perfusion scintigr...... that assists clinical decision-making with regard to medical treatment and intervention. A large body of evidence supports the current applications of MPS, which has become integral to several guidelines for clinical practice Udgivelsesdato: 2008/2...

  12. Certification ISO 9001 in clinical ethics consultation for improving quality and safety in healthcare.

    Science.gov (United States)

    Tozzo, Pamela; Mazzi, Anna; Aprile, Anna; Rodriguez, Daniele; Caenazzo, Luciana

    2018-03-24

    This paper refers to the quality management process of the Laboratory of Clinical Bioethics (LCB) of the University of Padua (Italy), which has obtained the quality certification to ISO 9001:2008, as a Clinical Ethics Support Service. Its activities consist mainly in clinical ethics consultations and training services, addressed to those who are called to decisions with ethical implications in the clinical setting, proposing a structured approach to identify and analyze the ethical issues that may loom in the relationships between health professionals and patients, and participating in their solution. The expected benefits of the application of ISO 9001 were mainly the following: to formalize the procedure adopted for clinical ethics consultation and training, to obtain a controlled management of documents, information and data, to ensure and demonstrate the quality of the provided activities and to make methods and organization publicly available. The main results which have been achieved with the 'quality management project' are summarized as follows: the enunciation of LCB Mission and Quality Policy; the drafting of the procedure by which clinical ethics consultation is provided; the formalization of members' skills and the adoption of relevant process and outcome indicators. Our experience may be useful in promoting accountability for the quality of ethics consultation services. We consider the certification process as a tool for transparent and reliable management of one of the most critical tasks in the current context of healthcare, motivating similar facilities to undertake similar pathways, with the aim to provide quality control on their activities.

  13. Safety evaluation of phytosterols in laying hens: effects on laying performance, clinical blood parameters, and organ development.

    Science.gov (United States)

    Shi, S R; Shen, Y R; Chang, L L; Zhou, C J; Bo, Z; Wang, Z Y; Tong, H B; Zou, J M

    2014-03-01

    Phytosterols are intended for use as a novel food ingredient with plasma cholesterol-lowering activity. Although phytosterols are naturally present in the normal diet, daily consumption is insufficient to ensure plasma cholesterol-lowering levels. Therefore, phytosterols may be added to the diets to achieve the desired cholesterol-lowering activity. A subchronic laying hen safety study was conducted to examine if high-dose phytosterols could affect the safety of hens. Three hundred sixty 21-wk-old Hy-Line Brown laying hens were randomly assigned to 5 groups with 6 replicates of 12 birds each; after 3 wk, birds were fed diets supplemented with 0, 20, 80, 400, and 800 mg/kg of phytosterols for 12 wk. Throughout the study, clinical observations and laying performance were measured. At the end of the study, birds were subjected to a full postmortem examination: blood samples were taken for clinical pathology, selected organs were weighed, and specified tissues were taken for subsequent histological examination. No treatment-related changes that were considered to be of toxicological significance were observed. Therefore, a nominal phytosterol concentration of 800 mg/kg was considered to be the no-observed-adverse-effect level.

  14. Pre-clinical Safety and Off-Target Studies to Support Translation of AAV-Mediated RNAi Therapy for FSHD

    Directory of Open Access Journals (Sweden)

    Lindsay M. Wallace

    2018-03-01

    Full Text Available RNAi emerged as a prospective molecular therapy nearly 15 years ago. Since then, two major RNAi platforms have been under development: oligonucleotides and gene therapy. Oligonucleotide-based approaches have seen more advancement, with some promising therapies that may soon reach market. In contrast, vector-based approaches for RNAi therapy have remained largely in the pre-clinical realm, with limited clinical safety and efficacy data to date. We are developing a gene therapy approach to treat the autosomal-dominant disorder facioscapulohumeral muscular dystrophy. Our strategy involves silencing the myotoxic gene DUX4 using adeno-associated viral vectors to deliver targeted microRNA expression cassettes (miDUX4s. We previously demonstrated proof of concept for this approach in mice, and we are now taking additional steps here to assess safety issues related to miDUX4 overexpression and sequence-specific off-target silencing. In this study, we describe improvements in vector design and expansion of our miDUX4 sequence repertoire and report differential toxicity elicited by two miDUX4 sequences, of which one was toxic and the other was not. This study provides important data to help advance our goal of translating RNAi gene therapy for facioscapulohumeral muscular dystrophy.

  15. Modulation of Brain Activity with Noninvasive Transcranial Direct Current Stimulation (tDCS: Clinical Applications and Safety Concerns

    Directory of Open Access Journals (Sweden)

    Haichao Zhao

    2017-05-01

    Full Text Available Transcranial direct current stimulation (tDCS is a widely-used tool to induce neuroplasticity and modulate cortical function by applying weak direct current over the scalp. In this review, we first introduce the underlying mechanism of action, the brief history from discovery to clinical scientific research, electrode positioning and montages, and parameter setup of tDCS. Then, we review tDCS application in clinical samples including people with drug addiction, major depression disorder, Alzheimer's disease, as well as in children. This review covers the typical characteristics and the underlying neural mechanisms of tDCS treatment in such studies. This is followed by a discussion of safety, especially when the current intensity is increased or the stimulation duration is prolonged. Given such concerns, we provide detailed suggestions regarding safety procedures for tDCS operation. Lastly, future research directions are discussed. They include foci on the development of multi-tech combination with tDCS such as with TMS and fMRI; long-term behavioral and morphological changes; possible applications in other research domains, and more animal research to deepen the understanding of the biological and physiological mechanisms of tDCS stimulation.

  16. Cardiovascular safety of liraglutide assessed in a patient-level pooled analysis of phase 2: 3 liraglutide clinical development studies.

    Science.gov (United States)

    Marso, Steven P; Lindsey, Jason B; Stolker, Joshua M; House, John A; Martinez Ravn, Gabriela; Kennedy, Kevin F; Jensen, Troels M; Buse, John B

    2011-07-01

    We assessed the cardiovascular safety of liraglutide, a glucagon-like peptide-1 receptor agonist, using existing clinical data. Patient-level results from all completed phase 2 and 3 studies from the liraglutide clinical development programme were pooled to determine rates of major adverse cardiovascular events (MACE): cardiovascular death, myocardial infarction, stroke. MACE were identified by querying the study database using Medical Dictionary for Regulatory Activities (MedDRA) terms combined with serious adverse events recorded by study investigators. Broad, narrow, and custom groups of MedDRA queries were used. Candidate events from each query were independently adjudicated post hoc. In 15 studies (6638 patients; 4257 liraglutide treated), there were 114 patients with MACE identified using the broad MedDRA query. Of these, 44 were classified as serious adverse events and 39 were adjudicated as MACE. The incidence ratio for adjudicated broad/serious MACE associated with liraglutide was 0.73 (95% CI 0.38-1.41) versus all comparator drugs (metformin, glimepiride, rosiglitazone, insulin glargine, placebo), within cardiovascular safety limits defined by the United States Food & Drug Administration for diabetes therapies under current investigation.

  17. ASSESSMENT OF RELATED ANAMNESTIC AND CLINICAL FACTORS ON EFFICACY AND SAFETY OF ANTI-HELICOBACTER PYLORI THERAPY

    Directory of Open Access Journals (Sweden)

    D. N. Andreev

    2016-01-01

    Full Text Available The article presents the results of a prospective clinical study in which 100 patients with H. pylori-associated peptic ulcer disease of stomach/duodenum were examined. The aim of the study was to assess the effect of concomitant anamnestic and clinical factors on the efficacy and safety of eradication therapy (ET. Type 2 diabetes mellitus is a factor that significantly reduces the efficiency of ET with OR 0.21 (95% CI 0,06-0,69, p = 0,0102. Using a macrolide antibiotics prior to ET during the previous 12 months is associated with a reduction in the effectiveness of H. pylori eradication with OR 0.27 (95% CI 0,08-0,90, p = 0,0342. Despite the lack of statistical significance observed negative effect on the efficiency of ET factors such as smoking and increased BMI. Smoking, female gender, age over 50 years and the presence of type 2 diabetes mellitus had no significant impact on the safety profile of ET. 

  18. Efficacy and Safety of Cariprazine in Acute Exacerbation of Schizophrenia: Results From an International, Phase III Clinical Trial.

    Science.gov (United States)

    Kane, John M; Zukin, Stephen; Wang, Yao; Lu, Kaifeng; Ruth, Adam; Nagy, Krisztián; Laszlovszky, István; Durgam, Suresh

    2015-08-01

    This phase III study evaluated the efficacy and safety of cariprazine, a dopamine D3 and D2 receptor partial agonist with preferential binding to D3 receptors, in patients with acute exacerbation of schizophrenia. Patients were randomized to 6-week double-blind treatment with placebo, cariprazine 3 to 6 mg/d, or cariprazine 6 to 9 mg/d. Primary and secondary efficacy: change from baseline to week 6 in Positive and Negative Syndrome Scale total and Clinical Global Impressions-Severity scores, respectively, analyzed using a mixed-effects model for repeated measures adjusting for multiple comparisons. Safety included treatment-emergent adverse events, clinical laboratory values, vital signs, electrocardiograms, ophthalmologic examination, Columbia-Suicide Severity Rating Scale, and extrapyramidal symptom scales. In the Safety Population (placebo, n = 147; cariprazine 3-6 mg/d, n = 151; cariprazine 6-9 mg/d, n = 148), 60.5% of patients completed the study. At week 6, statistically significant least squares mean differences in favor of cariprazine versus placebo were observed for Positive and Negative Syndrome Scale total score (3-6 mg/d: -6.8, P = 0.003; 6-9 mg/d: -9.9, P Global Impressions-Severity (3-6 mg/d: -0.3, P = 0.012; 6-9 mg/d: -0.5, P < 0.001). Common treatment-emergent adverse events (≥5% and twice the rate of placebo) in both cariprazine groups were akathisia, extrapyramidal disorder, and tremor; most were mild to moderate in severity. Mean changes in metabolic parameters were generally small and similar between groups. Prolactin levels decreased in all groups. In conclusion, cariprazine 3 to 6 and 6 to 9 mg/d versus placebo demonstrated significant improvement on primary and secondary efficacy parameters. Cariprazine was generally well tolerated. These results suggest that cariprazine may be a new and effective treatment for schizophrenia.

  19. Cross matching observations on toxicological and clinical data for the assessment of tolerability and safety of Ginkgo biloba leaf extract.

    Science.gov (United States)

    Heinonen, Tuula; Gaus, Wilhelm

    2015-01-02

    Ginkgo biloba is one of the most widely used herbal remedies in Europe and the US. It may be purchased in different types of formulations, but most of the clinical studies have been performed with the controlled G. biloba extract EGb761(®). Indications include Alzheimers disease, cardiovascular disease, dementia, memory loss, and cerebral ischemia. The pharmacological modes of action cover antioxidant effects, radical scavenging, inhibition of platelet activating factor, alterations in membrane fluidity (signal transduction), and inhibition of glucocorticoid synthesis. Due to the widespread and long-term use of G. biloba - about a million doses of EGb761(®) are sold per day - tolerability and safety are a crucial issue. Based on broad and long-term clinical use of G. biloba extracts, it is regarded as well tolerated in man. Cross matching, a tool we introduced, combines different fields of knowledge and types of data to a consolidated result. In this article, we combine toxicological and clinical data and utilize other sources of information to assess tolerability and safety of G. biloba. It is well known that because of biological differences between animals and man or even between animal species, animal experiments do not necessarily mimic the effects in humans. Therefore, for adequate risk assessment, the relevance of non-clinical toxicological findings should be correlated with human data. The cross matching of toxicological data and results from clinical studies is possible because many toxicological and clinical studies are available on G. biloba. We give an in depth analysis of the modes of action in animals and describe toxicological studies with regard to metabolism, pharmacokinetics, genotoxicity, as well as carcinogenicity (e.g., the Technical Report TR 578 of the US National Toxicology Program). In addition, 75 clinical trials with high methodological quality are summarized. They included a total of 7115 patients treated with G. biloba. Based on this

  20. Patient safety is improved with an incident learning system-Clinical evidence in brachytherapy.

    Science.gov (United States)

    Deufel, Christopher L; McLemore, Luke B; de Los Santos, Luis E Fong; Classic, Kelly L; Park, Sean S; Furutani, Keith M

    2017-10-01

    Health leaders have advocated for incident learning systems (ILSs) to prevent errors, but there is limited evidence demonstrating that ILSs improve cancer patient safety. Herein, we report a long-term retrospective review of ILS reports for the brachytherapy practice at a large academic institution. Over a nine-year period, the brachytherapy practice was encouraged to report all standard operating procedure deviations, including low risk deviations. A multidisciplinary committee assigned root causes and risk scores to all incidents. Evidence based practice changes were made using ILS data, and relevant incidents were communicated to all staff in order to reduce recurrence rates. 5258 brachytherapy procedures were performed and 2238 incidents were reported from 2007 to 2015. A ramp-up period was observed in ILS participation between 2007 (0.12 submissions/procedures) and 2011 (1.55 submissions/procedures). Participation remained stable between 2011 and 2015, and we achieved a 60% (psafety policy and a 70% (ppatient care. Safety improvements have been sustained over several years. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  1. Safety, tolerability, and risks associated with first- and second-generation antipsychotics: a state-of-the-art clinical review

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    Solmi M

    2017-06-01

    -generation antipsychotics (SGAs ushered in a progressive shift from the paternalistic management of SMI symptoms to a patient-centered approach, which emphasized targets important to patients – psychosocial functioning, quality of life, and recovery. These drugs are no longer limited to specific Diagnostic and Statistical Manual of Mental Disorders (DSM categories. Evidence indicates that SGAs show an improved safety and tolerability profile compared with FGAs. The incidence of treatment-emergent extrapyramidal side effects is lower, and there is less impairment of cognitive function and treatment-related negative symptoms. However, treatment with SGAs has been associated with a wide range of untoward effects, among which treatment-emergent weight gain and metabolic abnormalities are of notable concern. The present clinical review aims to summarize the safety and tolerability profile of selected FGAs and SGAs and to link treatment-related adverse effects to the pharmacodynamic profile of each drug. Evidence, predominantly derived from systematic reviews, meta-analyses, and clinical trials of the drugs amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, sertindole, ziprasidone, CPZ, haloperidol, loxapine, and perphenazine, is summarized. In addition, the safety and tolerability profiles of antipsychotics are discussed in the context of the “behavioral toxicity” conceptual framework, which considers the longitudinal course and the clinical and therapeutic consequences of treatment-emergent side effects. In SMI, SGAs with safer metabolic profiles should ideally be prescribed first. However, alongside with safety, efficacy should also be considered on a patient-tailored basis. Keywords: antipsychotics, side effects, tolerability, safety, psychosis, psychiatry

  2. Clinical effectiveness and safety of montelukast in asthma. What are the conclusions from clinical trials and meta-analyses?

    Directory of Open Access Journals (Sweden)

    Hon KLE

    2014-06-01

    Full Text Available Kam Lun Ellis Hon,1 Ting Fan Leung,1 Alexander KC Leung21Department of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong; 2Department of Pediatrics, The University of Calgary, Calgary, AB, CanadaAbstract: Asthma is a common childhood atopic disease associated with chronicity and impaired quality of life. As there is no cure for this disease, treatment relies on avoidance of triggers such as food and aeroallergens, the use of inhaled bronchodilators/corticosteroids and antiallergic or immunomodulating therapies. Inhaled corticosteroids (ICSs and bronchodilators have been the mainstay. However, in Asia, myths and fallacies regarding Western medicine and corticosteroids are prevalent and lead to nonadherence to treatment. Also, use of traditional and proprietary herbal medicines is popular. In the past decades, a novel class of nonsteroidal immunomodulating montelukasts has become available. This article reviews the evidence for the effectiveness and clinical efficacy of these medications. A number of randomized and controlled trials have been performed over the years. The majority of studies confirm the usefulness of montelukast as monotherapy and add-on therapy to ICS in mild to moderate childhood asthma across all age groups. ICSs are generally superior to montelukasts for asthma management. However, montelukast has a place in the treatment of young children with viral-triggered wheezing diseases, exercise-induced asthma, and in children whose parents are steroid-phobic and find ICS unacceptable.Keywords: cysteinyl leukotriene receptor antagonist, inhaled corticosteroid, randomized control trial, meta analysis

  3. In the Ethos of the Safety Net: An Expanded Role for Clinical Ethics Mediation.

    Science.gov (United States)

    McGreevy, Jolion

    2015-01-01

    Clinical ethics mediation is invaluable for resolving intractable disputes in the hospital. But it is also a critical day-to-day skill for clinicians, especially those who serve a disproportionate number of vulnerable patients. While mediation is typically reserved for intractable cases, there are two important opportunities to expand its use. First is preventative mediation, in which clinicians incorporate clinical ethics mediation into their daily routine in order to address value-laden conflicts before they reach the point at which outside consultation becomes necessary. Second is guided mediation, in which clinical teams resolve conflicts with patients or surrogates with guidance from an ethics consultant, who operates at some distance from the conflict and, rather than recommending a single action, counsels clinicians on the process they can use to resolve the conflict on their own. These approaches build the capacity of all clinicians to use clinical ethics mediation to improve the care of vulnerable patients. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

  4. Black cohosh (Actaea/Cimicifuga racemosa): review of the clinical data for safety and efficacy in menopausal symptoms.

    Science.gov (United States)

    Mahady, Gail B

    2005-01-01

    Since the publication of the results of the Women's Health Initiative that described the risks of hormone replacement therapy, many women are actively seeking alternative treatments for menopausal symptoms. Black cohosh (Actaea racemosa, syn. Cimicifuga racemosa) is one such alternative that has been used in the US for over 100 years. To date only two cimicifuga extracts have been tested clinically, and the current recommended dosage is 40-80 mg/day. Review of the published clinical data suggests that cimicifuga may be useful for the treatment of menopausal symptoms, such as hot flashes, profuse sweating, insomnia, and anxiety. However, the methodology used in most of the trials is poor and further clinical assessment of cimicifuga is needed. In terms of safety, transient adverse events such as nausea, vomiting, headaches, dizziness, mastalgia, and weight gain have been observed in clinical trials. A few cases of hepatotoxicity have been reported, but a direct association with the ingestion of cimicifuga has not been demonstrated. The most recent data suggest that cimicifuga is not estrogenic.

  5. Study of clinical applications and safety for Pascal® laser photocoagulation in retinal vascular disorders.

    Science.gov (United States)

    Muqit, Mahiul M K; Sanghvi, Chintan; McLauchlan, Rita; Delgado, Christine; Young, Lorna B; Charles, Stephen J; Marcellino, George R; Stanga, Paulo E

    2012-03-01

    To establish safe laser parameter standards for 10-30 ms Pascal(®) laser in clinical practice and to evaluate clinical and visual outcomes using this 532-nm multi-spot photocoagulation system. Retrospective observational case series of 313 patients treated between 2006 and 2008. Evaluation of eight groups: A - panretinal photocoagulation (PRP) for proliferative diabetic retinopathy (PDR); B - focal laser treatment for clinically significant diabetic macular oedema; C - grid laser for diffuse diabetic macular oedema; D - sector PRP for ischaemic branch retinal vein occlusions (I-BRVO); E - full PRP for ischaemic central retinal vein occlusions (I-CRVO); F - macular laser treatment for macular oedema secondary to non-ischaemic BRVO; G - full PRP for rubeosis iridis and/or neovascular glaucoma (NVG) secondary to I-BRVO, I - CRVO or PDR; H - laser retinopexy for retinal breaks/degenerations. Mean LogMAR visual acuity for all procedures improved postlaser (p = 0.065), and laser prevented visual loss in 85% eyes. Topical anaesthesia was only required. At mean follow-up of 5 months, 72% procedures had a successful clinical outcome. Significantly higher powers were required for PRP using Pascal(®) compared to conventional laser (p = 0.001) in PDR, I-BRVO, I-CRVO and NVG. Sixty-seven per cent of patients (15/20) were successfully treated with single-session 20-ms PRP using a mean 1952 burns. There were no laser-associated adverse effects or ocular complications associated with multi-spot PRP or macular Pascal(®) arrays. The clinical efficacy using 10- to 30-ms pulse duration Pascal(®) laser is comparable to conventional standard protocols used for the treatment of vascular retinal disorders. Higher power, 10- to 30-ms pulse duration laser may be safely and effectively used in clinical practice. © 2010 The Authors. Acta Ophthalmologica © 2010 Acta Ophthalmologica Scandinavica Foundation.

  6. Review of endoscopic radiofrequency in biliopancreatic tumours with emphasis on clinical benefits, controversies and safety

    Science.gov (United States)

    Alvarez-Sánchez, María-Victoria; Napoléon, Bertrand

    2016-01-01

    Most pancreatic cancers and extrahepatic cholangiocarcinomas are unresectable at the time of diagnosis, and even in case of a resectable cancer, for elderly or patients with coexistent comorbidities, surgery is not an option. Current treatment alternatives in these scenarios are very limited. Biliary stenting with self-expanding metal stents (SEMS) is the mainstay palliative treatment of biliary obstruction due to unresectable pancreatic cancer or cholangiocarcinoma. Nevertheless, more than 50% of SEMS become occluded after 6 mo due to tumour over- and ingrowth, leading to hospital readmissions and reinterventions that significantly impair quality of life. Regimes of chemotherapy or chemoradiotherapy also provide minimal survival benefits. Therefore, novel therapies are eagerly awaited. Radiofrequency (RF) energy causes coagulative necrosis leading to local destruction of the accessed malignant tissue and has an established role in the treatment of malignancies in several solid organs, especially liver cancers. However, pancreatic and extrahepatic biliary cancers are not easily accessed by a percutaneous route, making the procedure dangerous. Over the past five years, the development of dedicated devices compatible with endoscopic instruments has offered a minimally invasive option for RF energy delivery in biliopancreatic cancers. Emerging experience with endoscopic RF ablation (RFA) in this setting has been reported in the literature, but little is known about its feasibility, efficacy and safety. A literature review makes it clear that RFA in biliopancreatic tumours is feasible with high rates of technical success and acceptable safety profile. Although available data suggest a benefit of survival with RFA, there is not enough evidence to draw a firm conclusion about its efficacy. For this reason, prospective randomized trials comparing RFA with standard palliative treatments with quality-of-life and survival endpoints are required. Anecdotal reports have also

  7. Efficacy and safety of garenoxacin tablets on clinically diagnosed atypical pneumonia: postmarketing surveillance in Japan.

    Science.gov (United States)

    Izumikawa, Koichi; Watanabe, Akira; Miyashita, Naoyuki; Ishida, Tadashi; Hosono, Hiroaki; Kushimoto, Satoru; Kohno, Shigeru

    2014-09-01

    We performed a postmarketing surveillance study to determine the efficacy and safety of the oral quinolone antibacterial agent garenoxacin (Geninax(®) Tablets 200 mg) against atypical pneumonia. Between October 2009 and July 2011, patients with community-acquired pneumonia visited 26 facilities in Japan; we collected survey forms from 105 of these patients who were suspected of having atypical pneumonia based on the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults. We examined the safety in 105 patients and the efficacy in 71 patients. 1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients) and 92.3% (12/13 patients), respectively. The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain). 2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively. In conclusion, garenoxacin showed an efficacy rate of greater than 90% for suspected atypical pneumonia and confirmed atypical pneumonia. Garenoxacin is considered to be useful in daily practice. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  8. Clinical efficacy and safety of Securflux®, an anti-reflux device for intravenous infusion.

    Science.gov (United States)

    Barreras, Ferran; Cabeza, Manuel; Collantes de Terán, Laura

    2013-01-01

    Catheter obstruction or patency inhibition of the venous access cannula is a frequently experienced problem in patients to whom intravenous (IV) solutions are administered. In this study we assessed the efficacy and safety of Securflux® a disposable device with a back-check valve to prevent reflux in IV infusion sets. A total of 177 adult patients requiring IV medication for at least 24 hours duration were randomized into two groups: with and without the use of Securflux®. Assessments were performed the 10 days after catheter insertion, over three daily visits. The incidence of the onset of reflux (visual/non-visual) and the consequences of reflux for both the patient and healthcare staff were assessed. There were 4577 follow-up (study) visits (53.4% in patients with Securflux® and 46.6% without Securflux®). Venous reflux was observed in 14.2% of all visits, more frequently without Securflux® (21.3% vs. 8.1%; P<.05). Reflux was mostly visual without Securflux® (7.6% vs. 0.7%) and non-visual with Securflux® (13.6% vs. 7.3%). The onset of venous reflux carried more consequences, such as inhibition of the line and patient discomfort, in the infusions without Securflux® (81.1% vs. 73.5% of the visits; P<.05). There were no safety concerns related to Securflux®. Securflux® is effective, safe and useful for the prevention of venous reflux onset in patients administered IV medication.

  9. Nebulized formoterol: a review of clinical efficacy and safety in COPD

    Directory of Open Access Journals (Sweden)

    Nicholas J Gross

    2010-06-01

    Full Text Available Nicholas J Gross1, James F Donohue21Hines VA Hospital, Stritch Loyola School of Medicine, Hines, IL, USA; 2University of North Carolina School of Medicine, Chapel Hill, NC, USAAbstract: A nebulized formulation of formoterol, Perforomist®, 20 μg/2 ml, has been available since 2007 for the maintenance treatment of chronic obstructive pulmonary disease (COPD. We review the safety and efficacy data obtained during its development. In a dose-finding study, formoterol inhalation solution (FFIS was similar to the formoterol originator, Foradil® 12 μg DPI (FA in patients with COPD. In a 12-week efficacy study, FFIS manifested a rapid onset of action and FEV1 peak, AUC0–12, and trough levels similar to FA. No loss of efficacy, tachyphylaxis, was observed over 12 weeks of regular administration. In placebo-controlled studies in COPD patients receiving maintenance tiotropium, the addition of FFIS significantly augmented bronchodilation over the 6-week treatment duration, signifying that nebulized formoterol can further improve lung function in patients who are receiving tiotropium without an observed increase in adverse reactions. The safety profile of FFIS during 12-week and 1-year studies revealed adverse events that were similar to those of placebo and FA. Cardiac rhythm studies, including frequent ECGs and Holter monitoring, did not indicate any increase in rate or rhythm disturbances greater than placebo or FA. We conclude that maintenance use of Perforomist® is appropriate for patients with COPD who require or prefer a nebulizer for management of their disease.Keywords: long-acting bronchodilator, β-agonist, chronic bronchitis, pulmonary emphysema, Perforomist®, chronic obstructive pulmonary disease

  10. Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Sidney Glina

    2011-12-01

    Full Text Available PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs. As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174 or ketoprofen 100 mg IV plus placebo (n = 164. 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174 or ketoprofen 100 mg IV(n = 164 plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID at 30 minutes by visual analog scale (VAS (per-protocol population. An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD mPID30 min was 33.84 (24.61 and 35.16 (26.01 for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.

  11. Intervertebral disc repair with activated nucleus pulposus cell transplantation: a three-year, prospective clinical study of its safety

    Directory of Open Access Journals (Sweden)

    J Mochida

    2015-03-01

    Full Text Available Degeneration of the lumbar intervertebral discs is irreversible, with no treatment currently available. Building upon experimental studies that demonstrated the importance of the nucleus pulposus (NP in preserving disc structure, we demonstrated that reinsertion of NP cells slowed further disc degeneration and that direct cell-to-cell contact co-culture with mesenchymal stromal cells (MSCs significantly upregulated the viability of NP cells in basic and pre-clinical studies in vitro and in vivo using animal models and human cells. Here, we report a 3-year result of a prospective clinical study, aimed to assess the safety and efficacy of activated NP cell transplantation in the degenerate lumbar intervertebral disc. Candidates were 9 patients aged 20-29 years who had Pfirrmann’s grade III disc degeneration at the level adjacent to the level scheduled for posterior lumbar intervertebral fusion. Viable NP cells from the fused disc were co-cultured in direct contact with autologous bone marrow-derived MSCs. One million activated NP cells were transplanted into the degenerated disc adjacent to the fused level at 7 d after the first fusion surgery. No adverse effects were observed during the 3-year follow-up period. Magnetic resonance imaging did not show any detrimental effects to the transplanted discs and revealed a mild improvement in 1 case. No cases reported any low back pain. Our clinical study confirmed the safety of activated NP cell transplantation, and the findings suggest the minimal efficacy of this treatment to slow the further degeneration of human intervertebral discs.

  12. An Integrated Intervention for Increasing Clinical Nurses’ Knowledge of HIV/AIDS-Related Occupational Safety

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    Liping He

    2016-11-01

    Full Text Available Background: Approximately 35 new HIV (Human Immunodeficiency Virus, HIV cases and at least 1000 serious infections are transmitted annually to health care workers. In China, HIV prevalence is increasing and nursing personnel are encountering these individuals more than in the past. Contaminated needle-stick injuries represent a significant occupational burden for nurses. Evidence suggests that nurses in China may not fully understand HIV/AIDS (Acquired immunodeficiency syndrome, AIDS and HIV-related occupational safety. At this time, universal protection precautions are not strictly implemented in Chinese hospitals. Lack of training may place nurses at risk for occupational exposure to blood-borne pathogens. Objectives: To assess the effectiveness of integrated interventions on nurses’ knowledge improvement about reducing the risk of occupationally acquired HIV infection. Methods: We audited integrated interventions using 300 questionnaires collected from nurses at the Affiliated Hospital of Xiangnan University, a public polyclinic in Hunan Province. The intervention studied was multifaceted and included appropriate and targeted training content for hospital, department and individual levels. After three months of occupational safety integrated interventions, 234 participants who completed the program were assessed. Results: Of the subjects studied, 94.3% (283/300 were injured one or more times by medical sharp instruments or splashed by body fluids in the last year and 95.3% considered their risk of occupational exposure high or very high. After the intervention, awareness of HIV/AIDS-related knowledge improved significantly (χ2 = 86.34, p = 0.00, and correct answers increased from 67.9% to 82.34%. Correct answers regarding risk perception were significantly different between pre-test (54.4% and post-test (66.6% (χ2 = 73.2, p = 0.00. When coming into contact with patient body fluids and blood only 24.0% of subjects used gloves regularly

  13. Blood transfusions using 27 gauge PICC lines: a retrospective clinical study on safety and feasibility.

    Science.gov (United States)

    Repa, A; Mayerhofer, M; Worel, N; Cardona, F; Deindl, P; Pollak, A; Berger, A; Haiden, N

    2014-01-01

    Blood transfusions are required by most extremely low birth weight (ELBW) infants, but sometimes an adequate peripheral venous access cannot be achieved. Under these circumstances, we used 27 Gauge (G) peripherally inserted central catheter (PICC) lines that are routinely inserted on the second day of life. Due to their narrow lumen, hemolysis of transfused erythrocytes was a major concern. We therefore performed a retrospective study in ELBW infants to analyze the incidence, safety and feasibility of PRBC transfusions via 27 G PICC lines. ELBW infants admitted from 08/2011-07/2012 were screened for packed red blood cell (PRBC) transfusions. Those applied via 27 G PICC lines were identified. For analysis of transfusion safety (hemolysis), hemoglobin and potassium levels as well as cardiovascular variables (invasive mean arterial blood pressure and heart rate) were evaluated before and after transfusion. For analysis of transfusion feasibility, catheter removal after transfusion and the reason for removal were recorded. A total of 648 transfusions were applied in 110 ELBW infants. 27 infants (24%) received no transfusion. In 12/83 (14.5%) infants who received PRBCs, transfusions were applied using a 27 G PICC line (38/648, 5.9%). Patients who received PRBCs via the PICC line were smaller at birth (582 g [range 380-752 g] vs. 710 g [430-972 g]; 23+6 [23+1-27+6] vs. 26+0 [23+1-31+4]) and required a higher number of PRBC transfusions (n=13 vs. n=5) overall. Transfusion analysis showed an appropriate increase of blood hemoglobin levels and stable potassium levels as well as cardiovascular parameters. 4/38 of PICC lines were removed within 24 h after transfusion, one due to occlusion (15 h after transfusion). We conclude that PRBC transfusions via 27 G PICC lines were feasible and performed without signs of hemolysis in ELBW infants. Our findings may help clinicians in the management of ELBW infants requiring transfusions if a peripheral venous access

  14. Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial.

    Science.gov (United States)

    Ranasinghe, Priyanga; Jayawardena, Ranil; Pigera, Shehani; Wathurapatha, Wasundara Sevwandi; Weeratunga, Hasitha Dhananjaya; Premakumara, G A Sirimal; Katulanda, Prasad; Constantine, Godwin Roger; Galappaththy, Priyadarshani

    2017-12-28

    Cinnamon is considered as a treatment for many ailments in native medicine. Evidence suggests that Cinnamomum zeylanicum (CZ) has anti-microbial, anti-parasitic, anti-oxidant, blood glucose lowering properties and beneficial cardiovascular effects. The present study aims to evaluate Pharmacodynamic properties and safety of CZ in healthy adults using a Phase I Clinical Trial. This phase I clinical trial was conducted at the Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka. Thirty healthy adults were recruited for the study, conducted for a period of 3 months, with the dose of CZ (water extract) increased at monthly intervals (85 mg, 250 mg and 500 mg). Data collection was carried out at baseline and during each monthly follow up visit. Anthropometric, clinical and biochemical assessments were done at baseline and during follow up. Adverse effects and drug compliance was also evaluated. Twenty eight subjects completed the three months follow up. Mean age was 38.8 ± 10.4 years and 50% were males. There were no significant changes in the anthropometric parameters during the three months follow up. Both systolic and diastolic blood pressure reduced significant during the 1st month and this reduction was sustained throughout follow up. Full blood count, renal function tests, liver function tests, fasting blood glucose, HDL-c, VLDL-d and triglycerides remained within the normal range without any significant alteration during the 3 months. A significant reduction in the TC (p < 0.05) and LDL-c (p < 0.001) was noted at the end of the 3 months follow up period. There were no serious adverse effects (including hypersensitivity) noted. In two participants dyspepsia necessitated the discontinuation of study participation. Drug compliance was between 85 and 95% during the study period. This is the first phase I clinical trial in health adults evaluating efficacy and safety of CZ. Our results demonstrate no significant side

  15. Practice-Based Evidence: Profiling the Safety of Cilostazol by Text-Mining of Clinical Notes

    OpenAIRE

    Leeper, Nicholas J.; Bauer-Mehren, Anna; Iyer, Srinivasan V.; LePendu, Paea; Olson, Cliff; Shah, Nigam H.

    2013-01-01

    Background Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with conges...

  16. Percutaneous left atrial appendage closure devices: safety, efficacy, and clinical utility

    OpenAIRE

    Swaans, Martin; Wintgens,Lisette; Alipour,Arash; Rensing,Benno; Boersma,Lucas

    2016-01-01

    Martin J Swaans, Lisette IS Wintgens, Arash Alipour,  Benno JWM Rensing, Lucas VA Boersma Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands Abstract: Atrial fibrillation (AF) is the most common arrhythmia treated in the clinical practice. One of the major complications of AF is a thromboembolic cerebral ischemic event. Up to 20% of all strokes are caused by AF. Thromboembolic cerebral ischemic event in patients with AF occurs due ...

  17. Rasagiline meta-analysis: a spotlight on clinical safety and adverse events when treating Parkinson's disease.

    Science.gov (United States)

    Solís-García del Pozo, Julián; Mínguez-Mínguez, Sara; de Groot, Piet W J; Jordán, Joaquín

    2013-07-01

    Rasagiline (Azilect, AGN 1135) is a selective irreversible inhibitor of monoamine oxidase B (MAO-B). MAO-B regulates the brain concentrations of important neurotransmitters that are related to movement, emotion, and cognition. Oral rasagiline, as monotherapy or as adjunctive therapy to levodopa, was effective in the symptomatic treatment of adult patients with Parkinson's disease participating in double-blind, placebo-controlled, international studies. This article reviews the reported adverse effects of rasagiline. A MEDLINE search was performed for all articles from 1990 to present, which reported any adverse effects from rasagiline or related references. We conducted an analysis of the adverse effects of rasagiline based on the reported clinical studies. Furthermore, we compared the incidence of adverse events in clinical trials for rasagiline and placebo. Among the most frequently reported adverse effects for rasagiline as monotherapy are headache, dizziness, and insomnia. Depression, dizziness, somnolence, and other sleep disorders are reported when used in combination therapy. Our analysis demonstrates that the most frequently reported adverse effects in trials did not occur more often with rasagiline than placebo. In conclusion, rasagiline is a well-tolerated MAO-B inhibitor that may help to achieve the desired level of clinical benefit in Parkinson's disease.

  18. Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa

    Directory of Open Access Journals (Sweden)

    Marta Sacchetti

    2015-01-01

    Full Text Available Aims. Several treatments have been proposed to slow down progression of Retinitis pigmentosa (RP, a hereditary retinal degenerative condition leading to severe visual impairment. The aim of this study is to systematically review data from randomized clinical trials (RCTs evaluating safety and efficacy of medical interventions for the treatment of RP. Methods. Randomized clinical trials on medical treatments for syndromic and nonsyndromic RP published up to December 2014 were included in the review. Visual acuity, visual field, electroretinogram, and adverse events were used as outcome measures. Results. The 19 RCTs included in this systematic review included trials on hyperbaric oxygen delivery, topical brimonidine tartrate, vitamins, docosahexaenoic acid, gangliosides, lutein, oral nilvadipine, ciliary neurotrophic factor, and valproic acid. All treatments proved safe but did not show significant benefit on visual function. Long term supplementation with vitamin A showed a significantly slower decline rate in electroretinogram amplitude. Conclusions. Although all medical treatments for RP appear safe, evidence emerging from RCTs is limited since they do not present comparable results suitable for quantitative statistical analysis. The limited number of RCTs, the poor clinical results, and the heterogeneity among studies negatively influence the strength of recommendations for the long term management of RP patients.

  19. Identifying Subgroups of Adult Superutilizers in an Urban Safety-Net System Using Latent Class Analysis: Implications for Clinical Practice.

    Science.gov (United States)

    Rinehart, Deborah J; Oronce, Carlos; Durfee, Michael J; Ranby, Krista W; Batal, Holly A; Hanratty, Rebecca; Vogel, Jody; Johnson, Tracy L

    2018-01-01

    Patients with repeated hospitalizations represent a group with potentially avoidable utilization. Recent publications have begun to highlight the heterogeneity of this group. Latent class analysis provides a novel methodological approach to utilizing administrative data to identify clinically meaningful subgroups of patients to inform tailored intervention efforts. The objective of the study was to identify clinically distinct subgroups of adult superutilizers. Retrospective cohort analysis. Adult patients who had an admission at an urban safety-net hospital in 2014 and 2 or more admissions within the preceding 12 months. Patient-level medical, mental health (MH) and substance use diagnoses, social characteristics, demographics, utilization and charges were obtained from administrative data. Latent class analyses were used to determine the number and characteristics of latent subgroups that best represented these data. In this cohort (N=1515), a 5-class model was preferred based on model fit indices, clinical interpretability and class size: class 1 (16%) characterized by alcohol use disorder and homelessness; class 2 (14%) characterized by medical conditions, MH/substance use disorders and homelessness; class 3 (25%) characterized primarily by medical conditions; class 4 (13%) characterized by more serious MH disorders, drug use disorder and homelessness; and class 5 (32%) characterized by medical conditions with some MH and substance use. Patient demographics, utilization, charges and mortality also varied by class. The overall cohort had high rates of multiple chronic medical conditions, MH, substance use disorders, and homelessness. However, the patterns of these conditions were different between subgroups, providing important information for tailoring interventions.

  20. Lisdexamfetamine: chemistry, pharmacodynamics, pharmacokinetics, and clinical efficacy, safety, and tolerability in the treatment of binge eating disorder.

    Science.gov (United States)

    Ward, Kristen; Citrome, Leslie

    2018-02-01

    The indications for lisdexamfetamine (LDX), a central nervous system stimulant, were recently expanded to include treatment of moderate to severe binge eating disorder (BED). Areas covered: This review aims to describe the chemistry and pharmacology of LDX, as well as the clinical trials investigating the efficacy and safety of this medication for the management of BED. Expert opinion: LDX is the first medication with United States Food and Drug Administration approval for the treatment of BED. It is an inactive prodrug of d-amphetamine that extends the half-life of d-amphetamine to allow for once daily dosing. D-amphetamine acts primarily to increase the concentrations of synaptic dopamine and norepinephrine. Metabolism of LDX to d-amphetamine occurs when peptidases in red blood cells cleave the covalent bond between d-amphetamine and l-lysine. D-amphetamine is then further metabolized by CYP2D6. Excretion is primarily through renal mechanisms. In clinical trials, LDX demonstrated statistical and clinical superiority over placebo in reducing binge eating days per week at doses of 50 and 70 mg daily. Commonly reported side effects of LDX include dry mouth, insomnia, weight loss, and headache, and its use should be avoided in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia or coronary artery disease. As with all CNS stimulants, risk of abuse needs to be assessed prior to prescribing.

  1. The potential carcinogenic risk of tanning beds: clinical guidelines and patient safety advice

    International Nuclear Information System (INIS)

    Mogensen, Mette; Jemec, Gregor BE

    2010-01-01

    In 2009, the WHO listed ultraviolet (UV) radiation as a group 1 carcinogen. In spite of this, each year, millions of people tan indoor in Western countries. The aim of this review is to summarize evidence of tanning bed carcinogenesis and to present guidelines for use of tanning beds and patient safety advice. A narrative review of the literature was conducted based on both PubMed and Medline searches and on literature review of the retrieved papers. Use of indoor tanning beds represents a significant and avoidable risk factor for the development of both melanoma and nonmelanoma skin cancers. Frequent tanners are more often adolescent females. Tanning beds have additional potential adverse effects such as burns, solar skin damage, infection, and possibly also addictive behavior. The effort in preventing UV light-induced carcinogenesis should currently be aimed at developing new strategies for public health information. Tanning beds are one preventable source of UV radiation. In the majority of people solar UV radiation continues to be the major factor and therefore anti-tanning campaigns must always include sunbathers

  2. EEG in non-clinical drug safety assessments: Current and emerging considerations.

    Science.gov (United States)

    Authier, Simon; Delatte, Marcus S; Kallman, Mary-Jeanne; Stevens, Joanne; Markgraf, Carrie

    2016-01-01

    Electroencephalogram (EEG) data in nonclinical species can play a critical role in the successful evaluation of a compound during drug development, particularly in the evaluation of seizure potential and for monitoring changes in sleep. Yet, while non-invasive electrocardiogram (ECG) monitoring is commonly included in preclinical safety studies, pre-dose or post-dose EEG assessments are not. Industry practices as they relate to preclinical seizure liability and sleep assessments are not well characterized and the extent of preclinical EEG testing varies between organizations. In the current paper, we discuss the various aspects of preclinical EEG to characterize drug-induced seizure risk and sleep disturbances, as well as describe the use of these data in a regulatory context. An overview of EEG technology-its correct application and its limitations, as well as best practices for setting up the animal models is presented. Sleep and seizure detection are discussed in detail. A regulatory perspective on the use of EEG data is provided and, tying together the previous topics is a discussion of the translational aspects of EEG. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  3. Clinical Alarms in intensive care: implications of alarm fatigue for the safety of patients

    Directory of Open Access Journals (Sweden)

    Adriana Carla Bridi

    2014-12-01

    Full Text Available OBJECTIVES: to identify the number of electro-medical pieces of equipment in a coronary care unit, characterize their types, and analyze implications for the safety of patients from the perspective of alarm fatigue.METHOD: this quantitative, observational, descriptive, non-participatory study was conducted in a coronary care unit of a cardiology hospital with 170 beds.RESULTS: a total of 426 alarms were recorded in 40 hours of observation: 227 were triggered by multi-parametric monitors and 199 were triggered by other equipment (infusion pumps, dialysis pumps, mechanical ventilators, and intra-aortic balloons; that is an average of 10.6 alarms per hour.CONCLUSION: the results reinforce the importance of properly configuring physiological variables, the volume and parameters of alarms of multi-parametric monitors within the routine of intensive care units. The alarms of equipment intended to protect patients have increased noise within the unit, the level of distraction and interruptions in the workflow, leading to a false sense of security.

  4. The clinical efficacy, safety and functionality of anion textile in the treatment of atopic dermatitis.

    Science.gov (United States)

    Kim, Sang Hyun; Hwang, Sung Hwan; Hong, Soon Kwon; Seo, Jong Keun; Sung, Ho Suk; Park, Sung Wook; Shin, Jeong Hwan

    2012-11-01

    Several previous studies have suggested the improvement of atopic dermatitis (AD) in response to special fabrics. In particular, beneficial effects have been reported, following the use of anion textiles. The purpose of this study is to evaluate the effectiveness and safety of an anion textile in patients suffering from AD. We compared an anion textile with a pure cotton textile. Fifty-two atopic patients (n=52) were enrolled and divided into two groups. The patients in the test (n=25) and control (n=19) groups wore undergarments made of an anion textile or pure cotton over a period of 4 weeks. The overall severity of disease was evaluated using the SCORing atopic dermatitis (SCORAD) index, whereas, the treatment efficacy was measured using a Tewameter® (Courage & Khazaka, Cologne, Germany), Mexameter® (Courage & Khazaka) and Corneo meter® (Courage & Khazaka). At the end of the study, a significant decrease in the SCORAD index was observed among the patients with AD in the test group (mean SCORAD decreased from 47.2 to 36.1). Similarly, improvements in the mean transepidermal water loss, skin erythema and stratum corneum hydration were significantly greater among the patients with AD in the test group than in the control group. Anion textiles may be used to significantly improve the objective and subjective symptoms of AD, and are similar in terms of comfort to cotton textiles. The use of anion textiles may be beneficial in the management of patients with AD.

  5. Different bismuth-based therapies for eradicating Helicobacter pylori: Randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Gokcan, Hale; Oztas, Erkin; Onal, Ibrahim Koral

    2016-02-01

    Bismuth salts are used for treating dyspepsia, and they exert antibacterial effects on Helicobacter pylori. This study aimed to compare the efficacy and safety of three bismuth-containing combination regimens for H. pylori eradication in a Turkish population. In this single-center study, 149 patients, who were diagnosed with H. pylori infection with urea breath test and histopathological examination, were randomized to receive the following therapies for 14 days: (1) bismuth-containing clarithromycin-based triple therapy (CBS-LAC), (2) bismuth-containing levofloxacin-based triple therapy (CBS-LAL), and (3) bismuth-containing quadruple therapy (BCQT). Eradication rates were evaluated six weeks after the treatment by performing intention to treat (ITT) and per protocol (PP) analyses. In addition, data on side effect profiles and patient compliance were collected. PP and ITT analyses showed that eradication rates were 86% and 81.1%, respectively, with BCQT; 68.3% and 66.7%, respectively, with CBS-LAL therapy; and 65.3% and 59.3%, respectively, with CBS-LAC therapy. Eradication rates obtained using PP and ITT analyses were statistically significant for all the regimens. Addition of bismuth to standard triple and levofloxacin-based regimen did not show an acceptable increase in eradication rates. Therefore, BCQT may be preferred for the first-line treatment of H. pylori infection. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  6. Clinical evaluation of the efficacy and safety of fractional bipolar radiofrequency for the treatment of moderate to severe acne scars.

    Science.gov (United States)

    Verner, Ines

    2016-01-01

    Several treatment modalities are used for the treatment of acne scars with variable results. Recent studies showed that fractional radiofrequency may be an effective treatment modality for acne scars. The objective of this study was to assess the efficacy, safety, tolerability and patient satisfaction of fractional bipolar radiofrequency (RF), the eTwo™ system (Syneron Candela Ltd., Yokneam, Israel) for treating acne scars. Twelve patients with moderate to severe acne scars received 3-5 treatments with the Sublative fractionated bipolar RF applicator of the eTwo device at 1-month intervals. Patients were evaluated clinically and photographically at each visit and 3 months after the final treatment. Very good improvement (at least one scale) was seen after completing the five treatments. The patient satisfaction survey (Global Aesthetic Improvement Scale scores) revealed that half (6 out of 12) of the patients reported to be satisfied with treatment results, while the other half reported to be very satisfied. Beyond the expected erythema and minimal scab formation in the treated areas, which was mild and transient, none of the participants reported any adverse events. The data presented here support the high efficacy and safety of fractionated bipolar RF for the aesthetic improvement of moderate to severe acne scars. © 2015 Wiley Periodicals, Inc.

  7. SU-D-201-07: A Survey of Radiation Oncology Residents’ Training and Preparedness to Lead Patient Safety Programs in Clinics

    International Nuclear Information System (INIS)

    Spraker, M; Nyflot, M; Ford, E; Kane, G; Zeng, J; Hendrickson, K

    2016-01-01

    Purpose: Safety and quality has garnered increased attention in radiation oncology, and physicians and physicists are ideal leaders of clinical patient safety programs. However, it is not clear whether residency programs incorporate formal patient safety training and adequately equip residents to assume this leadership role. A national survey was conducted to evaluate medical and physics residents’ exposure to safety topics and their confidence with the skills required to lead clinical safety programs. Methods: Radiation oncology residents were identified in collaboration with ARRO and AAPM. The survey was released in February 2016 via email using REDCap. This included questions about exposure to safety topics, confidence leading safety programs, and interest in training opportunities (i.e. workshops). Residents rated their exposure, skills, and confidence on 4 or 5-point scales. Medical and physics residents responses were compared using chi-square tests. Results: Responses were collected from 56 of 248 (22%) physics and 139 of 690 (20%) medical residents. More than two thirds of all residents had no or only informal exposure to incident learning systems (ILS), root cause analysis (RCA), failure mode and effects analysis (FMEA), and the concept of human factors engineering (HFE). Likewise, 63% of residents had not heard of RO-ILS. Response distributions were similar, however more physics residents had formal exposure to FMEA (p<0.0001) and felt they were adequately trained to lead FMEAs in clinic (p<0.001) than medical residents. Only 36% of residents felt their patient safety training was adequate, and 58% felt more training would benefit their education. Conclusion: These results demonstrate that, despite increasing desire for patient safety training, medical and physics residents’ exposure to relevant concepts is low. Physics residents had more exposure to FMEA than medical residents, and were more confident in leading FMEA. This suggests that increasing

  8. SU-D-201-07: A Survey of Radiation Oncology Residents’ Training and Preparedness to Lead Patient Safety Programs in Clinics

    Energy Technology Data Exchange (ETDEWEB)

    Spraker, M; Nyflot, M; Ford, E; Kane, G; Zeng, J; Hendrickson, K [University of Washington, Seattle, WA (United States)

    2016-06-15

    Purpose: Safety and quality has garnered increased attention in radiation oncology, and physicians and physicists are ideal leaders of clinical patient safety programs. However, it is not clear whether residency programs incorporate formal patient safety training and adequately equip residents to assume this leadership role. A national survey was conducted to evaluate medical and physics residents’ exposure to safety topics and their confidence with the skills required to lead clinical safety programs. Methods: Radiation oncology residents were identified in collaboration with ARRO and AAPM. The survey was released in February 2016 via email using REDCap. This included questions about exposure to safety topics, confidence leading safety programs, and interest in training opportunities (i.e. workshops). Residents rated their exposure, skills, and confidence on 4 or 5-point scales. Medical and physics residents responses were compared using chi-square tests. Results: Responses were collected from 56 of 248 (22%) physics and 139 of 690 (20%) medical residents. More than two thirds of all residents had no or only informal exposure to incident learning systems (ILS), root cause analysis (RCA), failure mode and effects analysis (FMEA), and the concept of human factors engineering (HFE). Likewise, 63% of residents had not heard of RO-ILS. Response distributions were similar, however more physics residents had formal exposure to FMEA (p<0.0001) and felt they were adequately trained to lead FMEAs in clinic (p<0.001) than medical residents. Only 36% of residents felt their patient safety training was adequate, and 58% felt more training would benefit their education. Conclusion: These results demonstrate that, despite increasing desire for patient safety training, medical and physics residents’ exposure to relevant concepts is low. Physics residents had more exposure to FMEA than medical residents, and were more confident in leading FMEA. This suggests that increasing

  9. National Use of Safety-Net Clinics for Primary Care among Adults with Non-Medicaid Insurance in the United States.

    Science.gov (United States)

    Nguyen, Oanh Kieu; Makam, Anil N; Halm, Ethan A

    2016-01-01

    To describe the prevalence, characteristics, and predictors of safety-net use for primary care among non-Medicaid insured adults (i.e., those with private insurance or Medicare). Cross-sectional analysis using the 2006-2010 National Ambulatory Medical Care Surveys, annual probability samples of outpatient visits in the U.S. We estimated national prevalence of safety-net visits using weighted percentages to account for the complex survey design. We conducted bivariate and multivariate logistic regression analyses to examine characteristics associated with safety-net clinic use. More than one-third (35.0%) of all primary care safety-net clinic visits were among adults with non-Medicaid primary insurance, representing 6,642,000 annual visits nationally. The strongest predictors of safety-net use among non-Medicaid insured adults were: being from a high-poverty neighborhood (AOR 9.53, 95% CI 4.65-19.53), being dually eligible for Medicare and Medicaid (AOR 2.13, 95% CI 1.38-3.30), and being black (AOR 1.97, 95% CI 1.06-3.66) or Hispanic (AOR 2.28, 95% CI 1.32-3.93). Compared to non-safety-net users, non-Medicaid insured adults who used safety-net clinics had a higher prevalence of diabetes (23.5% vs. 15.0%, pclinics (pclinics are important primary care delivery sites for non-Medicaid insured minority and low-income populations with a high burden of chronic illness. The critical role of safety-net clinics in care delivery is likely to persist despite expanded insurance coverage under the Affordable Care Act.

  10. Isavuconazole for the treatment of invasive aspergillosis and mucormycosis: current evidence, safety, efficacy, and clinical recommendations

    Directory of Open Access Journals (Sweden)

    Natesan SK

    2016-12-01

    Full Text Available Suganthini Krishnan Natesan,1,2 Pranatharthi H Chandrasekar1 1Division of Infectious Diseases, Department of Internal Medicine, Wayne State University, 2John D Dingell VA Medical Center, Detroit, MI, USA Abstract: The majority of invasive mold infections diagnosed in immunocompromised cancer patients include invasive aspergillosis (IA and mucormycosis. Despite timely and effective therapy, mortality remains considerable. Antifungal agents currently available for the management of these serious infections include triazoles, polyenes, and echinocandins. Until recently, posaconazole has been the only triazole with a broad spectrum of anti-mold activity against both Aspergillus sp. and mucorales. Other clinically available triazoles voriconazole and itraconazole, with poor activity against mucorales, have significant drug interactions in addition to a side effect profile inherent for all triazoles. Polyenes including lipid formulations pose a problem with infusion-related side effects, electrolyte imbalance, and nephrotoxicity. Echinocandins are ineffective against mucorales and are approved as salvage therapy for refractory IA. Given that all available antifungal agents have limitations, there has been an unmet need for a broad-spectrum anti-mold agent with a favorable profile. Following phase III clinical trials that started in 2006, isavuconazole (ISZ seems to fit this profile. It is the first novel triazole agent recently approved by the United States Food and Drug Administration (FDA for the treatment of both IA and mucormycosis. This review provides a brief overview of the salient features of ISZ, its favorable profile with regard to spectrum of antifungal activity, pharmacokinetic and pharmacodynamic parameters, drug interactions and tolerability, clinical efficacy, and side effects. Keywords: isavuconazole, aspergillosis, mucormycosis, efficacy, antifungal therapy, novel azole, tolerability, drug interactions

  11. Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study.

    Science.gov (United States)

    Hoerauf, Hans; Feltgen, Nicolas; Weiss, Claudia; Paulus, Eva-Maria; Schmitz-Valckenberg, Steffen; Pielen, Amelie; Puri, Pankaj; Berk, Hüsnü; Eter, Nicole; Wiedemann, Peter; Lang, Gabriele E; Rehak, Matus; Wolf, Armin; Bertelmann, Thomas; Hattenbach, Lars-Olof

    2016-09-01

    To compare the efficacy and safety of the European labels of ranibizumab 0.5 mg vs dexamethasone 0.7 mg in patients with macular edema secondary to central retinal vein occlusion (CRVO). Phase IIIb, multicenter, double-masked, randomized clinical trial. Patients were randomized (1:1) to receive either monthly ranibizumab followed by pro re nata (PRN) treatment (n = 124) or 1 sustained-release dexamethasone implant followed by PRN sham injections (n = 119). Main outcomes were mean average change in best-corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean change in BCVA, and adverse events (AEs). Of 243 patients, 185 (76.1%) completed the study. No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2. From month 3 to month 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs 2.96 letters; difference 9.91 letters, 95% confidence interval [6.51-13.30]; P < .0001). Mean injection number of ranibizumab was 4.52. Ocular AEs were reported in more patients in the dexamethasone than in the ranibizumab group (86.6% vs 55.6%). Using the European labels, similar efficacy was observed for ranibizumab and dexamethasone at months 1 and 2. However, ranibizumab maintained its efficacy throughout the study, whereas dexamethasone declined from month 3 onward. The main limitation of the study was that dexamethasone patients received only a single treatment during the 6-month study. In clinical practice, dexamethasone retreatment may be required earlier than 6 months. Safety findings were similar to those previously reported. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Analysis of effectiveness, safety and optimization of tocilizumab in a cohort of patients with rheumatoid arthritis in clinical practice.

    Science.gov (United States)

    Mena-Vázquez, Natalia; Manrique-Arija, Sara; Rojas-Giménez, Marta; Ureña-Garnica, Inmaculada; Jiménez-Núñez, Francisco G; Fernández-Nebro, Antonio

    2017-07-01

    To evaluate the effectiveness and safety of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in clinical practice, establishing the optimized regimen and switching from intravenous (IV) to subcutaneous (SC) therapy. Retrospective observational study. We included 53 RA patients treated with TCZ. The main outcome was TCZ effectiveness at week 24. Secondary outcome variables included effectiveness at week 52, therapeutic maintenance, physical function and safety. The effectiveness of optimization and the switch from IV to SC was evaluated at 3 and 6 months. The efficacy was measured with the Disease Activity Score. Paired t-tests or Wilcoxon were used to evaluate effectiveness and survival time using Kaplan-Meier. The proportion of patients who achieved remission or low disease activity at weeks 24 and 52 was 75.5% and 87.3%, respectively. The mean retention time (95% confidence interval [95% CI] was 81.7 months [76.6-86.7]). Twenty-one of 53 patients (39.6%) optimized the TCZ dose and 35 patients switched from IV TCZ to SC, with no changes in effectiveness. The adverse event rate was 13.6 events/100 patient-years. Tocilizumab appears to be effective and safe in RA in clinical practice. The optimized regimen appears to be effective in most patients in remission, even when they change from IV to SC. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  13. Clinical efficacy and safety of lamotrigine monotherapy in newly diagnosed pediatric patients with epilepsy

    Directory of Open Access Journals (Sweden)

    Ji Hye Han

    2010-04-01

    Full Text Available Purpose : To verify the efficacy and safety of lamotrigine (LTG monotherapy in newly diagnosed children with epilepsy. Methods : We prospectively enrolled 148 children who had undergone LTG monotherapy at our institution between September 2002 and June 2009. Twenty-nine patients were excluded: 19 due to incomplete data and 10 were lost to follow up. The data of the remaining 119 patients was analyzed. Results : We enrolled 119 pediatric epilepsy patients (aged 2.8-19.3 years; 66 males and 53 females in this study. Out of 119 patients, 29 (25.2% had generalized epilepsy and 90 (74.8% had partial epilepsy. The responses of seizure reduction were as follows: Seizure freedom (no seizure attack for at least 6 months in 87/111 (78.4%, n=111 patients; partial response (reduced seizure frequency compared to baseline in 13 (11.7% patients; and persistent seizure in 11 (9.9% patients. The seizure freedom rate was in 81.6% in patients with partial seizure (75.9% for complex partial seizure and 90.9% for benign rolandic epilepsy and 44.8% in patients with generalized epilepsy (30.0% for absence seizure, 35.7% for juvenile myoclonic epilepsy patients, and 100.0% for idiopathic generalized epilepsy patients. Adverse reactions were reported in 17 (14.3% patients, and 8 patients (6.7% discontinued LTG because of rash and tic. No patient experienced severe adverse reaction such as Stevens-Johnson syndrome. Conclusion : LTG showed excellent therapeutic response and had few significant adverse effects. Our findings report may contribute in promoting the use of LTG monotherapy in epileptic children.

  14. The effectiveness and safety of lacosamide in children with epilepsy in a clinical practice setting.

    Science.gov (United States)

    Sanmartí-Vilaplana, Francesc; Díaz-Gómez, Asunción

    2018-02-01

    Seizures in up to 30% of children with epilepsy become refractory to treatment, decreasing their quality of life. Studies suggest that lacosamide may be effective in pediatric patients with refractory epilepsy. To assess the effectiveness and safety of lacosamide in a population of children with mostly focal refractory epilepsy. Retrospective analysis of children aged <18years presenting to a single hospital in Spain. Data from baseline, and 3, 6, and 12months after lacosamide initiation were collected and analyzed. Response to lacosamide was categorized by seizure frequency (seizure freedom or ≥75%, ≥50%, and <50% reduction in seizures). One hundred ninety-one pediatric patients (~55% male) with focal epilepsy treated with lacosamide were included. The mean age at lacosamide initiation was 9.4years, and the mean duration of epilepsy was 5.4years. Seizure-free rates at 3, 6, and 12months were 9.7%, 11.8%, and 16.0%. At 12months, 44.4% of the population had a ≥50% reduction in seizure frequency. When analyzing response according to the number of previous/concomitant AEDs, those patients who received ≤2 previous AEDs/fewer concomitant AEDs had significantly greater response rates than those who received greater numbers of previous/concomitant AEDs; however, no predictive factors for response were identified. The most common adverse events were seizure number increased (14.7%), diplopia (5.2%), dizziness (3.7%), ataxia (2.1%), and drowsiness (2.1%). Lacosamide use in children with refractory focal epilepsy can result in a reduction in seizure rate that improves progressively over time with few adverse effects, making lacosamide a promising option in these patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Overview of the Clinical Consult Case Review of Adverse Events Following Immunization: Clinical Immunization Safety Assessment Network (CISA) 2004-2009

    Science.gov (United States)

    Williams, S Elizabeth; Klein, Nicola P; Halsey, Neal; Dekker, Cornelia L; Baxter, Roger P; Marchant, Colin D; LaRussa, Philip S; Sparks, Robert C; Tokars, Jerome I; Pahud, Barbara A; Aukes, Laurie; Jakob, Kathleen; Coronel, Silvia; Choi, Howard; Slade, Barbara A; Edwards, Kathryn M

    2016-01-01

    Background In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations. PMID:21801776

  16. Overview of the Clinical Consult Case Review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004-2009.

    Science.gov (United States)

    Williams, S Elizabeth; Klein, Nicola P; Halsey, Neal; Dekker, Cornelia L; Baxter, Roger P; Marchant, Colin D; LaRussa, Philip S; Sparks, Robert C; Tokars, Jerome I; Pahud, Barbara A; Aukes, Laurie; Jakob, Kathleen; Coronel, Silvia; Choi, Howard; Slade, Barbara A; Edwards, Kathryn M

    2011-09-16

    In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

  17. Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye: a Japanese Phase II clinical trial

    Directory of Open Access Journals (Sweden)

    Toshida H

    2017-06-01

    Full Text Available Hiroshi Toshida,1 Toshinari Funaki,2 Koichi Ono,3 Nobuhito Tabuchi,4 Sota Watanabe,4 Tamotsu Seki,5 Hiroshi Otake,6 Takuji Kato,7 Nobuyuki Ebihara,8 Akira Murakami2 1Department of Ophthalmology, Juntendo University Shizuoka Hospital, Shizuoka, 2Department of Ophthalmology, Juntendo University Graduate School of Medicine, 3Department of Ophthalmology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, 4Pharmaceutical Research Laboratories, Lion Corporation, Kanagawa, 5Tamagawa Eye Clinic, Tokyo, 6Otake Eye Clinic, Kanagawa, 7Kato Eye Clinic, Tokyo, 8Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan Purpose: The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal ophthalmic solution (500 IU/mL for the treatment of patients with dry eye. Patients and methods: This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1 into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. Results: In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks (P<0.05 and P<0.01, respectively. Furthermore, the fluorescein clearance rate (fluorescein staining score was significantly higher in the VApal group at 4 weeks (P<0.05. The VApal group showed a significant improvement in blurred vision at 1 and 2 weeks (P<0.01 and P<0.05, respectively, and the mean change in the total score for subjective symptoms from baseline was significantly lower in the VApal group at 1 week (P<0.05. In before- and after-intervention comparisons, the

  18. Surgical Precision in Clinical Documentation Connects Patient Safety, Quality of Care, and Reimbursement.

    Science.gov (United States)

    Kittinger, Benjamin J; Matejicka, Anthony; Mahabir, Raman C

    2016-01-01

    Emphasis on quality of care has become a major focus for healthcare providers and institutions. The Centers for Medicare and Medicaid Services has multiple quality-of-care performance programs and initiatives aimed at providing transparency to the public, which provide the ability to directly compare services provided by hospitals and individual physicians. These quality-of-care programs highlight the transition to pay for performance, rewarding physicians and hospitals for high quality of care. To improve the use of pay for performance and analyze quality-of-care outcome measures, the Division of Plastic Surgery at Scott & White Memorial Hospital participated in an inpatient clinical documentation accuracy project (CDAP). Performance and improvement on metrics such as case mix index, severity of illness, risk of mortality, and geometric mean length of stay were assessed after implementation. After implementation of the CDAP, the division of plastic surgery showed increases in case mix index, calculated severity of illness, and calculated risk of mortality and a decrease in length of stay. For academic plastic surgeons, quality of care demands precise documentation of each patient. The CDAP provides one avenue to hone clinical documentation and performance on quality measures.

  19. Randomized clinical trial: pharmacokinetics and safety of multimatrix mesalamine for treatment of pediatric ulcerative colitis

    Directory of Open Access Journals (Sweden)

    Cuffari C

    2016-02-01

    Full Text Available Carmen Cuffari,1 David Pierce,2 Bartosz Korczowski,3 Krzysztof Fyderek,4 Heather Van Heusen,5 Stuart Hossack,6 Hong Wan,5 Alena YZ Edwards,7 Patrick Martin5 1Department of Pediatrics, Division of Pediatric Gastroenterology and Nutrition, The Johns Hopkins University School of Medicine, Baltimore, MD, USA; 2Shire, Basingstoke, UK; 3Medical College, University of Rzeszów, Rzeszów, Poland; 4University Children’s Hospital of Cracow, Cracow, Poland; 5Shire, Wayne, PA, USA; 6Covance Clinical Research Unit Limited, Leeds, UK; 7ICON Early Phase Services, Marlow, Buckinghamshire, UK Background: Limited data are available on mesalamine (5-aminosalicylic acid; 5-ASA use in pediatric ulcerative colitis (UC.Aim: To evaluate pharmacokinetic and safety profiles of 5-ASA and metabolite acetyl-5-ASA (Ac-5-ASA after once-daily, oral administration of multimatrix mesalamine to children and adolescents with UC.Methods: Participants (5–17 years of age; 18–82 kg, stratified by weight with UC received multimatrix mesalamine 30, 60, or 100 mg/kg/day once daily (to 4,800 mg/day for 7 days. Blood samples were collected pre-dose on days 5 and 6. On days 7 and 8, blood and urine samples were collected and safety was evaluated. 5-ASA and Ac-5-ASA plasma and urine concentrations were analyzed by non-compartmental methods and used to develop a population pharmacokinetic model.Results: Fifty-two subjects (21 [30 mg/kg]; 22 [60 mg/kg]; 9 [100 mg/kg] were randomized. On day 7, systemic exposures of 5-ASA and Ac-5-ASA exhibited a dose-proportional increase between 30 and 60 mg/kg/day cohorts. For 30, 60, and 100 mg/kg/day doses, mean percentages of 5-ASA absorbed were 29.4%, 27.0%, and 22.1%, respectively. Simulated steady-state exposures and variabilities for 5-ASA and Ac-5-ASA (coefficient of variation approximately 50% and 40%–45%, respectively were similar to those observed previously in adults at comparable doses. Treatment-emergent adverse events were

  20. Feasibility and safety of electrochemotherapy (ECT) in the pancreas: a pre-clinical investigation

    International Nuclear Information System (INIS)

    Girelli, Roberto; Prejanò, Simona; Cataldo, Ivana; Corbo, Vincenzo; Martini, Lucia; Scarpa, Aldo; Claudio, Bassi

    2015-01-01

    Pancreatic ductal adenocarcinoma (PDAC) is a lethal disease generally refractory to standard chemotherapeutic agents; therefore improvements in anticancer therapies are mandatory. A major determinant of therapeutic resistance in PDAC is the poor drug delivery to neoplastic cells, mainly due to an extensive fibrotic reaction. Electroporation can be used in vivo to increase cancer cells’ local uptake of chemotherapeutics (electrochemotherapy, ECT), thus leading to an enhanced tumour response rate. In the present study, we evaluated the in vivo effects of reversible electroporation in normal pancreas in a rabbit experimental model. We also tested the effect of electroporation on pancreatic cancer cell lines in order to evaluate their increased sensitivity to chemotherapeutic agents. The application in vivo of the European Standard Operating Procedure of Electrochemotherapy (ESOPE) pulse protocol (1000 V/cm, 8 pulses, 100 μs, 5 KHz) was tested on the pancreas of normal New Zealand White Rabbits and short and long-term toxicity were assessed. PANC1 and MiaPaCa2 cell lines were tested for in vitro electrochemotherapy experiments with and without electroporation. Levels of cell permeabilization were determined by flow cytometry, whereas cell viability and drug (cisplatin and bleomycin) sensitivity of pulsed cells were measured by 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl) -2H-tetrazolium (MTS) assay. In healthy rabbits, neither systemic nor local toxic effects due to the electroporation procedure were observed, demonstrating the safety of the optimized electric parameters in the treatment of the pancreas in vivo. In parallel, we established an optimized protocol for ECT in vitro that determined an enhanced anti-cancer effect of bleomycin and cisplatin with respect to treatment without electroporation. Our data suggest that electroporation is a safe procedure in the treatment of PDAC because it does not affect normal pancreatic parenchyma

  1. [Good clinical practices in clinical trials: the responsibility of the researcher. A survey of 827 hospital physicians (I). Availability. Monitoring. Safety. Contract].

    Science.gov (United States)

    Dal-Ré, R

    1993-03-06

    The Law of Medicaments establishes that clinical trials (CT) with drugs must be carried out following the of Good Clinical Practice guidelines (GCP). The attitude of hospital physicians to the GCP prior to its implementation as mandatory in accordance with Spanish legislation was considered to be of interest. An anonymous survey was used with closed response questions. Questions referring to the responsibilities of the investigator included in the GCP were included. From December 1988 to February 1990 the survey was distributed among 1,706 hospital medical staff members, of any specialty, who had or had not participated in CT. In this article the results of the questions regarding the availability of the investigative team, CT monitorization, management of adverse reactions, the safety of the participants in the CT and the contract between the sponsor and the researcher are presented. A total of 827 hospital doctors replied to the survey. Fifty-nine percent had intervened in CT with drugs. At least 94% of those surveyed considered that the researcher must have the time and number of eligible patients which the CT requires. There was high acceptance (> or = 78%) of the clinical audits to be performed by the health authorities and the sponsor company of the CT. The need of urgent communication of the severe adverse reactions is admitted by a great majority (> or = 95%) of those surveyed. Eighty-five percent believe that patients should be insured against damage derived from CT with 76% considering that the investigator should sign a contract with the sponsor; 68% and 59% would hand in a copy of the same to the CT committee and the remainder of the research team, respectively. According to the Good Clinical Practice dealt with in this article, the responsibilities of the investigator have been widely accepted by the hospital physicians surveyed, therefore no problems should be expected upon the implementation of the same in this country. However, the economic

  2. Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System.

    Science.gov (United States)

    Rossi, Elio G; Bellandi, Tommaso; Picchi, Marco; Baccetti, Sonia; Monechi, Maria Valeria; Vuono, Catia; Sabatini, Federica; Traversi, Antonella; Di Stefano, Mariella; Firenzuoli, Fabio; Albolino, Sara; Tartaglia, Riccardo

    2017-12-16

    Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.

  3. Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System

    Directory of Open Access Journals (Sweden)

    Elio G. Rossi

    2017-12-01

    Full Text Available Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA and failure modes and effects analysis (FMEA. Methods: SEA is the selected tool for studying adverse events (AE and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS. This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN, and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.

  4. Efficacy and safety of mifepristone-buccal misoprostol for early medical abortion in an Australian clinical setting.

    Science.gov (United States)

    Goldstone, Philip; Walker, Clara; Hawtin, Katherine

    2017-06-01

    In 2014, a composite pack containing mifepristone-buccal misoprostol, indicated for use to 63 days gestation replaced the existing regimen for early medical abortion (EMA) in Australia. To provide updated efficacy and safety information for the use of mifepristone-buccal misoprostol for EMA in Australia, and assess the effect of patient age and gestational age on efficacy. Observational cohort study of 15 008 women attending one of 16 Marie Stopes International clinics in Australia for an EMA (gestational age ≤ 63 days) between 1 March 2013 and 30 September 2015. Administration of 200 mg oral mifepristone in-clinic was followed 24-48 h later by 800 μg buccal misoprostol self-administered at home. Method success was defined as complete abortion not requiring surgical intervention. Follow-up information was available for 87.14% (13 078/15 008) of women. Likelihood of follow-up was significantly lower for women from rural or remote locations (adjusted odds ratio, 0.47; P misoprostol is an effective and safe alternative to surgical termination of pregnancy up to 63 days gestation. © 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  5. Safety and Efficacy of Antiviral Therapy for Prevention of Cytomegalovirus Reactivation in Immunocompetent Critically Ill Patients: A Randomized Clinical Trial.

    Science.gov (United States)

    Cowley, Nicholas J; Owen, Andrew; Shiels, Sarah C; Millar, Joanne; Woolley, Rebecca; Ives, Natalie; Osman, Husam; Moss, Paul; Bion, Julian F

    2017-06-01

    Latent cytomegalovirus (CMV) infection is present in more than half the adult population, and a viral reactivation (ie, when the virus becomes measurable in body fluids such as blood) can occur in up to one-third of these individuals during episodes of critical illness. To determine whether antiviral therapy is safe and effective for preventing CMV reactivation in a general population of critically ill patients. A single-center, open-label, randomized, controlled clinical trial recruited 124 CMV-seropositive patients undergoing mechanical ventilation for at least 24 hours in the intensive care unit between January 1, 2012, and January 31, 2014. The mean baseline Acute Physiology and Chronic Health Evaluation II score of all patients was 17.6. Patients were randomized to receive anti-CMV prophylaxis with valacyclovir hydrochloride (n = 34) or low-dose valganciclovir hydrochloride (n = 46) for up to 28 days to suppress viral reactivation, or to a control group with no intervention (n = 44). Time to first CMV reactivation in blood within the 28-day follow-up period following initiation of the study drug. Among the 124 patients in the study (46 women and 78 men; mean [SD] age, 56.9 [16.9] years), viral reactivation in the blood occurred in 12 patients in the control group, compared with 1 patient in the valganciclovir group and 2 patients in the valacyclovir group (combined treatment groups vs control: hazard ratio, 0.14; 95% CI 0.04-0.50). Although this trial was not powered to assess clinical end points, the valacyclovir arm was halted prematurely because of higher mortality; 14 of 34 patients (41.2%) had died by 28 days, compared with 5 of 37 (13.5%) patients in the control arm at the point of the decision to halt this arm. Other safety end points showed similar outcomes between groups. Antiviral prophylaxis with valacyclovir or low-dose valganciclovir suppresses CMV reactivation in patients with critical illness. However, given the higher mortality, a

  6. Multi-method laboratory user evaluation of an actionable clinical performance information system: Implications for usability and patient safety.

    Science.gov (United States)

    Brown, Benjamin; Balatsoukas, Panos; Williams, Richard; Sperrin, Matthew; Buchan, Iain

    2018-01-01

    Electronic audit and feedback (e-A&F) systems are used worldwide for care quality improvement. They measure health professionals' performance against clinical guidelines, and some systems suggest improvement actions. However, little is known about optimal interface designs for e-A&F, in particular how to present suggested actions for improvement. We developed a novel theory-informed system for primary care (the Performance Improvement plaN GeneratoR; PINGR) that covers the four principal interface components: clinical performance summaries; patient lists; detailed patient-level information; and suggested actions. As far as we are aware, this is the first report of an e-A&F system with all four interface components. (1) Use a combination of quantitative and qualitative methods to evaluate the usability of PINGR with target end-users; (2) refine existing design recommendations for e-A&F systems; (3) determine the implications of these recommendations for patient safety. We recruited seven primary care physicians to perform seven tasks with PINGR, during which we measured on-screen behaviour and eye movements. Participants subsequently completed usability questionnaires, and were interviewed in-depth. Data were integrated to: gain a more complete understanding of usability issues; enhance and explain each other's findings; and triangulate results to increase validity. Participants committed a median of 10 errors (range 8-21) when using PINGR's interface, and completed a median of five out of seven tasks (range 4-7). Errors violated six usability heuristics: clear response options; perceptual grouping and data relationships; representational formats; unambiguous description; visually distinct screens for confusable items; and workflow integration. Eye movement analysis revealed the integration of components largely supported effective user workflow, although the modular design of clinical performance summaries unnecessarily increased cognitive load. Interviews and

  7. Clinical safety of magnetic resonance imaging in patients with implanted SynchroMed EL infusion pumps

    Energy Technology Data Exchange (ETDEWEB)

    Diehn, Felix E.; Wood, Christopher P.; Watson, Robert E.; Hunt, Christopher H. [Mayo Clinic, Department of Radiology, Rochester, MN (United States); Mauck, William D. [Mayo Clinic, Department of Anesthesiology, Rochester, MN (United States); Burke, Michelle M. [Mayo Clinic, Department of Psychiatry and Psychology, Rochester, MN (United States)

    2011-02-15

    Patients with implanted SynchroMed spinal infusion pumps (Medtronic, Inc., Minneapolis, MN) routinely undergo magnetic resonance imaging at our institution. In August 2008, Medtronic issued an urgent medical device correction report regarding several pumps. Because of the rare potential ''for a delay in the return of proper drug infusion'' and ''for a delay in the logging of motor stall events,'' ''a patient's pump must be interrogated after MRI exposure in order to confirm proper pump functionality.'' This is particularly important in patients receiving intrathecal baclofen, for whom a delay in return of proper pump infusion could lead to life-threatening baclofen withdrawal syndrome. The objective of this report is to present our experience and protocol of performing magnetic resonance imaging in patients with implanted SynchroMed EL pumps. We retrospectively reviewed records of 86 patients with implanted SynchroMed EL spinal infusion pumps who underwent 112 examinations on 1.5-T magnetic resonance imaging scanners from September 1, 1998 to July 7, 2004. No SynchroMed EL pumps were damaged by magnetic resonance imaging, and the programmable settings remained unchanged in all patients. Our data suggest that SynchroMed EL pump malfunction is indeed rare after routine clinical 1.5-T magnetic resonance imaging examinations. However, based on the Medtronic correction report, we perform pump interrogation before and after imaging. (orig.)

  8. Clinical safety of magnetic resonance imaging in patients with implanted SynchroMed EL infusion pumps

    International Nuclear Information System (INIS)

    Diehn, Felix E.; Wood, Christopher P.; Watson, Robert E.; Hunt, Christopher H.; Mauck, William D.; Burke, Michelle M.

    2011-01-01

    Patients with implanted SynchroMed spinal infusion pumps (Medtronic, Inc., Minneapolis, MN) routinely undergo magnetic resonance imaging at our institution. In August 2008, Medtronic issued an urgent medical device correction report regarding several pumps. Because of the rare potential ''for a delay in the return of proper drug infusion'' and ''for a delay in the logging of motor stall events,'' ''a patient's pump must be interrogated after MRI exposure in order to confirm proper pump functionality.'' This is particularly important in patients receiving intrathecal baclofen, for whom a delay in return of proper pump infusion could lead to life-threatening baclofen withdrawal syndrome. The objective of this report is to present our experience and protocol of performing magnetic resonance imaging in patients with implanted SynchroMed EL pumps. We retrospectively reviewed records of 86 patients with implanted SynchroMed EL spinal infusion pumps who underwent 112 examinations on 1.5-T magnetic resonance imaging scanners from September 1, 1998 to July 7, 2004. No SynchroMed EL pumps were damaged by magnetic resonance imaging, and the programmable settings remained unchanged in all patients. Our data suggest that SynchroMed EL pump malfunction is indeed rare after routine clinical 1.5-T magnetic resonance imaging examinations. However, based on the Medtronic correction report, we perform pump interrogation before and after imaging. (orig.)

  9. A clinical review of GLP-1 receptor agonists: efficacy and safety in diabetes and beyond

    Directory of Open Access Journals (Sweden)

    Lalita Prasad-Reddy

    2015-07-01

    Full Text Available The prevalence of type 2 diabetes is increasing at an astounding rate. Many of the agents used to treat type 2 diabetes have undesirable adverse effects of hypoglycemia and weight gain. Glucagon-like peptide-1 (GLP-1 receptor agonists represent a unique approach to the treatment of diabetes, with benefits extending outside glucose control, including positive effects on weight, blood pressure, cholesterol levels, and beta-cell function. They mimic the effects of the incretin hormone GLP-1, which is released from the intestine in response to food intake. Their effects include increasing insulin secretion, decreasing glucagon release, increasing satiety, and slowing gastric emptying. There are currently four approved GLP-1 receptor agonists in the United States: exenatide, liraglutide, albiglutide, and dulaglutide. A fifth agent, lixisenatide, is available in Europe. There are important pharmacodynamic, pharmacokinetic, and clinical differences of each agent. The most common adverse effects seen with GLP-1 therapy include nausea, vomiting, and injection-site reactions. Other warnings and precautions include pancreatitis and thyroid cell carcinomas. GLP-1 receptor agonists are an innovative and effective option to improve blood glucose control, with other potential benefits of preserving beta-cell function, weight loss, and increasing insulin sensitivity. Once-weekly formulations may also improve patient adherence. Overall, these are effective agents for patients with type 2 diabetes, who are either uncontrolled on metformin or intolerant to metformin.

  10. Percutaneous Ultrasound-Guided Carpal Tunnel Release: Study Upon Clinical Efficacy and Safety

    Energy Technology Data Exchange (ETDEWEB)

    Petrover, David, E-mail: dpetrover@yahoo.fr; Silvera, Jonathan, E-mail: silvera.jonathan@gmail.com [Imagerie Médicale Paris Centre Bachaumont-clinique Blomet RamsayGDS, Department of Interventional Radiology (France); Baere, Thierry De, E-mail: Debaere@igr.fr [Gustave Roussy Institute (France); Vigan, Marie, E-mail: marie.vigan@gmail.com [Association pour la recherche en chirurgie de l’épaule et du coude, clinique Drouot (France); Hakimé, Antoine, E-mail: thakime@yahoo.com [Imagerie Médicale Paris Centre Bachaumont-clinique Blomet RamsayGDS, Department of Interventional Radiology (France)

    2017-04-15

    ObjectivesTo evaluate the feasibility and 6 months clinical result of sectioning of the transverse carpal ligament (TCL) and median nerve decompression after ultra-minimally invasive, ultrasound-guided percutaneous carpal tunnel release (PCTR) surgery.MethodsConsecutive patients with carpal tunnel syndrome were enrolled in this descriptive, open-label study. The procedure was performed in the interventional radiology room. Magnetic resonance imaging was performed at baseline and 1 month. The Boston Carpal Tunnel Questionnaire was administered at baseline, 1, and 6 months.Results129 patients were enrolled. Significant decreases in mean symptom severity scores (3.3 ± 0.7 at baseline, 1.7 ± 0.4 at Month 1, 1.3 ± 0.3 at Month 6) and mean functional status scores (2.6 ± 1.1 at baseline, 1.6 ± 0.4 at Month 1, 1.3 ± 0.5 at Month 6) were noted. Magnetic resonance imaging showed a complete section of all TCL and nerve decompression in 100% of patients. No complications were identified.ConclusionsUltrasound-guided PCTR was used successfully to section the TCL, decompress the median nerve, and reduce self-reported symptoms.

  11. Safety of amisulpride in combination with antidepressants under common clinical practice conditions.

    Science.gov (United States)

    Ceskova, Eva; Suchopar, Josef; Priborska, Zuzana

    2011-06-01

    The main objective was to identify the occurrence of adverse events associated with amisulpride when combined with antidepressants (ADs). A non-interventional questionnaire-based study focussed on identification of occurrence and tolerance of combinations of amisulpride with ADs under common clinical practice conditions. Combinations of amisulpride with ADs were administered to 3178 patients suffering from depression. The average daily dose of amisulpride was 54.8 ± 17 mg (range 50-150 mg/day). The most frequently administered ADs were SSRIs. A total of 4463 adverse events were recorded in 1624 (51%) of all treated patients. The most frequent adverse event was weight gain, followed by headache, fatigue and sleepiness. Only 2% of all adverse events were evaluated as adverse events of medium or high intensity. Higher occurrences of some adverse events were noted for specific combinations. The advantages of AD combinations undoubtedly include administration of lower doses and a reduction of adverse events associated with higher doses of individual ADs. On the other hand, adverse events can also sum. Nevertheless it is generally agreed that, in some patients, a combination of ADs, with different mechanisms of action, can be considered safe and effective polypharmacy.

  12. Clinical review: Balancing the therapeutic, safety, and economic issues underlying effective antipseudomonal carbapenem use

    Science.gov (United States)

    Slama, Thomas G

    2008-01-01

    Antipseudomonal carbapenems have played a useful role in our antimicrobial armamentarium for 20 years. However, a review of their use during that period creates concern that their clinical effectiveness is critically dependent on attainment of an appropriate dosing range. Unfortunately, adequate carbapenem dosing is missed for many reasons, including benefit/risk misconceptions, a narrow therapeutic window for imipenem and meropenem (due to an increased rate of seizures at higher doses), increasingly resistant pathogens requiring higher doses than are typically given, and cost containment issues that may limit their use. To improve the use of carbapenems, several initiatives should be considered: increase awareness about appropriate treatment with carbapenems across hospital departments; determine optimal dosing regimens for settings where multidrug resistant organisms are more likely encountered; use of, or combination with, an alternative antimicrobial agent having more favorable pharmacokinetic, pharmacodynamic, or adverse event profile; and administer a newer carbapenem with lower propensity for resistance development (for example, reduced expression of efflux pumps or greater stability against carbapenemases). PMID:18983709

  13. Pre-clinical in vitro and in vivo safety evaluation of Cimicifuga heracleifolia.

    Science.gov (United States)

    Yun, Jun-Won; You, Ji-Ran; Kim, Yun-Soon; Cho, Eun-Young; Kim, Seung-Hyun; Yoon, Jung-Hee; Kwon, Euna; Chung, Doo Hyun; Kim, Young Tae; Jang, Ja-June; Che, Jeong-Hwan; Kang, Byeong-Cheol

    2015-10-01

    The rhizomes of Cimicifuga species, including Cimicifuga heracleifolia (CH), have been widely used as antipyretic, analgesic, and anti-inflammatory agents in oriental countries. However, information regarding its toxicity, especially long-term toxicity and genotoxicity, is limited. Therefore, we performed the subchronic toxicity and genotoxicity assays of the CH extract in accordance with the test guidelines published by the Organization for Economic Cooperation and Development. In a 13-week repeat-dose oral toxicity study, the CH extract did not influence body weight, food/water consumption, mortality, clinical signs, and urinalysis throughout the study. Noteworthy, the CH extract groups exhibited increased liver weights along with serum alanine transaminase activity rise at doses of 667 and 2000 mg/kg in females. No-observed-adverse-effect-level of the CH extract administered orally was concluded to be 2000 mg/kg body weight/day for male rats and 222 mg/kg body weight/day for female rats. The CH extract did not exert a mutagenic or clastogenic effect in Ames test, in vitro chromosome aberration assay and in vivo micronucleus assay. Overall findings of the subchronic toxicity study indicate for the first time that the CH extract may possess hepatotoxic potential in female rats, suggesting that further mechanistic studies should be performed to have more conclusive results on hepatotoxic potential of the CH extract. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics.

    Science.gov (United States)

    Burn, Julie; Sims, Andrew J; Keltie, Kim; Patrick, Hannah; Welham, Sally A; Heaney, Liam G; Niven, Robert M

    2017-10-01

    Bronchial thermoplasty (BT) is a novel treatment for severe asthma. Its mode of action and ideal target patient group remain poorly defined, though clinical trials provided some evidence on efficacy and safety. This study presents procedural and short-term safety evidence from routine UK clinical practice. Patient characteristics and safety outcomes (procedural complications, 30-day readmission and accident and emergency (A&E) attendance, length of stay) were assessed using two independent data sources, the British Thoracic Society UK Difficult Asthma Registry (DAR) and Hospital Episodes Statistics (HES) database. A matched cohort (with records in both) was used to estimate safety outcome event rates and compare them with clinical trials. Between June 2011 and January 2015, 215 procedure records (83 patients; 68 treated in England) were available from DAR and 203 (85 patients) from HES. 152 procedures matched (59 patients; 6 centres), and of these, 11.2% reported a procedural complication, 11.8% resulted in emergency respiratory readmission, 0.7% in respiratory A&E attendance within 30 days (20.4% had at least one event) and 46.1% involved a post-procedure stay. Compared with published clinical trials which found lower hospitalisation rates, BT patients in routine clinical practice were, on average, older, had worse baseline lung function and asthma quality of life. A higher proportion of patients experienced adverse events compared with clinical trials. The greater severity of disease amongst patients treated in clinical practice may explain the observed rate of post-procedural stay and readmission. Study of long-term safety and efficacy requires continuing data collection.

  15. Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety.

    Science.gov (United States)

    Palos, Claudia Cristina; Maturana, Ana P; Ghersel, Frederico R; Fernandes, Cesar E; Oliveira, Emerson

    2018-01-01

    The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications. This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings. Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement. The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

  16. Cultivating engaged leadership through a learning collaborative: lessons from primary care renewal in Oregon safety net clinics.

    Science.gov (United States)

    McMullen, Carmit K; Schneider, Jennifer; Firemark, Alison; Davis, James; Spofford, Mark

    2013-01-01

    The aim of this study was to explore how learning collaboratives cultivate leadership skills that are essential for implementing patient-centered medical homes (PCMHs). We conducted an ethnographic evaluation of a payor-incentivized PCMH implementation in Oregon safety net clinics, known as Primary Care Renewal. Analyses primarily drew on in-depth interviews with organizational leaders who were involved in the initiative. We solicited perspectives on the history, barriers, facilitators, and other noteworthy factors related to the implementation of PCMH. We reviewed and summarized transcripts and created and applied a coding dictionary to identify emergent leadership themes. We reviewed field notes from clinic site visits and observations of learning collaborative activities for additional information on the role of engaged leadership. Interview data suggested that organizations followed a similar, sequential process of Primary Care Renewal implementation having 2 phases-inspiration and implementation-and that leaders needed and learned different leadership skills in each phase. Leaders reported that collaborative learning opportunities were critical for developing engaged leadership skills during the inspiration phase of transformation. Facilitative and modeling aspects of engaged leadership were most important for codesigning a vision and plan for change. Adaptive leadership skills became more important during the implementation phase, when specific operational and management skills were needed to foster standardization and spread of the Primary Care Renewal initiative throughout participating clinics. The PCMH has received much attention as a way to reorganize and potentially improve primary care. Documenting steps and stages for cultivating leaders with the vision and skills to transform their organizations into PCMHs may offer a useful roadmap to other organizations considering a similar transformation.

  17. Small bowel capsule endoscopy in the management of established Crohn's disease: clinical impact, safety, and correlation with inflammatory biomarkers.

    Science.gov (United States)

    Kopylov, Uri; Nemeth, Artur; Koulaouzidis, Anastasios; Makins, Richard; Wild, Gary; Afif, Waqqas; Bitton, Alain; Johansson, Gabriele Wurm; Bessissow, Talat; Eliakim, Rami; Toth, Ervin; Seidman, Ernest G

    2015-01-01

    Multiple studies have established the superior diagnostic accuracy of video capsule endoscopy (VCE) for the diagnosis of small bowel (SB) Crohn's disease (CD). However, data on the clinical impact of VCE in patients with established CD are scarce. The aim of this study was to examine the impact and safety of VCE on the clinical management of patients with established CD. A retrospective, multicenter, cross-sectional study. The study cohort included consecutive patients with established SB CD who underwent VCE in 4 tertiary referral centers (1 Canada, 1 Sweden, and 2 United Kingdom) from January 2008 to October 2013. Patients were excluded if VCE was performed as a part of the initial diagnostic workup. The presence of SB mucosal inflammation was quantified using the Lewis score. Inflammatory biomarkers (C-reactive protein and fecal calprotectin) were measured and correlated with the Lewis score. The study included 187 patients. No SB inflammation was observed in 28.4%, mild-to-moderate inflammation in 26.6%, and moderate-to-severe inflammation in 45% of the patients (median Lewis score, 662; range, 0-6400). A change in management was recommended in 52.3% of the patients based on VCE findings. Elevated C-reactive protein, fecal calprotectin, or the combination of both were poorly correlated with significant SB inflammation. SB capsule retention occurred in 4 patients (2.1%). VCE in patients with established CD is safe, and the results often have a significant clinical impact. VCE should not be limited to CD patients with positive inflammatory markers because their predictive value for significant SB inflammation is poor.

  18. Liver resection in hepatitis B-related hepatocellular carcinoma: clinical outcomes and safety in overweight and obese patients.

    Directory of Open Access Journals (Sweden)

    Haiqing Wang

    Full Text Available OBJECTIVE AND BACKGROUND: Although many studies on evaluating the safety of liver resection in obese patients have been conducted, the results remain contradictory. The aim of our study was to investigate the safety of overweight and obese patients undergoing liver resection for hepatitis B-related hepatocellular carcinoma in a large sample. METHODS: In a retrospective cohort with 1543 hepatitis B-related hepatocellular carcinoma patients, the subjects were stratified into four groups according to their body mass index(BMI: obesity(BMI≥28, overweight(BMI:24.0-27.9, normal weight(BMI:18.5-23.9 and underweight(BMI<18.5. The Dindo-Clavien classification system was used for grading complications. Clinical characteristics and operative outcomes were compared among the four groups. Risk factors for postoperative complications were evaluated by multivariate analysis. RESULTS: According to the category criteria of the Working Group on Obesity in China (WGOC criteria, 73(4.7% obese, 412(26.7% overweight, 982(63.6% normal weight and 76(4.9% underweight patients were included in our cohort. Overweight and obese patients had more preoperative comorbidities such as hypertension(P<0.001. Mortality, total complications and complications classified by Clavien system were similar among the four groups except that the underweight patients had fewer total complications. However, postoperative wound complication was more common in overweight and obese patients(6.3% vs 2.5%,P<0.001,11.0% vs 2.5%,P = 0.001. Multivariate analysis revealed that BMI was not an independently significant factor for postoperative complications. CONCLUSIONS: Liver resection for obese and overweight patients is safe and BMI itself is not a risk factor for mortality and morbidity.

  19. Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Yushmanova Irina

    2011-03-01

    Full Text Available Abstract It is important for patients that treatments for diabetes not increase cardiovascular (CV risk. The objective of this analysis was to examine retrospectively the CV safety of exenatide BID, a GLP-1 receptor agonist approved for treating hyperglycemia in patients with type 2 diabetes not adequately controlled with diet and exercise. Individual participant data was pooled to assess the relative risk (RR of CV events with exenatide BID versus a pooled comparator (PC group treated with either placebo or insulin from 12 controlled, randomized, clinical trials ranging from 12-52 weeks. Mean baseline values for HbA1c (8.33-8.38%, BMI (31.3-31.5 kg/m2, and duration of diabetes (8 y were similar between groups. Trials included patients with histories of microvascular and/or macrovascular disease. Customized primary major adverse CV events (MACE included stroke, myocardial infarction, cardiac mortality, acute coronary syndrome, and revascularization procedures. The Primary MACE RR (0.7; 95% CI 0.38, 1.31, calculated by the Mantel-Haenszel method (stratified by study, suggested that exenatide use (vs. PC did not increase CV risk; this result was consistent across multiple analytic methods. Because the trials were not designed to assess CV outcomes, events were identified retrospectively from a list of preferred terms by physicians blinded to treatment. Other limitations included the low number of CV events, the short duration of trials (≤1 y, and a single active comparator (insulin. The results of these analyses are consistent with those of a recent retrospective analysis of a large insurance database that found that patients treated with exenatide twice daily were less likely to have a CV event than were patients treated with other glucose-lowering therapies. Keywords: GLP-1 receptor agonist, diabetes, cardiovascular safety

  20. Safety and Tolerability of Ixekizumab: Integrated Analysis of Injection-Site Reactions from 11 Clinical Trials.

    Science.gov (United States)

    Shear, Neil H; Paul, Carle; Blauvelt, Andrew; Gooderham, Melinda; Leonardi, Craig; Reich, Kristian; Ohtsuki, Mamitaro; Pangallo, Beth; Xu, Wen; Ball, Susan; Ridenour, Terri; Torisu-Itakura, Hitoe; Agada, Noah; Mallbris, Lotus

    2018-02-01

    BACKGROUND: Injection-site reactions (ISRs) are reported with biologic therapies. The objective of this study was to comprehensively characterize ISRs among moderate-to-severe psoriasis patients treated with ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A. METHODS: ISRs are presented from UNCOVER-1, UNCOVER-2, and UNCOVER-3 (12 weeks) and all ixekizumab-exposed patients in 11 controlled and uncontrolled trials (156 weeks). RESULTS: At week 12, reported ISR frequency with 80 mg ixekizumab every 2 weeks (IXE Q2W, 16.8%) was comparable with etanercept twice weekly (16.4%); both were significantly higher than placebo (3.3%). With IXE Q2W, ISRs were mild (12.3%), moderate (3.9%), or severe (0.7%), typically reported in the first 2 weeks (median onset, 6.6 days), and most commonly characterized as nonspecified, erythema, and pain. Generally, erythema onset was delayed, whereas pain occurred around drug administration. Discontinuation from ixekizumab due to ISRs (0.4%) occurred in the first 12 weeks. After 2 weeks, ISR frequency decreased and remained stable (≤4.2%) through week 156. No ISR-related serious adverse events were reported in ixekizumab-treated patients. ISR data were solicited if patients reported injection-associated events. Since nonspecified ISR was the most commonly reported term, specific types might be underreported. CONCLUSIONS: ISRs have been reported with ixekizumab during clinical trials. These reactions are typically tolerable, manageable, and decrease over time. Clinicaltrials.gov: NCT01474512 (UNCOVER-1); NCT01597245 (UNCOVER-2); NCT01646177 (UNCOVER-3); NCT01777191 (UNCOVER-A); NCT01624233 (UNCOVER-J); NCT01107457 (I1F-MC-RHAJ); NCT02561806 (I1F-MC-RHBS); NCT02387801 (I1F-US-RHBO);NCT02513550 (I1F-MC-RHBP); NCT02634801 (I1F-EW-RHBZ) J Drugs Dermatol. 2018;17(2):200-206. THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN

  1. Clinical potential, safety, and tolerability of arbaclofen in the treatment of autism spectrum disorder

    Directory of Open Access Journals (Sweden)

    Frye RE

    2014-05-01

    the treatment of gastroesophageal reflux suggest that arbaclofen is safe and well-tolerated. Clearly, further clinical studies are needed in order to refine the symptoms and characteristics of children with ASD that are best treated with arbaclofen.Keywords: autism spectrum disorder, Fragile X, gamma-aminobutyric acid, arbaclofen, R-baclofen, STX209

  2. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection.

    Science.gov (United States)

    Guimarães, Patrícia O; Lopes, Renato D; Stevens, Susanna R; Zimerman, André; Wruck, Lisa; James, Stefan K; Haque, Ghazala; Giraldez, Roberto Rocha C V; Alexander, John H; Alexander, Karen P

    2017-04-24

    End points and adverse events (AEs) are collected separately in clinical trials, yet regulatory requirements for serious AE reporting vary across regions, so classifying end points according to seriousness criteria can be useful in global trials. In the Apixaban for Prevention of Acute Ischemic Events 2 (APPRAISE-2) trial, patients with a recent acute coronary syndrome were randomized to apixaban or placebo for the prevention of recurrent ischemic events. Suspected end points (myocardial infarction, stroke, or bleeding) were adjudicated by an independent clinical events classification committee. Safety criteria were collected for suspected end points and AEs. Patient-level event rates per 100 patient-days of follow-up, modeled using Poisson regression, explored the influence of region and patient characteristics on event reporting. Overall, 13 909 events were reported by 858 sites in 39 countries; 8.4% (n=1166) were suspected end points, and 91.6% (n=12 743) were AEs. Overall, 66.0% of suspected end points were confirmed by the clinical events classification committee. Most clinical events classification committee-confirmed end points met criteria to be classified as serious (94.0%); many clinical events classification committee-negated end points also did (63.2%), but fewer AEs met seriousness criteria (17.9%). The most common seriousness criterion was hospitalization (79.9%, n=2594). Region explained 28.7% of end point- and 26.4% of serious AE-reporting variation, and patient characteristics explained an additional 25.4% of end point and 13.4% of serious AE variation. Nonserious AE-reporting variation was not explained by adjustment. An integrated collection of end points and serious AEs is feasible in a multinational trial and illustrates the shared characteristics of events. Tailoring event collection to fit the phase and purpose of the trial is achievable and informative. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00831441. © 2017 The

  3. Phase 2 clinical study of 123I-IBF, a dopamine D2 receptor imaging agent, to evaluate clinical efficacy and safety in Parkinson's disease and Parkinson syndromes

    International Nuclear Information System (INIS)

    Torizuka, Kanji; Mizuno, Yoshikuni; Kubo, Atsushi

    1999-01-01

    A Phase 2 multicenter trial of 123 I-IBF, (S)-5-iodo-7-N-[(1-ethyl-2-pyrrolidinyl)methyl] carboxamido-2,3-dihydrobenzofuran, was conducted to evaluate its clinical efficacy and safety in 158 patients with Parkinson's disease (PD) or Parkinson syndromes (PS). SPECT data were acquired at two hours (2H-SPECT), after intravenous injection of 123 I-IBF (167 MBq). Additional SPECT scan at three hours (3H-SPECT) and dynamic SPECT scan at most until one hour were performed when possible. No severe side effects due to 123 I-IBF injection were observed. The sensitivity, specificity and accuracy for discriminating PS from PD using the striatal specific binding count-to-frontal cortex count ratio (St/Fc-1) in 3H-SPECT were 72.7%, 81.0% and 78.1% in 64 clinically definite cases (i.e., typical cases), respectively. The putamen-to-caudate ratios were significantly lower in striatonigral degeneration compared with those in PD. The contralateral-to-ipsilateral ratios against the symptomatic side of tremor and/or rigidity in the patients with PD (Hoehn and Yahr I) were significantly higher than the left-to-right ratios in the normal controls. St/Fc-1 in 3H-SPECT was significantly lower in the patients showing a poor response to levodopa than in those showing a good response. The dopamine D 2 receptor binding potential (k 3 /k 4 ), obtained by dynamic SPECT based on compartment model analysis, correlated well with the striatal specific binding count-to-occipital cortex count ratio. These results suggest that 123 I-IBF is a promising agent for differential diagnosis and pathophysiological evaluation of PD and PS. (author)

  4. Non-clinical safety and pharmacokinetic evaluations of propylene glycol aerosol in Sprague-Dawley rats and Beagle dogs.

    Science.gov (United States)

    Werley, Michael S; McDonald, Paddy; Lilly, Patrick; Kirkpatrick, Daniel; Wallery, Jeffrey; Byron, Peter; Venitz, Jürgen

    2011-09-05

    Aerosolized propylene glycol (PG) was generated as log-normally distributed particulate clouds in different concentrations using a novel capillary aerosol generator (CAG) and evaluated in a battery of non-clinical studies intended to assess its potential inhalation and systemic toxicity in 2 species before ICH-compliant "first-time-in-man" studies. Exposures were nose-only in rats, and via face mask with oropharyngeal tube in dogs. The CAG-generated PG aerosol had a mass median aerodynamic diameter (MMAD) of 2.29μm, with a 1.56 geometric standard deviation (GSD) in the rat studies, and a MMAD of 1.34μm (1.45 GSD) in the dog studies, consistent with expected particle size exposures in man. International Congress on Harmonization (ICH) Guidelines were followed, which recommend preliminary non-clinical safety studies using the vehicle and device (CAG-PG) prior to the first human exposure including safety pharmacology, pharmacokinetic (PK) studies, single dose toxicity studies, and repeated dose toxicity studies in two species. In the rat, the only biologically relevant findings included clinical signs of ocular and nasal irritation indicated by minor bleeding around the eyes and nose, and minimal laryngeal squamous metaplasia. This finding is commonly observed in inhalation studies in the rat, and likely related to the unique sensitivity of the tissue, as well as the circuitous airflow pathway through the larynx which increases particle deposition. In the female Beagle dog, treatment-related decreases in hemoglobin, red blood cells and hematocrit were observed in the two highest exposure groups, equivalent to approximately 18 and 60mg/kg/day. In male dogs from the high dose group, similar small decreases, albeit, non-statistically significant decreases were observed in these hematological markers as well. PK studies in rats and dogs showed that the absorption of PG following pulmonary inhalation exposure occurs rapidly, and equilibrium between lung tissue and plasma

  5. A Methodology for Validating Safety Heuristics Using Clinical Simulations: Identifying and Preventing Possible Technology-Induced Errors Related to Using Health Information Systems

    Science.gov (United States)

    Borycki, Elizabeth; Kushniruk, Andre; Carvalho, Christopher

    2013-01-01

    Internationally, health information systems (HIS) safety has emerged as a significant concern for governments. Recently, research has emerged that has documented the ability of HIS to be implicated in the harm and death of patients. Researchers have attempted to develop methods that can be used to prevent or reduce technology-induced errors. Some researchers are developing methods that can be employed prior to systems release. These methods include the development of safety heuristics and clinical simulations. In this paper, we outline our methodology for developing safety heuristics specific to identifying the features or functions of a HIS user interface design that may lead to technology-induced errors. We follow this with a description of a methodological approach to validate these heuristics using clinical simulations. PMID:23606902

  6. Clinical trial: Preliminary efficacy and safety study of a new Budesonide-MMX® 9 mg extended-release tablets in patients with active left-sided ulcerative colitis

    NARCIS (Netherlands)

    D'Haens, G. R.; Kovács, A.; Vergauwe, P.; Nagy, F.; Molnár, T.; Bouhnik, Y.; Weiss, W.; Brunner, H.; Lavergne-Slove, A.; Binelli, D.; Di Stefano, A. F. D.; Marteau, P.

    2010-01-01

    Ulcerative colitis (UC) is a chronic inflammatory disease with relapses. Many patients need systemic corticosteroids to induce clinical remission. Efficacy and safety of Budesonide-MMX® 9 mg tablets, a new oral, extended-release formulation, were evaluated in patients suffering from active,

  7. Safety and feasibility of a diagnostic algorithm combining clinical probability, D-dimer test and ultrasonography in suspected upper extremity deep vein thrombosis

    NARCIS (Netherlands)

    Kleinjan, A.; Di Nisio, M.; Kamphuisen, P.W.; Büller, H.R.

    2010-01-01

    Background: Ultrasonography is currently used as the reference test for clinically suspected upper extremity deep vein thrombosis (UEDVT) although the diagnostic accuracy of the test for this indication remains less well established compared to DVT of the legs. The safety of withholding

  8. Safety and feasibility of a diagnostic algorithm combining clinical probability, d-dimer testing, and ultrasonography for suspected upper extremity deep venous thrombosis : a prospective management study

    NARCIS (Netherlands)

    Kleinjan, Ankie; Di Nisio, Marcello; Beyer-Westendorf, Jan; Camporese, Giuseppe; Cosmi, Benilde; Ghirarduzzi, Angelo; Kamphuisen, Pieter W.; Otten, Hans-Martin; Porreca, Ettore; Aggarwal, Anita; Brodmann, Marianne; Guglielmi, Maria Domenica; Iotti, Matteo; Kaasjager, Karin; Kamvissi, Virginia; Lerede, Teresa; Marschang, Peter; Meijer, Karina; Palareti, Gualtiero; Rickles, Frederick R.; Righini, Marc; Rutjes, Anne W.S.; Tonello, Chiara; Verhamme, Peter; Werth, Sebastian; Van Wissen, Sanne; Büller, Harry R.

    2014-01-01

    Background: Although well-established for suspected lower limb deep venous thrombosis, an algorithm combining a clinical decision score, D-dimer testing, and ultrasonography has not been evaluated for suspected upper extremity deep venous thrombosis (UEDVT). Objective: To assess the safety and

  9. A new method for the assessment of patient safety competencies during a medical school clerkship using an objective structured clinical examination

    Directory of Open Access Journals (Sweden)

    Renata Mahfuz Daud-Gallotti

    2011-01-01

    Full Text Available INTRODUCTION: Patient safety is seldom assessed using objective evaluations during undergraduate medical education. OBJECTIVE: To evaluate the performance of fifth-year medical students using an objective structured clinical examination focused on patient safety after implementation of an interactive program based on adverse events recognition and disclosure. METHODS: In 2007, a patient safety program was implemented in the internal medicine clerkship of our hospital. The program focused on human error theory, epidemiology of incidents, adverse events, and disclosure. Upon completion of the program, students completed an objective structured clinical examination with five stations and standardized patients. One station focused on patient safety issues, including medical error recognition/disclosure, the patient-physician relationship and humanism issues. A standardized checklist was completed by each standardized patient to assess the performance of each student. The student's global performance at each station and performance in the domains of medical error, the patient-physician relationship and humanism were determined. The correlations between the student performances in these three domains were calculated. RESULTS: A total of 95 students participated in the objective structured clinical examination. The mean global score at the patient safety station was 87.59 ± 1.24 points. Students' performance in the medical error domain was significantly lower than their performance on patient-physician relationship and humanistic issues. Less than 60% of students (n = 54 offered the simulated patient an apology after a medical error occurred. A significant correlation was found between scores obtained in the medical error domains and scores related to both the patient-physician relationship and humanistic domains. CONCLUSIONS: An objective structured clinical examination is a useful tool to evaluate patient safety competencies during the medical

  10. A new method for the assessment of patient safety competencies during a medical school clerkship using an objective structured clinical examination.

    Science.gov (United States)

    Daud-Gallotti, Renata Mahfuz; Morinaga, Christian Valle; Arlindo-Rodrigues, Marcelo; Velasco, Irineu Tadeu; Martins, Milton Arruda; Tiberio, Iolanda Calvo

    2011-01-01

    Patient safety is seldom assessed using objective evaluations during undergraduate medical education. To evaluate the performance of fifth-year medical students using an objective structured clinical examination focused on patient safety after implementation of an interactive program based on adverse events recognition and disclosure. In 2007, a patient safety program was implemented in the internal medicine clerkship of our hospital. The program focused on human error theory, epidemiology of incidents, adverse events, and disclosure. Upon completion of the program, students completed an objective structured clinical examination with five stations and standardized patients. One station focused on patient safety issues, including medical error recognition/disclosure, the patient-physician relationship and humanism issues. A standardized checklist was completed by each standardized patient to assess the performance of each student. The student's global performance at each station and performance in the domains of medical error, the patient-physician relationship and humanism were determined. The correlations between the student performances in these three domains were calculated. A total of 95 students participated in the objective structured clinical examination. The mean global score at the patient safety station was 87.59 ± 1.24 points. Students' performance in the medical error domain was significantly lower than their performance on patient-physician relationship and humanistic issues. Less than 60% of students (n = 54) offered the simulated patient an apology after a medical error occurred. A significant correlation was found between scores obtained in the medical error domains and scores related to both the patient-physician relationship and humanistic domains. An objective structured clinical examination is a useful tool to evaluate patient safety competencies during the medical student clerkship.

  11. HPV16 E7 DNA tattooing: safety, immunogenicity, and clinical response in patients with HPV-positive vulvar intraepithelial neoplasia.

    Science.gov (United States)

    Samuels, Sanne; Marijne Heeren, A; Zijlmans, Henry J M A A; Welters, Marij J P; van den Berg, Joost H; Philips, Daisy; Kvistborg, Pia; Ehsan, Ilina; Scholl, Suzy M E; Nuijen, Bastiaan; Schumacher, Ton N M; van Beurden, Marc; Jordanova, Ekaterina S; Haanen, John B A G; van der Burg, Sjoerd H; Kenter, Gemma G

    2017-09-01

    Usual type vulvar intraepithelial neoplasia (uVIN) is caused by HPV, predominantly type 16. Several forms of HPV immunotherapy have been studied, however, clinical results could be improved. A novel intradermal administration route, termed DNA tattooing, is superior in animal models, and was tested for the first time in humans with a HPV16 E7 DNA vaccine (TTFC-E7SH). The trial was designed to test safety, immunogenicity, and clinical response of TTFC-E7SH in twelve HPV16 + uVIN patients. Patients received six vaccinations via DNA tattooing. The first six patients received 0.2 mg TTFC-E7SH and the next six 2 mg TTFC-E7SH. Vaccine-specific T-cell immunity was evaluated by IFNγ-ELISPOT and multiparametric flow cytometry. Only grade I-II adverse events were observed upon TTFC-E7SH vaccination. The ELISPOT analysis showed in 4/12 patients a response to the peptide pool containing shuffled E7 peptides. Multiparametric flow cytometry showed low CD4 + and/or CD8 + T-cell responses as measured by increased expression of PD-1 (4/12 in both), CTLA-4 (2/12 and 3/12), CD107a (5/12 and 4/12), or the production of IFNγ (2/12 and 1/12), IL-2 (3/12 and 4/12), TNFα (2/12 and 1/12), and MIP1β (3/12 and 6/12). At 3 months follow-up, no clinical response was observed in any of the twelve vaccinated patients. DNA tattoo vaccination was shown to be safe. A low vaccine-induced immune response and no clinical response were observed in uVIN patients after TTFC-E7SH DNA tattoo vaccination. Therefore, a new phase I/II trial with an improved DNA vaccine format is currently in development for patients with uVIN.

  12. Clinical Efficacy and Safety of Total Glucosides of Paeony for Primary Sjögren’s Syndrome: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Liang Jin

    2017-01-01

    Full Text Available Objective. To evaluate the clinical efficacy and safety of total glucosides of paeony (TGP for primary Sjögren’s syndrome (pSS. Methods. Eight electronic databases were searched from their inception to July 2016. Clinical randomized controlled trials (RCTs were included. The study quality was evaluated according to the standard suggested in the Cochrane Handbook. RevMan 5.1 was used for statistical analysis. Results. Seven RCTs involving 443 patients were included. The results showed that TGP combined with an immunosuppressant (IS showed greater efficacy for improving the saliva flow test of pSS compared to immunosuppressant alone (WMD −6.88, 95% CI −9.02 to −4.74, and P<0.00001. And the same trend favouring TGP-IS dual combination was found in Schirmer test (WMD 1.63, 95% CI 0.26 to 3.01, and P=0.02, ESR (WMD 7.33, 95% CI −10.08 to −4.59, and P<0.00001, CRP (WMD −6.00, 95% CI −7.17 to −4.83, and P<0.00001, IgM (WMD = −0.42, 95% CI −0.70 to 0.13, and P=0.004, and IgG (WMD −3.22, 95% CI −4.32 to −2.12, and P<0.00001 analysis. However, TGP did not affect IgA (WMD 0.53, 95% CI −1.34 to −0.29, and P=0.20. The adverse events manifested no significant differences between the two groups. Conclusions. The TGP-IS combination is superior to IS alone in the treatment of pSS. However, due to the low quality of included studies, high-quality RCTs are needed to confirm the beneficial effects of TGP.

  13. The comparative study of clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury

    Directory of Open Access Journals (Sweden)

    Dejun Luo

    2017-05-01

    Full Text Available In the present study we compared the clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury. A total of 150 patients were enrolled in the present study and were divided into two groups with 75 patients in each group, receiving baclofen or tolperisone, respectively. We used Modified Ashworth Scale, Medical research council scale, Barthel Index, and Coefficient of efficacy to measure clinical efficacy. After 6-week treatment, both groups demonstrated significant improvement in muscle tone, muscle strength and functional outcome (Group I, 1.55 ± 0.053, 2.79 ± 0.032, 59.31 ± 1.32; Group II, 1.57 ± 0.053, 3.04 ± 0.032, 73 ± 1.32 respectively. There was no significant difference regarding improvement in muscle tone and muscle strength between the two groups (Group I, 1.055 ± 0.053 vs Group II, 1.57 ± 0.053; Group I, 2.79 ± 0.032 vs Group II, 3.04 ± 0.032, p > 0.05. However, the improvement in functional outcomes was greater in group II as compared to that in group I (Group I, 59.31 ± 1.32 vs Group II, 73 ± 1.32, p < 0.05. In addition, overall efficacy coefficient was greater for group II as compared to group I (Group I, 3.6 vs Group II, 2.3, p < 0.05. Group I had more side effects compared to Group II. Compared to baclofen, tolperisone offers greater improvement in activities of daily living compared to baclofen.

  14. Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial.

    Science.gov (United States)

    Zhang, Wei; Kong, Yujia; Jiang, Zhiwei; Li, Chanjuan; Wang, Ling; Xia, Jielai

    2016-04-02

    Human enterovirus 71 (EV71) is a causative agent of hand, foot, and mouth disease (HFMD). In a previous phase III trial in children, a human diploid cell-based inactivated EV71 vaccine elicited EV71 specific immune responses and protection against EV71 associated HFMD. This study aimed to assess the factors influencing the severity of adverse events observed in this previous trial. This was a randomized, double-blinded, placebo-controlled, phase III clinical trial of a human diploid vaccine carried out in 12,000 children in Guangxi Zhuang Autonomous Region, China (ClinicalTrials.gov: NCT01569581). Solicited events were recorded for 7 days and unsolicited events were reported for 28 days after each injection. Age trend analysis of adverse reaction was conducted in each treatment group. Multiple logistic regression models were built to identify factors influencing the severity of adverse reactions. Fewer solicited adverse reactions were observed in older participants within the first 7 days after vaccination (P < 0.0001), except local pain and pruritus. More severe adverse reactions were observed after the initial injection than after the booster injection. Serious cold or respiratory tract infections (RTI) were observed more often in children aged 6-36 months than in older children. Only the severity of local swelling was associated with body mass index. Children with throat discomfort before injection had a higher risk of serious cold or RTI. These results indicated that the human diploid cell-based vaccine achieved a satisfactory safety profile.

  15. Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    A. A. Harandi

    2011-01-01

    Full Text Available Objective. To investigate the safety and efficacy of MLC601 (NeuroAid as a traditional Chinese medicine on motor recovery after ischemic stroke. Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 1 month ischemic stroke. All patients were given either MLC601 (100 patients or placebo (50 patients, 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months. Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P>.05. Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P<.001. Good tolerability to treatment was shown, and adverse events were mild and transient. Conclusion. MLC601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medications especially in the severe and moderate cases.

  16. Multicenter surveillance of adult atypical pneumonia in Japan: its clinical features, and efficacy and safety of clarithromycin.

    Science.gov (United States)

    Goto, Hajime

    2011-02-01

    A prospective multicenter study involving 156 Japanese medical institutions was conducted to clarify the clinical features of adult atypical pneumonia and the efficacy and safety of clarithromycin. Atypical pneumonia was suspected in 730 patients according to the Japanese Respiratory Society's Guidelines for the Management of Community-Acquired Pneumonia in Adults, and clarithromycin was administered. On the basis of bacteriological and serological tests, 465 patients were diagnosed with atypical pneumonia. Mycoplasma pneumonia was common among younger patients and chlamydia pneumonia among older patients. Underlying respiratory disease was uncommon among mycoplasma patients but prevalent among chlamydia patients. According to the severity classification given in the abovementioned guidelines, most mycoplasma patients had mild infection, whereas a high percentage of chlamydia patients had moderate infections. Body temperature was higher and coughing more severe in the mycoplasma patients than in the chlamydia patients. On the other hand, intergroup differences were not observed regarding extent of lung shadowing on plain radiographs, peripheral white blood cell count, or C-reactive protein (CRP). The effectiveness of clarithromycin was 96.8% in mycoplasma patients (153/158), 92.9% in chlamydia patients (78/84), and 96.0% in the group comprising all atypical pneumonia patients, including those with superinfection (288/300). The incidence of adverse drug reactions was 3.4% (24/698). Macrolide resistance in Mycoplasma pneumoniae has been reported in Japan, but the results of this surveillance study showed that clarithromycin is effective in treating adult atypical pneumonia.

  17. The efficacy and safety of calidron tablets for management of Osteoporosis in Jordanian Women; A random clinical trial

    International Nuclear Information System (INIS)

    Shilbayeh, Sireen; S-Zumeili, A.; Hilow, Hisham M.

    2004-01-01

    The aim of this study was to evaluate the efficacy and safety of daily alendronate (Calidron) 5 and 10 mg for treatment and prevention of osteoporosis in postmenopausal Jordanian women. Subjects were randomly assigned to receive oral treatment with alendronate in the form of Calidron 5 mg or 10 mg; or identically appearing oral placebo pills. Bone mineral density (BMD) was measured by dual energy X-ray absorptiometry at lumbar spine, femoral neck, trochanter and wards at baseline and 12 months visits. After 12 months of treatment, 20 women (74%) in 10 mg/d Calidron, 18(50%) in 10mg/d placebo, 11(55%) in 5 mg/d Calidron, and 13(38%) in 5mg/d placebo arms remained in study and had BMD measurements. Much greater effects of Calidron 5mg tablets was observed at the other sites of the hip; 3.9% (vs YA), 6.4% (vs AM), 7.13% (vs YA), 10.9% (vs AM), 10.1%(vs YA), and 12%(vs AM) increase at the femoral neck, wards and trochanter (p<0.01). In conclusion, our study generally support the conclusion that Calidron 10mg is relatively effective for maintenance of BMD and it possess real clinical value for preserving and normalizing bone mass in menopausal women with or without osteoporosis or osteopenia. (author)

  18. Immunization in pregnancy clinical research in low- and middle-income countries - Study design, regulatory and safety considerations.

    Science.gov (United States)

    Kochhar, Sonali; Bonhoeffer, Jan; Jones, Christine E; Muñoz, Flor M; Honrado, Angel; Bauwens, Jorgen; Sobanjo-Ter Meulen, Ajoke; Hirschfeld, Steven

    2017-12-04

    Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally. Copyright © 2017. Published by Elsevier Ltd.

  19. Oncological Safety of Lipofilling in Patients with Breast Cancer: A Meta-analysis and Update on Clinical Practice.

    Science.gov (United States)

    Wazir, Umar; El Hage Chehade, Hiba; Headon, Hannah; Oteifa, Medhat; Kasem, Abdul; Mokbel, Kefah

    2016-09-01

    Lipofilling is an increasingly popular technique for breast reconstruction following both mastectomy and breast-conserving surgery (BCS). However, concerns remain over its oncological safety and its effect on cancer recurrence. A systematic literature review and meta-analysis was carried out. Patients who had undergone mastectomy or BCS were investigated separately in order to find out whether the addition of lipofilling had a significant effect on locoregional recurrence rate. Eleven studies were used in the analysis, yielding a total of 2,382 patients. For patients undergoing mastectomy (mean follow-up=36.2 months, range=12-90 months) or BCS (mean follow-up=30.2 months, range=12-60 months), the addition of lipofilling was not found to significantly affect the locoregional recurrence rate. This meta-analysis demonstrates that lipofilling is an oncologically safe procedure to be incorporated into breast reconstruction following either mastectomy or BCS for breast cancer. However, a careful oncological follow-up is recommended. In the future, more adequately powered controlled clinical trials are needed in order to fully understand long-term outcomes after lipofilling. Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  20. Clinical effectiveness and safety of leflunomide in inflammatory arthritis: a report from the RAPPORT database with supporting patient survey.

    Science.gov (United States)

    Schultz, Morgan; Keeling, Stephanie O; Katz, Steven J; Maksymowych, Walter P; Eurich, Dean T; Hall, Jill J

    2017-07-01

    Leflunomide is indicated for the treatment of adults with rheumatoid arthritis, yet is underutilized. Given the cost of biologic therapy, understanding real-life effectiveness, safety, and sustainability of leflunomide, particularly in patients who have failed methotrexate, would be of value. The primary objective was to assess the proportion of patients achieving clinically meaningful benefit following an adequate trial of leflunomide. A retrospective analysis of a cohort supplemented with patient self-reported data using a standardized questionnaire. Data were analyzed using descriptive statistics, with a database multivariate logistic regression analysis to determine predictors of leflunomide response. Of the cohort available (N = 2591), 1671 patients with confirmed leflunomide use were included in the retrospective analysis, of whom 249 were incident users. Low disease activity (DAS-28 reported by 29% of incident users and after 1 year, 45% remained on leflunomide. Achievement of "minimal or no joint symptoms" was reported by 34% in the 661 analyzable survey responses (39% response rate). AE were reported by 55%, with nuisance (hair loss, nausea, stomach pain) AE and diarrhea being most common. Leflunomide was discontinued by 67% of responders within 1 year. An important proportion of patients, the majority of whom had previously failed methotrexate, achieved disease response with leflunomide with a low risk of serious adverse effects, suggesting that a trial of leflunomide may be a reasonable and cost-effective strategy prior to biologic therapy.

  1. IRQN award paper: Operational rounds: a practical administrative process to improve safety and clinical services in radiology.

    Science.gov (United States)

    Donnelly, Lane F; Dickerson, Julie M; Lehkamp, Todd W; Gessner, Kevin E; Moskovitz, Jay; Hutchinson, Sally

    2008-11-01

    As part of a patient safety program in the authors' department of radiology, operational rounds have been instituted. This process consists of radiology leaders' visiting imaging divisions at the site of imaging and discussing frontline employees' concerns about patient safety, the quality of care, and patient and family satisfaction. Operational rounds are executed at a time to optimize the number of attendees. Minutes that describe the issues identified, persons responsible for improvement, and updated improvement plan status are available to employees online. Via this process, multiple patient safety and other issues have been identified and remedied. The authors believe that the process has improved patient safety, the quality of care, and the efficiency of operations. Since the inception of the safety program, the mean number of days between serious safety events involving radiology has doubled. The authors review the background around such walk rounds, describe their particular program, and give multiple illustrative examples of issues identified and improvement plans put in place.

  2. Clinical efficacy and safety of IV ferric carboxymaltose (FCM) treatment of RLS: a multi-centred, placebo-controlled preliminary clinical trial.

    Science.gov (United States)

    Allen, Richard P; Adler, Charles H; Du, Wei; Butcher, Angelia; Bregman, David B; Earley, Christopher J

    2011-10-01

    Intravenous (IV) iron has been used as a treatment to reduce Restless Legs Syndrome (RLS) symptoms, but two double-blinded trials of a frequently prescribed IV iron formulation, iron sucrose, failed to show lasting efficacy. This study evaluates efficacy and safety of a new IV iron formulation (ferric carboxymaltose, FCM) with molecular properties that may make iron more available for uptake to the brain than iron sucrose does. In this 28-day, multi-centre, randomised, placebo-controlled trial 46 RLS patients were discontinued from all RLS treatment. Twenty-four received 500 mg FCM in two doses 5 days apart and 22 received a matching placebo. At day 28, those on placebo were given a single 1000 mg IV FCM and those not responding to initial treatment were given a third dose of 500 mg FCM. Patients were followed up for 24 weeks or until needing added RLS treatment. FCM significantly improved primary and secondary outcomes compared to placebo: International Restless Legs Syndrome study group severity scale (IRLS) average (SD) decrease of 8.9 (8.52) versus 4.0 (6.11), p=0.040; Clinical Global Inventory of Change (CGI-1) very much or much improved 48.3% versus 14.3%, p=0.004. Quality of life was also significantly improved. Of the 24 with initial iron treatment 45% responded and 29% remitted (IRLS ≤ 10) at day 28, and 25% continued free of other RLS medications at 24 weeks after treatment. The single 1000 mg dose on day 28 produced the same degree of treatment response as the divided dose, but the added 500 mg dose for those not responding to the initial treatment showed little benefit. There were no significant adverse events. IV FCM provided a safe and effective treatment for RLS that lasted for at least 24 weeks for some patients. Larger studies are needed to confirm these results. Copyright © 2011 Elsevier B.V. All rights reserved.

  3. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    Science.gov (United States)

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  4. Safety and Tolerability of Empagliflozin in Patients with Type 2 Diabetes: Pooled Analysis of Phase I-III Clinical Trials.

    Science.gov (United States)

    Kohler, Sven; Zeller, Cordula; Iliev, Hristo; Kaspers, Stefan

    2017-07-01

    We characterized the safety and tolerability of empagliflozin in patients with type 2 diabetes (T2DM) randomized 1:1:1 to placebo, empagliflozin 10 mg, or empagliflozin 25 mg in clinical trials. Pooled data were analyzed from patients with T2DM treated with placebo (N = 4203), empagliflozin 10 mg (N = 4221), or empagliflozin 25 mg (N = 4196) in 15 randomized phase I-III trials plus four extension studies. Adverse events (AEs) were assessed descriptively in participants who took at least one dose of study drug. AE incidence rates per 100 patient-years were calculated to adjust for differences in drug exposure between trials. Total exposure was 7369, 7782, and 7754 patient-years in the placebo, empagliflozin 10 mg, and 25 mg groups, respectively. The incidence of any AEs, severe AEs, serious AEs, and AEs leading to discontinuation was no higher in participants treated with empagliflozin vs. placebo. Empagliflozin was not associated with an increased risk of hypoglycemia vs. placebo, except in participants on background sulfonylurea. The incidence of events consistent with urinary tract infection was similar across treatment groups (8.7-9.5/100 patient-years). Events consistent with genital infection occurred more frequently in participants treated with empagliflozin 10 and 25 mg (3.5 and 3.4/100 patient-years, respectively) than placebo (0.9/100 patient-years). The incidence of AEs consistent with volume depletion was similar across treatment groups (1.7-1.9/100 patient-years) but was higher with empagliflozin 10 mg and 25 mg vs. placebo in participants aged 75 years or older (3.2 and 3.0 vs. 2.3/100 patient-years, respectively). The rates of bone fractures, cancer events, renal AEs, venous thromboembolic events, hepatic injury, acute pancreatitis, lower limb amputations, and diabetic ketoacidosis were similar across treatment groups. This analysis of pooled safety data based on more than 15,000 patient-years' exposure supports a favorable

  5. [The efficacy and safety of high-dose irbesartan in treatment of clinical proteinuria in patients with chronic kidney disease].

    Science.gov (United States)

    Li, Xin; Chen, Xiang-dong; Li, Zhong-xin

    2011-12-01

    To evaluate the efficacy and safety of high-dose irbesartan in the treatment of mild and moderate proteinuria in patients with chronic kidney disease (CKD). A single center, prospective, observational study was performed. A total of 96 subjects were given irbesartan 150 mg/d for 4 weeks. Twenty-six were divided into single-dose (150 mg/d) irbesartan group when their clinical efficacy were eligible for improvement criteria and 70 were divided into high-dose (300 - 600 mg/d) irbesartan group when there were no effect for single-dose treatment. Both groups received treatment for 48 weeks. Then 24-hour quantitative urine protein, systolic pressure, diastolic pressure, TC, LDL-C, plasma albumin, serum creatinine, blood urea nitrogen, blood uric acid, serum potassium and ALT were determined. The proteinuria level after treatment in the single-dose irbesartan group was decreased by 68.3% with a statistically significant difference (P proteinuria was decreased by 63.4% (P proteinuria in high-dose group was 72.9% (51/70). Among the blood pressure sub-groups, the effective rates for the normal blood pressure group and hypertension group in treating proteinuria were 68.2% and 76.9% respectively (P > 0.05). However, in the normal blood pressure group and hypertension group, the proteinuria was decreased by 61.9% and 67.5% respectively after treatment (P 0.05). The effective rates of high doses of 300, 450 and 600 mg/d of irbesartan in treating proteinuria were 70.8%, 63.6% and 66.7%, respectively. The difference in effective rates of treating proteinuria among different doses had no statistical significance (P > 0.05). No obvious increase of SCr value before and after treatment in high-dose group (P = 0.583). The increasing level of serum potassium in high-dose group after treatment was higher than that in the single-dose group (P proteinuria in CKD patients with a good safety and tolerance and the efficacy is independent of lowering blood pressure.

  6. A Clinical Trial Comparing the Safety and Efficacy of Topical Tacrolimus versus Methylprednisolone in Ocular Graft-versus-Host Disease.

    Science.gov (United States)

    Abud, Tulio B; Amparo, Francisco; Saboo, Ujwala S; Di Zazzo, Antonio; Dohlman, Thomas H; Ciolino, Joseph B; Hamrah, Pedram; Dana, Reza

    2016-07-01

    To evaluate the safety and efficacy of topical tacrolimus 0.05% versus topical methylprednisolone 0.5% in patients with ocular graft-versus-host disease (GVHD). Phase 1/2 prospective, randomized, double-masked clinical trial. Eighty eyes of 40 patients diagnosed with chronic ocular GVHD were enrolled. Forty patients with ocular GVHD were randomized; 24 patients were treated with topical tacrolimus 0.05% and 16 patients were treated with topical methylprednisolone 0.5% twice daily for 10 weeks, in addition to continuing their baseline treatment regimen. Safety was evaluated based on occurrence of adverse events. Tolerability was assessed based on subject reports of discomfort after drop instillation. Intraocular pressure (IOP) was monitored. The main efficacy end points were corneal fluorescein staining (CFS), tear film break-up time (TBUT), Schirmer test results, and expression of the ocular surface inflammatory markers human leukocyte antigen-DR (HLA-DR) and intercellular adhesion molecule-1 (ICAM-1). Symptoms were evaluated using the Ocular Surface Disease Index (OSDI). After 10 weeks of treatment, no major adverse events occurred in either treatment group, and there was no significant difference in the composite tolerability scores between the 2 groups (P = 0.06). However, burning sensation was more pronounced with tacrolimus (P = 0.002). Topical tacrolimus was more effective than methylprednisolone in reducing the CFS score at week 10 (55% vs. 23% reduction, respectively; P = 0.01) and achieved significant improvement in TBUT when compared with baseline (P < 0.001). Reduction in OSDI score achieved statistical significance with tacrolimus (27% reduction; P = 0.02), but was marginal with methylprednisolone (32% reduction; P = 0.06). Expression of ICAM-1 by ocular surface epithelium decreased significantly in both groups (tacrolimus, P = 0.003; methylprednisolone, P = 0.008), whereas HLA-DR expression decreased significantly only in the tacrolimus group

  7. Infant safety during and after maternal valacyclovir therapy in conjunction with antiretroviral HIV-1 prophylaxis in a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Alison L Drake

    Full Text Available Maternal administration of the acyclovir prodrug valacyclovir is compatible with pregnancy and breastfeeding. However, the safety profile of prolonged infant and maternal exposure to acyclovir in the context of antiretrovirals (ARVs for prevention of mother-to-child HIV-1 transmission (PMTCT has not been described.Pregnant Kenyan women co-infected with HIV-1/HSV-2 with CD4 counts > 250 cells/mm(3 were enrolled at 34 weeks gestation and randomized to twice daily 500 mg valacyclovir or placebo until 12 months postpartum. Women received zidovudine from 28 weeks gestation and single dose nevirapine was given to women and infants at the time of delivery for PMTCT. Infant blood was collected at 6 weeks for creatinine and ALT. Breast milk specimens were collected at 2 weeks postpartum from 71 women in the valacyclovir arm; acyclovir levels were determined for a random sample of 44 (62% specimens. Fisher's Exact and Wilcoxon rank-sum tests were used for analysis.One hundred forty-eight women were randomized and 146 mother-infant pairs were followed postpartum. PMTCT ARVs were administered to 98% of infants and all mothers. Valacyclovir was not associated with infant or maternal toxicities or adverse events, and no congenital malformations were observed. Infant creatinine levels were all normal (< 0.83 mg/dl and median creatinine (median 0.50 mg/dl and infant growth did not differ between study arms. Acyclovir was detected in 35 (80% of 44 breast milk samples collected at 2 weeks postpartum. Median and maximum acyclovir levels were 2.62 and 10.15 mg/ml, respectively (interquartile range 0.6-4.19.Exposure to PMTCT ARVs and acyclovir after maternal administration of valacyclovir during pregnancy and postpartum to women co-infected with HIV-1/HSV-2 was not associated with an increase in infant or maternal toxicities or adverse events.ClinicalTrials.gov NCT00530777.

  8. Randomized clinical trial on the efficacy and safety of four professional at-home tooth whitening gels.

    Science.gov (United States)

    Alonso de la Peña, V; López Ratón, M

    2014-01-01

    This randomized clinical trial evaluated the efficacy and safety of four gels of differing concentrations used for at-home vital bleaching. Ninety-six volunteers participated in the study and were divided into four groups of 24 individuals. A gel of differing concentration was used for each group: 10% and 15% carbamide peroxide and 7.5% and 9.5% hydrogen peroxide. The patients used the whitening agent in a tray without reservoirs for one hour per day for two weeks. The measurement of the change in tooth color was made by two observers in the maxillary right central incisor and with a colorimeter in both upper central incisors and canines, using the CIE L*a*b* and CIE L*C*h* values. Sensitivity was evaluated by the participants on a scale with values as follows: 0 = absent, 1 = minor, 2 = moderate, 3 = considerable, 4 = severe. At the baseline, the observers noted darker colors than the colorimeter (pL*a*b* and CIE L*C*h* values (pL*a*b* and CIE L*C*h* parameters, there were color changes in the assessments made in the four maxillary teeth after treatment (p<0.001). There were no differences in ΔL* and ΔE* between the groups. The number of patients who experienced sensitivity and the intensity of the sensitivity were not significant. There were no differences in the degree of whitening among the different products. With all of the products there was an increase in L*, a decrease in chromatic intensity (C*), and an increase in the value (tone) or hue (h*).

  9. Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial

    Science.gov (United States)

    Thomas, James S.; France, Christopher R.; Applegate, Megan E.; Leitkam, Samuel T.; Walkowski, Stevan

    2016-01-01

    Whereas the fear-avoidance model of chronic low back pain (CLBP) posits a generic avoidance of movement that is perceived as threatening, we have repeatedly shown that individuals with high fear and CLBP specifically avoid flexion of the lumbar spine. Accordingly, we developed a virtual dodgeball intervention designed to elicit graded increases in lumbar spine flexion while reducing expectations of fear and harm by engaging participants in a competitive game that is both entertaining and distracting. We recruited 52 participants (48% female) with CLBP and high fear of movement and randomized them to either a game group (n=26) or a control group (n=26). All participants completed a pregame baseline and a follow up assessment (4–6 days later) of lumbar spine motion and expectations of pain and harm during standardized reaches to high (easier), middle, and low (hardest to reach) targets. For three consecutive days, participants in the game group completed 15 minutes of virtual dodgeball between baseline and follow up. For the standardized reaching tests, there were no significant effects of group on changes in lumbar spine flexion, expected pain, or expected harm. However, virtual dodgeball was effective at increasing lumbar flexion within and across gameplay sessions. Participants reported strong positive endorsement of the game, no increases in medication use, pain, or disability, and no adverse events. Although these findings indicate that very brief exposure to this game did not translate to significant changes outside the game environment, this was not surprising given that graded exposure therapy for fear of movement among individuals with low back pain typically last 8–12 sessions. Given the demonstration of safety, feasibility and ability to encourage lumbar flexion within gameplay, these findings provide support for a clinical trial wherein the treatment dose is more consistent with traditional graded-exposure approaches to CLBP. PMID:27616607

  10. Neuraxial Analgesia In Neonates And Infants: Review of Clinical and Preclinical Strategies for the Development of Safety and Efficacy Data

    Science.gov (United States)

    Walker, Suellen M.; Yaksh, Tony L.

    2015-01-01

    Neuraxial agents provide robust pain control, have the potential to improve outcomes, and are an important component of the perioperative care of children. Opioids or clonidine improve analgesia when added to perioperative epidural infusions; analgesia is significantly prolonged by addition of clonidine, ketamine, neostigmine or tramadol to single shot caudal injections of local anesthetic; and neonatal intrathecal anesthesia/analgesia is increasing in some centers. However, it is difficult to determine the relative risk-benefit of different techniques and drugs without detailed and sensitive data related to analgesia requirements, side-effects, and follow-up. Current data related to benefits and complications in neonates and infants are summarized, but variability in current neuraxial drug use reflects the relative lack of high quality evidence. Recent preclinical reports of adverse effects of general anesthetics on the developing brain have increased awareness of the potential benefit of neuraxial anesthesia/analgesia to avoid or reduce general anesthetic dose requirements. However, the developing spinal cord is also vulnerable to drug-related toxicity, and although there are well-established preclinical models and criteria for assessing spinal cord toxicity in adult animals, until recently there had been no systematic evaluation during early life. Therefore, the second half of this review presents preclinical data evaluating age-dependent changes in the pharmacodynamic response to different spinal analgesics, and recent studies evaluating spinal toxicity in specific developmental models. Finally, we advocate use of neuraxial agents with the widest demonstrable safety margin and suggest minimum standards for preclinical evaluation prior to adoption of new analgesics or preparations into routine clinical practice. PMID:22798528

  11. Safety Studies for Use of Adipose Tissue-Derived Mesenchymal Stromal/Stem Cells in a Rabbit Model for Osteoarthritis to Support a Phase I Clinical Trial.

    Science.gov (United States)

    Riester, Scott M; Denbeigh, Janet M; Lin, Yang; Jones, Dakota L; de Mooij, Tristan; Lewallen, Eric A; Nie, Hai; Paradise, Christopher R; Radel, Darcie J; Dudakovic, Amel; Camilleri, Emily T; Larson, Dirk R; Qu, Wenchun; Krych, Aaron J; Frick, Matthew A; Im, Hee-Jeong; Dietz, Allan B; Smith, Jay; van Wijnen, Andre J

    2017-03-01

    Adipose-derived mesenchymal stem cells (AMSCs) offer potential as a therapeutic option for clinical applications in musculoskeletal regenerative medicine because of their immunomodulatory functions and capacity for trilineage differentiation. In preparation for a phase I clinical trial using AMSCs to treat patients with osteoarthritis, we carried out preclinical studies to assess the safety of human AMSCs within the intra-articular joint space. Culture-expanded human AMSCs grown in human platelet-lysate were delivered via intra-articular injections into normal healthy rabbit knees and knees at risk for the development of osteoarthritis after bilateral medial anterior hemimeniscectomy. Treatment outcomes and safety were evaluated by assessing the general health, function, and behavior of the animals. Joint tissues were analyzed by x-ray, magnetic resonance imaging, and histopathology. Intra-articular AMSC therapy was well tolerated in this study. We did not observe adverse systemic reactions, nor did we find evidence of damage to intra-articular joint tissues. Thus, the data generated in this study show a favorable safety profile for AMSCs within the joint space in support of a phase I clinical trial evaluating the clinical utility of AMSCs to treat osteoarthritis. Stem Cells Translational Medicine 2017;6:910-922. © 2016 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  12. Effects and safety of 99Tc-MDP in patients with refractory ankylosing spondylitis: a 2-stage (30-week follow-up) clinical trial.

    Science.gov (United States)

    Xu, Yunyun; Zhong, Yi; Zhao, Minjing; Tu, Liudan; Fan, Meida; Zhang, Pingping; Wei, Qiujing; Cao, Shuangyan; Li, Qiuxia; Liao, Zetao; Lin, Zhiming; Pan, Yunfeng; Jin, Ou; Gu, Jieruo

    2017-11-14

    To evaluate the clinical efficacy and safety in patients with refractory ankylosing spondylitis (AS) initiating 99Tc-MDP therapy and explore the mechanisms. Refractory AS patients were enrolled in the clinical trial and received 99Tc-MDP treatments for 3 or 5 courses according to ASAS improvement. Efficacy and safety evaluations were conducted during the follow-up. 37 cytokines were quantified by Luminex at baseline and week 30. p-valuesMDP treatment, 32 (62.75%) patients achieved ASAS20 improvement, 24 (47.06%) patients achieved a clinically significant improvement (ΔASDAS-CRP≥1.1). 27 patients entered the second stage to complete 5 courses of the treatment, all of whom achieved ASAS20 improvement, 18 (66.67%) patients achieved a clinically significant improvement. All clinical parameters including ASAS and ASDAS significantly improved as the treatment was continued. Cytokines also had significant down-regulation after the treatment, and the reductions had positive correlations with the improvements of disease activity. No serious adverse event was observed. This investigation confirmed the remarkable efficacy of 99Tc-MDP in a large number of refractory AS patients, and highlighted the mechanism by dramatic regulation on cytokines. 99Tc-MDP was safe in clinical application.

  13. Revisions to the 2009 American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards: expanding the scope to include inpatient settings.

    Science.gov (United States)

    Jacobson, Joseph O; Polovich, Martha; Gilmore, Terry R; Schulmeister, Lisa; Esper, Peg; Lefebvre, Kristine B; Neuss, Michael N

    2012-01-01

    In November 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) jointly published a set of 31 voluntary chemotherapy safety standards for adult patients with cancer, as the end result of a highly structured, multistakeholder process. The standards were explicitly created to address patient safety in the administration of parenteral and oral chemotherapeutic agents in outpatient oncology settings. In January 2011, a workgroup consisting of ASCO and ONS members was convened to review feedback received since publication of the standards, to address interim changes in practice, and to modify the standards as needed. The most significant change to the standards is to extend their scope to the inpatient setting. This change reflects the conviction that the same standards for chemotherapy administration safety should apply in all settings. The proposed set of standards has been approved by the Board of Directors for both ASCO and ONS and has been posted for public comment. Comments were used as the basis for final editing of the revised standards. The workgroup recognizes that the safety of oral chemotherapy usage, nononcology medication reconciliation, and home chemotherapy administration are not adequately addressed in the original or revised standards. A separate process, cosponsored by ASCO and ONS, will address the development of safety standards for these areas.

  14. Urban and Rural Safety Net Health Care System Clinics: No Disparity in HPV4 Vaccine Completion Rates

    OpenAIRE

    Sandri, Kelly Jo; Verdenius, Inge; Bartley, Mitchell J.; Else, Britney M.; Paynter, Christopher A.; Rosemergey, Beth E.; Harris, George D.; Malnar, Gerard J.; Harper, Sean M.; Griffith, R. Stephen; Bonham, Aaron J.; Harper, Diane M.

    2014-01-01

    OBJECTIVE: Safety net health care centers in the US serve vulnerable and underinsured females. The primary aim of this work was to determine if HPV4 dosing compliance differs between females who receive doses at rural vs. urban core safety net health care locations. METHODS: Females exclusively receiving health care in the Truman Medical Center (TMC) safety net system at the urban core and rural locations were identified by their HPV4 vaccine records. Dates and number of HPV4 doses as well as...

  15. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    OpenAIRE

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Herv?; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Kr?ger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 ho...

  16. Clinical effect and short-term safety of telbivudine in blocking mother-to-child transmission of HBV

    Directory of Open Access Journals (Sweden)

    PAN Yuchen

    2017-09-01

    Full Text Available ObjectiveTo evaluate the clinical effect and short-term safety of telbivudine administered in late pregnancy for blocking mother-to-child transmission of HBV in pregnant women with high HBV DNA load. MethodsPregnant women with positive HBsAg and HBeAg and HBV DNA ≥2×106 IU/ml who underwent blockade of mother-to-child transmission in The First Hospital of Jilin University from July 2012 to June 2015 were enrolled. These patients were informed of current methods for blocking mother-to-child transmission of hepatitis B, and according to their own will, they were divided into active/passive immunization+telbivudine (telbivudine group and active/passive immunization group (immunization group. The patients in the telbivudine group were given oral telbivudine (600 mg, once a day from week 32 of pregnancy to delivery, and those in the immunization group were not given antiviral therapy. The infants in both groups were given 20 μg hepatitis B vaccine combined with 100 IU hepatitis B immunoglobulin after birth. Positive HBsAg in infants at an age of 7 months was defined as failed blockade of mother-to-child transmission. The t-test was used for comparison of normally distributed continuous data between groups, and the Wilcoxon rank sun test was used for comparison of non-normally distributed continuous data between groups; the chi-square test or the Fisher′s exact test was used for comparison of categorical data between groups. ResultsA total of 447 pregnant women were enrolled, and there were 81 pregnant women in the telbivudine group and 366 women in the immunization group. Compared with the immunization group, the telbivudine group had a significantly higher mean age (28.8±3.3 years vs 27.6±3.8 years, t=-2.55, P=0.01 and a significantly higher proportion of pregnant women with HBV DNA load >108 IU/ml (82.7% vs 61.5%, χ2=1321, P<0.001. There were no significant differences in alanine aminotransferase level, delivery mode, and feeding

  17. [Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS].

    Science.gov (United States)

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Xu, Wen-fu

    2015-12-01

    This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.

  18. Safety and usefulness of Laghu shankha prakshalana in patients with essential hypertension: A self controlled clinical study

    Directory of Open Access Journals (Sweden)

    Prakash Mashyal

    2014-01-01

    Full Text Available Background: Yoga and Ayurveda texts emphasize the role of cleansing the bowel as an important component of management of hypertension (HTN. Observations during our clinical experience and pilot studies on Laghu shankha prakshalana kriya (LSP, a yogic bowel cleansing technique, appeared to be safe and complimentary. Objective: To test the safety and effectiveness of LSP in patients with essential hypertension. Materials and Methods: This self control study recruited 32 patients with mild to moderate essential HTN admitted for a week long residential integrated yoga therapy program at the integrative health home in Bengaluru. Patients had a daily routine of 6 hours of integrated approach of yoga therapy (IAYT module for HTN that included physical postures, relaxation sessions, pranayama and meditations. LSP, an additional practice, that involved drinking of luke-warm water (with or without a herbal combination, triphala followed by a set of specific yoga postures that activates defecation reflex, was administered on 2 nd (LSP without triphala and 5 th day (LSP with triphala. Assessments (sitting blood pressure and pulse rate were done just before and after both the sessions of LSP. Secondary outcome measures such as body mass index (BMI, symptom scores, medication scores, fatigue, state and trait anxiety, general health and quality of life were assessed on 1 st and 6 th day of IAYT intervention. Results: There was significant (P < 0.001, paired t test reduction in blood pressure (systolic and diastolic and pulse rate immediately after both the sessions (LSP with and without triphala. There were no adverse effects reported during or after LSP. There was no significant difference between the two techniques (P < 0.505, independent samples t test, although the percentage change appeared to be higher after triphala LSP session. The number of visits to clear the bowel during the procedure was significantly (P < 0.001, independent samples t test higher

  19. Intraoperative stress and anxiety reduction with music therapy: a controlled randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Jiménez-Jiménez, Maria; García-Escalona, Alma; Martín-López, Alejandra; De Vera-Vera, Raquel; De Haro, Joaquin

    2013-09-01

    The purpose of this study was to investigate the music therapy (MT) effect in levels of intraoperative anxiety in patients undergoing crossectomy with stripping of the great saphenous vein and to assess the efficacy, safety, and feasibility of this alternative therapy as a complement of standard intraoperative care. The study is a simple blind, controlled, parallel groups, prospective randomized clinical trial. Patients were allocated by means of randomized controlled sampling. The study was performed in the surgery room of Getafe University Hospital in Madrid. The study was carried out in 40 patients, 20 randomized to the experimental group and 20 randomized to the control group, with an age range from 27 to 70 years. The control group was given intraoperative routine attention, and the experimental group was given an MT passive intervention that consisted of audition of musical fragments during varicose veins surgery. These pieces previously showed relaxing actions on the cardiovascular system. The anxiety levels were measured by means of pre- and postsurgical questionnaires by a blinded investigator for the study arm to which the patients had been randomized. Heart rate and systolic and diastolic blood pressures were determined during the intervention, and adrenaline and noradrenaline plasma levels were determined before and after the surgical procedure. The majority of the patients in the MT group (95%) and standard care group (90%) completed the study. There were no statistical differences between the control and experimental groups in heart rate gradient or systolic and diastolic blood pressures measured after the intervention. The anxiety state and the stress feeling scale score after surgery were significantly inferior in the MT group (94.7% vs 57.9% decrease in anxiety levels, P < .05, and stress score of 1.31 vs 2.36, P < .05, respectively). The adverse events ratio was low and occurred with similar frequency in both groups. The MT intervention was easily

  20. Patients’ safety: is there a systemic release of gentamicin by gentamicin-coated tibia nails in clinical use?

    Directory of Open Access Journals (Sweden)

    Moghaddam A

    2016-09-01

    Full Text Available Arash Moghaddam,1 Viola Graeser,1 Fabian Westhauser,1 Ulrike Dapunt,1 Till Kamradt,1 Stefan M Woerner,2 Gerhard Schmidmaier1 1HTRG – Heidelberg Traume Research Group Center for Orthopedics, Trauma and Spinal Cord Injury, University Hospital Heidelberg, Heidelberg, Germany; 2Department of Internal Medicine and Clinical Chemistry, University Hospital Heidelberg, Heidelberg, Germany Introduction: Osteitis is one of the most serious complications in orthopedic surgery. Expert Tibia Nail (ETN PROtect™ coated with a biodegradable layer of gentamicin-laden polymer was developed for prophylaxis of osteomyelitis. In systemic administration, gentamicin has only a small therapeutic index and serious side effects; it is potentially nephrotoxic as well as ototoxic. It is not yet known if relevant gentamicin concentrations are released into the systemic circulation after implantation of gentamicin-coated nails. In order to evaluate the patients’ risks profiles and increase patient safety, we measured gentamicin levels in pre- and postoperative serum samples of patients undergoing implantation of ETN PROtect.Methods: Twenty-five patients who received ETN PROtect between March 2012 and August 2014 were included in this study. Collection of blood samples occurred before the operation, at weeks 1–4, 3 and 6 months, and up to 1 year after the implantation. Measurement of gentamicin levels in serum samples was performed at the central laboratory of Heidelberg University Hospital. Additionally, laboratory parameters, C-reactive protein, leukocyte number, urea and creatinine concentrations were analyzed in routine controls before and after operating and assessed for systemic side effects.Results: Over the course of this prospective observational study, we were able to determine that gentamicin-coated nails do not release gentamicin into the systemic circulation above the lowest detectable level of 0.2 mg/dL. There were slight increases in the mean

  1. Evaluation of immediate and 12-week effects of a smartphone sun-safety mobile application: a randomized clinical trial.

    Science.gov (United States)

    Buller, David B; Berwick, Marianne; Lantz, Kathy; Buller, Mary Klein; Shane, James; Kane, Ilima; Liu, Xia

    2015-05-01

    Mobile applications on smartphones can communicate a large amount of personalized, real-time health information, including advice on skin cancer prevention, but their effectiveness may be affected by whether recipients can be convinced to use them. To evaluate a smartphone mobile application (Solar Cell) delivering real-time advice about sun protection for a second time in a randomized clinical trial. A previous trial conducted in 2012 used a randomized pretest-posttest design. For the present trial, we collected data from a volunteer sample of 202 adults 18 years or older who owned a smartphone. Participants were recruited nationwide through online promotions. Screening procedures and a 3-week run-in period were added to increase the use of the mobile application. We conducted follow-ups at 3 and 8 weeks after randomization to examine the immediate and the longer-term effects of the intervention. Use of the mobile application. The application gave feedback on sun protection (ie, sun-safety practices and the risk for sunburn) and alerted users to apply or to reapply sunscreen and to get out of the sun. The application also displayed the hourly UV Index and vitamin D production based on the forecast UV Index, time, and location. Percentage of days with the use of sun protection, time spent outdoors in the midday sun (days and hours), and the number of sunburns in the last 3 months. Participants in the intervention group used wide-brimmed hats more at 7 weeks than control participants (23.8% vs 17.4%; F = 4.07; P = .045). Women who used the mobile application reported using all sun protection combined more than men (46.4% vs 43.3%; F = 1.49; P = .04), whereas men and older individuals reported less use of sunscreen (32.7% vs 35.5%; F = 5.36; P = .02) and hats (15.6% vs 17.9%; F = 4.72; P = .03). The mobile application initially appeared to confer weak improvement of sun protection. Use of the mobile application was greater than in a previous trial and was

  2. Clinical efficacy and safety of autologous stem cell transplantation for patients with ST-segment elevation myocardial infarction

    Directory of Open Access Journals (Sweden)

    Li R

    2016-08-01

    Full Text Available Rong Li,1,* Xiao-Ming Li,2,* Jun-Rong Chen,3 1Department of Intensive Care Unit, The People’s Hospital of Baoji City, 2Department of Cardiovascular Medicine, 3Department of Function, Baoji Central Hospital, Baoji, Shaanxi, People’s Republic of China *These authors contributed equally to this work Purpose: The purpose of this study is to evaluate the therapeutic efficacy and safety of stem cells for the treatment of patients with ST-segment elevation myocardial infarction (STEMI.Materials and methods: We performed a systematic review and meta-analysis of relevant published clinical studies. A computerized search was conducted for randomized controlled trials of stem cell therapy for STEMI.Results: Twenty-eight randomized controlled trials with a total of 1,938 STEMI patients were included in the present meta-analysis. Stem cell therapy resulted in an improvement in long-term (12 months left ventricular ejection fraction of 3.15% (95% confidence interval 1.01–5.29, P<0.01. The 3-month to 4-month, 6-month, and 12-month left ventricular end-systolic volume showed favorable results in the stem cell therapy group compared with the control group (P≤0.05. Significant decrease was also observed in left ventricular end-diastolic volume after 3-month to 4-month and 12-month follow-up compared with controls (P<0.05. Wall mean score index was reduced significantly in stem cell therapy group when compared with the control group at 6-month and 12-month follow-up (P=0.01. Moreover, our analysis showed a significant change of 12-month infarct size decrease in STEMI patients treated with stem cells compared with controls (P<0.01. In addition, no significant difference was found between treatment group and control in adverse reactions (P>0.05.Conclusion: Overall, stem cell therapy is efficacious in the treatment of patients with STEMI, with low rates of adverse events compared with control group patients. Keywords: ST-segment elevation myocardial

  3. Clinical safety of SonoVue, a new contrast agent for ultrasound imaging, in healthy volunteers and in patients with chronic obstructive pulmonary disease.

    Science.gov (United States)

    Bokor, D; Chambers, J B; Rees, P J; Mant, T G; Luzzani, F; Spinazzi, A

    2001-02-01

    To evaluate the safety profile of SonoVue, a new echo-contrast agent based on stabilized sulfur hexafluoride (SF6) microbubbles, in healthy volunteers and in patients with chronic obstructive pulmonary disease (COPD). Safety and tolerability of SonoVue were evaluated in 66 healthy volunteers during two placebo-controlled phase I studies (a single intravenous ascending-dose study in 36 volunteers given SonoVue doses of 0.003 to 0.12 mL/kg and a multiple-dose study in 30 subjects given cumulative doses of 0.15 to 0.6 mL/kg) and in 12 patients with COPD of various degrees of clinical severity, who were given SonoVue at a dosage of 4 mL (corresponding to 0.057 mL/kg in a 70-kg patient). Adverse events were monitored up to 48 to 72 hours after administration. All volunteers underwent extensive safety assessments (monitoring of vital signs, electrocardiogram, blood oxygen saturation, laboratory assessments, and Mini-Mental test) up to 24 to 72 hours after administration. In addition, patients with COPD underwent specific lung function tests, such as forced expiratory volume, forced vital capacity, and forced midexpiratory flow. No serious adverse events occurred throughout the study. All nonserious adverse events were minor, mild, and rapidly self-resolving. No difference in the incidence of adverse events was observed among the various dosages of SonoVue and between SonoVue and placebo. There were no clinically significant changes in any of the safety assessments. No statistically significant differences between SonoVue and placebo were observed in mean forced expiratory volume, forced vital capacity, or forced midexpiratory flow levels. No substantial changes from baseline in blood oxygen saturation were observed for either study agent at any postinjection time point. SonoVue showed a good safety profile both in healthy subjects and in patients with COPD.

  4. THE EFFICACY AND SAFETY OF CARMOLIS GEL IN THE COMBINATION THERAPY OF KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    I. N. Denisov

    2015-01-01

    Full Text Available Osteoarthritis (OA is one of the most common rheumatic diseases. Knee OA is particularly frequently encountered among all forms of OA, the prevalence of knee OA being about 25% in the general population. Despite multiple guidelines for the management of knee OA, which have been prepared by the European League Against Rheumatism (EULAR, the American College of Rheumatology (ACR, and the Osteoarthritis Research Society International (OARSI, many problems of its treatment policy remain to be solved. The same holds true for not only the symptomatic and disease-modifying effects of chondroprotectors, but also topical therapy options.Objective: to evaluate the clinical efficacy and safety of Carmolis gel in patients with knee OA.Subjects and methods.The trial included 280 patients with knee OA (a study group consisted of 190 patents; a control group comprised 90 patients. The mean age was 58.3±9.3 years in the study group and 59±10.5 years in the control group. The disease duration was 10.3±5.5 and 10.1±4.1 years, respectively. Carmolis gel was applied to the region of the most painful knee joint up to 4–5 times daily, followed by massage of this skin area. The treatment cycle lasted for 2 weeks. No therapy was performed in the control patients. The clinical efficacy was determined by the changes in joint pains at rest or on movement and palpation, according to a visual analogue scale (VAS, WOMAC questionnaire, the synovitis intensity (assessed by ultrasonography, patient and physician global assessments of disease activity (Likert scale, and the possibility of reducing the daily dosage of nonsteroidal anti-inflammatory drugs (NSAIDs. The onset the therapeutic effect of the gel and the duration of its action were recorded.Results and discussion. The topical application of Carmolis gel caused a statistically significant reduction in joint pain at rest and on movement from 57.7±6.8 to 12±1.8 mm (р < 0.01 and from 52±5.3 to 17±2.7 mm

  5. The creation and impact of a dedicated section on quality and patient safety in a clinical academic department.

    Science.gov (United States)

    Boudreaux, Arthur M; Vetter, Thomas R

    2013-02-01

    Optimizing the effectiveness, efficiency, integration, and satisfaction associated with delivered health care is not only highly principled but also good business practice in an extremely competitive environment. Programs that foster quality improvement and patient safety efforts while also promoting a scholarly focus can generate the incentives and organizational recognition needed to make patient safety and quality improvement bona fide components of the academic mission. The authors describe the development, implementation, and results of a dedicated Section on Quality and Patient Safety (SQPS) within an academic anesthesiology department. Spearheaded by a physician champion and vigorously supported by the departmental chair, this SQPS engaged core leaders from the Department of Anesthesiology. This departmental quality and patient safety management team adopted quality improvement and performance improvement techniques that have been successfully used in other industries. The SQPS has gained support through data-driven results and reiterative promotion. Transparency and accountability have also been powerful motivators for achieving clinician buy-in and changing behavior. Since its inception in 2007, the SQPS has initiated or managed through to completion more than 25 quality and performance improvement projects, including an intraoperative corneal injury reduction program, a wrong-sided regional anesthesia procedure, a drug-eluting coronary stent protocol, and a practice-improvement initiative for resident physicians. The SQPS has not only robustly promoted a departmental culture of quality patient care and safety but also set the standard for other departments and stakeholders within the authors' health system.

  6. A behavioural Bayes approach to the determination of sample size for clinical trials considering efficacy and safety: imbalanced sample size in treatment groups.

    Science.gov (United States)

    Kikuchi, Takashi; Gittins, John

    2011-08-01

    The behavioural Bayes approach to sample size determination for clinical trials assumes that the number of subsequent patients switching to a new drug from the current drug depends on the strength of the evidence for efficacy and safety that was observed in the clinical trials. The optimal sample size is the one which maximises the expected net benefit of the trial. The approach has been developed in a series of papers by Pezeshk and the present authors (Gittins JC, Pezeshk H. A behavioral Bayes method for determining the size of a clinical trial. Drug Information Journal 2000; 34: 355-63; Gittins JC, Pezeshk H. How Large should a clinical trial be? The Statistician 2000; 49(2): 177-87; Gittins JC, Pezeshk H. A decision theoretic approach to sample size determination in clinical trials. Journal of Biopharmaceutical Statistics 2002; 12(4): 535-51; Gittins JC, Pezeshk H. A fully Bayesian approach to calculating sample sizes for clinical trials with binary responses. Drug Information Journal 2002; 36: 143-50; Kikuchi T, Pezeshk H, Gittins J. A Bayesian cost-benefit approach to the determination of sample size in clinical trials. Statistics in Medicine 2008; 27(1): 68-82; Kikuchi T, Gittins J. A behavioral Bayes method to determine the sample size of a clinical trial considering efficacy and safety. Statistics in Medicine 2009; 28(18): 2293-306; Kikuchi T, Gittins J. A Bayesian procedure for cost-benefit evaluation of a new drug in multi-national clinical trials. Statistics in Medicine 2009 (Submitted)). The purpose of this article is to provide a rationale for experimental designs which allocate more patients to the new treatment than to the control group. The model uses a logistic weight function, including an interaction term linking efficacy and safety, which determines the number of patients choosing the new drug, and hence the resulting benefit. A Monte Carlo simulation is employed for the calculation. Having a larger group of patients on the new drug in general

  7. [Patient safety -- mission for the future: The importance of Critical Incident Reporting Systems (CIRS) in clinical practice].

    Science.gov (United States)

    Maas, Matthias; Güß, Tim

    2014-07-01

    Every day patients experience harm due to errors and complications. To improve this situation, patient safety is increasingly becoming important in the treatment process. One aspect to increase patient safety is the Critical Incident Reporting System (CIRS). Observers and members of the care team are given the opportunity to anonymously report critical incidents and thus allow an analysis by an evaluation team. The goal is not to sanction the behavior of an individual, but to identify particular structural and organizational sources of error and to derive improvements. © Georg Thieme Verlag Stuttgart · New York.

  8. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    Science.gov (United States)

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  9. Safety and effectiveness of stem cell therapies in early-phase clinical trials in stroke: a systematic review and meta-analysis.

    Science.gov (United States)

    Nagpal, Anjali; Choy, Fong Chan; Howell, Stuart; Hillier, Susan; Chan, Fiona; Hamilton-Bruce, Monica A; Koblar, Simon A

    2017-08-30

    Stem cells have demonstrated encouraging potential as reparative therapy for patients suffering from post-stroke disability. Reperfusion interventions in the acute phase of stroke have shown significant benefit but are limited by a narrow window of opportunity in which they are beneficial. Thereafter, rehabilitation is the only intervention available. The current review summarises the current evidence for use of stem cell therapies in stroke from early-phase clinical trials. The safety and feasibility of administering different types of stem cell therapies in stroke seem to be reasonably proven. However, the effectiveness needs still to be established through bigger clinical trials with more pragmatic clinical trial designs that address the challenges raised by the heterogeneous nature of stroke per se, as well those due to unique characteristics of stem cells as therapeutic agents.

  10. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds

    DEFF Research Database (Denmark)

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne

    2011-01-01

    events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds.......This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated...... weekly with Leucopatch, prepared at the point of care from a donation of the patients' blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm(2) (median 2.3 cm(2)) and had not responded to previous...

  11. Four-hour quantitative real-time polymerase chain reaction-based comprehensive chromosome screening and accumulating evidence of accuracy, safety, predictive value, and clinical efficacy.

    Science.gov (United States)

    Treff, Nathan R; Scott, Richard T

    2013-03-15

    Embryonic comprehensive chromosomal euploidy may represent a powerful biomarker to improve the success of IVF. However, there are a number of aneuploidy screening strategies to consider, including different technologic platforms with which to interrogate the embryonic DNA, and different embryonic developmental stages from which DNA can be analyzed. Although there are advantages and disadvantages associated with each strategy, a series of experiments producing evidence of accuracy, safety, clinical predictive value, and clinical efficacy indicate that trophectoderm biopsy and quantitative real-time polymerase chain reaction (qPCR)-based comprehensive chromosome screening (CCS) may represent a useful strategy to improve the success of IVF. This Biomarkers in Reproductive Medicine special issue review summarizes the accumulated experience with the development and clinical application of a 4-hour blastocyst qPCR-based CCS technology. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  12. Clinical efficacy, safety and pharmacokinetics of a newly developed controlled release morphine sulphate suppository in patients with cancer pain

    NARCIS (Netherlands)

    Moolenaar, F.; Meijler, W.J.; Frijlink, H.W.; Visser, Jan; Proost, J.H.

    Objective: To compare the efficacy, safety and pharmacokinetics of a newly developed controlled-release suppository (MSR) with MS Contin tablets (MSC) in cancer patients with pain. Methods: In a double-blind, randomised, two-way crossover trial, 25 patients with cancer pain were selected with a

  13. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment

    NARCIS (Netherlands)

    Fineman, M.S.; Mace, K.F.; Diamant, M.; Darsow, T.; Cirincione, B.B.; Porter, T.K.B.; Kinninger, L.A.; Trautmann, M.E.

    2012-01-01

    Aims: Antibody formation to therapeutic peptides is common. This analysis characterizes the time-course and cross-reactivity of anti-exenatide antibodies and potential effects on efficacy and safety. Methods: Data from intent-to-treat patients in 12 controlled (n = 2225,12-52weeks) and 5

  14. Clinical Trials

    Medline Plus

    Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  16. Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

    Directory of Open Access Journals (Sweden)

    Nagamu Inoue

    2017-07-01

    Full Text Available Background/Aims: Intestinal Behçet's disease (BD is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671.Methods: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs were examined. The efficacy was assessed on the basis of marked improvement (MI and complete remission (CR using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments.Results: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years. No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively.Conclusions: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

  17. Safety, efficacy and pharmacokinetics of rVIII-SingleChain in children with severe hemophilia A: results of a multicenter clinical trial.

    Science.gov (United States)

    Stasyshyn, O; Djambas Khayat, C; Iosava, G; Ong, J; Abdul Karim, F; Fischer, K; Veldman, A; Blackman, N; St Ledger, K; Pabinger, I

    2017-04-01

    Essentials rVIII-SingleChain is a novel recombinant factor VIII with covalently bonded heavy and light chains. Efficacy, safety and pharmacokinetics were studied in pediatric patients with severe hemophilia A. Across all prophylaxis regimens, the median annualized spontaneous bleeding rate was 0.00. rVIII-SingleChain showed excellent hemostatic efficacy and a favorable safety profile. Background rVIII-SingleChain is a novel B-domain truncated recombinant factor VIII (rFVIII) comprised of covalently bonded FVIII heavy and light chains, demonstrating a high binding affinity to von Willebrand factor. Objectives This phase III study investigated the safety, efficacy and pharmacokinetics of rVIII-SingleChain in previously treated pediatric patients hemophilia A. Patients/Methods Patients could be assigned to prophylaxis or on-demand therapy by the investigator. For patients assigned to prophylaxis, the treatment regimen and dose were based on the bleeding phenotype. For patients receiving on-demand therapy, dosing was guided by World Federation of Hemophilia recommendations. The primary endpoint was treatment success, defined as a rating of 'excellent' or 'good' on the investigator's clinical assessment of hemostatic efficacy for all treated bleeding events. Results The study enrolled 84 patients (0 to 50 EDs. In the 347 bleeds treated and evaluated by the investigator, hemostatic efficacy was rated as excellent or good in 96.3%. The median annualized spontaneous bleeding rate was 0.00 (Q1, Q3: 0.00, 2.20), and the median annualized bleeding rate was 3.69 (Q1, Q3: 0.00, 7.20) across all prophylaxis regimens. No participant developed an inhibitor. Conclusions rVIII-SingleChain is a novel rFVIII molecule showing excellent hemostatic efficacy and a favorable safety profile in a clinical study in children hemophilia A. © 2017 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and

  18. 'It's a matter of patient safety': understanding challenges in everyday clinical practice for achieving good care on the surgical ward - a qualitative study.

    Science.gov (United States)

    Jangland, Eva; Nyberg, Berit; Yngman-Uhlin, Pia

    2017-06-01

    Surgical care plays an important role in the acute hospital's delivery of safe, high-quality patient care. Although demands for effectiveness are high in surgical wards quality of care and patient safety must also be secured. It is therefore necessary to identify the challenges and barriers linked to quality of care and patient safety with a focus on this specific setting. To explore situations and processes that support or hinder good safe patient care on the surgical ward. This qualitative study was based on a strategic sample of 10 department and ward leaders in three hospitals and six surgical wards in Sweden. Repeated reflective interviews were analysed using systematic text condensation. Four themes described the leaders' view of a complex healthcare setting that demands effectiveness and efficiency in moving patients quickly through the healthcare system. Quality of care and patient safety were often hampered factors such as a shift of care level, with critically ill patients cared for without reorganisation of nurses' competencies on the surgical ward. There is a gap between what is described in written documents and what is or can be performed in clinical practice to achieve good care and safe care on the surgical ward. A shift in levels of care on the surgical ward without reallocation of the necessary competencies at the patient's bedside show consequences for quality of care and patient safety. This means that surgical wards should consider reviewing their organisation and implementing more advanced nursing roles in direct patient care on all shifts. The ethical issues and the moral stress on nurses who lack the resources and competence to deliver good care according to professional values need to be made more explicit as a part of the patient safety agenda in the surgical ward. © 2016 Nordic College of Caring Science.

  19. Clinical Correlates of Surveillance Events Detected by National Healthcare Safety Network Pneumonia and Lower Respiratory Infection Definitions—Pennsylvania, 2011–2012

    Science.gov (United States)

    See, Isaac; Chang, Julia; Gualandi, Nicole; Buser, Genevieve L.; Rohrbach, Pamela; Smeltz, Debra A.; Bellush, Mary Jo; Coffin, Susan E.; Gould, Jane M.; Hess, Debra; Hennessey, Patricia; Hubbard, Sydney; Kiernan, Andrea; O’Donnell, Judith; Pegues, David A.; Miller, Jeffrey R.; Magill, Shelley S.

    2017-01-01

    Objective To determine the clinical diagnoses associated with National Healthcare Safety Network (NHSN) pneumonia (PNEU) or lower respiratory infection (LRI) surveillance events. Design Retrospective chart review. Setting Eight acute care hospitals in Pennsylvania. Patients All patients hospitalized during 2011–2012. Methods Medical records were reviewed from a random sample of patients reported to NHSN to have PNEU or LRI, excluding adults with ventilator-associated PNEU. Documented clinical diagnoses corresponding temporally to the PNEU/LRI events were recorded. Results We reviewed 250 (30%) of 838 eligible PNEU and LRI events reported to NHSN; 29 (12%) of reported events fulfilled neither PNEU nor LRI case criteria. Differences interpreting radiology reports accounted for most misclassification. Of 81 PNEU events in adults not on mechanical ventilation, 84% had clinician-diagnosed pneumonia, of which 25% were attributed to aspiration. Of 43 adult LRI, 88% were in mechanically ventilated patients and 35% had no corresponding clinical diagnosis (infectious or non-infectious) documented at the time of LRI. Of 36 pediatric PNEU events, 72% were ventilator-associated, and 70% corresponded to a clinical pneumonia diagnosis. Of 61 pediatric LRI, 84% were in mechanically-ventilated patients, and 21% had no corresponding clinical diagnosis documented. Conclusions In adults not on mechanical ventilation and in children, most NHSN-defined PNEU events corresponded to compatible clinical conditions documented in the medical record. In contrast, NHSN LRI events often did not. As a result, substantial modifications to the LRI definitions were implemented in 2015. PMID:27072043

  20. CLINICAL STUDIES OF REACTOGENICITY, SAFETY AND IMMUNOGENICITY OF LIVE MONOVALENT INFLUENZA VACCINE (STRAIN А/17/CALIFORNIA/2009/38 — H1N1 IN CHILDREN

    Directory of Open Access Journals (Sweden)

    D.S. Bushmenkov

    2010-01-01

    Full Text Available Results of performed pre-clinical and clinical studies with volunteers 18-60 years old allowed registration of vaccine «INFLUVIR» (live monovalent vaccine for the prophylaxis of influenza A/H1N1, strain A/17/California/2009/38 (H1N1, developed by NPO «Microgen» in Russian Federation so timely vaccination campaign was performed. As a result, the level of morbidity with influenza A/H1N1 in Russia was decreased, and development of complication was prevented. Clinical studies in different groups of children were performed for the purpose of widening indications for vaccine «INFLUVIR» administration. According to the results of studies vaccine «INFLUVIR» has good tolerability and safety, low reactogenicity, and significant immunogenicity. This fact will allow changing of present normative documentation and administration of «INFLUVIR» in children of different age for prophylaxis of influenza A/H1N1.Key words: children, influenza, virus A/H1N1, live influenza vaccine, tolerability, safety, immunogenicity.(Voprosy sovremennoi pediatrii — Current Pediatrics. – 2010;9(4:101-105

  1. Application of a human factors classification framework for patient safety to identify precursor and contributing factors to adverse clinical incidents in hospital.

    Science.gov (United States)

    Mitchell, Rebecca J; Williamson, Ann; Molesworth, Brett

    2016-01-01

    This study aimed to identify temporal precursor and associated contributing factors for adverse clinical incidents in a hospital setting using the Human Factors Classification Framework (HFCF) for patient safety. A random sample of 498 clinical incidents were reviewed. The framework identified key precursor events (PE), contributing factors (CF) and the prime causes of incidents. Descriptive statistics and correspondence analysis were used to examine incident characteristics. Staff action was the most common type of PE identified. Correspondence analysis for all PEs that involved staff action by error type showed that rule-based errors were strongly related to performing medical or monitoring tasks or the administration of medication. Skill-based errors were strongly related to misdiagnoses. Factors relating to the organisation (66.9%) or the patient (53.2%) were the most commonly identified CFs. The HFCF for patient safety was able to identify patterns of causation for the clinical incidents, highlighting the need for targeted preventive approaches, based on an understanding of how and why incidents occur. Copyright © 2015 Elsevier Ltd and The Ergonomics Society. All rights reserved.

  2. Prevalence of Substance Use in an HIV Primary Care Safety Net Clinic: A Call for Screening.

    Science.gov (United States)

    Dawson-Rose, Carol; Draughon, Jessica E; Zepf, Roland; Cuca, Yvette P; Huang, Emily; Freeborn, Kellie; Lum, Paula J

    Substance use complicates HIV care and prevention. Primary care clinics are an ideal setting to screen for and offer interventions for unhealthy alcohol and drug use; however, few HIV clinics routinely screen for substance use. We enrolled 208 clinic patients at an urban underserved HIV primary care clinic. We screened the patients for substance use with the Alcohol, Smoking, and Substance Involvement Score Test and measured urine toxicology. Of the 168 participants who completed screening, the majority reported tobacco or nonprescribed substance use in the previous 3 months. More African American participants reported low or no risk amphetamine use compared to Hispanic, White, or Other race participants (p < .001). Implementing standard clinic practice for screening and assessing substance use in HIV primary care clinics is needed. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  3. The LVIS Jr. microstent to assist coil embolization of wide-neck intracranial aneurysms: clinical study to assess safety and efficacy

    International Nuclear Information System (INIS)

    Moehlenbruch, M.; Herweh, C.; Behrens, L.; Jestaedt, L.; Bendszus, M.; Pham, M.; Amiri, H.; Ringleb, P.A.

    2014-01-01

    This study was aimed to assess clinical safety and efficacy of the LVIS Jr. microstent in stent-assisted coil embolization of wide-neck intracranial aneurysms. IRB approved single-center interventional clinical study in 22 patients (10 females, 12 males, mean age 55, age range 33-74 years) for the endovascular treatment of wide-neck aneurysms. After obtaining informed consent, patients were included according to the following criteria: aneurysm fundus-to-neck ratio 4 mm, and a parent vessel diameter of ≤3.5 mm. Primary end point for clinical safety was absence of death, absence of major or minor stroke, and absence of transient ischemic attack. Primary end point for treatment efficacy was complete angiographic occlusion according to the Raymond-Roy Occlusion Classification (RROC) immediately after the procedure and at follow-up after 3 and 6 months on magnetic resonance imaging (MRI). In 20/22 (91 %) of patients, the primary end point of safety was reached; in the two remaining patients, transient ischemic attack, but no permanent deficit was observed; in 16/22 (73 %), efficient occlusion (RROC1) was reached, and in 6/22 (27 %), a residual neck remained (RROC2). Single [seven with antegrade, two in crossover configuration, and four with ''first-balloon-then-stent'' (FBTS) technique] or double-stent (eight patients with Y configuration and one patient with X configuration) deployment was technically successful in all cases. Deployment of the LVIS Jr. microstent in various single- or double-stent configurations is safe and effective to assist the treatment of intracranial wide-neck aneurysms. (orig.)

  4. Compliant flooring to prevent fall-related injuries in older adults: A scoping review of biomechanical efficacy, clinical effectiveness, cost-effectiveness, and workplace safety.

    Science.gov (United States)

    Lachance, Chantelle C; Jurkowski, Michal P; Dymarz, Ania C; Robinovitch, Stephen N; Feldman, Fabio; Laing, Andrew C; Mackey, Dawn C

    2017-01-01

    Compliant flooring, broadly defined as flooring systems or floor coverings with some level of shock absorbency, may reduce the incidence and severity of fall-related injuries in older adults; however, a lack of synthesized evidence may be limiting widespread uptake. Informed by the Arksey and O'Malley framework and guided by a Research Advisory Panel of knowledge users, we conducted a scoping review to answer: what is presented about the biomechanical efficacy, clinical effectiveness, cost-effectiveness, and workplace safety associated with compliant flooring systems that aim to prevent fall-related injuries in healthcare settings? We searched academic and grey literature databases. Any record that discussed a compliant flooring system and at least one of biomechanical efficacy, clinical effectiveness, cost-effectiveness, or workplace safety was eligible for inclusion. Two independent reviewers screened and abstracted records, charted data, and summarized results. After screening 3611 titles and abstracts and 166 full-text articles, we included 84 records plus 56 companion (supplementary) reports. Biomechanical efficacy records (n = 50) demonstrate compliant flooring can reduce fall-related impact forces with minimal effects on standing and walking balance. Clinical effectiveness records (n = 20) suggest that compliant flooring may reduce injuries, but may increase risk for falls. Preliminary evidence suggests that compliant flooring may be a cost-effective strategy (n = 12), but may also result in increased physical demands for healthcare workers (n = 17). In summary, compliant flooring is a promising strategy for preventing fall-related injuries from a biomechanical perspective. Additional research is warranted to confirm whether compliant flooring (i) prevents fall-related injuries in real-world settings, (ii) is a cost-effective intervention strategy, and (iii) can be installed without negatively impacting workplace safety. Avenues for future research are

  5. Surgical and clinical safety and effectiveness of robot-assisted laparoscopic hysterectomy compared to conventional laparoscopy and laparotomy for cervical cancer: A systematic review and meta-analysis.

    Science.gov (United States)

    Park, D A; Yun, J E; Kim, S W; Lee, S H

    2017-06-01

    This study aimed to evaluate the surgical safety and clinical effectiveness of RH versus LH and laparotomy for cervical cancer. We searched Ovid-Medline, Ovid-EMBASE, and the Cochrane library through May 2015, and checked references of relevant studies. We selected the comparative studies reported the surgical safety (overall; peri-operative; and post-operative complications; death within 30 days; and specific morbidities), and clinical effectiveness (survival; recurrence; length of stay [LOS]; estimated blood loss [EBL]; operative time [OT]) and patient-reported outcomes. Fifteen studies comparing RH with OH and 11 comparing RH with LH were identified. No significant differences were found in survival outcomes. The LOS was shorter and transfusion rate was lower with RH compared to OH or LH. EBL was significantly reduced with RH compared to OH. Compared to OH, overall complications, urinary infection, wound infection, and fever were significantly less frequent with RH. The overall, peri-operative, and post-operative complications were similar in other comparisons. Several patient-reported outcomes were improved with RH, though each outcome was reported in only one study. RH appears to have a positive effect in reducing overall complications, individual adverse events including wound infection, fever, urinary tract infection, transfusion, LOS, EBL, and time to diet than OH for cervical cancer patients. Compared to LH, the current evidence is not enough to clearly determine its clinical safety and effectiveness. Further rigorous prospective studies with long-term follow-up that overcome the many limitations of the current evidence are needed. Copyright © 2016 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

  6. A phase IIa randomized controlled pilot study evaluating the safety and clinical outcomes following the use of rhGDF-5/β-TCP in regenerative periodontal therapy.

    Science.gov (United States)

    Windisch, Péter; Stavropoulos, Andreas; Molnár, Bálint; Szendröi-Kiss, Dóra; Szilágyi, Emese; Rosta, Péter; Horváth, Attila; Capsius, Björn; Wikesjö, Ulf M E; Sculean, Anton

    2012-08-01

    To present the safety profile, the early healing phase and the clinical outcomes at 24 weeks following treatment of human intrabony defects with open flap debridement (OFD) alone or with OFD and rhGDF-5 adsorbed onto a particulate β-tricalcium phosphate (β-TCP) carrier. Twenty chronic periodontitis patients, each with at least one tooth exhibiting a probing depth ≥6 mm and an associated intrabony defect ≥4 mm entered the study. Ten subjects (one defect/patient) were randomized to receive OFD alone (control) and ten subjects OFD combined with rhGDF-5/β-TCP. Blood samples were collected at screening, and at weeks 2 and 24 to evaluate routine hematology and clinical chemistry, rhGDF-5 plasma levels, and antirhGDF-5 antibody formation. Plaque and gingival indices, bleeding on probing, probing depth, clinical attachment level, and radiographs were recorded pre- and 24 weeks postsurgery. Comparable safety profiles were found in the two treatment groups. Neither antirhGDF-5 antibody formation nor relevant rhGDF-5 plasma levels were detected in any patient. At 6 months, treatment with OFD + rhGDF-5/β-TCP resulted in higher but statistically not significant PD reduction (3.7 ± 1.2 vs. 3.1 ± 1.8 mm; p = 0.26) and CAL gain (3.2 ± 1.7 vs. 1.7 ± 2.2 mm; p = 0.14) compared to OFD alone. In the tested concentration, the use of rhGDF-5/β-TCP appeared to be safe and the material possesses a sound biological rationale. Thus, further adequately powered, randomized controlled clinical trials are warranted to confirm the clinical relevance of this new approach in regenerative periodontal therapy. rhGDF-5/β-TCP may represent a promising new techology in regenerative periodontal therapy.

  7. Serious adverse drug events related to non‐investigational drugs in academic clinical trials: another source of safety data for risk assessment?

    Science.gov (United States)

    Gimbert, Anne; Colin, Anne‐Laurène; Salvo, Francesco; Becker, Madlyne; Marty, Valérie; Montastruc, Jean‐Louis; Petitpain, Nadine

    2016-01-01

    Aims Sponsors of clinical trials have to analyze serious adverse events (SAEs). Both sponsors and investigators determine the relationship between the investigational medicinal product, the investigational device or procedure and SAEs. SAEs related to another cause, such as a non‐investigational medicinal product (NIMP), do not have clear pharmacovigilance reporting requirements. The aim of this study was to evaluate the amount and the nature of NIMP‐related SAEs recorded by three French academic sponsors and to propose pharmacovigilance requirements for these cases. Methods This was a retrospective descriptive study including all cases of NIMP‐related SAEs occurring in clinical trials and reported to three academic sponsors between January 2009 and October 2014. Results Among 5870 cases of SAEs, 300 (5%) were related to a NIMP in 50 clinical trials. Involved NIMPs were mainly antithrombotics, cytostatics and immunosuppressants. Some of these drugs were currently followed by a risk management plan (e.g. rivoxaban). The most frequent NIMP‐related SAEs were neurological, gastrointestinal and infectious disorders. Seven NIMP‐related SAEs were known as ‘rare’ or ‘very rare’ and two were ‘unlabelled’. Conclusions As far as we know, this is the first study to focus about NIMP‐related SAEs occurring in clinical trials. This work highlights the potential high quality source of safety data via NIMP‐related SAE collection. Globally, we propose that NIMP‐related SAEs occurring in clinical trials should systematically be notified to the pharmacovigilance system of the concerned country. Clearer procedures of interactions between safety units of academic sponsors and pharmacovigilance systems are needed to allow an effective recording of NIMP‐related SAEs. PMID:27276241

  8. Safety and feasibility of a diagnostic algorithm combining clinical probability, d-dimer testing, and ultrasonography for suspected upper extremity deep venous thrombosis: a prospective management study.

    Science.gov (United States)

    Kleinjan, Ankie; Di Nisio, Marcello; Beyer-Westendorf, Jan; Camporese, Giuseppe; Cosmi, Benilde; Ghirarduzzi, Angelo; Kamphuisen, Pieter W; Otten, Hans-Martin; Porreca, Ettore; Aggarwal, Anita; Brodmann, Marianne; Guglielmi, Maria Domenica; Iotti, Matteo; Kaasjager, Karin; Kamvissi, Virginia; Lerede, Teresa; Marschang, Peter; Meijer, Karina; Palareti, Gualtiero; Rickles, Frederick R; Righini, Marc; Rutjes, Anne W S; Tonello, Chiara; Verhamme, Peter; Werth, Sebastian; van Wissen, Sanne; Büller, Harry R

    2014-04-01

    Although well-established for suspected lower limb deep venous thrombosis, an algorithm combining a clinical decision score, d-dimer testing, and ultrasonography has not been evaluated for suspected upper extremity deep venous thrombosis (UEDVT). To assess the safety and feasibility of a new diagnostic algorithm in patients with clinically suspected UEDVT. Diagnostic management study. (ClinicalTrials.gov: NCT01324037) SETTING: 16 hospitals in Europe and the United States. 406 inpatients and outpatients with suspected UEDVT. The algorithm consisted of the sequential application of a clinical decision score, d-dimer testing, and ultrasonography. Patients were first categorized as likely or unlikely to have UEDVT; in those with an unlikely score and normal d-dimer levels, UEDVT was excluded. All other patients had (repeated) compression ultrasonography. The primary outcome was the 3-month incidence of symptomatic UEDVT and pulmonary embolism in patients with a normal diagnostic work-up. The algorithm was feasible and completed in 390 of the 406 patients (96%). In 87 patients (21%), an unlikely score combined with normal d-dimer levels excluded UEDVT. Superficial venous thrombosis and UEDVT were diagnosed in 54 (13%) and 103 (25%) patients, respectively. All 249 patients with a normal diagnostic work-up, including those with protocol violations (n = 16), were followed for 3 months. One patient developed UEDVT during follow-up, for an overall failure rate of 0.4% (95% CI, 0.0% to 2.2%). This study was not powered to show the safety of the substrategies. d-Dimer testing was done locally. The combination of a clinical decision score, d-dimer testing, and ultrasonography can safely and effectively exclude UEDVT. If confirmed by other studies, this algorithm has potential as a standard approach to suspected UEDVT. None.

  9. Safety and pharmacokinetics of recombinant human hepatocyte growth factor (rh-HGF) in patients with fulminant hepatitis: a phase I/II clinical trial, following preclinical studies to ensure safety.

    Science.gov (United States)

    Ido, Akio; Moriuchi, Akihiro; Numata, Masatsugu; Murayama, Toshinori; Teramukai, Satoshi; Marusawa, Hiroyuki; Yamaji, Naohisa; Setoyama, Hitoshi; Kim, Il-Deok; Chiba, Tsutomu; Higuchi, Shuji; Yokode, Masayuki; Fukushima, Masanori; Shimizu, Akira; Tsubouchi, Hirohito

    2011-05-08

    Hepatocyte growth factor (HGF) stimulates hepatocyte proliferation, and also acts as an anti-apoptotic factor. Therefore, HGF is a potential therapeutic agent for treatment of fatal liver diseases. We performed a translational medicine protocol with recombinant human HGF (rh-HGF), including a phase I/II study of patients with fulminant hepatitis (FH) or late-onset hepatic failure (LOHF), in order to examine the safety, pharmacokinetics, and clinical efficacy of this molecule. Potential adverse effects identified through preclinical safety tests with rh-HGF include a decrease in blood pressure (BP) and an increase in urinary excretion of albumin. Therefore, we further investigated the effect of rh-HGF on circulatory status and renal toxicity in preclinical animal studies. In a clinical trial, 20 patients with FH or LOHF were evaluated for participation in this clinical trial, and four patients were enrolled. Subjects received rh-HGF (0.6 mg/m2/day) intravenously for 12 to 14 days. We established an infusion method to avoid rapid BP reduction in miniature swine, and confirmed reversibility of renal toxicity in rats. Although administration of rh-HGF moderately decreased BP in the participating subjects, this BP reduction did not require cessation of rh-HGF or any vasopressor therapy; BP returned to resting levels after the completion of rh-HGF infusion. Repeated doses of rh-HGF did not induce renal toxicity, and severe adverse events were not observed. Two patients survived, however, there was no evidence that rh-HGF was effective for the treatment of FH or LOHF. Intravenous rh-HGF at a dose of 0.6 mg/m2 was well tolerated in patients with FH or LOHF; therefore, it is desirable to conduct further investigations to determine the efficacy of rh-HGF at an increased dose.

  10. Safety and pharmacokinetics of recombinant human hepatocyte growth factor (rh-HGF in patients with fulminant hepatitis: a phase I/II clinical trial, following preclinical studies to ensure safety

    Directory of Open Access Journals (Sweden)

    Setoyama Hitoshi

    2011-05-01

    Full Text Available Abstract Background Hepatocyte growth factor (HGF stimulates hepatocyte proliferation, and also acts as an anti-apoptotic factor. Therefore, HGF is a potential therapeutic agent for treatment of fatal liver diseases. We performed a translational medicine protocol with recombinant human HGF (rh-HGF, including a phase I/II study of patients with fulminant hepatitis (FH or late-onset hepatic failure (LOHF, in order to examine the safety, pharmacokinetics, and clinical efficacy of this molecule. Methods Potential adverse effects identified through preclinical safety tests with rh-HGF include a decrease in blood pressure (BP and an increase in urinary excretion of albumin. Therefore, we further investigated the effect of rh-HGF on circulatory status and renal toxicity in preclinical animal studies. In a clinical trial, 20 patients with FH or LOHF were evaluated for participation in this clinical trial, and four patients were enrolled. Subjects received rh-HGF (0.6 mg/m2/day intravenously for 12 to 14 days. Results We established an infusion method to avoid rapid BP reduction in miniature swine, and confirmed reversibility of renal toxicity in rats. Although administration of rh-HGF moderately decreased BP in the participating subjects, this BP reduction did not require cessation of rh-HGF or any vasopressor therapy; BP returned to resting levels after the completion of rh-HGF infusion. Repeated doses of rh-HGF did not induce renal toxicity, and severe adverse events were not observed. Two patients survived, however, there was no evidence that rh-HGF was effective for the treatment of FH or LOHF. Conclusions Intravenous rh-HGF at a dose of 0.6 mg/m2 was well tolerated in patients with FH or LOHF; therefore, it is desirable to conduct further investigations to determine the efficacy of rh-HGF at an increased dose.

  11. Pre-Clinical Efficacy and Safety of Experimental Vaccines Based on Non-Replicating Vaccinia Vectors against Yellow Fever

    Science.gov (United States)

    Schäfer, Birgit; Holzer, Georg W.; Joachimsthaler, Alexandra; Coulibaly, Sogue; Schwendinger, Michael; Crowe, Brian A.; Kreil, Thomas R.; Barrett, P. Noel; Falkner, Falko G.

    2011-01-01

    Background Currently existing yellow fever (YF) vaccines are based on the live attenuated yellow fever virus 17D strain (YFV-17D). Although, a good safety profile was historically attributed to the 17D vaccine, serious adverse events have been reported, making the development of a safer, more modern vaccine desirable. Methodology/Principal Findings A gene encoding the precursor of the membrane and envelope (prME) protein of the YFV-17D strain was inserted into the non-replicating modified vaccinia virus Ankara and into the D4R-defective vaccinia virus. Candidate vaccines based on the recombinant vaccinia viruses were assessed for immunogenicity and protection in a mouse model and compared to the commercial YFV-17D vaccine. The recombinant live vaccines induced γ-interferon-secreting CD4- and functionally active CD8-T cells, and conferred full protection against lethal challenge already after a single low immunization dose of 105 TCID50. Surprisingly, pre-existing immunity against wild-type vaccinia virus did not negatively influence protection. Unlike the classical 17D vaccine, the vaccinia virus-based vaccines did not cause mortality following intracerebral administration in mice, demonstrating better safety profiles. Conclusions/Significance The non-replicating recombinant YF candidate live vaccines induced a broad immune response after single dose administration, were effective even in the presence of a pre-existing immunity against vaccinia virus and demonstrated an excellent safety profile in mice. PMID:21931732

  12. Following the (Clinical Decision) Rules: Opportunities for Improving Safety and Resource Utilization With the Bacterial Meningitis Score.

    Science.gov (United States)

    Hagedorn, Philip A; Shah, Samir S; Kirkendall, Eric S

    2016-05-01

    The Bacterial Meningitis Score accurately classifies children with cerebrospinal fluid (CSF) pleocytosis at very low risk (VLR) versus not very low risk (non-VLR) for bacterial meningitis. Most children with CSF pleocytosis detected during emergency department evaluation are hospitalized despite the high accuracy of this prediction rule and the decreasing incidence of bacterial meningitis. The lack of widespread use of this rule may contribute to unnecessary risk exposure and costs. This cross-sectional study included 1049 patients who, between January 2010 and May 2013, had suspicion for meningitis and underwent both a complete blood cell count and CSF studies during their emergency department evaluation. We then examined their hospitalizations to characterize exposure to drugs, radiologic studies, and the costs associated with their care to determine the safety and value repercussions of these VLR admissions. Primary outcomes include duration of antibiotics, exposure to drugs and radiology studies, safety events, and costs incurred during these VLR admissions. Twenty patients classified as VLR were admitted to the hospital. On average they received 35 hours of antibiotic therapy. There was 1 adverse drug event and 1 safety event. The VLR patients admitted to the hospital were exposed to risk and costs despite their low risk stratification. Systematic application of the Bacterial Meningitis Score could prevent these exposures and costs. Copyright © 2016 by the American Academy of Pediatrics

  13. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds

    DEFF Research Database (Denmark)

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne

    2011-01-01

    This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated...... treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm(2) (range = 0-9.6cm(2)). There were no serious adverse...

  14. Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial

    Science.gov (United States)

    Demarin, Vida; Bašić Kes, Vanja; Trkanjec, Zlatko; Budišić, Mislav; Bošnjak Pašić, Marija; Črnac, Petra; Budinčević, Hrvoje

    2017-01-01

    Objectives The aim of this randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of Ginkgo biloba extract in patients diagnosed with vascular cognitive impairment (VCI). Methods A total of 90 patients (aged 67.1±8.0 years; 59 women) were randomly allocated (1:1:1) to receive G. biloba 120 mg, G. biloba 60 mg, or placebo during a 6-month period. Assessment was made for efficacy indicators, including neuropsychological tests scores (Sandoz Clinical Assessment Geriatric Scale, Folstein Mini-Mental State Examination, Mattis Dementia Rating Scale, and Clinical Global Impression) and transcranial Doppler ultrasound findings. Safety indicators included laboratory findings, reported adverse reactions, and clinical examination. Results At the end of 6-month study period, G. biloba 120 and 60 mg showed a statistically significant positive effect in comparison with placebo only on the Clinical Global Impression score (2.6±0.8 vs 3.1±0.7 vs 2.8±0.7, respectively; P=0.038). The Clinical Global Impression score showed a significant deterioration from the baseline values in the placebo group (−0.3±0.5; P=0.021) as opposed to G. biloba groups. No significant differences were found in the transcranial Doppler ultrasound findings. Adverse reactions were significantly more common and serious in the placebo group (16 subjects) than in either of the two G. biloba extract groups (eight and nine subjects, respectively), whereas laboratory findings and clinical examinations revealed no differences between the groups receiving G. biloba extract and placebo. Conclusion According to our results, G. biloba seemed to slow down the cognitive deterioration in patients with VCI, but the effect was shown in only one of the four neuropsychological tests administered. However, because of this mild effect in combination with a few adverse reactions, we cannot say that it is ineffective or unsafe either. Further studies are still needed to provide

  15. Clinical Outcomes and Safety of Partial Full-Thickness Myotomy versus Circular Muscle Myotomy in Peroral Endoscopic Myotomy for Achalasia Patients

    Directory of Open Access Journals (Sweden)

    Chenyu Li

    2017-01-01

    Full Text Available Background. Here we aimed to evaluate and compare the efficacy and safety between partial full-thickness myotomy and circular muscle myotomy during POEM procedure in achalasia patients. Methods. Clinical data of achalasia of cardia (AC patients who underwent POEM in our center during January 2014 to January 2015 was collected (34 cases. 19 patients who received partial full-thickness myotomy were assigned to group A and 14 patients who received circular muscle myotomy were assigned to group B. The procedure-related parameters between the two groups were compared. Symptom relief rate and postprocedure manometry outcomes were compared to evaluate the efficacy. Procedure-related adverse events and complications were compared to evaluate the safety. Results. (1 Mean operation times were significantly shorter in group A than group B (62.42±23.17 vs 87.86±26.44 min, p0.05. (3 Comparison of procedure-related adverse events and complications had no statistical differences (all p>0.05. Conclusion. Partial full-thickness myotomy had no significant differences in efficacy or safety with circular myotomy, but partial full-thickness myotomy significantly reduced the procedure time.

  16. Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial.

    Science.gov (United States)

    Martinez-Atienza, Juliana; Rosso-Fernández, Clara; Roca, Cristina; Aydillo, Teresa A; Gavaldà, Joan; Moreno, Asunción; Montejo, Jose M; Torre-Cisneros, Julian; Fariñas, M Carmen; Fortun, Jesus; Sabé, Nuria; Muñoz, Patricia; Blanes-Julia, Marino; Suárez-Benjumea, Alejandro; López-Medrano, Francisco; Pérez-Romero, Pilar; Cordero, Elisa

    2014-08-28

    Despite administration of annual influenza vaccination, influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death. Although influenza vaccination has been proven to be the most effective measure to reduce influenza infection after transplantation, transplant recipients are still vulnerable to influenza infections, with lower serological responses to vaccination compared to the general population. In order to assess the efficacy and safety of an alternative immunization scheme for solid organ transplant recipients, the TRANSGRIPE1-2 Study Group aimed to test a booster dose administration 5 weeks after the standard vaccination. The primary objective of this trial was to compare short-term and long-term neutralizing antibody immunogenicity of a booster dose of influenza vaccination to the standard single-dose immunization scheme. Secondary objectives included the evaluation of the efficacy and/or safety, cellular immune response, incidence of influenza infection, graft rejection, retransplant and mortality rates. This phase III, randomized, controlled, open-label clinical trial was conducted between October 2012 and December 2013 in 12 Spanish public referral hospitals. Solid organ transplant recipients (liver, kidney, heart or lung), older than 16 years of age more than 30 days after transplantation were eligible to participate. Patients (N = 514) were stratified 1:1 by center, type of organ and time after transplantation and who either received the standard single dose (n = 257) or were treated according to a novel influenza vaccination schedule comprising the administration of a booster dose 5 weeks after standard vaccination (n = 254). Seroconversion rates were measured as a determinant of protection against influenza (main outcome). Efficacy and safety outcomes were followed until 1 year after influenza vaccination with assessment of short-term (0, 5, 10 and 15 weeks) and long-term (12 months

  17. Safety, immune and clinical responses in metastatic melanoma patients vaccinated with a long peptide derived from indoleamine 2,3-dioxygenase in combination with ipilimumab

    DEFF Research Database (Denmark)

    Bjørn, Jon; Iversen, Trine Zeeberg; Nitschke, Nikolaj Juul

    2016-01-01

    BACKGROUND AIM: Indoleamine 2,3-dioxygenase (IDO) is an emerging new target in cancer therapy that can be targeted with active immunotherapy (e.g. through peptide vaccination). Furthermore, IDO has been identified as a key mechanism underlying resistance to treatment with the checkpoint blocking...... antibody ipilimumab (ipi). METHODS: Ten patients with metastatic melanoma participated in a phase I first-in-human clinical study assessing safety of combining ipi with a 21-mer synthetic peptide vaccine from IDO denoted IDOlong. Secondary and tertiary end points included vaccine and clinical response....... RESULTS: Treatment was generally safe and well tolerated. Vaccine related adverse reactions included grade I and II erythema, oedema and pruritus at the vaccination site, which were manageable with mild topical corticosteroids. One patient developed presumed ipi-induced colitis. It initially responded...

  18. Tocilizumab use in pregnancy: Analysis of a global safety database including data from clinical trials and post-marketing data.

    Science.gov (United States)

    Hoeltzenbein, Maria; Beck, Evelin; Rajwanshi, Richa; Gøtestam Skorpen, Carina; Berber, Erhan; Schaefer, Christof; Østensen, Monika

    2016-10-01

    Analyze the cumulative evidence for pregnancy outcomes after maternal exposure to tocilizumab, an anti-interleukin-6-receptor monoclonal antibody used for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis. At present, published experience on tocilizumab use during pregnancy is very limited. We have analyzed all pregnancy-related reports documented in the Roche Global Safety Database until December 31, 2014 (n = 501). After exclusion of ongoing pregnancies, duplicates, and cases retrieved from the literature, 399 women were found to have been exposed to tocilizumab shortly before or during pregnancy, with pregnancy outcomes being reported in 288 pregnancies (72.2%). Of these 288 pregnancies, 180 were prospectively reported resulting in 109 live births (60.6%), 39 spontaneous abortions (21.7%), 31 elective terminations of pregnancy (17.2%), and 1 stillbirth. The rate of malformations was 4.5%. Co-medications included methotrexate in 21.1% of the prospectively ascertained cases. Compared to the general population, an increased rate of preterm birth (31.2%) was observed. Retrospectively reported pregnancies (n = 108) resulted in 55 live births (50.9%), 31 spontaneous abortions (28.7%), and 22 elective terminations (20.4%). Three infants/fetuses with congenital anomalies were reported in this group. No increased risks for adverse pregnancy outcomes were observed after paternal exposure in 13 pregnancies with known outcome. No indication for a substantially increased malformation risk was observed. Considering the limitations of global safety databases, the data do not yet prove safety, but provide information for physicians and patients to make informed decisions. This is particularly important after inadvertent exposure to tocilizumab, shortly before or during early pregnancy. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

    Science.gov (United States)

    Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

    2016-12-01

    Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

  20. SAFETY OF CELL-DERIVED SUBUNIT ADJUVANTED INFLUENZA VACCINE FOR CHILDREN VACCINATION: DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    S.M. Kharit

    2010-01-01

    Full Text Available This article presents the safety data for cell-derived inactivated subunit adjuvanted influenza vaccine «Grippol Neo» in children 3–17 years old in comparison with reference egg-derived inactivated subunit vaccine «Grippol plus». Good test vaccine tolerability and high efficacy profile is demonstrated. Based on the results obtained vaccine «Grippol Neo» is recommended for mass influenza prophylaxis in pediatry, including National Immunization Schedule.Key words: children, influenza, vaccination, «Grippol Neo».(Voprosy sovremennoi pediatrii — Current Pediatrics. – 2010;9(4:44-49

  1. Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice.

    Science.gov (United States)

    Hwang, You-Cheol; Kim, Ari; Jo, Euna; Yang, Yeoree; Cho, Jae-Hyoung; Lee, Byung-Wan

    2017-10-25

    Randomized clinical trials have shown the efficacy and safety of short-acting exenatide in patients with type 2 diabetes mellitus (T2DM). The aim of this observational study was to investigate the effectiveness and safety of exenatide twice a day in Korean patients with T2DM who are suboptimally controlled with oral hypoglycemic agents. This study was a post hoc analysis of multi-center (71 centers), prospective, observational, single-arm, post-marketing study of short-acting exenatide 5 to 10 μg twice a day from March 2008 to March 2014 and analyzed those who finished the follow-up over 20 weeks of medication. Changes of hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and body weight values before and after exenatide treatment were analyzed. Adverse events and adverse drug reactions were estimated in patients who were treated with exenatide at least once and for whom follow-up for safety has been completed. After 20 weeks treatment with exenatide, mean HbA1c and body weight were significantly reduced from 8.4% to 7.7% and from 83.4 kg to 80.2 kg, respectively (both p levels showed an independent association with a greater reduction in glucose level. In addition, short duration of diabetes less than 5 years was an independent predictor for the improvement in glucose level. The majority of study subjects showed a reduction in both body weight and glucose level (63.3%) after exenatide treatment. In terms of safety profile, exenatide treatment was generally well-tolerated and the incidence of severe adverse event was rare (0.8%). The gastrointestinal side effects were most common and hypoglycemia was reported in 1.7% of subjects. In real clinical practice, 20 weeks treatment with short-acting exenatide was well tolerated and showed a significant body weight and glucose reduction in Korean patients with T2D who are suboptimally controlled with oral hypoglycemic agents. ClinicalTirals.gov , number NCT02090673 , registered 14 February 2008.

  2. Safety and efficacy of letibotulinumtoxinA(BOTULAX®) in treatment of post stroke upper limb spasticity: a randomized, double blind, multi-center, phase III clinical trial.

    Science.gov (United States)

    Do, Kyung Hee; Chun, Min Ho; Paik, Nam-Jong; Park, Yoon Ghil; Lee, Shi-Uk; Kim, Min-Wook; Kim, Don-Kyu

    2017-09-01

    To investigate a new botulinum neurotoxin type A, termed letibotulinumtoxinA(Botulax ® ) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox ® ). A prospective, double-blinded, multicenter, randomized controlled clinical study. Six university hospitals in Korea. A total of 187 stroke participants with upper limb spasticity. Two kinds of botulinum neurotoxin type A were used. One set of injection was performed and total injected doses were 309.21±62.48U(Botulax) and 312.64±49.99U(Botox)( P>0.05). Primary outcome was measured using the modified Ashworth scale for wrist flexors at week 4 and secondary outcome was measured using modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and thumb flexors as well as Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale. Safety measures including adverse events, vital signs and physical examination, and laboratory tests were also monitored. The mean ages for the Botulax group were 56.81±9.49 and which for the Botox group were 56.93±11.93( P>0.05). In primary outcome, the change in modified Ashworth scale for wrist flexors was -1.45±0.61 in the Botulax group and -1.40±0.57 in the Botox group, and the difference between the two groups was -0.06(95% CI:-0.23-0.12, P>0.05). In secondary outcome, both groups demonstrated significant improvements with respect to modified Ashworth scale, Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale ( P0.05). In addition, safety measures showed no significant differences between the two groups ( P>0.05). The efficacy and safety of Botulax were comparable with those of Botox in treatment of post-stoke upper limb spasticity.

  3. Pooled analysis of clinical trial data evaluating the safety and effectiveness of diclofenac epolamine topical patch 1.3% for the treatment of acute ankle sprain

    Directory of Open Access Journals (Sweden)

    Lionberger DR

    2011-07-01

    Full Text Available David R Lionberger1, Eric Joussellin2, Jillmarie Yanchick3, Merrell Magelli3,4, Arturo Lanzarotti51Southwest Orthopedic Group, LLP, Houston, TX, USA; 2Institut National du Sport, Paris, France; 3Formerly Alpharma Pharmaceuticals LLC, Piscataway, NJ, USA; 4GTx, Inc., Memphis, TN, USA; 5Institut Biochimique SA, SwitzerlandAbstract: This pooled analysis assessed the efficacy and safety of the diclofenac epolamine topical patch 1.3% (DETP for the treatment of acute mild-to-moderate ankle sprain. Data from 2 randomized, double-blind, placebo-controlled studies enrolling 274 male and female patients aged 18 to 65 years with acute ankle sprain were pooled and evaluated. The primary end point was pain reduction on movement assessed using a 100 mm visual analog scale (VAS. Safety and tolerability were also assessed. Beginning approximately 3 hours after initial treatment, DETP-treated patients experienced statistically significant and sustained lower mean VAS scores in pain intensity on movement (mean ± SD, 54.1 ± 20.0 mm versus 60.3 ± 16.8 mm compared with placebo-treated patients, representing a 20% versus 13% reduction in VAS pain scores from baseline (P = 0.012. This statistically significant difference in mean VAS score was maintained through day 7 (9.4 ± 14.4 mm versus 18.4 ± 18.2 mm, P < 0.0001. The DETP and placebo patches were well tolerated. These results further confirm the efficacy and safety of DETP for the treatment of acute pain from ankle sprains.Keywords: soft tissue injury, acute pain, visual analog scale, clinical trial, double-blind, safety

  4. Specialized consultant in radiological safety to the Reforma peripheral clinic, PEMEX. - III. - September and October of 2002

    International Nuclear Information System (INIS)

    Angeles C, A.; Rodriguez A, F.; Garcia A, J.

    2003-02-01

    The Reforma peripheral clinic, dependent of PEMEX, It request consultant of the ININ to be able to maintain their sanitary license for the use of X-ray equipment for the radiologic diagnostic.The proposal of the ININ was to be a program of technical attendance, schedule monthly to be able to solve the observations that are presented in the use of those equipment, and that the clinic can conserve its respective sanitary license.(Author)

  5. Specialized consultant in radiological safety to the Reforma peripheral clinic, PEMEX. - IV. - November and December of 2002

    International Nuclear Information System (INIS)

    Angeles C, A.; Hernandez C, J. E.; Rodriguez A, F.; Garcia A, J.

    2003-02-01

    The Reforma peripheral clinic, dependent of PEMEX, It request consultant of the ININ to be able to maintain their sanitary license for the use of X-ray quipment for the radiologic diagnostic.The proposal of the ININ was to be a program of technical attendance, schedule monthly to be able to solve the observations that are presented in the use of those equipment, and that the clinic can conserve its respective sanitary license.(Author)

  6. Specialized consultant in radiological safety to the Macuspana peripheral clinic, PEMEX. - IV. - November and December of 2002

    International Nuclear Information System (INIS)

    Angeles C, A.; Hernandez C, J. E.; Garcia A, J.; Rodriguez A, F.

    2003-02-01

    The Macuspana peripheral clinic, dependent of PEMEX, It request consultant of the ININ to be able to maintain their sanitary license for the use of X-ray equipment for the radiologic diagnostic.The proposal of the ININ was to be a program of technical attendance, schedule monthly to be able to solve the observations that are presented in the use of those equipment, and that the clinic can conserve its respective sanitary license.(Author)

  7. Specialized consultant in radiological safety to the Reforma peripheral clinic, PEMEX. - I. - May-June of 2003

    International Nuclear Information System (INIS)

    Torres P, A.; Garcia A, J.; Rodriguez A, F.

    2003-07-01

    The Reforma peripheral clinic, dependent of PEMEX, It request consultant of the ININ to be able to maintain their sanitary license for the use of X-ray equipment for the radiologic diagnostic.The proposal of the ININ was to be a program of technical attendance, schedule monthly to be able to solve the observations that are presented in the use of those equipment, and that the clinic can conserve its respective sanitary license.(Author)

  8. Understanding the digital divide in the clinical setting: the technology knowledge gap experienced by US safety net patients during teleretinal screening.

    Science.gov (United States)

    George, Sheba; Moran, Erin; Fish, Allison; Ogunyemi, Lola

    2013-01-01

    Differential access to everyday technology and healthcare amongst safety net patients is associated with low technological and health literacies, respectively. These low rates of literacy produce a complex patient "knowledge gap" that influences the effectiveness of telehealth technologies. To understand this "knowledge gap", six focus groups (2 African-American and 4 Latino) were conducted with patients who received teleretinal screenings in U.S. urban safety-net settings. Findings indicate that patients' "knowledge gap" is primarily produced at three points: (1) when patients' preexisting personal barriers to care became exacerbated in the clinical setting; (2) through encounters with technology during screening; and (3) in doctor-patient follow-up. This "knowledge gap" can produce confusion and fear, potentially affecting patients' confidence in quality of care and limiting their disease management ability. In rethinking the digital divide to include the consequences of this knowledge gap faced by patients in the clinical setting, we suggest that patient education focus on both their disease and specific telehealth technologies deployed in care delivery.

  9. Clinical safety and effectiveness of transversus abdominis plane (TAP) block in post-operative analgesia: a systematic review and meta-analysis.

    Science.gov (United States)

    Ma, Ning; Duncan, Joanna K; Scarfe, Anje J; Schuhmann, Susanne; Cameron, Alun L

    2017-06-01

    Transversus abdominis plane (TAP) blocks can provide analgesia postoperatively for a range of surgeries. Abundant clinical trials have assessed TAP block showing positive analgesic effects. This systematic review assesses safety and effectiveness outcomes of TAP block in all clinical settings, comparing with both active (standard care) and inactive (placebo) comparators. PubMed, EMBASE, The Cochrane Library and the University of York CRD databases were searched. RCTs were screened for their eligibility and assessed for risk of bias. Meta-analyses were performed on available data. TAP block showed an equivalent safety profile to all comparators in the incidence of nausea (OR = 1.07) and vomiting (OR = 0.81). TAP block was more effective in reducing morphine consumption [MD = 13.05, 95% CI (8.33, 51.23)] and in delaying time to first analgesic request [MD = 123.49, 95% CI (48.59, 198.39)]. Postoperative pain within 24 h was reduced or at least equivalent in TAP block compared to its comparators. Therefore, TAP block is a safe and effective procedure compared to standard care, placebo and other analgesic techniques. Further research is warranted to investigate whether the TAP block technique can be improved by optimizing dose and technique-related factors.

  10. COMPARATIVE ANALYSIS OF EFFECTIVENESS AND SAFETY OF PHYTO- AND ANTIBIOTIC THERAPY OF ACUTE BRONCHITIS IN CHILDREN: RESULTS OF A MULTICENTER DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    L. S. Namazova-Baranova

    2014-01-01

    Full Text Available Although viruses cause most cases of acute bronchitis, antibacterial drugs are still widely used to treat children with such diseases; this results in development of antibiotic resistance. Therefore, one of the key objectives of clinical medicine is now an effort to reduce unreasonable use of antibacterial agents. A multicenter double blind randomized clinical trial (E-BRO-PCT involved 182 2-6-years-old children and was aimed at assessing effectiveness and safety of phytotherapy (the syrup characterized by a fixed combination of thyme herb and ivy leaf extracts of acute bronchitis. Patients were divided into groups according to the type of therapy: phyto-, antibacterial or multimodal therapy. The level of procalcitonin (PCT – a bacterial inflammation marker – was measured retrospectively in the blood samples of all the children obtained at inclusion to the study. Therapy effectiveness was assessed by means of overall assessment of response to treatment on day 7. The share of children with low PCT and positive response to phytotherapy was comparable to the share of children subjected to antibiotic therapy. This is also true for all the patients included in the study regardless of the PCT level. Phyto- and antibacterial therapy featured a comparable safety profile; however, according to the researchers, the former one came out slightly better. Results of this study convincingly demonstrate that phytotherapy is an effective and well-tolerated type of treatment of acute bronchitis in children. 

  11. Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial.

    Science.gov (United States)

    Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Lee, Soo Young; Kim, Hyun-Hee; Kim, Jong-Hyun; Lee, Kyung-Yil; Ma, Sang Hyuk; Park, Joon Soo; Kim, Hwang Min; Kim, Chun Soo; Kim, Dong Ho; Choi, Young Youn; Cha, Sung-Ho; Hong, Young Jin; Kang, Jin Han

    2015-01-01

    A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8-67.2), 53.4% (95% CI: 48.1-58.7), and 54.9% (95% CI: 48.1-60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6-97.3), 93.8% (95% CI: 91.2-96.4), and 95.3% (95% CI: 93.0-97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective.

  12. First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility.

    Science.gov (United States)

    Theodore, Nicholas; Hlubek, Randall; Danielson, Jill; Neff, Kristin; Vaickus, Lou; Ulich, Thomas R; Ropper, Alexander E

    2016-08-01

    A porous bioresorbable polymer scaffold has previously been tested in preclinical animal models of spinal cord contusion injury to promote appositional healing, spare white matter, decrease posttraumatic cysts, and normalize intraparenchymal tissue pressure. This is the first report of its human implantation in a spinal cord injury patient during a pilot study testing the safety and feasibility of this technique (ClinicalTrials.gov Identifier: NCT02138110). A 25-year-old man had a T11-12 fracture dislocation sustained in a motocross accident that resulted in a T11 American Spinal Injury Association Impairment Scale (AIS) grade A traumatic spinal cord injury. He was treated with acute surgical decompression and spinal fixation with fusion, and enrolled in the spinal scaffold study. A 2 × 10 mm bioresorbable scaffold was placed in the spinal cord parenchyma at T12. The scaffold was implanted directly into the traumatic cavity within the spinal cord through a dorsal root entry zone myelotomy at the caudal extent of the contused area. By 3 months, his neurological examination improved to an L1 AIS grade C incomplete injury. At 6-month postoperative follow-up, there were no procedural complications or apparent safety issues related to the scaffold implantation. Although longer-term follow-up and investigation are required, this case demonstrates that a polymer scaffold can be safely implanted into an acutely contused spinal cord. This is the first human surgical implantation, and future outcomes of other patients in this clinical trial will better elucidate the safety and possible efficacy profile of the scaffold. AIS, American Spinal Injury Association Impairment ScaleSCI, spinal cord injurytSCI, traumatic spinal cord injury.

  13. Clinical and genomic safety of treatment with Ginkgo biloba L. leaf extract (IDN 5933/Ginkgoselect®Plus) in elderly: a randomised placebo-controlled clinical trial [GiBiEx].

    Science.gov (United States)

    Bonassi, Stefano; Prinzi, Giulia; Lamonaca, Palma; Russo, Patrizia; Paximadas, Irene; Rasoni, Giuseppe; Rossi, Raffaella; Ruggi, Marzia; Malandrino, Salvatore; Sánchez-Flores, Maria; Valdiglesias, Vanessa; Benassi, Barbara; Pacchierotti, Francesca; Villani, Paola; Panatta, Martina; Cordelli, Eugenia

    2018-01-22

    Numerous health benefits have been attributed to the Ginkgo biloba leaf extract (GBLE), one of the most extensively used phytopharmaceutical drugs worldwide. Recently, concerns of the safety of the extract have been raised after a report from US National Toxicology Program (NTP) claimed high doses of GBLE increased liver and thyroid cancer incidence in mice and rats. A safety study has been designed to assess, in a population of elderly residents in nursing homes, clinical and genomic risks associated to GBLE treatment. GiBiEx is a multicentre randomized clinical trial, placebo controlled, double blinded, which compared subjects randomized to twice-daily doses of either 120-mg of IDN 5933 (also known as Ginkgoselect®Plus) or to placebo for a 6-months period. IDN 5933 is extracted from dried leaves and contains 24.3% flavone glycosides and 6.1% of terpene lactones (2.9% bilobalide, 1.38% ginkgolide A, 0.66% ginkgolide B, 1.12% ginkgolide C) as determined by HPLC. The study was completed by 47 subjects, 20 in the placebo group and 27 in the treatment group. Clinical (adverse clinical effect and liver injury) and genomic (micronucleus frequency, comet assay, c-myc, p53, and ctnnb1 expression profile in lymphocytes) endpoints were assessed at the start and at the end of the study. No adverse clinical effects or increase of liver injury markers were reported in the treatment group. The frequency of micronuclei [Mean Ratio (MR) = 1.01, 95% Confidence Intervals (95% CI) 0.86-1.18), and DNA breaks (comet assay) (MR = 0.91; 95% CI 0.58-1.43), did not differ in the two study groups. No significant difference was found in the expression profile of the three genes investigated. None of the markers investigated revealed a higher risk in the treatment group, supporting the safety of IDN 5933 at doses prescribed and for duration of six months. ClinicalTrials.gov Identifier: NCT03004508 , December 20, 2016. Trial retrospectively registered.

  14. Clinical safety, tolerability, pharmacokinetics and effects on urinary electrolyte excretion of AZD997, a novel, selective mineralocorticoid receptor modulator.

    Science.gov (United States)

    Erlandsson, Fredrik; Albayaty, Muna; Chialda, Ligia; Ericsson, Hans; Amilon, Carl; Nelander, Karin; Jansson-Löfmark, Rasmus; Wernevik, Linda; Kjaer, Magnus; Bamberg, Krister; Hartleib-Geschwindner, Judith

    2018-02-21

    AZD9977 is the first MR modulator in clinical development exerting similar organ protection as eplerenone with minimal urinary electrolyte effects in pre-clinical studies. The aim was to perform the initial clinical assessment of AZD9977. A first in man trial explored doses from 5-1200 mg. To study effects on urinary electrolyte excretion an additional randomized placebo controlled cross-over 4 period clinical trial was performed. 23 healthy volunteers were administered fludrocortisone alone or in combination with AZD9977, eplerenone or both. AZD9977/eplerenone combination was given to assess if AZD9977 can attenuate eplerenone induced natriuresis. AZD9977 at doses from 5-1200 mg were safe and well tolerated and pharmacokinetics were compatible with further development. AZD9977 exhibited similar effects on urinary ln [Na + ]/ [K + ] as eplerenone when using fludrocortisone as MR agonist, and the combination had an additive effect on ln [Na + K + ]. The results in man contradict the results in rodent models driven by aldosterone, in which AZD9977 has minimal electrolyte effects. Future clinical studies with AZD9977 should be performed in presence of endogenous or exogenous aldosterone to assess potential benefit of AZD9977 in patients. This article is protected by copyright. All rights reserved.

  15. The Clinical Efficacy and Safety of the Sahastara Remedy versus Diclofenac in the Treatment of Osteoarthritis of the Knee: A Double-Blind, Randomized, and Controlled Trial

    Directory of Open Access Journals (Sweden)

    Piya Pinsornsak

    2015-01-01

    Full Text Available Introduction. The Sahastara (SHT remedy is a Thai traditional medicine that has been acknowledged in the Thai National List of Essential Medicine and has been used as an alternative medicine to treat knee osteoarthritis. Although SHT remedies have been used in Thai traditional medical practices for a long period of time, there are few reports on their clinical trials. Aim of the Study. To investigate the clinical efficacy and safety of the SHT remedy in treating OA of the knee when compared to diclofenac. Methods. A phase 2, double-blind, randomized, and controlled trial study with a purpose to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee osteoarthritis. Sixty-six patients, ages between 45 and 80 years of age, were randomly allocated into 2 groups. The SHT group received 1,000 mg of SHT powdered capsules 3 times per day, orally before meals, while another group received 25 mg of diclofenac sodium capsules 3 times a day, orally after meals for 28 days. All patients were followed up at 14 and 28 days for the evaluation of the efficacy and safety by using clinical examinations, blood tests, a visual analogue scale (VAS for pain, and the 100-meter walktime test. Improvement on the quality of life was also assessed by the WOMAC index. Results. There were 31 and 30 patients in SHT and diclofenac groups, respectively, who had completed the study. Both medications have shown to significantly reduce the VAS for pain, and significantly improve the 100-meter walktime test and the WOMAC index score. However, there were no differences in the efficacy between the two groups. The blood chemistry showed no toxicity on renal and/or liver functions after taking SHT for 28 days but the patients who took diclofenac showed significant increases in their AST, ALT, and ALP. Systolic and diastolic blood pressure slightly increased in the diclofenac group but the SHT group did not effect on blood pressure

  16. An emerging playbook for antibody-drug conjugates: lessons from the laboratory and clinic suggest a strategy for improving efficacy and safety.

    Science.gov (United States)

    Drake, Penelope M; Rabuka, David

    2015-10-01

    Antibody-drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development. The field has rushed to follow the initial successes of Kadcyla™ and Adcetris™, and moved forward with new targets without much pause for optimization. In some respects, the ADC space has become divided into the clinical realm-where the proven technologies continue to represent the bulk of clinical candidates with a few exceptions-and the research realm-where innovations in conjugation chemistry and linker technologies have suggested that there is much room for improvement in the conventional methods. Now, two and four years after the approvals of Kadcyla™ and Adcetris™, respectively, consensus may at last be building that these two drugs rely on rather unique target antigens that enable their success. It is becoming increasingly clear that future target antigens will require additional innovative approaches. Next-generation ADCs have begun to move out of the lab and into the clinic, where there is a pressing need for continued innovation to overcome the twin challenges of safety and efficacy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Clinical efficacy and safety evaluation of tailoring iron chelation practice in thalassaemia patients from Asia-Pacific: a subanalysis of the EPIC study of deferasirox.

    Science.gov (United States)

    Viprakasit, Vip; Ibrahim, Hishamshah; Ha, Shau-Yin; Ho, Phoebe Joy; Li, Chi-Kong; Chan, Lee-Lee; Chiu, Chang-Fang; Sutcharitchan, Pranee; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Xue, Hong-Ling; Bowden, Donald K; Lin, Kai-Hsin

    2011-03-01

    Although thalassaemia is highly prevalent in the Asia-Pacific region, clinical data on efficacy and safety profiles of deferasirox in patients from this region are rather limited. Recently, data from the multicentre Evaluation of Patients' Iron Chelation with Exjade (EPIC) study in 1744 patients with different anaemias has provided an opportunity to analyse 1115 thalassaemia patients, of whom 444 patients were from five countries in the Asia-Pacific region (AP) for whom thalassaemia management and choice of iron chelators were similar. Compared to the rest of the world (ROW), baseline clinical data showed that the AP group appeared to be more loaded with iron (3745.0 vs. 2822.0 ng/ml) and had a higher proportion on deferoxamine monotherapy prior to the study (82.9 vs. 58.9%). Using a starting deferasirox dose based on transfusional iron intake and tailoring it to individual patient response, clinical efficacy based on serum ferritin reduction in AP and ROW thalassaemia patients was similar. Interestingly, the AP group developed a higher incidence of drug-related skin rash compared to ROW (18.0 vs. 7.2%), which may indicate different pharmacogenetic backgrounds in the two populations. Our analysis confirms that, with appropriate adjustment of dose, deferasirox can be clinically effective across different regions, with manageable side effects.

  18. Assessment of the efficacy and safety of a new complex skin cream in Asian women: A controlled clinical trial.

    Science.gov (United States)

    Jung, Yu Seok; Lee, Ji Hae; Bae, Jung Min; Lee, Dong Won; Kim, Gyong Moon

    2017-06-01

    Medical products such as hydroquinone and tretinoin have been widely used to treat various types of skin hyperpigmentation. However, these products are limited in daily use given their adverse effects. Other alternative agents with fewer adverse side effects have been developed. However, single agents often do not produce satisfactory results. To evaluate the efficacy and safety of a new brightening complex cream containing niacinamide, tranexamic acid, oxyresveratrol, glutathione disulfide, and linoleic acid. A total of 26 Korean women seeking to lighten their skin were enrolled. The product was applied on the face two times per day for 12 weeks. Standardized photographs were taken at baseline, 4 weeks, 8 weeks, and 12 weeks. Efficacy was assessed using melanin index (MI), erythema index (EI), and chromatic aberration values (L*, a*, and b*). Improvement perceived by investigators and patients was measured as well. The L*-value was increased at 8 weeks (0.7±2.5, PAsian women. © 2017 Wiley Periodicals, Inc.

  19. Efficacy and safety of topical Matricaria chamomilla L. (chamomile) oil for knee osteoarthritis: A randomized controlled clinical trial.

    Science.gov (United States)

    Shoara, Ruhollah; Hashempur, Mohammad Hashem; Ashraf, Alireza; Salehi, Alireza; Dehshahri, Shadab; Habibagahi, Zahra

    2015-08-01

    To assess the efficacy and safety of topical Matricaria chamomilla (Chamomile) oil in patients with knee osteoarthritis. Patients were randomized and treated with topical chamomile oil, diclofenac or placebo, 3 times/day for 3 weeks. They were allowed to use acetaminophen as analgesic. The patients were asked about their total acetaminophen use. Moreover, they were assessed in the terms of pain, physical function and stiffness by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at the enrolling and weekly. Chamomile oil significantly reduced the patients' need for acetaminophen (P = 0.001) compared with diclofenac and placebo. However, there were no significant differences in WOMAC questionnaire domains. The patients did not report any adverse events by using chamomile oil. Chamomile oil decreased the analgesic demand of patients with knee osteoarthritis. In addition, it may show some beneficial effects on physical function, and stiffness of the patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Comparative efficacy and safety of nortriptyline and fluoxetine in the treatment of major depression: a clinical study.

    Science.gov (United States)

    Fabre, L F; Scharf, M B; Itil, T M

    1991-06-01

    The safety and efficacy of nortriptyline and fluoxetine were compared in a double-blind, randomized, multicenter 5-week trial involving 205 outpatients with acute major depression of moderate severity. Seventy-two nortriptyline and 84 fluoxetine patients completed at least 2 weeks of medication and were included in the efficacy analysis; all patients were evaluated for side effects. Average total scores on the Hamilton Rating Scale for Depression (HAM-D) for both treatment groups declined from 22-23 at baseline to 11.5 at the conclusion of the 5-week period. At Week, 5, 71% of nortriptyline patients and 65% of fluoxetine patients were much or very much improved. Fluoxetine was associated more frequently with nausea (p less than .05), while nortriptyline was associated more frequently with dry mouth (p less than .05). These results are discussed in the context of selecting between nortriptyline and fluoxetine for a particular depressed patient.

  1. Randomized clinical trial: efficacy and safety of PPC-5650 on experimental esophageal pain and hyperalgesia in healthy volunteers

    DEFF Research Database (Denmark)

    Olesen, Anne Estrup; Nielsen, Lecia Møller; Larsen, Isabelle Myriam

    2015-01-01

    OBJECTIVE: Gastroesophageal reflux disease (GERD) is a common condition associated with symptoms as heart burn, regurgitation, chest pain, and gastrointestinal discomfort. PPC-5650 is a new pharmacological agent that can modulate acid-sensing ion channel activity, potentially leading to reduction...... in the pain signal. In healthy volunteers the esophagus was sensitized with acid to mimic GERD with the aims: 1) to assess the efficacy of a single bolus of PPC-5650 locally applied to the esophagus using multimodal pain stimulations, and 2) to assess the safety profile of PPC-5650. MATERIALS AND METHODS......: The study was a randomized, double-blinded, placebo-controlled, crossover trial in healthy males. Esophageal electrical, thermal, mechanical, and chemical stimulations were performed, pain perception was rated, and referred pain areas were drawn. Sensitization was induced by intraluminal esophageal acid...

  2. Clinical Correlates of Surveillance Events Detected by National Healthcare Safety Network Pneumonia and Lower Respiratory Infection Definitions-Pennsylvania, 2011-2012.

    Science.gov (United States)

    See, Isaac; Chang, Julia; Gualandi, Nicole; Buser, Genevieve L; Rohrbach, Pamela; Smeltz, Debra A; Bellush, Mary Jo; Coffin, Susan E; Gould, Jane M; Hess, Debra; Hennessey, Patricia; Hubbard, Sydney; Kiernan, Andrea; O'Donnell, Judith; Pegues, David A; Miller, Jeffrey R; Magill, Shelley S

    2016-07-01

    OBJECTIVE To determine the clinical diagnoses associated with the National Healthcare Safety Network (NHSN) pneumonia (PNEU) or lower respiratory infection (LRI) surveillance events DESIGN Retrospective chart review SETTING A convenience sample of 8 acute-care hospitals in Pennsylvania PATIENTS All patients hospitalized during 2011-2012 METHODS Medical records were reviewed from a random sample of patients reported to the NHSN to have PNEU or LRI, excluding adults with ventilator-associated PNEU. Documented clinical diagnoses corresponding temporally to the PNEU and LRI events were recorded. RESULTS We reviewed 250 (30%) of 838 eligible PNEU and LRI events reported to the NHSN; 29 reported events (12%) fulfilled neither PNEU nor LRI case criteria. Differences interpreting radiology reports accounted for most misclassifications. Of 81 PNEU events in adults not on mechanical ventilation, 84% had clinician-diagnosed pneumonia; of these, 25% were attributed to aspiration. Of 43 adult LRI, 88% were in mechanically ventilated patients and 35% had no corresponding clinical diagnosis (infectious or noninfectious) documented at the time of LRI. Of 36 pediatric PNEU events, 72% were ventilator associated, and 70% corresponded to a clinical pneumonia diagnosis. Of 61 pediatric LRI patients, 84% were mechanically ventilated and 21% had no corresponding clinical diagnosis documented. CONCLUSIONS In adults not on mechanical ventilation and in children, most NHSN-defined PNEU events corresponded with compatible clinical conditions documented in the medical record. In contrast, NHSN LRI events often did not. As a result, substantial modifications to the LRI definitions were implemented in 2015. Infect Control Hosp Epidemiol 2016;37:818-824.

  3. Safety and efficacy of allogeneic adipose tissue-derived mesenchymal stem cells for treatment of dogs with inflammatory bowel disease: Clinical and laboratory outcomes.

    Science.gov (United States)

    Pérez-Merino, E M; Usón-Casaús, J M; Zaragoza-Bayle, C; Duque-Carrasco, J; Mariñas-Pardo, L; Hermida-Prieto, M; Barrera-Chacón, R; Gualtieri, M

    2015-12-01

    Mesenchymal stem cells (MSCs) have shown immunomodulatory and anti-inflammatory effects in experimental colitis, and promising clinical results have been obtained in humans with Crohn's disease and ulcerative colitis. The aim of this study was to determine the safety and feasibility of adipose tissue-derived MSC (ASC) therapy in dogs with inflammatory bowel disease (IBD). Eleven dogs with confirmed IBD received one ASC intravascular (IV) infusion (2 × 10(6) cells/kg bodyweight). The outcome measures were clinical response based on percentage reduction of the validated Clinical Inflammatory Bowel Disease Activity Index (CIBDAI) and Canine Chronic Enteropathy Clinical Activity Index (CCECAI), as well as normalisation of C-reactive protein (CRP), albumin, folate and cobalamin serum concentrations at day 42 post-treatment. The Wilcoxon test was used to compare variables before and after treatment. No acute reaction to ASC infusion and no side effects were reported during follow-up in any dog. Six weeks post-treatment, the CIBDAI and CCECAI decreased significantly and albumin, cobalamin and folate concentrations increased substantially. Differences in CRP concentrations pre- and post-treatment were not significant (P = 0.050). Clinical remission (defined by a reduction of initial CIBDAI and CCECAI >75%) occurred in 9/11 dogs at day 42. The two remaining dogs showed a partial response with reduction percentages of 69.2% and 71.4%. In conclusion, a single IV infusion of allogeneic ASCs was well tolerated and appeared to produce clinical benefits in dogs with severe IBD. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Safety, Effectiveness, and Treatment Persistence of Golimumab in Elderly Patients with Rheumatoid Arthritis in Real-World Clinical Practice in Japan.

    Science.gov (United States)

    Okazaki, Masateru; Kobayashi, Hisanori; Shimizu, Hirohito; Ishii, Yutaka; Yajima, Tsutomu; Kanbori, Masayoshi

    2018-03-02

    Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥ 75 years) with rheumatoid arthritis. This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided into two age groups (younger: effectiveness, and treatment persistence of golimumab were assessed. Also, the reasons for discontinuing golimumab treatment were analyzed by multi-logistic regression. During golimumab treatment over 24 weeks, younger and elderly groups exhibited comparable improvement of disease activity as measured by EULAR response criteria with similar overall rates of adverse events. However, the survival curve of golimumab for elderly patients was significantly different from that for younger patients due largely to the discontinuation at 4 weeks. The most common reason for discontinuation in elderly patients was patient choice, while it was disease progression in younger patients. Analysis of elderly patients who discontinued treatment by their own decision identified EULAR good response as a factor associated with continuation of golimumab treatment whereas no predictive factor associated with discontinuation was identified. The safety and effectiveness of golimumab treatment in elderly Japanese patients aged 75 years or older were comparable to those in younger patients in real-world clinical practice. Analysis of the survival curves suggested that continuous use of golimumab might further improve clinical benefit of golimumab in elderly patients, underpinning the importance of effective communication between physicians and elderly patients based on the treat-to-target strategy

  5. 75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Science.gov (United States)

    2010-08-06

    ... Products Research Project Grant (R01) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... per year. B. Research Objectives The goal of FDA's OPD grant program is to support the clinical...: Track AOR Status Step 6: Register With Electronic Research Administration (eRA) Commons Steps 1 through...

  6. HPV16 E7 DNA tattooing: safety, immunogenicity, and clinical response in patients with HPV-positive vulvar intraepithelial neoplasia

    NARCIS (Netherlands)

    Samuels, Sanne; Marijne Heeren, A.; Zijlmans, Henry J. M. A. A.; Welters, Marij J. P.; van den Berg, Joost H.; Philips, Daisy; Kvistborg, Pia; Ehsan, Ilina; Scholl, Suzy M. E.; Nuijen, Bastiaan; Schumacher, Ton N. M.; van Beurden, Marc; Jordanova, Ekaterina S.; Haanen, John B. A. G.; van der Burg, Sjoerd H.; Kenter, Gemma G.

    2017-01-01

    Usual type vulvar intraepithelial neoplasia (uVIN) is caused by HPV, predominantly type 16. Several forms of HPV immunotherapy have been studied, however, clinical results could be improved. A novel intradermal administration route, termed DNA tattooing, is superior in animal models, and was tested

  7. Safety aspects of Chinese herbal medicine in pregnancy-re-evaluation of experimental data of two animal studies and the clinical experience.

    Science.gov (United States)

    Wiebrecht, Axel; Gaus, Wilhelm; Becker, Simon; Hummelsberger, Josef; Kuhlmann, Kirsten

    2014-10-01

    Chinese herbal medicine is an increasingly popular worldwide medical therapy which also has an impact in pregnancy. However, the question of its drug safety during pregnancy remains unresolved. Potential problems include teratogenicity, abortion, perinatal toxicity, pre- and postnatal developmental abnormalities, and eventually an increased risk for carcinomas in the offspring. Standard Materia Medica textbooks contain unreliable information when it comes to risks during pregnancy. Wang and co-workers conducted an experimental study (WS) on mice in which they investigated the effects of 17 Chinese medicinals regarding embryotoxicity and fetotoxicity. All these drugs seemed to exhibit multiple significant toxic effects. Another study by Li and co-workers (LS) investigated the reproductive toxicity of Atractylodis macrocephalae Rhizoma in mice, rats and rabbits. They described an increased pre- and postnatal mortality and, at high doses, congenital malformations. In an attempt to identify the risks of the tested medicinals during pregnancy, we analysed these two experimental studies and compared their results with possible safety data for humans from two reviews of clinical studies on threatened miscarriage (AR and CR). We re-evaluated WS and LS in relation to accordance with internationally accepted rules, equivalence to human dose, biometric accuracy, plausibility, and coherence. Eligible studies of the two reviews on threatened miscarriage were evaluated for specific pregnancy risks concerning the 17 medicinals tested in WS and LS. We found that WS does not conform to international ICH guidelines and includes many inconsistencies, implausibilities and several severe biometrical flaws. It reported a total of 364 significant events out of which 145 false significant results are expected. The data-handling pointed to irregularities. Analysis of LS exhibited also many inconsistencies. The results regarding congenital malformations were statistically insignificant and

  8. Safety of an Oral Fixed Combination of Netupitant and Palonosetron (NEPA): Pooled Data From the Phase II/III Clinical Program.

    Science.gov (United States)

    Aapro, Matti; Hesketh, Paul J; Jordan, Karin; Gralla, Richard J; Rossi, Giorgia; Rizzi, Giada; Palmas, Marco

    2016-04-01

    Standard prophylaxis for chemotherapy-induced nausea and vomiting (CINV) with highly emetogenic and anthracycline-cyclophosphamide-based chemotherapy includes a 5-hydroxytryptamine-3 receptor antagonist, a neurokinin-1 receptor antagonist (NK1RA), and corticosteroid therapy. NEPA is a fixed combination of netupitant and palonosetron. The primary objective of this analysis was to document the safety profile, including cardiac safety, of NEPA + dexamethasone in comparison with current therapies across all phase II/III trials. This pooled analysis was based on data from 3,280 patients in 4 randomized, double-blind clinical trials. Patients were categorized into 1 of 3 pooled groups on the basis of actual treatment received: NEPA + dexamethasone, palonosetron + dexamethasone, and aprepitant + ondansetron/palonosetron + dexamethasone. Safety was assessed by number and frequency of adverse events (AEs) and changes from baseline electrocardiogram measures. Most patients were female and younger than 65 years of age. Demographic characteristics varied among studies and pooled groups. Frequencies of treatment-emergent AEs (TEAEs) and treatment-related AEs (TRAEs) were similar across groups. TEAEs were mostly mild and consistent with expected chemotherapy and disease-related AEs (hematologic events, hair loss, general weakness). TRAEs in ≥2% of patients were headache and constipation. Frequencies of cardiac TEAEs were similar across groups, with QT prolongation (1.6%), tachycardia (1.1%), and dyspnea (0.9%) the most common. Serious cardiac TEAEs were rare. NEPA was well-tolerated, with an AE profile as expected for the regimen. Sample size, demographic characteristics, study design, chemotherapy, and antiemetic regimen differences across the four studies may have contributed to differences in frequencies of neutropenia and alopecia. Adding an NK1RA to a CINV prophylaxis regimen can improve outcomes without additional toxicity. Supportive care for cancer should ideally be

  9. Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme.

    Science.gov (United States)

    Angelo, Maria-Genalin; David, Marie-Pierre; Zima, Julia; Baril, Laurence; Dubin, Gary; Arellano, Felix; Struyf, Frank

    2014-05-01

    The purpose of this study is to further evaluate the safety of the human papillomavirus (HPV)-16/18-AS04-adjuvanted vaccine (HPV-16/18-vaccine Cervarix®, GlaxoSmithKline, Belgium) through a pooled analysis of data from 42 completed/ongoing clinical studies. Unsolicited adverse events (AEs) were reported for 30 days after each dose. Medically significant conditions, serious AEs (SAEs), potential immune-mediated diseases (pIMDs) and pregnancy outcomes were captured until study completion. Events leading to subject withdrawal were reviewed. Relative risks compared incidences of spontaneous abortion and pIMDs in controlled studies. Thirty one thousand one hundred seventy-three adolescent girls/women received HPV-16/18-vaccine alone (HPV group), 2166 received HPV-16/18-vaccine coadministered with another vaccine and 24 241 were controls. Mean follow-up was 39 months (range 0-113.3). Incidences of unsolicited AEs reported within 30 days after any dose were similar between HPV and Control groups (30.8%/29.7%). During the entire study period, reports of medically significant conditions (25.0%/28.3%) and SAEs (7.9%/9.3%) were also similarly distributed between groups. Deaths were rare: HPV (alone/coadministered) n = 25, controls n = 20 (n = 18 in blinded groups). pIMDs within 1 year were reported by 0.2% of HPV-16/18 vaccinees and controls. For each pIMD event category, no increased relative risks were reported for HPV-16/18 vaccinees versus controls. Coadministration did not change the overall safety profile. Pregnancy outcomes and withdrawal rates were similar between groups. Analysis of safety data arising from 57 580 subjects and 96 704 HPV-16/18-vaccine doses shows that the incidences and distribution of AEs were similar among HPV-16/18-vaccine recipients and controls. No new safety signals were identified. The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and adult women.

  10. Applying the Plan-Do-Study-Act (PDSA) approach to a large pragmatic study involving safety net clinics.

    Science.gov (United States)

    Coury, Jennifer; Schneider, Jennifer L; Rivelli, Jennifer S; Petrik, Amanda F; Seibel, Evelyn; D'Agostini, Brieshon; Taplin, Stephen H; Green, Beverly B; Coronado, Gloria D

    2017-06-19

    The Plan-Do-Study-Act (PDSA) cycle is a commonly used improvement process in health care settings, although its documented use in pragmatic clinical research is rare. A recent pragmatic clinical research study, called the Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), used this process to optimize the research implementation of an automated colon cancer screening outreach program in intervention clinics. We describe the process of using this PDSA approach, the selection of PDSA topics by clinic leaders, and project leaders' reactions to using PDSA in pragmatic research. STOP CRC is a cluster-randomized pragmatic study that aims to test the effectiveness of a direct-mail fecal immunochemical testing (FIT) program involving eight Federally Qualified Health Centers in Oregon and California. We and a practice improvement specialist trained in the PDSA process delivered structured presentations to leaders of these centers; the presentations addressed how to apply the PDSA process to improve implementation of a mailed outreach program offering colorectal cancer screening through FIT tests. Center leaders submitted PDSA plans and delivered reports via webinar at quarterly meetings of the project's advisory board. Project staff conducted one-on-one, 45-min interviews with project leads from each health center to assess the reaction to and value of the PDSA process in supporting the implementation of STOP CRC. Clinic-selected PDSA activities included refining the intervention staffing model, improving outreach materials, and changing workflow steps. Common benefits of using PDSA cycles in pragmatic research were that it provided a structure for staff to focus on improving the program and it allowed staff to test the change they wanted to see. A commonly reported challenge was measuring the success of the PDSA process with the available electronic medical record tools. Understanding how the PDSA process can be applied to pragmatic

  11. Uterine fibroid embolization with spheric micro-particles using flow guiding: safety, technical success and clinical results

    International Nuclear Information System (INIS)

    Richter, G.M.; Radeleff, B.; Kauffmann, G.W.; Rimbach, S.

    2004-01-01

    Materials and Methods: Twenty of the first 26 consecutive patients referred for potential UFE were enrolled in the study. Pre-interventional MRI was used to assess morphologic contraindication to UFE. The embolization procedures were performed from a unilateral femoral approach using 4F selective catheters in straight vessels, >2 mm in diameter, and micro-catheters in smaller and tortuous arteries. The endpoint of the 'flow guided' embolization was defined by reaching the angiography 'pruned tree' appearance and sluggish flow in the main stem of the uterine artery. Assessment of morphologic mid term success was done by MRI 10 days, 3 months, 6 months, 9 months and 1 year after UFE. The clinical mid term success was assessed by having questionaires completed for menstrual bleeding, retention of clinical (symptomatic) benefit and quality of life. Results: Technical success was 100%, with 8 minor (2 post-interventional collapses, 2 hematomas, 4 relevant post-embolizations syndromes, 1 spontaneous expulsion of a submucous myoma) and 3 major complications (1 hysterectomy because of vaginal bleeding for 5 weeks, 1 transient amenorrhea and 1 spontaneous expulsion of myoma with transient bleeding requiring admission). In 17 of 19 patients, MRI showed total fibroid devascularization throughout the entire follow-up. The average shrinkage of the dominant fibroid was 71.3% at one year. The menstrual bleeding record in the cohort group fell from an average of 501.6 before treatment to 76.2 points at one year. At the same time, the clinical symptoms significantly improved. The patient satisfaction with the applied therapy was >95% at 1 year. One patient with residual fibroid perfusion underwent a second procedure, which achieved complete devascularization and adequate clinical success at one year. The second patient with incomplete devascularization had a persistent clinical benefit. (orig.)

  12. Clinical Trials

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    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  13. Clinical Trials

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    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  14. Clinical Trials

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    Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  16. Safety and Efficacy of Focused Ultrasound Thalamotomy for Patients With Medication-Refractory, Tremor-Dominant Parkinson Disease: A Randomized Clinical Trial.

    Science.gov (United States)

    Bond, Aaron E; Shah, Binit B; Huss, Diane S; Dallapiazza, Robert F; Warren, Amy; Harrison, Madaline B; Sperling, Scott A; Wang, Xin-Qun; Gwinn, Ryder; Witt, Jennie; Ro, Susie; Elias, W Jeffrey

    2017-12-01

    Clinical trials have confirmed the efficacy of focused ultrasound (FUS) thalamotomy in essential tremor, but its effectiveness and safety for managing tremor-dominant Parkinson disease (TDPD) is unknown. To assess safety and efficacy at 12-month follow-up, accounting for placebo response, of unilateral FUS thalamotomy for patients with TDPD. Of the 326 patients identified from an in-house database, 53 patients consented to be screened. Twenty-six were ineligible, and 27 were randomized (2:1) to FUS thalamotomy or a sham procedure at 2 centers from October18, 2012, to January 8, 2015. The most common reasons for disqualification were withdrawal (8 persons [31%]), and not being medication refractory (8 persons [31%]). Data were analyzed using intention-to-treat analysis, and assessments were double-blinded through the primary outcome. Twenty patients were randomized to unilateral FUS thalamotomy, and 7 to sham procedure. The sham group was offered open-label treatment after unblinding. The predefined primary outcomes were safety and difference in improvement between groups at 3 months in the on-medication treated hand tremor subscore from the Clinical Rating Scale for Tremor (CRST). Secondary outcomes included descriptive results of Unified Parkinson's Disease Rating Scale (UPDRS) scores and quality of life measures. Of the 27 patients, 26 (96%) were male and the median age was 67.8 years (interquartile range [IQR], 62.1-73.8 years). On-medication median tremor scores improved 62% (IQR, 22%-79%) from a baseline of 17 points (IQR, 10.5-27.5) following FUS thalamotomy and 22% (IQR, -11% to 29%) from a baseline of 23 points (IQR, 14.0-27.0) after sham procedures; the between-group difference was significant (Wilcoxon P = .04). On-medication median UPDRS motor scores improved 8 points (IQR, 0.5-11.0) from a baseline of 23 points (IQR, 15.5-34.0) following FUS thalamotomy and 1 point (IQR, -5.0 to 9.0) from a baseline of 25 points (IQR, 15.0-33.0) after sham

  17. Initial experience with a robotically operated video optical telescopic-microscope in cranial neurosurgery: feasibility, safety, and clinical applications.

    Science.gov (United States)

    Gonen, Lior; Chakravarthi, Srikant S; Monroy-Sosa, Alejandro; Celix, Juanita M; Kojis, Nathaniel; Singh, Maharaj; Jennings, Jonathan; Fukui, Melanie B; Rovin, Richard A; Kassam, Amin B

    2017-05-01

    OBJECTIVE The move toward better, more effective optical visualization in the field of neurosurgery has been a focus of technological innovation. In this study, the authors' objectives are to describe the feasibility and safety of a new robotic optical platform, namely, the robotically operated video optical telescopic-microscope (ROVOT-m), in cranial microsurgical applications. METHODS A prospective database comprising patients who underwent a cranial procedure between April 2015 and September 2016 was queried, and the first 200 patients who met the inclusion criteria were selected as the cohort for a retrospective chart review. Only adults who underwent microsurgical procedures in which the ROVOT-m was used were considered for the study. Preoperative, intraoperative, and postoperative data were retrieved from electronic medical records. The authors address the feasibility and safety of the ROVOT-m by studying various intraoperative variables and by reporting perioperative morbidity and mortality, respectively. To assess the learning curve, cranial procedures were categorized into 6 progressively increasing complexity groups. The main categories of pathology were I) intracerebral hemorrhages (ICHs); II) intraaxial tumors involving noneloquent regions or noncomplex extraaxial tumors; III) intraaxial tumors involving eloquent regions; IV) skull base pathologies; V) intraventricular lesions; and VI) cerebrovascular lesions. In addition, the entire cohort was evenly divided into early and late cohorts. RESULTS The patient cohort comprised 104 female (52%) and 96 male (48%) patients with a mean age of 56.7 years. The most common pathological entities encountered were neoplastic lesions (153, 76.5%), followed by ICH (20, 10%). The distribution of cases by complexity categories was 11.5%, 36.5%, 22%, 20%, 3.5%, and 6.5% for Categories I, II, II, IV, V, and VI, respectively. In all 200 cases, the surgical goal was achieved without the need for intraoperative conversion

  18. Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort.

    Science.gov (United States)

    Calleja, Jose Luis; Crespo, Javier; Rincón, Diego; Ruiz-Antorán, Belén; Fernandez, Inmaculada; Perelló, Christie; Gea, Francisco; Lens, Sabela; García-Samaniego, Javier; Sacristán, Begoña; García-Eliz, María; Llerena, Susana; Pascasio, Juan Manuel; Turnes, Juan; Torras, Xavier; Morillas, Rosa Maria; Llaneras, Jordi; Serra, Miguel A; Diago, Moises; Rodriguez, Conrado Fernández; Ampuero, Javier; Jorquera, Francisco; Simon, Miguel A; Arenas, Juan; Navascues, Carmen Alvarez; Bañares, Rafael; Muñoz, Raquel; Albillos, Agustin; Mariño, Zoe

    2017-06-01

    Clinical trials evaluating second-generation direct-acting antiviral agents (DAAs) have shown excellent rates of sustained virologic response (SVR) and good safety profiles in patients with chronic hepatitis C virus (HCV) genotype 1 infection. We aimed to investigate the effectiveness and safety of two oral DAA combination regimens, ombitasvir/paritaprevir/ritonavir plus dasabuvir (OMV/PTV/r+DSV) and ledipasvir/sofosbuvir (LDV/SOF), in a real-world clinical practice. Data from HCV genotype 1 patients treated with either OMV/PTV/r+DSV±ribavirin (RBV) (n=1567) or LDV/SOF±RBV (n=1758) in 35 centers across Spain between April 1, 2015 and February 28, 2016 were recorded in a large national database. Demographic, clinical and virological data were analyzed. Details of serious adverse events (SAEs) were recorded. The two cohorts were not matched with respect to baseline characteristics and could not be compared directly. The SVR12 rate was 96.8% with OMV/PTVr/DSV±RBV and 95.8% with LDV/SOF±RBV. No significant differences were observed in SVR according to HCV subgenotype (p=0.321 [OMV/PTV/r+DSV±RBV] and p=0.174 [LDV/SOF]) or degree of fibrosis (c0.548 [OMV/PTV/r/DSV±RBV] and p=0.085 [LDV/SOF]). Only baseline albumin level was significantly associated with failure to achieve SVR (p<0.05) on multivariate analysis. Rates of SAEs and SAE-associated treatment discontinuation were 5.4% and 1.7%, in the OMV/PTV/r+DSV subcohort and 5.5% and 1.5% in the LDV/SOF subcohort, respectively. Hepatocellular carcinoma (HCC) recurred in 30% of patients with a complete response to therapy for previous HCC. Incident HCC was reported in 0.93%. In this large cohort of patients managed in the real-world setting in Spain, OMV/PTV/r+DSV and LDV/SOF achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with similarly good safety profiles. In clinical trials, second-generation direct-acting antiviral agents (DAAs) have been shown to cure over 90% of

  19. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial.

    Science.gov (United States)

    Giugliano, Robert P; Pedersen, Terje R; Park, Jeong-Gun; De Ferrari, Gaetano M; Gaciong, Zbigniew A; Ceska, Richard; Toth, Kalman; Gouni-Berthold, Ioanna; Lopez-Miranda, Jose; Schiele, François; Mach, François; Ott, Brian R; Kanevsky, Estella; Pineda, Armando Lira; Somaratne, Ransi; Wasserman, Scott M; Keech, Anthony C; Sever, Peter S; Sabatine, Marc S

    2017-10-28

    LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). In this prespecified secondary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up. We used multivariable modelling to adjust for baseline factors associated with achieved LDL cholesterol. This trial is registered with ClinicalTrials.gov, number NCT01764633. Between Feb 8, 2013, and June 5, 2015, 27 564 patients were randomly assigned a treatment in the FOURIER study. 1025 (4%) patients did not have an LDL cholesterol measured at 4 weeks and 557 (2%) had already had a primary endpoint event or one of the ten prespecified safety events before the week-4 visit. From the remaining 25 982 patients (94% of those randomly assigned) 13 013 were assigned evolocumab and 12 969 were assigned placebo. 2669 (10%) of 25 982 patients achieved LDL-cholesterol concentrations of less than 0·5 mmol/L, 8003 (31%) patients achieved concentrations between 0·5 and less than 1·3 mmol/L, 3444 (13%) patients achieved concentrations between 1·3 and less than 1·8 mmol/L, 7471 (29%) patients achieved concentrations between 1·8 to less than 2·6 mmol/L, and 4395 (17%) patients achieved

  20. CLINICAL EFFECTIVENESS AND SAFETY OF IVABRADINE USE IN PATIENTS WITH UNSTABLE ANGINA AND DIABETES MELLITUS TYPE 2

    Directory of Open Access Journals (Sweden)

    A. I. Kondratiev

    2011-01-01

    Full Text Available Aim – to estimate the clinical and pharmacological effects of ivabradine in complex treatment of patients with acute coronary syndrome anddiabetes mellitus type 2 (DM 2.Materials and methods. The study included 36 patients with acute coronary insufficiency (unstable angina and acute left ventricular failure(Killip class I–III during concomitant type 2 diabetes.Results. Prescribing ivabradine in treatment of unstable angina pectoris complicated by type 2 diabetes led to decrease in clinical symptoms,heart rate and reduce in number of myocardial ischemia episodes. Patients treated with ivabradine, showed a significant tendency to increase left ventricular ejection fraction (12.3 %. Mo adverse reactions were recorded, including hypotensive complications.Conclusion. Ivabradine therapy was characterized by high ischemic and antianginal efficacy, good tolerability, did not lead to the developmentof tolerance and was not accompanied by the appearance of withdrawal syndrome.

  1. CLINICAL EFFECTIVENESS AND SAFETY OF IVABRADINE USE IN PATIENTS WITH UNSTABLE ANGINA AND DIABETES MELLITUS TYPE 2

    Directory of Open Access Journals (Sweden)

    A. I. Kondratiev

    2014-07-01

    Full Text Available Aim – to estimate the clinical and pharmacological effects of ivabradine in complex treatment of patients with acute coronary syndrome anddiabetes mellitus type 2 (DM 2.Materials and methods. The study included 36 patients with acute coronary insufficiency (unstable angina and acute left ventricular failure(Killip class I–III during concomitant type 2 diabetes.Results. Prescribing ivabradine in treatment of unstable angina pectoris complicated by type 2 diabetes led to decrease in clinical symptoms,heart rate and reduce in number of myocardial ischemia episodes. Patients treated with ivabradine, showed a significant tendency to increase left ventricular ejection fraction (12.3 %. Mo adverse reactions were recorded, including hypotensive complications.Conclusion. Ivabradine therapy was characterized by high ischemic and antianginal efficacy, good tolerability, did not lead to the developmentof tolerance and was not accompanied by the appearance of withdrawal syndrome.

  2. Specialized consultant in radiological safety to the clinical north central hospital of high speciality, PEMEX. IV. - December of 2001

    International Nuclear Information System (INIS)

    Angeles C, A.; Vizuet G, J.; Benitez S, J. A.; Garcia A, J.; Rodriguez A, F.

    2002-01-01

    The clinical north central hospital of high speciality, dependent of PEMEX, It request consultant of the ININ to be able to maintain their sanitary license for the use of X-ray equipment for the radiologic diagnostic.The proposal of the ININ was to be a program of technical attendance, schedule monthly to be able to solve the observations that are presented in the use of those equipment, and that the hospital can conserve its respective sanitary license.(Author)

  3. A questionnaire study regarding local anesthesia in dentistry and safety measures in dental clinics among dental students

    OpenAIRE

    オオケ, ハナコ; クドウ, マサル; シンヤ, ノボル; Hanako, OHKE; Masaru, KUDO; Noboru, SHINYA

    2005-01-01

    This reports the results of a questionnaire study of dental students on the awareness of "local anesthesia" and "use of patient monitoring systems" in dental clinics. Subjects participated in the present study included 96 sixth year dental students (D6) and 93 first year dental students (D1). The results indicate that the majority of respondents including both D6 and D1 support the notion that a "dentist" is the most suitable person to perform local anesthesia in dental treatment. With respec...

  4. Xenograft biologic mesh in parietal and general surgery: Technical assessment and review of clinical effectiveness and safety data.

    Science.gov (United States)

    Sainfort, A; Denis Hallouard, I; Hartmann, D; Aulagner, G; Francois, Y; Tiffet, O; Barabino, G; Nuiry, O; Armoiry, X

    2016-12-01

    To describe the main technical characteristics of biologic prostheses used for parietal reinforcement and to present the state of the art on their risk/benefit ratio. We conducted a technical analysis of manufacturer specifications of the biologic prostheses that are currently available in France accompanied by a literature review by selecting meta-analyses and systematic reviews, randomized controlled trials and publications of health technology rating agencies. Biological implants for parietal reinforcement are mainly intended for use in a contaminated environment where the use of synthetic prostheses is contra-indicated. We identified fourteen systematic reviews and meta-analyses and one randomized controlled trial. Six ongoing clinical trials were identified as well as two clinical trials that had been interrupted. In the current state of knowledge, there are no high-level evidence data on the therapeutic contribution of biologic prostheses that allow prioritization of the various biologic prostheses according to their characteristics or their different manufacturing processes. Pending the results of current randomized controlled trials to validate the indications and an eventual specific reimbursement, indications for the use of biologic parietal reinforcement prostheses seems to be limited to rare clinical situations and only after collegial discussion. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  5. Using Interactive Web-Based Screening, Brief Intervention and Referral to Treatment in an Urban, Safety-Net HIV Clinic.

    Science.gov (United States)

    Dawson Rose, Carol; Cuca, Yvette P; Kamitani, Emiko; Eng, Shannon; Zepf, Roland; Draughon, Jessica; Lum, Paula

    2015-06-01

    Substance use among people living with HIV is high, and screening, brief intervention, and referral to treatment (SBIRT) is an evidence-based approach to addressing the issue. We examined whether patients would participate in a technology-based SBIRT program in an urban HIV clinic. An SBIRT intervention was programmed into the clinic's web-based patient portal linked to their personal health record. We examined: demographic, health, HIV, and substance use characteristics of participants who completed the web-based intervention compared to those who did not. Fewer than half of the 96 participants assigned to the web-based SBIRT completed it (n = 39; 41 %). Participants who completed the web-based intervention had significantly higher amphetamine SSIS scores than those who did not complete the intervention. Participants whose substance use is more harmful may be more motivated to seek help from a variety of sources. In addition, it is important that technology-based approaches to behavioral interventions in clinics take into consideration feasibility, client knowledge, and comfort using technology.

  6. Safety and clinical performance of kyphoplasty and SpineJack(®) procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

    Science.gov (United States)

    Noriega, D C; Ramajo, R H; Lite, I S; Toribio, B; Corredera, R; Ardura, F; Krüger, A

    2016-06-01

    Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack® and Kyphx Xpander® balloon) were compared in patients with osteoporotic compression fractures. Both techniques were safe, efficient, and led to a rapid and marked improvement in clinical signs; nevertheless, SpineJack showed better restoration of vertebral heights and angles, maintained over time. In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack® (SJ) and balloon kyphoplasty (BKP) led to a rapid and marked improvement in clinical signs. This pilot, monocentric, investigator-initiated, prospective study aimed to compare two percutaneous vertebral augmentation procedures in the painful osteoporotic VCF treatment. Thirty patients were randomized to receive SJ (n = 15) or BKP (n = 15). Analgesic consumption, back pain intensity (visual analog scale (VAS)), and Oswestry Disability Index (ODI) scores were recorded preoperatively, at 5 days and 1, 3, 6, and 12 months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12 months. Spine X-rays were taken 48 h prior to procedure and 5 days and 6 and 12 months after. SpineJack® led to a significantly shorter intervention period (23 vs 32 min; p SpineJack® procedure has a higher potential for vertebral body height restoration and maintenance over time.

  7. Decreasing Turnaround Time and Increasing Patient Satisfaction in a Safety Net Hospital-Based Pediatrics Clinic Using Lean Six Sigma Methodologies.

    Science.gov (United States)

    Jayasinha, Yasangi

    2016-01-01

    Increasingly, health care quality indicators are focusing on patient-centeredness as an indicator of performance. The National Quality Forum lists assessment of patient experience, often conducted using patient surveys, as a top priority. We developed a patient-reported time stamp data collection tool that was used to collect cycle times in a safety net hospital-based outpatient pediatrics clinic. Data were collected using patient-reported survey to obtain cycle times in Pediatric clinic, as well as qualitative and quantitative patient satisfaction data. Several rapid-cycle improvements were performed using Lean Six Sigma methodologies to reduce cycle time by eliminating waste and revise unnecessary processes to improve operational effectiveness and patient and staff satisfaction. A total of 94 surveys were collected and revealed average cycle time of 113 minutes. Our measured patient satisfaction rating was 87%. Discharge and check-in processes were identified as the least efficient and were targeted for intervention. Following implementation, the overall cycle time was decreased from 113 to 90 minutes. Patient satisfaction ratings increased from 87% to 95%. We demonstrate that using Lean Six Sigma tools can be invaluable to clinical restructuring and redesign and results in measurable, improved outcomes in care delivery.

  8. The safety and clinical efficacy of recombinant human granulocyte colony stimulating factor injection for colon cancer patients undergoing chemotherapy

    Directory of Open Access Journals (Sweden)

    Jie Chen

    Full Text Available Summary Objective: The present study was designed to evaluate safety and efficacy of recombinant human granulocyte colony stimulating factor (G-CSF injection and whether this regimen could reduce the incidence of adverse events caused by chemotherapy. Method: A total of 100 patients with colon cancer who were treated with chemotherapy in our hospital from January 2011 to December 2014 were randomly divided into two groups, with 50 patients in each group. The patients in the treatment group received G-CSF 24 hours after chemotherapy for consecutive three days; the patients in the control group received the same dose of normal saline. Routine blood tests were performed 7 days and 14 days after chemotherapy. Results: Compared with the control group, the incidences of febrile neutropenia and leukocytopenia in the treatment group were significantly lower (p<0.05. In addition, the incidence of liver dysfunction in the treatment group was lower than that of the control group, without statistical significance. The incidence of myalgia in the treatment was higher than that of the control group without statistical significance. Conclusion: The present study indicated that G-CSF injection after chemotherapy is safe and effective for preventing adverse events in colon cancer patients with chemotherapy.

  9. Multicenter analysis of tolerance and clinical safety of the extracellular MR contrast agent gadobenate dimeglumine (MultiHance registered)

    International Nuclear Information System (INIS)

    Herborn, Christoph U.; Jaeger-Booth, I.; Goyen, M.; Lodemann, K.P.; Spinazzi, A.

    2009-01-01

    Purpose: Retrospective analysis of the occurrence of adverse events and the diagnostic efficacy of a paramagnetic contrast agent with weak intermittent protein binding and high relaxivity. Materials end methods: Postmarketing surveillance studies for gadobenate dimeglumine (MultiHance, BRACCO Altana Pharma, Constance) were conducted in Germany between 1998 and 2006 and then retrospectively analyzed. Demographic data, relevant comorbidities, and allergies were recorded. The safety and tolerability of MultiHance were logged on a standardized data sheet. Results: A total of 38568 patients were included in the study. 829 patients (2.1%) had a known intolerance against contrast media. The examined regions included the central nervous system, the liver, and the vascular bed. The injection rate with automated injectors (n = 10456) varied between 1.0 und 3.0 ml/sec in 86.5% of patients. Adverse events totaled 1.2%. 11 patients (0.03%) experienced serious adverse events. The most frequent findings were nausea, vomiting and a feeling of warmth. Conclusion: MultiHance is a safe and very well tolerated contrast agent for magnetic resonance imaging (MRI) with a profile and frequency of adverse events similar to other extracellular MR contrast materials. (orig.)

  10. Safety evaluation of p-synephrine following 15 days of oral administration to healthy subjects: A clinical study.

    Science.gov (United States)

    Shara, Mohd; Stohs, Sidney J; Smadi, Mahmoud M

    2018-01-01

    Extracts of bitter orange (BOE, Citrus aurantium L.) and its primary protoalkaloid p-synephrine are extensively consumed as dietary supplements. p-Synephrine is also present in foods and juices prepared from various Citrus species. The safety of p-synephrine has been questioned as a result of structural similarities with ephedrine. This study assessed the cardiovascular (stimulant) and hemodynamic effects of BOE (49 mg p-synephrine) daily given to 16 healthy subjects for 15 days in a placebo-controlled, cross-over, double-blinded study. A physical evaluation by a cardiologist, as well as heart rates, blood pressures, and electrocardiograms were determined, and blood samples were drawn at baseline, and Days 5, 10, and 15. Serum levels for caffeine and p-synephrine were measured at 1 and 2 weeks. Subjects completed a 10-item health and metabolic questionnaire at baseline and on Day 15. No significant changes occurred in heart rate, electrocardiograms, systolic blood or diastolic pressures, blood cell counts, or blood chemistries in either the control or p-synephrine treated groups at any time point. No adverse effects were reported in response to the bitter orange (p-synephrine). Caffeine consumed by the participants varied markedly. Under these experimental conditions, BOE and p-synephrine were without stimulant (cardiovascular) and adverse effects. Copyright © 2017 John Wiley & Sons, Ltd.

  11. A pilot clinical trial to determine the safety and efficacy of aerosolized hyaluronan as a treatment for COPD

    Directory of Open Access Journals (Sweden)

    Cantor J

    2017-09-01

    Full Text Available Jerome Cantor,1 Shuren Ma,2 Gerard Turino2 1Department of Pharmaceutical Sciences, St John’s University, 2Department of Medicine, St Luke’s Mount Sinai Hospital Center, New York, NY, USA Abstract: A novel therapy for COPD involving the use of aerosolized hyaluronan (HA was tested on a small cohort of COPD patients to determine both its safety and efficacy in reducing levels of desmosine and isodesmosine (DID, biomarkers for elastin degradation. In a 2-week, randomized, double-blind trial, 8 patients receiving 150 kDa HA (mean molecular weight and 3 others given placebo did not show significant adverse effects with regard to spirometry, electrocardiograms, and hematological indices. Furthermore, measurements of DID in plasma from HA-treated patients indicated a progressive decrease over a 3-week period following initiation of treatment (r=−0.98; p=0.02, whereas patients receiving placebo showed no reduction in DID (r=−0.70; p=0.30. Measurements of sputum in the HA-treated group also revealed a progressive decrease in DID (r=−0.97; p=0.03, but this finding was limited by the absence of similar measurements in the placebo group. Nevertheless, the results of this small, pilot study support a longer-term trial of HA in a larger population of COPD patients. Keywords: hyaluronan, COPD, desmosine, elastin

  12. Safety and efficacy of helminth treatment in relapsing-remitting multiple sclerosis: Results of the HINT 2 clinical trial.

    Science.gov (United States)

    Fleming, John; Hernandez, Gianna; Hartman, Leslie; Maksimovic, Jane; Nace, Sara; Lawler, Benjamin; Risa, Todd; Cook, Thomas; Agni, Rashmi; Reichelderfer, Mark; Luzzio, Christopher; Rolak, Loren; Field, Aaron; Fabry, Zsuzsanna

    2017-10-01

    The hygiene hypothesis suggests that microbial replacement may be therapeutic in allergic and autoimmune diseases. Nevertheless, the results of helminth treatment, including in multiple sclerosis (MS), have been inconclusive. To assess safety and brain magnetic resonance imaging (MRI) activity in subjects with relapsing-remitting multiple sclerosis (RRMS) during oral administration of ova from the porcine whipworm, Trichuris suis (TSO). A total of 16 disease-modifying treatment (DMT) naive RRMS subjects were studied in a baseline versus treatment (BVT) controlled prospective study. MRI scans were performed during 5 months of screening-observation, 10 months of treatment, and 4 months of post-treatment surveillance. No serious symptoms or adverse events occurred during treatment. For the cohort, there was a trend consistent with a 35% diminution in active lesions when observation MRIs were compared to treatment MRIs ( p = 0.08), and at the level of individuals, 12 of 16 subjects improved during TSO treatment. T regulatory lymphocytes were increased during TSO treatment. TSO is safe in RRMS subjects. Potentially favorable MRI outcomes and immunoregulatory changes were observed during TSO treatment; however, the magnitude of these effects was modest, and there was considerable variation among the responses of individual subjects.

  13. Safety and dose flexibility clinical evaluation of intravesical liposome in patients with interstitial cystitis or painful bladder syndrome

    Directory of Open Access Journals (Sweden)

    Wei-Ching Lee

    2011-10-01

    Full Text Available To present single institution open-label experience with intravesical liposomes (LPs, a mucosal protective agent, in patients with interstitial cystitis/painful bladder syndrome (IC/PBS and to assess the safety and efficacy on IC/PBS symptoms. A total of 17 symptomatic IC/PBS patients were treated with intravesical LPs (80 mg/40 mL distilled water once a week for 4 weeks (n=12 or twice a week treatment for 4 weeks (n=5. The primary outcome was the change in the O’Leary-Sant Symptom/Problem score and O’Leary-Sant total Score from baseline to Week 4 and Week 8. Other outcome measurements included the changes in pain scale, urgency scale, voiding log, and patient global assessment. Both weekly and biweekly LP instillation regiments were well tolerated. The incidence of urinary incontinence, retention, or unanticipated adverse changes was not noted at any dose either during the treatment or at the 4-week follow-up. The O’Leary-Sant Symptom/Problem score, O’Leary-Sant total Score, and pain score were significantly improved from baseline at both dose regimens with added benefit with the biweekly regimen. Intravesical LPs treatment is safe and its efficacy has sustained duration. Furthermore large-scale, placebo-controlled studies are warranted to assess the efficacy for this promising new treatment for IC/PBS.

  14. Clinical Research of the Efficacy and the Safety of Dioscoreae Rhizoma (Sanyak Pharmacopuncture Therapy for Peripheral Facial Paralysis Patients

    Directory of Open Access Journals (Sweden)

    Sung In-Soo

    2012-12-01

    Full Text Available Objectives: The aim of this study is to evaluate the efficacy and the safety of Sanyak pharmacopuncture therapy for the treatment of peripheral facial paralysis patients. Methods: This study was a retrospective investigation of a total of 70 patients who were inpatients of the Oriental Hospital of Daejeon University between January 1, 2011, and May 31, 2012, and who were diagnosed as having peripheral facial paralysis by physical examination, the patients received three different interventions. Eleven (11 patients were treated with acupuncture and alcohol Dioscorea rhizoma pharmacopuncture (ADG, 25 patients with acupuncture and distillation Dioscorea rhizoma pharmacopuncture (DDG, and 34 patients with acupuncture and non-Dioscorea rhizoma pharmacopuncture (NDG. The resulting data were analyzed. Results: The changed H-B grades indicated significant improvements in all three groups, and the ADG and the DDG groups showed significant results after two weeks of treatment when compared to the NDG group. The changed y-Scores indicated significant improvements in all three groups, and the ADG group showed significant results after 10 and 15 days of treatment when compared to the NDG group. Dioscorea rhizoma pharmacopuncture may be safe for the human body because in most cases, the only abnormal finding was the pain could by the application of pharmacopuncture. Conclusions: The results of this study suggest that Oriental medical treatment with dioscoreae Rhizoma (Sanyak pharmacopuncture complex therapy may be effective and safe in patient with peripheral facial paralysis

  15. Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).

    Science.gov (United States)

    Biancone, Livia; Annese, Vito; Ardizzone, Sandro; Armuzzi, Alessandro; Calabrese, Emma; Caprioli, Flavio; Castiglione, Fabiana; Comberlato, Michele; Cottone, Mario; Danese, Silvio; Daperno, Marco; D'Incà, Renata; Frieri, Giuseppe; Fries, Walter; Gionchetti, Paolo; Kohn, Anna; Latella, Giovanni; Milla, Monica; Orlando, Ambrogio; Papi, Claudio; Petruzziello, Carmelina; Riegler, Gabriele; Rizzello, Fernando; Saibeni, Simone; Scribano, Maria Lia; Vecchi, Maurizio; Vernia, Piero; Meucci, Gianmichele

    2017-04-01

    Inflammatory bowel diseases are chronic conditions of unknown etiology, showing a growing incidence and prevalence in several countries, including Italy. Although the etiology of Crohn's disease and ulcerative colitis is unknown, due to the current knowledge regarding their pathogenesis, effective treatment strategies have been developed. Several guidelines are available regarding the efficacy and safety of available drug treatments for inflammatory bowel diseases. Nevertheless, national guidelines provide additional information adapted to local feasibility, costs and legal issues related to the use of the same drugs. These observations prompted the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) to establish Italian guidelines on the safety of currently available treatments for Crohn's disease and ulcerative colitis. These guidelines discuss the use of aminosalicylates, systemic and low bioavailability corticosteroids, antibiotics (metronidazole, ciprofloxacin, rifaximin), thiopurines, methotrexate, cyclosporine A, TNFα antagonists, vedolizumab, and combination therapies. These guidelines are based on current knowledge derived from evidence-based medicine coupled with clinical experience of a national working group. Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  16. A prospective clinical study to evaluate the safety and performance of wireless localization of nonpalpable breast lesions using radiofrequency identification technology.

    Science.gov (United States)

    Dauphine, Christine; Reicher, Joshua J; Reicher, Murray A; Gondusky, Christina; Khalkhali, Iraj; Kim, Michelle

    2015-06-01

    The purpose of this study was to evaluate the safety and performance of localizing nonpalpable breast lesions using radiofrequency identification technology. Twenty consecutive women requiring preoperative localization of a breast lesion were recruited. Subjects underwent placement of both a hook wire and a radiofrequency identification tag immediately before surgery. The radiofrequency identification tag was the primary method used by the operating surgeon to localize each lesion during excision, with the hook wire serving as backup in case of tag migration or failed localization. Successful localization with removal of the intended lesion was the primary outcome measured. Tag migration and postoperative infection were also noted to assess safety. Twenty patients underwent placement of a radiofrequency identification tag, 12 under ultrasound guidance and eight with stereotactic guidance. In all cases, the radiofrequency identification tag was successfully localized by the reader at the level of the skin before incision, and the intended lesion was removed along with the radiofrequency identification tag. There were no localization failures and no postoperative infections. Tag migration did not occur before incision, but in three cases, occurred as the lesion was being retracted with fingers to make the final cut along the deep surface of the specimen. In this initial clinical study, radiofrequency tags were safe and able to successfully localize nonpalpable breast lesions. Radiofrequency identification technology may represent an alternative method to hook wire localization.

  17. Renal safety in pediatric imaging: randomized, double-blind phase IV clinical trial of iobitridol 300 versus iodixanol 270 in multidetector CT

    Energy Technology Data Exchange (ETDEWEB)

    Zo' o, Martin; Dosseur, Patrick Le [CHU Charles Nicolle, Radiology Department, Rouen (France); Hoermann, Marcus; Balassy, Csilla [AKH, Radiology Department, Vienna (Austria); Brunelle, Francis [Necker Hospital, Radiopediatry Department, Paris (France); Azoulay, Robin [Robert Debre Hospital, Radiopediatry Department, Paris (France); Pariente, Daniele [Kremlin-Bicetre Hospital, Radiopediatry Department, Kremlin-Bicetre (France); Panuel, Michel [Nord Hospital, Medical Imaging Department, Marseille (France)

    2011-11-15

    It is debated whether iso-osmolar and low-osmolar contrast media are associated with different incidences of contrast medium-induced nephropathy (CIN) in patients with renal insufficiency. To compare the incidence of CIN in children undergoing contrast-enhanced multidetector computer tomography (MDCT) with intravenous injection of low-osmolar (iobitridol, Xenetix {sup registered} 300) or an iso-osmolar (iodixanol, Visipaque {sup registered} 270) iodinated contrast medium. One hundred forty-six children with normal renal function were included in this multicenter trial and underwent contrast-enhanced MDCT. The primary endpoint was the relative change in creatinine clearance from 48 h pre- to 72 h postcontrast medium administration using a noninferiority analysis in the intent-to-treat (ITT, n = 128) and per protocol (n = 68) populations. Secondary endpoints were incidence of CIN, global image quality, diagnostic efficacy and clinical safety. In the ITT population, the noninferiority of iobitridol over iodixanol was demonstrated. CIN incidence was 4.8% (three cases) with iobitridol and 10.6% (seven cases) with iodixanol (not significant). No statistically significant differences were observed for the secondary endpoints. Comparable satisfactory safety profiles were confirmed for both contrast media, with no significant difference in the incidence of CIN in children with normal renal function. (orig.)

  18. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  19. A multi-center, randomized, clinical study to compare the effect and safety of autologous cultured osteoblast(Ossron™ injection to treat fractures

    Directory of Open Access Journals (Sweden)

    Jeon Taek-Soo

    2009-02-01

    Full Text Available Abstract Background We performed a multicenter, open, randomized, clinical study of autologous cultured osteoblast injection for long-bone fracture, to evaluate the fracture healing acceleration effect and the safety of autologous cultured osteoblasts. Methods Sixty-four patients with long-bone fractures were randomly divided into two groups, i.e. those who received autologous cultured osteoblast injection and those who received no treatment. The sum of the difference in the callus formation scores after four and eight weeks, was used as the first efficacy variable. Results The autologous cultured osteoblast injection group showed fracture healing acceleration of statistical significance, and there were no specific patient complications when using this treatment. Conclusion Autologous cultured osteoblast injection should therefore be considered as a successful treatment option for treating long-bone fracture. Trial registration Current Controlled Trials ISRCTN10637905

  20. Reducing wound pain in venous leg ulcers with Biatain Ibu: A randomized, controlled double-blind clinical investigation on the performance and safety

    DEFF Research Database (Denmark)

    Gottrup, F.; Jorgensen, B.; Karlsmark, T.

    2008-01-01

    Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu...... without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly......-47, the patients in the ibuprofen-foam group had a significant (p Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between...

  1. Reducing wound pain in venous leg ulcers with Biatain Ibu: A randomized, controlled double-blind clinical investigation on the performance and safety

    DEFF Research Database (Denmark)

    Gottrup, F.; Jorgensen, B.; Karlsmark, T.

    2008-01-01

    Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu...... without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly...... higher in the ibuprofen-foam group, as compared with the comparator on day 1-5, with a quick onset of action (p Wound pain intensity was significantly reduced with the ibuprofen foam during day 1-5 with 40% from baseline, compared with 30% with the comparator (p

  2. Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Demarin V

    2017-02-01

    Full Text Available Vida Demarin,1,2 Vanja Bašić Kes,1 Zlatko Trkanjec,1 Mislav Budišić,1 Marija Bošnjak Pašić,3,4 Petra Črnac,5 Hrvoje Budinčević4,5 1Department of Neurology, University Hospital Center “Sestre Milosrdnice”, 2International Institute for Brain Health, 3Department of Neurology, University Hospital Center Zagreb, Zagreb, 4Department of Neurology, School of Medicine, University Josip Juraj Strossmayer, Osijek, 5Department of Neurology, Stroke and Intensive Care Unit, University Hospital “Sveti Duh”, Zagreb, Croatia Objectives: The aim of this randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of Ginkgo biloba extract in patients diagnosed with vascular cognitive impairment (VCI. Methods: A total of 90 patients (aged 67.1±8.0 years; 59 women were randomly allocated (1:1:1 to receive G. biloba 120 mg, G. biloba 60 mg, or placebo during a 6-month period. Assessment was made for efficacy indicators, including neuropsychological tests scores (Sandoz Clinical Assessment Geriatric Scale, Folstein Mini-Mental State Examination, Mattis Dementia Rating Scale, and Clinical Global Impression and transcranial Doppler ultrasound findings. Safety indicators included laboratory findings, reported adverse reactions, and clinical examination. Results: At the end of 6-month study period, G. biloba 120 and 60 mg showed a statistically significant positive effect in comparison with placebo only on the Clinical Global Impression score (2.6±0.8 vs 3.1±0.7 vs 2.8±0.7, respectively; P=0.038. The Clinical Global Impression score showed a significant deterioration from the baseline values in the placebo group (-0.3±0.5; P=0.021 as opposed to G. biloba groups. No significant differences were found in the transcranial Doppler ultrasound findings. Adverse reactions were significantly more common and serious in the placebo group (16 subjects than in either of the two G. biloba extract groups (eight and nine subjects

  3. Superselective transcatheter renal arterial embolization for acute renal bleeding in patients with renal insufficiency: its clinical efficacy and safety

    International Nuclear Information System (INIS)

    Hu Tingyang; Zhou Bing; Yu Wenqiang; Luo Zuyan; Mao Yingmin; Chen Fanghong; Li Bo; Yuan Jianhua

    2010-01-01

    Objective: To discuss the clinical efficacy and complications of super selective renal arterial embolization in treating acute renal arterial bleeding in patients with renal insufficiency, and to evaluate the influence of the treatment on the renal function. Methods: During the period of January 2000 December 2009, super selective renal arterial embolization was performed in our institution for acute renal bleeding in 13 patients with renal insufficiency. The complete clinical and imaging materials of all patients were properly collected. The clinical effectiveness, the renal function, the extent of embolization and the complications were observed and the relationship between each other was analyzed. Results: The embolization procedure was successfully completed in all patients with a technical success rate of 100%. The mean embolized territory was 22% of a single kidney. Three days after the procedure, the hemoglobin level, hematocrit, blood pressure and heart rate were considerably improved in all patients. Compared to the corresponding preoperative data, all the differences were statistically significant (P 0.05), while the blood urea nitrogen was markedly decreased (P=0.011). Post embolization syndrome occurred in 5 patients and progressive aggravation of the renal function was observed in one patient, who had to receive hemodialysis finally. The embolized territory in patients occurring complications was larger than that in patients without occurring complications (U=1.500, P=0.006). Conclusion: Super selective renal arterial embolization is an effective and safe treatment for acute renal arterial bleeding in patients with renal insufficiency, the therapy will not significantly worsen the renal function. Appropriate and reasonable extent of embolization, as small as possible, is the key point for reducing the complications. (authors)

  4. Immediate and long-term efficacy and safety of photodynamic therapy with Photolon (Fotolon): a seven-year clinical experience

    Science.gov (United States)

    Istomin, Yuri P.; Kaplan, Michael A.; Shliakhtsin, Siarhei V.; Lapzevich, Tatsiana P.; Cerkovsky, Dmitriy A.; Marchanka, Ludmila N.; Fedulov, Alexander S.; Trukhachova, Tatsiana V.

    2009-06-01

    The purpose of the present study was to summarize data on the long-term efficacy of photodynamic therapy (PDT) with Photolon in patients with malignant tumors of various types and localizations. The data obtained show that PDT with Photolon is a highly effective therapeutic modality for the treatment of skin tumors, cervical intraepithelial neoplasias, lung cancers, disseminated forms of melanoma, primary and metastatic brain tumors, several ophthalmologic diseases. This paper provides a review of most illustrative studies of the application of PDT with Photolon for the treatment of different oncological and non-oncological diseases performed in leading clinical centers of the Republic of Belarus and Russia.

  5. Vernakalant (RSD1235) in the management of atrial fibrillation: a review of pharmacological properties, clinical efficacy and safety

    DEFF Research Database (Denmark)

    Weeke, Peter; Andersson, Charlotte; Brendorp, Bente

    2008-01-01

    Vernakalant (RSD1235) is a novel antiarrhythmic agent for conversion of rapid onset atrial fibrillation (AF). It is an atria-selective multichannel ion blocker (blocks I(Kur), I(Na), I(Ca, L), I(to) and I(Kr)), with a small effect on ventricular repolarization. In clinical Phase II and III studie...... effect, with no reported cases of torsades de pointes in direct relation to vernakalant administration in Phase II and III studies. Overall, there are few reported serious adverse events....

  6. A clinical trial designed to evaluate the safety and effectiveness of a thermosensitive hydrogel-type cultured epidermal allograft for deep second-degree burns.

    Science.gov (United States)

    Yim, Haejun; Yang, Hyeong-Tae; Cho, Yong-Suk; Kim, Dohern; Kim, Jong-Hyun; Chun, Wook; Hur, Jun

    2014-12-01

    This study is a phase 1 and 2 clinical trial for investigating the safety profile, effective treatment dose and effectiveness of the newly developed thermosensitive hydrogel-type cultured epidermal allograft. For phase 1, the keratinocytes were divided into 3 groups as follows, with 5 patients in each group: (1) low-dose group (6.7×10(6)/1.5mL), (2) medium-dose group (2×10(7)/1.5mL), and (3) high-dose group (6.0×10(7)/1.5mL). The second phase of the trial proceeded with 10 cases after choosing the most effective dose based on the analysis of the first phase. When comparing re-epithelialization time, medium- and high-dose group showed significantly shorter re-epithelialization time than low-dose group (p=0.003 and p=0.002). A total of 15 cases, 5 cases selected from phase 1 and 10 cases test in phase 2 with the medium dose, were compared with the re-epithelialization period. The re-epithelialization period was 9.6±4.0 days in the test site and 12.4±4.8 days in the control site. In the test site, re-epithelialization was 2.8±1.8 days faster than in the control site (p<0.0001). There was no significant adverse reaction in our clinical trial. In conclusion, this new type of CEAllo accelerates wound healing time and shows the safety. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

  7. Comparisons of Safety and Clinical Outcomes Between Multiple-level and Single-level Cervical Disk Replacement for Cervical Spondylosis: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Jiang, Lianghai; Tan, Mingsheng; Yang, Feng; Yi, Ping; Tang, Xiangsheng; Hao, Qingying

    2016-12-01

    This is a systematic review and meta-analysis. The aim of this study was to evaluate the efficacy and safety of multiple-level cervical disk replacement (CDR) over single-level CDR for the treatment of cervical spondylosis. Some authors advocate for the multiple-level CDR instead of anterior decompression and fusion in cervical multiple-level spondylosis. However, whether the efficacy and safety of multi-level CDR are as favorable as that of single-level CDR remains controversial. MEDLINE, EMBASE, and Cochrane library databases were searched up to November 2015 for controlled studies that compared the clinical outcomes of single-level and multiple-level CDR for the treatment of cervical spondylosis. The following outcomes were extracted and analyzed: prevalence of heterotopic ossification and reoperation, preoperative and postoperative Neck Disability Index scores, preoperative and postoperative Visual Analog Scale scores, and success rate using the Odom grading system. Ten studies involving 1402 patients were included: including 3 randomized controlled trials, 5 prospective studies, and 3 retrospective studies. No significant differences between single-level and multiple-level groups were found in terms of the prevalence of heterotopic ossification and reoperation rate, Neck Disability Index score, Visual Analog Scale score, and success rate using the Odom grading system. On the basis of this meta-analysis, clinical outcomes of multiple-level CDR are similar to those of single-level CDR for cervical spondylosis, which suggests the multiple-level CDR is as effective and safe as the single-level CDR. Nonetheless, more well-designed studies are needed for further evaluation.

  8. An open-label, prospective clinical study to evaluate the efficacy and safety of TLPL/AY/01/2008 in the management of functional constipation

    Directory of Open Access Journals (Sweden)

    Renuka Munshi

    2011-01-01

    Full Text Available Functional constipation is one of the most common gastrointestinal symptoms across the globe. Its high prevalence rate, economic burden, and adverse implications on the quality of life make constipation a major public health issue. Though various treatment options are available for the management of constipation, evidence for their efficacy and safety are limited. An open-label, prospective, interventional, and exploratory clinical trial was carried out to evaluate the efficacy and safety of "TLPL/AY/01/2008" in 34 patients suffering from functional constipation. "TLPL/AY/01/2008" is an Ayurvedic proprietary polyherbal formulation in powder form, containing Isabgol husk, Senna extract, and Triphala extract. Administration of "TLPL/AY/01/2008" for 14 days showed a significant increase in mean weekly bowel movements from 10.19 ± 05.64 to 18.29 ± 05.72 (P<0.05. The mean average time spent on toilet for bowel evacuation reduced significantly from 11.02 ± 05.43 minutes (baseline value to 08.70 ± 04.72 minutes on day 14 (P<0.05. Mean stool form score assessed on Bristol stool form scale was improved from 02.97 ± 00.48 (baseline value to 04.61 ± 00.84 (P<0.05 on day 14. A significant improvement (P<0.05 was also noted in straining during defecation, sensation of incomplete evacuation, sensation of anorectal blockage, and other associated symptoms of functional constipation. The significant improvement in most of the above symptoms was endured for a post-treatment observatory period of one week. All the study patients showed an excellent tolerability to the study drug. These findings suggest that "TLPL/AY/01/2008" is an effective, safe, and non-habit-forming herbal laxative formulation for the management of constipation. Comparative clinical studies with larger sample size would be able to confirm the above findings.

  9. Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Yu Chih-Chieh

    2012-05-01

    Full Text Available Abstract Background Reducing low-density lipoprotein cholesterol (LDL-C is associated with reduced risk for major coronary events. Despite statin efficacy, a considerable proportion of statin-treated hypercholesterolemic patients fail to reach therapeutic LDL-C targets as defined by guidelines. This study compared the efficacy of ezetimibe added to ongoing statins with doubling the dose of ongoing statin in a population of Taiwanese patients with hypercholesterolemia. Methods This was a randomized, open-label, parallel-group comparison study of ezetimibe 10 mg added to ongoing statin compared with doubling the dose of ongoing statin. Adult Taiwanese hypercholesterolemic patients not at optimal LDL-C levels with previous statin treatment were randomized (N = 83 to ongoing statin + ezetimibe (simvastatin, atorvastatin or pravastatin + ezetimibe at doses of 20/10, 10/10 or 20/10 mg or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg or pravastatin 40 mg for 8 weeks. Percent change in total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C and triglycerides, and specified safety parameters were assessed at 4 and 8 weeks. Results At 8 weeks, patients treated with statin + ezetimibe experienced significantly greater reductions compared with doubling the statin dose in LDL-C (26.2% vs 17.9%, p = 0.0026 and total cholesterol (20.8% vs 12.2%, p = 0.0003. Percentage of patients achieving treatment goal was greater for statin + ezetimibe (58.6% vs doubling statin (41.2%, but the difference was not statistically significant (p = 0.1675. The safety and tolerability profiles were similar between treatments. Conclusion Ezetimibe added to ongoing statin therapy resulted in significantly greater lipid-lowering compared with doubling the dose of statin in Taiwanese patients with hypercholesterolemia. Studies to assess clinical outcome benefit are ongoing. Trial registration Registered at ClinicalTrials.gov: NCT00652327

  10. A review of clinical efficacy, safety, new developments and adherence to allergen-specific immunotherapy in patients with allergic rhinitis caused by allergy to ragweed pollen (Ambrosia artemisiifolia

    Directory of Open Access Journals (Sweden)

    Turkalj M

    2017-02-01

    Full Text Available Mirjana Turkalj,1,2 Ivana Banic,1 Srdjan Ante Anzic1 1Children’s Hospital Srebrnjak, Zagreb, 2Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia Abstract: Allergic rhinitis is a common health problem in both children and adults. The number of patients allergic to ragweed (Ambrosia artemisiifolia is on the rise throughout Europe, having a significant negative impact on the patients’ and their family’s quality of life. Allergen-specific immunotherapy (AIT has disease-modifying effects and can induce immune tolerance to allergens. Both subcutaneous immunotherapy and sublingual immunotherapy with ragweed extracts/preparations have clear positive clinical efficacy, especially over pharmacological treatment, even years after the treatment has ended. AIT also has very good safety profiles with extremely rare side effects, and the extracts/preparations used in AIT are commonly well tolerated by patients. However, patient adherence to treatment with AIT seems to be quite low, mostly due to the fact that treatment with AIT is relatively time-demanding and, moreover, due to patients not receiving adequate information and education about the treatment before it starts. AIT is undergoing innovations and improvements in clinical efficacy, safety and patient adherence, especially with new approaches using new adjuvants, recombinant or modified allergens, synthetic peptides, novel routes of administration (epidermal or intralymphatic, and new protocols, which might make AIT more acceptable for a wider range of patients and novel indications. Patient education and support (eg, recall systems is one of the most important goals for AIT in the future, to further enhance treatment success. Keywords: allergic rhinitis, allergy, ragweed, allergen-specific immunotherapy, Ambrosia artemisiifolia

  11. Preclinical pharmacology, efficacy, and safety of varenicline in smoking cessation and clinical utility in high risk patients

    Directory of Open Access Journals (Sweden)

    Zheng-Xiong Xi

    2010-04-01

    Full Text Available Zheng-Xiong XiNational Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USAAbstract: Smoking is still the most prominent cause of preventable premature death in the United States and an increasing cause of morbidity and mortality throughout the world. Although the current treatments such as nicotine replacement therapy (NRT and bupropion are effective, long-term abstinence rates are low. Mechanism studies suggest that the pleasurable effects of smoking are mediated predominantly by nicotine, which activates the brain reward system by activation of brain α4β2 nicotinic acetylcholine receptors (nAChRs. Varenicline is a novel α4β2 nAChR partial agonist and has been found to be even more effective than NRT or bupropion in attenuating smoking satisfaction and in relieving craving and withdrawal symptoms after abstinence. Thus, varenicline has been recently approved to be a first-line medication for smoking cessation in the United States and European countries. Varenicline is generally well tolerated in healthy adult smokers, with the most commonly reported adverse effects being nausea, insomnia, and headache. However, growing postmarketing data has linked varenicline to an increase in neuropsychiatric symptoms such as seizures, suicidal attempts, depression, and psychosis as well as serious injuries potentially relating to unconsciousness, dizziness, visual disturbances, or movement disorders. Therefore, new safety warnings are issued to certain high risk populations, such as patients with mental illness and operators of commercial vehicles and heavy machinery. In particular, pilots, air traffic controllers, truck and bus drivers have been banned from taking varenicline.Keywords: nicotine, varenicline, α4β2 nicotinic acetylcholine receptor, nAChRs, partial agonist, smoking cessation

  12. Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy.

    Science.gov (United States)

    Wang, Julie; Jones, Stacie M; Pongracic, Jacqueline A; Song, Ying; Yang, Nan; Sicherer, Scott H; Makhija, Melanie M; Robison, Rachel G; Moshier, Erin; Godbold, James; Sampson, Hugh A; Li, Xiu-Min

    2015-10-01

    Food Allergy Herbal Formula-2 (FAHF-2) is a 9-herb formula based on traditional Chinese medicine that blocks peanut-induced anaphylaxis in a murine model. In phase I studies FAHF-2 was found to be safe and well tolerated. We sought to evaluate the safety and effectiveness of FAHF-2 as a treatment for food allergy. In this double-blind, randomized, placebo-controlled study 68 subjects aged 12 to 45 years with allergies to peanut, tree nut, sesame, fish, and/or shellfish, which were confirmed by baseline double-blind, placebo-controlled oral food challenges (DBPCFCs), received FAHF-2 (n = 46) or placebo (n = 22). After 6 months of therapy, subjects underwent DBPCFCs. For those who demonstrated increases in the eliciting dose, a repeat DBPCFC was performed 3 months after stopping therapy. Treatment was well tolerated, with no serious adverse events. By using intent-to-treat analysis, the placebo group had a higher eliciting dose and cumulative dose (P = .05) at the end-of-treatment DBPCFC. There was no difference in the requirement for epinephrine to treat reactions (P = .55). There were no significant differences in allergen-specific IgE and IgG4 levels, cytokine production by PBMCs, or basophil activation between the active and placebo groups. In vitro immunologic studies performed on subjects' baseline PBMCs incubated with FAHF-2 and food allergen produced significantly less IL-5, greater IL-10 levels, and increased numbers of regulatory T cells than untreated cells. Notably, 44% of subjects had poor drug adherence for at least one third of the study period. FAHF-2 is a safe herbal medication for subjects with food allergy and shows favorable in vitro immunomodulatory effects; however, efficacy for improving tolerance to food allergens is not demonstrated at the dose and duration used. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  13. Clinical experience with the first 40 cases with femtosecond laser cataract surgery technology: safety of the learning curve

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    Joao Crispim

    2015-10-01

    Full Text Available ABSTRACT Objective: To evaluate the introduction of the femtosecond laser (FSL to perform the key steps of the traditional cataract surgery process and the operational difficulties and safety of this new technology during routine use in an operating room in Brazil. Methods A retrospective study was conducted using the first cases operated on at a single center using the laser platform LenSx/Alcon with a soft contact lens patient interface.All patients underwent a detailed preoperative assessment.The anterior capsulotomy, nuclear fragmentation, and corneal incisions were created with the FSL; then, the surgery was completed following the standard phacoemulsification procedure. The main outcome measurements were difficulties and complications related to the learning curve and an analysis of postoperative uncorrected distance visual acuity (UDVA. Results: Of 31 patients (40 eyes, 9 patients had FSL cataract surgery in both eyes.The mean age was 64 ± 12 years (ranging from 42 to 82, the mean cataract nuclear sclerosis was grading 2 ± 0.6 (ranging from 1 to 4, and the preoperative mean UDVA in logMAR was 0.4 ± 0.2 (ranging from 0.1 to 1.3. Anterior capsulotomy was complete in all patients, and scissors were not needed to cut off any intact portion. The postoperative corneal incisions were not completely linear and showed some irregularities. Laser phaco-fragmentation was effective, with the division of the nucleus into smaller segments easily performed before phacoemulsification.After 1 month, the postoperative mean UDVA in logMAR was 0.1 ± 0.1 (ranging from 0.0 to 0.4 (P < 0.0001. Conclusion: With increasing surgical cases and experience, the phacoemulsification steps are performed precisely and effectively with FSL pretreatment, resulting in a safe learning curve.

  14. Effects of MHRA drug safety advice on time trends in prescribing volume and indices of clinical toxicity for quinine

    Science.gov (United States)

    Acheampong, Paul; Cooper, Gill; Khazaeli, Behshad; Lupton, David J; White, Sue; May, Margaret T; Thomas, Simon H L

    2013-01-01

    Aims To ascertain the effects of the Medicines and Healthcare products Regulatory Agency's (MHRA) safety update in June 2010 on the volume of prescribing of quinine and on indices of quinine toxicity. Methods We analysed quarterly primary care total and quinine prescribing data for England and quinine prescribing volume for individual Primary Care Trusts in the North East of England from 2007/8 to 2011/12 obtained from the ePACT.net database. We also analysed quinine toxicity enquiries to the National Poisons Information Service (NPIS) via Toxbase® and by telephone between 2004/5 and 2011/12. Joinpoint regression and Pearson's correlation tests were used to ascertain changes in trends in prescribing and indices of toxicity and associations between prescribing and indices of toxicity, respectively. Results Total prescribing continued to increase, but annual growth in quinine prescribing in England declined from 6.0 to −0.6% following the MHRA update [difference −0.04 (95% confidence interval −0.07 to −0.01) quinine prescriptions per 100 patients per quarter, P = 0.0111]. Much larger reductions were observed in Primary Care Trusts that introduced comprehensive prescribing reviews. The previously increasing trend in Toxbase® quinine searches was reversed [difference −19.76 (95% confidence interval −39.28 to −9.20) user sessions per quarter, P = 0.0575]. Telephone enquiries to NPIS for quinine have declined, with stabilization of the proportion of moderate to severe cases of quinine poisoning since the update. Conclusions The MHRA advice was followed by limited reductions in the growth in quinine prescribing and in indicators of quinine overdose and toxicity. Quinine prescribing, however, remains common, and further efforts are needed to reduce availability and use. PMID:23594200

  15. Clinical study on safety and immunogenicity of therapeutic dual-plasmid HBV DNA vaccine mediated by in vivo electroporation

    Directory of Open Access Journals (Sweden)

    Hai-yan YANG

    2013-03-01

    Full Text Available Objective  To evaluate the safety and immunogenicity of the therapeutic dual-plasmid HBV DNA vaccine mediated by electroporation (EP in vivo against the hepatitis B virus in healthy adult volunteers. Methods The enrolled 30 healthy volunteers were randomly divided into three dosage groups (10 volunteers in each group, namely: high-dose (4mg, middle-dose (2mg and low-dose (1mg groups. Volunteers received four intramuscular injections of HBV DNA vaccine mediated by in vivo EP at the 0, 4th, 12th and 24th week. Each dose group was further divided into 2 sub-groups (5 persons/per group with different EP frequencies, i.e. 36 and 60 volt. The changes in response was determined by physical diagnosis (ECG, chest X-ray, type-B ultrasound, lab findings (blood and urine routine, blood biochemistry, prothrombin time, thyroid function, tumor biomarkers, immunological variables (IFN-γ, ANA, anti-dsDNA Ab, serological variables pertaining to HBV (HBsAg, HBcAb, HBeAg, HBeAb, HBV DNA and serum anti-HBs status in volunteers before and after receiving EP mediated HBV DNA vaccination. Results The dual-plasmid HBV DNA vaccination mediated by in vivo EP was well tolerated in all healthy volunteers with a stable life signs. It was found that EP-mediated immunization of the therapeutic DNA vaccine against hepatitis B virus had a specific and obvious anti-HBs humoral immune response in one volunteer (17.22mU/ml. Four repeated intramuscular injections of the vaccine did not show any significant adverse effects in the receptors. Although mild elevation of serum ALT and enlarged spleen were found in one individual, the abnormalities disappeared spontaneously at the end of the trial. Conclusions EP-mediated dual-plasmid HBV DNA vaccine is safe and well tolerated with certain degree of humoral immunogenicity.

  16. Clinical Trial with Sodium99mTc-Pertechnetate Produced by a Medium-Energy Cyclotron: Biodistribution and Safety Assessment in Patients with Abnormal Thyroid Function.

    Science.gov (United States)

    Selivanova, Svetlana V; Lavallée, Éric; Senta, Helena; Caouette, Lyne; McEwan, Alexander J B; Guérin, Brigitte; Lecomte, Roger; Turcotte, Éric

    2017-05-01

    A single-site prospective open-label clinical study with cyclotron-produced sodium 99m Tc-pertechnetate ( 99m Tc-NaTcO 4 ) was performed in patients with indications for a thyroid scan to demonstrate the clinical safety and diagnostic efficacy of the drug and to confirm its equivalence with conventional 99m Tc-NaTcO 4 eluted from a generator. Methods: 99m Tc-NaTcO 4 was produced from enriched 100 Mo (99.815%) with a cyclotron (24 MeV; 2 h of irradiation) or supplied by a commercial manufacturer (bulk vial eluted from a generator). Eleven patients received 325 ± 29 (mean ± SD) MBq of the cyclotron-produced 99m Tc-NaTcO 4 , whereas the age- and sex-matched controls received a comparable amount of the generator-derived tracer. Whole-body and thyroid planar images were obtained for each participant. In addition to the standard-energy window (140.5 keV ± 7.5%), data were acquired in lower-energy (117 keV ± 10%) and higher-energy (170 keV ± 10%) windows. Vital signs and hematologic and biochemical parameters were monitored before and after tracer administration. Results: Cyclotron-produced 99m Tc-NaTcO 4 showed organ and whole-body distributions identical to those of conventional 99m Tc-NaTcO 4 and was well tolerated. All images led to a clear final diagnosis. The fact that the number of counts in the higher-energy window was significantly higher for cyclotron-produced 99m Tc-NaTcO 4 did not influence image quality in the standard-energy window. Image definition in the standard-energy window with cyclotron-produced 99m Tc was equivalent to that with generator-eluted 99m Tc and had no particular features allowing discrimination between the 99m Tc production methods. Conclusion: The systemic distribution, clinical safety, and imaging efficacy of cyclotron-produced 99m Tc-NaTcO 4 in humans provide supporting evidence for the use of this tracer as an equivalent for generator-eluted 99m Tc-NaTcO 4 in routine clinical practice. © 2017 by the Society of Nuclear Medicine

  17. Evaluation of the safety and efficacy of pregabalin in older patients with neuropathic pain: results from a pooled analysis of 11 clinical studies

    Directory of Open Access Journals (Sweden)

    Zlateva Gergana

    2010-11-01

    Full Text Available Abstract Background Older patients are typically underrepresented in clinical trials of medications for chronic pain. A post hoc analysis of multiple clinical studies of pregabalin in patients with painful diabetic peripheral neuropathy (DPN or postherpetic neuralgia (PHN was conducted to evaluate the efficacy and safety of pregabalin in older patients. Methods Data from 11 double-blind, randomized, placebo-controlled clinical studies of pregabalin in patients with DPN or PHN were pooled. Efficacy outcomes included change in Daily Pain Rating Scale score, ≥30% and ≥50% responders, and endpoint pain score ≤3. Safety was based on adverse events (AEs. Primary efficacy was analyzed by analysis of covariance with terms for treatment, age category, protocol, baseline pain, and treatment-by-age category interaction. Results 2516 patients (white, n = 2344 [93.2%]; men, n = 1347 [53.5%]; PHN, n = 1003 [39.9%]; pregabalin, n = 1595 were included in the analysis. Patients were grouped by age: 18 to 64 years (n = 1236, 65 to 74 years (n = 766, and ≥75 years (n = 514. Baseline mean pain and sleep interference scores were comparable across treatment and age groups. Significant improvements in endpoint mean pain were observed for all pregabalin dosages versus placebo in all age groups (p ≤ 0.0009, except for the lowest dosage (150 mg/day in the youngest age group. Clinically meaningful pain relief, defined as ≥30% and ≥50% pain response, was observed in all age groups. The most common AEs were dizziness, somnolence, peripheral edema, asthenia, dry mouth, weight gain, and infections. The relative risks for these AEs increased with pregabalin dose, but did not appear related to older age or type of neuropathic pain. Conclusions Pregabalin (150-600 mg/day significantly reduced pain in older patients (age ≥65 years with neuropathic pain and improvements in pain were comparable to those observed in younger patients. Titration of pregabalin to the

  18. Safety, pharmacokinetic, and functional effects of the nogo-a monoclonal antibody in amyotrophic lateral sclerosis: a randomized, first-in-human clinical trial.

    Directory of Open Access Journals (Sweden)

    Vincent Meininger

    Full Text Available The neurite outgrowth inhibitor, Nogo-A, has been shown to be overexpressed in skeletal muscle in amyotrophic lateral sclerosis (ALS; it is both a potential biomarker and therapeutic target. We performed a double-blind, two-part, dose-escalation study, in subjects with ALS, assessing safety, pharmacokinetics (PK and functional effects of ozanezumab, a humanized monoclonal antibody against Nogo-A. In Part 1, 40 subjects were randomized (3∶1 to receive single dose intravenous ozanezumab (0.01, 0.1, 1, 5, or 15 mg/kg or placebo. In Part 2, 36 subjects were randomized (3∶1 to receive two repeat doses of intravenous ozanezumab (0.5, 2.5, or 15 mg/kg or placebo, approximately 4 weeks apart. The primary endpoints were safety and tolerability (adverse events [AEs], vital signs, electrocardiogram (ECG, and clinical laboratory tests. Secondary endpoints included PK, immunogenicity, functional endpoints (clinical and electrophysiological, and biomarker parameters. Overall, ozanezumab treatment (0.01-15 mg/kg was well tolerated. The overall incidence of AEs in the repeat dose 2.5 mg/kg and 15 mg/kg ozanezumab groups was higher than in the repeat dose placebo group and repeat dose 0.5 mg/kg ozanezumab group. The majority were considered not related to study drug by the investigators. Six serious AEs were reported in three subjects receiving ozanezumab; none were considered related to study drug. No study drug-related patterns were identified for ECG, laboratory, or vital signs parameters. One subject (repeat dose 15 mg/kg ozanezumab showed a weak, positive anti-ozanezumab-antibody result. PK results were generally consistent with monoclonal antibody treatments. No apparent treatment effects were observed for functional endpoints or muscle biomarkers. Immunohistochemical staining showed dose-dependent co-localization of ozanezumab with Nogo-A in skeletal muscle. In conclusion, single and repeat dose ozanezumab treatment was well tolerated and demonstrated

  19. Evaluation of the efficacy and safety of lanreotide in combination with targeted therapies in patients with neuroendocrine tumours in clinical practice: a retrospective cross-sectional analysis

    International Nuclear Information System (INIS)

    Capdevila, Jaume; Sevilla, Isabel; Alonso, Vicente; Antón Aparicio, Luís; Jiménez Fonseca, Paula; Grande, Enrique; Reina, Juan José; Manzano, José Luís; Alonso Lájara, Juan Domingo; Barriuso, Jorge; Castellano, Daniel; Medina, Javier; López, Carlos; Segura, Ángel; Carrera, Sergio; Crespo, Guillermo; Fuster, José; Munarriz, Javier; García Alfonso, Pilar

    2015-01-01

    Based on the mechanism of action, combining somatostatin analogues (SSAs) with mTOR inhibitors or antiangiogenic agents may provide synergistic effects for the treatment of patients with neuroendocrine tumours (NETs). Herein, we investigate the use of these treatment combinations in clinical practice. This retrospective cross-sectional analysis of patients with NETs treated with the SSA lanreotide and targeted therapies at 35 Spanish hospitals evaluated the efficacy and safety of lanreotide treatment combinations in clinical practice. The data of 159 treatment combinations with lanreotide in 133 patients was retrospectively collected. Of the 133 patients, with a median age of 59.4 (16–83) years, 70 (52.6 %) patients were male, 64 (48.1 %) had pancreatic NET, 23 (17.3 %) had ECOG PS ≥2, 41 (30.8 %) had functioning tumours, 63 (47.7 %) underwent surgery of the primary tumour, 45 (33.8 %) had received prior chemotherapy, and 115 (86.5 %) had received prior SSAs. 115 patients received 1 lanreotide treatment combination and 18 patients received between 2 and 5 combinations. Lanreotide was mainly administered in combination with everolimus (73 combinations) or sunitinib (61 combinations). The probability of being progression-free was 78.5 % (6 months), 68.6 % (12 months) and 57.0 % (18 months) for patients who only received everolimus plus lanreotide (n = 57) and 89.3 % (6 months), 73.0 % (12 months), and 67.4 % (18 months) for patients who only received sunitinib and lanreotide (n = 50). In patients who only received everolimus plus lanreotide the median time-to-progression from the initiation of lanreotide combination treatment was 25.8 months (95 % CI, 11.3, 40.3) and it had not yet been reached among the subgroup of patients only receiving sunitinib plus lanreotide. The safety profile of the combination treatment was comparable to that of the targeted agent alone. The combination of lanreotide and targeted therapies, mainly everolimus and sunitinib, is widely

  20. A behavioral Bayes method to determine the sample size of a clinical trial considering efficacy and safety.

    Science.gov (United States)

    Kikuchi, Takashi; Gittins, John

    2009-08-15

    It is necessary for the calculation of sample size to achieve the best balance between the cost of a clinical trial and the possible benefits from a new treatment. Gittins and Pezeshk developed an innovative (behavioral Bayes) approach, which assumes that the number of users is an increasing function of the difference in performance between the new treatment and the standard treatment. The better a new treatment, the more the number of patients who want to switch to it. The optimal sample size is calculated in this framework. This BeBay approach takes account of three decision-makers, a pharmaceutical company, the health authority and medical advisers. Kikuchi, Pezeshk and Gittins generalized this approach by introducing a logistic benefit function, and by extending to the more usual unpaired case, and with unknown variance. The expected net benefit in this model is based on the efficacy of the new drug but does not take account of the incidence of adverse reactions. The present paper extends the model to include the costs of treating adverse reactions and focuses on societal cost-effectiveness as the criterion for determining sample size. The main application is likely to be to phase III clinical trials, for which the primary outcome is to compare the costs and benefits of a new drug with a standard drug in relation to national health-care. Copyright 2009 John Wiley & Sons, Ltd.

  1. Clinical efficacy and safety of surface imaging guided radiosurgery (SIG-RS) in the treatment of benign skull base tumors.

    Science.gov (United States)

    Lau, Steven K M; Patel, Kunal; Kim, Teddy; Knipprath, Erik; Kim, Gwe-Ya; Cerviño, Laura I; Lawson, Joshua D; Murphy, Kevin T; Sanghvi, Parag; Carter, Bob S; Chen, Clark C

    2017-04-01

    Frameless, surface imaging guided radiosurgery (SIG-RS) is a novel platform for stereotactic radiosurgery (SRS) wherein patient positioning is monitored in real-time through infra-red camera tracking of facial topography. Here we describe our initial clinical experience with SIG-RS for the treatment of benign neoplasms of the skull base. We identified 48 patients with benign skull base tumors consecutively treated with SIG-RS at a single institution between 2009 and 2011. Patients were diagnosed with meningioma (n = 22), vestibular schwannoma (n = 20), or nonfunctional pituitary adenoma (n = 6). Local control and treatment-related toxicity were retrospectively assessed. Median follow-up was 65 months (range 61-72 months). Prescription doses were 12-13 Gy in a single fraction (n = 18), 8 Gy × 3 fractions (n = 6), and 5 Gy × 5 fractions (n = 24). Actuarial tumor control rate at 5 years was 98%. No grade ≥3 treatment-related toxicity was observed. Grade ≤2 toxicity was associated with symptomatic lesions (p = 0.049) and single fraction treatment (p = 0.005). SIG-RS for benign skull base tumors produces clinical outcomes comparable to conventional frame-based SRS techniques while enhancing patient comfort.

  2. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial.

    Science.gov (United States)

    Abdel-Ghaffar, Hala Saad; Mohamed, Sahar Abd-Elbaky; Fares, Khaled M; Osman, Mohamed Abdel-Kadr

    2016-05-01

    The optimum dose of dexmedetomidine for shivering control with the least hemodynamic derangements is still under research. To compare the efficacy, hemodynamic and side effects of dexmedetomidine in 3 different doses with those of meperidine for the treatment of shivering in patients undergoing spinal anesthesia for minor elective lower abdominal surgery. Prospective double-blind