WorldWideScience

Sample records for efficacy safety quality

  1. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents

    Directory of Open Access Journals (Sweden)

    J.B. Calixto

    2000-02-01

    Full Text Available This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs. Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

  2. [JUSTIFICATION OF USING EQUIVALENCE OF THE INDICES OF QUALITY, SAFETY, AND EFFICACY IN DEVELOPING BIOANALOGS].

    Science.gov (United States)

    Niyazov, R R; Goryachev, D V; Gavrishina, E V; Romodanovskii, D P; Dranitsyna, M A

    2015-01-01

    We describe general principles of demonstrating biosimilarity, as well as selecting the biosimilarity margins. Any change in the structure of a biological molecule can modify its functional activity. Therefore, therapeutic equivalence between a biosimilar product and the corresponding reference product cannot be demonstrated using a single criterion. To demonstrate biosimilarity between two medicinal products, their various characteristics have to be evaluated which may, directly or indirectly, justify that clinically significant differences are absent. Insufficient understanding of 6ritical quality attributes brings a risk for the biosimilar product developer. This will either increase the number of non-clinical and clinical tests and trials needed or will result in awareness that the manufacturing process needs to be improved at the late stages of development, after investing significant resources in the development process. At the same time, the specification of the biological medicinal product cannot solely ensure safety and efficacy thereof. Properly characterized and controlled manufacturing process, which ensures consistency in its attributes not adequately controlled in specifications but influencing safety and efficacy profiles and showing their relevance in non-clinical tests and clinical trials, is an additional quality assurance factor. Justification of all development strategy details, including biosimilarity margins, has to be provided each time when the development process is initiated or when proceeding to the next steps. All problems encountered by the developer have to be resolved in close communication with the regulatory authority. In order to increase the quality of investigation and developer's adherence to good practices, clinical trial results should be published in detail.

  3. Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework.

    Science.gov (United States)

    Abdel-Tawab, Mona

    2018-04-01

    Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs. Compared to PFSs with only one single herb, PFSs containing herbal mixtures were more involved in moderate and severe clinical courses. Although prohibited by regulation, misleading labels on PFSs are common. Above all, only vague evidence for the efficacy of PFSs exists. Notwithstanding the unproven efficacy and insufficient safety assessment, PFSs represent a relevant source for consumers to get access to herbal preparations in the United States and meanwhile also in Europe, as launching of licensed/registered European herbal medicinal products (HMPs) has steadily decreased. However, being non-vitamin, non-mineral products, PFSs are neither food nor drugs. In terms of protecting public health and providing the consumer with high-quality, effective, and safe PFSs, possibilities are shown how to deal with the many challenges of PFSs. Last but not least, suggestions are made for assigning PFSs a separate regulatory category being less regulated compared to HMPs but more strictly regulated compared to food laws including implementation of good manufacturing practices and a scientific pre-marketing review process by an expert commission. Georg Thieme Verlag KG Stuttgart · New York.

  4. Peptide receptor radionuclide therapy in the management of gastrointestinal neuroendocrine tumors: efficacy profile, safety, and quality of life

    Directory of Open Access Journals (Sweden)

    Severi S

    2017-01-01

    Full Text Available Stefano Severi,1 Ilaria Grassi,1 Silvia Nicolini,1 Maddalena Sansovini,1 Alberto Bongiovanni,2 Giovanni Paganelli1 1Nuclear Medicine Unit, 2Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST IRCCS, Meldola, Italy Abstract: Peptide receptor radionuclide therapy (PRRT, developed over the last two decades, is carried out using radiopharmaceuticals such as 90Y-DOTA-Tyr3-octreotide and 177Lu-DOTA-Tyr3-octreotate (177Lu-Dotatate. These radiocompounds are obtained by labeling a synthetic somatostatin analog with a β-emitting radioisotope. The compounds differ from each other in terms of their energetic features (due to the radionuclide and peptide receptor affinity (due to the analog but share the common characteristic of binding specific membrane somatostatin receptors that are (generally overexpressed in neuroendocrine neoplasms (NENs and their metastases. NENs are tumors arising from diffuse neuroendocrine system cells that are classified according to grading based on Ki67 percentage values (Grades 1 and 2 are classed as neuroendocrine tumors [NETs] and to the anatomical site of occurrence (in this paper, we only deal with gastroenteropancreatic [GEP]-NETs, which account for 60%–70% of all NENs. They are also characterized by specific symptoms such as diarrhea and flushing (30% of cases. Despite substantial experience gained in the area of PRRT and its demonstrable effects in terms of efficacy, safety, and improvement in quality of life, these compounds are still not registered (registration of 177Lu-Dotatate for the treatment of midgut NETs is expected soon. Thus, PRRT can only be used in experimental protocols. We provide an overview of the work of leading groups with wide-ranging experience and continuity in data publication in the area of GEP-NET PRRT and report our own personal experience of using different dosage schedules based on the presence of kidney and bone marrow risk factors

  5. 177Lu-DKFZ-PSMA-617 therapy in metastatic castration resistant prostate cancer: safety, efficacy, and quality of life assessment

    International Nuclear Information System (INIS)

    Yadav, Madhav Prasad; Ballal, Sanjana; Tripathi, Madhavi; Damle, Nishikant Avinash; Bal, Chandrasekhar; Sahoo, Ranjit Kumar; Seth, Amlesh

    2017-01-01

    The purpose of this study was to evaluate the efficacy and safety of a novel theranostic agent, 177 Lu-DKFZ-PSMA-617 therapy in metastatic castration resistant prostate cancer (mCRPC). Thirty-one mCRPC patients with progressive disease despite second-line hormonal therapy and/or docetaxel chemotherapy were recruited for the study. All patients underwent diagnostic 68 Ga-PSMA-HBED-CCPET/CT, prior to inclusion for therapy. Included patients then underwent quarterly 177 Lu-DKFZ-PSMA-617 therapy. Hematological, kidney function, liver function tests, and serum PSA levels were recorded before and after therapy at 2 weeks, 4 weeks, and 3 month intervals. Biochemical response was assessed with trend in serum PSA levels. Metabolic response was assessed by PERCIST 1 criteria. Clinical response was assessed by visual analogue score (VASmax) analgesic score (AS), Karanofsky performance status (KPS), and toxicity and response criteria of the Eastern Cooperative Oncology Group (ECOG) criteria. The mean age of patients was 65.93 ± 9.77 years (range: 38-81 years). The mean activity administered in the 31 patients was 5069 ± 1845 MBq ranging from one to four cycles. There was a decline in the mean serum PSA levels from the baseline (baseline: 275 ng/mL, post 1st cycle therapy: 141.75 ng/mL). Based on biochemical response criteria 2/31, 20/31, 3/31, and 6/31 had complete response (CR), partial response(PR), stable disease (SD), and progressive disease (PD), respectively. Metabolic response revealed 2/6 patients with CR, and the remaining 3/6 patients with PR and 1/6 patients with SD. The mean VASmax score decreased from 7.5 to 3. The mean analgesic score decreased from 2.5 to 1.8 after therapy. The mean KPS score improved from 50.32 to 65.42 after therapies. The mean ECOG performance status improved from 2.54 to 1.78 after therapy. Two patients experienced grade I and grade II hemoglobin toxicity each. None of the patients experienced nephrotoxicity or hepatotoxicity. 177 Lu

  6. WHO informal consultation on quality, safety and efficacy specifications for live attenuated rotavirus vaccines Mexico City, Mexico, 8-9 February 2005.

    Science.gov (United States)

    Wood, David

    2005-12-01

    Rotavirus vaccines are at an advanced stage of development but there are as yet no WHO recommendations on production and quality control to provide regulatory guidance. A meeting of experts was convened by WHO and PAHO/AMRO to review the scientific basis for production and quality control of rotavirus vaccines, and to discuss specific measures to assure the safety and efficacy of rotavirus vaccines. The meeting was attended by 25 experts from 14 countries, drawn from academia, public health, national regulatory authorities and vaccine producers. It was agreed that existing guidance for other live virus vaccines provides a very good basis for product characterization, especially for source materials and control of production. The basis for attenuation of current vaccines or vaccine candidates is not known but, at least for the vaccines based on the Jennerian approach of using animal (bovine) rotaviruses, is likely to be multigenic. The risk of intussusception in humans is influenced by genetic background and age. Recent analyzes of large vaccine safety trials found that certain strains of vaccine virus were not associated with intussusception, although in these trials the first dose of vaccine was not administered to children over 3 months of age. Since age is a risk factor for intussusception, this may suggest that early delivery of the first dose of vaccine is desirable. However, maternal antibodies may mitigate against early delivery of the first vaccine dose. Factors which could affect vaccine efficacy or safety include strain diversity, malnutrition, other enteric infections, parasitic infection or immune suppression. It was concluded that data from clinical trials conducted in one part of the world would not necessarily be predictive of vaccine efficacy in other places. It was agreed that in nonclinical evaluations there was a need to use oral dosing for toxicity studies and, because rotavirus is non-neurovirulent, that there was no need for an animal

  7. Studies on safety and efficacy of gamma-irradiated ginseng -Development of irradiation techniques for quality improvement of ginseng products-

    International Nuclear Information System (INIS)

    Cho, Han Ok; Byun, Myung Woo; Cho, Sung Kee; Kand, Il Joon; Yook, Hong Sun

    1995-02-01

    Gamma irradiation was applied to red ginseng powder for improving microbiological and physicochemical quality. Irradiation at 5-10 kGy was effective for sterilizing all contaminated microorganisms of red ginseng powder. At the dose levels, major physicochemical properties (saponin, amino acids, sugars, proximate composition, color, pH, acidity, hydrogen donating activity, fatty acids and minerals) were not changed by gamma irradiation upto 10 kGy. Based upon the results, it is concluded that gamma irradiation can effectively improve the microbiological quality of red ginseng powders without significant unfavorable changes. Therefore, it is suggested that irradiation technology is a viable alternative method to other sanitary process containing chemical fumigant and will be useful for the improvement of the quality of red ginseng powders and their products. 5 figs, 18 tabs, 92 refs. (Author)

  8. Studies on safety and efficacy of gamma-irradiated ginseng -Development of irradiation techniques for quality improvement of ginseng products-

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Han Ok; Byun, Myung Woo; Cho, Sung Kee; Kand, Il Joon; Yook, Hong Sun [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    1995-02-01

    Gamma irradiation was applied to red ginseng powder for improving microbiological and physicochemical quality. Irradiation at 5-10 kGy was effective for sterilizing all contaminated microorganisms of red ginseng powder. At the dose levels, major physicochemical properties (saponin, amino acids, sugars, proximate composition, color, pH, acidity, hydrogen donating activity, fatty acids and minerals) were not changed by gamma irradiation upto 10 kGy. Based upon the results, it is concluded that gamma irradiation can effectively improve the microbiological quality of red ginseng powders without significant unfavorable changes. Therefore, it is suggested that irradiation technology is a viable alternative method to other sanitary process containing chemical fumigant and will be useful for the improvement of the quality of red ginseng powders and their products. 5 figs, 18 tabs, 92 refs. (Author).

  9. Studies on safety and efficacy of gamma-irradiated ginseng -Development of irradiation techniques for quality improvement of ginseng products

    International Nuclear Information System (INIS)

    Cho, Han Ok; Byeon, Meong Uh; Yang, Jae Seung; Cho, Seong Ki; Kang, Il Joon

    1993-10-01

    The fourth year research program on Korean ginseng was carried out in order to improve in the microbiological quality and physical properties of red ginseng and its processing by application of irradiation technology. The quality of red ginseng and their products were strictly controlled by government invested Korean Tobacco Ginseng Co., but there is a need of alternative technology for decontaminating and disinfestating in view of supplying stable raw material and securing the hygienic production because the use of food fumigants and preservatives has been restricted due to their harmful effects on human and environment. It is desirable that the limited moisture content of red ginseng product should be increased, considering the economic and physical properties of its products, by application of irradiation technology for sterilization of prepackaged red ginseng products. Red ginseng products were irradiated at dose of 0, 5, 7.5, 10 kGy respectively, following moisture content of sample were increased up to 14%, 16%, 18% and 20% by keeping at humidity controlled desiccator. Each sample stored at ambient temperature (20 deg C, 70% RH) and accelerated storage condition (40 deg C, 90% RH) were used for the evaluation of microbiological quality, TBA value, color difference measurement, hydrogen donating activity, HPLC pattern and content of saponins, change of fatty acids and characteristics of moisture absorption

  10. Open-label study on the long-term efficacy, safety, and impact on quality of life of OROS hydromorphone ER in patients with chronic low back pain.

    Science.gov (United States)

    Wallace, Mark; Thipphawong, John

    2010-10-01

    To investigate the efficacy, safety, and impact on quality of life of long-term administration of OROS hydromorphone ER (8-128mg) in patients with chronic low back pain. A total of 113 adults with chronic low back pain who completed a 6-week open-label study were enrolled in this 6-month extension study. The primary end point was the daily pain relief rating obtained during monthly study visits. Secondary end points included Investigator and Patient Global Evaluations, Brief Pain Inventory scores obtained at monthly study visits, and quality-of-life measures (Medical Outcomes Study Questionnaire and 36-Item Short-Form Health Survey score) obtained at monthly intervals. Mean±SD change from baseline in pain relief with OROS hydromorphone ER for the Month 6 visit was 0.9±2.55 (P=0.0007) and for the last assessment of the extension study was 0.9±2.53 (P=0.0002). At the Month 6 visit, 81.3% of investigators and 71.0% of patients rated their satisfaction of pain relief with OROS hydromorphone ER treatment as good, very good, or excellent. Changes on the 36-item Short Form Health Survey, a quality-of-life measure, were statistically significant for the physical composite scores for all extension phase time points, including Month 6 (2.1±5.34; Psleep disturbances. Adverse events included gastrointestinal and central nervous system symptoms. The results support the long-term use of OROS hydromorphone ER in managing chronic moderate to severe low back pain. Wiley Periodicals, Inc.

  11. FOOD QUALITY MANAGEMENT AND SAFETY

    OpenAIRE

    Rizwana Khatoon; Debkumar Chakraborty; R.C. Chandni; Amar Sankar; A.V. Raghu

    2017-01-01

    Food safety system mainly focuses on identifying and preventing hazards that may lead product to deteriorate. The main important of manufacturing practice is a system that ensures that products meet food safety, quality and legal requirements. The hazard analysis and critical control point system, applies to food safety management, uses the approach of controlling critical points in food handling to prevent food safety problems. Besides enhancing food safety, other benefits of applying HACCP ...

  12. Quality and safety evaluation of a Ghanaian polyherbal product EAF ...

    African Journals Online (AJOL)

    McRoy

    means that issues concerning their quality, safety and efficacy need to be answered. In the current study, ... taken by several agencies like the World ..... this class of secondary metabolites detected ... during the manufacturing process as they.

  13. Antipsychotic agents: efficacy and safety in schizophrenia

    Directory of Open Access Journals (Sweden)

    de Araújo AN

    2012-11-01

    Full Text Available Arão Nogueira de Araújo,1 Eduardo Pondé de Sena,1,2 Irismar Reis de Oliveira,1,3 Mario F Juruena41Postgraduation Program in Interactive Processes of Organs and Systems, 2Department of Pharmacology, Institute of Health Sciences, 3Department of Neurosciences and Mental Health, School of Medicine, Federal University of Bahia, Salvador, Brazil; 4Stress and Affective Disorders Program, Department of Neuroscience and Behavior, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Sao Paulo, BrazilAbstract: Antipsychotics have provided a great improvement in the management of people with schizophrenia. The first generation antipsychotics could establish the possibility of managing many psychotic subjects in an outpatient setting. With the advent of the second (SGA and third generation antipsychotics (TGA, other psychiatric disorders such as bipolar depression, bipolar mania, autism, and major depressive disorder have now been approved for the use of these drugs for their treatment. Also, the administration of more specific assessment tools has allowed for better delineation of the repercussions of these drugs on symptoms and the quality of life of patients who use antipsychotic agents. In general, the SGA share similar mechanisms of action to achieve these results: dopamine-2 receptor antagonism plus serotonin-2A receptor antagonism. The TGA (eg, aripiprazole have partial agonist activity at the dopamine-2 receptor site, and are also called dopaminergic stabilizers. The pharmacological profile of SGA and TGA may provide better efficacy against negative symptoms, and are less likely to produce extrapyramidal symptoms; however, the SGA and TGA are associated with many other adverse events. The clinician has to balance the risks and benefits of these medications when choosing an antipsychotic for an individual patient.Keywords: antipsychotic agents, schizophrenia, pharmacology, safety

  14. Quality and safety in radiotherapy

    CERN Document Server

    Pawlicki, Todd

    2010-01-01

    The first text to focus solely on quality and safety in radiotherapy, this work encompasses not only traditional, more technically oriented, quality assurance activities, but also general approaches of quality and safety. It includes contributions from experts both inside and outside the field to present a global view. The task of assuring quality is no longer viewed solely as a technical, equipment-dependent endeavor. Instead, it is now recognized as depending on both the processes and the people delivering the service. Divided into seven broad categories, the text covers: Quality Management

  15. Women's perceptions of contraceptive efficacy and safety.

    Science.gov (United States)

    Kakaiya, Roshni; Lopez, Lia L; Nelson, Anita L

    2017-01-01

    Adoption of contraceptive implants and intrauterine devices has been less than might be expected given their superior efficacy and convenience. The purpose of this study was to assess knowledge and beliefs held by women, which may influence their contraceptive choices and theirongoing utilization of contraceptive methods. English speaking, nonpregnant, reproductive-age women, who were not surgically sterilized, were individually interviewed to obtain limited demographic characteristics and to assess their knowledge about the efficacy of various contraceptive methods in typical use and about the relative safety of oral contraceptives. A convenience sample of 500 women aged 18-45 years, with education levels that ranged from middle school to postdoctoral level was interviewed. The efficacy in typical use of both combined oral contraceptives and male condoms was correctly estimated by 2.2%; over two-thirds of women significantly over estimated the efficacy of each of those methods in typical use. Oral contraceptives were thought to be at least as hazardous to a woman's health as pregnancy by 56% of women. The majority of reproductive aged women surveyed substantially overestimated the efficacy of the two most popular contraceptive methods, often saying that they were 99% effective. Women with higher education levels were most likely to overestimate efficacy of oral contraceptives. Women of all ages and education levels significantly overestimated the health hazards of oral contraceptives compared to pregnancy. Overestimation of effectiveness of these methods of contraception, may contribute to lower adoption of implants and intrauterine devices. When individualizing patient counselling, misperceptions must be identified and addressed with women of all educational backgrounds. Not applicable.

  16. Food quality and safety management

    Directory of Open Access Journals (Sweden)

    Agnieszka Bilska

    2014-09-01

    Full Text Available Ensuring quality and safety of food are nowadays the most important goals set by companies who produce and distribute it. As a result, regulations have been introduced in the European Union countries concerning the production and distribution of food as well as norms which oblige companies to implement and execute several quality management systems.

  17. Safety and efficacy of Bolus administration of magnesium sulphate ...

    African Journals Online (AJOL)

    Safety and efficacy of Bolus administration of magnesium sulphate for preeclampsia. ... On-going research is addressing its administration in terms of dosage, duration and safety. Objective: We evaluated a ... Keywords: safety, efficacy, bolus magnesium sulphate, preeclampsia, University of Benin Teaching Hospital

  18. [Human papillomavirus vaccine. Efficacy and safety].

    Science.gov (United States)

    Bruni, Laia; Serrano, Beatriz; Bosch, Xavier; Castellsagué, Xavier

    2015-05-01

    Human papillomavirus (HPV) related disease remains a major cause of morbidity and mortality worldwide. Prophylactic vaccines have been recognized as the most effective intervention to control for HPV-related diseases. This article reviews the major phaseii/iii trials of the bivalent (HPVs16/18), quadrivalent (HPVs6/11/16/18), and the recently approved 9-valent vaccine (HPVs6/11/16/18/31/33/45/52/58). Large trials have been conducted showing the safety, immunogenicity and high efficacy of the bivalent and quadrivalent vaccines in the prevention of pre-invasive lesions and infection, especially when administered at young ages before exposure to HPV. Trials of the 9-valent vaccine have also demonstrated the safety, immunogenicity and efficacy of the vaccine in the prevention of infection and disease associated with the vaccine types, and its potential to substantially increase the overall prevention of HPV-related diseases. Post-licensure country reports have shown the recent and early impact of these vaccines at population level after the implementation of established HPV vaccination programs, including decreases in the prevalence of vaccine HPV types, the incidence of genital warts, and the incidence of high-grade cervical abnormalities. If widely implemented, current HPV vaccines may drastically reduce the incidence of cervical cancer and other HPV-related cancers and diseases. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  19. Patient Safety and Healthcare Quality

    Directory of Open Access Journals (Sweden)

    Aikaterini Toska

    2012-01-01

    Full Text Available Introduction: Due to a variety of circumstances and world-wide research findings, patient safety andquality care during hospitalization have emerged as major issues. Patient safety deficits may burdenhealth systems as well as allocated resources. The international community has examined severalproposals covering general and systemic aspects in order to improve patient safety; several long-termprograms and strategies have also been implemented promoting the participation of health-relatedagents, and also government agencies and non-governmental organizations.Aim: Those factors that have negative correlations with patient safety and quality healthcare weredetermined; WHO and EU programs as well as the Greek health policy were also reviewed.Method: Local and international literature was reviewed, including EU and WHO official publications,by using the appropriate keywords.Conclusions: International cooperation on patient safety is necessary in order to improvehospitalization and healthcare quality standards. Such incentives depend heavily on establishing worldwideviable and effective health programs and planning. These improvements also require further stepson safe work procedures, environment safety, hazard management, infection control, safe use ofequipment and medication, and sufficient healthcare staff.

  20. Model quality and safety studies

    DEFF Research Database (Denmark)

    Petersen, K.E.

    1997-01-01

    The paper describes the EC initiative on model quality assessment and emphasizes some of the problems encountered in the selection of data from field tests used in the evaluation process. Further, it discusses the impact of model uncertainties in safety studies of industrial plants. The model...... that most of these have never been through a procedure of evaluation, but nonetheless are used to assist in making decisions that may directly affect the safety of the public and the environment. As a major funder of European research on major industrial hazards, DGXII is conscious of the importance......-tain model is appropriate for use in solving a given problem. Further, the findings from the REDIPHEM project related to dense gas dispersion will be highlighted. Finally, the paper will discuss the need for model quality assessment in safety studies....

  1. Safety and efficacy of drugs in pregnancy.

    Science.gov (United States)

    Knoppert, David

    2011-01-01

    Although most drugs are used to treat chronic or pregnancy-induced conditions during pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The information we have on drugs taken during pregnancy and lactation is usually obtained after market approval through published case reports or case series and from pregnancy exposure or retrospective birth defect registries. Furthermore, generic drugs approved for use in this vulnerable population may be approved based on results from a male trial population. This disregards the changes that can occur during pregnancy which can affect the pharmacokinetics of drugs. In an effort to improve the information provided to prescribers, in 2008 the United States Food and Drug Administration proposed a change in product labelling where information from pregnancy exposure registries would be required. As of 2009, European Medicines Agency requires additional statements on use during pregnancy within drug labelling information. In Canada, it is anticipated that the efficacy and safety of drugs in pregnancy will be included under the Drug Safety and Effectiveness Network initiative, and that this will offer a unified approach for such assessments. Pregmedic, a non-profit organization for the advancement of safe and effective use of drugs in pregnancy, has presented a number of proposals and draft guidelines to Health Canada on the inclusion of pregnant women in pharmacokinetic studies and the establishment of registries for women who take drugs during pregnancy. Pregmedic advocates for ensuring that drugs indicated for women are studied in women.

  2. Efficacy and safety of the TVT-SECUR® and impact on quality of life in women with stress urinary incontinence: a 2-year follow-up.

    Science.gov (United States)

    Shin, Yu Seob; Cha, Jai Seong; Cheon, Min Woo; Kim, Young Gon; Kim, Myung Ki

    2011-05-01

    As recently reported, the short-term results of the tension-free vaginal tape SECUR® (TVT-S) procedure seem to be similar to those of the conventional transobturator tape (TOT) procedure. However, results of efficacy and satisfaction with TVT-S are insufficient in patients with more than 1 year of follow-up. Therefore, we evaluated the results of the TVT-S procedure in women with stress urinary incontinence (SUI) during 2 years. We evaluated 51 patients with clinical and urodynamic diagnoses of SUI who underwent the TVT-S procedure from March 2008 to February 2009. Preoperative evaluation included a history, cough stress test with full bladder, urodynamic study, and incontinence quality of life (I-QoL) questionnaire. Following the postoperative period, urinary incontinence status was examined through a physical examination and the I-QoL questionnaire was completed in an outpatient setting or by telephone. Data from 2 years of follow-up were available for 46 of 51 patients. The cure rate was 80.4% at 1 month after TVT-S and 76.0% at 2 years after TVT-S. The cure or improvement rate was 93.5% at 1 month after TVT-S and 86.8% at 2 years after TVT-S. The mean total I-QoL score increased by 42 points at 1 month after TVT-S (pTVT-S (pTVT-S. The results of this study suggest that TVT-S is an efficient and safe procedure for the improvement of both the quality of life of the patients and the SUI itself.

  3. Safety, Efficacy and Recurrence rate following tenosynovectomy and ...

    African Journals Online (AJOL)

    Objective: This study was conducted to compare the safety, efficacy and recurrence rate of primary tenosynovectomy versus intralesional steroid injection in the treatment of sclerosing tenosynovitis of deQuervain. Method: A prospective, comparative study of the safety, efficacy and recurrence rate following intralesional ...

  4. Efficacy and safety of histamine-2 receptor antagonists

    NARCIS (Netherlands)

    van der Pol, Rachel; Langendam, Miranda; Benninga, Marc; van Wijk, Michiel; Tabbers, Merit

    2014-01-01

    Histamine-2 receptor antagonists (H2RAs) are frequently used in the treatment of gastroesophageal reflux disease (GERD) in children; however, their efficacy and safety is questionable. To systematically review the literature to assess the efficacy and safety of H2RAs in pediatric GERD. PubMed,

  5. Efficacy and Safety of Antidepressants for the Treatment of Irritable Bowel Syndrome: A Meta-Analysis

    OpenAIRE

    Xie, Chen; Tang, Yurong; Wang, Yunfeng; Yu, Ting; Wang, Yun; Jiang, Liuqin; Lin, Lin

    2015-01-01

    Aim The aim of this meta-analysis was to analyze the efficacy and safety of antidepressants for the treatment of irritable bowel syndrome. Methods We searched MEDLINE, EMBASE, Scopus and The Cochrane Library for randomized controlled trials investigating the efficacy and safety of antidepressants in the treatment of irritable bowel syndrome. Article quality was evaluated by Jadad score. RevMan 5.0 and Stata 12.0 were used for the meta-analysis. Results Twelve randomized controlled trials were...

  6. {sup 177}Lu-DKFZ-PSMA-617 therapy in metastatic castration resistant prostate cancer: safety, efficacy, and quality of life assessment

    Energy Technology Data Exchange (ETDEWEB)

    Yadav, Madhav Prasad; Ballal, Sanjana; Tripathi, Madhavi; Damle, Nishikant Avinash; Bal, Chandrasekhar [All India Institute of Medical Sciences, Department of Nuclear Medicine, Ansari Nagar, New Delhi (India); Sahoo, Ranjit Kumar [All India Institute of Medical Sciences, Department of Medical Oncology, BR Ambedkar Rotary Cancer Hospital, New Delhi (India); Seth, Amlesh [All India Institute of Medical Sciences, Department of Urology, New Delhi (India)

    2017-01-15

    The purpose of this study was to evaluate the efficacy and safety of a novel theranostic agent, {sup 177}Lu-DKFZ-PSMA-617 therapy in metastatic castration resistant prostate cancer (mCRPC). Thirty-one mCRPC patients with progressive disease despite second-line hormonal therapy and/or docetaxel chemotherapy were recruited for the study. All patients underwent diagnostic{sup 68}Ga-PSMA-HBED-CCPET/CT, prior to inclusion for therapy. Included patients then underwent quarterly {sup 177}Lu-DKFZ-PSMA-617 therapy. Hematological, kidney function, liver function tests, and serum PSA levels were recorded before and after therapy at 2 weeks, 4 weeks, and 3 month intervals. Biochemical response was assessed with trend in serum PSA levels. Metabolic response was assessed by PERCIST 1 criteria. Clinical response was assessed by visual analogue score (VASmax) analgesic score (AS), Karanofsky performance status (KPS), and toxicity and response criteria of the Eastern Cooperative Oncology Group (ECOG) criteria. The mean age of patients was 65.93 ± 9.77 years (range: 38-81 years). The mean activity administered in the 31 patients was 5069 ± 1845 MBq ranging from one to four cycles. There was a decline in the mean serum PSA levels from the baseline (baseline: 275 ng/mL, post 1st cycle therapy: 141.75 ng/mL). Based on biochemical response criteria 2/31, 20/31, 3/31, and 6/31 had complete response (CR), partial response(PR), stable disease (SD), and progressive disease (PD), respectively. Metabolic response revealed 2/6 patients with CR, and the remaining 3/6 patients with PR and 1/6 patients with SD. The mean VASmax score decreased from 7.5 to 3. The mean analgesic score decreased from 2.5 to 1.8 after therapy. The mean KPS score improved from 50.32 to 65.42 after therapies. The mean ECOG performance status improved from 2.54 to 1.78 after therapy. Two patients experienced grade I and grade II hemoglobin toxicity each. None of the patients experienced nephrotoxicity or hepatotoxicity

  7. Quality and safety in Spain

    International Nuclear Information System (INIS)

    Prieto Barrio, J. M.; Martinez Martin, D. J.

    2015-01-01

    For three decades, and after the entry of Spain into the EU, it has been developed a regulatory, stable but evolving, framework that has allowed to create the conditions and structures to have stringent safety conditions of products and manufacturing facilities, as well as all the activities necessary for their certification and control. This development has been possible, among others, by the work of impulse and coordination of the Ministry of industry, Energy and Tourism, and particularly of the quality and Industrial safety sub directorate. On the other hand it has been developed a quality infrastructure that has, at the State level, with a standardisation (AENOR) entity and an accreditation body (ENAC) with recognized prestige around the world. In this article, in the first part, a list the regulations which apply to products and manufacturing facilities is shown, as well as explain the role played by standards and accreditation system in industrial safety and the factor of competitiveness that this entails for our industrial sector, and, in the second part, the institutional role of the Ministry and, the aforementioned Sub directorate, is described. The aim of the article is to be a descriptive reference of the current regulatory framework as well as the role of the State in this process. (Author)

  8. Comparison of the efficacy and safety of budesonide turbuhaler ...

    African Journals Online (AJOL)

    Comparison of the efficacy and safety of budesonide turbuhaler administered once daily with twice the dose of beclomethasone dipropionate using pressurised metered dose inhaler in patients with mild to moderate asthma.

  9. Preclinical efficacy and safety of herbal formulation for management ...

    African Journals Online (AJOL)

    Preclinical efficacy and safety of herbal formulation for management of wounds. ... The effects of the treatments on rate of wound closure, epithelialisation time ... inflammation and better tissue remodeling for rats treated with herbal product.

  10. Quality and safety evaluation of a Ghanaian polyherbal product EAF ...

    African Journals Online (AJOL)

    Background: The widespread use of herbal medicines in recent years means that issues concerning their quality, safety and efficacy need to be answered. In the current study, the polyherbal formulation EAF-2011 used in the Centre for Scientific Research into Plant Medicine, Mampong- Akwapemfor the management of ...

  11. [Drinking water quality and safety].

    Science.gov (United States)

    Gómez-Gutiérrez, Anna; Miralles, Maria Josepa; Corbella, Irene; García, Soledad; Navarro, Sonia; Llebaria, Xavier

    2016-11-01

    The purpose of drinking water legislation is to guarantee the quality and safety of water intended for human consumption. In the European Union, Directive 98/83/EC updated the essential and binding quality criteria and standards, incorporated into Spanish national legislation by Royal Decree 140/2003. This article reviews the main characteristics of the aforementioned drinking water legislation and its impact on the improvement of water quality against empirical data from Catalonia. Analytical data reported in the Spanish national information system (SINAC) indicate that water quality in Catalonia has improved in recent years (from 88% of analytical reports in 2004 finding drinking water to be suitable for human consumption, compared to 95% in 2014). The improvement is fundamentally attributed to parameters concerning the organoleptic characteristics of water and parameters related to the monitoring of the drinking water treatment process. Two management experiences concerning compliance with quality standards for trihalomethanes and lead in Barcelona's water supply are also discussed. Finally, this paper presents some challenges that, in the opinion of the authors, still need to be incorporated into drinking water legislation. It is necessary to update Annex I of Directive 98/83/EC to integrate current scientific knowledge, as well as to improve consumer access to water quality data. Furthermore, a need to define common criteria for some non-resolved topics, such as products and materials in contact with drinking water and domestic conditioning equipment, has also been identified. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  12. Safety and efficacy of quetiapine in bipolar depression.

    Science.gov (United States)

    Bogart, Gregory T; Chavez, Benjamin

    2009-11-01

    To review the clinical data investigating the efficacy and safety of quetiapine in bipolar depression. Searches of MEDLINE and PubMed (1977-July 2009) were conducted using the key words quetiapine and bipolar depression. The references of literature found were cross-referenced. The pharmaceutical company that produces quetiapine was contacted to obtain the posters for the EMBOLDEN I and EMBOLDEN II trials. Only double-blind, placebo-controlled trials were included for review, as well as any subanalyses of the literature that matched this criterion. There was a total of 5 double-blind, placebo-controlled trials and 5 subanalyses reviewed. The results of these data demonstrated quetiapine's efficacy in the treatment of depressive phases of bipolar disorder, including statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS). In the trials reviewed in this article, the change in MADRS scores ranged from -15.4 to -16.94 within the quetiapine groups, and from -10.26 to -11.93 in the placebo groups. There were also statistically significant improvements in the Hamilton Anxiety Rating Scale, the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire, the Pittsburgh Sleep Quality Index, and the Sheehan Disability Scale. All of these trials had a duration of 8 weeks and therefore cannot be applied to the long-term use of quetiapine in bipolar depression. The most common adverse events were sedation, somnolence, and dry mouth. The overall dropout rates for the trials reviewed ranged from 24% to 47%. Based on the literature reviewed here, quetiapine appears to be a safe and efficacious short-term treatment option for bipolar depression. Patients with bipolar type I showed greater improvement on the MADRS than those with bipolar type II. Patients with a rapid-cycling disease course showed an improvement in depressive symptoms, regardless of bipolar type.

  13. The Efficacy, Safety and Applications of Medical Hypnosis.

    Science.gov (United States)

    Häuser, Winfried; Hagl, Maria; Schmierer, Albrecht; Hansen, Ernil

    2016-04-29

    The efficacy and safety of hypnotic techniques in somatic medicine, known as medical hypnosis, have not been supported to date by adequate scientific evidence. We systematically reviewed meta-analyses of randomized controlled trials (RCTs) of medical hypnosis. Relevant publications (January 2005 to June 2015) were sought in the Cochrane databases CDSR and DARE, and in PubMed. Meta-analyses involving at least 400 patients were included in the present analysis. Their methodological quality was assessed with AMSTAR (A Measurement Tool to Assess Systematic Reviews). An additional search was carried out in the CENTRAL and PubMed databases for RCTs of waking suggestion (therapeutic suggestion without formal trance induction) in somatic medicine. Out of the 391 publications retrieved, five were reports of metaanalyses that met our inclusion criteria. One of these meta-analyses was of high methodological quality; three were of moderate quality, and one was of poor quality. Hypnosis was superior to controls with respect to the reduction of pain and emotional stress during medical interventions (34 RCTs, 2597 patients) as well as the reduction of irritable bowel symptoms (8 RCTs, 464 patients). Two meta-analyses revealed no differences between hypnosis and control treatment with respect to the side effects and safety of treatment. The effect size of hypnosis on emotional stress during medical interventions was low in one meta-analysis, moderate in one, and high in one. The effect size on pain during medical interventions was low. Five RCTs indicated that waking suggestion is effective in medical procedures. Medical hypnosis is a safe and effective complementary technique for use in medical procedures and in the treatment of irritable bowel syndrome. Waking suggestions can be a component of effective doctor-patient communication in routine clinical situations.

  14. Real-Life Efficacy, Immunogenicity and Safety of Biosimilar Infliximab.

    Science.gov (United States)

    Vegh, Zsuzsanna; Kurti, Zsuzsanna; Lakatos, Peter L

    2017-01-01

    Recently, the use of biosimilar infliximab (IFX) in the treatment of inflammatory bowel diseases has become widespread in some European and non-European countries. Data on the efficacy, safety and immunogenicity from real-life cohorts are accumulating. The first reports showed similar outcomes in the induction and maintenance of remission, mucosal healing, safety and immunogenicity profile to the originator IFX. In the present review, we aimed to summarize the existing knowledge on the efficacy, safety and immunogenicity profile of biosimilar IFX reported from real-life cohorts. © 2017 S. Karger AG, Basel.

  15. Desonide: a review of formulations, efficacy and safety.

    Science.gov (United States)

    Kahanek, Nr; Gelbard, Cg; Hebert, Aa

    2008-07-01

    Desonide is a low-potency topical corticosteroid that has been used for decades in the treatment of steroid-responsive dermatoses. The favorable safety profile of this topical agent makes it ideal for patients of all ages. This article provides a review of desonide's history, pharmacodynamic properties, vehicle technology, efficacy and safety. Randomized controlled trials, as well as open-label and non-comparative studies, case series and reports, experimental models, and data from the Galderma pharmacovigiliance program were reviewed in order to address the clinical efficacy and safety of desonide. Clinical efficacy and safety have been proven in multiple clinical trials. In addition to cream, lotion and ointment formulations, the recently developed hydrogel and foam preparations have increased desonide's versatility and patient tolerability.

  16. Pregabalin versus oxcarbazepine in painful diabetic neuropathy in elderly population: Efficacy and safety in terms of pain relief, cognitive function, and overall quality of life

    Directory of Open Access Journals (Sweden)

    Syed H Amir

    2018-01-01

    Full Text Available Background and Aims: The treatment of painful diabetic neuropathy (PDN in elderly patients is challenging considering the adverse effects associated with long term use of drugs. Pregabalin has been recommended as the first line therapy for relief of neuropathic pain in such patients. However, the occurrence of side effects especially cognitive dysfunction and peripheral edema raised concerns during long term therapy in elderly population. Recently, few studies have highlighted the role of oxcarbazepine, a second generation antiepileptic, in PDN. This prospective, randomized, single-blind, parallel-group study was done to compare pregabaline and oxcarbazepine monotherapy in patients of PDN. Materials and Methods: 150 elderly patients of painful diabetic neuropathy, for at least 6 months of duration with an average baseline pain score ≥ 4 on 11 point numeric rating scale (NRS, were divided into two groups to receive either pregabalin 150 mg/day or oxcarbazepine 600 mg/day. Assessment of pain scores, cognitive functions and quality of life were performed at different time intervals during the course of treatment. Results: Patients in both the study groups showed significant reduction in pain scores from the baseline; however no significant differences in pain scores were noted between the two groups during the course of treatment. The incidence of cognitive dysfunction as measured by BCRS score was significantly more in pregabalin group while no significant changes were noted in oxcarbazepine group. The overall quality of life as demonstrated by SF12 scores was significantly better in both the study groups as compared to baseline. Conclusion: Oxcarbazepine can be used as an alternative to pregabalin in elderly patients with PDN considering the similar degree of pain relief and better cognitive profile.

  17. Workplace Safety: Indoor Environmental Quality

    Science.gov (United States)

    ... Safety Construction Safety and Health Emergency Preparedness for Business Occupational Respiratory Disease Surveillance (ORDS) Office Environment Storm and Flood Cleanup Tuberculosis Follow NIOSH Facebook Flickr Pinterest Twitter YouTube NIOSH Homepage NIOSH A- ...

  18. Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction

    Directory of Open Access Journals (Sweden)

    Finley Allen

    2007-09-01

    Full Text Available Abstract Background Distraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique consists of an osteotomy of the bone to be lengthened, application of an external fixator, followed by gradual and controlled distraction of the bone ends. Although limb lengthening using the Ilizarov distraction osteogenesis principle yields excellent results in most cases, the technique has numerous problems and is not well tolerated by many children. The objective of the current study is to determine if Botulinum Toxin A (BTX-A, which is known to possess both analgesic and paralytic actions, can be used to alleviate post-operative pain and improve the functional outcome of children undergoing distraction osteogenesis. Methods/Design The study design consists of a multi centre, randomized, double-blinded, placebo-controlled trial. Patients between ages 5–21 years requiring limb lengthening or deformity correction using distraction will be recruited from 6 different sites (Shriners Hospital for Children in Montreal, Honolulu, Philadelphia and Portland as well as DuPont Hospital for Children in Wilmington, Delaware and Hospital for Sick Children in Toronto, Ont. Approximately 150 subjects will be recruited over 2 years and will be randomized to either receive 10 units per Kg of BTX-A or normal saline (control group intraoperatively following the surgery. Functional outcome effects will be assessed using pain scores, medication dosages, range of motion, flexibility, strength, mobility function and quality of life of the patient. IRB approval was obtained from all sites and adverse reactions will be monitored vigorously and reported to IRB, FDA and Health Canada. Discussion BTX-A injection has been widely used world wide with no major side effects reported. However, to the best of our knowledge, this is the first time BTX

  19. Efficacy and safety of cinitapride in functional dyspepsia

    International Nuclear Information System (INIS)

    Baqi, M.; Malik, M.N.

    2013-01-01

    Objective: To study the efficacy and safety of cinitapride in the treatment of functional dyspepsia, and to evaluate the improvement of patients quality of life. Methods: The prospective cross-sectional multi-centre phase IV study was conducted at Jinnah Hospital, Lahore, Ziauddin Medical University, Karachi and Pakistan Railways General Hospital, Rawalpindi, from July 2009 to June 2010 and comprised 121 patients of functional dyspepsia who were given cinitapride 1mg thrice daily 15 minutes before meals and were followed up for four weeks. Primary clinical response was assessed by using the Global Index Score. Secondary response was seen by percentage change of the total score as well as of each dyspepsia symptom compared with baseline and the overall subjective assessment of patients by using the 7-point Likert's scale. Reduction in Nepean Dyspepsia Index-Short Farm was used to evaluate the improvement in quality of life of patients at week 2 and 4. SPSS 15 used for statistical analysis. Results: After 4 weeks of treatment, the Global Index Score showed statistically significant reduction in 58 (48.92%) patients (p<0.01). Similar reduction (p<0.01) was seen in individual dyspepsia symptoms; early satiety, post-prandial fullness, and abdominal distension. The 7 point Likert's scale also showed similar improvement in subjective response (p<0.01). The quality of life also improved significantly at week 2 and 4 (p<0.01). No abnormal results were seen in vital signs, physical and laboratory examination except an unexplained rise in globulin level. Only one adverse event (sore throat) was reported during the study. Conclusion: The drug was effective in minimising dyspepsia symptoms, and improving the quality of life of patients. It was well tolerated and was almost free of side effects. (author)

  20. Polyhexanide - safety and efficacy as an antiseptic.

    Science.gov (United States)

    Fjeld, Hilde; Lingaas, Egil

    2016-05-01

    BACKGROUND Polyhexamethylene biguanide hydrochloride/polyhexanide/polyaminopropyl biguanide (PHMB) is used as a disinfectant and antiseptic. This article discusses the use of the substance as an antiseptic. We summarise published data on its antimicrobial effect in vitro and its clinical effect and safety when used on skin, wounds and mucosa.MATERIAL AND METHOD A literature search was conducted in PubMed for articles published in the last five years. Articles available as of June 2014 were considered.RESULTS Of 332 articles identified, 27 were included. In vitro studies have demonstrated an antimicrobial effect on Gram-negative bacteria, Gram-positive bacteria and Candida albicans. The clinical studies are small, not well controlled and frequently sponsored by industry. Few adverse effects from the substance were reported.INTERPRETATION Better designed, larger-scale clinical studies of effect and safety are needed in order to give recommendations on the use of polyhexanide on skin, wounds and mucosa.

  1. Patient Safety and Healthcare Quality

    OpenAIRE

    Aikaterini Toska; Panagiotis Kyloudis; Maria Rekleiti; Maria Saridi

    2012-01-01

    Introduction: Due to a variety of circumstances and world-wide research findings, patient safety andquality care during hospitalization have emerged as major issues. Patient safety deficits may burdenhealth systems as well as allocated resources. The international community has examined severalproposals covering general and systemic aspects in order to improve patient safety; several long-termprograms and strategies have also been implemented promoting the participation of health-relatedagent...

  2. Safety culture and quality management

    International Nuclear Information System (INIS)

    Edmondson, B.

    1992-01-01

    The concept of Safety Culture is defined along with its general attributes. The characteristics of a satisfactory level of Safety Culture, as it applies to an operating organisation are then presented in two ways, descriptive and as sets of questions against which an organisation's provision may be judged. (author) 1 fig

  3. Biologics in pediatric psoriasis - efficacy and safety.

    Science.gov (United States)

    Dogra, Sunil; Mahajan, Rahul

    2018-01-01

    Childhood psoriasis is a special situation that is a management challenge for the treating dermatologist. As is the situation with traditional systemic agents, which are commonly used in managing severe psoriasis in children, the biologics are being increasingly used in the recalcitrant disease despite limited data on long term safety. Areas covered: We performed an extensive literature search to collect evidence-based data on the use of biologics in pediatric psoriasis. The relevant literature published from 2000 to September 2017 was obtained from PubMed, using the MeSH words 'biologics', 'biologic response modifiers' and 'treatment of pediatric/childhood psoriasis'. All clinical trials, randomized double-blind or single-blind controlled trials, open-label studies, retrospective studies, reviews, case reports and letters concerning the use of biologics in pediatric psoriasis were screened. Articles covering the use of biologics in pediatric psoriasis were screened and reference lists in the selected articles were scrutinized to identify other relevant articles that had not been found in the initial search. Articles without relevant information about biologics in general (e.g. its mechanism of action, pharmacokinetics and adverse effects) and its use in psoriasis in particular were excluded. We screened 427 articles and finally selected 41 relevant articles. Expert opinion: The available literature on the use of biologics such as anti-tumor necrosis factor (TNF)-α agents, and anti-IL-12/23 agents like ustekinumab suggests that these are effective and safe in managing severe pediatric psoriasis although there is an urgent need to generate more safety data. Dermatologists must be careful about the potential adverse effects of the biologics before administering them to children with psoriasis. It is likely that with rapidly evolving scenario of biologics in psoriasis, these will prove to be very useful molecules particularly in managing severe and recalcitrant

  4. Software Quality Assurance for Nuclear Safety Systems

    International Nuclear Information System (INIS)

    Sparkman, D R; Lagdon, R

    2004-01-01

    The US Department of Energy has undertaken an initiative to improve the quality of software used to design and operate their nuclear facilities across the United States. One aspect of this initiative is to revise or create new directives and guides associated with quality practices for the safety software in its nuclear facilities. Safety software includes the safety structures, systems, and components software and firmware, support software and design and analysis software used to ensure the safety of the facility. DOE nuclear facilities are unique when compared to commercial nuclear or other industrial activities in terms of the types and quantities of hazards that must be controlled to protect workers, public and the environment. Because of these differences, DOE must develop an approach to software quality assurance that ensures appropriate risk mitigation by developing a framework of requirements that accomplishes the following goals: (sm b ullet) Ensures the software processes developed to address nuclear safety in design, operation, construction and maintenance of its facilities are safe (sm b ullet) Considers the larger system that uses the software and its impacts (sm b ullet) Ensures that the software failures do not create unsafe conditions Software designers for nuclear systems and processes must reduce risks in software applications by incorporating processes that recognize, detect, and mitigate software failure in safety related systems. It must also ensure that fail safe modes and component testing are incorporated into software design. For nuclear facilities, the consideration of risk is not necessarily sufficient to ensure safety. Systematic evaluation, independent verification and system safety analysis must be considered for software design, implementation, and operation. The software industry primarily uses risk analysis to determine the appropriate level of rigor applied to software practices. This risk-based approach distinguishes safety

  5. 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 ...

  6. Efficacy and safety of telmisartan monotherapy in the black ...

    African Journals Online (AJOL)

    The use of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in addition to control of blood pressure delays the development of end organ damage associated with hypertension. This study was undertaken to investigate the efficacy and safety of telmisartan as monotherapy in Nigerian black ...

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

    African Journals Online (AJOL)

    Double blind clinical trail comparing the safety and efficacy of nimesulide (100g) and diclofenac in osteoarthrosis of the hip and knee joints. ... A significant proportion of the patients in the diclofenac group (50% vs 17.6%) had break through pain that warranted the use of at least two tablets of 500mg of paracetamol per week ...

  8. Safety and efficacy of procedural sedation and analgesia (PSA ...

    African Journals Online (AJOL)

    Safety and efficacy of procedural sedation and analgesia (PSA) conducted by medical officers in a level 1 hospital in Cape Town. ... Respiratory complications were treated with simple airway manoeuvres; no patient required intubation or experienced respiratory problems after waking up. There was no significant difference ...

  9. Efficacy and safety of ginger in osteoarthritis patients

    DEFF Research Database (Denmark)

    Bartels, E M; Folmer, V N; Bliddal, Henning

    2015-01-01

    The aim of this study was to assess the clinical efficacy and safety of oral ginger for symptomatic treatment of osteoarthritis (OA) by carrying out a systematic literature search followed by meta-analyses on selected studies. Inclusion criteria were randomized controlled trials (RCTs) comparing ...

  10. Safety and efficacy of opicinumab in acute optic neuritis (RENEW)

    DEFF Research Database (Denmark)

    Cadavid, Diego; Balcer, Laura J; Galetta, Steven L

    2017-01-01

    BACKGROUND: The human monoclonal antibody opicinumab (BIIB033, anti-LINGO-1) has shown remyelinating activity in preclinical studies. We therefore assessed the safety and tolerability, and efficacy of opicinumab given soon after a first acute optic neuritis episode. METHODS: This randomised, doub...

  11. 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.

  12. Efficacy, safety, and patient acceptability of the Essure™ procedure

    Directory of Open Access Journals (Sweden)

    Hopkins MR

    2011-04-01

    Full Text Available Collette R Lessard, Matthew R HopkinsDepartment of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USAAbstract: The Essure™ system for permanent contraception was developed as a less invasive method of female sterilization. Placement of the Essure™ coil involves a hysteroscopic transcervical technique. This procedure can be done in a variety of settings and with a range of anesthetic options. More than eight years have passed since the US Food and Drug Administration approval of Essure™. Much research has been done to evaluate placement success, adverse outcomes, satisfaction, pain, and the contraceptive efficacy of the Essure™. The purpose of this review is to summarize the available literature regarding the efficacy, safety, and patient satisfaction with this new sterilization technique.Keywords: hysteroscopic sterilization, Essure™, safety, efficacy, acceptability

  13. Direct-acting antiviral agent efficacy and safety in renal transplant recipients with chronic hepatitis C virus infection

    OpenAIRE

    Chen, Keliang; Lu, Pei; Song, Rijin; Zhang, Jiexiu; Tao, Rongzhen; Wang, Zijie; Zhang, Wei; Gu, Min

    2017-01-01

    Abstract Background: The efficacy and safety of direct-acting antivirals (DAAs) for treating hepatitis C virus (HCV)-infected renal transplant recipients (RTRs) has not been determined. Methods: We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials and assessed the quality of eligible studies using the Joanna Briggs Institute scale. DAA efficacy and safety were assessed using standard mean difference (SMD) with 95% confidence intervals (95%CIs). Results: Six studi...

  14. Hospital disinfection: efficacy and safety issues.

    Science.gov (United States)

    Dettenkofer, Markus; Block, Colin

    2005-08-01

    To review recent publications relevant to hospital disinfection (and cleaning) including the reprocessing of medical instruments. The key question as to whether the use of disinfectants on environmental surfaces rather than cleaning with detergents only reduces nosocomial infection rates still awaits conclusive studies. New disinfectants, mainly peroxygen compounds, show good sporicidal properties and will probably replace more problematical substances such as chlorine-releasing agents. The safe reprocessing of medical devices requires a well-coordinated approach, starting with proper cleaning. New methods and substances show promising activity for preventing the transmission of prions. Different aspects of virus inactivation have been studied, and the transmissibility, e.g. of norovirus, shows the need for sound data on how different disinfectant classes perform. Biofilms or other forms of surface-adherent organisms pose an extraordinary challenge to decontamination. Although resistance to biocides is generally not judged to be as critical as antibiotic resistance, scientific data support the need for proper use, i.e. the avoidance of widespread application, especially in low concentrations and in consumer products. Chemical disinfection of heat-sensitive instruments and targeted disinfection of environmental surfaces are established components of hospital infection control. To avoid danger to staff, patients and the environment, prudent use as well as established safety precautions are required. New technologies and products should be evaluated with sound methods. As emerging resistant pathogens will challenge healthcare facilities in the future even more than at present, there is a need for well-designed studies addressing the role of disinfection in hospital infection control.

  15. Efficacy and Safety of Topical Niacinamide for Acne Vulgaris

    Directory of Open Access Journals (Sweden)

    Zeynep Nurhan Saraçoğlu

    2011-06-01

    Full Text Available Background and Design: To investigate the efficacy and safety of topical 4% naicinamide gel cream in the treatment of mild to moderate acne vulgaris and to assess the quality of life of acne patients.Material and Method: Twenty-nine female patients aged 16-38 (mean: 23.57±5.42 years with mild to moderate acne vulgaris who presented in dermatology outpatient clinic were enrolled in the study. All patients applied 4% niacinamide gel cream (Vivatinell-acnecinamide gel cream® on their faces twice daily for eight weeks. The number of lesions (inflammatory and non-inflammatory was counted at 0, 2, 4 and 8 weeks. The side effects (erythema, desquamation, burning and dryness were recorded. The Skindex-29, a quality-of-life measure for patients with skin disease, was administered to the subjects at the beginning and the end of treatment.Results: The decrease in the mean number of inflammatory lesions was statistically significant at the end of the treatment (pre-treatment vs. post-treatment: 12.24 vs. 6.14; p =0.000. However, there was no statistically significant decrease in the number of non-inflammatory lesions at the end of the eight weeks. The niacinamide gel cream was generally well tolerated. There was statistically significant improvement in the Skindex-29 scale scores (p =0.000 at the end of the treatment.Conclusion: Topical 4% niacinamide gel cream may be an alternative treatment for inflammatory lesions of mild to moderate acne vulgaris.

  16. European demands for food quality and safety

    OpenAIRE

    Bulatsyk, Sofiya; Yavorska, Nadiya

    2017-01-01

    In this article was investigated regulations and other normative documents of the European Union concerning food quality and safety and was arranged EU demands regards to food safety. There were determined the basic business concerns of the domestic enterprises in the process of manufacturing and marketing food products

  17. Efficacy and safety of sirolimus in lymphangioleiomyomatosis.

    Science.gov (United States)

    McCormack, Francis X; Inoue, Yoshikazu; Moss, Joel; Singer, Lianne G; Strange, Charlie; Nakata, Koh; Barker, Alan F; Chapman, Jeffrey T; Brantly, Mark L; Stocks, James M; Brown, Kevin K; Lynch, Joseph P; Goldberg, Hilary J; Young, Lisa R; Kinder, Brent W; Downey, Gregory P; Sullivan, Eugene J; Colby, Thomas V; McKay, Roy T; Cohen, Marsha M; Korbee, Leslie; Taveira-DaSilva, Angelo M; Lee, Hye-Seung; Krischer, Jeffrey P; Trapnell, Bruce C

    2011-04-28

    Lymphangioleiomyomatosis (LAM) is a progressive, cystic lung disease in women; it is associated with inappropriate activation of mammalian target of rapamycin (mTOR) signaling, which regulates cellular growth and lymphangiogenesis. Sirolimus (also called rapamycin) inhibits mTOR and has shown promise in phase 1-2 trials involving patients with LAM. We conducted a two-stage trial of sirolimus involving 89 patients with LAM who had moderate lung impairment--a 12-month randomized, double-blind comparison of sirolimus with placebo, followed by a 12-month observation period. The primary end point was the difference between the groups in the rate of change (slope) in forced expiratory volume in 1 second (FEV(1)). During the treatment period, the FEV(1) slope was -12±2 ml per month in the placebo group (43 patients) and 1±2 ml per month in the sirolimus group (46 patients) (Plife and functional performance. There was no significant between-group difference in this interval in the change in 6-minute walk distance or diffusing capacity of the lung for carbon monoxide. After discontinuation of sirolimus, the decline in lung function resumed in the sirolimus group and paralleled that in the placebo group. Adverse events were more common with sirolimus, but the frequency of serious adverse events did not differ significantly between the groups. In patients with LAM, sirolimus stabilized lung function, reduced serum VEGF-D levels, and was associated with a reduction in symptoms and improvement in quality of life. Therapy with sirolimus may be useful in selected patients with LAM. (Funded by the National Institutes of Health and others; MILES ClinicalTrials.gov number, NCT00414648.).

  18. Nuclear safety and quality systems

    International Nuclear Information System (INIS)

    Kunaj, H.; Tireli, E.

    2002-01-01

    According to ISO 8402:1994 [1] Quality is totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. According to ISO 9000:2000 [3] Quality is degree to which a set of inherent characteristics fulfils the requirements.(author)

  19. Quality control guarantees the safety of radiotherapy

    International Nuclear Information System (INIS)

    Aaltonen, P.

    1994-01-01

    While radiotherapy equipment has seen some decisive improvements in the last few decades, the technology has also become more complicated. The advanced equipment produces increasingly good treatment results, but the condition of the equipment must be controlled efficiently so as to eliminate any defects that might jeopardise patient safety. The quality assurance measures that are taken to show that certain equipment functions as required are known as quality control. The advanced equipment and stricter requirements set for the precision of radiotherapy have meant that more attention must be paid to quality control. The present radiation legislation stipulates that radiotherapy equipment must undergo regular quality control. The implementation of the quality control is supervised by the Finnish Centre for Radiation and Nuclear Safety (STUK). Hospitals carry out quality control in accordance with a programme approved by STUK, and STUK inspectors periodically visit hospitals to check the results of quality control. (orig.)

  20. Anticonvulsant treatment of asphyxiated newborns under hypothermia with lidocaine : efficacy, safety and dosing

    NARCIS (Netherlands)

    van den Broek, Marcel P. H.; Rademaker, Carin M. A.; van Straaten, Henrica L. M.; Huitema, Alwin D. R.; Toet, Mona C.; de Vries, Linda S.; Egberts, Antoine C. G.; Groenendaal, Floris

    BACKGROUND: Lidocaine is an antiarrythmicum used as an anticonvulsant for neonatal seizures, also during therapeutic hypothermia following (perinatal) asphyxia. Hypothermia may affect the efficacy, safety and dosing of lidocaine in these patients. OBJECTIVE: To study the efficacy and safety of

  1. Determining animal drug combinations based on efficacy and safety.

    Science.gov (United States)

    Kratzer, D D; Geng, S

    1986-08-01

    A procedure for deriving drug combinations for animal health is used to derive an optimal combination of 200 mg of novobiocin and 650,000 IU of penicillin for nonlactating cow mastitis treatment. The procedure starts with an estimated second order polynomial response surface equation. That surface is translated into a probability surface with contours called isoprobs. The isoprobs show drug amounts that have equal probability to produce maximal efficacy. Safety factors are incorporated into the probability surface via a noncentrality parameter that causes the isoprobs to expand as safety decreases, resulting in lower amounts of drug being used.

  2. Safety and efficacy of aneurysm treatment with WEB

    DEFF Research Database (Denmark)

    Pierot, Laurent; Costalat, Vincent; Moret, Jacques

    2016-01-01

    OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide......-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical....... RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting...

  3. Leadership, safety climate, and continuous quality improvement: impact on process quality and patient safety.

    Science.gov (United States)

    McFadden, Kathleen L; Stock, Gregory N; Gowen, Charles R

    2014-10-01

    Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

  4. Sibutramine: efficacy and safety of prescribing in routine clinical practice

    Directory of Open Access Journals (Sweden)

    Tat'yana Ivanovna Romantsova

    2015-11-01

    Full Text Available The 17th European Congress of endocrinology was held in Dublin in May 2015. Within the section «Obesity» the preliminary results of the observational program "PRIMAVERA" in the form of an oral report were presented. This article presents a brief review of the literature, reflecting the issues of mechanism of action, efficacy and safety of sibutramine and also includes an extended version of the main provisions of the report.

  5. Management of atopic dermatitis: safety and efficacy of phototherapy

    Directory of Open Access Journals (Sweden)

    Patrizi A

    2015-10-01

    Full Text Available Annalisa Patrizi, Beatrice Raone, Giulia Maria RavaioliDepartment of Specialized, Diagnostic and Experimental Medicine, Division of Dermatology, University of Bologna, Bologna, ItalyAbstract: Atopic dermatitis (AD is a common chronic inflammatory skin disease that can affect all age groups. It is characterized by a relapsing course and a dramatic impact on quality of life for patients. Environmental interventions together with topical devices represent the mainstay of treatment for AD, in particular emollients, corticosteroids, and calcineurin inhibitors. Systemic treatments are reserved for severe cases. Phototherapy represents a valid second-line intervention in those cases where non-pharmacological and topical measures have failed. Different forms of light therapy are available, and have showed varying degrees of beneficial effect against AD: natural sunlight, narrowband (NB-UVB, broadband (BB-UVB, UVA, UVA1, cold-light UVA1, UVA and UVB (UVAB, full-spectrum light (including UVA, infrared and visible light, saltwater bath plus UVB (balneophototherapy, Goeckerman therapy (coal tar plus UVB radiation, psoralen plus UVA (PUVA, and other forms of phototherapy. In particular, UVA1 and NB-UVB have gained importance in recent years. This review illustrates the main trials comparing the efficacy and safety of the different forms of phototherapy. No sufficiently large randomized controlled studies have been performed as yet, and no light modality has been defined as superior to all. Parameters and dosing protocols may vary, although clinicians mainly refer to the indications included in the American Academy of Dermatology psoriasis guidelines devised by Menter et al in 2010. The efficacy of phototherapy (considering all forms in AD has been established in adults and children, as well as for acute (UVA1 and chronic (NB-UVB cases. Its use is suggested with strength of recommendation B and level of evidence II. Home phototherapy can also be performed

  6. Safety and efficacy of venom immunotherapy: a real life study.

    Science.gov (United States)

    Kołaczek, Agnieszka; Skorupa, Dawid; Antczak-Marczak, Monika; Kuna, Piotr; Kupczyk, Maciej

    2017-04-01

    Venom immunotherapy (VIT) is recommended as the first-line treatment for patients allergic to Hymenoptera venom. To analyze the safety and efficacy of VIT in a real life setting. One hundred and eighty patients undergoing VIT were studied to evaluate the safety, efficacy, incidence and nature of symptoms after field stings and adverse reactions to VIT. Significantly more patients were allergic to wasp than bee venom (146 vs. 34, p bees, and were not associated with angiotensin convertase inhibitors (ACEi) or β-adrenergic antagonists use. Systemic reactions were observed in 4 individuals on wasp VIT (2.7%) and in 6 patients allergic to bees (17.65%). The VIT was efficacious as most patients reported no reactions (50%) or reported only mild local reactions (43.75%) to field stings. The decrease in sIgE at completion of VIT correlated with the dose of vaccine received ( r = 0.53, p = 0.004). Beekeeping (RR = 29.54, p venom allergy. Venom immunotherapy is highly efficacious and safe as most of the adverse events during the induction and maintenance phase are mild and local. Side effects of VIT are more common in subjects on bee VIT. Beekeeping and female sex are associated with a higher risk of allergy to Hymenoptera venom.

  7. Testosterone Replacement Therapy: Long-Term Safety and Efficacy

    Directory of Open Access Journals (Sweden)

    Giovanni Corona

    2017-08-01

    Full Text Available Recent position statements and guidelines have raised the distinction between a true and false, age-related hypogonadism (HG or late-onset hypogonadism (LOH. The former is the consequence of congenital or acquired “organic” damage of the brain centers or of the testis. The latter is mainly secondary to age-related comorbidities and does not require testosterone (T therapy (TTh. In addition, concerns related to cardiovascular (CV safety have further increased the scepticism related to TTh. In this paper, we reviewed the available evidence supporting the efficacy of TTh in non-organic HG and its long term safety. A large amount of evidence has documented that sexual symptoms are the most specific correlates of T deficiency. TTh is able to improve all aspects of sexual function independent of the pathogenetic origin of the disease supporting the scientific demonstration that LOH does exist according to an “ex-juvantibus” criterion. Although the presence of metabolic derangements could mitigate the efficacy of TTh on erectile dysfunction, the positive effect of TTh on body composition and insulin sensitivity might counterbalance the lower efficacy. CV safety concerns related to TTh are essentially based on a limited number of observational and randomized controlled trials which present important methodological flaws. When HG is properly diagnosed and TTh correctly performed no CV and prostate risk have been documented.

  8. EFFICACY AND SAFETY OF THE INFLUENZA VACCINE AMONG CHILDREN WITH DIFFERENT HEALTH CONDITIONS

    OpenAIRE

    M.G. Galitskaya

    2007-01-01

    Efficacy and safety of vaccine «Grippol» among children with different health status was analyzed. The most efficacy of the influenza vaccine revealed in the group of children with compromised health status, as well as in the group of allergic children. The safety of influenza vaccination was confirmed in children with different health conditions.Key words: children, vaccination, influenza, efficacy, safety.

  9. [Efficacy and safety of levofloxacin to non-gonorrheal urethritis].

    Science.gov (United States)

    Onodera, Shoichi; Onoe, Yasuhiko; Hosobe, Takahide; Kato, Tetsuro; Yoshida, Masaki

    2012-12-01

    We investigated the efficacy and safety of levofloxacin (LVFX) 500mg once a day in patients with non-gonorrheal urethritis. Men, aged 20 years or older, with urethritis symptoms, and detection of Chlamydia trachomatis (C. trachomatis) or Mycoplasma genitalium (M. genitalium) by a microbiological examination were eligible for this study. Patients were administered LVFX 500mg, orally, once a day and the dosage period was seven days. We assumed 22 patients for a safety and efficacy analysis. In 22 patients, 17 patients had urethritis with C. trachomatis, 4 patients urethritis with M. genitalium, and one patient mixed infection of C. trachomatis and M. genitalium. In the clinial study, the primary endpoint was set as the bacteriological eradication rate at two to four weeks after completion of treatment. The bacterial eradication rate in the urethritis was 86.4% (19/22). The bacterial eradication rate in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 94.1% (16/17), 50.0% (2/4), 100% (1/1), respectively. A significant difference was not recognized among the three groups. The clinical efficacy at two to four weeks after completion of treatment was 90.9% (20/22). The clinical efficacy rates in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 100% (17/17), 50.0% (2/4), 100% (1/1), respectively. The efficacy rate of urethritis with M. genitalium was significantly low. No adverse drug reactions were observed. These results suggest that once-a-day levofloxacin (500mg) is effective and safe treatment for non-gonorrheal urethritis.

  10. Improving patient safety through quality assurance.

    Science.gov (United States)

    Raab, Stephen S

    2006-05-01

    Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. To review some of the anatomic pathology laboratory patient safety quality assurance practices. Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.

  11. Consumer perception of meat quality and safety

    DEFF Research Database (Denmark)

    Brunsø, Karen; Grunert, Klaus G.; Bredahl, Lone

    2003-01-01

    The evaluation of meat quality and safety is not an easy task for consumers. In this article, the Total Food Quality Model will be introduced as a framework for understanding how consumers perceive meat quality, and results from a Danish study dealing with consumer perception and experience of beef...... will be presented. Consumers form expectations about the eating quality of meat at the point of purchase, based on prior experience and information available in the shopping environment, while the eating quality is experienced in the home during and after meal preparation. Results show that consumers have...... difficulty in evaluating meat quality, resulting in uncertainty and dissatisfaction, and reveal a need for educating consumers about evaluating eating quality during shopping....

  12. Efficacy and Safety of Antiintegrin Antibody for Inflammatory Bowel Disease

    Science.gov (United States)

    Lin, Lianjie; Liu, Xiang; Wang, Dongxu; Zheng, Changqing

    2015-01-01

    Abstract We sought to evaluate the safety and efficacy of available biologics that inhibit T-cell migration by blocking α4β7 integrins in inflammatory bowel diseases. The aim of this study is to evaluate whether Crohn disease (CD) patients receiving either vedolizumab or natalizumab have any different effect in CD Activity Index (CDAI). Using Medline, Excerpta Medica dataBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar until October 31, 2013, we identified 10 studies examining the safety and efficacy of specific integrin inhibitors—vedolizumab, which targets an epitope comprising the α4β7 heterodimer; natalizumab, which recognizes the α4 integrin subunit; etrolizumab, which is specific for the β7 subunit—in the treatment of CD and ulcerative colitis (UC). CD patients receiving either vedolizumab or natalizumab demonstrated a modest increase in remission rate, when compared with that of the placebo group. Further, although both treatments reduced the CDAI slightly, the observed clinical response was less robust than that of the remission rate. UC patients treated with vedolizumab and natalizumab were found to show more prominent increases in both remission and clinical response, compared with placebo, than patients with CD. Etrolizumab, however, was not found to significantly affect either response or remission rates in UC patients. Biologics targeting integrins show promise as therapeutics in the treatment of inflammatory bowel disease in patients who are either nonresponsive or intolerant to traditional approaches, though further research is necessary to optimize treatment efficacies. PMID:25761174

  13. Efficacy and Safety of Fingolimod in an Unselected Patient Population.

    Directory of Open Access Journals (Sweden)

    Maria Rasenack

    Full Text Available Fingolimod is a first in class oral compound approved for the treatment of relapsing-remitting multiple sclerosis (RR-MS. The aim of this study was to evaluate clinical and neuroradiological responses to fingolimod as well as the safety and tolerability in RR-MS patients in clinical practice. In addition, a panel of pro-inflammatory serum cytokines was explored as potential biomarker for treatment response.We conducted a retrospective, non-randomized, open-label, observational study in 105 patients with RR-MS and measured cytokines in longitudinal serum samples.Compared to the year before fingolimod start the annualized relapse rate was reduced by 44%. Also, the percentage of patients with a worsening of the EDSS decreased. Accordingly, the fraction of patients with no evidence of disease activity (no relapse, stable EDSS, no new active lesions in MRI increased from 11% to 38%. The efficacy and safety were comparable between highly active patients or patients with relevant comorbidities and our general patient population.The efficacy in reducing relapses was comparable to that observed in the phase III trials. In our cohort fingolimod was safe and efficacious irrespective of comorbidities and previous treatment.

  14. Approaches to document the efficacy and safety of microdermabrasion procedure.

    Science.gov (United States)

    Spencer, James M; Kurtz, Ellen S

    2006-11-01

    Microdermabrasion is a popular cosmetic procedure for skin rejuvenation, which is achieved by mechanical abrasion of the skin at a superficial level. The objective was to study the efficacy of microdermabrasion in photoaging and to investigate the compatibility of a cleanser and a lotion with microdermabrasion. Sixteen women underwent microdermabrasion to the face once a week for a total of six treatments. Subjects were also given a personal skin care regimen (cleanser and lotion). Colorimetry values as well as investigator and patients ratings for safety and efficacy were analyzed at various time points and compared to baseline. There were no significant changes in safety and tolerance variables throughout the study. Clinical efficacy variables (fine wrinkles, dullness, pigmentation, and large pores) significantly improved by the third treatment, with further improvement by the end of the study (six treatments). Subjects perceived improvement in facial photoaging variables. Colorimetry showed increased brightness and decreased yellowness of target skin sites on the face throughout the study. Multiple microdermabrasions were effective in significantly improving various facial photoaging variables. The personal skin care regimen used was well tolerated by the subjects.

  15. Safety and efficacy of Labisia pumila containing products

    Directory of Open Access Journals (Sweden)

    Muhammad Syafiq Saleh

    2016-01-01

    Full Text Available Labisia pumila is a traditional medicinal plant which has wide therapeutic application including induction of labor and treatment of dysentery, dysmenorrhea and gonorrhea. We aimed for systematic review of the efficacy andsafety of L. pumila extract or its other commercial products availabe in Malaysian market. The marketed 500 mg capsule is composed of 40 mg L. pumila, 10 mg C. caudatum extract and 450 mg excipient. The commercial products did not follow the registration guidelines of Malaysian National Pharmaceutical Control Bureau (NPCB and advertisement guidelines of Malaysian Advertisement Board. Randomized, placebo controlled clinical trials reported the safe consumpotion of L. pumila water extract on postmanoposal women. Information on the efficacy and safety of commercial products are not sufficiently available. Many unregistered products (mostly capsule form are flooded in Malaysian market without having scientific information. Consumption of those products may seriously impair the health of the people.

  16. Premarket safety and efficacy studies for ADHD medications in children.

    Directory of Open Access Journals (Sweden)

    Florence T Bourgeois

    Full Text Available Attention-deficit hyperactivity disorder (ADHD is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419. Eleven drugs (55% were approved after <100 participants were studied and 14 (70% after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9, with 5 (38% drugs approved after participants were studied <4 weeks and 10 (77% after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.

  17. Watershed safety and quality control by safety threshold method

    Science.gov (United States)

    Da-Wei Tsai, David; Mengjung Chou, Caroline; Ramaraj, Rameshprabu; Liu, Wen-Cheng; Honglay Chen, Paris

    2014-05-01

    Taiwan was warned as one of the most dangerous countries by IPCC and the World Bank. In such an exceptional and perilous island, we would like to launch the strategic research of land-use management on the catastrophe prevention and environmental protection. This study used the watershed management by "Safety Threshold Method" to restore and to prevent the disasters and pollution on island. For the deluge prevention, this study applied the restoration strategy to reduce total runoff which was equilibrium to 59.4% of the infiltration each year. For the sediment management, safety threshold management could reduce the sediment below the equilibrium of the natural sediment cycle. In the water quality issues, the best strategies exhibited the significant total load reductions of 10% in carbon (BOD5), 15% in nitrogen (nitrate) and 9% in phosphorus (TP). We found out the water quality could meet the BOD target by the 50% peak reduction with management. All the simulations demonstrated the safety threshold method was helpful to control the loadings within the safe range of disasters and environmental quality. Moreover, from the historical data of whole island, the past deforestation policy and the mistake economic projects were the prime culprits. Consequently, this study showed a practical method to manage both the disasters and pollution in a watershed scale by the land-use management.

  18. FURNAS activities in safety and quality assurance

    International Nuclear Information System (INIS)

    Dezordi, W.L.; Correa Filho, S.M.; Sacco, W.; Morais, L.H.G. de

    1980-01-01

    The aspects involved in the quality assurance performed by FURNAS for Nuclear Power Plant - Angra Unit I, are shown. Furnas' responsabilities in the licensing regarding reactor safety are also discussed. A summary of the computer codes used in the licensing process is given. (e.G.) [pt

  19. Food safety and total quality management

    NARCIS (Netherlands)

    Barendsz, A.W.

    1998-01-01

    Food safety is a growing global concern not only because of its continuing importance for public health but also because of its impact on international trade. The application of total quality management (TQM) provides the best possible care by continuously improving products and services to meet or

  20. Role of quality assurance in reactor safety

    International Nuclear Information System (INIS)

    Roedel, J.A.

    1975-01-01

    A quality assurance program based on common sense, designed to accomplish what is reasonable and necessary, giving proper consideration to safety and economics can be an effective and essential management tool for the design, construction and operation of safe and economical nuclear power plants

  1. Safety versus Security in the Quality Calculus

    DEFF Research Database (Denmark)

    Nielson, Hanne Riis; Nielson, Flemming

    2013-01-01

    Safety and security are both needed for ensuring that cyber-physical systems live up to expectations, but often an intelligent trade-off is called for, because sometimes it is impossible to obtain optimal safety at the same time as optimal security. In the context of the Quality Calculus we develop...... a type system for checking the extent to which safety and security goals have been met. Safety goals include showing that certain error configurations are in fact not reachable and hence do not require intelligent error handling. Security goals include showing that highly trusted communications can only...... of the implicit flow). This is illustrated on a worked example taken from the automotive sector and we conclude with a discussion of the theoretical properties of the type system....

  2. [Safety and efficacy of ketamine for pain relief].

    Science.gov (United States)

    Niesters, Marieke; Dahan, Albert; van Kleef, Maarten

    2016-01-01

    Intravenous ketamine treatment is frequently used for the management of chronic pain, especially in those patients who do not benefit from other therapies. In this commentary we discuss the efficacy of ketamine for relief of chronic pain and ketamine's safety profile. A review of the literature indicates that only a few studies show that intravenous ketamine has analgesic effects that persist beyond the infusion period, an effect that occurs in about two-thirds of patients. Ketamine has multiple safety issues, ranging from psychotomimetic and schizotypal symptoms, sympathetic stimulation, tachycardia and hypertension, and damage to the liver and the urogenital tract. Damage to the urogenital tract seems to be restricted to individuals who chronically abuse ketamine. We indicate the need for large randomized trials in which ketamine is compared with an 'active' placebo.

  3. Efficacy and Safety of Remifentanil as an Alternative Labor Analgesic

    Directory of Open Access Journals (Sweden)

    Sandeep Devabhakthuni

    2013-01-01

    Full Text Available The objective of this review was to evaluate the clinical efficacy and safety of remifentanil in the management of labor pain. Although neuraxial analgesia is the best option during labor, alternative analgesic options are needed for patients with contraindications. Using a systematic literature search, clinical outcomes of remifentanil for labor pain have been summarized. Also, comparisons of remifentanil to other options including meperidine, epidural analgesia, fentanyl, and nitrous oxide are provided. Based on the literature review, remifentanil is associated with high overall maternal satisfaction and favorable side-effect profile. However, due to the low reporting of adverse events, large, randomized controlled trials are needed to evaluate maternal and neonatal safety adequately and determine the optimal dosing needed to provide effective analgesia. While remifentanil is a feasible alternative for patients who cannot or do not want to receive epidural analgesia, administration should be monitored closely for potential adverse effects.

  4. Quality assurance for software important to safety

    International Nuclear Information System (INIS)

    2000-01-01

    Software applications play an increasingly relevant role in nuclear power plant systems. This is particularly true of software important to safety used in both: calculations for the design, testing and analysis of nuclear reactor systems (design, engineering and analysis software); and monitoring, control and safety functions as an integral part of the reactor systems (monitoring, control and safety system software). Computer technology is advancing at a fast pace, offering new possibilities in nuclear reactor design, construction, commissioning, operation, maintenance and decommissioning. These advances also present new issues which must be considered both by the utility and by the regulatory organization. Refurbishment of ageing instrumentation and control systems in nuclear power plants and new safety related application areas have emerged, with direct (e.g. interfaces with safety systems) and indirect (e.g. operator intervention) implications for safety. Currently, there exist several international standards and guides on quality assurance for software important to safety. However, none of the existing documents provides comprehensive guidance to the developer, manager and regulator during all phases of the software life-cycle. The present publication was developed taking into account the large amount of available documentation, the rapid development of software systems and the need for updated guidance on h ow to do it . It provides information and guidance for defining and implementing quality assurance programmes covering the entire life-cycle of software important to safety. Expected users are managers, performers and assessors from nuclear utilities, regulatory bodies, suppliers and technical support organizations involved with the development and use of software applied in nuclear power plants

  5. Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

    Science.gov (United States)

    Adams, David Z; Gruss, Richard; Abrahams, Alan S

    2017-04-01

    Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents

    DEFF Research Database (Denmark)

    Halken, Susanne; Agertoft, Lone; Seidenberg, Jürgen

    2010-01-01

    The efficacy and safety of five-grass pollen 300IR sublingual immunotherapy (SLIT) tablets (Stallergènes SA, France) have previously been demonstrated in paediatric patients. This report presents additional data concerning efficacy at pollen peak, efficacy and safety according to age, nasal and o...

  7. The SIESTA Trial: A Randomized Study Investigating the Efficacy, Safety, and Tolerability of Acupressure versus Sham Therapy for Improving Sleep Quality in Patients with End-Stage Kidney Disease on Hemodialysis

    Directory of Open Access Journals (Sweden)

    Kunyu Shen

    2017-01-01

    Full Text Available Objectives. To compare the effectiveness of real acupressure versus sham acupressure therapy in improving sleep quality in patients receiving hemodialysis (HD or hemodiafiltration (HDF. Methods. A multicenter, single-blind, randomized controlled trial was conducted in two Australian dialysis units located in Princess Alexandra Hospital and Logan Hospital, respectively. Forty-two subjects with self-reported poor sleep quality were randomly assigned to real (n=21 or sham (n=21 acupressure therapy delivered thrice weekly for four consecutive weeks during routine dialysis sessions. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI score measured at week four adjusted for baseline PSQI measurements. Secondary outcomes were quality of life (QOL (SF-8, adverse events, and patient acceptability (treatment acceptability questionnaire, TAQ. Results. The two groups were comparable on global PSQI scores (difference 0.19, 95% confidence interval [CI] −1.32 to 1.70 and on the subscale scores. Similar results were observed for QOL both in the mental (difference −3.88, 95% CI −8.63 to 0.87 and the physical scores (difference 2.45, 95% CI −1.69 to 6.58. There were no treatment-related adverse events and acupressure was perceived favorably by participants. Conclusion. Acupressure is a safe, well-tolerated, and highly acceptable therapy in adult hemodialysis patients in a Western healthcare setting with uncertain implications for therapeutic efficacy.

  8. Efficacy and safety of adalimumab in ankylosing spondylitis

    Directory of Open Access Journals (Sweden)

    Mounach A

    2014-08-01

    Full Text Available Aziza Mounach, Abdellah El MaghraouiRheumatology Department, Military Hospital Mohammed V, Rabat, MoroccoAbstract: Ankylosing spondylitis (AS is the most common and most severe subtype of spondyloarthritis. It also may be an outcome of any of the other spondyloarthritis subtypes. AS preferentially affects the sacroiliac joints and the tip of the column, with a tendency to later ankylosis. Peripheral joints, enthesis, and other extra-articular involvement may be observed. Tumor necrosis factor (TNF inhibitors are now well-established, effective drugs in the treatment of AS symptoms. Adalimumab, which is a fully human monoclonal antibody that binds to and neutralizes TNF, has demonstrated efficacy in treating AS symptoms, including axial involvement, peripheral arthritis, enthesitis, uveitis, gut involvement, and psoriasis. Furthermore, adalimumab has showed an overall acceptable safety profile. In this paper, we review the efficacy and safety profile of adalimumab in the treatment of AS, and discuss its differences from the other anti-TNF drugs reported in the literature.Keywords: ankylosing spondylitis, spondyloarthritis, adalimumab, tumor necrosis factor-α

  9. Animal models for microbicide safety and efficacy testing.

    Science.gov (United States)

    Veazey, Ronald S

    2013-07-01

    Early studies have cast doubt on the utility of animal models for predicting success or failure of HIV-prevention strategies, but results of multiple human phase 3 microbicide trials, and interrogations into the discrepancies between human and animal model trials, indicate that animal models were, and are, predictive of safety and efficacy of microbicide candidates. Recent studies have shown that topically applied vaginal gels, and oral prophylaxis using single or combination antiretrovirals are indeed effective in preventing sexual HIV transmission in humans, and all of these successes were predicted in animal models. Further, prior discrepancies between animal and human results are finally being deciphered as inadequacies in study design in the model, or quite often, noncompliance in human trials, the latter being increasingly recognized as a major problem in human microbicide trials. Successful microbicide studies in humans have validated results in animal models, and several ongoing studies are further investigating questions of tissue distribution, duration of efficacy, and continued safety with repeated application of these, and other promising microbicide candidates in both murine and nonhuman primate models. Now that we finally have positive correlations with prevention strategies and protection from HIV transmission, we can retrospectively validate animal models for their ability to predict these results, and more importantly, prospectively use these models to select and advance even safer, more effective, and importantly, more durable microbicide candidates into human trials.

  10. Efficacy and safety of febuxostat in elderly female patients

    Directory of Open Access Journals (Sweden)

    Mizuno T

    2014-09-01

    Full Text Available Tomohiro Mizuno,1,2 Takahiro Hayashi,3 Sayo Hikosaka,1 Yuka Shimabukuro,1 Maho Murase,1 Kazuo Takahashi,2 Hiroki Hayashi,2 Yukio Yuzawa,2 Tadashi Nagamatsu,1 Shigeki Yamada3 1Department of Analytical Pharmacology, Graduate School of Pharmacy, Meijo University, Nagoya, Japan; 2Department of Nephrology, School of Medicine, Fujita Health University, Toyoake, Japan; 3Department of Clinical Pharmacy, School of Medicine, Fujita Health University, Toyoake, Japan Background: Maintenance of low serum urate levels is important for the management of gout. Achieving the recommended serum urate levels of less than 6.0 mg/dL is difficult in elderly (65 years of age or older patients with renal impairment. Xanthine oxidase inhibitors allopurinol and febuxostat are used for this purpose. Although febuxostat had been shown to be efficacious in elderly patients, its safety and efficacy in elderly female patients with hyper­uricemia remain unclear.Objective: The aim of this study was to assess the efficacy and safety of febuxostat in elderly female patients.Methods: We studied a retrospective cohort study. The study included elderly Japanese patients (65 years of age or older who were treated with febuxostat at Fujita Health University Hospital from January 2012 to December 2013. The treatment goal was defined as achievement of serum urate levels of 6.0 mg/dL or lower within 16 weeks; this was the primary endpoint in the present study. Adverse events of febuxostat were defined as more than twofold increases in Common Terminology Criteria for adverse events scores from baseline. Results: We evaluated 82 patients treated with febuxostat during the observation period and classified them into male (n=53 and female (n=29 groups. The mean time to achievement of the treatment goal was significantly shorter in the female group (53 days than in the male group (71 days. There were no significant differences in adverse events between the 2 groups.Conclusion: Our

  11. Comparison of the efficacy and safety of topical clindamycin and 5% benzoyl peroxide with nadifloxacin cream and 5% benzoyl peroxide gel in the treatment of acne vulgaris and assessment of the effects of these treatments on quality of life

    Directory of Open Access Journals (Sweden)

    Aslıhan Kırkağaç

    2015-03-01

    Full Text Available Background and Design: Acne vulgaris is a multifactorial chronic inflammatory disase of the pilosebaceous unit. Topical antibiotics and anti-inflammatory treatment are used for mild and moderate acne. Clindamycin is frequently used for acne treatment, altough nadifloxacin is a relatively new agent. There are few studies evaluating nadifloxacin efficacy. It's impact on quality of life has not been determined previously. In this study, it is aimed to compare the effect of these two agents, and to evaluate the effect of these treatments on quality of life. Materials and Methods: Eighty patients with mild-moderate acne vulgaris were divided in two groups of 40 people that had no difference in terms of age, gender and acne severity. The combination of topical clindamycin and 5% benzoyl peroxide gel twice a day was given to group 1 for 12 weeks. The combination of nadifloxacin cream and 5% benzoyl peroxide gel twice a day was given to group 2 for 12 weeks. The number of the inflammatory and non-inflammatory lesions were recorded at baseline and on weeks 2, 4, 8, 12 and side effects were recorded and evaluated. Global improvement was evaluated separately by patients and doctor after the treatment. Before and after the treatment, the quality of life of the patients were evaluated with Skindex-29. Results: Both treatment group regimens were significantly effective on inflammatory and non-inflammatory lesions and were well tolerated by patients in terms of side effects. It was also observed that there was statistically significant recovery after treatment in terms of clinical severity and quality of life. There was not any statistically significant difference between two treatment methods in terms of effectiveness, side effect and quality of life. Conclusion: Nadifloxacin and 5% benzoyl peroxide combination is effective in the treatment and improvement of quality of life in acne patients.

  12. MR arthrography: pharmacology, efficacy and safety in clinical trials

    International Nuclear Information System (INIS)

    Schulte-Altedorneburg, G.; Gebhard, M.; Wohlgemuth, W.A.; Fischer, W.; Zentner, J.; Bohndorf, K.; Wegener, R.; Balzer, T.

    2003-01-01

    A meta-analysis was carried out of clinical trials published between 1987 and 2001 in respect of the clinical pharmacology and safety as well as the diagnostic efficacy of gadolinium-DTPA (Gd-DTPA) for direct intra-articular injection before MRI examination.Design. Scientific papers (clinical, postmortem and experimental studies) and information from the manufacturer regarding intra-articular injection of Gd-DTPA that addressed questions of mode of action, optimal concentration and dose, elimination and safety were reviewed. Clinical studies were classified according to their study design. The sensitivity, specificity and accuracy of MR arthrography (MRA) were compared with a ''gold standard'' (arthroscopy, arthrotomy) and other radiological evidence for different joints.Results. Fifty-two clinical studies of the overall 112 studies addressed aspects of diagnostic efficacy of MRA in patients or in healthy volunteers. The shoulder was the most assessed joint (29 of 52 studies). Good (>80%) or even excellent (90-100%) sensitivity, specificity and accuracy were found for MRA in most indications, especially for the shoulder and knee joints and induced extension of rotator cuff lesions, labrum abnormalities and postoperative meniscal tears. Two millimoles per liter has proven to be the best concentration for intra-articular administration of Gd-DTPA. After passive complete diffusion from the joint within 6-24 h, complete and rapid renal elimination takes place after intra-articular injection. Local safety proved to be excellent after intra-articular administration of Gd-DTPA. Regarding systemic tolerance almost no side effects have been reported, but the same safety considerations apply for intra-articular administration of Gd-DTPA as for intravenous injection.Conclusions. The diagnostic efficacy of intra-articular MRA in most clinical conditions affecting major joints is greater than that of plain MRI. In some diagnostic problems MRA achieves almost the same

  13. Efficacy and Safety of Human Retinal Progenitor Cells

    Science.gov (United States)

    Semo, Ma'ayan; Haamedi, Nasrin; Stevanato, Lara; Carter, David; Brooke, Gary; Young, Michael; Coffey, Peter; Sinden, John; Patel, Sara; Vugler, Anthony

    2016-01-01

    Purpose We assessed the long-term efficacy and safety of human retinal progenitor cells (hRPC) using established rodent models. Methods Efficacy of hRPC was tested initially in Royal College of Surgeons (RCS) dystrophic rats immunosuppressed with cyclosporine/dexamethasone. Due to adverse effects of dexamethasone, this drug was omitted from a subsequent dose-ranging study, where different hRPC doses were tested for their ability to preserve visual function (measured by optokinetic head tracking) and retinal structure in RCS rats at 3 to 6 months after grafting. Safety of hRPC was assessed by subretinal transplantation into wild type (WT) rats and NIH-III nude mice, with analysis at 3 to 6 and 9 months after grafting, respectively. Results The optimal dose of hRPC for preserving visual function/retinal structure in dystrophic rats was 50,000 to 100,000 cells. Human retinal progenitor cells integrated/survived in dystrophic and WT rat retina up to 6 months after grafting and expressed nestin, vimentin, GFAP, and βIII tubulin. Vision and retinal structure remained normal in WT rats injected with hRPC and there was no evidence of tumors. A comparison between dexamethasone-treated and untreated dystrophic rats at 3 months after grafting revealed an unexpected reduction in the baseline visual acuity of dexamethasone-treated animals. Conclusions Human retinal progenitor cells appear safe and efficacious in the preclinical models used here. Translational Relevance Human retinal progenitor cells could be deployed during early stages of retinal degeneration or in regions of intact retina, without adverse effects on visual function. The ability of dexamethasone to reduce baseline visual acuity in RCS dystrophic rats has important implications for the interpretation of preclinical and clinical cell transplant studies. PMID:27486556

  14. Management services, quality assurance, and safety

    International Nuclear Information System (INIS)

    Anon.

    1987-01-01

    Broad technical and administrative support for the programmatic research and development activities of the Fusion Energy Division is provided by the Management Services Section and by the division's quality assurance (QA) and safety programs. Support is provided through effective communication with division programmatic staff and through the coordination of resources from disciplines outside the division. The QA activity in the division emphasizes the development and documentation of a QA program that conforms to national standards, the review and approval of engineering documents, supplier surveillance, identification and documentation of nonconforming items, audits, and QA assessments/plans. The division's safety activities include a formal safety program, emergency planning activities, and environmental protection services. Efforts devoted to the removal of hazardous wastes from division facilities were expanded during 1986

  15. Enteral feeding pumps: efficacy, safety, and patient acceptability

    Directory of Open Access Journals (Sweden)

    White H

    2014-08-01

    Full Text Available Helen White, Linsey King Nutrition and Dietetic Group, School of Health and Wellbeing, Faculty Health and Social Science, Leeds Metropolitan University, Leeds, United Kingdom Abstract: Enteral feeding is a long established practice across pediatric and adult populations, to enhance nutritional intake and prevent malnutrition. Despite recognition of the importance of nutrition within the modern health agenda, evaluation of the efficacy of how such feeds are delivered is more limited. The accuracy, safety, and consistency with which enteral feed pump systems dispense nutritional formulae are important determinants of their use and acceptability. Enteral feed pump safety has received increased interest in recent years as enteral pumps are used across hospital and home settings. Four areas of enteral feed pump safety have emerged: the consistent and accurate delivery of formula; the minimization of errors associated with tube misconnection; the impact of continuous feed delivery itself (via an enteral feed pump; and the chemical composition of the casing used in enteral feed pump manufacture. The daily use of pumps in delivery of enteral feeds in a home setting predominantly falls to the hands of parents and caregivers. Their understanding of the use and function of their pump is necessary to ensure appropriate, safe, and accurate delivery of enteral nutrition; their experience with this is important in informing clinicians and manufacturers of the emerging needs and requirements of this diverse patient population. The review highlights current practice and areas of concern and establishes our current knowledge in this field. Keywords: nutrition, perceptions, experience

  16. Tincture of opium for treating opioid dependence: a systematic review of safety and efficacy.

    Science.gov (United States)

    Nikoo, Mohammadali; Nikoo, Nooshin; Anbardan, Sanam Javid; Amiri, Afshar; Vogel, Marc; Choi, Fiona; Sepehry, Amir Ali; Bagheri Valoojerdi, Amir Hooshang; Jang, Kerry; Schütz, Christian; Akhondzadeh, Shahin; Krausz, Michael

    2017-03-01

    Recently, there has been a growing interest in using opium tincture (OT) for treating opioid dependence in certain regions. We aimed to assess the evidence on its safety and efficacy for this indication. We searched several databases (CENTRAL, Medline, EMBASE, Web of Science, PsychINFO, ProQuest Dissertation and Theses Database, Iran Medex, clinicaltrials.gov and who.int/trialsearch) with no language or publication date limitations. Two reviewers selected randomized controlled trials (RCT), cohort/case-control/cross-sectional studies and case-series on safety or efficacy of OT for treating opioid dependence and then extracted reported measures of mentioned outcomes from selected studies. We used the Effective Public Health Practice Project (EPHPP) Quality Assessment tool for appraisal. From nine selected studies; in three RCTs and one cohort analytical analysis on detoxification, 110 patients were treated with 15-140 morphine equivalents/day (mEq/d) of OT; in four prospective and one retrospective uncontrolled case-series on long-term/maintenance treatment, 570 patients were treated with 100-400 mEq/d of OT. Only two studies on detoxification included a comparison: one concluded equal efficacy of OT and methadone in suppressing withdrawal symptoms (P = 0.32) and the other concluded OT to be less efficacious than buprenorphine/naloxone in suppressing withdrawal [OT = 12.20, 95% confidence interval (CI) = 11.00, 13.40]; control: 5.20 (95% CI = 4.69, 5.71) and craving (OT = 303.0, 95% CI = -144.664, 750.664; control: 0.0) but not significantly different (P = 0.26) in retaining participants in treatment. No major adverse events were reported. Conclusive recommendations about the safety and efficacy of opium tincture for treating opioid dependence are not possible at this time. © 2016 Society for the Study of Addiction.

  17. Circles of quality in radiological safety

    International Nuclear Information System (INIS)

    Gonzalez F, J.A.

    1991-01-01

    The concept of Circles of quality arose in Japan like an option to capitalize the enormous potential that the workers had developed as a result of its training in the statistical tools of quality. There are presented a series of steps that could be given with the purpose of implementing a program of ALARA circles. The radiological safety is in it finishes instance responsibility of each hard-working one and there won't be a protection program that can work among apathetic people, it is in this sense where the ALARA circles can provide its maximum contribution creating a conscience of responsibility and participation

  18. Differentiated Evaluation of Extract-Specific Evidence on Cimicifuga racemosa's Efficacy and Safety for Climacteric Complaints.

    Science.gov (United States)

    Beer, A-M; Neff, A

    2013-01-01

    Past reviews on Cimicifuga racemosa (CR) without differentiation between extracts, quality, and indication altogether led to inconsistent data. Therefore, for the first time, we meet the requirements of the system's logic of evidence-based phytotherapy by taking into consideration extracts, pharmaceutical quality (reflected in a regulatory status as medicinal product), and indication. A literature search for clinical studies examining CR's efficacy and safety for menopausal complaints was conducted. The results were sorted by type of extract, regulatory status, and indication. Accordingly, Oxford Levels of Evidence (LOE) and Grades of Recommendation (GR) were determined. CR extracts demonstrated a good to very good safety in general, on estrogen-sensitive organs and the liver. However, only registered CR medicinal products were able to prove their efficacy. Best evidence was provided by the isopropanolic CR extract (iCR): the multitude of studies including more than 11,000 patients demonstrated consistent confirmatory evidence of LOE 1b (LOE 1a for safety) leading to GR A. The studies on the ethanolic extract BNO 1055 including more than 500 patients showed exploratory evidence of LOE 2b resulting in GR B. A positive benefit-risk profile is stated and limited to Cimicifuga racemosa products holding a marketing authorisation for treating climacteric complaints.

  19. Efficacy and safety of intravenous fentanyl administered by ambulance personnel

    DEFF Research Database (Denmark)

    Friesgaard, Kristian Dahl; Nikolajsen, Lone; Giebner, Matthias

    2016-01-01

    BACKGROUND: Management of pain in the pre-hospital setting is often inadequate. In 2011, ambulance personnel were authorized to administer intravenous fentanyl in the Central Denmark Region. The aim of this study was to evaluate the efficacy and safety of intravenous fentanyl administered...... by ambulance personnel. METHODS: Pre-hospital medical charts from 2348 adults treated with intravenous fentanyl by ambulance personnel during a 6-month period were reviewed. The primary outcome was the change in pain intensity on a numeric rating scale (NRS) from before fentanyl treatment to hospital arrival...... patients (1.3%) and hypotension observed in 71 patients (3.0%). CONCLUSION: Intravenous fentanyl caused clinically meaningful pain reduction in most patients and was safe in the hands of ambulance personnel. Many patients had moderate to severe pain at hospital arrival. As the protocol allowed higher doses...

  20. Bitter melon (Momordica charantia): a review of efficacy and safety.

    Science.gov (United States)

    Basch, Ethan; Gabardi, Steven; Ulbricht, Catherine

    2003-02-15

    The pharmacology, clinical efficacy, adverse effects, drug interactions, and place in therapy of bitter melon are described. Bitter melon (Momordica charantia) is an alternative therapy that has primarily been used for lowering blood glucose levels in patients with diabetes mellitus. Components of bitter melon extract appear to have structural similarities to animal insulin. Antiviral and antineoplastic activities have also been reported in vitro. Four clinical trials found bitter melon juice, fruit, and dried powder to have a moderate hypoglycemic effect. These studies were small and were not randomized or double-blind, however. Reported adverse effects of bitter melon include hypoglycemic coma and convulsions in children, reduced fertility in mice, a favism-like syndrome, increases in gamma-glutamyltransferase and alkaline phosphatase levels in animals, and headaches. Bitter melon may have additive effects when taken with other glucose-lowering agents. Adequately powered, randomized, placebo-controlled trials are needed to properly assess safety and efficacy before bitter melon can be routinely recommended. Bitter melon may have hypoglycemic effects, but data are not sufficient to recommend its use in the absence of careful supervision and monitoring.

  1. Efficacy and safety of methimazole ointment for patients with hyperthyroidism.

    Science.gov (United States)

    Wu, Xi; Liu, Hong; Zhu, Xixing; Shen, Jun; Shi, Yongquan; Liu, Zhimin; Gu, Mingjun; Song, Zhimin

    2013-11-01

    Oral methimazole has been widely used to treat hyperthyroidism, but its usage is restricted by its adverse systemic effects. The aim of this study was to investigate the efficacy and safety of methimazole ointment for the treatment of hyperthyroidism. One hundred forty-four subjects with hyperthyroidism were initially enrolled. These patients were initially divided into two groups and given the following treatments for 12 weeks: patients in group A received 5% methimazole ointment applied to the skin around the thyroid and an oral placebo; and patients in group B received methimazole tablets and placebo ointment. One hundred thirty-one subjects were included in the final analysis. Therapeutic efficacy was assessed via the levels of free triiodothyronine and thyroxine in the serum and by biweekly monitoring of the symptoms of thyrotoxicosis. Adverse effects were recorded. Fifty-nine (89.40%) patients in group A and 57 (87.69%) patients in group B were euthyroid and experienced alleviation of thyrotoxicosis symptoms (complete control; p>0.05). The median times required to achieve complete control for the patients in the two groups were 6.5 weeks and 6.4 weeks for groups A and B, respectively (p>0.05). Systemic adverse effects (e.g., rash, liver dysfunction, leucopenia, etc.) were significantly less common in group A (1.5%) than in group B (12.3%; peffects in patients with hyperthyroidism. Copyright © 2013 Elsevier B.V. All rights reserved.

  2. A review on safety and efficacy of products containing Longifolia

    Directory of Open Access Journals (Sweden)

    Abdul Hafeez Ahmad Hamdi

    2016-01-01

    Full Text Available Eurycoma longifolia (commonly called tongkat ali is a flowering plant in the family Simaroubaceae, native to Indonesia, Malaysia, and, to a lesser extent, Thailand, Vietnam and also Laos. The roots extract of E. longifolia, is a well-known traditional herbal medicine in Asia used for many purposes such as sexual dysfunction, aging, malaria, cancer, diabetes, anxiety, aches, constipation, exercise recovery, fever, increased energy, increased strength, leukemia, osteoporosis, stress, syphilis and glandular swelling. The roots are also used as an aphrodisiac, antibiotic, appetite stimulant and health supplement. It is very important to conserve this valuable medicinal plant for the health benefit of future generations. The purpose of this review article is to evaluate and summarize the existing literatures regarding the efficacy and safety of products which contain E. longifolia as its main ingredient. In summary, based on the literature evaluated in this review article, products which contain tongkat ali showed a clinical benefit on improving erectile dysfunction as well as a good safety profile. We recommend consumers to check the level of the bioactive compound “eurycomanone” as their guide before choosing any E. longifolia product.

  3. Review of key Belotero Balance safety and efficacy trials.

    Science.gov (United States)

    Lorenc, Z Paul; Fagien, Steven; Flynn, Timothy C; Waldorf, Heidi A

    2013-10-01

    Belotero Balance is a novel highly cross-linked hyaluronic acid that uses cohesive polydensified matrix technology to achieve cohesive gel; improved adaptation by the dermis; and a soft, smooth fill. Several studies have now compared Belotero Balance to bovine collagen and other hyaluronic acids. Two pivotal studies demonstrated the noninferiority and superiority of Belotero Balance to bovine collagen. In the first study, more than half of the patients maintained optimal correction at 6 months on the Belotero-treated side of the face. The second of those two studies followed patients to week 96 and demonstrated that the effects of Belotero Balance in this long-term, open-label study persisted in the majority of subjects without repeated treatment for at least one interval of 48 weeks. The filler was well tolerated, with only one of 34 total adverse events (injection-site bruising) considered to be related to the study device. A third study compared the safety and efficacy of other hyaluronic acids (i.e., Juvéderm and Restylane) with Belotero Balance. In this study, the safety profiles of all three hyaluronic acids were generally favorable, with site-specific adverse events mild to moderate and comparable across each hyaluronic acid. Aesthetic results were also similar, although Belotero Balance resulted in greater evenness than Restylane at 4 weeks by one indicator used in the study. Finally, a 5-year retrospective safety review of 317 patients treated with Belotero Balance over a 5-year period revealed no severe adverse events in any patients, including the absence of persistent nodules or granulomas.

  4. IOT for Agriculture: Food Quality and Safety

    Science.gov (United States)

    Witjaksono, Gunawan; Abdelkreem Saeed Rabih, Almur; Yahya, Noorhana bt; Alva, Sagir

    2018-03-01

    Food is the main energy source for the living beings; as such food quality and safety have been in the highest demand throughout the human history. Internet of things (IOT) is a technology with a vision to connect anything at anytime and anywhere. Utilizing IOT in the food supply chain (FSC) is believed to enhance the quality of life by tracing and tracking the food conditions and live-sharing the obtained data with the consumers or the FSC supervisors. Currently, full application of IOT in the FSC is still in the developing stage and there is a big gap for improvements. The purpose of this paper is to explore the possibility of applying IOT for agriculture to trace and track food quality and safety. Mobile application for food freshness investigation was successfully developed and the results showed that consumer mobile camera could be used to test the freshness of food. By applying the IOT technology this information could be shared with all the consumers and also the supervisors.

  5. Safety and efficacy of pharmacologic thromboprophylaxis following blunt head injury: a systematic review.

    Science.gov (United States)

    Reeves, Fairleigh; Batty, Lachlan; Pitt, Veronica; Chau, Marisa; Pattuwage, Loyal; Gruen, Russell L

    2013-10-01

    Patients with blunt head injury are at high risk of venous thromboembolism. However, pharmacologic thromboprophylaxis (PTP) may cause progression of intracranial hemorrhage, and clinicians must often weigh up the risks and benefits. This review aimed to determine whether adding PTP to mechanical prophylaxis confers net benefit or harm and the optimal timing, dose, and agent for PTP in patients with blunt head injury. We searched MEDLINE, EMBASE, The Cochrane Library Central Register of Controlled Trials (CENTRAL), and www.clinicaltrials.gov on April 24, 2013, to identify controlled studies and ongoing trials that assessed the efficacy or safety of thromboprophylaxis interventions in the early management of head-injured patients. Studies were classified based on types of interventions and comparisons, and the quality of included studies was assessed using Cochrane risk-of-bias tool and the Newcastle-Ottawa Quality Assessment Scale. We intended to undertake a meta-analysis if studies were sufficiently similar. Sixteen studies met the inclusion criteria, including four randomized controlled trials. At least two randomized controlled trials were at high risk of bias owing to inadequate randomization and concealment of allocation, and observational studies were potentially confounded by substantial differences between comparison groups. Heterogeneity of included studies precluded meta-analysis. Results were mixed, with some studies supporting and others refuting addition of PTP to mechanical interventions. Little evidence was available about dose or choice of agent. The safety and efficacy of early PTP in patients without early progression of hemorrhage is unclear. There is currently insufficient evidence to guide thromboprophylaxis in patients with blunt head injury. Standardized definitions and outcome measurements would facilitate comparison of outcomes across future studies. Studies in mixed populations should report head-injured specific subgroup data. Future

  6. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    Science.gov (United States)

    Vlachojannis, Christian

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  7. Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy.

    Science.gov (United States)

    Polydefkis, Michael; Arezzo, Joseph; Nash, Marshall; Bril, Vera; Shaibani, Aziz; Gordon, Robert J; Bradshaw, Kate L; Junor, Roderick W J

    2015-12-01

    We examined the efficacy and safety of ranirestat in patients with diabetic sensorimotor polyneuropathy (DSPN). Patients (18-75 years) with stable type 1/2 diabetes mellitus and DSPN were eligible for this global, double-blind, phase II/III study (ClinicalTrials.gov NCT00927914). Patients (n = 800) were randomized 1 : 1 : 1 to placebo, ranirestat 40 mg/day or 80 mg/day (265 : 264 : 271). Change in peroneal motor nerve conduction velocity (PMNCV) from baseline to 24 months was the primary endpoint with a goal improvement vs. placebo ≥1.2 m/s. Other endpoints included symptoms, quality-of-life, and safety. Six hundred thirty-three patients completed the study. The PMNCV difference from placebo was significant at 6, 12, and 18 months in both ranirestat groups, but diabetes. © 2015 Peripheral Nerve Society.

  8. Long-term efficacy and safety of tacalcitol ointment in patients with chronic plaque psoriasis.

    NARCIS (Netherlands)

    Kerkhof, P.C.M. van de; Berth-Jones, J.; Griffiths, C.E.; Harrison, P.V.; Honigsmann, H.; Marks, R.; Roelandts, R.; Schopf, E.; Trompke, C.

    2002-01-01

    BACKGROUND: As psoriasis patients often require continuous treatment optimal therapy has to provide efficacy and a good safety profile over the long term. OBJECTIVES: The aim of this multicentre study was to assess the efficacy, safety and tolerability of tacalcitol (4 microg g(-1)) ointment

  9. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis

    DEFF Research Database (Denmark)

    Wahn, Ulrich; Tabar, Ana; Kuna, Piotr

    2009-01-01

    BACKGROUND: The efficacy and safety of the 300-index of reactivity (IR) dose of 5-grass-pollen sublingual immunotherapy (SLIT) tablets (Stallergènes, Antony, France) have been demonstrated for the treatment of hay fever in adults. OBJECTIVE: We sought to assess the efficacy and safety of this tab...

  10. Efficacy and safety of pregabalin in generalised anxiety disorder : A critical review of the literature

    NARCIS (Netherlands)

    Baldwin, David S.; den Boer, Johan A.; Lyndon, Gavin; Emir, Birol; Schweizer, Edward; Haswell, Hannah

    2015-01-01

    The aim of this review is to summarise the literature on the efficacy and safety of pregabalin for the treatment of generalised anxiety disorder (GAD). Of 241 literature citations, 13 clinical trials were identified that were specifically designed to evaluate the efficacy and safety of pregabalin in

  11. Tranexamic Acid in Total Joint Arthroplasty: Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Rasouli

    2015-01-01

    relatively rare, the majority of studies that evaluated the efficacy of TA are underpowered for evaluation of its safety. In a recent study by Poeran et al. using a large national database including 872,416 patients who had total hip or knee arthroplasty, the authors suggested that TA is effective in reducing the need for blood transfusions while not increasing the risk of VTE and renal complications (8. However, it is still advised that patients with cardiac stents and previous thromboembolic events including ischemic stroke not be administered TA. TA can also cause gastrointestinal disturbance and its dose needs to be adjusted in patients with renal impairment (5.   In conclusion, administration of TA in TJA patient is a cost-effective blood conservation strategy and there is strong evidence to support the efficacy and safety of the drug in reducing blood loss and transfusion in TJA patients. Given the adverse effects of allogeneic blood transfusion on the outcome of TJA, administration of TA should be considered in patients with no contraindication for its use.

  12. Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI.

    Science.gov (United States)

    Giustino, Gennaro; Chieffo, Alaide; Palmerini, Tullio; Valgimigli, Marco; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A; Hong, Myeong-Ki; Kim, Byeong-Keuk; Jang, Yangsoo; Kim, Hyo-Soo; Park, Kyung Woo; Gilard, Martine; Morice, Marie-Claude; Sawaya, Fadi; Sardella, Gennaro; Genereux, Philippe; Redfors, Bjorn; Leon, Martin B; Bhatt, Deepak L; Stone, Gregg W; Colombo, Antonio

    2016-10-25

    Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p interaction  = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p interaction  = 0.96). Results were consistent by per-treatment landmark analysis. Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT. Copyright © 2016 American College

  13. Efficacy and safety of a polyherbal formulation in hemorrhoids

    Directory of Open Access Journals (Sweden)

    Raakhi K Tripathi

    2015-01-01

    Full Text Available Background: The medical management of hemorrhoids should include an integrated approach. This integrated approach can be achieved by polyherbal formulations containing anti-inflammatory, styptics, analgesics, and laxative effect which reduce inflammation, pain, and bleeding, and increase gastro-intestinal motility and soften stools. One such polyherbal kit is "Arshkeyt™, a 7 day kit," which consists of oral tablets and powder along with topical cream. Objective: Efficacy and safety of Arshkeyt™, a 7 day kit, a marketed polyherbal formulation was evaluated in comparison with conventional therapy practiced in surgery outpatient departments. Materials and Methods: Patients (n = 90 with hemorrhoids were randomly allocated to receive either Arshkeyt™ or standard therapy (combination of oral Isabgul powder and 2% lidocaine gel for 14 days. Assessment on the basis of rectal symptoms and proctoscopic examination was done on day 0, 7, and 14 to derive a "composite score" which ranged from 0 to 25 by a blinded evaluator. The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14. Inter-group analysis was done using Chi-square test. Results: On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy. The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score score (P = 0.047, anal sphincter spasm (P = 0.0495 and a decrease in the grade of hemorrhoids (P = 0.0205 on day 14. Arshkeyt™ was also more beneficial in case of bleeding hemorrhoids as compared to nonbleeding hemorrhoids (P < 0.05. The incidence of adverse drug reactions in both groups was comparable and no patient required any treatment for the same. Conclusion: "Arshkeyt™, a 7 day kit," was effective in the treatment of hemorrhoids and had a good safety profile.

  14. Efficacy and Safety of Ethanol Ablation for Branchial Cleft Cysts.

    Science.gov (United States)

    Ha, E J; Baek, S M; Baek, J H; Shin, S Y; Han, M; Kim, C-H

    2017-12-01

    Branchial cleft cyst is a common congenital lesion of the neck. This study evaluated the efficacy and safety of ethanol ablation as an alternative treatment to surgery for branchial cleft cyst. Between September 2006 and October 2016, ethanol ablation was performed in 22 patients who refused an operation for a second branchial cleft cyst. After the exclusion of 2 patients who were lost to follow-up, the data of 20 patients were retrospectively evaluated. All index masses were confirmed as benign before treatment. Sonography-guided aspiration of the cystic fluid was followed by injection of absolute ethanol (99%) into the lesion. The injected volume of ethanol was 50%-80% of the volume of fluid aspirated. Therapeutic outcome, including the volume reduction ratio, therapeutic success rate (volume reduction ratio of >50% and/or no palpable mass), and complications, was evaluated. The mean index volume of the cysts was 26.4 ± 15.7 mL (range, 3.8-49.9 mL). After ablation, the mean volume of the cysts decreased to 1.2 ± 1.1 mL (range, 0.0-3.5 mL). The mean volume reduction ratio at last follow-up was 93.9% ± 7.9% (range, 75.5%-100.0%; P branchial cleft cysts who refuse, or are ineligible for, an operation. © 2017 by American Journal of Neuroradiology.

  15. Potential benefit of dolutegravir once daily: efficacy and safety

    Directory of Open Access Journals (Sweden)

    Fantauzzi A

    2013-02-01

    Full Text Available Alessandra Fantauzzi,1 Ombretta Turriziani,2 Ivano Mezzaroma11Department of Clinical Medicine, 2Department of Molecular Medicine, Sapienza, University of Rome, Rome, ItalyAbstract: The viral integrase enzyme has recently emerged as a primary alternative target to block HIV-1 replication, and integrase inhibitors are considered a pivotal new class of antiretroviral drugs. Dolutegravir is an investigational next-generation integrase inhibitor showing some novel and intriguing characteristics, ie, it has a favorable pharmacokinetic profile with a prolonged intracellular half-life, rendering feasible once-daily dosing without the need for ritonavir boosting and without regard to meals. Moreover, dolutegravir is primarily metabolized via uridine diphosphate glucuronosyltranferase 1A1, with a minor component of the cytochrome P450 3A4 isoform, thereby limiting drug–drug interactions. Furthermore, its metabolic profile enables coadministration with most of the other available antiretroviral agents without dose adjustment. Recent findings also demonstrate that dolutegravir has significant activity against HIV-1 isolates with resistance mutations associated with raltegravir and/or elvitegravir. The attributes of once-daily administration and the potential to treat integrase inhibitor-resistant viruses make dolutegravir an interesting and promising investigational drug. In this review, the main concerns about the efficacy and safety of dolutegravir as well as its resistance profile are explored by analysis of currently available data from preclinical and clinical studies.Keywords: antiretroviral drugs, HIV-1 integrase, integrase inhibitors, dolutegravir, once daily

  16. Ibuprofen versus steroids: risk and benefit, efficacy and safety

    Directory of Open Access Journals (Sweden)

    M. Giovannini

    2013-10-01

    Full Text Available In the last few years we have observed an upward trend in the employment of ibuprofen as anti-inflammatory and antipyretic therapy. Therefore the pediatrician has often a precious option in the anti-inflammatory and antipyretic treatment in children instead of using steroids and paracetamol. In clinical practice ibuprofen can be used in the treatment of headache, toothache, otalgy, dysmenorrhea, neuralgia, arthralgia, myalgia, abdominal pain and fever: it is the first choice for these common diseases. However, the use of steroids is a routine, even if non-corticosteroid anti-inflammatory molecules could be useful. Certainly steroids are powerful anti-inflammatory, indicated for the treatment of chronic inflammatory disorders and in acute respiratory and allergic diseases. Beside, thanks to their chemical and pharmacological profile, they also provide patients with an antipyretic effect. However, the use of steroids must be reserved to cases in which other classical antipyretics such as non-steroidal anti-inflammatory drugs are not effective. The possible side effects and risks associated with stepping down steroids must be considered. Although “steroids-phobia” should be discouraged, steroids are to be reserved only as the first indication. In all other cases the pediatrician can use ibuprofen, whose efficacy and safety are widely demonstrated by now.

  17. Pharmacovigilance: Boon for the safety and efficacy of Ayuvedic formulations

    Science.gov (United States)

    Chaudhary, Anand; Singh, Neetu; Kumar, Neeraj

    2010-01-01

    Pharmacovigilance is a corrective process originating in pharmaco-epidemiology. The 1997 Erice Declaration, presented at the World Health Organisation, became the basis on which the concept was implemented internationally for conventional systems of medicine. The increasing international acceptance of Ayurveda, led regulators to implement a similar program for Ayurveda, particularly as some medical professionals, scientists and members of the public reported adverse reactions after taking Ayurvedic formulations. The World Health Organisation therefore persuaded the Department of AYUSH, Ministry of Health and Family Welfare, Government of India, to implement a pharmacovigilance program for Ayurveda, as a means to ensuring the safety and efficacy of Ayurvedic medicines. After a year of due diligence, the pharmacovigilance program was launched nationally on 29 September 2008. Since that time, Ayurveda, Siddha and Unani medicines have been monitored according to the provisions of a protocol prepared by the National Pharmacovigilance Resource Centre, IPGTRA, Jamnagar, and approved by Department of AYUSH. The program was reviewed, first, on 21st January 2009 by the National Pharmaco-vigilance Consultative Committee for ASU drugs (NPCC-ASU), and again, on 15 Feburary, 2010, when an evaluation meeting effectively rubber stamped the program. Among the outcomes of these meetings were several suggestions of measures to improve the program’s efficiency. Recent developments include the constitution of pharmacovigilance centers at all Ayurveda Teaching institutes and research centers. PMID:21731371

  18. Efficacy and safety of a transdermal contraceptive system.

    Science.gov (United States)

    Smallwood, G H; Meador, M L; Lenihan, J P; Shangold, G A; Fisher, A C; Creasy, G W

    2001-11-01

    To evaluate the efficacy, cycle control, compliance, and safety of a transdermal contraceptive system that delivers norelgestromin 150 microg and ethinyl estradiol 20 microg daily. In this open-label, 73-center study, 1672 healthy, ovulatory, sexually active women received ORTHO EVRA/EVRA for six (n = 1171) or 13 cycles (n = 501). The treatment regimen for each cycle was three consecutive 7-day patches (21 days) followed by 1 patch-free week. The overall and method-failure probabilities of pregnancy through 13 cycles were 0.7% and 0.4%, respectively. The incidence of breakthrough bleeding was low throughout the study. Perfect compliance (21 consecutive days of dosing, followed by a 7-day drug-free interval; no patch could be worn for more than 7 days) was achieved in 90% of subject cycles; only 1.9% of patches detached completely. Adverse events were typical of hormonal contraception, and most were mild-to-moderate in severity and not treatment limiting. The most common adverse events resulting in discontinuation were application site reactions (1.9%), nausea (1.8%), emotional lability (1.5%), headache (1.1%), and breast discomfort (1.0%). The transdermal contraceptive patch provides effective contraception and cycle control, and is well tolerated. The weekly change schedule for the contraceptive patch is associated with excellent compliance and wearability characteristics.

  19. Safety and Efficacy of Warfarin Therapy in Kawasaki Disease.

    Science.gov (United States)

    Baker, Annette L; Vanderpluym, Christina; Gauvreau, Kimberly A; Fulton, David R; de Ferranti, Sarah D; Friedman, Kevin G; Murray, Jenna M; Brown, Loren D; Almond, Christopher S; Evans-Langhorst, Margaret; Newburger, Jane W

    2017-10-01

    To describe the safety and efficacy of warfarin for patients with Kawasaki disease and giant coronary artery aneurysms (CAAs, ≥8 mm). Giant aneurysms are managed with combined anticoagulation and antiplatelet therapies, heightening risk of bleeding complications. We reviewed the time in therapeutic range; percentage of international normalization ratios (INRs) in range (%); bleeding events, clotting events; INRs ≥6; INRs ≥5 and warfarin therapy was 7.2 years (2.3-13.3 years). Goal INR was 2.0-3.0 (n = 6) or 2.5-3.5 (n = 3), based on CAA size and history of CAA thrombosis. All patients were treated with aspirin; 1 was on dual antiplatelet therapy and warfarin. The median time in therapeutic range was 59% (37%-85%), and median percentage of INRs in range was 68% (52%-87%). INR >6 occurred in 3 patients (4 events); INRs ≥5 warfarin and aspirin, with INRs in range only two-thirds of the time. Future studies should evaluate the use of direct oral anticoagulants in children as an alternative to warfarin. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Pharmacotherapy of Insomnia with Ramelteon: Safety, Efficacy and Clinical Applications

    Directory of Open Access Journals (Sweden)

    Seithikurippu R. Pandi-Perumal

    2011-01-01

    Full Text Available Ramelteon is a tricyclic synthetic analog of melatonin that acts specifically on MT 1 and MT 2 melatonin receptors. Ramelteon is the first melatonin receptor agonist approved by the Food and Drug Administration (FDA for the treatment of insomnia characterized by sleep onset difficulties. Ramelteon is both a chronobiotic and a hypnotic that has been shown to promote sleep initiation and maintenance in various preclinical and in clinical trials. The efficacy and safety of ramelteon in patients with chronic insomnia was initially confirmed in short-term placebo-controlled trials. These showed little evidence of next-day residual effects, withdrawal symptoms or rebound insomnia. Other studies indicated that ramelteon lacked abuse potential and had a minimal risk of producing dependence or adverse effects on cognitive or psychomotor performance. A 6-month placebo-controlled international study and a 1-year open-label study in the USA demonstrated that ramelteon was effective and well tolerated. Other potential off-label uses of ramelteon include circadian rhythm sleep disorders such as shift-work and jet lag. At the present time the drug should be cautiously prescribed for short-term treatment only.

  1. Current treatment for anorexia nervosa: efficacy, safety, and adherence

    Directory of Open Access Journals (Sweden)

    Lindsay P Bodell

    2010-10-01

    Full Text Available Lindsay P Bodell, Pamela K KeelDepartment of Psychology, Florida State University, Tallahassee, FL, USAAbstract: Anorexia nervosa (AN is a serious psychiatric illness associated with significant medical and psychiatric morbidity, psychosocial impairment, increased risk of death, and chronicity. Given the severity of the disorder, the establishment of safe and effective treatments is necessary. Several treatments have been tried in AN, but few favorable results have emerged. This paper reviews randomized controlled trials in AN, and provides a synthesis of existing data regarding the efficacy, safety, and adherence associated with pharmacologic and psychological interventions. Randomized controlled trials for the treatment of AN published in peer-reviewed journals were identified by electronic and manual searches. Overall, pharmacotherapy has limited benefits in the treatment of AN, with some promising preliminary findings associated with olanzapine, an antipsychotic agent. No single psychological intervention has demonstrated clear superiority in treating adults with AN. In adolescents with AN, the evidence base is strongest for the use of family therapy over alternative individual psychotherapies. Results highlight challenges in both treating individuals with AN and in studying the effects of those treatments, and further emphasize the importance of continued efforts to develop novel interventions. Treatment trials currently underway and areas for future research are discussed.Keywords: anorexia nervosa, treatment, pharmacotherapy, psychotherapy, randomized controlled trials

  2. Rotavirus vaccines: safety, efficacy and public health impact.

    Science.gov (United States)

    Gray, J

    2011-09-01

    Rotaviruses are the cause of acute gastroenteritis, and disease is widespread amongst infants and young children throughout the world. Also, rotavirus is associated with significant mortality in developing countries with more than 500 000 children dying each year as a result of the severe dehydration associated with rotavirus disease. Efforts have been ongoing for more than 30 years to develop a safe and effective rotavirus vaccine. Currently, two vaccines, RotaRix and RotaTeq, have been licensed for use in many countries throughout the world following comprehensive safety and efficiency trials. Monitoring their effectiveness after licensure has confirmed that their incorporation into early childhood vaccination schedules can significantly prevent severe rotavirus diarrhoea, which would have resulted in hospitalizations, emergency room visits or increased diarrhoea-related mortality. Although the efficacy of both vaccines is lower at approximately 40-59% in developing countries, their use could significantly reduce the mortality associated with rotavirus disease that is concentrated in these countries. © 2011 The Association for the Publication of the Journal of Internal Medicine.

  3. Golimumab in the treatment of psoriatic arthritis: efficacy and safety

    Directory of Open Access Journals (Sweden)

    Tatiana Viktorovna Korotaeva

    2015-01-01

    Full Text Available Tumor necrosis factor-α (TNF-α holds a central position in the pathogenesis of autoimmune inflammatory diseases of the locomotor apparatus. A separate class of drugs, namely, TNF-α inhibitors, that are effective against multicomponent diseases, such as psoriatic arthritis (PsA, is now available to physicians. The paper reviews the results of clinical trials of the TNF-α inhibitor golimumab, a human TNF-α monoclonal antibody. Golimumab exerts a positive effect on all manifestations of PsA: arthritis, psoriatic skin and nail lesions, dactylitis, enthesitis, and quality of life. The drug is noted for its convenient route of administration – its standard dose is 50 mg injected subcutaneously once a month and for its low molecular immunogenicity. Recent data suggest that golimumab is an effective drug with a safety profile similar to that of the entire class of TNF-α inhibitors.

  4. Assessment of the efficacies, potencies and bacteriological qualities ...

    African Journals Online (AJOL)

    The efficacies, potencies and qualities of these antibiotics were tested against some clinical isolates which include Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pyogenes in vitro. The overall mean zones of inhibition for the test organisms ranged from 33.0 ...

  5. Efficacy and safety of CPAP in low- and middle-income countries.

    Science.gov (United States)

    Thukral, A; Sankar, M J; Chandrasekaran, A; Agarwal, R; Paul, V K

    2016-05-01

    We conducted a systematic review to evaluate the (1) feasibility and efficacy and (2) safety and cost effectiveness of continuous positive airway pressure (CPAP) therapy in low- and middle-income countries (LMIC). We searched the following electronic bibliographic databases-MEDLINE, Cochrane CENTRAL, CINAHL, EMBASE and WHOLIS-up to December 2014 and included all studies that enrolled neonates requiring CPAP therapy for any indication. We did not find any randomized trials from LMICs that have evaluated the efficacy of CPAP therapy. Pooled analysis of four observational studies showed 66% reduction in in-hospital mortality following CPAP in preterm neonates (odds ratio 0.34, 95% confidence interval (CI) 0.14 to 0.82). One study reported 50% reduction in the need for mechanical ventilation following the introduction of bubble CPAP (relative risk 0.5, 95% CI 0.37 to 0.66). The proportion of neonates who failed CPAP and required mechanical ventilation varied from 20 to 40% (eight studies). The incidence of air leaks varied from 0 to 7.2% (nine studies). One study reported a significant reduction in the cost of surfactant usage with the introduction of CPAP. Available evidence suggests that CPAP is a safe and effective mode of therapy in preterm neonates with respiratory distress in LMICs. It reduces the in-hospital mortality and the need for ventilation thereby minimizing the need for up-transfer to a referral hospital. But given the overall paucity of studies and the low quality evidence underscores the need for large high-quality studies on the safety, efficacy and cost effectiveness of CPAP therapy in these settings.

  6. Total Quality Management and the System Safety Secretary

    Science.gov (United States)

    Elliott, Suzan E.

    1993-01-01

    The system safety secretary is a valuable member of the system safety team. As downsizing occurs to meet economic constraints, the Total Quality Management (TQM) approach is frequently adopted as a formula for success and, in some cases, for survival.

  7. Investigating Change in Adolescent Self-Efficacy of Food Safety through Educational Interventions

    Science.gov (United States)

    Beavers, Amy S.; Murphy, Lindsay; Richards, Jennifer K.

    2015-01-01

    A successfully targeted intervention can influence food safety knowledge, attitudes, and behaviors, as well as encourage participants to recognize their own responsibility for safe food handling. This acknowledgement of an individual's responsibility and capacity to address food safety can be understood as self-efficacy of food safety (SEFS). This…

  8. IAEA code and safety guides on quality assurance

    International Nuclear Information System (INIS)

    Raisic, N.

    1980-01-01

    In the framework of its programme in safety standards development, the IAEA has recently published a Code of Practice on Quality Assurance for Safety in Nuclear Power Plants. The Code establishes minimum requirements for quality assurance which Member States should use in the context of their own nuclear safety requirements. A series of 10 Safety Guides which describe acceptable methods of implementing the requirements of specific sections of the Code are in preparation. (orig.)

  9. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study.

    Directory of Open Access Journals (Sweden)

    Lamberto Manzoli

    Full Text Available To evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes, directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both.Prospective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up.Direct contact and structured questionnaires by phone or via internet.Adults (30-75 years were included if they were smokers of ≥1 tobacco cigarette/day (tobacco smokers, users of any type of e-cigarettes, inhaling ≥50 puffs weekly (e-smokers, or smokers of both tobacco and e-cigarettes (dual smokers. Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence.Sustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily.We used linear and logistic regression, with region as cluster unit.Follow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%. All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19; 95% CI: 3.35-8.02, whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall.Adding e-cigarettes to tobacco smoking did not facilitate smoking cessation or reduction. If e-cigarette safety will be confirmed, however, the use of e

  10. Quality and Safety as a Core Leadership Competency.

    Science.gov (United States)

    Bleich, Michael R

    2018-05-01

    A leader's toolbox of competencies comprises knowledge, skills, and abilities in clinical care, finance, human resource management, and more. As essential as these are, a strong command of quality and safety competencies is sovereign in leading and managing, ensuring an optimal patient experience. Four core areas of quality and safety competencies are presented: systems science, knowledge workers, implementation science and big data, and quality safety tools and techniques. J Contin Educ Nurs. 2018;49(5):200-202. Copyright 2018, SLACK Incorporated.

  11. Efficacy and safety of OK-432 immunotherapy of lymphatic malformations.

    Science.gov (United States)

    Smith, Mark C; Zimmerman, M Bridget; Burke, Diane K; Bauman, Nancy M; Sato, Yutaka; Smith, Richard J H

    2009-01-01

    To determine the efficacy and safety of the immunostimulant OK-432 (Picibanil) as a treatment option in the management of children with cervicofacial lymphatic malformations. A prospective, randomized, multi-institutional phase II clinical trial at 27 U.S. academic medical centers. 182 patients with lymphatic malformations (LM) were enrolled between January 1998 and November 2004. Of the 151 patients with complete case report forms, 117 patients were randomized into immediate or delayed treatment groups; 34 patients were nonrandomized and assigned to the open-label group. Treatment consisted of a four-dose intralesional injection series of OK-432 at eight-week intervals. Patients randomized into the delayed treatment group served as observational controls for spontaneous regression. Response to therapy was measured radiographically by quantitating change in lesion size and graded as complete (90%-100%), substantial (60%-89%), intermediate (20%-59%), or none (<20%). Of 117 patients randomized with intent-to-treat, 68% demonstrated a complete or substantial response to OK-432 immunotherapy. Response data for macrocystic LM were higher, with a complete or substantial response in 94% of patients; 63% of patients with mixed macrocystic-microcystic LM responded to treatment; no patients with microcystic LM responded to treatment. Spontaneous resolution occurred in less than 2% of patients. Median follow-up of 2.9 years demonstrated a 9% recurrence rate. Major adverse effects related to therapy occurred in 11 patients. As compared to historical surgical data on LM, OK-432 immunotherapy is more effective (P < .001) and has a lower morbidity (P < .001). OK-432 immunotherapy is an effective, safe, and simple treatment option for the management of macrocystic cervicofacial LM. ClinicalTrials.gov Identifier: NCT00010452.

  12. Efficacy and safety of topical tranexamic acid in knee arthroplasty.

    Science.gov (United States)

    López-Hualda, Álvaro; Dauder-Gallego, Cristina; Ferreño-Márquez, David; Martínez-Martín, Javier

    2018-02-26

    Tranexamic acid (TXA) is commonly used to control postoperative blood loss in total knee arthroplasty. In order to avoid adverse effects associated with intravenous administration, topical use has been proposed as an alternative. Our aim was to evaluate the efficacy and safety of topical TXA in total knee arthroplasty. A total of 90 patients scheduled for unilateral total knee arthroplasty were included in a prospective randomised study. All surgeries were performed under spinal anaesthesia, tourniquet and the same postoperative protocol. Patients were allocated to one of the 3 groups according to the application of TXA: group A (n=30) 1g of topical TXA; group B (n=30) 1g of TXA intravenous and in group C or the control group (n=30) no drug was administrated. Parameters related to blood loss and drain outputs were compared between the 3 groups. The results revealed that post-operative decrease in haemoglobin level was significantly lower in group A (1.95g/dL) than group B (2.25g/dL) and group C (2.96g/dL), P<.01. Total postoperative blood loss was lower in group A (195mL) than group B (466mL) and group C (718mL), P<.01. There was no significant difference in complications and allogenic blood transfusion rate between the 3 groups. According to the results, topical application of 1g TXA significantly reduced blood loss in patients undergoing total knee arthroplasty more than intravenous or no administration of TXA. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

  13. Efficacy and safety of Saccharomyces boulardii for acute diarrhea.

    Science.gov (United States)

    Feizizadeh, Sahar; Salehi-Abargouei, Amin; Akbari, Vajihe

    2014-07-01

    The efficacy of Saccharomyces boulardii for treatment of childhood diarrhea remains unclear. Our objective was to systematically review data on the effect of S. boulardii on acute childhood diarrhea. Our data sources included Medline, Embase, CINAHL, Scopus, and The Cochrane Library up to September 2013 without language restrictions. Randomized controlled trials and non-randomized trials that evaluated effectiveness of S. boulardii for treatment of acute diarrhea in children were included. Two reviewers independently evaluated studies for eligibility and quality and extracted the data. In total, 1248 articles were identified, of which 22 met the inclusion criteria. Pooling data from trials showed that S. boulardii significantly reduced the duration of diarrhea (mean difference [MD], -19.7 hours; 95% confidence interval [CI], -26.05 to -13.34), stool frequency on day 2 (MD, -0.74; 95% CI, -1.38 to -0.10) and day 3 (MD, -1.24; 95% CI, -2.13 to -0.35), the risk for diarrhea on day 3 (risk ratio [RR], 0.41; 95% CI, 0.27 to 0.60) and day 4 (RR, 0.38; 95% CI, 0.24 to 0.59) after intervention compared with control. The studies included in this review were varied in the definition of diarrhea, the termination of diarrhea, inclusion and exclusion criteria, and their methodological quality. This review and meta-analysis show that S. boulardii is safe and has clear beneficial effects in children who have acute diarrhea. However, additional studies using head-to-head comparisons are needed to define the best dosage of S. boulardii for diarrhea with different causes. Copyright © 2014 by the American Academy of Pediatrics.

  14. Efficacy and safety of miconazole for oral candidiasis: a systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, L-W; Fu, J-Y; Hua, H; Yan, Z-M

    2016-04-01

    The objective of this study is to assess the efficacy and safety of miconazole for treating oral candidiasis. Twelve electronic databases were searched for randomized controlled trials evaluating treatments for oral candidiasis and complemented by hand searching. The clinical and mycological outcomes, as well as adverse effects, were set as the primary outcome criteria. Seventeen trials were included in this review. Most studies were considered to have a high or moderate level of bias. Miconazole was more effective than nystatin for thrush. For HIV-infected patients, there was no significant difference in the efficacy between miconazole and other antifungals. For denture wearers, microwave therapy was significantly better than miconazole. No significant difference was found in the safety evaluation between miconazole and other treatments. The relapse rate of miconazole oral gel may be lower than that of other formulations. This systematic review and meta-analysis indicated that miconazole may be an optional choice for thrush. Microwave therapy could be an effective adjunct treatment for denture stomatitis. Miconazole oral gel may be more effective than other formulations with regard to long-term results. However, future studies that are adequately powered, large-scale, and well-designed are needed to provide higher-quality evidence for the management of oral candidiasis. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Antipsychotic treatments for the elderly: efficacy and safety of aripiprazole

    Directory of Open Access Journals (Sweden)

    Izchak Kohen

    2010-03-01

    Full Text Available Izchak Kohen1, Paula E Lester2, Sum Lam31Division of Geriatric Psychiatry, Zucker-Hillside Hospital, Glen Oaks, NY, USA; 2Division of Geriatric Medicine, Winthrop University Hospital, Mineola, NY, USA; 3Division of Pharmacy and Geriatrics, St. John’s University College of Pharmacy and Allied Health Professions, Queens, NY, USAAbstract: Delusions, hallucinations and other psychotic symptoms can accompany a number of conditions in late life. As such, elderly patients are commonly prescribed antipsychotic medications for the treatment of psychosis in both acute and chronic conditions. Those conditions include schizophrenia, bipolar disorder, depression and dementia. Elderly patients are at an increased risk of adverse events from antipsychotic medications because of age-related pharmacodynamic and pharmacokinetic changes as well as polypharmacy. Drug selection should be individualized to the patient’s previous history of antipsychotic use, current medical conditions, potential drug interactions, and potential side effects of the antipsychotic. Specifically, metabolic side effects should be closely monitored in this population. This paper provides a review of aripiprazole, a newer second generation antipsychotic agent, for its use in a variety of psychiatric disorders in the elderly including schizophrenia, bipolar disorder, dementia, Parkinson’s disease and depression. We will review the pharmacokinetics and pharmacodynamics of aripiprazole as well as dosing, diagnostic indications, efficacy studies, and tolerability including its metabolic profile. We will also detail patient focused perspectives including quality of life, patient satisfaction and adherence.Keywords: aripiprazole, antipsychotics, elderly, adverse drug reaction

  16. Systematic Review on the Efficacy and Safety of Herbal Medicines for Vascular Dementia

    Directory of Open Access Journals (Sweden)

    Sui Cheung Man

    2012-01-01

    Full Text Available We present a systematic review of existing research that aims to assess the efficacy and safety of herbal medications (HM, as either monotherapy or adjunct to orthodox medications (OM, mainly comprised of cholinesterase inhibitors, for vascular dementia (VaD. We included 47 studies conducted in mainland China, each testing different HM. Of 43 HM monotherapy studies, 37 reported HM to be significantly better than OM or placebo; six reported similar efficacy between HM and OM. All four HM adjuvant studies reported significant efficacy. No major adverse events for HM were reported. Heterogeneity in diagnostic criteria, interventions and outcome measures hindered comprehensive data analysis. Studies suggested that HM can be a safe and effective treatment for VaD, either alone or in conjunction with OM. However, methodological flaws in the design of the studies limited the extent to which the results could be interpreted. Thirty most commonly used herbal constituents, including Rhizoma Chuanxiong (Chuanxiong in Chinese, Radix Polygoni Multiflori (Heshouwu in Chinese and Radix Astragali (Huangqi in Chinese. were ranked. Further multi-center trials with large sample sizes, high methodological quality and standardized HM ingredients are necessary for clinical recommendations to be made.

  17. Research on Cooperation Strategy of Enterprises’ Quality and Safety in Food Supply Chain

    Directory of Open Access Journals (Sweden)

    Jining Wang

    2015-01-01

    Full Text Available In order to prevent and control risk factors which harm the quality and safety of the food supply chain effectively and reduce the probability of food safety incidents, this paper investigated on some problems of the upstream and downstream enterprises of the food supply chain under the three different forms of cooperation based on the neoclassic economics and game theory method. These problems include the effectiveness of the quality and safety efforts, the profits, the effect of the losses that the food safety incidents caused on the quality efforts’ efficacy, and the social welfare comparison. Meanwhile, we constructed evolutionary game model to analyze the macro and micro factors that influenced the cooperation strategy and demonstrated the effect of diversity of decision-making parameters on evolution results based on numerical simulation. By the theoretical and simulation analysis, we found that (1 the quality efforts’ efficacy, the profits, the sensitivity coefficient of the quality efforts efficiency to the losses, and the social welfare without thinking about the externality all met their maximum under the full cooperation situation; (2 strengthening supervision over the source of the food supply chain can reduce the probability of food safety incidents; (3 macro and micro environment will be the important basis for companies’ decision-making on cooperation strategy in the food supply chain.

  18. Food quality and safety: Consumer perception and demand

    DEFF Research Database (Denmark)

    Grunert, Klaus G.

    2005-01-01

    choice and consumer demand, addressing questions of price perception and the validity of willingness-to-pay measurements. It is concluded that food quality and safety are central issues in today's food economics, though many research questions remain to be addressed. Udgivelsesdato: SEP 1......Research on consumer quality perception is reviewed using the Total Food Quality Model as a structuring device. The relationship between food safety and quality is addressed, and is discussed in the context of research on consumer risk perception. Quality and safety perception is linked to food...

  19. Food quality and safety: Consumer perception and demand

    DEFF Research Database (Denmark)

    Grunert, Klaus G.

    2005-01-01

    Research on consumer quality perception is reviewed using the Total Food Quality Model as a structuring device. The relationship between food safety and quality is addressed, and is discussed in the context of research on consumer risk perception. Quality and safety perception is linked to food...... choice and consumer demand, addressing questions of price perception and the validity of willingness-to-pay measurements. It is concluded that food quality and safety are central issues in today's food economics, though many research questions remain to be addressed. Udgivelsesdato: SEP 1...

  20. 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.

  1. Safety, feasibility and efficacy of a rapid ART initiation in pregnancy ...

    African Journals Online (AJOL)

    Safety, feasibility and efficacy of a rapid ART initiation in pregnancy pilot programme in Cape Town, South Africa. S Black, R Zulliger, L Myer, R Marcus, S Jeneker, R Taliep, D Pienaar, R Wood, L-G Bekker ...

  2. Efficacy, safety, and economics of bracing after spine surgery: a systematic review of the literature.

    Science.gov (United States)

    Zhu, Mary P; Tetreault, Lindsay A; Sorefan-Mangou, Fatimah; Garwood, Philip; Wilson, Jefferson R

    2018-01-31

    Bracing is often used after spinal surgery to immobilize the spine, improve fusion, and relieve pain. However, controversy exists regarding the efficacy, necessity, and safety of various bracing techniques in the postsurgical setting. In this systematic review, we aimed to compare the effectiveness, safety, and cost-effectiveness of postoperative bracing versus no postoperative bracing after spinal surgery in patients with several common operative spinal pathologies. A systematic review was carried out to compare postoperative bracing and no postoperative bracing. A systematic search was conducted of MEDLINE, Embase, and the Cochrane Collaboration Library from 1970 to May 2017, supplemented by manual searching of the reference list of relevant studies and previously published reviews. Studies were included if they compared disability, quality of life, functional impairment, radiographic outcomes, cost-effectiveness, or complications between patients treated with postoperative bracing and patients not receiving any postoperative bracing. Each article was critically appraised independently by two reviewers, and the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. Of the 858 retrieved citations, 5 studies met the inclusion criteria and were included in this review, consisting of 4 randomized controlled trials and 1 prospective cohort study. Low to moderate evidence suggests that there are no significant differences in most measures of disability, pain, quality of life, functional impairment, radiographic outcomes, and safety between groups. Isolated studies reported statistically significant and inconsistent differences between groups with respect to Neck Disability Index at 6 weeks postoperatively or Short Form-36 Physical Component Score at 1.5, 3, 6, and 12 months postoperatively. Based on limited evidence, postoperative bracing does not result in improved

  3. Diode laser cyclophotocoagulation in Indian eyes: efficacy and safety.

    Science.gov (United States)

    Singh, Kirti; Jain, Divya; Veerwal, Vikas

    2017-02-01

    Diode laser cyclophotocoagulation (DLCP) has emerged as a time-tested procedure for end-stage glaucoma with fewer complications. By means of this study, we have evaluated its wide indications, its efficacy, and safety in darkly pigmented Asian Indian eyes. Ninety-one eyes with uncontrolled glaucoma presenting to glaucoma clinic of a tertiary care center over a period of 6 years were scheduled for DLCP. The semiconductor diode laser with a G probe was used with laser energy delivered about 1.5 mm behind the surgical limbus. The extent of clock hours of laser application was determined by pretreatment intraocular pressure (IOP) and superior area was spared in cases where future filtration surgery was contemplated. The DLCP was repeated earliest at 1 month in case of non-response and a maximum of three laser procedures were performed for any patient. Ninety-one eyes of 89 patients (40 males, 49 females) were included. Common indications included secondary glaucoma (37.3 %), failed trabeculectomies (27.4 %), angle closure glaucoma (17.5 %), etc. Laser power delivered ranged from 990 to 1800 mW, (mean 1396 + 182.14 mW) with an average of 17 spots. Patients improved from pretreatment IOP of 38.18 + 8.96 mmHg (range 20.6-64) to post treatment IOP of 17.86 + 7.75 mmHg (range 10-42). Qualified success was defined as final IOP of 20 mm Hg or less on topical medications that could be achieved in 70 % eyes with one or repeat treatment. Pre op visual acuity ranged from PL+ to 6/18 showing a slight improvement to PL+ to 6/12 post op. A 58.5 % reduction of IOP was noted. No incidence of serious complications was noted during follow-up ranging from 9 months to 3 years. DLCP is an effective and safe tool to be used in Indian population for control of IOP. It can be safely used as a primary modality to bring IOP to permissible levels before trabeculectomy.

  4. Efficacy and safety of pirfenidone for idiopathic pulmonary fibrosis

    Directory of Open Access Journals (Sweden)

    Takeda Y

    2014-03-01

    many of these are mild and manageable. Clinical experience has shown that reduction in pirfenidone dose and the supportive use of gastrointestinal drugs are effective ways to manage these symptoms. Thus, pirfenidone treatment provides a means of intervention in the clinical course of IPF, and is a promising candidate for improving patient prognosis. For future development, it is important to establish the appropriate modality of treatment with pirfenidone and/or novel potential drugs. Keywords: pirfenidone, safety, efficacy, anti-fibrotic drugs

  5. Efficacy and safety of benazepril for advanced chronic renal insufficiency.

    Science.gov (United States)

    Hou, Fan Fan; Zhang, Xun; Zhang, Guo Hua; Xie, Di; Chen, Ping Yan; Zhang, Wei Ru; Jiang, Jian Ping; Liang, Min; Wang, Guo Bao; Liu, Zheng Rong; Geng, Ren Wen

    2006-01-12

    Angiotensin-converting-enzyme inhibitors provide renal protection in patients with mild-to-moderate renal insufficiency (serum creatinine level, 3.0 mg per deciliter or less). We assessed the efficacy and safety of benazepril in patients without diabetes who had advanced renal insufficiency. We enrolled 422 patients in a randomized, double-blind study. After an eight-week run-in period, 104 patients with serum creatinine levels of 1.5 to 3.0 mg per deciliter (group 1) received 20 mg of benazepril per day, whereas 224 patients with serum creatinine levels of 3.1 to 5.0 mg per deciliter (group 2) were randomly assigned to receive 20 mg of benazepril per day (112 patients) or placebo (112 patients) and then followed for a mean of 3.4 years. All patients received conventional antihypertensive therapy. The primary outcome was the composite of a doubling of the serum creatinine level, end-stage renal disease, or death. Secondary end points included changes in the level of proteinuria and the rate of progression of renal disease. Of 102 patients in group 1, 22 (22 percent) reached the primary end point, as compared with 44 of 108 patients given benazepril in group 2 (41 percent) and 65 of 107 patients given placebo in group 2 (60 percent). As compared with placebo, benazepril was associated with a 43 percent reduction in the risk of the primary end point in group 2 (P=0.005). This benefit did not appear to be attributable to blood-pressure control. Benazepril therapy was associated with a 52 percent reduction in the level of proteinuria and a reduction of 23 percent in the rate of decline in renal function. The overall incidence of major adverse events in the benazepril and placebo subgroups of group 2 was similar. Benazepril conferred substantial renal benefits in patients without diabetes who had advanced renal insufficiency. (ClinicalTrials.gov number, NCT00270426.) Copyright 2006 Massachusetts Medical Society.

  6. Safety and efficacy of antibiotics among acutely decompensated cirrhosis patients.

    Science.gov (United States)

    Habib, Shahid; Patel, Nehali; Yarlagadda, Sandeep; Hsu, Chiu-Hsieh; Patel, Sarah; Schader, Lindsey; Walker, Courtney; Twesigye, Innocent

    2018-04-26

    Infection is a leading precipitant of acute-on-chronic liver failure. This study aims to determine the safety and efficacy of antibiotics within acute-on-chronic liver failure. Retrospective study of 457 acute-on-chronic liver failure patients admitted to the University of Arizona Health Network between January 1 and December 31, 2014. Eligibility criteria were as follows: at least 18 years of age and 6 months follow-up, data available to calculate systemic inflammatory response syndrome (SIRS), and acute-on-chronic liver failure. This study collected patient's clinical features and historical data. Key data points were infection, antibiotic use, and SIRS. This study used Cox proportional hazards to model the effects of clinical factors on risk of death. A total of 521 of 1243 met the inclusion criteria, and 64 had missing data, leaving 457 patients. Infection resulted in higher hazard (hazard ratio [HR] = 1.6, confidence interval [CI]: 1.1-1.3, P = 0.01). Patients with infections and antibiotics, compared with non-infected patients without antibiotics, had higher hazard (HR = 1.633, CI: 1.022-2.609, P = .04). Of those infected patients with antibiotics, SIRS patients experienced higher hazard (HR = 1.9, CI: 1.1-3.0, P = .007). Multivariable Cox proportional hazards associated the following with higher hazard: SIRS (HR = 1.866, CI: 1.242-2.804, P = 0.003), vancomycin (HR = 1.640, CI: 1.119-2.405, P = 0.011), Model for End-Stage Liver Disease (HR = 1.051, CI: 1.030-1.073, P < 0.001), gastrointestinal bleeding (HR = 1.727, CI: 1.180-2.527, P = 0.005), and hepatic encephalopathy (HR = 1.807, CI: 1.247-2.618, P = 0.002). Overall, treatment of infection with antibiotics did not improve survival; however, patients not meeting SIRS criteria had better outcomes, and vancomycin was associated with poorer survival among acute-on-chronic liver failure patients. © 2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley

  7. [Efficacy and safety of Saw Palmetto Extract Capsules in the treatment of benign prostatic hyperplasia].

    Science.gov (United States)

    Ju, Xiao-bing; Gu, Xiao-jian; Zhang, Zheng-yu; Wei, Zhong-qing; Xu, Zhuo-qun; Miao, Hui-dong; Zhou, Wei-min; Xu, Ren-fang; Cheng, Bin; Ma, Jian-guo; Niu, Tian-li; Qu, Ping; Xue, Bo-xin; Zhang, Wei

    2015-12-01

    To assess the efficacy and safety of Saw Palmetto Extract Capsules in the treatment of benign prostatic hyperplasia (BPH). We conducted a multi-centered open clinical study on 165 BPH patients treated with Saw Palmetto Extract Capsules at a dose of 160 mg qd for 12 weeks. At the baseline and after 6 and 12 weeks of medication, we compared the International Prostate Symptom Scores (IPSS), prostate volume, postvoid residual urine volume, urinary flow rate, quality of life scores (QOL), and adverse events between the two groups of patients. Compared with the baseline, both IPSS and QOL were improved after 6 weeks of medication, and at 12 weeks, significant improvement was found in IPSS, QOL, urinary flow rate, and postvoid residual urine. Mild stomachache occurred in 1 case, which necessitated no treatment. Saw Palmetto Extract Capsules were safe and effective for the treatment of BPH.

  8. Myocardial Contrast Agents – Safety Considerations and Clinical Efficacy in Stress Echocardiography

    Directory of Open Access Journals (Sweden)

    Maier Anca

    2016-11-01

    Full Text Available Transthoracic echocardiographic examination is known to be a safe, non-invasive and reproducible method, used in every day clinical practice to obtain important information about cardiac structure and function. Unfortunately, a significant proportion of studies have highlighted the considerable technically difficultly in producing diagnostic images due to a poor acoustic window and more than 33% of patients undergoing stress echocardiography have suboptimal echocardiographic images. All these limitations have led to the use of contrast agents to improve the quality of standard ultrasound examination to provide a better delineation of left ventricle endocardial borders or to obtain information that cannot be achieved by using standard echocardiography, such as assessing myocardial microcirculation and therefore perfusion. This paper sought to review the clinical efficacy and safety of ultrasound contrast agents focusing on stress echocardiography.

  9. Xingnao Kaiqiao needling method for acute ischemic stroke: a meta-analysis of safety and efficacy

    Directory of Open Access Journals (Sweden)

    Zhi-xin Yang

    2017-01-01

    Results: Twelve studies met the inclusion criteria for this review. The meta-analysis showed that between Xingnao Kaiqiao acupuncture and the control treatment, Xingnao Kaiqiao acupuncture reduced the disability rate [risk ratio (RR = 0.51, 95% confidence interval (CI = 0.27–0.98, z = 2.03, P 0.05. Conclusion: The Xingnao Kaiqiao needling method is effective and safe for acute ischemic stroke. However, there was selective bias in this study, and the likelihood of measurement bias is high. Thus, more high-quality randomized controlled trials are needed to provide reliable evidence of the efficacy and safety of Xingnao Kaiqiao acupuncture in the treatment of acute ischemic stroke.

  10. Symptomatic efficacy and safety of diacerein in the treatment of osteoarthritis

    DEFF Research Database (Denmark)

    Bartels, E. M.; Bliddal, Henning; Schøndorff, P. K.

    2010-01-01

    To estimate the efficacy and safety of diacerein as a pain-reducing agent in the treatment of osteoarthritis (OA), using meta-analysis of published randomized placebo-controlled trials (RCTs).......To estimate the efficacy and safety of diacerein as a pain-reducing agent in the treatment of osteoarthritis (OA), using meta-analysis of published randomized placebo-controlled trials (RCTs)....

  11. The Evidence Base on the Efficacy and Safety of Ibuprofen in Pediatrics

    Directory of Open Access Journals (Sweden)

    Yu.V. Marushko

    2013-10-01

    Full Text Available The article deals with an analysis of the world literature of recent years, the aim of which was to study the efficacy and safety of ibuprofen use as first-line antipyretic in pediatric practice. Special attention was paid to researches on the study the pharmacokinetics, efficacy and safety of ibuprofen in fever in children of all ages, as well as the use of different forms of ibuprofen (suspension, suppositories.

  12. Safety and efficacy of fenproporex for obesity treatment: a systematic review

    OpenAIRE

    Paumgartten,Francisco José Roma; Pereira,Sabrina Schaaf Teixeira Costa; Oliveira,Ana Cecilia Amado Xavier de

    2016-01-01

    ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to trea...

  13. Results of the safety and efficacy of iobitridol in more than 61,000 patients

    International Nuclear Information System (INIS)

    Petersein, J.; Peters, C.R.; Wolf, M.; Hamm, B.

    2003-01-01

    We present results of a postmarketing surveillance study with iobitridol (Xenetix, Sulzbach, Germany) in more than 61,000 patients from 1996 until 2000. The purpose of this study was the assessment of safety and diagnostic efficacy of the non-ionic contrast agent iobitridol in the setting of a post-marketing surveillance study. Iobitridol (Xenetix) has been registered in Germany since 1996. Between 1996 and 2000 207 radiologists have documented in a questionnaire the routine use of Xenetix in 61,754 patients that have received Xenetix for diagnostic procedures. On each questionnaire parameters regarding demographic data, safety, and diagnostic efficacy were assessed. The data were statistically evaluated and analysed. The examination allowed for a diagnosis in 99% of cases. Image quality was rated as ''excellent'' or ''good'' in 89.8% of cases. In obese patients there was a significantly higher percentage (p<0.001) of poor image quality. In 0.1% poor contrast was noted. Of patients, 28.8% had at least one risk factor, and 3.1% had three or more. Adverse events were noted in 2.3% of the examinations, but nearly half of them (1.1%) presented with ''feeling of warmth'' as the only symptom. Of adverse events, 0.2% were non-transient, and 1 patient died. In 0.2% of patients the procedure was stopped due to adverse events. In 0.9% of patients the causal relationship with the contrast agent was rated as probable (probable+possible=1.1%). The percentage of adverse events (excluding warmth) was independent of iodine concentration and of dose, and was higher in young patients. Xenetix is an efficient contrast agent for radiological procedures and is associated with a low rate of adverse events. (orig.)

  14. quality and safety characteristics of cassava crisps sold in urban

    African Journals Online (AJOL)

    ACSS

    QUALITY AND SAFETY CHARACTERISTICS OF CASSAVA CRISPS SOLD IN. URBAN KENYA. G.O. ABONG', S.I. SHIBAIRO, ... This study sought to characterise the quality and safety in terms of cyanide levels of cassava crisps ... Crantz) to food security and incomes for rural communities in sub-Saharan Africa, cannot be.

  15. Factors impacting on the microbiological quality and safety of ...

    African Journals Online (AJOL)

    Problems with the safety and shelf life of export hake have been raised by the Namibian fishing industry. This prompted an investigation into the factors that may have an impact on the microbiological quality and safety of processed hake. Samples were collected along the processing line; the general microbiological quality ...

  16. Evaluating the safety and efficacy of dextromethorphan/quinidine in the treatment of pseudobulbar affect

    Directory of Open Access Journals (Sweden)

    Schoedel KA

    2014-06-01

    Full Text Available Kerri A Schoedel,1 Sarah A Morrow,2 Edward M Sellers3,4 1Altreos Research Partners, Inc., Toronto, 2Western University, London, 3DL Global Partners, Inc., Toronto, 4University of Toronto, Toronto, Ontario, Canada Abstract: Pseudobulbar affect (PBA is a common manifestation of brain pathology associated with many neurological diseases, including amyotrophic lateral sclerosis, Alzheimer’s disease, stroke, multiple sclerosis, Parkinson’s disease, and traumatic brain injury. PBA is defined by involuntary and uncontrollable expressed emotion that is exaggerated and inappropriate, and also incongruent with the underlying emotional state. Dextromethorphan/quinidine (DM/Q is a combination product indicated for the treatment of PBA. The quinidine component of DM/Q inhibits the cytochrome P450 2D6-mediated metabolic conversion of dextromethorphan to its active metabolite dextrorphan, thereby increasing dextromethorphan systemic bioavailability and driving the pharmacology toward that of the parent drug and away from adverse effects of the dextrorphan metabolite. Three published efficacy and safety studies support the use of DM/Q in the treatment of PBA; significant effects were seen on the primary end point, the Center for Neurologic Study-Lability Scale, as well as secondary efficacy end points and quality of life. While concentration–effect relationships appear relatively weak for efficacy parameters, concentrations of DM/Q may have an impact on safety. Some special safety concerns exist with DM/Q, primarily because of the drug interaction and QT prolongation potential of the quinidine component. However, because concentrations of dextrorphan (which is responsible for many of the parent drug’s side effects and quinidine are lower than those observed in clinical practice with these drugs administered alone, some of the perceived safety issues may not be as relevant with this low dose combination product. However, since patients with PBA have a

  17. comparative efficacy and safety of cefixime and ciprofloxacin

    African Journals Online (AJOL)

    2011-09-31

    common cause of hospital admission in Nigeria, and, ... respiratory pathogens to antibacterials have raised concerns about the decreasing efficacy of currently ... community-acquired pneumonia, between July 1 and September 31, 2011 at two.

  18. Efficacy and Safety of Tribendimidine Against Clonorchis sinensis

    OpenAIRE

    Qian, Men-Bao; Yap, Peiling; Yang, Yi-Chao; Liang, Hai; Jiang, Zhi-Hua; Li, Wei; Tan, Yu-Guang; Zhou, Hui; Utzinger, Jürg; Zhou, Xiao-Nong; Keiser, Jennifer

    2017-01-01

    In this randomized open-label trial, tribendimidine was shown to have an efficacy comparable to praziquantel for the treatment of Clonorchis sinensis infection. Patients treated with praziquantel experienced significantly more adverse events than tribendimidine recipients.

  19. Process safety improvement--quality and target zero.

    Science.gov (United States)

    Van Scyoc, Karl

    2008-11-15

    Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.

  20. Process safety improvement-Quality and target zero

    International Nuclear Information System (INIS)

    Van Scyoc, Karl

    2008-01-01

    Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The 'plan, do, check, act' improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given

  1. Process safety improvement-Quality and target zero

    Energy Technology Data Exchange (ETDEWEB)

    Van Scyoc, Karl [Det Norske Veritas (U.S.A.) Inc., DNV Energy Solutions, 16340 Park Ten Place, Suite 100, Houston, TX 77084 (United States)], E-mail: karl.van.scyoc@dnv.com

    2008-11-15

    Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The 'plan, do, check, act' improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.

  2. Building quality into performance and safety assessment software

    International Nuclear Information System (INIS)

    Wojciechowski, L.C.

    2011-01-01

    Quality assurance is integrated throughout the development lifecycle for performance and safety assessment software. The software used in the performance and safety assessment of a Canadian deep geological repository (DGR) follows the CSA quality assurance standard CSA-N286.7 [1], Quality Assurance of Analytical, Scientific and Design Computer Programs for Nuclear Power Plants. Quality assurance activities in this standard include tasks such as verification and inspection; however, much more is involved in producing a quality software computer program. The types of errors found with different verification methods are described. The integrated quality process ensures that defects are found and corrected as early as possible. (author)

  3. Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

    DEFF Research Database (Denmark)

    Egeberg, A; Ottosen, M B; Gniadecki, R

    2018-01-01

    BACKGROUND: Real-life data on newer biologic and biosimilar agents for moderate-to-severe psoriasis are lacking. OBJECTIVES: To examine safety, efficacy, and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab, and ustekinumab) and compare origina...... the long-term safety of novel biologics for psoriasis. This article is protected by copyright. All rights reserved....

  4. Efficacy and safety of ablation for people with non-paroxysmal atrial fibrillation.

    Science.gov (United States)

    Nyong, Jonathan; Amit, Guy; Adler, Alma J; Owolabi, Onikepe O; Perel, Pablo; Prieto-Merino, David; Lambiase, Pier; Casas, Juan Pablo; Morillo, Carlos A

    2016-11-22

    The optimal rhythm management strategy for people with non-paroxysmal (persistent or long-standing persistent) atrial fibrilation is currently not well defined. Antiarrhythmic drugs have been the mainstay of therapy. But recently, in people who have not responded to antiarrhythmic drugs, the use of ablation (catheter and surgical) has emerged as an alternative to maintain sinus rhythm to avoid long-term atrial fibrillation complications. However, evidence from randomised trials about the efficacy and safety of ablation in non-paroxysmal atrial fibrillation is limited. To determine the efficacy and safety of ablation (catheter and surgical) in people with non-paroxysmal (persistent or long-standing persistent) atrial fibrillation compared to antiarrhythmic drugs. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, conference abstracts, clinical trial registries, and Health Technology Assessment Database. We searched these databases from their inception to 1 April 2016. We used no language restrictions. We included randomised trials evaluating the effect of radiofrequency catheter ablation (RFCA) or surgical ablation compared with antiarrhythmic drugs in adults with non-paroxysmal atrial fibrillation, regardless of any concomitant underlying heart disease, with at least 12 months of follow-up. Two review authors independently selected studies and extracted data. We evaluated risk of bias using the Cochrane 'Risk of bias' tool. We calculated risk ratios (RRs) for dichotomous data with 95% confidence intervals (CIs) a using fixed-effect model when heterogeneity was low (I² 40%). Using the GRADE approach, we evaluated the quality of the evidence and used the GRADE profiler (GRADEpro) to import data from Review Manager 5 to create 'Summary of findings' tables. We included three randomised trials with 261 participants (mean age: 60 years) comparing RFCA (159 participants) to antiarrhythmic drugs (102) for non

  5. Perceived Indications, Safety and Efficacy of Perinatal Use of ...

    African Journals Online (AJOL)

    Cheboi SK

    Subjects and Methods: A descriptive cross- sectional ... easy labour and safe delivery (39.6%); and treatment of common ailments (28.5%). Majority ... structures for censoring, training, regulation of TM practice and safety of remedies used.

  6. Implementation of Programmatic Quality and the Impact on Safety

    Science.gov (United States)

    Huls, Dale Thomas; Meehan, Kevin

    2005-01-01

    The purpose of this paper is to discuss the implementation of a programmatic quality assurance discipline within the International Space Station Program and the resulting impact on safety. NASA culture has continued to stress safety at the expense of quality when both are extremely important and both can equally influence the success or failure of a Program or Mission. Although safety was heavily criticized in the media after Colimbiaa, strong case can be made that it was the failure of quality processes and quality assurance in all processes that eventually led to the Columbia accident. Consequently, it is possible to have good quality processes without safety, but it is impossible to have good safety processes without quality. The ISS Program quality assurance function was analyzed as representative of the long-term manned missions that are consistent with the President s Vision for Space Exploration. Background topics are as follows: The quality assurance organizational structure within the ISS Program and the interrelationships between various internal and external organizations. ISS Program quality roles and responsibilities with respect to internal Program Offices and other external organizations such as the Shuttle Program, JSC Directorates, NASA Headquarters, NASA Contractors, other NASA Centers, and International Partner/participants will be addressed. A detailed analysis of implemented quality assurance responsibilities and functions with respect to NASA Headquarters, the JSC S&MA Directorate, and the ISS Program will be presented. Discussions topics are as follows: A comparison of quality and safety resources in terms of staffing, training, experience, and certifications. A benchmark assessment of the lessons learned from the Columbia Accident Investigation (CAB) Report (and follow-up reports and assessments), NASA Benchmarking, and traditional quality assurance activities against ISS quality procedures and practices. The lack of a coherent operational

  7. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    OpenAIRE

    Vlachojannis, Christian; Zimmermann, Benno F.; Chrubasik-Hausmann, Sigrun

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate ...

  8. Long-term opioid treatment of chronic nonmalignant pain: unproven efficacy and neglected safety?

    Directory of Open Access Journals (Sweden)

    Kissin I

    2013-07-01

    Full Text Available Igor Kissin Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA Background: For the past 30 years, opioids have been used to treat chronic nonmalignant pain. This study tests the following hypotheses: (1 there is no strong evidence-based foundation for the conclusion that long-term opioid treatment of chronic nonmalignant pain is effective; and (2 the main problem associated with the safety of such treatment – assessment of the risk of addiction – has been neglected. Methods: Scientometric analysis of the articles representing clinical research in this area was performed to assess (1 the quality of presented evidence (type of study; and (2 the duration of the treatment phase. The sufficiency of representation of addiction was assessed by counting the number of articles that represent (1 editorials; (2 articles in the top specialty journals; and (3 articles with titles clearly indicating that the addiction-related safety is involved (topic-in-title articles. Results: Not a single randomized controlled trial with opioid treatment lasting >3 months was found. All studies with a duration of opioid treatment ≥6 months (n = 16 were conducted without a proper control group. Such studies cannot provide the consistent good-quality evidence necessary for a strong clinical recommendation. There were profound differences in the number of addiction articles related specifically to chronic nonmalignant pain patients and to opioid addiction in general. An inadequate number of chronic pain-related publications were observed with all three types of counted articles: editorials, articles in the top specialty journals, and topic-in-title articles. Conclusion: There is no strong evidence-based foundation for the conclusion that long-term opioid treatment of chronic nonmalignant pain is effective. The above identified signs indicating neglect of addiction associated with the

  9. A&I - Data Quality - State Safety Data Quality Map

    Data.gov (United States)

    Department of Transportation — Data Quality identifies FMCSA resources for evaluating, monitoring, and improving the quality of data submitted by States to the Motor Carrier Management Information...

  10. Efficacy and Safety of Antidepressants for the Treatment of Irritable Bowel Syndrome: A Meta-Analysis

    Science.gov (United States)

    Wang, Yunfeng; Yu, Ting; Wang, Yun; Jiang, Liuqin; Lin, Lin

    2015-01-01

    Aim The aim of this meta-analysis was to analyze the efficacy and safety of antidepressants for the treatment of irritable bowel syndrome. Methods We searched MEDLINE, EMBASE, Scopus and The Cochrane Library for randomized controlled trials investigating the efficacy and safety of antidepressants in the treatment of irritable bowel syndrome. Article quality was evaluated by Jadad score. RevMan 5.0 and Stata 12.0 were used for the meta-analysis. Results Twelve randomized controlled trials were included in this study and most of these trials were of high quality (Jadad score ≥4). Five articles focused on tricyclic antidepressants, six articles involved selective serotonin reuptake inhibitors, and one article investigated both types of treatment. The pooled risk ratio showed antidepressant treatment can improve global symptoms (RR = 1.38, 95% CI 1.08, 1.77). In the subgroup analysis, treatment with tricyclic antidepressants showed an improvement in global symptoms (RR = 1.36, 95% CI 1.07, 1.71), while treatment with selective serotonin reuptake inhibitors showed no statistically significant difference in global symptoms compared with the control groups (RR = 1.38, 95% CI 0.83, 2.28). The pooled risk ratio of dropout due to side effects following antidepressant treatment was 1.71 with 95% CI (0.98, 2.99). The subgroup analysis showed the pooled risk ratio of dropout in the tricyclic antidepressants group was 1.92 with 95% CI (0.89, 4.17). In the selective serotonin reuptake inhibitors group, the pooled risk ratio of dropout was 1.5 with 95% CI (0.67, 3.37). Selective serotonin reuptake inhibitors showed no benefit in alleviating abdominal pain and improving quality of life. There was no difference in the incidence of common adverse events between treatment and control groups. Conclusions TCAs can improve global symptoms of irritable bowel syndrome, while there was no strong evidence to confirm the effectiveness of SSRIs for the treatment of IBS. PMID:26252008

  11. Efficacy and Safety of Antidepressants for the Treatment of Irritable Bowel Syndrome: A Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Chen Xie

    Full Text Available The aim of this meta-analysis was to analyze the efficacy and safety of antidepressants for the treatment of irritable bowel syndrome.We searched MEDLINE, EMBASE, Scopus and The Cochrane Library for randomized controlled trials investigating the efficacy and safety of antidepressants in the treatment of irritable bowel syndrome. Article quality was evaluated by Jadad score. RevMan 5.0 and Stata 12.0 were used for the meta-analysis.Twelve randomized controlled trials were included in this study and most of these trials were of high quality (Jadad score ≥4. Five articles focused on tricyclic antidepressants, six articles involved selective serotonin reuptake inhibitors, and one article investigated both types of treatment. The pooled risk ratio showed antidepressant treatment can improve global symptoms (RR = 1.38, 95% CI 1.08, 1.77. In the subgroup analysis, treatment with tricyclic antidepressants showed an improvement in global symptoms (RR = 1.36, 95% CI 1.07, 1.71, while treatment with selective serotonin reuptake inhibitors showed no statistically significant difference in global symptoms compared with the control groups (RR = 1.38, 95% CI 0.83, 2.28. The pooled risk ratio of dropout due to side effects following antidepressant treatment was 1.71 with 95% CI (0.98, 2.99. The subgroup analysis showed the pooled risk ratio of dropout in the tricyclic antidepressants group was 1.92 with 95% CI (0.89, 4.17. In the selective serotonin reuptake inhibitors group, the pooled risk ratio of dropout was 1.5 with 95% CI (0.67, 3.37. Selective serotonin reuptake inhibitors showed no benefit in alleviating abdominal pain and improving quality of life. There was no difference in the incidence of common adverse events between treatment and control groups.TCAs can improve global symptoms of irritable bowel syndrome, while there was no strong evidence to confirm the effectiveness of SSRIs for the treatment of IBS.

  12. Efficacy and Safety of Chinese Medicinal Herbs for the Treatment of Hyperuricemia: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Jianping Lin

    2016-01-01

    Full Text Available Background. Chinese medicinal herbs may be useful for the treatment of hyperuricemia, but there has been no systematic assessment of their efficacy and safety. Objectives. To systematically assess the efficacy and safety of Chinese medicinal herbs for the treatment of hyperuricemia. Methods. Six electronic databases were searched from their inception to December 2015. Randomized controlled clinical trials (RCTs were included. Cochrane criteria were applied to assess the risk of bias. Data analysis was performed using RevMan software version 5.2. Results. Eleven RCTs with 838 patients were included. There was no significant difference in serum uric acid between Chinese medicinal herbs and traditional Western medicine (SME: 0.19, 95% CI: −0.04 to 0.43; p=0.10. In terms of overall efficacy, the Chinese medicinal herbs were significantly superior to Western medicine (RR: 1.11; 95% CI: 1.04 to 1.17; p=0.0007. The Chinese medicinal herbs were better than Western medicine in reducing the adverse reactions (RR: 0.30; 95% CI: 0.15 to 0.62; p=0.001. And all these funnel plots showed unlikelihood of publishing bias. Conclusions. The results indicate that Chinese medicinal herbs may have greater overall efficacy with fewer adverse drug reactions, although the evidence is weak owing to the low methodological quality and the small number of the included trials.

  13. Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

    Science.gov (United States)

    Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

    2016-02-01

    Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

  14. Safety and efficacy of health supplement (Pegaga based product

    Directory of Open Access Journals (Sweden)

    Firdaus Abd Rahman

    2016-01-01

    Conclusions: Most traditional products claim contained herbs and have many indication although not proven by evidence based. Hence, consumers must be more selective before buying any health products. MOH continuing demonstrate enforcement action and educating the public in this matter. More research also must be conducted to confirm the efficacy and the appropriate dose for a particular situation either for prevention or treatment of disease.

  15. 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

  16. How does the efficacy and safety of Oralair® compare to other products on the market?

    Directory of Open Access Journals (Sweden)

    Larenas-Linnemann D

    2016-05-01

    Full Text Available Désirée Larenas-Linnemann Pediatric Allergy and Asthma Clinic, Department of Investigation, Hospital Médica Sur, México City, México Abstract: Due to differences between allergen immunotherapy (AIT trials in patient populations, trial design (including primary efficacy variables, the definition of a pollen season, data analysis, and comparisons between AIT products with existing data, is not possible nor valid. The efficacy of two grass pollen AIT tablets, Oralair® and Grazax®/Grastek®, should not be compared by looking at the percentage of score improvement in their respective trials. However, the evidence available concerning the efficacy and safety in trials can be compared by paying close attention to the scientific quality of the trials, details in the administration schedules, and safety issues. It can be concluded due to the high level of evidence available, that Oralair® is effective in a pre (2-months-coseasonal schedule to reduce symptoms and medication use, and improve a patients’ quality of life during the treatment season. For the long-term, where the quality of efficacy evidence is moderate at 2-year posttreatment due to a high dropout rate, the pre (4-months-coseasonal schedule should be used. No clinical efficacy data exists for starting treatment in-season, but the clinical onset of action of Oralair® is detectable after only 1 month of treatment. In the pivotal trials in Europe and the USA, no tablet-related epinephrine was needed, though some rare severe local reactions have been reported. Research for Grazax®/Grastek® showed that the long-term efficacy needs a continuous 3-year administration (moderate-low quality evidence available, and in two patients, tablet-related epinephrine was given. Further details on the comparative efficacy of both tablets would only be possible if both were evaluated in the same, adequately powered trial. Keywords: sublingual allergen immunotherapy, grass pollen, allergic rhinitis

  17. Food safety and quality assurance : foods of animal origin

    National Research Council Canada - National Science Library

    Hughes, Keith L; Hinton, Michael H; Hubbert, William T; Hagstad, Harry V; Spangler, Elizabeth

    1996-01-01

    The second edition of Food Safety and Quality Assurance is a basic reference for veterinarians, extension specialists, and others who help food-animal producers throughout the food chain to provide...

  18. New Paradigm in Nuclear Safety from Quality Assurance to Safety Management System

    International Nuclear Information System (INIS)

    Lim, Nam-Jin; Park, Chan-Gook; Nam, Ji-Hee; Kim, Kwan-Hyun; Kwon, Hyuk-il; Lee, Young-Gun Lee

    2006-01-01

    The initial concept of Quality Control (QC) controlling the quality of products is now evolving toward the Management System (MS) achieving safety, through Quality Assurance (QA) ensuring the quality of products and Quality Management (QM) managing the quality by a systematic approach. Nuclear safety can be achieved through an integrated MS that ensures the health, environmental, security, quality and economic requirements being considered together with nuclear safety requirements. MS approach is developed through realizing that most of nuclear accidents had occurred not by the malfunction of hardware or equipment, but by the human error. The MS is a set of inter-related or interacting elements (system) that establishes policies and objectives and which enables those objectives to be achieved in an efficient and effective way

  19. Efficacy and safety of immunomodulatory drugs in patients with anterior uveitis

    Science.gov (United States)

    Gómez-Gómez, Alejandro; Loza, Estíbaliz; Rosario, Maria Piedad; Espinosa, Gerard; de Morales, José M. García Ruiz; Herreras, Jose M.; Muñoz-Fernández, Santiago; Cordero-Coma, Miguel

    2017-01-01

    Abstract Background: To assess the efficacy and safety of immunomodulatory drugs in patients with noninfectious anterior uveitis (AU). Methods: Systematic review of studies were retrieved from Medline (1961 to March 2016), Embase (1961 to March 2016), and Cochrane Library (up to March 2016), and a complementary hand search was also performed. The selection criteria were as follows: (population) noninfectious AU patients, adults; (intervention) immunomodulatory drugs (any dose, regimen, route of administration, duration of treatment); (outcome) control of inflammation, steroid-sparing effect, AU flares, adverse events, and so on; (study design) systematic literature reviews, randomized controlled trials, and observational studies. The study quality was assessed using the Jadad scale and according to The Oxford Centre for Evidence-based Medicine (update 2009). Results: We included 13 studies of moderate-poor quality, with a mean duration from 5 months to 20 years, and number of AU patients ranging from 9 to 274. Patient's demographic and clinical characteristics were very heterogeneous. In most cases, uveitis anatomic classification criteria and outcomes definitions were unclear. Some of the studies only included AU patients with a systemic disease associated, mostly spondyloarthritis, others, mixed populations (idiopathic and systemic disease associated patients), and in some articles this data is not described. We found that methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might prevent AU flares, improve ocular inflammation and visual acuity, and decrease systemic steroids doses. Conclusions: Although there is a lack of robust evidence, methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might be effective in AU patients. PMID:29049193

  20. Efficacy and safety of immunomodulatory drugs in patients with anterior uveitis: A systematic literature review.

    Science.gov (United States)

    Gómez-Gómez, Alejandro; Loza, Estíbaliz; Rosario, Maria Piedad; Espinosa, Gerard; Morales, José M García Ruiz de; Herreras, Jose M; Muñoz-Fernández, Santiago; Cordero-Coma, Miguel

    2017-10-01

    To assess the efficacy and safety of immunomodulatory drugs in patients with noninfectious anterior uveitis (AU). Systematic review of studies were retrieved from Medline (1961 to March 2016), Embase (1961 to March 2016), and Cochrane Library (up to March 2016), and a complementary hand search was also performed. The selection criteria were as follows: (population) noninfectious AU patients, adults; (intervention) immunomodulatory drugs (any dose, regimen, route of administration, duration of treatment); (outcome) control of inflammation, steroid-sparing effect, AU flares, adverse events, and so on; (study design) systematic literature reviews, randomized controlled trials, and observational studies. The study quality was assessed using the Jadad scale and according to The Oxford Centre for Evidence-based Medicine (update 2009). We included 13 studies of moderate-poor quality, with a mean duration from 5 months to 20 years, and number of AU patients ranging from 9 to 274. Patient's demographic and clinical characteristics were very heterogeneous. In most cases, uveitis anatomic classification criteria and outcomes definitions were unclear. Some of the studies only included AU patients with a systemic disease associated, mostly spondyloarthritis, others, mixed populations (idiopathic and systemic disease associated patients), and in some articles this data is not described. We found that methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might prevent AU flares, improve ocular inflammation and visual acuity, and decrease systemic steroids doses. Although there is a lack of robust evidence, methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might be effective in AU patients.

  1. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review.

    Science.gov (United States)

    Ramkumar, Davendra; Rao, Satish S C

    2005-04-01

    Constipation is common, and its treatment is unsatisfactory. Although many agents have been tried, there are limited data to support their use. Our aim was to undertake a systematic review of the efficacy and safety of traditional medical therapies for chronic constipation and to make evidence-based recommendations. We searched the English literature for drug trials evaluating treatment of constipation by using MEDLINE and PUBMED databases from 1966 to 2003. Only studies that were randomized, conducted on adult subjects, and published as full manuscripts were included. Studies were assigned a quality score based on published methodology. Standard forms were used to abstract data regarding study design, duration, outcome measures, and adverse events. By using the cumulative evidence of published data for each agent, recommendations were made regarding their use following the United States Preventive Services Task Force guidelines. Good evidence (Grade A) was found to support the use of polyethylene glycol (PEG) and tegaserod. Moderate evidence (Grade B) was found to support the use of psyllium, and lactulose. There was a paucity of quality data regarding many commonly used agents including milk of magnesia, senna, bisacodyl, and stool softeners. There is good evidence to support the use of PEG, tegaserod, lactulose, and psyllium. Surprisingly, there is a paucity of trials for many commonly used agents. These aspects should be considered when designing trials comparing new agents with traditional therapies because their use may not be well validated.

  2. Quality assurance and nuclear power plant safety

    International Nuclear Information System (INIS)

    Mullan, J.V.

    1983-01-01

    Quality assurance in the nuclear industry was born in the late 1960s. Atomic Energy Control Board staff began its regulatory practice on quality assurance during that period. In this presentation the author traces the circumstances that first led to the establishment of Canadian nuclear power plant quality assurance programmes, summarizes progress over the last decade and a half, and outlines the current regulatory approach and what has been learned so far

  3. A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue.

    Science.gov (United States)

    Blackhall, Leslie; Petroni, Gina; Shu, Jianfen; Baum, Lora; Farace, Elena

    2009-05-01

    Fatigue is a common symptom that lowers the quality of life of patients with cancer, affecting between 60% and 90% of patients. Relatively few options are available for the treatment of this debilitating condition. Modafinal, a psychostimulant developed for the treatment of narcolepsy, has been used to treat fatigue in other diseases such as multiple sclerosis, but little data support its use in cancer patients. The primary objective of this open-label pilot study was to evaluate the safety, and efficacy of modafinil in improving cancer-related fatigue (CRF) as measured by the Brief Fatigue Inventory (BFI). The effect of this agent on depression, quality of life, functional status, and cognitive function was also assessed. Modafinal was self-administered at a dose of 100 mg/d during weeks 1-2, and 200 mg during weeks 3-4. Assessments were performed at baseline, 2, and 4 weeks. BFI score was improved in 46% of patients at 2 weeks and 75% at 4 weeks (p = 0.025). Hospital Anxiety and Depression Scale scores declined at 2 and 4 weeks (p < 0.001). Most scales for neurocognitive function were unchanged. Score for all Functional Assessment of Cancer Therapy-Brain (FACT-BR) subscales (measuring quality of life), except social/family well-being, were improved (p < 0.05) at 2 and 4 weeks. Significant changes in Eastern Cooperative Oncology Group (ECOG) performance status were noted, with 40% of patients improving at least one level. Modafinil was well-tolerated with only one patient discontinuing treatment due to drug-related toxicity. In this pilot study modafinil was well-tolerated and effective for fatigue in patients with cancer. Improvements were also seen in mood, quality of life, and functional status.

  4. THE EFFICACY AND SAFETY OF OXCARBAZEPINE AS ADD-ON THERAPY IN INTRACTABLE EPILEPSY IN CHILDREN

    OpenAIRE

    Azita TAVASSOLI; Mohammad GHOFRANI; Mohsen ROUZROKH; Eznollah AZARGASHB

    2010-01-01

    Objective1-3% of the population suffer from epilepsy. Up to 30% of them develop refractory epilepsy and their seizures occur more than once per month despite receiving at least 2 first line antiepileptic drugs. In  this group, more efficacious antiepileptics are needed. This study was undertaken to evaluate the efficacy and safety of Oxcarbazepine as an adjunction therapy in children with refractory epilepsy.Materials & MethodsFrom Feb 2004 until Sep 2006, 30 patients with refractory epilepsy...

  5. Safety and efficacy of personal care products containing colloidal oatmeal

    OpenAIRE

    Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

    2012-01-01

    Maryline Criquet,1 Romain Roure,1 Liliane Dayan,2 Virginie Nollent,1 Christiane Bertin11Johnson & Johnson Santé Beauté France, Issy les Moulineaux, 2Independent consultant dermatologist, Paris, FranceBackground: Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vu...

  6. Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis

    DEFF Research Database (Denmark)

    Sorensen, Per S; Lisby, Steen; Grove, Richard

    2014-01-01

    OBJECTIVES: We present the first study to explore safety and efficacy of the human CD20 monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis (RRMS). METHODS: In this randomized, double-blind, placebo-controlled study, patients received 2 ofatumumab infusions (100 mg, 300 mg......, or 700 mg) or placebo 2 weeks apart. At week 24, patients received alternate treatment. Safety and efficacy were assessed. RESULTS: Thirty-eight patients were randomized (ofatumumab/placebo, n = 26; placebo/ofatumumab, n = 12) and analyzed; 36 completed the study. Two patients in the 300-mg group...

  7. Safety culture and quality management of Kartini research reactor

    Energy Technology Data Exchange (ETDEWEB)

    Syarip [Yogyakarta Nuclear Research Centre, Yogyakarta (Indonesia); Hauptmanns, Ulrich [Department of Plant Design and Safety, Otto-Von-Guericke-University, Magdeburg (Germany)

    1999-10-01

    The evaluation for assessing the safety culture and quality of safety management of Kartini research reactor is presented. The method is based on the concept of management control of safety (audit) as well as by using the developed method i.e. the questionnaires concerning areas of relevance which have to be answered with value statements. There are seven statements or qualifiers in answering the questions. Since such statements are vague, they are represented by fuzzy numbers. The weaknesses can be identified from the different areas contemplated. The evaluation result show that the quality of safety management of Kartini research reactor is globally rated as 'Average'. The operator behavior in the implementation of 'safety culture' concept is found as a weakness, therefore this area should be improved. (author)

  8. Safety culture and quality management of Kartini research reactor

    International Nuclear Information System (INIS)

    Syarip; Hauptmanns, Ulrich

    1999-01-01

    The evaluation for assessing the safety culture and quality of safety management of Kartini research reactor is presented. The method is based on the concept of management control of safety (audit) as well as by using the developed method i.e. the questionnaires concerning areas of relevance which have to be answered with value statements. There are seven statements or qualifiers in answering the questions. Since such statements are vague, they are represented by fuzzy numbers. The weaknesses can be identified from the different areas contemplated. The evaluation result show that the quality of safety management of Kartini research reactor is globally rated as 'Average'. The operator behavior in the implementation of 'safety culture' concept is found as a weakness, therefore this area should be improved. (author)

  9. Tank safety screening data quality objective. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Hunt, J.W.

    1995-04-27

    The Tank Safety Screening Data Quality Objective (DQO) will be used to classify 149 single shell tanks and 28 double shell tanks containing high-level radioactive waste into safety categories for safety issues dealing with the presence of ferrocyanide, organics, flammable gases, and criticality. Decision rules used to classify a tank as ``safe`` or ``not safe`` are presented. Primary and secondary decision variables used for safety status classification are discussed. The number and type of samples required are presented. A tabular identification of each analyte to be measured to support the safety classification, the analytical method to be used, the type of sample, the decision threshold for each analyte that would, if violated, place the tank on the safety issue watch list, and the assumed (desired) analytical uncertainty are provided. This is a living document that should be evaluated for updates on a semiannual basis. Evaluation areas consist of: identification of tanks that have been added or deleted from the specific safety issue watch lists, changes in primary and secondary decision variables, changes in decision rules used for the safety status classification, and changes in analytical requirements. This document directly supports all safety issue specific DQOs and additional characterization DQO efforts associated with pretreatment and retrieval. Additionally, information obtained during implementation can assist in resolving assumptions for revised safety strategies, and in addition, obtaining information which will support the determination of error tolerances, confidence levels, and optimization schemes for later revised safety strategy documentation.

  10. Safety and efficacy of personal care products containing colloidal oatmeal.

    Science.gov (United States)

    Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

    2012-01-01

    Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized. In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin. We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation. Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.

  11. Safety and efficacy of personal care products containing colloidal oatmeal

    Directory of Open Access Journals (Sweden)

    Criquet M

    2012-11-01

    Full Text Available Maryline Criquet,1 Romain Roure,1 Liliane Dayan,2 Virginie Nollent,1 Christiane Bertin11Johnson & Johnson Santé Beauté France, Issy les Moulineaux, 2Independent consultant dermatologist, Paris, FranceBackground: Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized.Methods: In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin.Results: We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation.Conclusion: Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.Keywords: Avena sativa, colloids, protective agents, atopic dermatitis, irritant dermatitis, allergenic dermatitis, skin

  12. Early safety and efficacy of fingolimod treatment in Denmark

    DEFF Research Database (Denmark)

    Voldsgaard, A; Koch-Henriksen, N; Magyari, M

    2017-01-01

    BACKGROUND: Initiation of fingolimod treatment is associated with a transient decrease of heart rate, and atrioventricular (AV) conduction block may occur. OBJECTIVE: To evaluate the therapeutic effect and safety of fingolimod treatment in MS patients in Denmark with focus on cardiac and pulmonary...... to bradycardia and/or second-degree AV block type I. All patients recovered spontaneously. Two patients discontinued fingolimod. Eleven (5.4%) patients reported respiratory complaints and two of these patients discontinued treatment. CONCLUSIONS: Fingolimod appears to be safe and effective in MS patients...

  13. Factors impacting on the microbiological quality and safety of ...

    African Journals Online (AJOL)

    hope&shola

    2010-12-06

    Dec 6, 2010 ... microbiological quality and safety of processed hake. Samples were collected along the processing line; the general microbiological quality (mesophylic and psychrotrophic aerobic plate counts), total. Vibrio species and common fish spoilage bacterial counts were performed. The results constantly showed ...

  14. Safety of timber : An analysis of quality control options

    NARCIS (Netherlands)

    Kovryga, A.; Stapel, P.; Van de Kuilen, J.W.G.

    2014-01-01

    The quality assurance of timber properties is important for the safety of timber structures. In the current study, the quality control options of timber are analysed under the prism of the different growth regions. Therefore, these options - machine and output control - are simulated in accordance

  15. The 7 basic tools of quality applied to radiological safety

    International Nuclear Information System (INIS)

    Gonzalez F, J.A.

    1991-01-01

    This work seeks to establish a series of correspondences among the search of the quality and the optimization of the doses received by the occupationally exposed personnel. There are treated about the seven basic statistic tools of the quality: the Pareto technique, Cause effect diagrams, Stratification, Verification sheet, Histograms, Dispersion diagrams and Graphics and control frames applied to the Radiological Safety

  16. Ibogaine: complex pharmacokinetics, concerns for safety, and preliminary efficacy measures.

    Science.gov (United States)

    Mash, D C; Kovera, C A; Pablo, J; Tyndale, R F; Ervin, F D; Williams, I C; Singleton, E G; Mayor, M

    2000-09-01

    Ibogaine is an indole alkaloid found in the roots of Tabernanthe Iboga (Apocynaceae family), a rain forest shrub that is native to western Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and thirst, and in higher doses as a sacrament in religious rituals. Members of American and European addict self-help groups have claimed that ibogaine promotes long-term drug abstinence from addictive substances, including psychostimulants and opiates. Anecdotal reports attest that a single dose of ibogaine eliminates opiate withdrawal symptoms and reduces drug craving for extended periods of time. The purported efficacy of ibogaine for the treatment of drug dependence may be due in part to an active metabolite. The majority of ibogaine biotransformation proceeds via CYP2D6, including the O-demethylation of ibogaine to 12-hydroxyibogamine (noribogaine). Blood concentration-time effect profiles of ibogaine and noribogaine obtained for individual subjects after single oral dose administrations demonstrate complex pharmacokinetic profiles. Ibogaine has shown preliminary efficacy for opiate detoxification and for short-term stabilization of drug-dependent persons as they prepare to enter substance abuse treatment. We report here that ibogaine significantly decreased craving for cocaine and heroin during inpatient detoxification. Self-reports of depressive symptoms were also significantly lower after ibogaine treatment and at 30 days after program discharge. Because ibogaine is cleared rapidly from the blood, the beneficial aftereffects of the drug on craving and depressed mood may be related to the effects of noribogaine on the central nervous system.

  17. Review of the Safety and Efficacy of Moringa oleifera.

    Science.gov (United States)

    Stohs, Sidney J; Hartman, Michael J

    2015-06-01

    Moringa oleifera leaves, seeds, bark, roots, sap, and flowers are widely used in traditional medicine, and the leaves and immature seed pods are used as food products in human nutrition. Leaf extracts exhibit the greatest antioxidant activity, and various safety studies in animals involving aqueous leaf extracts indicate a high degree of safety. No adverse effects were reported in association with human studies. Five human studies using powdered whole leaf preparations of M. oleifera have been published, which have demonstrated anti-hyperglycemic (antidiabetic) and anti-dyslipidemic activities. These activities have been confirmed using extracts as well as leaf powders in animal studies. A rapidly growing number of published studies have shown that aqueous, hydroalcohol, or alcohol extracts of M. oleifera leaves possess a wide range of additional biological activities including antioxidant, tissue protective (liver, kidneys, heart, testes, and lungs), analgesic, antiulcer, antihypertensive, radioprotective, and immunomodulatory actions. A wide variety of polyphenols and phenolic acids as well as flavonoids, glucosinolates, and possibly alkaloids is believed to be responsible for the observed effects. Standardization of products is an issue. However, the results of published studies to date involving M. oleifera are very promising. Additional human studies using standardized extracts are highly desirable. © 2015 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.

  18. Omics approaches in fish quality and safety

    Directory of Open Access Journals (Sweden)

    Maria Lúcia Guerra Monteiro

    2017-05-01

    Full Text Available Omics is a new technology that uses genomics, proteomics, and metabolomics to investigate metabolites from foods. The global demand for fish has shown a progressive increase because it is a significant source of high quality protein, polyunsaturated fatty acids, especially omega-3, and essential minerals. However, there are barriers in the fishery production chain such as lack of standardization, knowledge, and technology transfer to industry. Moreover, fish effective monitoring is difficult due to restricted quality parameters and analytical methods determined by current Brazilian legislation. This review details the limiting chemical parameters and recent advances in analytical procedures for fish quality determination. To improve fish quality monitoring, total volatile basic nitrogen (TVB-N, trimethylamine (TMA, ammonia, pH, and biogenic amines values should be revised and established by fish category and/or type of fish product. On the other hand, protein carbonyl concentration, free fatty acids (FFAs, peroxide values (POV, and thiobarbituric acid reactive substances (TBARS should be included in the national legislation. Simultaneously, the official authorities should take into account effective, practical, and low cost analytical methodologies, which lead to faster results in order to facilitate and enhance the quality control of the products from the fish production chain, ensuring the consumer’s health. Moreover, analytical techniques for the identification of fish species must be introduced in the Brazilian legislation in order to avoid illegal substitutions and negative impacts to consumers.

  19. Quality management of pharmacology and safety pharmacology studies

    DEFF Research Database (Denmark)

    Spindler, Per; Seiler, Jürg P

    2002-01-01

    to safety pharmacology studies, and, when indicated, to secondary pharmacodynamic studies, does not influence the scientific standards of studies. However, applying formal GLP standards will ensure the quality, reliability and integrity of studies, which reflect sound study management. It is important...... to encourage a positive attitude among researchers and academics towards these lines, whenever possible. GLP principles applied to the management of non-clinical safety studies are appropriate quality standards when studies are used in the context of protecting public health, and these quality standards...... of pharmacology studies (ICH S7A): primary pharmacodynamic, secondary pharmacodynamic and safety pharmacology studies, and guidance on the quality standards (expectations for GLP conformity) for these study types have been provided. Primary pharmacodynamic studies are the only study types that are fully exempt...

  20. Quality management, a directive approach to patient safety.

    Science.gov (United States)

    Ayuso-Murillo, Diego; de Andrés-Gimeno, Begoña; Noriega-Matanza, Concha; López-Suárez, Rafael Jesús; Herrera-Peco, Ivan

    Nowadays the implementation of effective quality management systems and external evaluation in healthcare is a necessity to ensure not only transparency in activities related to health but also access to health and patient safety. The key to correctly implementing a quality management system is support from the managers of health facilities, since it is managers who design and communicate to health professionals the strategies of action involved in quality management systems. This article focuses on nursing managers' approach to quality management through the implementation of cycles of continuous improvement, participation of improvement groups, monitoring systems and external evaluation quality models (EFQM, ISO). The implementation of a quality management system will enable preventable adverse effects to be minimized or eliminated, and promote patient safety and safe practice by health professionals. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  1. Epidemiological characteristics, safety and efficacy of medical cannabis in the elderly.

    Science.gov (United States)

    Abuhasira, Ran; Schleider, Lihi Bar-Lev; Mechoulam, Raphael; Novack, Victor

    2018-03-01

    There is a substantial growth in the use of medical cannabis in recent years and with the aging of the population, medical cannabis is increasingly used by the elderly. We aimed to assess the characteristics of elderly people using medical cannabis and to evaluate the safety and efficacy of the treatment. A prospective study that included all patients above 65 years of age who received medical cannabis from January 2015 to October 2017 in a specialized medical cannabis clinic and were willing to answer the initial questionnaire. Outcomes were pain intensity, quality of life and adverse events at six months. During the study period, 2736 patients above 65 years of age began cannabis treatment and answered the initial questionnaire. The mean age was 74.5 ± 7.5 years. The most common indications for cannabis treatment were pain (66.6%) and cancer (60.8%). After six months of treatment, 93.7% of the respondents reported improvement in their condition and the reported pain level was reduced from a median of 8 on a scale of 0-10 to a median of 4. Most common adverse events were: dizziness (9.7%) and dry mouth (7.1%). After six months, 18.1% stopped using opioid analgesics or reduced their dose. Our study finds that the therapeutic use of cannabis is safe and efficacious in the elderly population. Cannabis use may decrease the use of other prescription medicines, including opioids. Gathering more evidence-based data, including data from double-blind randomized-controlled trials, in this special population is imperative. Copyright © 2018. Published by Elsevier B.V.

  2. Quality and safety of construction materials

    International Nuclear Information System (INIS)

    Rodulfo Zabala, L.

    2015-01-01

    CEPCO represents 20 industrial sectors, which take charge of construction materials production, and whose expectations of European and Spanish legislation observance (specially the articles related to quality, security and environmental respect) reach a very high level. This performance is equally taken to their internal competitiveness and to their huge international enlargement produced on the recent years. In addition to this principle, the Confederation includes its own this principle, the Confederation includes its own doctrine of trying to consolidate important heights of quality related to the evolution of the product trough I+D+i. (Author)

  3. Safety, efficacy, and patient acceptability of rifaximin for hepatic encephalopathy

    DEFF Research Database (Denmark)

    Kimer, Nina; Krag, Aleksander; Gluud, Lise L

    2014-01-01

    Hepatic encephalopathy is a complex disease entity ranging from mild cognitive dysfunction to deep coma. Traditionally, treatment has focused on a reduction of ammonia through a reduced production, absorption, or clearance. Rifaximin is a nonabsorbable antibiotic, which reduces the production of ...... and safety of long-term treatment with rifaximin and evaluate effects of combination therapy with lactulose and branched-chain amino acids for patients with liver cirrhosis and hepatic encephalopathy.......Hepatic encephalopathy is a complex disease entity ranging from mild cognitive dysfunction to deep coma. Traditionally, treatment has focused on a reduction of ammonia through a reduced production, absorption, or clearance. Rifaximin is a nonabsorbable antibiotic, which reduces the production...... of ammonia by gut bacteria and, to some extent, other toxic derivatives from the gut. Clinical trials show that these effects improve episodes of hepatic encephalopathy. A large randomized trial found that rifaximin prevents recurrent episodes of hepatic encephalopathy. Most patients were treated...

  4. Studies on safety and efficacy of gamma-irradiated ginseng

    International Nuclear Information System (INIS)

    Kwon, Joong Ho; Cho, Han Oak; Byun, Myung Woo; Kim, Suk Won; Yang, Jae Seung; You, Young Soo; Jin, Joon Ha; Park, Soon Chul

    1992-09-01

    Microbiological qualities were evaluated for the commercial red ginseng. Molds, which might cause microbial spoilage of stored ginseng, were isolated and identified for determining radiosensitivity and growth characteristics on ginseng-extract agar media. Red ginseng inoculated with isolated molds was incubated under the ideal condition following irradiation at different doses to pre-establish the effective dose-range for decontamination by confirming mold growth on the surface of the sample. At this point of time, moisture content was determined for the corresponding sample. By comparing the monolayer moisture content of red ginseng and its actual moisture level causing microbial spoilage during storage, it was intended to establish a basal condition for the continued project regarding irradiation effects on the quality of high-moisture products and their storage stability. (Author)

  5. Ensuring the quality of occupational safety risk assessment.

    Science.gov (United States)

    Pinto, Abel; Ribeiro, Rita A; Nunes, Isabel L

    2013-03-01

    In work environments, the main aim of occupational safety risk assessment (OSRA) is to improve the safety level of an installation or site by either preventing accidents and injuries or minimizing their consequences. To this end, it is of paramount importance to identify all sources of hazards and assess their potential to cause problems in the respective context. If the OSRA process is inadequate and/or not applied effectively, it results in an ineffective safety prevention program and inefficient use of resources. An appropriate OSRA is an essential component of the occupational safety risk management process in industries. In this article, we performed a survey to elicit the relative importance for identified OSRA tasks to enable an in-depth evaluation of the quality of risk assessments related to occupational safety aspects on industrial sites. The survey involved defining a questionnaire with the most important elements (tasks) for OSRA quality assessment, which was then presented to safety experts in the mining, electrical power production, transportation, and petrochemical industries. With this work, we expect to contribute to the main question of OSRA in industries: "What constitutes a good occupational safety risk assessment?" The results obtained from the questionnaire showed that experts agree with the proposed OSRA process decomposition in steps and tasks (taxonomy) and also with the importance of assigning weights to obtain knowledge about OSRA task relevance. The knowledge gained will enable us, in the near future, to build a framework to evaluate OSRA quality for industrial sites. © 2012 Society for Risk Analysis.

  6. Preclinical safety and efficacy of a new recombinant FIX drug product for treatment of hemophilia B.

    Science.gov (United States)

    Dietrich, Barbara; Schiviz, Alexandra; Hoellriegl, Werner; Horling, Frank; Benamara, Karima; Rottensteiner, Hanspeter; Turecek, Peter L; Schwarz, Hans Peter; Scheiflinger, Friedrich; Muchitsch, Eva-Maria

    2013-11-01

    Baxter has developed a new recombinant factor IX (rFIX) drug product (BAX326) for treating patients with hemophilia B, or congenital FIX deficiency. An extensive preclinical program evaluated the pharmacokinetics, efficacy, and safety of BAX326 in different species. The efficacy of BAX326 was tested in three mouse models of primary pharmacodynamics: tail-tip bleeding, carotid occlusion, and thrombelastography. The pharmacokinetics was evaluated after a single intravenous bolus injection in mice, rats, and macaques. Toxicity was assessed in rats and macaques, safety pharmacology in rabbits and macaques, and immunogenicity in mice. BAX326 was shown to be efficacious in all three primary pharmacodynamic studies (P ≤ 0.0076). Hemostatic efficacy was dose related and similar for the three lots tested. Pharmacokinetic results showed that rFIX activity and rFIX antigen concentrations declined in a bi-phasic manner, similar to a previously licensed rFIX product. BAX326 was well tolerated in rabbits and macaques at all dose levels; no thrombogenic events and no adverse clinical, respiratory, or cardiovascular effects occurred. BAX326 was also shown to have a similar immunogenicity profile to the comparator rFIX product in mice. These results demonstrate that BAX326 has a favorable preclinical safety and efficacy profile, predictive of a comparable effect to that of the previously licensed rFIX in humans.

  7. Efficacy and Safety of Leucine Supplementation in the Elderly.

    Science.gov (United States)

    Borack, Michael S; Volpi, Elena

    2016-12-01

    Leucine supplementation has grown in popularity due to the discovery of its anabolic effects on cell signaling and protein synthesis in muscle. The current recommendation is a minimum intake of 55 mg ⋅ kg -1 . d -1 Leucine acutely stimulates skeletal muscle anabolism and can overcome the anabolic resistance of aging. The value of chronic leucine ingestion for muscle growth is still unclear. Most of the research into leucine consumption has focused on efficacy. To our knowledge, very few studies have sought to determine the maximum safe level of intake. Limited evidence suggests that intakes of ≤1250 mg ⋅ kg -1 . d -1 do not appear to have any health consequences other than short-term elevated plasma ammonia concentrations. Similarly, no adverse events have been reported for the leucine metabolite β-hydroxy-β-methylbutyrate (HMB), although no studies have tested HMB toxicity in humans. Therefore, future research is needed to evaluate leucine and HMB toxicity in the elderly and in specific health conditions. © 2016 American Society for Nutrition.

  8. Safety and efficacy of low-dose, subacute exposure of mature ewes to sodium chlorate

    Science.gov (United States)

    The objective was to determine the safety and efficacy of low-dose, subacute exposure of mature ewes to NaClO3 in the drinking water. Twenty-five ewes (BW = 62.5 ± 7.3 kg) were placed indoors in individual pens with ad libitum access to water and feed. After 7 d of adaptation, ewes were assigned ran...

  9. Safety and protective efficacy of porcine reproductive and respiratory syndrome recombinant virus vaccines in young pigs.

    NARCIS (Netherlands)

    Verheije, M.H.; Kroese, M.V.; Linden, van der I.F.A.; Boer-Luijtze, de E.A.; Rijn, van P.A.; Pol, J.M.A.; Meulenberg, J.J.M.; Steverink, P.J.G.M.

    2003-01-01

    Three porcine reproductive and respiratory syndrome virus (PRRSV) recombinants, generated by mutagenesis of an infectious cDNA clone of the Lelystad virus (LV) isolate, were tested for their safety and protective efficacy as potential PRRSV vaccines in pigs. Recombinant vABV688 contains two amino

  10. 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.

  11. Assessment of efficacy and safety of praziquantel in the treatment of ...

    African Journals Online (AJOL)

    This study assessed the efficacy and safety of PZQ in school-aged children in four ... All pupils were also treated with a single dose of PZQ at 40 mg/kg. ... The presence of S. haematobium was neither age nor sex dependent (p>0.05).

  12. Efficacy and Safety of Canagliflozin in Patients with Type 2 Diabetes and Stage 3 Nephropathy

    NARCIS (Netherlands)

    Yamout, Hala; Perkovic, Vlado; Davies, Melanie; Woo, Vincent; de Zeeuw, Dick; Mayer, Cristiana; Vijapurkar, Ujjwala; Kline, Irina; Usiskin, Keith; Meininger, Gary; Bakris, George

    2014-01-01

    Background/Aims: Some sodium glucose co-transporter 2 (SGLT2) inhibitors are approved for the treatment of patients with type 2 diabetes mellitus (T2DM) with an estimated glomerular filtration rate (eGFR) of >= 45 ml/mm/1.73 m(2). The efficacy and safety of canagliflozin, an approved SGLT(2)

  13. Safety and efficacy of Profermin(R) to induce remission in ulcerative colitis

    DEFF Research Database (Denmark)

    Krag, Aleksander; Israelsen, Hans; von Ryberg, Bjørn

    2012-01-01

    AIM: To test the efficacy and safety of Profermin(R) in inducing remission in patients with active ulcerative colitis (UC). METHODS: The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index (SCCAI) > 4 and < 12 (median: 7.5), who were treated ope...

  14. Neonatal pearls : safety and efficacy of medication use in fetus and neonate

    NARCIS (Netherlands)

    Lugt, Neeltje Margaretha van der

    2013-01-01

    Neonatal health care is provided with medication and protocols for almost all morbidities. Before the use of these medicines is allowed, they are extensively studied and tested for efficacy and safety. As patient population and knowledge on specific diseases changes with time, repeated evaluation

  15. A meta-analysis of the efficacy of preoperative surgical safety ...

    African Journals Online (AJOL)

    A meta-analysis of the efficacy of preoperative surgical safety checklists to improve perioperative outcomes. BM Biccard, RN Rodseth, L Cronje, P Agaba, E Chikumba, L du Toit, Z Farina, S Fischer, PD Gopalan, K Govender, J Kanjee, AC Kingwill, F Madzimbamuto, D Mashava, B Mrara, M Mudely, E Ninise, J Swanevelder, ...

  16. Clinical assessment of the efficacy and safety of T-Angelica Herbal ...

    African Journals Online (AJOL)

    The safety, efficacy, and acceptability of T-Angelica Herbal Tonic (THAT), a phytomedicinal beverage was studied over a period of one week in ten healthy volunteers for regulatory purposes. The study started after an overnight fast with each subject drinking 150ml of the beverage every night and every morning for a period ...

  17. Efficacy and safety of ursodeoxycholic acid versus cholestyramine in intrahepatic cholestasis of pregnancy

    NARCIS (Netherlands)

    Kondrackiene, Jurate; Beuers, Ulrich; Kupcinskas, Limas

    2005-01-01

    BACKGROUND & AIMS: Treatment of intrahepatic cholestasis of pregnancy with ursodeoxycholic acid appears promising, but data are limited so far. The aim of this randomized study was to evaluate the efficacy and safety of ursodeoxycholic acid in comparison with cholestyramine. METHODS: Eighty-four

  18. Safety and efficacy of influenza vaccination in systemic lupus erythematosus patients with quiescent disease

    NARCIS (Netherlands)

    Holvast, A; Huckriede, A; Wilschut, J; Horst, G; De Vries, JJC; Benne, CA; Kallenberg, CGM; Bijl, M

    Objective: to assess the safety and efficacy of influenza vaccination in patients with systemic lupus erythematosus (SLE), and to evaluate the influence of immunosuppressive drugs on the immune response. Methods: SLE patients (n = 56) and healthy controls (n = 18) were studied. All patients had

  19. Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma

    DEFF Research Database (Denmark)

    Pedersen, Søren; Engelstätter, Renate; Weber, Hans-Jochen

    2009-01-01

    BACKGROUND: Ciclesonide is a new inhaled corticosteroid (ICS). Information about its clinical efficacy and safety in relation to other ICS in children is needed for clinical positioning. OBJECTIVE: This 12-week, randomized, double-blind, double-dummy, three-arm, parallel-group study compared the ...

  20. Translational PKPD modeling in schizophrenia: linking receptor occupancy of antipsychotics to efficacy and safety

    NARCIS (Netherlands)

    Pilla Reddy, Venkatesh; Kozielska, Magdalena; Johnson, Martin; Vermeulen, An; Liu, Jing; de Greef, Rik; Groothuis, Genoveva; Danhof, Meindert; Proost, Johannes

    2012-01-01

    Objectives: To link the brain dopamine D2 receptor occupancy (D2RO) of antipsychotic drugs with clinical endpoints of efficacy and safety to assess the therapeutic window of D2RO. Methods: Pharmacokinetic-Pharmacodynamic (PK-PD) models were developed to predict the D2 receptor occupancy of

  1. Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies

    DEFF Research Database (Denmark)

    Eron, Joseph J; Cooper, David A; Steigbigel, Roy T

    2013-01-01

    Two randomised, placebo-controlled trials-BENCHMRK-1 and BENCHMRK-2-investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5 years (the end ...

  2. Acupuncture therapy: mechanism of action, efficacy, and safety: a potential intervention for psychogenic disorders?

    Science.gov (United States)

    2014-01-01

    Scientific bases for the mechanism of action of acupuncture in the treatment of pain and the pathogenic mechanism of acupuncture points are briefly summarized. The efficacy and safety of acupuncture therapy is discussed based on the results of German clinical trials. A conclusion on the role for acupuncture in the treatment of psychogenic disorders could not be reached. PMID:24444292

  3. Safety and Efficacy of Ferric Carboxymaltose in Anemic Pregnant Women: A Retrospective Case Control Study

    NARCIS (Netherlands)

    Pels, Anouk; Ganzevoort, Wessel

    2015-01-01

    Background. Anemia during pregnancy is commonly caused by iron deficiency and can have severe consequences for both the mother and the developing fetus. The aim of this retrospective study was to assess the safety and efficacy of intravenous ferric carboxymaltose (FCM) in pregnant women. Methods.

  4. Gamma-Knife surgery (GKS) in patients with acromegaly: safety and efficacy

    International Nuclear Information System (INIS)

    Katz, D.; Miragaya, K.; Tenca, E.; Margni, A.; Artes, C.; Antico, J.

    2007-01-01

    The acromegaly is associated with increased morbidity and mortality than the general population. Since the surgical and pharmacological treatment for acromegaly have specific limitations, the GKS has been used as a therapeutic option in selected patients. The object is to evaluate the efficacy and safety of GKS in patients with acromegaly [es

  5. Safety and efficacy of anticoagulation for secondary stroke prevention in atrial fibrillation patients: The AMADEUS trial

    NARCIS (Netherlands)

    Lane, D.A.; Kamphuisen, P.W.; Minini, P.; Buller, H.R.; Lip, G.Y.H.

    2010-01-01

    ackground: Patients with atrial fibrillation (AF) and previous ischemic stroke are at high risk of recurrent stroke, but are also perceived to be at increased bleeding risk while treated with anticoagulants. Methods: Post-hoc analyses examined the efficacy and safety of anticoagulation of 4576 AF

  6. Efficacy, safety and tolerability of simvastatin in children with familial hypercholesterolaemia - Rationale, design and baseline characteristics

    NARCIS (Netherlands)

    de Jongh, S.; Stalenhoef, A. F. H.; Tuohy, M. B.; Mercuri, M.; Bakker, H. D.; Kastelein, J. J. P.

    2002-01-01

    Objective: To describe the rationale, design and baseline data of a study conducted to determine the efficacy, safety and tolerability of simvastatin in children and adolescents with heterozygous familial hypercholesterolaemia (heFH). Methods: Patients were recruited from nine lipid clinics

  7. Safety and Efficacy of BAY 94-9027, a Prolonged-Half-Life Factor VIII

    DEFF Research Database (Denmark)

    Reding, M T; Ng, H J; Poulsen, Lone Hvitfeldt

    2017-01-01

    BACKGROUND: BAY 94-9027 is a B-domain-deleted prolonged-half-life recombinant factor VIII (FVIII) conjugates in a site-specific manner with polyethylene glycol. OBJECTIVE: Assess efficacy and safety of BAY 94-9027 for prophylaxis and treatment of bleeds in patients with severe hemophilia A PATIEN...

  8. Efficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder

    Science.gov (United States)

    Findling, Robert L.; Childress, Ann C.; Cutler, Andrew J.; Gasior, Maria; Hamdani, Mohamed; Ferreira-Cornwell, M. Celeste; Squires, Liza

    2011-01-01

    Objective: To examine lisdexamfetamine dimesylate (LDX) efficacy and safety versus placebo in adolescents with attention-deficit/hyperactivity disorder (ADHD). Method: Adolescents (13 through 17) with at least moderately symptomatic ADHD (ADHD Rating Scale IV: Clinician Version [ADHD-RS-IV] score greater than or equal to 28) were randomized to…

  9. Assuring fish safety and quality in international fish trade

    International Nuclear Information System (INIS)

    Ababouch, Lahsen . E-mail lahsen.ababouch@fao.org

    2006-01-01

    International trade in fishery commodities reached US$ 58.2 billion in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US$ 17.4 billion in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building

  10. Assuring fish safety and quality in international fish trade

    Energy Technology Data Exchange (ETDEWEB)

    Ababouch, Lahsen [United Nations, Food and Agricultural Organization, Chief, Fish Utilization and Marketing Services, FAO Headquarters, F-607 Rome (Italy)]. E-mail lahsen.ababouch@fao.org

    2006-07-01

    International trade in fishery commodities reached US$ 58.2 billion in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US$ 17.4 billion in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building.

  11. Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

    Science.gov (United States)

    Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian

    2011-06-01

    Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

  12. Comparative efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion

    DEFF Research Database (Denmark)

    Regnier, Stephane A; Larsen, Michael; Bezlyak, Vladimir

    2015-01-01

    OBJECTIVE: To compare the efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion (BRVO). DESIGN: Randomised controlled trials (RCTs) evaluating the efficacy and safety of approved treatments for macular oedema secondary to BRVO were identified from...... an updated systematic review. SETTING: A Bayesian network meta-analysis of RCTs of treatments for macular oedema secondary to BRVO. INTERVENTIONS: Ranibizumab 0.5 mg pro re nata, aflibercept 2 mg monthly (2q4), dexamethasone 0.7 mg implant, laser photocoagulation, ranibizumab+laser, or sham intervention...... pressure (IOP)/ocular hypertension (OH). RESULTS: 8 RCTs were identified for inclusion with 1743 adult patients. The probability of being the most efficacious treatment at month 6 or 12 based on letters gained was 54% for ranibizumab monotherapy, 30% for aflibercept, 16% for ranibizumab plus laser...

  13. Clinical efficacy and safety of vitrectomy combined with cyclophotocoagulation in treatment of traumatic glaucoma

    Directory of Open Access Journals (Sweden)

    Guo-Ning Ye

    2018-02-01

    Full Text Available AIM: To analyze the clinical efficacy and safety of vitrectomy combined with cyclophotocoagulation in the treatment of traumatic glaucoma, and to provide an effective treatment for improving the quality of life of patients with traumatic glaucoma.METHODS: Totally 90 patients(90 eyeswith traumatic glaucoma admitted in our hospital from January 2011 to July 2016 were divided into two groups(45 patients in each groupaccording to different treatment methods. The patients in the observation group underwent vitrectomy combined with cyclophotocoagulation under direct vision; the control group underwent vitrectomy combined with trans-scleral cyclophotocoagulation. We observed the effect of different treatment on visual acuity, intraocular pressure and complication of the two groups. RESULTS: The visual acuity of the observation group was significantly better than that of the control group after treatment(Z=-5.689, PP>0.05. The change of decreased intraocular pressure in the observation group was less than that in the contral group after operation(PP>0.05. The complications of the two groups after treatment were vitreous hemorrhage, choroidal detachment, low intraocular pressure, increased intraocular pressure and other complications, but the complication rate of two groups were no different(χ2=1.553, P=0.213. CONCLUSION: Vitrectomy combined with cyclophotocoagulation under direct vision brings patients better visual acuity than that combined with trans-scleral cyclophotocoagulation.

  14. Office Visits to Monitor Stimulant Medication Safety and Efficacy: Recommended Care.

    Science.gov (United States)

    Zima, Bonnie T; Norquist, Grayson S; Altchuler, Steven I; Behrens, Jacob; Iles-Shih, Matthew D; Ng, Yiu Kee Warren; Schaepper, Mary Ann

    2018-06-01

    The clinical guidance based on the research article, "Specific Components of Pediatricians' Medication-Related Care Predict Attention-Deficit/Hyperactivity Disorder Improvement," published in the June 2017 issue, 1 might be premature. The authors, Epstein et al., suggest that "Physicians do not need to necessarily rely on office visits to monitor medication response and side effects in the week(s) after initially prescribing medication, but instead could use phone calls or email correspondence to check in with the family" (p. 489). However, this advice has the potential to be misinterpreted that phone or email contact is acceptable clinical practice to monitor stimulant medication safety and efficacy, especially during the maintenance phase. It also could be erroneously interpreted that phone or email contact is sufficient for follow-up care for children receiving medication treatment for attention-deficit/hyperactivity disorder (ADHD) for national quality measures. Copyright © 2018 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  15. Omalizumab for treating chronic spontaneous urticaria: an expert review on efficacy and safety.

    Science.gov (United States)

    Giménez-Arnau, Ana M

    2017-03-01

    Chronic spontaneous urticaria (CSU) is characterized by the recurrence of itchy hives and/or angioedema for greater than six weeks, with no known external trigger. Omalizumab, a humanized, recombinant, monoclonal anti-IgE antibody, is the only approved add-on therapy for H1-antihistamine refractory CSU patients. Areas covered: The objective of this article is to discuss the mechanism of action, pharmacokinetics and pharmacodynamics of omalizumab for the treatment of CSU. The review also summarizes efficacy and safety data from proof-of-concept, phase II (X-CUISITE, MYSTIQUE), and pivotal phase III omalizumab studies (ASTERIA I, ASTERIA II, and GLACIAL). Expert opinion: Omalizumab is a clinically effective and safe biological therapy for treating H1-antihistamine refractory CSU patients. It significantly reduces CSU symptoms (hives, itch and angioedema), and improves patient health-related quality of life. While omalizumab is already integral to the treatment of antihistamine refractory CSU, widespread use will depend on legal and economic factors, as well as improvements in the early and accurate diagnosis of CSU patients who would benefit from treatment.

  16. Safety and efficacy assessment of standardized herbal formula PM012

    Science.gov (United States)

    2012-01-01

    Background This study was conducted to evaluate the efficacy of the herbal formula PM012 on an Alzheimer's disease model, human presenilin 2 mutant transgenic mice (hPS2m), and also to evaluate the toxicity of PM012 in Sprague-Dawely rats after 4 or 26 weeks treatment with repeated oral administration. Methods Spatial learning and memory capacities of hPS2m transgenic mice were evaluated using the Morris Water Maze. Simultaneously, PM012 was repeatedly administered orally to male and female SD rats (15/sex/group) at doses of 0 (vehicle control), 500, 1,000 and 2,000 mg/kg/day for 4 or 26 weeks. To evaluate the recovery potential, 5 animals of each sex were assigned to vehicle control and 2,000 mg/kg/day groups during the 4-week recovery period. Results The results showed that PM012-treated hPS2m transgenic mice showed significantly reduced escape latency when compared with the hPS2m transgenic mice. The repeated oral administration of PM012 over 26 weeks in male and female rats induced an increase and increasing trend in thymus weight in the female treatment groups (main and recovery groups), but the change was judged to be toxicologically insignificant. In addition, the oral administration of the herbal medicine PM012 did not cause adverse effects as assessed by clinical signs, mortality, body weight, food and water consumption, ophthalmology, urinalysis, hematology, serum biochemistry, blood clotting time, organ weights and histopathology. The No Observed Adverse Effects Levels of PM012 was determined to be 2,000 mg/kg/day for both sexes, and the target organ was not identified. Conclusion These results suggest that PM012 has potential for use in the treatment of the Alzheimer's disease without serious adverse effects. PMID:22458507

  17. Safety-efficacy balance of S-ketamine and S-norketamine in acute and chronic pain

    NARCIS (Netherlands)

    Noppers, Ingeborg Marieke

    2011-01-01

    The balance between safety and efficacy is important in pharmacotherapy. When the indication of a registered drug shifts to another disease or a different patient population, studies on safety and efficacy need to be performed. Ketamine is a relatively ‘old’ drug and used for almost 50 years as an

  18. 78 FR 60290 - Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Reopening of...

    Science.gov (United States)

    2013-10-01

    ..., 2013, on the following topics: (1) What factors should be considered in masking study data (e.g., data...] Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Reopening of Comment Period... of Masked and De- identified Non-Summary Safety and Efficacy Data; Request for Comments,'' which...

  19. Efficacy and safety of sotagliflozin in treating diabetes type 1.

    Science.gov (United States)

    Rendell, Marc S

    2018-02-01

    Sotagliflozin is the first dual SGLT1/SGLT2 inhibitor developed for use in diabetes. Sotagliflozin blocks SGLT2 in the kidneys and SGLT1 in the intestines resulting in reduced early phase glucose absorption and increased blood levels of GLP-1 and PYY. Urinary glucose excretion is lower than with other agents as a result of decreased glucose absorption. The primary development effort to date has been in Type 1 diabetes. Areas covered: The published information on sotagliflozin is reviewed, along with the recent results of several pivotal Type 1 diabetes trials. Expert opinion: Sotagliflozin treatment lowers HbA1c and reduces glucose variability, with a trend to less hypoglycemic events. In the Type 1 trials, sotagliflozin treated individuals experienced DKA at a higher rate than placebo treated patients. An additional safety issue arises from the as yet unknown potential risks in women of child bearing potential in whom DKA is of utmost concern. The sotagliflozin development program has now been extended to trials in Type 2 diabetes, and long term studies will be needed to assess the benefits and risks of the agent in comparison to other currently marketed SGLT2 inhibitors.

  20. Efficacy, safety and tolerability of rasagiline as adjunctive therapy in elderly patients with Parkinson's disease.

    Science.gov (United States)

    Tolosa, E; Stern, M B

    2012-02-01

    Rasagiline, an MAO-B inhibitor, is indicated for the treatment of Parkinson's disease (PD). In this post hoc analysis, the efficacy, safety and tolerability of rasagiline as an adjunct to levodopa were compared with placebo in elderly (≥70 years) and younger (Rasagiline: Efficacy and Safety on the Treatment of 'OFF' and Lasting effect in Adjunct therapy with Rasagiline Given Once daily randomized, double-blind, placebo-controlled trials with the primary efficacy end-point being the reduction from baseline in daily OFF time. Secondary efficacy end-points included scores for Clinical Global Improvement (CGI)-Examiner during ON time, Unified Parkinson's Disease Rating Scale (UPDRS)-ADL during OFF time, UPDRS-Motor during ON time and total daily ON time with and without troublesome dyskinesia. Tolerability was evaluated from adverse events (AEs) in the two age groups. Rasagiline decreased daily OFF time versus placebo (Prasagiline but were not significant. Between-group comparisons (≥70 vs. efficacy was unaffected by age for all end-points (P>0.1), and rasagiline was well tolerated amongst both groups of patients with a comparable incidence of total and dopaminergic AEs (P>0.1). Adjunct rasagiline is efficacious and well tolerated in elderly non-demented patients (≥70 years) with moderate to advanced PD. Confirmation of the efficacy and safety of rasagiline in the elderly patient subgroup is especially relevant because of the increasing number of elderly patients with PD. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.

  1. Safety and efficacy of erenumab for preventive treatment of chronic migraine

    DEFF Research Database (Denmark)

    Tepper, Stewart; Ashina, Messoud; Reuter, Uwe

    2017-01-01

    BACKGROUND: The calcitonin gene-related peptide (CGRP) pathway is important in migraine pathophysiology. We assessed the efficacy and safety of erenumab, a fully human monoclonal antibody against the CGRP receptor, in patients with chronic migraine. METHODS: This was a phase 2, randomised, double...... assignment. The primary endpoint was the change in monthly migraine days from baseline to the last 4 weeks of double-blind treatment (weeks 9-12). Safety endpoints were adverse events, clinical laboratory values, vital signs, and anti-erenumab antibodies. The efficacy analysis set included patients who...... received at least one dose of investigational product and completed at least one post-baseline monthly measurement. The safety analysis set included patients who received at least one dose of investigational product. The study is registered with ClinicalTrials.gov, number NCT02066415. FINDINGS: From April...

  2. Quality assurance requirements for the computer software and safety analyses

    International Nuclear Information System (INIS)

    Husarecek, J.

    1992-01-01

    The requirements are given as placed on the development, procurement, maintenance, and application of software for the creation or processing of data during the design, construction, operation, repair, maintenance and safety-related upgrading of nuclear power plants. The verification and validation processes are highlighted, and the requirements put on the software documentation are outlined. The general quality assurance principles applied to safety analyses are characterized. (J.B.). 1 ref

  3. THE STUDY THE EFFICACY AND SAFETY OF ANTIMICROBIAL AGENTS

    Directory of Open Access Journals (Sweden)

    V. V. Bagaeva

    2015-01-01

    Full Text Available Abstract:Effective treatment of patients with infectious and inflammatory diseases of the skin and mucous membranes often involves the use of antimicrobial agents.The purpose of the study was an in vitro estimation of cytotoxicity and the efficiency of national resources for local use: gel with bacteriophages («Otofag», «Fagogin», «Fagoderm», «Fagodent» and antiseptic — «Сhlorhexidine» and «Miramistin».Materials and Methods. To study the effectiveness of antimicrobial agents they used to provide crop strains of Staphylococcus aureus and Streptococcus pyogenes as one of the most common representatives of pathogens. The study of cell viability and cytotoxicity antimicrobials performed on cell lines KB — epidermoid carcinoma of the oral cavity of a human. For this purpose we use mikrotetrazoly test, which is widely used in the assessment of the effects on the cells of toxins, pharmaceuticals, adverse environmental factors, allowing to evaluate the toxicity of investigational drugs in vitro.The results showed that the efficacy against pathogens Staphylococcus aureus and Streptococcus pyogenes, has even a 10‑fold dilution of «Сhlorhexidine» 0.05% and gels with bacteriophages. Antiseptic «Miramistin» is effective only on the initial concentration. The study of cytotoxicity showed that the processing of epidermoid carcinoma cells with «Chlorhexidine» and «Мiramistin» invokes the irreversible reactions, while the composition processing of gels based on bacteriophages not further affect cell viability.Conclusions The results of the experiment confirmed the significant toxicity of tools such as «Сhlorhexidine» and «Miramistin» in proposed concentrations in the pharmacy network. Despite the high efficiency of these vehicles with regard to the studied pathogens, their long-term use in treatment of inflammatory diseases of the skin and mucous membranes can cause a slowing of repair processes. Gel means with bacteriophages

  4. Efficacy and safety of atomoxetine hydrochloride in Korean adults with attention-deficit hyperactivity disorder.

    Science.gov (United States)

    Lee, Soyoung Irene; Song, Dong-Ho; Shin, Dong Won; Kim, Ji Hoon; Lee, Young Sik; Hwang, Jun-Won; Park, Tae Won; Yook, Ki-Hwan; Lee, Jong Il; Bahn, Geon Ho; Hirata, Yuko; Goto, Taro; Takita, Yasushi; Takahashi, Michihiro; Lee, Sanghoon; Treuer, Tamás

    2014-12-01

    This article aims to assess the efficacy and safety of atomoxetine in Korean adults with attention-deficit hyperactivity disorder (ADHD). This post hoc double-blind, placebo-controlled study of atomoxetine (40-120 mg/day) over 10 weeks in adults with ADHD at 45 Japanese, Korean, and Taiwanese study sites focused on patient data from Korea (atomoxetine, n = 37; placebo, n = 37). Primary efficacy outcome was change in baseline-to-endpoint Conners' Adult ADHD Rating Scale-Investigator-rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms score. Secondary efficacy outcomes included changes in Adult ADHD Quality of Life (AAQoL) total, Behavior Rating Inventory of Executive Function-Adult Version Self-Report (BRIEF-A:Self-Report), and Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) scale scores. Atomoxetine-treated patients demonstrated a mean 18.9-point reduction in CAARS-Inv:SV total ADHD Symptoms score, compared with the 7.45-point reduction in placebo-treated patients (P ≤ 0.01). Significantly greater improvement was found for atomoxetine versus placebo in CGI-ADHD-S (P ≤ 0.01), BRIEF-A:Self-Report global executive composite (P ≤ 0.05), and metacognition index (P ≤ 0.01) executive function scores. Nausea, decreased appetite, and dry mouth were reported with significantly greater frequency by atomoxetine-treated patients, and only one placebo-treated patient discontinued because of adverse event. A 2.1-kg reduction in weight and a 7.5-beat/minute increase in pulse rate were observed in atomoxetine-treated patients. These data support a significant benefit of 80- to 120-mg once daily atomoxetine versus placebo for treatment of ADHD in adult Korean patients. A high placebo response rate was observed in this adult Korean sample; a higher discontinuation rate was also observed in atomoxetine-treated patients. These observations warrant further investigation. © 2014 Wiley Publishing Asia Pty Ltd.

  5. Safety and efficacy of a new tourniquet system

    Directory of Open Access Journals (Sweden)

    Sato Junko

    2012-08-01

    Full Text Available Abstract Background In upper limb surgery, the pneumatic tourniquet is an essential tool to provide a clean, bloodless surgical field, improving visualization of anatomical structures and preventing iatrogenic failure. Optimal inflation pressure to accomplish these objects without injuring normal tissue and inducing complications is not yet established. Use of the minimum tourniquet pressure necessary to produce a bloodless surgical field is preferable in order to prevent injury to normal tissue. Various methods have been implemented in an effort to lower effective cuff pressure. The purpose of this study is to report clinical experience with a new tourniquet system in which pressure is synchronized with systolic blood pressure (SBP using a vital information monitor. Methods We routinely used the tourniquet system in 120 consecutive upper limb surgeries performed under general anaesthesia in our operating room instead of our clinic. Cuff pressure was automatically regulated to additional 100 mmHg based on the SBP and was renewed every 2.5 minutes intervals. Results An excellent bloodless field was obtained in 119 cases, with the exception of one case of a 44-year-old woman who underwent internal screw fixation of metacarpal fracture. No complications, such as compartment syndrome, deep vein disorder, skin disorder, paresis, or nerve damage, occurred during or after surgery. Conclusions This new tourniquet system, synchronized with SBP, can be varied to correspond with sharp rises or drops in SBP to supply adequate pressure. The system reduces labor needed to deflate and re-inflate to achieve different pressures. It also seemed to contribute to the safety in upper limb surgery, in spite of rare unexpected oozing mid-surgery, by reducing tissue pressure.

  6. Innovation of Supervision System for Quality and Safety of Edible Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    Xingxing; MEI; Zhongchao; FENG

    2014-01-01

    This paper elaborated multidimensional characteristics of quality and safety of agricultural products,introduced current situation of quality and safety supervision of edible agricultural products in China,analyzed existing problems of quality and safety supervision system and corresponding reasons,and finally came up with recommendations for innovation of supervision system for quality and safety of agricultural products.

  7. CYD-TDV dengue vaccine: systematic review and meta-analysis of efficacy, immunogenicity and safety.

    Science.gov (United States)

    Godói, Isabella Piassi; Lemos, Livia Lovato Pires; de Araújo, Vânia Eloisa; Bonoto, Braúlio Cesar; Godman, Brian; Guerra Júnior, Augusto Afonso

    2017-03-01

    Dengue virus (DENV) is a serious global health problem. CYD-TDC (Dengvaxia ® ) was the first vaccine to gain regulatory approval to try and address this problem. Summarize all available evidence on the immunogenicity, efficacy and safety of the CYD-TDV dengue vaccine. Meta-analysis and systematic review. The best and worst immunogenicity results were for DENV4 and DENV1, respectively. Vaccine efficacy of 60% was derived from studies with participants aged 2-16 years old, with DENV4 and DENV2 presenting the best and worst results, respectively. Erythema and swelling were more frequent with CYD-TDV. No differences were detected for systemic adverse events. CYD-TDV showed moderate efficacy in children and adolescents. From the immunogenicity results in adults, we can expect satisfactory efficacy from vaccination in this population.

  8. Intragastric Balloon for Obesity Treatment: Safety, Tolerance, and Efficacy

    Directory of Open Access Journals (Sweden)

    Joana Ribeiro da Silva

    2017-12-01

    Full Text Available Background: Obesity is an increasing worldwide problem associated with a vast number of comorbidities. Decreasing body weight by only 5-10% has been shown to slow and even prevent the onset of obesity-related comorbidities. Between pharmacological therapy and bariatric surgery a great variety of endoscopic techniques are available, the most common being intragastric balloon (IGB. The purpose of this study was to assess the safety, tolerance, and kinetics of IGBs in weight loss. The kinetics of weight loss were evaluated in 2 different contexts and phases: after the IGB's removal and after follow-up that varied between 6 and 12 months. Successful weight loss was defined as ≥10% weight loss after 6-12 months. Methods: The study included 51 patients who had undergone Orbera® IGB placement between September 2014 and February 2016. Inclusion criteria were age between 18 and 65 years; body mass index (BMI 28-35 with severe obesity-related disorders; or BMI 35-40. The IGB was removed 6 months later. All patients were followed for a minimum period of 6-12 months. Results: Of 51 patients, 16 were excluded (7 due to intolerance and 35 patients entered the study, of which 83% were followed for more than 6-12 months. The average weight loss (WL and % excess WL (%EWL after 6 months of treatment were 11.94 kg and 42.16%, respectively. At 6-12 months, after removal of the IGB, the mean WL was 8.25 kg and %EWL was 30.27%. Nineteen patients attained a WL of ≥10% the baseline value at IGB removal and 12 maintained their weight below this threshold during the 6-12 following months. Conclusions: After temporary IGB implantation in overweight or obese individuals, a WL that was ≥10% of weight at baseline was achieved in 54.3% and sustained at 6-12 months in 41.4% of participants. IGBs are an attractive intermediate option between diet and exercise programs and bariatric surgery. In general, IGB placement is a safe and well-tolerated procedure.

  9. Visualising differences in professionals' perspectives on quality and safety.

    Science.gov (United States)

    Travaglia, Joanne Francis; Nugus, Peter Ivan; Greenfield, David; Westbrook, Johanna Irene; Braithwaite, Jeffrey

    2012-09-01

    The safety-and-quality movement is now two decades old. Errors persist despite best efforts, indicating that there are entrenched overt and perhaps less explicit barriers limiting the success of improvement efforts. OBJECTIVES AND HYPOTHESES: To examine the perspectives of five groups of healthcare workers (administrative staff, nurses, medical practitioners, allied health and managers) and to compare and contrast their descriptions of quality-and-safety activities within their organisation. Differences in perspectives can be an indicator of divergence in the conceptualisation of, and impetus for, quality-improvement strategies which are intended to engage healthcare professions and staff. Study data were collected in a defined geographical healthcare jurisdiction in Australia, via individual and group interviews held across four service streams (aged care and rehabilitation; mental health; community health; and cancer services). Data were collected in 2008 and analysed, using data-mining software, in 2009. Clear differences in the perspectives of professional groups were evident, suggesting variations in the perceptions of, and priorities for, quality and safety. The visual representation of quality and safety perspectives provides insights into the conceptual maps currently utilised by healthcare workers. Understanding the similarity and differences in these maps may enable more effective targeting of interprofessional improvement strategies.

  10. Safety and Efficacy of Glucomannan for Weight Loss in Overweight and Moderately Obese Adults

    Directory of Open Access Journals (Sweden)

    Joyce K. Keithley

    2013-01-01

    Full Text Available Background. Few safe and effective dietary supplements are available to promote weight loss. We evaluated the safety and efficacy of glucomannan, a water-soluble fiber supplement, for achieving weight loss in overweight and moderately obese individuals consuming self-selected diets. Methods. Participants were randomly assigned to take 1.33 grams of glucomannan or identically looking placebo capsules with 236.6 mL (8 ounces of water one hour before breakfast, lunch, and dinner for 8 weeks. The primary efficacy outcome was change in body weight after 8 weeks. Other efficacy outcomes were changes in body composition, hunger/fullness, and lipid and glucose concentrations. Safety outcomes included gastrointestinal symptoms/tolerance and serum liver enzymes and creatinine levels. Results. A total of 53 participants (18–65 years of age; BMI 25–35 kg/m2 were enrolled and randomized. The two groups did not differ with respect to baseline characteristics and compliance with the study supplement. At 8 weeks, there was no significant difference between the glucomannan and placebo groups in amount of weight loss (−.40±.06 and −.43±.07, resp. or other efficacy outcomes or in any of the safety outcomes. Conclusions. Glucomannan supplements administered over 8 weeks were well tolerated but did not promote weight loss or significantly alter body composition, hunger/fullness, or lipid and glucose parameters. This trial is registered with NCT00613600.

  11. Efficacy and Safety of Ibuprofen in Infants Aged Between 3 and 6 Months.

    Science.gov (United States)

    Ziesenitz, Victoria C; Zutter, Andreas; Erb, Thomas O; van den Anker, Johannes N

    2017-08-01

    Ibuprofen is a non-steroidal anti-inflammatory drug frequently administered to children of various ages for relief of fever and pain and is approved as an over-the-counter medication in many countries worldwide. Although there are extensive data on its efficacy and safety in children and adults, there are divergent dosing recommendations for analgesia and treatment of fever in infants, especially in the age group between 3 and 6 months of age. In this article, we have assessed the safety and efficacy of ibuprofen use in infants in an attempt to find the optimal method of pain and fever management in this specific age group. Based on the current evidence, short-term use of ibuprofen is considered safe in infants older than 3 months of age having a body weight above 5-6 kg when special attention is given to the hydration of the patient. Ibuprofen should be prescribed based on body weight using a dose of 5-10 mg/kg. This dose can be administered 3-4 times a day resulting in a maximum total daily dose of 30-40 mg/kg. The rectal route has been shown to be less reliable because of erratic absorption, especially in young infants. Since most efficacy and safety data have been derived from trials in infants with fever, future studies should focus on the efficacy of ibuprofen in young infants with pain.

  12. Autologous Mesenchymal Stem Cell and Islet Cotransplantation: Safety and Efficacy.

    Science.gov (United States)

    Wang, Hongjun; Strange, Charlie; Nietert, Paul J; Wang, Jingjing; Turnbull, Taylor L; Cloud, Colleen; Owczarski, Stefanie; Shuford, Betsy; Duke, Tara; Gilkeson, Gary; Luttrell, Louis; Hermayer, Kathie; Fernandes, Jyotika; Adams, David B; Morgan, Katherine A

    2018-01-01

    Islet engraftment after transplantation is impaired by high rates of islet/β cell death caused by cellular stressors and poor graft vascularization. We studied whether cotransplantation of ex vivo expanded autologous bone marrow-derived mesenchymal stem cells (MSCs) with islets is safe and beneficial in chronic pancreatitis patients undergoing total pancreatectomy with islet autotransplantation. MSCs were harvested from the bone marrow of three islet autotransplantation patients and expanded at our current Good Manufacturing Practices (cGMP) facility. On the day of islet transplantation, an average dose of 20.0 ± 2.6 ×10 6 MSCs was infused with islets via the portal vein. Adverse events and glycemic control at baseline, 6, and 12 months after transplantation were compared with data from 101 historical control patients. No adverse events directly related to the MSC infusions were observed. MSC patients required lower amounts of insulin during the peritransplantation period (p = .02 vs. controls) and had lower 12-month fasting blood glucose levels (p = .02 vs. controls), smaller C-peptide declines over 6 months (p = .01 vs. controls), and better quality of life compared with controls. In conclusion, our pilot study demonstrates that autologous MSC and islet cotransplantation may be a safe and potential strategy to improve islet engraftment after transplantation. (Clinicaltrials.gov registration number: NCT02384018). Stem Cells Translational Medicine 2018;7:11-19. © 2017 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  13. Quality and Safety Aspects of Cereals (Wheat) and Their Products.

    Science.gov (United States)

    Varzakas, Theo

    2016-11-17

    Cereals and, most specifically, wheat are described in this chapter highlighting on their safety and quality aspects. Moreover, wheat quality aspects are adequately addressed since they are used to characterize dough properties and baking quality. Determination of dough properties is also mentioned and pasta quality is also described in this chapter. Chemometrics-multivariate analysis is one of the analyses carried out. Regarding production weighing/mixing of flours, kneading, extruded wheat flours, and sodium chloride are important processing steps/raw materials used in the manufacturing of pastry products. Staling of cereal-based products is also taken into account. Finally, safety aspects of cereal-based products are well documented with special emphasis on mycotoxins, acrylamide, and near infrared methodology.

  14. Quality and Safety Assurance of Iron Casts and Manufacturing Processes

    OpenAIRE

    Kukla S.

    2016-01-01

    The scope of this work focuses on the aspects of quality and safety assurance of the iron cast manufacturing processes. Special attention was given to the processes of quality control and after-machining of iron casts manufactured on automatic foundry lines. Due to low level of automation and huge work intensity at this stage of the process, a model area was established which underwent reorganization in accordance with the assumptions of the World Class Manufacturing (WCM). An analysis of wor...

  15. The Safety and Efficacy of Methylphenidate and Dexmethylphenidate in Adults with Attention Deficit/Hyperactivity Disorder

    Directory of Open Access Journals (Sweden)

    Michael A. Sopko

    2010-01-01

    Full Text Available Objective To review the literature on the safety and efficacy of methylphenidate, OROS-methylphenidate, methylphenidate ER, and dexmethylphenidate in adults with Attention-Deficit/Hyperactivity Disorder (ADHD. To analyze the effects of different doses of methylphenidate, it's various formulations, and methylphenidate on efficacy and safety in this population. Data Sources Literature retrieval was performed through Pubmed/MEDLINE (Up to May 2010 using the terms methylphenidate, dexmethylphenidate, and attention-deficit hyperactivity disorder. In addition, reference citations from publications identified were reviewed. Study Selection and Data Extraction Double-blinded, placebo-controlled clinical trials, as well as crossover and open-label trials found using the search criteria listed above were included for review. Case reports were not included in this review. Data Synthesis Attention-deficit/hyperactivity disorder (ADHD is a psychiatric condition that is commonly seen in children and adolescents, that persists into adulthood for about 50% of patients. Methylphenidate and dexmethylphenidate are often prescribed to treat the symptoms associated with ADHD. The literature validating the safety and efficacy of methylphenidate and dexmethylphenidate in children and adolescents with ADHD is substantial. However, the literature specifically addressing the safety and efficacy of these medications in the adult population is less extensive and prescribing is often anecdotal based on child and adolescent data. Understanding the literature regarding methylphenidate and dexmethylphenidate and its effects in adults can enhance evidence-based medicine (EBM and improve treatment outcomes Conclusion Methylphenidate and dexmethylphenidate are safe and effective medications to treat the symptoms of ADHD in adults. Based on the literature, increased doses are associated with better treatment response with moderate safety concerns. The different dosage forms

  16. Quality and safety training in primary care: making an impact.

    Science.gov (United States)

    Byrne, John M; Hall, Susan; Baz, Sam; Kessler, Todd; Roman, Maher; Patuszynski, Mark; Thakkar, Kruti; Kashner, T Michael

    2012-12-01

    Preparing residents for future practice, knowledge, and skills in quality improvement and safety (QI/S) is a requisite element of graduate medical education. Despite many challenges, residency programs must consider new curricular innovations to meet the requirements. We report the effectiveness of a primary care QI/S curriculum and the role of the chief resident in quality and patient safety in facilitating it. Through the Veterans Administration Graduate Medical Education Enhancement Program, we added a position for a chief resident in quality and patient safety, and 4 full-time equivalent internal medicine residents, to develop the Primary Care Interprofessional Patient-Centered Quality Care Training Curriculum. The curriculum includes a first-or second-year, 1-month block rotation that serves as a foundational experience in QI/S and interprofessional care. The responsibilities of the chief resident in quality and patient safety included organizing and teaching the QI/S curriculum and mentoring resident projects. Evaluation included prerotation and postrotation surveys of self-assessed QI/S knowledge, abilities, skills, beliefs, and commitment (KASBC); an end-of-the-year KASBC; prerotation and postrotation knowledge test; and postrotation and faculty surveys. Comparisons of prerotation and postrotation KASBC indicated significant self-assessed improvements in 4 of 5 KASBC domains: knowledge (P < .001), ability (P < .001), skills (P < .001), and belief (P < .03), which were sustained on the end-of-the-year survey. The knowledge test demonstrated increased QI/S knowledge (P  =  .002). Results of the postrotation survey indicate strong satisfaction with the curriculum, with 76% (25 of 33) and 70% (23 of 33) of the residents rating the quality and safety curricula as always or usually educational. Most faculty members acknowledged that the chief resident in quality and patient safety enhanced both faculty and resident QI/S interest and

  17. Efficacy and safety of the probiotic Saccharomyces boulardii for the prevention and therapy of gastrointestinal disorders

    Science.gov (United States)

    Kelesidis, Theodoros

    2012-01-01

    Several clinical trials and experimental studies strongly suggest a place for Saccharomyces boulardii as a biotherapeutic agent for the prevention and treatment of several gastrointestinal diseases. S. boulardii mediates responses resembling the protective effects of the normal healthy gut flora. The multiple mechanisms of action of S. boulardii and its properties may explain its efficacy and beneficial effects in acute and chronic gastrointestinal diseases that have been confirmed by clinical trials. Caution should be taken in patients with risk factors for adverse events. This review discusses the evidence for efficacy and safety of S. boulardii as a probiotic for the prevention and therapy of gastrointestinal disorders in humans. PMID:22423260

  18. Perinatal staff perceptions of safety and quality in their service.

    Science.gov (United States)

    Sinni, Suzanne V; Wallace, Euan M; Cross, Wendy M

    2014-11-28

    Ensuring safe and appropriate service delivery is central to a high quality maternity service. With this in mind, over recent years much attention has been given to the development of evidence-based clinical guidelines, staff education and risk reporting systems. Less attention has been given to assessing staff perceptions of a service's safety and quality and what factors may influence that. In this study we set out to assess staff perceptions of safety and quality of a maternity service and to explore potential influences on service safety. The study was undertaken within a new low risk metropolitan maternity service in Victoria, Australia with a staffing profile comprising midwives (including students), neonatal nurses, specialist obstetricians, junior medical staff and clerical staff. In depth open-ended interviews using a semi-structured questionnaire were conducted with 23 staff involved in the delivery of perinatal care, including doctors, midwives, nurses, nursing and midwifery students, and clerical staff. Data were analyzed using naturalistic interpretive inquiry to identify emergent themes. Staff unanimously reported that there were robust systems and processes in place to maintain safety and quality. Three major themes were apparent: (1) clinical governance, (2) dominance of midwives, (3) inter-professional relationships. Overall, there was a strong sense that, at least in this midwifery-led service, midwives had the greatest opportunity to be an influence, both positively and negatively, on the safe delivery of perinatal care. The importance of understanding team dynamics, particularly mutual respect, trust and staff cohesion, were identified as key issues for potential future service improvement. Senior staff, particularly midwives and neonatal nurses, play central roles in shaping team behaviors and attitudes that may affect the safety and quality of service delivery. We suggest that strategies targeting senior staff to enhance their performance in

  19. The relation between quality of clinical trials and acupuncture efficacy

    Directory of Open Access Journals (Sweden)

    David Gonçalves Nordon

    2013-06-01

    Full Text Available Introduction: Clinical trials of acupuncture not always have concordant results, mostly due to their great heterogeneity. Two indexes have been developed to analyze the quality of acupuncture trials. This study hypothesizes that, the more adequate the intervention and the control techniques, the more efficacious the acupuncture. Methods: Both indexes were applied to 27 randomized clinical trials comparing acupuncture to placebo. Results were compared by using the Mann-Whitney test. Results: Studies favorable to acupuncture had a intervention score’s median of 11.5; for the unfavorable ones, it was 7, p: 0.0017. Articles with and without statistically significant differences, though, had the same median for their scores in the control index: 6. Discussion: There is a positive relation between a better score for acupuncture technique and a statistically significant difference between acupuncture and interventional control. However, due to the little heterogeneity in the degree of physiological effect from each article, the control index had no statistical significance. Conclusion: This study established that, among acupuncture RCT controlled by placebo or sham of moderate physiological effect, the adequacy of the technique is more important than the adequacy of control in establishing a statistically significant difference between acupuncture and interventional control.

  20. Efficacy and safety of laxatives for chronic constipation in long-term care settings: A systematic review.

    Science.gov (United States)

    Alsalimy, N; Madi, L; Awaisu, A

    2018-06-09

    Constipation is a common disorder among long-term care (LTC) patients due to several factors. However, there are no systematic reviews investigating the use of laxatives for chronic constipation in LTC settings. This study aims to explore the safety and efficacy of laxatives in LTC patients. A systematic review of randomized controlled trials (RCTs) describing the efficacy and safety of laxatives for chronic constipation in LTC patients was conducted using the following databases and search engines: MEDLINE, Cochrane Database of Systematic Reviews, ScienceDirect, ProQuest and Google Scholar. Two of the investigators independently performed the searches, and the data were extracted using a standardized data abstraction tool. Seven RCTs involving 444 patients were included in the review. These studies included senna (with or without fibre, ie Plantago ovata), lactulose, sodium picosulphate, docusate sodium, docusate calcium, isotonic and hypotonic polyethylene glycol and Chinese herbal medicine. Senna and lactulose were the most studied laxatives in LTC patients, and senna was found to be superior to or as effective as other laxatives. Generally, the frequency and severity of adverse drug reactions (ADRs) were similar between the arms of the studies, and no serious ADRs were reported. Considering the short duration of the trials, the lack of trials including newer laxatives and the low quality of some of the included trials, the long-term efficacy and safety of these laxatives are not conclusive. There is a need to conduct more robust RCTs that include newer agents to evaluate long-term outcomes. © 2018 John Wiley & Sons Ltd.

  1. Quality procedure management for improved nuclear safety

    International Nuclear Information System (INIS)

    Forzano, P.; Castagna, P.

    1995-01-01

    Emergency Operating Procedures and Accident Management Procedures are the next step in the computerization of NPP control rooms. Different improvements are presently conceivable for this operator aid tool, and research activities are in development. Undergoing activities regard especially formal aspects of knowledge representation, Human-Machine interface and procedure life cycle management. These aspects have been investigated deeply by Ansaldo, and partially incorporated in the DIAM prototype. Nuclear Power Plant Procedures can be seen from essentially two viewpoints: the process and the information management. From the first point of view, it is important to supply the knowledge apt to solve problems connected with the control of the process, from the second one the focus of attention is on the knowledge representation, its structure, elicitation and maintenance, and formal quality assurance. These two aspects of procedure representation can be considered and solved separately. In particular, methodological, formal and management issues require long and tedious activities, that in most cases constitute a great barrier for procedures development and upgrade. To solve these problems, Ansaldo is developing DIAM, a wide integrated tool for procedure management to support in procedure writing, updating, usage, and documentation. One of the most challenging features of DIAM is AUTO-LAY, a CASE sub-tool that, in a complete automatical way, structures parts or complete flow diagram. This is the feature that is partial present in some other CASE products, that, anyway, do not allow complex graph handling and isomorphism between video and paper representation. AUTO-LAY has the unique prerogative to draw graphs of any complexity to section them in pages, and to automatically compose a document. This has been recognized in the literature as the most important a second-generation CASE improvement. (Author) 9 Figs., 5 Refs

  2. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults.

    Science.gov (United States)

    Hristovska, Ana-Marija; Duch, Patricia; Allingstrup, Mikkel; Afshari, Arash

    2017-08-14

    Acetylcholinesterase inhibitors, such as neostigmine, have traditionally been used for reversal of non-depolarizing neuromuscular blocking agents. However, these drugs have significant limitations, such as indirect mechanisms of reversal, limited and unpredictable efficacy, and undesirable autonomic responses. Sugammadex is a selective relaxant-binding agent specifically developed for rapid reversal of non-depolarizing neuromuscular blockade induced by rocuronium. Its potential clinical benefits include fast and predictable reversal of any degree of block, increased patient safety, reduced incidence of residual block on recovery, and more efficient use of healthcare resources. The main objective of this review was to compare the efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade caused by non-depolarizing neuromuscular agents in adults. We searched the following databases on 2 May 2016: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (WebSPIRS Ovid SP), Embase (WebSPIRS Ovid SP), and the clinical trials registries www.controlled-trials.com, clinicaltrials.gov, and www.centerwatch.com. We re-ran the search on 10 May 2017. We included randomized controlled trials (RCTs) irrespective of publication status, date of publication, blinding status, outcomes published, or language. We included adults, classified as American Society of Anesthesiologists (ASA) I to IV, who received non-depolarizing neuromuscular blocking agents for an elective in-patient or day-case surgical procedure. We included all trials comparing sugammadex versus neostigmine that reported recovery times or adverse events. We included any dose of sugammadex and neostigmine and any time point of study drug administration. Two review authors independently screened titles and abstracts to identify trials for eligibility, examined articles for eligibility, abstracted data, assessed the articles, and excluded obviously irrelevant reports. We resolved

  3. Quality and safety of nuclear installations: the role of administration, and, nuclear safety and regulatory procedures

    International Nuclear Information System (INIS)

    Queniart, D.

    1979-12-01

    In the first paper the author defines the concepts of safety and quality and describes the means of intervention by the Public Authorities in safety matters of nuclear installations. These include individual authorisations, definition and application of technical rules and surveillance of installations. In the second paper he defines the distinction between radiation protection and safety and presents the legislative and regulatory plan for nuclear safety in France. A central safety service for nuclear installations was created in March 1973 within the Ministry of Industrial and Scientific Development, where, amongst other tasks, it draws up regulatory procedures and organizes inspections of the installations. The main American regulations for light water reactors are outlined and the French regulatory system for different types of reactors discussed

  4. Modelling the microbial quality and safety of foods

    NARCIS (Netherlands)

    Wijtzes, T.

    1996-01-01

    Quality and safety of foods are often influenced by the presence and growth of microorganisms. Microorganisms in foods can be divided into two groups: pathogenic organisms, causing illness, and microorganisms that are not harmful to health, but that can spoil a product. Presence and growth of

  5. Postharvest quality and safety maintenance of the physical ...

    African Journals Online (AJOL)

    Biodegradable edible coatings from Moringa oil(MO) and Neem oil (NO) was applied to carrot fruits in order to provide environmentally friendly, healthy treatments (with which to better preserve fresh fruit quality) and safety during postharvest storage at ambient temperature of 27± 3oC and relative humidity of 50-60% .

  6. Quantification of microbial quality and safety in minimally processed foods

    NARCIS (Netherlands)

    Zwietering, M.H.

    2002-01-01

    To find a good equilibrium between quality and margin of safety of minimally processed foods, often various hurdles are used. Quantification of the kinetics should be used to approach an optimum processing and to select the main aspects. Due to many factors of which the exact quantitative effect is

  7. Water-safety strategies and local-scale spatial quality

    NARCIS (Netherlands)

    Nillesen, A.L.

    2013-01-01

    Delta regions throughout the world are subject to increasing flood risks. For protection, regional water safety strategies are being developed. Local-scale spatial qualities should be included in their evaluation. An experimental methodology has been developed for this purpose. This paper

  8. Can traceability improve consumers' confidence in food quality and safety?

    NARCIS (Netherlands)

    Rijswijk, van W.; Cornelisse-Vermaat, J.R.; Frewer, L.J.

    2006-01-01

    Abstract This paper investigates whether the implementation of traceability systems in line with the European General Food Law as well as food labelling laws related to allergens can impact on consumer confidence in food quality and safety. It aims to give insight into consumer demands regarding

  9. [Legislation and inspection for the health and safety of workers. Efficacy and limits].

    Science.gov (United States)

    Tozzi, G A

    2009-01-01

    To provide information regarding Occupational Health and Safety (OHS) Inspections in Europe. The dynamics that are transforming regulatory subsystems and complementary inspection services are described. Simplification initiatives, the limits and difficulties of applying the different models of Health and Safety Management Systems are discussed. Examples are given on how to evaluate legislation and technical standards during planning and enforcement. Different approaches for studying characteristics, methodologies and efficacy in practice of OHS Inspection are provided. Targeted inspections need to respond to the needs of enterprises and workers. Impartiality must be guaranteed and workers' participation should be facilitated.

  10. Efficacy, safety, and patient preference of monoamine oxidase B inhibitors in the treatment of Parkinson's disease

    Directory of Open Access Journals (Sweden)

    Bradley J Robottom

    2011-01-01

    Full Text Available Bradley J RobottomDepartment of Neurology, University of Maryland School of Medicine, Baltimore, MD, USAAbstract: Parkinson's disease (PD is the second most common neurodegenerative disease and the most treatable. Treatment of PD is symptomatic and generally focuses on the replacement or augmentation of levodopa. A number of options are available for treatment, both in monotherapy of early PD and to treat complications of advanced PD. This review focuses on rasagiline and selegiline, two medications that belong to a class of antiparkinsonian drugs called monoamine oxidase B (MAO-B inhibitors. Topics covered in the review include mechanism of action, efficacy in early and advanced PD, effects on disability, the controversy regarding disease modification, safety, and patient preference for MAO-B inhibitors.Keywords: monoamine oxidase inhibitors, rasagiline, selegiline, Parkinson's disease, efficacy, safety

  11. Increasing the safety and efficacy of chimeric antigen receptor T cell therapy

    Directory of Open Access Journals (Sweden)

    Hua Li

    2017-04-01

    Full Text Available Abstract Chimeric antigen receptor (CAR T cell therapy is a promising cancer treatment that has recently been undergoing rapid development. However, there are still some major challenges, including precise tumor targeting to avoid off-target or “on-target/off-tumor” toxicity, adequate T cell infiltration and migration to solid tumors and T cell proliferation and persistence across the physical and biochemical barriers of solid tumors. In this review, we focus on the primary challenges and strategies to design safe and effective CAR T cells, including using novel cutting-edge technologies for CAR and vector designs to increase both the safety and efficacy, further T cell modification to overcome the tumor-associated immune suppression, and using gene editing technologies to generate universal CAR T cells. All these efforts promote the development and evolution of CAR T cell therapy and move toward our ultimate goal—curing cancer with high safety, high efficacy, and low cost.

  12. Preclinical imaging methods for assessing the safety and efficacy of regenerative medicine therapies

    Science.gov (United States)

    Scarfe, Lauren; Brillant, Nathalie; Kumar, J. Dinesh; Ali, Noura; Alrumayh, Ahmed; Amali, Mohammed; Barbellion, Stephane; Jones, Vendula; Niemeijer, Marije; Potdevin, Sophie; Roussignol, Gautier; Vaganov, Anatoly; Barbaric, Ivana; Barrow, Michael; Burton, Neal C.; Connell, John; Dazzi, Francesco; Edsbagge, Josefina; French, Neil S.; Holder, Julie; Hutchinson, Claire; Jones, David R.; Kalber, Tammy; Lovatt, Cerys; Lythgoe, Mark F.; Patel, Sara; Patrick, P. Stephen; Piner, Jacqueline; Reinhardt, Jens; Ricci, Emanuelle; Sidaway, James; Stacey, Glyn N.; Starkey Lewis, Philip J.; Sullivan, Gareth; Taylor, Arthur; Wilm, Bettina; Poptani, Harish; Murray, Patricia; Goldring, Chris E. P.; Park, B. Kevin

    2017-10-01

    Regenerative medicine therapies hold enormous potential for a variety of currently incurable conditions with high unmet clinical need. Most progress in this field to date has been achieved with cell-based regenerative medicine therapies, with over a thousand clinical trials performed up to 2015. However, lack of adequate safety and efficacy data is currently limiting wider uptake of these therapies. To facilitate clinical translation, non-invasive in vivo imaging technologies that enable careful evaluation and characterisation of the administered cells and their effects on host tissues are critically required to evaluate their safety and efficacy in relevant preclinical models. This article reviews the most common imaging technologies available and how they can be applied to regenerative medicine research. We cover details of how each technology works, which cell labels are most appropriate for different applications, and the value of multi-modal imaging approaches to gain a comprehensive understanding of the responses to cell therapy in vivo.

  13. Efficacy and safety of endometrial ablation for treating abnormal uterine bleeding in pre- and postmenopausal women with liver cirrhosis.

    Science.gov (United States)

    Liu, Qing; Li, Xiu-Lan; Liu, Ji-Juan; Song, Xiao-Hong; Jiang, Xiao-Ying; Li, Wei; Zhang, Hua; Pan, Calvin Q

    2016-12-01

    Abnormal uterine bleeding (AUB) occurs in 10-30% of women of reproductive age and up to 61% of cirrhotic women. We evaluated the efficacy and safety of endometrial ablation (NovaSure therapy) for AUB in cirrhotic women. This prospective, two-arm, observational study enrolled patients for NovaSure treatment, and they were followed for 12 months. Primary measurements were the amenorrhea rate and changes of pictorial blood loss assessment chart (PBLAC) scores at 1-month post-therapy. Key secondary end-points included the longevity of amenorrhea at 12 months, safety profile, and progression of cirrhosis. Among 88 women, 26 were cirrhotic and 62 were non-cirrhotic. At 1-month post-NovaSure treatment, a significant reduction of mean PBLAC scores was observed in cirrhotic patients compared to those at baseline (0.4 ± 1.3 vs 215.2 ± 410.9, P < 0.001), and the amenorrhea rate was 88.5%. The efficacy outcomes of the PBLAC scores and amenorrhea rate were maintained until the end of the 12-month follow-up. A significant improvement in quality of life scores was observed 1-month post-therapy compared to those at baseline (5.4 ± 3.1 vs 20.5 ± 5.5, P < 0.001). Patients' satisfaction rates were 100% and 92.31% at 6 and 12 months, respectively. The aforementioned outcomes were comparable with those in non-cirrhotic patients. No significant progression of cirrhosis or safety concern was reported. Cirrhotic patients on NovaSure therapy had a high rate of amenorrhea 1-month post-treatment, which maintained longevity for 12 months. The safety profile was similar to that in non-cirrhotic patients. © 2016 Japan Society of Obstetrics and Gynecology.

  14. 77 FR 42738 - Patient Safety Organizations: Voluntary Relinquishment From the Coalition for Quality and Patient...

    Science.gov (United States)

    2012-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From the Coalition for Quality and Patient Safety of Chicagoland (CQPS.... SUMMARY: The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41,42...

  15. Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability

    Directory of Open Access Journals (Sweden)

    Abrouk M

    2016-12-01

    Full Text Available Michael Abrouk,1 Ethan Levin,2 Merrick Brodsky,1 Jessica R Gandy,1 Mio Nakamura,2 Tian Hao Zhu,3 Benjamin Farahnik,4 John Koo,2 Tina Bhutani2 1Irvine School of Medicine, Irvine, 2Department of Dermatology, Psoriasis and Skin Treatment Center, University of California, San Francisco, 3Department of Dermatology, University of Southern California Keck School of Medicine, Los Angeles, CA, 4Department of Dermatology, University of Vermont College of Medicine, Burlington, VT, USA Introduction: The 308 nm excimer laser is a widely used device throughout the field of dermatology for many diseases including psoriasis. Although the laser has demonstrated clinical efficacy, there is a lack of literature outlining the safety, efficacy, and patient acceptability of the excimer laser. Methods: A literature search on PubMed was used with combinations of the terms “excimer”, “excimer laser”, “308 nm”, “psoriasis”, “protocol”, “safety”, “efficacy”, acceptability”, “side effects”, and “dose”. The search results were included if they contained information pertaining to excimer laser and psoriasis treatment and description of the safety, efficacy, and patient acceptability of the treatment. Results: The 308 nm excimer laser is generally safe and well tolerated with minimal side effects including erythema, blistering, and pigmentary changes. It has a range of efficacies depending on the protocol used with several different treatment protocols, including the induration protocol, the minimal erythema dose protocol, and the newer minimal blistering dose protocol. Conclusion: Although the excimer laser is not a first-line treatment, it remains an excellent treatment option for psoriasis patients and has been demonstrated to be an effective treatment with little to no side effects. Keywords: excimer, laser, 308 nm, psoriasis, safety, efficacy

  16. Anesthesia Quality and Patient Safety in China: A Survey.

    Science.gov (United States)

    Zhu, Bin; Gao, Huan; Zhou, Xiangyong; Huang, Jeffrey

    There has been no nationwide investigation into anesthesia quality and patient safety in China. The authors surveyed Chinese anesthesiologists about anesthesia quality by sending a survey to all anesthesiologist members of the New Youth Anesthesia Forum via WeChat. The respondents could choose to use a mobile device or desktop to complete the survey. The overall response rate was 43%. Intraoperative monitoring: 77.9% of respondents reported that electrocardiogram monitoring was routinely applied for all patients; only 55% of the respondents reported that they routinely used end-tidal carbon dioxide monitoring for their patients under general anesthesia. 10.3% of respondents admitted that they had at least one wrong medicine administration in the past 3 months; 12.4% reported that they had at least one case of cardiac arrest in the past year. This is the first anesthesia quality survey in China. The findings revealed potential anesthesia safety issues in China.

  17. Software quality assurance plans for safety-critical software

    International Nuclear Information System (INIS)

    Liddle, P.

    2006-01-01

    Application software is defined as safety-critical if a fault in the software could prevent the system components from performing their nuclear-safety functions. Therefore, for nuclear-safety systems, the AREVA TELEPERM R XS (TXS) system is classified 1E, as defined in the Inst. of Electrical and Electronics Engineers (IEEE) Std 603-1998. The application software is classified as Software Integrity Level (SIL)-4, as defined in IEEE Std 7-4.3.2-2003. The AREVA NP Inc. Software Program Manual (SPM) describes the measures taken to ensure that the TELEPERM XS application software attains a level of quality commensurate with its importance to safety. The manual also describes how TELEPERM XS correctly performs the required safety functions and conforms to established technical and documentation requirements, conventions, rules, and standards. The program manual covers the requirements definition, detailed design, integration, and test phases for the TELEPERM XS application software, and supporting software created by AREVA NP Inc. The SPM is required for all safety-related TELEPERM XS system applications. The program comprises several basic plans and practices: 1. A Software Quality-Assurance Plan (SQAP) that describes the processes necessary to ensure that the software attains a level of quality commensurate with its importance to safety function. 2. A Software Safety Plan (SSP) that identifies the process to reasonably ensure that safety-critical software performs as intended during all abnormal conditions and events, and does not introduce any new hazards that could jeopardize the health and safety of the public. 3. A Software Verification and Validation (V and V) Plan that describes the method of ensuring the software is in accordance with the requirements. 4. A Software Configuration Management Plan (SCMP) that describes the method of maintaining the software in an identifiable state at all times. 5. A Software Operations and Maintenance Plan (SO and MP) that

  18. Efficacy and safety of icotinib in patients with brain metastases from lung adenocarcinoma

    OpenAIRE

    Xu, Jianping; Liu, Xiaoyan; Yang, Sheng; Zhang, Xiangru; Shi, Yuankai

    2016-01-01

    Jianping Xu, Xiaoyan Liu, Sheng Yang, Xiangru Zhang, Yuankai Shi Department of Internal Medicine, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China Objective: The objective of this study was to evaluate the efficacy and safety of icotinib in patients with brain metastases (BMs) from lung adenocarcinoma.Patients and methods: Clinical data of 28 cases with BMs from lung adenocarcinoma were retrospectively analyzed. All the patients took 125&am...

  19. The Safety and Efficacy of Adjustable Postoperative Position after Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment

    OpenAIRE

    Lin, Zhong; Sun, Jin Tao; Wu, Rong Han; Moonasar, Nived; Zhou, Ye Hui

    2017-01-01

    Purpose. To report the safety and efficacy of adjustable postoperative position for rhegmatogenous retinal detachment (RRD). Methods. Retrospective review of 536 consecutive RRD eyes that underwent vitrectomy surgery for retina repair from year 2008 to 2014. The retinal breaks were divided into superior, lateral (nasal, temporal, and macular), and inferior locations, according to the clock of breaks. Patients with superior and lateral break location were allowed to have facedown position or l...

  20. Safety and efficacy of herbal tea for patients with diabetes mellitus

    OpenAIRE

    Siti Syarihan Abdullah; Ali Saleh Alkhoshaiban; Vasudevan Mani; Muhammad Eid Akkawi; Long Chiau Ming

    2016-01-01

    Purpose: The aim of this report is to review (i) safety and efficacy and (ii) medical marketing and regulation of Glucos Cut (GC) Tea. Methodology: The electronic databases such as PubMed, ScienceDirect, Google Scholar, and MEDLINE via EBSCOhost were searched with no limit to year of publication. Additional information was obtained from the Micromedex, “Medicines (Advertisement and Sales) Act 1956” and the “Guideline on Advertising of Medicines and Medicinal Products to General Public 2006...

  1. Efficacy and Safety of Topical Corticosteroids for Management of Oral Chronic Graft versus Host Disease

    OpenAIRE

    Elsaadany, Basma Abdelaleem; Ahmed, Eman Magdy; Aghbary, Sana Maher Hasan

    2017-01-01

    Background. Oral chronic graft versus host disease (cGVHD) is a major complication in transplantation community, a problem that can be addressed with topical intervention. Topical corticosteroids are the first line of treatment although the choice remains challenging as none of the available treatments is supported by strong clinical evidence. Objective. This systematic review aims to determine the clinical efficacy and safety of topical corticosteroids for the management of the mucosal alter...

  2. Safety and efficacy evaluation of gelatin-based nanoparticles associated with UV filters.

    Science.gov (United States)

    Oliveira, Camila Areias de; Dario, Michelli Ferrera; Sarruf, Fernanda Daud; Mariz, Inês Fátima Afonso; Velasco, Maria Valéria Robles; Rosado, Catarina; Baby, André Rolim

    2016-04-01

    The safety and efficacy assessment of nanomaterials is a major concern of industry and academia. These materials, due to their nanoscale size, can have chemical, physical, and biological properties that differ from those of their larger counterparts. The encapsulation of natural ingredients can provide marked improvements in sun protection efficacy. This strategy promotes solubility enhancement of flavonoids and yields an improved active ingredient with innovative physical, physicochemical and functional characteristics. Rutin, a flavonoid, has chemical and functional stability in topical vehicles exerting a synergistic effect in association with ultraviolet (UV) filters. However, the solubility of rutin is a limiting factor. Additionally, this bioactive compound does not have tendency to permeate across the stratum corneum. As an alternative to common synthetic based sunscreens, rutin-entrapped gelatin nanoparticles were designed. The present study investigated the pre-clinical safety of gelatin nanoparticles (GNPs) using an in vitro method and also assessed the clinical safety and efficacy of the association of GNPs with three commonly used chemical UV filters (ethylhexyl dimethyl PABA, ethylhexyl methoxycinnamate and methoxydibenzoylmethane). The non-irritant and adequate safety profile under sun-exposed skin conditions of the nanomaterials and the emulsions qualified the products for clinical efficacy assays. The in vivo results indicated that the GNPs increased the antioxidant protection of the emulsions developed. However, the presence of rutin in the nanosized material did not enhance performance on the SPF test. In conclusion, these findings characterized the nanomaterials as an innovative platform for multifunctional bioactive sunscreens. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. Safety and efficacy of generic drugs with respect to brand formulation

    OpenAIRE

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-01-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to gener...

  4. Deep Brain Stimulation in Huntington’s Disease—Preliminary Evidence on Pathophysiology, Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    Lars Wojtecki

    2016-08-01

    Full Text Available Huntington’s disease (HD is one of the most disabling degenerative movement disorders, as it not only affects the motor system but also leads to cognitive disabilities and psychiatric symptoms. Deep brain stimulation (DBS of the pallidum is a promising symptomatic treatment targeting the core motor symptom: chorea. This article gives an overview of preliminary evidence on pathophysiology, safety and efficacy of DBS in HD.

  5. Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk

    Directory of Open Access Journals (Sweden)

    Covelli H

    2015-12-01

    Full Text Available Henry Covelli,1 Bonavuth Pek,2 Isabelle Schenkenberger,3 Catherine Scott-Wilson,4 Amanda Emmett,5 Courtney Crim4 1Kootenai Health, Coeur d’Alene, ID, USA; 2Clinique de Pneumologie et de Sommeil de Lanaudière, Quebec, Canada; 3Klinische Forschung, Berlin, Germany; 4GlaxoSmithKline Inc., Research Triangle Park, 5PAREXEL International, Durham, NC, USA Background: Fluticasone furoate/vilanterol (FF/VI is a novel, once-daily, inhaled corticosteroid/long-acting β2-agonist combination approved for the treatment of COPD and asthma. We compared the safety and efficacy of FF/VI and tiotropium (TIO in subjects with moderate-to-severe COPD with greater risk for comorbid cardiovascular disease (CVD.Methods: This randomized, blinded, double-dummy, parallel-group study compared a once-daily morning dose of FF/VI 100/25 mcg delivered via ELLIPTA™ with TIO 18 mcg via HandiHaler® for 12 weeks in subjects with diagnosed COPD, forced expiratory volume in 1 second (FEV1 30%–70% predicted, and CVD or CVD risk. The primary endpoint was change from baseline in 24-hour weighted mean FEV1 on Day 84. Other efficacy endpoints included time to onset of bronchodilation, trough FEV1, other spirometry measures, rescue medication use, symptoms, quality of life (St George’s Respiratory Questionnaire-COPD [SGRQ-C], and health status (COPD Assessment Tests [CAT] measures. Safety endpoints included cardiovascular monitoring, cortisol excretion, COPD exacerbations, and adverse events, including prespecified drug effects.Results: Both FF/VI and TIO improved the 24-hour weighted mean FEV1 from baseline after 12 weeks with no significant difference between treatments. Other endpoints favored FF/VI for time to onset of bronchodilation, rescue medication use, dyspnea, SGRQ-C and CAT scores, or favored TIO for change from baseline in forced vital capacity and inspiratory capacity. Pneumonia occurred more frequently in the FF/VI group, and two TIO-treated subjects died

  6. Pesticide Substitution: Combining Food Safety with Environmental Quality

    DEFF Research Database (Denmark)

    Fantke, Peter

    2015-01-01

    Various pesticides are authorized for use on agricultural food crops. Despite regulatory risk assessments aiming at ensuring consumer and environmental safety, pesticides contribute to human and environmental impacts. Guidance is needed to optimize pesticide use practice and minimize human...... and environmental exposure. Comparative pesticide substitution scenarios are presented to address this need. In a case study on wheat, different pesticides have been compared with respect to their substitution potential with focus on human health. Results demonstrate that health impacts can be reduced up to 99......% by defining adequate substitution scenarios. Comprehensive scenarios need to also consider worker and environmental burden, and information on crop rotation, pest pressure, environmental conditions, application costs and efficacy. Such scenarios help to increase food safety and more sustainable use...

  7. Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis.

    Science.gov (United States)

    Dorkin, Henry L; Staab, Doris; Operschall, Elisabeth; Alder, Jeff; Criollo, Margarita

    2015-01-01

    Treatment of infective bronchitis involving Pseudomonas aeruginosa is a cornerstone of care in patients with cystic fibrosis (CF). This phase IIb, randomised, double-blind, placebo-controlled study assessed the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in this population. Patients with CF, ≥12 years of age (N=286), were randomised to ciprofloxacin DPI (32.5 mg (n=93) or 48.75 mg (n=93)), or corresponding placebo (32.5 mg, n=65; 48.75 mg, n=35) twice daily for 28 days. The primary objective was the change in forced expiratory volume in 1 s (FEV1) from baseline (day 0) to end of treatment (day 29) in the intent-to-treat population for ciprofloxacin DPI compared with the corresponding placebo group. The primary effectiveness objective was not met; there were no significant differences in change in FEV1 between ciprofloxacin DPI and the corresponding placebo group for either dose (p=0.154). However, in pooled analyses, FEV1 decline from baseline to treatment end was significantly lower with ciprofloxacin DPI than with placebo (pooled data; p=0.02). Ciprofloxacin DPI showed positive effects on sputum bacterial load and quality of life, but these effects were not maintained at the 4-week follow-up. Ciprofloxacin DPI was well tolerated and there were no significant differences in type/incidence of treatment-emergent adverse events by treatment group (p=0.115). Further investigations are needed to determine the full scope of the beneficial effects of ciprofloxacin DPI for patients with CF. Clinicaltrials.gov NCT00645788; EudraCT 2008-008314-40.

  8. COMPARISON OF SAFETY AND EFFICACY OF LEVOSULPIRIDE AND ITOPRIDE IN TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE

    Directory of Open Access Journals (Sweden)

    Syed Ibrahim Hassan

    2017-01-01

    Full Text Available BACKGROUND Gastroesophageal Reflux Disease (GERD is a common condition caused by reflux of the liquid acidic contents of the stomach into the oesophagus. Prokinetic medications can be used to treat or control the disease. Such medications can have mild-toserious adverse effects. Levosulpiride and itopride are two such medications, which are used for treating GERD. The aim of the study is to assess the safety and efficacy of levosulpiride and itopride in the management of GERD and to study the side effects and treatment outcome. MATERIALS AND METHODS A total 210 patients aged 18 to 90 years, 99 males and 111 females (male:female ratio of 1:1.1 with reflux oesophagitis were divided into three groups and an endoscopy test was done before starting treatment. The control group received rabeprazole and the two test groups received levosulpiride and itopride. Clinical adverse events were recorded at the end of week 1 and week 2. Following treatment, relief of symptoms was assessed at the end of 2 weeks. RESULTS There were total 210 patients (99 males and 111 females. The male-to-female ratio was 1:1.1. GERD was more common in the 31-50 year age group. Most common symptoms were of dyspepsia, regurgitation, vomiting and heartburn. Improvement of symptoms during the treatment was seen in 53% levosulpiride and 41% itopride patients, respectively. The main adverse effects were abdominal pain and nausea. The percentage of nausea was high with itopride than levosulpiride. CONCLUSION Gastroesophageal reflux disease is a common problem frequently seen in both genders and in younger people. Symptomatic relief and endoscopic recovery is early with levosulpiride than itopride. Levosulpiride gives better quality of life earlier in the treatment than itopride and has lesser side effects and better healing outcome.

  9. Tranexamic acid for the treatment of heavy menstrual bleeding: efficacy and safety

    Science.gov (United States)

    Leminen, Henri; Hurskainen, Ritva

    2012-01-01

    Tranexamic acid has proven to be an effective treatment for heavy menstrual bleeding (HMB). It reduces menstrual blood loss (MBL) by 26%–60% and is significantly more effective than placebo, nonsteroidal anti-inflammatory drugs, oral cyclical luteal phase progestins, or oral etamsylate, while the levonorgestrel-releasing intrauterine system reduces MBL more than tranexamic acid. Other treatments used for HMB are oral contraceptives, danazol, and surgical interventions (endometrial ablation and hysterectomy). Medical therapy is usually considered a first-line treatment for idiopathic HMB. Tranexamic acid significantly improves the quality of life of women treated for HMB. The recommended oral dosage is 3.9–4 g/day for 4–5 days starting from the first day of the menstrual cycle. Adverse effects are few and mainly mild. No evidence exists of an increase in the incidence of thrombotic events associated with its use. An active thromboembolic disease is a contraindication. In the US, a history of thrombosis or thromboembolism, or an intrinsic risk for thrombosis or thromboembolism are considered contraindications as well. This review focuses on the efficacy and safety of tranexamic acid in the treatment of idiopathic HMB. We searched for medical literature published in English on tranexamic acid from Ovid Medline, PubMed, and Cinahl. Additional references were identified from the reference lists of articles. Ovid Medline, PubMed, and Cinahl search terms were “tranexamic acid” and “menorrhagia” or “heavy menstrual bleeding.” Searches were last updated on March 25, 2012. Studies with women receiving tranexamic acid for HMB were included; randomized controlled studies with a description of appropriate statistical methodology were preferred. Relevant data on the physiology of menstruation and the pharmacodynamics and pharmacokinetics of tranexamic acid are also included. PMID:22956886

  10. [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 channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

  11. Simultaneous sequential monitoring of efficacy and safety led to masking of effects.

    Science.gov (United States)

    van Eekelen, Rik; de Hoop, Esther; van der Tweel, Ingeborg

    2016-08-01

    Usually, sequential designs for clinical trials are applied on the primary (=efficacy) outcome. In practice, other outcomes (e.g., safety) will also be monitored and influence the decision whether to stop a trial early. Implications of simultaneous monitoring on trial decision making are yet unclear. This study examines what happens to the type I error, power, and required sample sizes when one efficacy outcome and one correlated safety outcome are monitored simultaneously using sequential designs. We conducted a simulation study in the framework of a two-arm parallel clinical trial. Interim analyses on two outcomes were performed independently and simultaneously on the same data sets using four sequential monitoring designs, including O'Brien-Fleming and Triangular Test boundaries. Simulations differed in values for correlations and true effect sizes. When an effect was present in both outcomes, competition was introduced, which decreased power (e.g., from 80% to 60%). Futility boundaries for the efficacy outcome reduced overall type I errors as well as power for the safety outcome. Monitoring two correlated outcomes, given that both are essential for early trial termination, leads to masking of true effects. Careful consideration of scenarios must be taken into account when designing sequential trials. Simulation results can help guide trial design. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Comparative efficacy and safety of mavacoxib and carprofen in the treatment of canine osteoarthritis.

    Science.gov (United States)

    Payne-Johnson, M; Becskei, C; Chaudhry, Y; Stegemann, M R

    2015-03-14

    A multi-site, masked, randomised parallel group study employing a double dummy treatment design was performed in canine veterinary patients to determine the comparative efficacy and safety of mavacoxib and carprofen in the treatment of pain and inflammation associated with osteoarthritis for a period of 134 days. Treatments were administered according to their respective summaries of product characteristics. Of 139 dogs screened, 124 were suitable for study participation: 62 of which were dosed with mavacoxib and 62 with carprofen. Both treatments resulted in a very similar pattern of considerable improvement as indicated in all parameters assessed by both owner and veterinarian. The primary efficacy endpoint 'overall improvement' was a composite score of owner assessments after approximately six weeks of treatment. Both drugs were remarkably effective, with 57/61 (93.4 per cent) of mavacoxib-treated dogs and 49/55 (89.1 per cent) of carprofen-treated dogs demonstrating overall improvement and with mavacoxib's efficacy being non-inferior to carprofen. The treatments had a similar safety profile as evidenced by documented adverse events and summaries of clinical pathology parameters. The positive clinical response to treatment along with the safety and dosing regimen of mavacoxib makes it an attractive therapy for canine osteoarthritis. British Veterinary Association.

  13. 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

  14. The role of attitudes about vaccine safety, efficacy, and value in explaining parents' reported vaccination behavior.

    Science.gov (United States)

    Lavail, Katherine Hart; Kennedy, Allison Michelle

    2013-10-01

    To explain vaccine confidence as it related to parents' decisions to vaccinate their children with recommended vaccines, and to develop a confidence measure to efficiently and effectively predict parents' self-reported vaccine behaviors. A sample of parents with at least one child younger than 6 years (n = 376) was analyzed using data from the HealthStyles 2010 survey. Questions were grouped into block variables to create three confidence constructs: value, safety, and efficacy. Regression equations controlling for demographic characteristics were used to identify the confidence construct(s) that best predicted parents' self-reported vaccination decisions (accept all, some, or none of the recommended childhood vaccines). Among the three constructs evaluated, confidence in the value of vaccines, that is the belief that vaccines are important and vaccinating one's children is the right thing to do, was the best predictor of parents' vaccine decisions, F(2, 351) = 119.199, p parents' self-reported vaccine decisions. Confidence in the safety or efficacy of vaccines failed to account for additional significant variance in parent-reported vaccination behavior. Confidence in the value of vaccines is a helpful predictor of parent-reported vaccination behavior. Attitudinal constructs of confidence in the safety and efficacy of vaccines failed to account for additional significant variance in parents' vaccination behaviors. Future research should assess the role of vaccine knowledge and tangible barriers, such as access and cost, to further explain parents' vaccination behaviors.

  15. Efficacy and safety of the urolift® system for the treatment of benign prostate hyperplasia symptoms: systematic review.

    Science.gov (United States)

    Sánchez-Gómez, L M; Polo-deSantos, M; Gómez-Sancha, F; Luengo-Matos, S

    2015-06-01

    Interest in having alternatives in the treatment of benign prostate hyperplasia. To assess the efficacy and safety of the Urolift® system for treating the symptoms of benign prostate hyperplasia. Systematic review of the literature through searches on PubMed, Cochrane Library, CRD, Clinical Trials and EuroScan, collecting indicators of efficacy and safety. We included 5 case series and one clinical trial. The patients' mean age ranged from 65-74.3 years, and the mean prostate volume was 41-55cm3. The mean number of Urolif® implants was 3.7-5.5. The maximum follow-up in months was 24, 12 (3 studies) and one (2 studies). Improvements were found in lower urinary tract symptoms, as measured with the International Prostate Symptom Score, Benign Prostatic Hyperplasia Impact Index (BPHII), maximum urinary flow (Qmax) and postvoid residual (PVR) volume. Improvements were in found sexual dysfunction symptoms, as measured with the Sexual Health Inventory for Men (SHIM) and the Male Sexual Health Questionnaire or Ejaculatory Dysfunction (MHSQ-EjD), and in quality of life (QoL). In the clinical trial, the differences were significant for International Prostate Symptom Score, BPHII, Qmax and QoL (p<.05). The adverse effects were mild. Although the quality of evidence is low, Urolift® constitutes a good therapeutic alternative for patients with benign prostate hyperplasia. The short to medium-term results show that the technique contributes to improving lower urinary tract symptoms, with no relevant side effects, does not affect sexual function and improves quality of life. Further research is required, especially on long-term results. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. 32-Phosphorus for bone pain palliation due to bone metastases, its safety and efficacy in patients with advanced cancer

    International Nuclear Information System (INIS)

    Fettich, J.; Nair, G.; Padky, A.K.; Stare, J.; Nair, N.; Moralles, R.; Riccabona, G.; Tanumihardia, M.

    2001-01-01

    Bone pain due to bony metastases can seriously affect a patient's quality of life. External irradiation, narcotic drugs and polyphosphates may cause important side effects or are expensive, therefore in many patients radionuclide treatment using a single dose of beta emitting bone seeking radiopharmaceuticals has become widely accepted. Except 32-Phosphorus (32-P) all of them are expensive and difficult to obtain in certain countries. The aim of the study was to evaluate safety and efficacy of 32-P for palliation of bone pain due to bony metastases by comparing it to 89-Strontium (89-Sr), the most commonly used radiopharmaceutical for bone pain palliation in the framework of a prospective IAEA co-ordinated multicenter study. A very strict protocol for unified patient inclusion and follow up was used. 93 cancer patients with osteoblastic bony metastases were included into the study, 48 were treated by 89-Sr (150 MBq) and 45 by 32-P (450 MBq). Pain score, analgesic consumption, quality of life, and indices of bone marrow depression were monitored 2 weeks pre- and up to 4 months post treatment. Favourable response to treatment was recorded in 75% of the patients treated with 89-Sr and in 60% of those treated with 32-P (p=0,122). There was no significant difference between the duration of favourable effect for both radiopharmaceuticals. Moderate decrease of white blood cell (WBC) and platelet counts, and haemoglobin (Hb) levels was detected more often in the 32-P treated group. Although 32-P appears to be more toxic, no toxic effects requiring specific treatment were seen in either group. Due to its comparable efficacy and safety, general availability and low cost its more widespread use should be encouraged to increase quality of life and reduce cost of medical care of patients with intractable bone pain due to cancer metastases. (author)

  17. The use of ketamine in ECT anaesthesia: A systematic review and critical commentary on efficacy, cognitive, safety and seizure outcomes.

    Science.gov (United States)

    Gálvez, Verònica; McGuirk, Lucy; Loo, Colleen K

    2017-09-01

    This review will discuss ECT efficacy and cognitive outcomes when using ketamine as an ECT anaesthetic compared to other anaesthetics, taking into account important moderator variables that have often not been considered to date. It will also include information on safety and other ECT outcomes (seizure threshold and quality). A systematic search through MEDLINE, PubMed, PsychINFO, Cochrane Databases and reference lists from retrieved articles was performed. Search terms were: "ketamine" and "Electroconvulsive Therapy", from 1995 to September 2016. Meta-analyses, randomised controlled trials, open-label and retrospective studies published in English of depressed samples receiving ECT with ketamine anaesthesia were included (n = 24). Studies were heterogeneous in the clinical populations included and ECT treatment and anaesthetic methods. Frequently, studies did not report on ECT factors (i.e., pulse-width, treatment schedule). Findings regarding efficacy were mixed. Tolerance from repeated use may explain why several studies found that ketamine enhanced efficacy early in the ECT course but not at the end. The majority of studies did not comprehensively examine cognition and adverse effects were not systematically studied. Only a minority of the studies reported on seizure threshold and expression. The routine use of ketamine anaesthesia for ECT in clinical settings cannot yet be recommended based on published data. Larger randomised controlled trials, taking into account moderator variables, specifically reporting on ECT parameters and systematically assessing outcomes are encouraged.

  18. Quality and safety implications of emergency department information systems.

    Science.gov (United States)

    Farley, Heather L; Baumlin, Kevin M; Hamedani, Azita G; Cheung, Dickson S; Edwards, Michael R; Fuller, Drew C; Genes, Nicholas; Griffey, Richard T; Kelly, John J; McClay, James C; Nielson, Jeff; Phelan, Michael P; Shapiro, Jason S; Stone-Griffith, Suzanne; Pines, Jesse M

    2013-10-01

    The Health Information Technology for Economic and Clinical Health Act of 2009 and the Centers for Medicare & Medicaid Services "meaningful use" incentive programs, in tandem with the boundless additional requirements for detailed reporting of quality metrics, have galvanized hospital efforts to implement hospital-based electronic health records. As such, emergency department information systems (EDISs) are an important and unique component of most hospitals' electronic health records. System functionality varies greatly and affects physician decisionmaking, clinician workflow, communication, and, ultimately, the overall quality of care and patient safety. This article is a joint effort by members of the Quality Improvement and Patient Safety Section and the Informatics Section of the American College of Emergency Physicians. The aim of this effort is to examine the benefits and potential threats to quality and patient safety that could result from the choice of a particular EDIS, its implementation and optimization, and the hospital's or physician group's approach to continuous improvement of the EDIS. Specifically, we explored the following areas of potential EDIS safety concerns: communication failure, wrong order-wrong patient errors, poor data display, and alert fatigue. Case studies are presented that illustrate the potential harm that could befall patients from an inferior EDIS product or suboptimal execution of such a product in the clinical environment. The authors have developed 7 recommendations to improve patient safety with respect to the deployment of EDISs. These include ensuring that emergency providers actively participate in selection of the EDIS product, in the design of processes related to EDIS implementation and optimization, and in the monitoring of the system's ongoing success or failure. Our recommendations apply to emergency departments using any type of EDIS: custom-developed systems, best-of-breed vendor systems, or enterprise systems

  19. Examining quality function deployment in safety promotion in Sweden.

    Science.gov (United States)

    Kullberg, Agneta; Nordqvist, Cecilia; Lindqvist, Kent; Timpka, Toomas

    2014-09-01

    The first-hand needs and demands of laypersons are not always considered when safety promotion programmes are being developed. We compared focal areas for interventions identified from residents' statements of safety needs with focal areas for interventions identified by local government professionals in a Swedish urban community certified by the international Safe Community movement supported by the World Health Organization. Quantitative and qualitative data on self-expressed safety needs from 787 housing residents were transformed into an intervention design, using the quality function deployment (QFD) technique and compared with the safety intervention programme developed by professionals at the municipality administrative office. The outcome of the comparison was investigated with regard to implications for the Safe Community movement. The QFD analysis identified the initiation and maintenance of social integrative processes in housing areas as the most highly prioritized interventions among the residents, but failed to highlight the safety needs of several vulnerable groups (the elderly, infants and persons with disabilities). The intervention programme designed by the public health professionals did not address the social integrative processes, but it did highlight the vulnerable groups. This study indicates that the QFD technique is suitable for providing residential safety promotion efforts with a quality orientation from the layperson's perspective. Views of public health professionals have to be included to ascertain that the needs of socially deprived residents are adequately taken into account. QFD can augment the methodological toolbox for safety promotion programmes, including interventions in residential areas. © The Author (2013). Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  20. IMPACTS OF SAFETY and QUALITY IN ENVIRONMENTAL RESTORATION AT HANFORD

    International Nuclear Information System (INIS)

    PREVETTE, S.S.

    2004-01-01

    The aim of this paper is to demonstrate the integration of safety methodology, quality tools, leadership, and teamwork at Hanford and their significant positive impact on safe performance of work. Control charts, Pareto Charts, Dr. W. Edward Deming's Red Bead Experiment, and Dr. Deming's System of Profound Knowledge have been the principal tools and theory of an integrated management system. Coupled with involved leadership and teamwork they have led to significant improvements in worker safety and protection, and environmental restoration at one of the nation's largest nuclear cleanup sites

  1. Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines.

    Science.gov (United States)

    Osselaere, A; Devreese, M; Watteyn, A; Vandenbroucke, V; Goossens, J; Hautekiet, V; Eeckhout, M; De Saeger, S; De Baere, S; De Backer, P; Croubels, S

    2012-08-01

    Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.44±0.70 mg/kg of feed and 7.54±2.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans.

  2. Safety and quality management at the high flux reactor Petten

    International Nuclear Information System (INIS)

    Zurita, A.; Ahlf, J.

    1995-01-01

    The High Flux Reactor (HFR) is one high power multi-purpose materials testing research reactor of the tank-in-pool type, cooled and moderated by light-water. It is operated at 45 MW at a prescribed schedule of 11 cycles per year, each comprising 25 operation days and three shut-down days. Since the licence for the operation of HFR was granted in 1962, a total of 14 amendments to the original licence have been made following different modifications in the installations. In the meantime, international nuclear standards were developed, especially in the framework of the NUSS programme of the IAEA, which were adopted by the Dutch Licensing Authorities. In order to implement the new standards, the situation at the HFR was comprehensively reviewed in the course of an audit performed by the Dutch Licensing Authorities in 1988. This also resulted in formulating the task of setting-up an 'HFR - Integral Quality Assurance Handbook' (HFR-IQAD) involving both organizations JRCIAM and ECN, which had the unique framework and basic guideline to assure the safe and efficient operation and exploitation of the HFR and to promote safety and quality in all aspects of HFR related activities. The assurance of safe and efficient operation and exploitation of the HFR is condensed together under the concepts of safety and quality of services and is achieved through the safety and quality management. (orig.)

  3. PATIENT SAFETY IN SURGERY: THE QUALITY OF IMPLEMENTATION OF PATIENT SAFETY CHECKLISTS IN A REGIONAL HOSPITAL

    Directory of Open Access Journals (Sweden)

    V. Karyadinata

    2012-09-01

    Full Text Available Introduction. Patient safety and the avoidance of inhospital adverse events is a key focus of clinical practice and medical audit. A large of proportion of medical errors affect surgical patients in the peri-operative setting. Safety checklists have been adopted by the medical profession from the aviation industry as a cheap and reliable method of avoiding errors which arise from complex or stressful situations. Current evidence suggests that the use of periooperative checklists has led to a decrease in surgical morbidity and hospital costs. Aim. To assess the quality of implementation of a modified patient safety checklist in a UK district general hospital. Methods. An observational tool was designed to assess in real time the peri-operative performance of the surgical safety checklist in patients undergoing general surgical, urological or orthopaedic procedures. Initiation of the checklist, duration of performance and staff participation were audited in real time. Results. 338 cases were monitored. Nurses were most active in initiating the safety checklist. The checklist was performed successfully in less than a minute in most cases. 11-24% of staff (according to professional group present in the operating room did not participate in the checklist. Critical safety checks (patient identity and procedure name were performed in all cases across all specialties. Variations were noted in checking other categories, such as deep vein thrombosis (DVT prophylaxis or patient warming. Conclusions. There is still a potential for improving the practice and culture of surgical patient safety activities. Staff training and designation of patient safety leadership roles is needed in increasing compliance and implementation of patient safety mechanism, such as peri-operative checklists. There is significant data to advocate the need to implement patient safety surgical checklists internationally

  4. Relationship of breastfeeding self-efficacy with quality of life in Iranian breastfeeding mothers.

    Science.gov (United States)

    Mirghafourvand, Mojgan; Kamalifard, Mahin; Ranjbar, Fatemeh; Gordani, Nasrin

    2017-07-20

    Due to the importance of breastfeeding, we decided to conduct a study to examine the relationship between breastfeeding self-efficacy and quality of life. This study was a cross-sectional study, which was carried out on 547 breastfeeding mothers that had 2-6 months old infants. The participants were selected randomly, and the sociodemographic characteristics questionnaire, Dennis' breastfeeding self-efficacy scale, and WHO's Quality of Life (WHOQOL) questionnaire were completed through interview. The multivariate linear regression model was used for data analysis. The means (standard deviations) of breastfeeding self-efficacy score and quality of life score were 134.5 (13.3) and 67.7 (13.7), respectively. Quality of life and all of its dimensions were directly and significantly related to breastfeeding self-efficacy. According to the results of multivariate linear regression analysis, there was a relationship between breastfeeding self-efficacy and the following variables: environmental dimension of quality of life, education, spouse's age, spouse's job, average duration of previous breastfeeding period and receiving breastfeeding training. Findings showed that there is direct and significant relationship between breastfeeding self-efficacy and quality of life. Moreover, it seems that the development of appropriate training programs is necessary for improving the quality of life of pregnant women, as it consequently enhances breastfeeding self-efficacy.

  5. Association between self-efficacy and quality of life in women with breast cancer undergoing chemotherapy

    Directory of Open Access Journals (Sweden)

    MZ. Kiaei

    2016-06-01

    Full Text Available Background: Self-efficacy is known as a factor which influences health behaviors, chronic diseases management and quality of life in patients with cancer. Objective: The aim of this study was to investigate the association of self-efficacy and quality of life in women with breast cancer undergoing chemotherapy. Methods: This cross sectional study was conducted in 100 women with breast cancer referred to Seyed Al-Shohada Hospital, Isfahan in 2015. The study subjects were selected by simple random sampling method. The measurement tools were the Sherer self-efficacy scale and the World Health Organization WHOQOL-BREF quality of life assessment. Data were analyzed using one-way ANOVA and Pearson’s correlation coefficient. Findings: Mean age was 48.25±11.93 years. The mean self-efficacy score and quality of life score were 55.78± 11 and 75.91±15.28, respectively and both of them were average. There was positive significant correlation between self-efficacy and quality of life. There was also significant association between self-efficacy and quality of life domains including physical health, mental health, social relationships and environment. Conclusion: With regards to the results, it seems that activities such as workshops for patients, presence of a psychologist in department of chemotherapy, and providing health facilities can be effective for increasing self-efficacy and quality of life in patients with cancer.

  6. Safety and efficacy of AMG 334 for prevention of episodic migraine

    DEFF Research Database (Denmark)

    Sun, Hong Yan; Dodick, David W; Silberstein, Stephen D

    2016-01-01

    BACKGROUND: The calcitonin gene-related peptide (CGRP) pathway is a promising target for preventive therapies in patients with migraine. We assessed the safety and efficacy of AMG 334, a fully human monoclonal antibody against the CGRP receptor, for migraine prevention. METHODS: In this multicentre...... in monthly migraine days from baseline to the last 4 weeks of the 12-week double-blind treatment phase. The primary endpoint was calculated using the least squares mean at each timepoint from a generalised linear mixed-effect model for repeated measures. Safety endpoints were adverse events, clinical...... laboratory values, vital signs, and anti-AMG 334 antibodies. The study is registered with ClinicalTrials.gov, number NCT01952574. An open-label extension phase of up to 256 weeks is ongoing and will assess the long-term safety of AMG 334. FINDINGS: From Aug 6, 2013, to June 30, 2014, 483 patients were...

  7. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety on dental hygienist

    International Nuclear Information System (INIS)

    Han, Eun Ok; Jun, Sung Hee

    2008-01-01

    The objective of this study is to draw an educational plant for reducing the probability of troubles caused by radiation for dental hygienists who are the major applicants of radiation equipments used in dental offices. This study investigated the knowledge and self-efficacy, which is the major variable that affects the attitude and behavior, on the radiation safety that is an educational approach. Also, this study obtained following results from a survey for 25 days from June 15, 2008 that was applied for 225 dental hygienists worked at dental offices and clinics in the area of Youngnam in order to verify the relationship between such variables. The average scores for the knowledge, attitude, and behavior were 54.28±16.33, 87.93±9.75, and 59.85±14.76, respectively. Also, the average score of the self-efficacy was 72.88±8.60. In the knowledge level for the radiation safety, ‘a case that prepares personal dosimeters’, ‘a case that establishes protection facilities’, ‘a case that presents 6⁓10 dental hygienists’, ‘a case that presents radiological technologists’, and ‘a case that is a general hospital’ represented high values. In the attitude level for the radiation safety, ‘a case who is a married person’, ‘a case that prepares personal dosimeters’, and ‘a case that is a general hospital’ showed high values. In the behavior level for the radiation safety, ‘a case that shows a career in dental hygienist or radiographic for 6⁓10 years’, ‘a case that attends radiation safety education’, ‘a case that establishes protection facilities’ showed high values. Also, in the self-efficacy level, ‘a case that who has a high education level more than graduate school education’ and ‘a case that establishes protection facilities’ represented high values. In the relationship between the knowledge, attitude, behavior, and self-efficacy for the radiation safety, it showed statistically significant differences in this

  8. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety on dental hygienist

    Energy Technology Data Exchange (ETDEWEB)

    Han, Eun Ok; Jun, Sung Hee [Daegu Health College, Daegu (Korea, Republic of)

    2008-11-15

    The objective of this study is to draw an educational plant for reducing the probability of troubles caused by radiation for dental hygienists who are the major applicants of radiation equipments used in dental offices. This study investigated the knowledge and self-efficacy, which is the major variable that affects the attitude and behavior, on the radiation safety that is an educational approach. Also, this study obtained following results from a survey for 25 days from June 15, 2008 that was applied for 225 dental hygienists worked at dental offices and clinics in the area of Youngnam in order to verify the relationship between such variables. The average scores for the knowledge, attitude, and behavior were 54.28±16.33, 87.93±9.75, and 59.85±14.76, respectively. Also, the average score of the self-efficacy was 72.88±8.60. In the knowledge level for the radiation safety, ‘a case that prepares personal dosimeters’, ‘a case that establishes protection facilities’, ‘a case that presents 6⁓10 dental hygienists’, ‘a case that presents radiological technologists’, and ‘a case that is a general hospital’ represented high values. In the attitude level for the radiation safety, ‘a case who is a married person’, ‘a case that prepares personal dosimeters’, and ‘a case that is a general hospital’ showed high values. In the behavior level for the radiation safety, ‘a case that shows a career in dental hygienist or radiographic for 6⁓10 years’, ‘a case that attends radiation safety education’, ‘a case that establishes protection facilities’ showed high values. Also, in the self-efficacy level, ‘a case that who has a high education level more than graduate school education’ and ‘a case that establishes protection facilities’ represented high values. In the relationship between the knowledge, attitude, behavior, and self-efficacy for the radiation safety, it showed statistically significant differences in this

  9. 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.)

  10. 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.

  11. 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.)

  12. The neuropharmacology of ADHD drugs in vivo: insights on efficacy and safety.

    Science.gov (United States)

    Heal, D J; Cheetham, S C; Smith, S L

    2009-12-01

    Results from in vivo techniques, especially intracerebral microdialysis in freely-moving rats, have provided insights into potential mechanisms responsible for the efficacy and safety of catecholaminergic drugs for ADHD treatment. The drugs reviewed come from distinct pharmacological classes: psychostimulant releasing agents, eg d-amphetamine; psychostimulant reuptake inhibitors, eg dl-threo-methylphenidate (dl-MPH), and non-stimulant reuptake inhibitors, eg atomoxetine. Psychostimulants, which currently deliver the best efficacy in treating ADHD, exhibit the following characteristics on extraneuronal catecholamine concentrations in rodent brain in vivo: 1) They enhance the efflux and function of both noradrenaline and dopamine in the central nervous system. 2) The increase of dopamine efflux that they produce is not limited to cortical regions. 3) They have a rapid onset of action with no ceiling on drug effect. d-Amphetamine has a mechanism independent of neuronal firing rate, displacing intraneuronal stores of catecholamines, delaying their reuptake and inhibiting catabolism by monoamine oxidase. dl-MPH has an enigmatic, extraneuronal action that is neuronal firing rate-dependent and reuptake transporter-mediated, yet paradoxically, almost as powerful as that of d-amphetamine. In safety terms, these powerful catecholaminergic effects also make the psychostimulants liable for abuse. Since efficacy and safety derive from the same pharmacological mechanisms, it has not yet been possible to separate these two components. However, the development of once-daily psychostimulant formulations and a prodrug, lisdexamfetamine, has improved patient compliance and markedly reduced scope for their diversion/abuse. This review will discuss the in vivo pharmacological profiles of approved catecholaminergic drugs for treatment of ADHD and implications for their clinical efficacy and abuse liability.

  13. Efficacy and safety of ginger in osteoarthritis patients: a meta-analysis of randomized placebo-controlled trials.

    Science.gov (United States)

    Bartels, E M; Folmer, V N; Bliddal, H; Altman, R D; Juhl, C; Tarp, S; Zhang, W; Christensen, R

    2015-01-01

    The aim of this study was to assess the clinical efficacy and safety of oral ginger for symptomatic treatment of osteoarthritis (OA) by carrying out a systematic literature search followed by meta-analyses on selected studies. Inclusion criteria were randomized controlled trials (RCTs) comparing oral ginger treatment with placebo in OA patients aged >18 years. Outcomes were reduction in pain and reduction in disability. Harm was assessed as withdrawals due to adverse events. The efficacy effect size was estimated using Hedges' standardized mean difference (SMD), and safety by risk ratio (RR). Standard random-effects meta-analysis was used, and inconsistency was evaluated by the I-squared index (I(2)). Out of 122 retrieved references, 117 were discarded, leaving five trials (593 patients) for meta-analyses. The majority reported relevant randomization procedures and blinding, but an inadequate intention-to-treat (ITT) analysis. Following ginger intake, a statistically significant pain reduction SMD = -0.30 ([95% CI: [(-0.50, -0.09)], P = 0.005]) with a low degree of inconsistency among trials (I(2) = 27%), and a statistically significant reduction in disability SMD = -0.22 ([95% CI: ([-0.39, -0.04)]; P = 0.01; I(2) = 0%]) were seen, both in favor of ginger. Patients given ginger were more than twice as likely to discontinue treatment compared to placebo ([RR = 2.33; 95% CI: (1.04, 5.22)]; P = 0.04; I(2) = 0%]). Ginger was modestly efficacious and reasonably safe for treatment of OA. We judged the evidence to be of moderate quality, based on the small number of participants and inadequate ITT populations. Prospero: CRD42011001777. Copyright © 2014 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  14. Real-life efficacy and safety of omalizumab in Portuguese patients with persistent uncontrolled asthma.

    Science.gov (United States)

    Pereira Barbosa, M; Bugalho de Almeida, A; Pereira, C; Chen, C-W; Georgiou, P; Peachey, G

    2015-01-01

    The real life effectiveness, safety and the use of omalizumab for Portuguese patients with uncontrolled persistent allergic asthma are not sufficiently well known. The objective of this report was to make an evaluation, in a post-marketing, non-interventional, observational registry, of the Portuguese population included in the eXpeRience study. The methods used in this report are the same as the global eXpeRience ones, applied to a Portuguese sub-population. Patients with uncontrolled allergic asthma who had started omalizumab within the previous 15 weeks were enrolled and received omalizumab add-on therapy for 24 months. The physicians' global evaluation of treatment effectiveness (GETE), asthma symptoms and control (ACT score), quality of life (mini-AQLQ score), exacerbations, and serious adverse events (SAE) were reported. Of the 943 patients recruited in the eXpeRience registry, 62 patients were from Portugal. 62.1% of them were observed to be responders with good/excellent GETE assessment at Week 16. Clinically meaningful improvements in asthma control (ACT score) and quality of life (mini-AQLQ score) were observed with omalizumab therapy at Months 12 (mean change: +7.7 [n=35]; +2.1 [n=20], respectively) and 24 (mean change: +7.0 [n=26]; +2.7 [n=13], respectively). Asthma symptoms and rescue medication usage were reduced to ≤1 day/week at Month 24 from a baseline of ≥3.5 days/week. The proportion of patients with no clinically significant exacerbations increased from 6.5% during pre-treatment (n=62) to 50% at Month 12 (n=54) and 60% at Month 24 (n=45). The findings from the Portugal subpopulation of eXpeRience registry confirm that omalizumab add-on therapy is efficacious and well tolerated in the management of uncontrolled persistent allergic asthma. Another pertinent issue is the fact that the Portuguese subpopulation response is similar to the international population average of the study. Copyright © 2014 Sociedade Portuguesa de Pneumologia

  15. Efficacy and safety of 120w greenlight photoselective vaporisation of prostate in patients receiving anticoagulant drugs

    International Nuclear Information System (INIS)

    Cakiroglu, B.; Gozukucuk, R.; Sinanoglu, O.

    2013-01-01

    Objective: To evaluate the efficacy and safety of photoselective prostate vapourisation with 120w potassium titanyl phosphate laser in benign prostate hyperplasia patients receiving oral anti-coagulant therapy. Methods: The retrospective study was conducted at Istanbul Hisar International Hosptial and comprised 63 male patients who were on anti-coagulant therapy for comorbidities and who underwent prostate vapourisation for benign prostate hyperplasia with 120 Watts potassium titanyl phosphate from November 2007 to December 2010. International Prostate Symptoms Score, Quality of Life scores, uroflowmetry pre-operatively and 3 months post-operatively were obtained. Ultrasound examination was performed for each patient to evaluate prostate and residual urine in the bladder. Plasma haemoglobin, haematocrit and International Normalised Ratio levels were also checked for patients in the pre- and post-operative period. Results: The age range of the patients was from 65-89 years with a mean of 72.3+-8 years. The mean prostate weight was 45+-17ml (range: 40-120). Mean operation time was 54+-16 minutes (25-90). The removal of urinary catheter took place 1-3 days post-operatively. None of the patients required transfusion. The International Prostate Symptoms Score was reduced (23+-6 vs 14+-3) at third month after the operation. Quality of Life scores were improved from 2.2+-1.1 to 4.7+-1.2, and maximal urine flow rate increased from 7.8+-2.3 to 16+-1 in the same period. Urinary obstruction due to clot retention was observed in 1 (1.58%) patient in post-operative 3 days. Urinary retention occurred in 5 (7.98%) patients after the removal of the urinary catheter. Permanent urinary retention, per-operative bleeding and post-operative incontinence were not observed. Conclusion: Treatment of benign prostate hyperplasia with photoselective prostate vapourisation is effective and safe in patients receiving anti-coaguant therapy. However, patients should be monitored in early post

  16. Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study - Efficacy, safety, and pharmacokinetics

    NARCIS (Netherlands)

    Sparr, Harald J.; Vermeyen, Karel M.; Beaufort, Anton M.; Rietbergen, Henk; Proost, Johannes H.; Saldien, Vera; Velik-Salchner, Corinna; Wierda, J. Mark K. H.

    Background: Sugammadex reverses the neuromuscular blocking effects of rocuronium by chemical encapsulation. The efficacy, safety, and pharmacokinetics of sugammadex for reversal of profound rocuronium-induced neuromuscular blockade were evaluated. Methods: Ninety-eight male adult patients were

  17. Safety and efficacy of thromboprophylaxis using enoxaparin sodium after cesarean section: A multi-center study in Japan

    Directory of Open Access Journals (Sweden)

    Maki Goto

    2015-06-01

    Conclusion: The current study demonstrates the safety and efficacy of enoxaparin for thromboprophylaxis after C/S. Further studies are required to determine the best method of preventing asymptomatic DVT.

  18. A Scholarly Pathway in Quality Improvement and Patient Safety.

    Science.gov (United States)

    Ferguson, Catherine C; Lamb, Geoffrey

    2015-10-01

    There are several challenges to teaching quality improvement (QI) and patient safety material to medical students, as successful programs should combine didactic and experiential teaching methods, integrate the material into the preclinical and clinical years, and tailor the material to the schools' existing curriculum. The authors describe the development, implementation, and assessment of the Quality Improvement and Patient Safety (QuIPS) Scholarly Pathway-a faculty-mentored, three-year experience for students interested in gaining exposure to QI and patient safety concepts at the Medical College of Wisconsin (MCW). The QuIPS pathway capitalized on the existing structure of scholarly pathways for MCW medical students, allowing QI and patient safety to be incorporated into the existing curriculum using didactic and experiential instruction and spanning preclinical and clinical education. Student reaction to the QuIPS pathway has been favorable. Preliminary data demonstrate that student knowledge as measured by the Quality Improvement Knowledge Assessment Tool significantly increased after the first year of implementation. A novel curriculum such as the QuIPS pathway provides an important opportunity to develop and test new assessment tools for curricula in systems-based practice and practice-based learning and improvement. The authors also hope that by bringing together local QI and patient safety experts and stakeholders during the curricular development process, they have laid the groundwork for the creation of a more pervasive curriculum that will reach all MCW students in the future. The model may be generalizable to other U.S. medical schools with scholarly pathways as well.

  19. Evaluation the efficacy and safety of simultaneous splenectomy in liver transplantation patients: A meta-analysis.

    Science.gov (United States)

    He, Chao; Liu, Xiaojuan; Peng, Wei; Li, Chuan; Wen, Tian-Fu

    2018-03-01

    Simultaneous splenectomy during liver transplantation (LT) is debated. The present meta-analysis assessed the efficacy and safety of splenectomy on the outcome of LT patients. We searched PubMed, Embase, and Wanfang databases for relevant studies published until the date of July 15, 2017. Quality assessment of the included studies was performed using a modified Newcastle-Ottawa Scale judgment. The data were analyzed using RevMan5.3 software. A total of 16 studies consisting of 2198 patients (892 patients received splenectomy during LT [SPLT group] and 1306 patients received LT only [LT group]) were included in the present meta-analysis. Efficacy analysis revealed that pooled hazard ratio for overall survival (OS) between 2 groups was not significantly different (hazard ratio = 1.03; 95% confidence interval [CI]: 0.71-1.50). SPLT group had less postoperative rejection (odds ratio [OR] = 0.63, 95% CI: 0.50-0.79) and small for size syndrome (OR = 0.23, 95% CI: 0.07-0.79). SPLT group had significantly lower preoperative platelet (mean difference [MD] = -17.23, 95% CI: -19.54, -14.91), but significantly higher postoperative platelet (MD = 170.45, 95% CI: 108.33-232.56). Conversely, SPLT group had significant higher preoperative portal pressure (MD = 1.54, 95% CI: 0.75-2.33) and significant lower postoperative portal pressure (MD = -1.17, 95% CI: -2.24, -0.11). Safety analysis revealed that SPLT group had significantly longer operation time (MD = 56.66, 95% CI: 35.96-77.35), more intraoperative blood loss (MD = 1.08, 95% CI: 0.25-1.91), and more intraoperative red blood cell (RBC) transfusion (MD = 3.77, 95% CI: 3.22-4.33). Furthermore, SPLT group had significantly higher incidence of postoperative hemorrhage (OR = 3.07, 95% CI: 1.92-4.91), postoperative thrombosis (OR = 3.63, 95% CI: 1.06-12.45), and perioperative infection (OR = 2.62, 95% CI: 1.76-3.90). In addition, perioperative mortality was significantly higher in

  20. Evaluation the efficacy and safety of simultaneous splenectomy in liver transplantation patients

    Science.gov (United States)

    He, Chao; Liu, Xiaojuan; Peng, Wei; Li, Chuan; Wen, Tian-fu

    2018-01-01

    Abstract Background: Simultaneous splenectomy during liver transplantation (LT) is debated. The present meta-analysis assessed the efficacy and safety of splenectomy on the outcome of LT patients. Methods: We searched PubMed, Embase, and Wanfang databases for relevant studies published until the date of July 15, 2017. Quality assessment of the included studies was performed using a modified Newcastle-Ottawa Scale judgment. The data were analyzed using RevMan5.3 software. Results: A total of 16 studies consisting of 2198 patients (892 patients received splenectomy during LT [SPLT group] and 1306 patients received LT only [LT group]) were included in the present meta-analysis. Efficacy analysis revealed that pooled hazard ratio for overall survival (OS) between 2 groups was not significantly different (hazard ratio = 1.03; 95% confidence interval [CI]: 0.71–1.50). SPLT group had less postoperative rejection (odds ratio [OR] = 0.63, 95% CI: 0.50–0.79) and small for size syndrome (OR = 0.23, 95% CI: 0.07–0.79). SPLT group had significantly lower preoperative platelet (mean difference [MD] = −17.23, 95% CI: −19.54, −14.91), but significantly higher postoperative platelet (MD = 170.45, 95% CI: 108.33–232.56). Conversely, SPLT group had significant higher preoperative portal pressure (MD = 1.54, 95% CI: 0.75–2.33) and significant lower postoperative portal pressure (MD = −1.17, 95% CI: −2.24, −0.11). Safety analysis revealed that SPLT group had significantly longer operation time (MD = 56.66, 95% CI: 35.96–77.35), more intraoperative blood loss (MD = 1.08, 95% CI: 0.25–1.91), and more intraoperative red blood cell (RBC) transfusion (MD = 3.77, 95% CI: 3.22–4.33). Furthermore, SPLT group had significantly higher incidence of postoperative hemorrhage (OR = 3.07, 95% CI: 1.92–4.91), postoperative thrombosis (OR = 3.63, 95% CI: 1.06–12.45), and perioperative infection (OR = 2.62, 95% CI: 1.76

  1. Active and intelligent packaging: The indication of quality and safety.

    Science.gov (United States)

    Janjarasskul, Theeranun; Suppakul, Panuwat

    2018-03-24

    The food industry has been under growing pressure to feed an exponentially increasing world population and challenged to meet rigorous food safety law and regulation. The plethora of media consumption has provoked consumer demand for safe, sustainable, organic, and wholesome products with "clean" labels. The application of active and intelligent packaging has been commercially adopted by food and pharmaceutical industries as a solution for the future for extending shelf life and simplifying production processes; facilitating complex distribution logistics; reducing, if not eliminating the need for preservatives in food formulations; enabling restricted food packaging applications; providing convenience, improving quality, variety and marketing features; as well as providing essential information to ensure consumer safety. This chapter reviews innovations of active and intelligent packaging which advance packaging technology through both scavenging and releasing systems for shelf life extension, and through diagnostic and identification systems for communicating quality, tracking and brand protection.

  2. 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

  3. Quality and safety is the integral part of our business

    International Nuclear Information System (INIS)

    Fadeev, Y.

    2011-01-01

    During 65 years from Joint-stock Company Afrikantov OKBM foundation over 400 reactor projects were developed - primarily, various modifications of marine propulsion reactors for nuclear submarines and icebreakers of several generations. Today, OKBM designs reactors of various types and purposes as well as equipment, control and protection mechanisms, and is the world leader in fast-neutron sodium-cooled reactor technology. Much attention in OKBM is given to the safety and quality of production, specialists education [ru

  4. EFFICACY AND SAFETY OF LIPID-LOWERING DRUGS IN PRIMARY AND SECONDARY PREVENTION OF CARDIOVASCULAR DISEASES IN THE ELDERLY

    Directory of Open Access Journals (Sweden)

    E. A. Ushkalova

    2016-01-01

    Full Text Available Effect of hyperlipidemia on morbidity and mortality in elderly patients is considered. Authors also cover issues of efficacy and safety of lipid-lowering therapy in primary and secondary prevention of cardiovascular diseases in patients ≥80 years of age who are the most quickly growing group of population and have the highest cardiovascular risk. They stress the need to take into account polymorbidity and polypharmacy that increase the risk of adverse reactions due to the use of both statins and their drug-drug interactions, which requires an assessment of risk/benefit ratio. In addition, there is a need for development of reliable prognostic tools to predict relevant outcomes (e.g., stroke, decrease in functionality/independence, quality of life reduction and rationales for lipid-lowering therapy in the elderly and also their adherence to treatment.

  5. Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome

    Directory of Open Access Journals (Sweden)

    Yang YM

    2015-09-01

    Full Text Available Young-Mo Yang, Eun Joo Choi College of Pharmacy, Chosun University, Gwangju, South Korea Background: Polycystic ovary syndrome (PCOS is an endocrinopathy that affects approximately 10% of reproductive-aged women throughout their lives. Women with PCOS present with heterogeneous symptoms including ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. Therefore, lifelong individualized management should be considered. Pharmacological agents commonly used to manage the symptoms are metformin and oral contraceptive pills. Although these medications have been beneficial in treating PCOS symptoms, their efficacy and safety are still not entirely elucidated. This study aimed to report the efficacy and safety of metformin, oral contraceptives, or their combination in the treatment of PCOS and to define their specific individual roles.Methods: A literature search of original studies published in PubMed and Scopus was conducted to identify studies comparing metformin with oral contraceptives or evaluating the combination of both in PCOS.  Results: Eight clinical trials involving 313 patients were examined in the review. The intervention dosage of metformin ranged from 1,000 to 2,000 mg/d and that of oral contraceptives was ethinylestradiol 35 µg and cyproterone acetate 2 mg. Lower body mass index was observed with regimens including metformin, but increased body mass index was observed in monotherapy with oral contraceptives. Administration of metformin or oral contraceptives, especially as monotherapy, had a negative effect on lipid profiles. In addition, there are still uncertainties surrounding the effects of metformin or oral contraceptives in the management of insulin level, although they improved total testosterone and sex hormone-binding globulin levels. In the included studies, significant side effects due to metformin or oral contraceptives were not reported.  Conclusion: The clinical trials suggest that metformin or oral

  6. Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal

    Directory of Open Access Journals (Sweden)

    Lemoine P

    2011-07-01

    Full Text Available Patrick Lemoine1, Doron Garfinkel2, Moshe Laudon3, Tali Nir3, Nava Zisapel3,41The Clinique Lyon-Lumière, Meyzieu, France; 2Geriatric-Palliative Department, Shoham Geriatric Medical Center, Pardes Hanna, Israel; 3Neurim Pharmaceuticals Ltd, Tel-Aviv, Israel; 4Department of Neurobiology Faculty of Life Sciences, Tel Aviv University, Tel Aviv, IsraelBackground: Prolonged-release melatonin (PRM 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinuation.Objective: To investigate the efficacy, safety, and withdrawal phenomena associated with 6–12 months PRM treatment.Methods: Data from a prospective 6–12-month open-label study of 244 community dwelling adults with primary insomnia, who had participated in a placebo-controlled, double-blind dose-ranging trial of PRM. Patients received PRM nightly, followed by a 2-week withdrawal period. Main outcome measures were patient-reported sleep quality ratings (diary, adverse events, vital signs, and laboratory tests recorded at each visit, and withdrawal symptoms (CHESS-84 [Check-list Evaluation of Somatic Symptoms]. Nocturnal urinary 6-sulfatoxymelatonin excretion, a measure of the endogenous melatonin production, was assessed upon discontinuing long-term PRM.Results: Of the 244 patients, 36 dropped out, 112 completed 6 months of treatment, and the other 96 completed 12 months of treatment. The mean number of nights by which patients reported sleep quality as "good" or "very good" was significantly higher during PRM than before treatment. There was no evidence of tolerance to PRM. Discontinuation of PRM was not associated with rebound insomnia or withdrawal symptoms; on the contrary, residual benefit was observed. PRM was well tolerated, and there was no suppression of endogenous melatonin production

  7. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis

    NARCIS (Netherlands)

    Bergmann, Karl-Christian; Demoly, Pascal; Worm, Margitta; Fokkens, Wytske J.; Carrillo, Teresa; Tabar, Ana I.; Nguyen, Hélène; Montagut, Armelle; Zeldin, Robert K.

    2014-01-01

    Preliminary studies have suggested the efficacy of sublingual tablets of house dust mite (HDM) extracts in adults with allergic rhinitis. We sought to assess the efficacy and safety of 2 doses of HDM sublingual tablets over 1 treatment year and the subsequent immunotherapy-free year. Adults with

  8. Efficacy and safety of nimodipine in treatment of vascular dementia: a systematic review

    Directory of Open Access Journals (Sweden)

    Tao CHEN

    2015-07-01

    Full Text Available Objective To systematically evaluate the clinical efficacy and safety of nimodipine in treating vascular dementia (VaD.  Methods Taking "nimodipine AND vascular dementia" as search terms, retrieve in databases such as PubMed, Cochrane Library, EMBASE/SCOPUS, Science Citation Index (SCI, China National Knowledge Infrastructure (CNKI, VIP and Wanfang Data (January 1995-March 2015. Annual searching was applied to retrieve partial periodical literatures and unpublished studies. Google Scholar was used for randomized controlled trials (RCTs about nimodipine in treating VaD. Jadad scale was used to evaluate the quality of literature, and Meta-analyses were performed by using RevMan 5.3 software.  Results Eleven literatures met inclusion criteria, including 10 clinical studies (1333 patients. All 10 studies were RCTs, including 4 nimodipine vs placebo, 5 nimodipine vs donepezil and one nimodipne vs hydergine, but only 2 described randomization methods. The results of Meta-analysis showed: nimodipine had better Mini-Mental State Examination (MMSE score than before treatment and placebo group (3 studies, MD = 0.270, 95%CI: 0.070—0.460, P = 0.007; one study of blank control, MD = 2.950, 95% CI: 1.670—4.200, P = 0.000. Patients treated with nimodipne had no significantly improved Activities of Daily Living (ADL score than placebo group [one study of ADL, MD = 5.800, 95%CI: 2.480—9.120, P = 0.000; one study of ADL Index, MD = -0.040, 95%CI: -0.110—0.030, P = 0.230; one study of instrumental ADL (IADL, MD = -0.080, 95%CI: -0.110—0.000, P = 0.060]. Both nimodipine and donepezil can improve MMSE and ADL scores, but the efficacy of nimodipine was not superior to donepezil [4 studies of MMSE (12-week observation, MD = -4.400, 95% CI: -4.870— -3.920, P = 0.000; one study of MMSE (24-week observation, MD = -8.800, 95% CI: -8.970— -7.430, P = 0.000; 2 studies of ADL, MD = 1.800, 95% CI: 1.360—2.230, P = 0.000]. Compared with hydergine

  9. Transformational Leadership: The Chief Nursing Officer Role in Leading Quality and Patient Safety.

    Science.gov (United States)

    Jones, Pam; Polancich, Shea; Steaban, Robin; Feistritzer, Nancye; Poe, Terri

    This department column highlights leadership perspectives of quality and patient safety practice. The purpose of this article is to provide strategic direction for transformational quality and safety leadership as the chief nursing officer (CNO) within the academic medical center environment.

  10. Efficacy, safety and tolerability of sildenafil in Brazilian hypertensive patients on multiple antihypertensive drugs

    Directory of Open Access Journals (Sweden)

    Denilson C. Albuquerque

    2005-08-01

    Full Text Available OBJECTIVE: To evaluate the efficacy, safety and tolerability of sildenafil among Brazilian patients with hypertension treated with combinations of anti-hypertensive drugs. MATERIALS AND METHODS: One hundred twenty hypertensive men aged 30 to 81 years old under treatment with 2 or more anti-hypertensive drugs and with erectile dysfunction (ED lasting for at least 6 months were enrolled at 7 research centers in Brazil. Patients were randomized to receive treatment with either sildenafil or placebo taken 1 hour before sexual intercourse (initial dose of 50 mg, adjusted to 25 mg or 100 mg according to efficacy and toxicity. During the following 8 weeks, patients were evaluated regarding vital signs, adverse events, therapeutic efficacy, satisfaction with treatment and use of concurrent medications. RESULTS: The primary evaluation of efficacy, which was based on responses to questions 3 and 4 of the International Index of Erectile Function, showed significant differences regarding treatment with sildenafil (p = 0.0002 and p < 0.0001, respectively. In the assessment of global efficacy, 87% of the patients treated with sildenafil reported improved erections, as compared with 37% of patients given placebos (p < 0.0001. The other secondary evaluations supported the results favoring sildenafil. The most frequent adverse events among patients treated with sildenafil were headaches (11.4%, vasodilation (11.4% and dyspepsia (6.5%. There were no significant changes in blood pressure measurements in both groups. CONCLUSION: Sildenafil is efficacious and safe for the treatment of hypertensive patients with ED who receive concurrent combinations of anti-hypertensive drugs.

  11. Safety and anti-hyperglycemic efficacy of various tea types in mice

    Science.gov (United States)

    Han, Manman; Zhao, Guangshan; Wang, Yijun; Wang, Dongxu; Sun, Feng; Ning, Jingming; Wan, Xiachun; Zhang, Jinsong

    2016-01-01

    Tea, a beverage consumed worldwide, has proven anti-hyperglycemic effects in animal models. Better efficacies of tea beverages are frequently associated with high-dose levels, whose safety attracts considerable attention. Based on the inherent nature of tea catechin oxidation, fresh tea leaves are manufactured into diverse tea types by modulating the oxidation degree of catechins. The present study aimed to assess various tea types for their safety properties and anti-hyperglycemic effects. Mice were allowed free access to tea infusion (1:30, w/v) for one week, and the rare smoked tea caused salient adverse reactions, including hepatic and gastrointestinal toxicities; meanwhile, the widely-consumed green and black teas, unlike the rare yellow tea, suppressed growth in fast-growing healthy mice. When mice were fed a high-fat diet and allowed free access to tea infusion (1:30, w/v) for 25 days, only yellow tea significantly reduced blood glucose. Therefore, various teas showed different safety profiles as well as anti-hyperglycemic efficacy strengths. To achieve an effective and safe anti-hyperglycemic outcome, yellow tea, which effectively suppressed high-fat diet-induced early elevation of hepatic thioredoxin-interacting protein, is an optimal choice. PMID:27531374

  12. EFFICACY OF DEPURATION ON SAFETY OF MEDITERRANEAN MUSSELS (Mytilus galloprovincialis REARED IN THE OLBIA GULF

    Directory of Open Access Journals (Sweden)

    R. Mazzette

    2013-02-01

    Full Text Available The aim of the present study was to investigate the effect of depuration on the safety of Mediterranean mussels harvested in the Olbia gulf and to evaluate the efficacy of E.coli and Salmonella spp. as indicators of the presence of naturally occurring Vibrios and other pathogens (viruses causing hepatitis, L.monocytogenes and S.aureus. Samples of mussels belonging to 5 batches of products, from 2 Depuration Centers, were collected before depuration (T0, after 4h (T4 and at the end of depuration (T8. Results showed an overall efficacy of the depuration in respect to E.coli moderate counts. A depuration for ~8 hours led to a rapid decline in the concentration, complying to the Food Safety Criteria of the Reg. (EC 2073/2005. The decline in numbers of E.coli, does not correlate with the presence of naturally occurring Vibrios, which decline at an even slower rate. The adoption of shorter treatments times for mussels with high initial counts of Vibrios could lead to a reduction unfitted to guarantee the safety of consumers.

  13. In vitro and in vivo evaluation of efficacy and safety of photoprotective formulations containing antioxidant extracts

    Directory of Open Access Journals (Sweden)

    Maria Cristina P.P. Reis Mansur

    Full Text Available ABSTRACT Chronic exposure to solar radiation could contribute to premature skin aging and skin cancer. Skin presents its own antioxidant defense, however when defenses are out of balance, reactive oxygen species could damage biological structures. In the present work, an oil-in-water photoprotective emulsion was developed and Bauhinia microstachya var. massambabensis Vaz, Fabaceae, extracts at 1% (obtained by extraction with different solvents were added to this emulsion. In vitro and in vivo efficacy and safety of the formulations were evaluated. Spectrophotometric methods and in vivo Colipa test were performed to evaluated efficacy of the formulations, through sun protection factor (SPF determination and UVA protection factor assessment. To the in vitro safety assessment HET-CAM, CAM-TBS and Red Blood Cell tests were performed. Results showed that both extracts contributed to a higher in vivo photoprotection (SPF 18 when compared to the formulation without extract (SPF 13, this result could be attributed to the antioxidant activity of the plant extracts that act by capturing reactive oxygen species. Concerning safety, all formulations were considered non-irritant according to in vitro tests. Formulations containing extracts could be considered efficient and safe for cosmetic use since they presented higher sun protection factor and passed the toxicity tests.

  14. 76 FR 7854 - Patient Safety Organizations: Voluntary Delisting From Quality Excellence, Inc./PSO

    Science.gov (United States)

    2011-02-11

    ... Arkansas Foundation for Medical Care, of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21--b... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety...

  15. The efficacy and safety of low-dose radiotherapy on pain and functioning in patients with osteoarthritis: a systematic review.

    Science.gov (United States)

    Minten, M J M; Mahler, E; den Broeder, A A; Leer, J W H; van den Ende, C H

    2016-01-01

    Low-dose radiotherapy (LD-RT) has been widely used for treatment of non-malignant disorders since its introduction and animal studies show anti-inflammatory effects in osteoarthritis (OA). However, the evidence for its effect in clinical practice remains unclear. Therefore, the aim of this study is to systematically summarise the literature on effectiveness of LD-RT on pain and functioning in patients with OA and its safety. Broad search terms were used to search PubMed, EMBASE and Web of Science. Primary inclusion criteria were osteoarthritis as indication, radiotherapy as intervention, written in English, German or Dutch and published since 1980. Study quality was assessed using the EPHPP Quality Assessment Tool for Quantitative Studies (scale: strong, moderate, weak). Seven studies were suitable for inclusion, all with retrospective uncontrolled observational design. Methodological quality of all studies was judged as weak. Most studies used 2-3 RT sessions per week for 2 weeks, some with booster session after 6 weeks. Generally, non-validated single-item measurement instruments were used to evaluate the effect of LD-RT on pain and function. Across the studies, in 25-90 and 29-71 % of the patients pain and functioning improved, respectively. Side effects were described in one study, none were reported. Our results show that there is insufficient evidence for efficacy or to confirm the safety of LD-RT in treatment of OA, due to absence of high-quality studies. Therefore, a well-designed, sham-controlled and blinded randomised trial, using validated outcome measures is warranted to demonstrate the value of LD-RT for OA in clinical practice.

  16. Microbiological quality and safety assessment of lettuce production in Brazil.

    Science.gov (United States)

    Ceuppens, Siele; Hessel, Claudia Titze; de Quadros Rodrigues, Rochele; Bartz, Sabrina; Tondo, Eduardo César; Uyttendaele, Mieke

    2014-07-02

    The microbiological quality and safety of lettuce during primary production in Brazil were determined by enumeration of hygiene indicators Escherichia coli, coliforms and enterococci and detection of enteric pathogens Salmonella and E. coli O157:H7 in organic fertilizers, soil, irrigation water, lettuce crops, harvest boxes and worker's hands taken from six different lettuce farms throughout the crop growth cycle. Generic E. coli was a suitable indicator for the presence of Salmonella and E. coli O157:H7, while coliforms and enterococci were not. Few pathogens were detected: 5 salmonellae and 2 E. coli O157:H7 from 260 samples, of which only one was lettuce and the others were manure, soil and water. Most (5/7) pathogens were isolated from the same farm and all were from organic production. Statistical analysis revealed the following environmental and agro-technical risk factors for increased microbial load and pathogen prevalence in lettuce production: high temperature, flooding of lettuce fields, application of contaminated organic fertilizer, irrigation with water of inferior quality and large distances between the field and toilets. Control of the composting process of organic fertilizers and the irrigation water quality appear most crucial to improve and/or maintain the microbiological quality and safety during the primary production of lettuce. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. Efficacy and safety evaluation of icotinib in patients with advanced non-small cell lung cancer.

    Science.gov (United States)

    Gu, Aiqin; Shi, Chunlei; Xiong, Liwen; Chu, Tianqing; Pei, Jun; Han, Baohui

    2013-02-01

    To evaluate the efficacy and safety of icotinib hydrochloride in patients with advanced non-small cell lung cancer (NSCLC). A total of 89 patients with stage IIIB or IV NSCLC received icotinib at a dose of 125 mg administered 3 times a day. Icotinib treatment was continued until disease progression or development of unacceptable toxicity. A total of 89 patients were assessable. In patients treated with icotinib, the overall response rate (RR) was 36.0% (32/89), and the disease control rate (DCR) was 69.7% (62/89). RR and DCR were significantly improved in patients with adenocarcinoma versus non-adenocarcinoma (Picotinib hydrochloride in the treatment of advanced NSCLC is efficacious and safe, and its toxic effects are tolerable.

  18. NAVIGATING A QUALITY ROUTE TO A NATIONAL SAFETY AWARD

    Energy Technology Data Exchange (ETDEWEB)

    PREVETTE SS

    2009-05-26

    Deming quality methodologies applied to safety are recognized with the National Safety Council's annual Robert W. Campbell Award. Over the last ten years, the implementation of Statistical Process Control and quality methodologies at the U.S. Department of Energy's Hanford Site have contributed to improved safety. Improvements attributed to Statistical Process Control are evidenced in Occupational Safety and Health records and documented through several articles in Quality Progress and the American Society of Safety Engineers publication, Professional Safety. Statistical trending of safety, quality, and occurrence data continues to playa key role in improving safety and quality at what has been called the world's largest environmental cleanup project. DOE's Hanford Site played a pivotal role in the nation's defense beginning in the 1940s, when it was established as part of the Manhattan Project. After more than 50 years of producing material for nuclear weapons, Hanford, which covers 586 square miles in southeastern Washington state, is now focused on three outcomes: (1) Restoring the Columbia River corridor for multiple uses; (2) Transitioning the central plateau to support long-term waste management; and (3) Putting DOE assets to work for the future. The current environmental cleanup mission faces challenges of overlapping technical, political, regulatory, environmental, and cultural interests. From Oct. 1, 1996 through Sept. 30, 2008, Fluor Hanford was a prime contractor to the Department of Energy's Richland Operations Office. In this role, Fluor Hanford managed several major cleanup activities that included dismantling former nuclear-processing facilities, cleaning up the Site's contaminated groundwater, retrieving and processing transuranic waste for shipment and disposal off-site, maintaining the Site's infrastructure, providing security and fire protection, and operating the Volpentest HAMMER Training and Education

  19. Nuclear safety: a large scale quality audit of pressurized equipment

    International Nuclear Information System (INIS)

    Faudon, Valerie

    2016-01-01

    This article notably refers to, quotes and comments a hearing organised by the French Public Office for the Assessment Scientific and Technological Choices (OPECST) on the issue of safety of pressurized equipment in nuclear reactors, and which gathered the main concerned actors (Areva, EDF, IRSN, ASN) to have an overview of quality controls in AREVA NP fabrication plants. Two different issues have been addressed: a technical metallurgical issue related to some boiler-making parts, and an issue related to quality assurance. These issues concern different older reactors (Fessenheim for example) as well as new ones (EPR Flamanville). The article indicates the different measures planned, envisaged or already implemented by the concerned actors in order to improve knowledge in the boiler-making industry, and to ensure a better quality

  20. Population analyses of efficacy and safety of ABT-594 in subjects with diabetic peripheral neuropathic pain.

    Science.gov (United States)

    Dutta, Sandeep; Hosmane, Balakrishna S; Awni, Walid M

    2012-06-01

    ABT-594, a neuronal nicotinic acetylcholine receptor ligand, is 30- to 100-fold more potent than morphine in animal models of nociceptive and neuropathic pain. Efficacy and safety of ABT-594 in subjects with painful diabetic polyneuropathy was evaluated in a phase 2 study. The objective of this work was to use a nonlinear mixed effects model-based approach for characterizing the relationship between dose and response (efficacy and safety) of ABT-594. Subjects (N = 266) were randomized into four groups in a double-blind, placebo-controlled, 7-week study to receive twice daily regimens of placebo or 150, 225, and 300 μg of ABT-594. The primary efficacy variable, pain score (11-point Likert scale), was assessed on five occasions. The probability of change from baseline pain score of ≥1, ≥2, and ≥3 was modeled using cumulative logistic regression with dose and days of treatment as explanatory variables. The incidence of five most frequently occurring adverse events (AEs) was modeled using linear logistic regression. ABT-594 ED(50) values (improvement in 50% of subjects) for improvement in pain scores of ≥1, ≥2, and ≥3 were 50, 215, and 340 μg, respectively, for the average number of days (33) on treatment. The rank order of ED(50) values for AEs was nausea, vomiting, dizziness, headache, and abnormal dreams; nicotine users were less sensitive to AEs. Population pharmacodynamic models developed to characterize the improvement in pain score and incidence of adverse events indicate an approximately twofold separation between the ED(50) values for efficacy and AEs.

  1. Safety and efficacy of subretinal visual implants in humans: methodological aspects.

    Science.gov (United States)

    Stingl, Katarina; Bach, Michael; Bartz-Schmidt, Karl-Ulrich; Braun, Angelika; Bruckmann, Anna; Gekeler, Florian; Greppmaier, Udo; Hörtdörfer, Gernot; Kusnyerik, Akos; Peters, Tobias; Wilhelm, Barbara; Wilke, Robert; Zrenner, Eberhart

    2013-01-01

    Replacing the function of visual pathway neurons by electronic implants is a novel approach presently explored by various groups in basic research and clinical trials. The novelty raises unexplored methodological aspects of clinical trial design that may require adaptation and validation. We present procedures of efficacy and safety testing for subretinal visual implants in humans, as developed during our pilot trial 2005 to 2009 and multi-centre clinical trial since 2010. Planning such a trial requires appropriate inclusion and exclusion criteria. For subretinal electronic visual implants, patients with photoreceptor degeneration are the target patient group, whereas presence of additional diseases affecting clear optic media or the visual pathway must be excluded. Because sham surgery is not possible, a masked study design with implant power ON versus OFF is necessary. Prior to the efficacy testing by psychophysical tests, the implant's technical characteristics have to be controlled via electroretinography (ERG). Moreover the testing methods require adaptation to the particular technology. We recommend standardised tasks first to determine the light perception thresholds, light localisation and movement detection, followed by grating acuity and vision acuity test via Landolt C rings. A laboratory setup for assessing essential activities of daily living is presented. Subjective visual experiences with the implant in a natural environment, as well as questionnaires and psychological counselling are further important aspects. A clinical trial protocol for artificial vision in humans, which leads a patient from blindness to the state of very low vision is a challenge and cannot be defined completely prior to the study. Available tests of visual function may not be sufficiently suited for efficacy testing of artificial vision devices. A protocol based on experience with subretinal visual implants in 22 patients is presented that has been found adequate to monitor

  2. A Comparative Study of Efficacy and Safety of Eberconazole versus Terbinafine in Patients of Tinea Versicolor.

    Science.gov (United States)

    Sharma, Jyoti; Kaushal, Jyoti; Aggarwal, Kamal

    2018-01-01

    Tinea versicolor (TV) is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%), respectively. However, early response (at the end of week 1) was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

  3. A comparative study of efficacy and safety of eberconazole versus terbinafine in patients of tinea versicolor

    Directory of Open Access Journals (Sweden)

    Jyoti Sharma

    2018-01-01

    Full Text Available Background: Tinea versicolor (TV is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. Aim: This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. Materials and Methods: An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. Results: There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%, respectively. However, early response (at the end of week 1 was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Conclusion: Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

  4. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery

    NARCIS (Netherlands)

    Dahl, Vegard; Pendeville, Philippe E.; Hollmann, Markus W.; Heier, Tom; Abels, Esther Am; Blobner, Manfred

    2009-01-01

    Background and objective The present randomized, safety-assessor blinded, placebo-controlled trial was designed to assess safety and efficacy of sugammadex, a novel selective relaxant-binding agent, in patients with underlying cardiovascular disease undergoing noncardiac surgery. Methods Overall,

  5. Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial

    DEFF Research Database (Denmark)

    Dahl, Ronald; Calverley, Peter M A; Anzueto, Antonio

    2015-01-01

    OBJECTIVES: This post hoc analysis of TIOtropium Safety and Performance In Respimat (TIOSPIR) evaluated safety and exacerbation efficacy in patients with stable (≥2 months) use of tiotropium HandiHaler 18 µg (HH18) prior to study entry, to evaluate whether there was a difference in risk for patie...

  6. 38 CFR 17.155 - Minimum standards of safety and quality for automotive adaptive equipment.

    Science.gov (United States)

    2010-07-01

    ... safety and quality for automotive adaptive equipment. 17.155 Section 17.155 Pensions, Bonuses, and... Minimum standards of safety and quality for automotive adaptive equipment. (a) The Under Secretary for... officials that it meets implicit standards of safety and quality adopted by the industry or as later...

  7. Beyond metrics? Utilizing 'soft intelligence' for healthcare quality and safety.

    Science.gov (United States)

    Martin, Graham P; McKee, Lorna; Dixon-Woods, Mary

    2015-10-01

    Formal metrics for monitoring the quality and safety of healthcare have a valuable role, but may not, by themselves, yield full insight into the range of fallibilities in organizations. 'Soft intelligence' is usefully understood as the processes and behaviours associated with seeking and interpreting soft data-of the kind that evade easy capture, straightforward classification and simple quantification-to produce forms of knowledge that can provide the basis for intervention. With the aim of examining current and potential practice in relation to soft intelligence, we conducted and analysed 107 in-depth qualitative interviews with senior leaders, including managers and clinicians, involved in healthcare quality and safety in the English National Health Service. We found that participants were in little doubt about the value of softer forms of data, especially for their role in revealing troubling issues that might be obscured by conventional metrics. Their struggles lay in how to access softer data and turn them into a useful form of knowing. Some of the dominant approaches they used risked replicating the limitations of hard, quantitative data. They relied on processes of aggregation and triangulation that prioritised reliability, or on instrumental use of soft data to animate the metrics. The unpredictable, untameable, spontaneous quality of soft data could be lost in efforts to systematize their collection and interpretation to render them more tractable. A more challenging but potentially rewarding approach involved processes and behaviours aimed at disrupting taken-for-granted assumptions about quality, safety, and organizational performance. This approach, which explicitly values the seeking out and the hearing of multiple voices, is consistent with conceptual frameworks of organizational sensemaking and dialogical understandings of knowledge. Using soft intelligence this way can be challenging and discomfiting, but may offer a critical defence against the

  8. Long-term safety and efficacy of etanercept in the treatment of ankylosing spondylitis

    Directory of Open Access Journals (Sweden)

    Senabre-Gallego JM

    2013-09-01

    Full Text Available José Miguel Senabre-Gallego,1 Carlos Santos-Ramirez,2 Gregorio Santos-Soler,1 Esteban Salas-Heredia,1 Mabel Sánchez-Barrioluengo,3 Xavier Barber,4 José Rosas1 On behalf of the AIRE-MB group 1Rheumatology, Hospital Marina Baixa, Villajoyosa, 2Rheumatology, Hospital Marina Salud, Denia, 3INGENIO (Instituto de Gestión de la Inovación y del Conocimiento (CSIC [Consejo Superior de Investigaciones Científicas]-UPV [Universidad Politécnica de Valencia], Universitat Politècnica de València, Valencia, 4CIO (Centro de Investigación Operativa-UMH (Universidad Miguel Hernández, Universidad Miguel Henández, Elche, Spain Abstract: To date, anti-tumor necrosis factor alfa (anti-TNF-α therapy is the only alternative to nonsteroidal anti-inflammatory drugs for the treatment of ankylosing spondylitis. Etanercept is a soluble TNF receptor, with a mode of action and pharmacokinetics different to those of antibodies and distinctive efficacy and safety. Etanercept has demonstrated efficacy in the treatment of ankylosing spondylitis, with or without radiographic sacroiliitis, and other manifestations of the disease, including peripheral arthritis, enthesitis, and psoriasis. Etanercept is not efficacious in inflammatory bowel disease, and its efficacy in the treatment of uveitis appears to be lower than that of other anti-TNF drugs. Studies of etanercept confirmed regression of bone edema on magnetic resonance imaging of the spine and sacroiliac joint, but failed to reduce radiographic progression, as do the other anti-TNF drugs. It seems that a proportion of patients remain in disease remission when the etanercept dose is reduced or administration intervals are extended. Etanercept is generally well tolerated with an acceptable safety profile in the treatment of ankylosing spondylitis. The most common adverse effect of etanercept treatment is injection site reactions, which are generally self-limiting. Reactivation of tuberculosis, reactivation of

  9. Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic review

    Directory of Open Access Journals (Sweden)

    Matricciani Lisa

    2011-12-01

    Full Text Available Abstract Background Effective treatment of tinea pedis and onychomycosis is crucial for patients with diabetes as these infections may lead to foot ulcers and secondary bacterial infections resulting in eventual lower limb amputation. Although numerous studies have assessed the effectiveness of antifungal drug and treatment regimens, most exclude patients with diabetes and examine otherwise healthy individuals. While these studies are useful, results cannot necessarily be extrapolated to patients with diabetes. The purpose of this study was to therefore identify the best evidence-based treatment interventions for tinea pedis or onychomycosis in people with diabetes. Methods The question for this systemic review was: 'what evidence is there for the safety and/or efficacy of all treatment interventions for adults with tinea pedis and/or onychomycosis in people with diabetes'? A systematic literature search of four electronic databases (Scopus, EbscoHost, Ovid, Web of Science was undertaken (6/1/11. The primary outcome measure for safety was self-reported adverse events likely to be drug-related, while the primary outcome measures assessed for 'efficacy' were mycological, clinical and complete cure. Results The systematic review identified six studies that examined the safety and/or efficacy of treatment interventions for onychomycosis in people with diabetes. No studies were identified that examined treatment for tinea pedis. Of the studies identified, two were randomised controlled trials (RCTs and four were case series. Based on the best available evidence identified, it can be suggested that oral terbinafine is as safe and effective as oral itraconazole therapy for the treatment of onychomycosis in people with diabetes. However, efficacy results were found to be poor. Conclusions This review indicates that there is good evidence (Level II to suggest oral terbinafine is as safe and effective as itraconazole therapy for the treatment of

  10. EFFICACY AND SAFETY OF ALENDRONIC ACID IN PATIENTS WITH JUVENILE RHEUMATOID ARTHRITIS AND OSTEOPOROSIS

    Directory of Open Access Journals (Sweden)

    A.O. Lisitsin

    2010-01-01

    Full Text Available Search for and practical application of new medications to treat of osteoporosis is one of the critical issues in pediatric rheumatology. The article reviews the efficacy and safety of alendronic acid in 64 subjects with juvenile rheumatoid arthritis and systemic osteoporosis. It is demonstrated that alendronate-based therapy in weekly 1 mg/kg doses over 12 months facilitated reliably increased bonedensity, decreased intensity of pain syndrome, and lowered C-terminal telopeptide serum concentration, which indicates improved bone metabolism processes.Key words: juvenile rheumatoid arthritis, osteoporosis, children, treatment, bisphosphonates, alendronic acid. (Pediatric Pharmacology. – 2010; 7(1:48-54

  11. Efficacy, safety, and patient preference of monoamine oxidase B inhibitors in the treatment of Parkinson's disease.

    Science.gov (United States)

    Robottom, Bradley J

    2011-01-20

    Parkinson's disease (PD) is the second most common neurodegenerative disease and the most treatable. Treatment of PD is symptomatic and generally focuses on the replacement or augmentation of levodopa. A number of options are available for treatment, both in monotherapy of early PD and to treat complications of advanced PD. This review focuses on rasagiline and selegiline, two medications that belong to a class of antiparkinsonian drugs called monoamine oxidase B (MAO-B) inhibitors. Topics covered in the review include mechanism of action, efficacy in early and advanced PD, effects on disability, the controversy regarding disease modification, safety, and patient preference for MAO-B inhibitors.

  12. Safety and efficacy of a low-cost glaucoma drainage device for refractory childhood glaucoma.

    Science.gov (United States)

    Kaushik, Sushmita; Kataria, Pankaj; Raj, Srishti; Pandav, Surinder Singh; Ram, Jagat

    2017-12-01

    To evaluate the safety and efficacy of a low-cost glaucoma drainage device (GDD), Aurolab aqueous drainage implant (AADI), similar in design to the Baerveldt glaucoma implant (BGI), in refractory childhood glaucoma. This prospective interventional study was conducted in a tertiary care postgraduate teaching institute. Children aged glaucoma valve implant in children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  13. 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.

  14. Efficacy and safety of latanoprost versus timolol for primary open angle glaucoma and ocular hypertension: a Meta-analysis

    Directory of Open Access Journals (Sweden)

    Yang-Yang Wu

    2014-03-01

    Full Text Available AIM: To evaluate the efficacy and safety of latanoprost versus timolol for primary open angle glaucoma(POAGand ocular hypertension(OHT.METHODS: This was an evidence-based medicine science study. Pertinent studies of randomized controlled trial(RCTwere identified through searches of PubMed, Medline, CNKI and China Biology Medicine disc. The intensive searching by hand and internet was also designed. According to inclusion and exclusion criteria, the study object was limited. Quality of literatures were evaluated by experienced researchers according to the Jadad Score. RevMan 5.0 offered by Cochrane was used for Meta-analysis aimed at the ratio of low intraocular tension and adverse drug reaction.RESULTS: A total of 9 RCT sadded up to 555 patients were involved. The results of meta-analysis showed that, athe difference at 2, 6, 12wk both had statistical significance, latanoprost showed greater intraocular pressure(IOPlowering efficacy compared with timolol. The weighted mean difference(WMDat 2, 6, 12wk was respectively \\〖-0.76, 95% CI(-1.32 to -0.20\\〗, \\〖-1.15, 95% CI(-1.68 to 0.63\\〗 and \\〖-1.01, 95% CI(-1.42 to -0.61\\〗. bThe difference in conjunctival congestion(OR=2.25, 95% CI 0.99 to 5.08and foreign body sensation(OR=2.48, 95% CI 1.02 to 6.03 between latanoprost and timolol group was not statistically significant. CONCLUSION: Latanoprost showed greater IOP lowering efficacy at 12wk compared with timolol for OAG and OH patients. The conjunctival hyperemia, foreign body sensation, iris pigmentation deepened, vision damage of latanoprost group at 12wk compared with timolol, the difference was not significant. This conclusion is not powerful enough in proof due to the medium methodology quality of the included studies, so a large number of high-quality RCTs with large sample are needed for objectively, precisely and entirely evaluating the efficacy.

  15. Food-packaging interactions influencing quality and safety.

    Science.gov (United States)

    Hotchkiss, J H

    1997-01-01

    Interactions between foods and packaging can be detrimental to quality and/or safety. Changes in product flavour due to aroma sorption and the transfer of undesirable flavours from packaging to foods are important mechanisms of deterioration when foods are packaged in polymer-based materials. Careful consideration must be given to those factors affecting such interactions when selecting packaging materials in order to maximize product quality, safety, and shelf-life while minimizing undesirable changes. Product considerations include sensitivity to flavour and related deteriorations, colour changes, vitamin loss, microbial activity, and amount of flavour available. Storage considerations include temperature, time, and processing method. Polymer considerations include type of polymer and processing method, volume or mass of polymer to product ratio, and whether the interaction is Fickian or non-Fickian. Methodology to determine the extent of such interactions must be developed. Direct interactions between food and packaging are not necessarily detrimental. The same principles governing undesirable interactions can be used to affect desirable outcomes. Examples include films which directly intercept or absorb oxygen, inhibit microorganisms, remove undesirable flavours by sorption, or indicate safety and product shelf-life.

  16. Food Safety and Quality Control: Hints from Proteomics

    Directory of Open Access Journals (Sweden)

    Angelo D'Alessandro

    2012-01-01

    Full Text Available Over the last decade, proteomics has been successfully applied to the study of quality control in production processes of food (including meat, wine and beer, transgenic plants and milk and food safety (screening for food-derived pathogens. Indeed, food quality and safety and their influence on the health of end consumers have growingly become a founding principle in the international agenda of health organizations. The application of proteomics in food science was at first characterized by exploratory analyses of food of various origin (bovine, swine, chicken or lamb meat, but also transgenic food such as genetically modified maize, for example and beverages (beer, wine, in parallel to the genomic and transcriptomic approaches seeking determination of quantitative trait loci. In the last few years, technical improvements such as microbial biotyping strategies have growingly allowed proteomicists to address the safety issue as well. The newly introduced technical improvements (instrumentation characterized by higher sensitivity such as mass spectrometers have paved the way for the individuation of food-contaminating pathogens in a fast and efficient workflow which is mandatory in industrial food production chains.

  17. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

    Directory of Open Access Journals (Sweden)

    Stout Lydia

    2007-12-01

    Full Text Available Abstract Background The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. Methods/Designs Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma, tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12. Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12 to determine subsequent fracture rates. Our co

  18. Efficacy and safety of induction therapy with alemtuzumab in kidney transplantation: a meta-analysis

    Institute of Scientific and Technical Information of China (English)

    SHOU Zhang-fei; ZHOU Qin; CAI Jie-ru; CHENG Jun; HE Qiang; WU Jian-yong; CHEN Jiang-hua

    2009-01-01

    Background Alemtuzumab, a humanized CD52 monoclonal antibody, with its profound lymphocyte depletion property, was expected to be a promising induction therapy agent for kidney transplantation (KTx). However, currently no consensus is available about its efficacy and safety. The aim of this meta-anaiysis was to make a profound review and an objective appraisal of this issue. Methods Relevant papers were searched, essentially in the PubMed database and the Cochrane library. After a thorough review, randomized controlled trials (RCTs) comparing the outcome of KTx using alemtuzumab induction therapy (test group) with a control group were collected according to the inclusion criteria. Data of general characteristic of studies and major outcomes of Ktx were extracted and meta-analyses were performed with RevMan 4.2 software. The odds ratio (OR) with a 95% confidence intervals (CI) was the principle measurement of effect. Results Five RCTs were included. The chi square test showed no significant between-study heterogeneity, thus fixed effect model was employed. Sub-group analysis with studies including alemtuzumab induction followed by a tacrolimus-based immunosuppressive regimen showed that the acute rejection rate (ARR) was lower relative to the control (OR=0.59, 95% CI 0.34-1.01, P=0.05). However, meta-analysis with all included studies revealed that neither ARR nor patient/graft survival rates differ significantly between the test and the control group, but the cytomegalovirus (CMV) infection rate was higher in the test group (OR 2.50, 95% CI 1.22-5.12, P=0.01 ). A great number of the test group recipients safely remained on a regimen that was steroid-free and with a reduced dose of conventional immunosuppressive drugs. Conclusions Alemtuzumab induction therapy for KTx was an effective and safe protocol in the tested follow-up period. Steroid avoidance and a dose reduction of conventional immunosuppressive drugs after alemtuzumab induction therapy may have clinical

  19. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults

    DEFF Research Database (Denmark)

    Hristovska, Ana-Marija; Duch, Patricia; Allingstrup, Mikkel

    2017-01-01

    , and undesirable autonomic responses. Sugammadex is a selective relaxant-binding agent specifically developed for rapid reversal of non-depolarizing neuromuscular blockade induced by rocuronium. Its potential clinical benefits include fast and predictable reversal of any degree of block, increased patient safety......, reduced incidence of residual block on recovery, and more efficient use of healthcare resources. OBJECTIVES: The main objective of this review was to compare the efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade caused by non-depolarizing neuromuscular agents......-depolarizing neuromuscular blocking agents for an elective in-patient or day-case surgical procedure. We included all trials comparing sugammadex versus neostigmine that reported recovery times or adverse events. We included any dose of sugammadex and neostigmine and any time point of study drug administration. DATA...

  20. Resistance training among young athletes: safety, efficacy and injury prevention effects.

    Science.gov (United States)

    Faigenbaum, A D; Myer, G D

    2010-01-01

    A literature review was employed to evaluate the current epidemiology of injury related to the safety and efficacy of youth resistance training. Several case study reports and retrospective questionnaires regarding resistance exercise and the competitive sports of weightlifting and powerlifting reveal that injuries have occurred in young lifters, although a majority can be classified as accidental. Lack of qualified instruction that underlies poor exercise technique and inappropriate training loads could explain, at least partly, some of the reported injuries. Current research indicates that resistance training can be a safe, effective and worthwhile activity for children and adolescents provided that qualified professionals supervise all training sessions and provide age-appropriate instruction on proper lifting procedures and safe training guidelines. Regular participation in a multifaceted resistance training programme that begins during the preseason and includes instruction on movement biomechanics may reduce the risk of sports-related injuries in young athletes. Strategies for enhancing the safety of youth resistance training are discussed.

  1. Efficacy and safety of granulocyte, monocyte/macrophage adsorptive in pediatric ulcerative colitis

    DEFF Research Database (Denmark)

    Ruuska, Tarja; Küster, Peter; Grahnquist, Lena

    2016-01-01

    AIM: To investigate efficacy and safety for granulocyte, monocyte apheresis in a population of pediatric patients with ulcerative colitis. METHODS: The ADAPT study was a prospective, open-label, multicenter study in pediatric patients with moderate, active ulcerative colitis with pediatric...... ulcerative colitis activity index (PUCAI) of 35-64. Patients received one weekly apheresis with Adacolumn(®) granulocyte, monocyte/macrophage adsorptive (GMA) apheresis over 5 consecutive weeks, optionally followed by up to 3 additional apheresis treatments over 3 consecutive weeks. The primary endpoint...... mg daily on average from Baseline to week 12. CONCLUSION: Adacolumn(®) GMA apheresis treatment was effective in pediatric patients with moderate active Ulcerative Colitis. No new safety signals were reported. The present data contribute to considering GMA apheresis as a therapeutic option...

  2. Modern Therapy for Gout through the Prism of Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    I.Yu. Golovach

    2015-04-01

    Full Text Available The modern data on the treatment of such common condition as gout were presented in this article. Gout management covers and unites two directions: firstly, adequate treatment of acute gout episodes and, secondly, a steady decline in serum urate level below 360 µmol/l (6 mg/dl or lower in some cases to prevent recurrences and to promote resorption of tophi. The therapeutic possibilities in acute gout episode include nonsteroidal anti-inflammatory drugs, colchicine and glucocorticoids; in the treatment of chronic gout, allopurinol is widely used. The efficacy and safety of innovative drugs in the treatment of gout — febuxostat and interleukin-1 inhibitors were shown. It is underlined that the main problems of gout treatment are related to long-term safety and comorbidities.

  3. Generalized Safety and Efficacy of Simplified Intravenous Thrombolysis Treatment (SMART) Criteria in Acute Ischemic Stroke

    DEFF Research Database (Denmark)

    Sørensen, Sigrid B; Barazangi, Nobl; Chen, Charlene

    2016-01-01

    BACKGROUND: Common intravenous recombinant tissue plasminogen activator (IV rt-PA) exclusion criteria may substantially limit the use of thrombolysis. Preliminary data have shown that the SMART (Simplified Management of Acute stroke using Revised Treatment) criteria greatly expand patient...... eligibility by reducing thrombolysis exclusions, but they have not been assessed on a large scale. We evaluated the safety and efficacy of general adoption of SMART thrombolysis criteria to a large regional stroke network. METHODS: Retrospective analysis of consecutive patients who received IV thrombolysis...... within a regional stroke network was performed. Patients were divided into those receiving thrombolysis locally versus at an outside hospital. The primary outcome was modified Rankin Scale score (≤1) at discharge and the main safety outcome was symptomatic intracranial hemorrhage (sICH) rate. RESULTS...

  4. 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.

  5. Efficacy and Safety of Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder

    Directory of Open Access Journals (Sweden)

    Michael R. Kohn

    2012-01-01

    Full Text Available Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD. Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication.

  6. Efficacy and Safety of Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder

    Science.gov (United States)

    Kohn, Michael R.; Tsang, Tracey W.; Clarke, Simon D.

    2012-01-01

    Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication. PMID:23641171

  7. GOLIMUMAB — A NEW TNF α-BLOCKER. THE REVIEW OF THE EFFICACY AND SAFETY EVALUATION RESULTS

    Directory of Open Access Journals (Sweden)

    R. V. Denisova

    2012-01-01

    Full Text Available The article represents the results of efficacy and safety evaluation of the human monoclonal antibodies — golimumab, according to the data of international multicenter randomized double-blind placebo-controlled trials, including patients with active stage of rheumatoid arthritis. It was shown, that golimumab was reliably more effective than placebo both when administered hypodermic and intravenous. The safety profile of golimumab is comparable to that of the other tumor necrosis factor alpha blockers. The review also contains information on the 3d phase of golimumab efficacy and safety research in patients with juvenile idiopathic arthritis.

  8. Procurement in the Nuclear Industry, Quality, Safety and Decision Making

    International Nuclear Information System (INIS)

    Jakobsson, Marianne; Svenson, Ola; Salo, Ilkka

    2010-03-01

    are formed. This means that external personal sometimes has to be engaged in such a team and therefore the emphasis on safety has to be communicated effectively to those joining the team from outside the plant. From a competition point of view, the number of potential suppliers is often too small. There is a feedback system of experience from previous contracts, but this information is of little use since it is not documented so that it is possible to conduct a quick and efficient information search, which would be a weakness when safety and quality information is needed quickly in a procurement process

  9. Electronic nicotine delivery systems ("e-cigarettes"): review of safety and smoking cessation efficacy.

    Science.gov (United States)

    Harrell, Paul Truman; Simmons, Vani Nath; Correa, John Bernard; Padhya, Tapan Ashvin; Brandon, Thomas Henry

    2014-09-01

    Cigarette smoking is common among cancer patients and is associated with negative outcomes. Electronic nicotine delivery systems ("e-cigarettes") are rapidly growing in popularity and use, but there is limited information on their safety or effectiveness in helping individuals quit smoking. The authors searched PubMed, Web of Science, and additional sources for published empirical data on safety and use of electronic cigarettes as an aid to quit smoking. We conducted a structured search of the current literature up to and including November 2013. E-cigarettes currently vary widely in their contents and are sometimes inconsistent with labeling. Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse effects, and secondhand toxicity exposure. Data on the use of e-cigarettes for quitting smoking are suggestive but ultimately inconclusive. Clinicians are advised to be aware that the use of e-cigarettes, especially among cigarette smokers, is growing rapidly. These devices are unregulated, of unknown safety, and of uncertain benefit in quitting smoking. In the absence of further data or regulation, oncologists are advised to discuss the known and unknown safety and efficacy information on e-cigarettes with interested patients and to encourage patients to first try FDA-approved pharmacotherapies for smoking cessation. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  10. Electronic Nicotine Delivery Systems (“E-Cigarettes”): Review of Safety and Smoking Cessation Efficacy

    Science.gov (United States)

    Harrell, Paul Truman; Simmons, Vani Nath; Correa, John Bernard; Padhya, Tapan Ashvin; Brandon, Thomas Henry

    2015-01-01

    Background and Objectives Cigarette smoking is common among cancer patients and is associated with negative outcomes. Electronic nicotine delivery systems (“e-cigarettes”) are rapidly growing in popularity and use, but there is limited information on their safety or effectiveness in helping individuals quit smoking. Data Sources The authors searched PubMed, Web of Science, and additional sources for published empirical data on safety and use of electronic cigarettes as an aid to quit smoking. Review Methods We conducted a structured search of the current literature up to and including November 2013. Results E-cigarettes currently vary widely in their contents and are sometimes inconsistent with labeling. Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse effects, and secondhand toxicity exposure. Data on the use of e-cigarettes for quitting smoking is suggestive, but ultimately inconclusive. Conclusions Clinicians are advised to be aware that the use of e-cigarettes, especially among cigarette smokers, is growing rapidly. These devices are unregulated, of unknown safety, and of uncertain benefit in quitting smoking. Implications for Practice In the absence of further data or regulation, oncologists are advised to discuss the known and unknown safety and efficacy information on e-cigarettes with interested patients, and to encourage patients to first try FDA-approved pharmacotherapies for smoking cessation. PMID:24898072

  11. Efficacy and safety of bupivacaine versus lidocaine in local anesthesia of the nasopharynx: A meta-analysis.

    Science.gov (United States)

    Yu, Xiaoyun; Wang, Jiyun; Huang, Lizhen; Yu, Xiao; He, Zheyun

    2016-09-30

    To assess the efficacy and safety of bupivacaine compared with lidocaine in local anesthesia of nasopharynx through meta-analysis. A number of medical literature data bases were searched electronically. Relevant journals and references of included studies were manually searched. Two reviewers independently performed data extraction and quality assessment. Four studies were included. Visual analog scale (VAS) scores, acceptable discomfort, and bleeding scores were analyzed for bupivacaine versus lidocaine. When considering the VAS scores, bupivacaine as a local anesthetic agent was better than lidocaine in controlling the pain of postoperative patients (p bupivacaine group demonstrated a higher acceptable discomfort than the patients in the lidocaine group (p = 0.008). With regard to the bleeding scores of the patients with nasal surgery, lidocaine was better at bleeding in postoperative patients compared with bupivacaine (p = 0.0007). These results indicated that bupivacaine showed better pain control of postoperative patients and acceptable discomfort in patients with upper gastrointestinal endoscopy. Lidocaine had a significantly increased ability the pain of patients with transnasal fiberoptic nasopharyngolaryngoscopic examination and bleeding in postoperative patients. No systemic adverse events were reported. Bupivacaine was found to have better promotion to pain control than did lidocaine for the patients after nasal surgery. Lidocaine had a significantly increased inhibition of bleeding in these postoperative patients; however, the efficacy between bupivacaine and lidocaine was unclear for the patients who had transnasal endoscopic examinations.

  12. Efficacy and safety of bubble CPAP in neonatal care in low and middle income countries: a systematic review.

    Science.gov (United States)

    Martin, Simone; Duke, Trevor; Davis, Peter

    2014-11-01

    Forty per cent of global child deaths occur in the neonatal period. Low and middle income countries need effective and simple methods to improve hospital-based neonatal care. Bubble continuous positive airway pressure (CPAP) may have a role in improving the quality of respiratory support in hospitals in low and middle income countries. To examine the evidence for the efficacy and safety of bubble CPAP in neonates with respiratory distress in low and middle income settings. A systematic search (1946-March 2014) was performed of Pubmed, Ovid MEDLINE, Web of Science, Google Scholar and the references of relevant articles. Articles meeting inclusion criteria (CPAP for respiratory distress in infants CPAP compared with oxygen therapy, followed by mechanical ventilation if required, reduced the need for mechanical ventilation by 30%-50%. In another three trials comparing bubble CPAP with ventilator CPAP, mortality and complication rates were similar, while meta-analysis of CPAP failure in these same trials showed a lower failure rate in the bubble CPAP groups (p CPAP is safe and reduces the need for mechanical ventilation. Further research into the efficacy of bubble CPAP in low-income and middle-income countries is needed. 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.

  13. The History of Infant Formula: Quality, Safety, and Standard Methods.

    Science.gov (United States)

    Wargo, Wayne F

    2016-01-01

    Food-related laws and regulations have existed since ancient times. Egyptian scrolls prescribed the labeling needed for certain foods. In ancient Athens, beer and wines were inspected for purity and soundness, and the Romans had a well-organized state food control system to protect consumers from fraud or bad produce. In Europe during the Middle Ages, individual countries passed laws concerning the quality and safety of eggs, sausages, cheese, beer, wine, and bread; some of these laws still exist today. But more modern dietary guidelines and food regulations have their origins in the latter half of the 19th century when the first general food laws were adopted and basic food control systems were implemented to monitor compliance. Around this time, science and food chemistry began to provide the tools to determine "purity" of food based primarily on chemical composition and to determine whether it had been adulterated in any way. Since the key chemical components of mammalian milk were first understood, infant formulas have steadily advanced in complexity as manufacturers attempt to close the compositional gap with human breast milk. To verify these compositional innovations and ensure product quality and safety, infant formula has become one of the most regulated foods in the world. The present paper examines the historical development of nutritional alternatives to breastfeeding, focusing on efforts undertaken to ensure the quality and safety from antiquity to present day. The impact of commercial infant formulas on global regulations is addressed, along with the resulting need for harmonized, fit-for-purpose, voluntary consensus standard methods.

  14. Theoretical Application of Supervision over Quality and Safety of Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    Xin; CHENG; Ying; ZHANG

    2013-01-01

    Supervision over quality and safety of agricultural products has received high attention of management department.Competent authorities have formulated and issued many measures to strengthen supervision over quality and safety of agricultural products and improve China’s agricultural product quality and safety level.From the perspective of management science,this paper elaborates basic contents of two basic management theories,Broken Windows Effect and Effect of Heat Furnace.Then,it analyzes influence of Broken Windows Effect and Effect of Heat Furnace on supervision over quality and safety of agricultural products.Finally,it comes up with recommendations for supervision over quality and safety of agricultural products.

  15. Gluten-Free Diet Indications, Safety, Quality, Labels, and Challenges.

    Science.gov (United States)

    Rostami, Kamran; Bold, Justine; Parr, Alison; Johnson, Matt W

    2017-08-08

    A gluten-free diet (GFD) is the safest treatment modality in patient with coeliac disease (CD) and other gluten-related disorders. Contamination and diet compliance are important factors behind persistent symptoms in patients with gluten related-disorders, in particular CD. How much gluten can be tolerated, how safe are the current gluten-free (GF) products, what are the benefits and side effects of GFD? Recent studies published in Nutrients on gluten-free products' quality, availability, safety, as well as challenges related to a GFD are discussed.

  16. The efficacy and safety of external cephalic version after a previous caesarean delivery.

    Science.gov (United States)

    Weill, Yishay; Pollack, Raphael N

    2017-06-01

    External cephalic version (ECV) in the presence of a uterine scar is still considered a relative contraindication despite encouraging studies of the efficacy and safety of this procedure. We present our experience with this patient population, which is the largest cohort published to date. To evaluate the efficacy and safety of ECV in the setting of a prior caesarean delivery. A total of 158 patients with a fetus presenting as breech, who had an unscarred uterus, had an ECV performed. Similarly, 158 patients with a fetus presenting as breech, and who had undergone a prior caesarean delivery also underwent an ECV. Outcomes were compared. ECV was successfully performed in 136/158 (86.1%) patients in the control group. Of these patients, 6/136 (4.4%) delivered by caesarean delivery. In the study group, 117/158 (74.1%) patients had a successful ECV performed. Of these patients, 12/117 (10.3%) delivered by caesarean delivery. There were no significant complications in either of the groups. ECV may be successfully performed in patients with a previous caesarean delivery. It is associated with a high success rate, and is not associated with an increase in complications. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  17. Silodosin for the treatment of clinical benign prostatic hyperplasia: safety, efficacy, and patient acceptability.

    Science.gov (United States)

    Cho, Hee Ju; Yoo, Tag Keun

    2014-01-01

    α1-Adrenergic receptor antagonists are commonly used to treat male lower urinary tract symptoms and benign prostatic hyperplasia (BPH). We performed a literature search using PubMed, Medline via Ovid, Embase, and the Cochrane Library databases to identify studies on the treatment of BPH by silodosin. Silodosin is a novel α1-adrenergic receptor antagonist whose affinity for the α1A-adrenergic receptor is greater than that for the α1B-adrenergic receptor. Therefore, silodosin does not increase the incidence of blood pressure-related side effects, which may result from the inhibition of the α1B-adrenergic receptor. Patients receiving silodosin at a daily dose of 8 mg showed a significant improvement in the International Prostate Symptom Score and maximum urinary flow rate compared with those receiving a placebo. Silodosin also improved both storage and voiding symptoms, indicating that silodosin is effective, even during early phases of BPH treatment. Follow-up extension studies performed in the United States, Europe, and Asia demonstrated its long-term safety and efficacy. In the European study, silodosin significantly reduced nocturia compared to the placebo. Although retrograde or abnormal ejaculation was the most commonly reported symptom in these studies, only a few patients discontinued treatment. The incidence of adverse cardiovascular events was also very low. Evidence showing solid efficacy and cardiovascular safety profiles of silodosin will provide a good solution for the treatment of lower urinary tract symptoms associated with BPH in an increasingly aging society.

  18. The Safety and Efficacy of Cryolipolysis: A Systematic Review of Available Literature.

    Science.gov (United States)

    Derrick, Chase D; Shridharani, Sachin M; Broyles, Justin M

    2015-09-01

    In the past decade, the practice of body contouring using cryolipolysis has increased tremendously. While numerous anecdotal reports extol the efficacy of this product, the majority of these studies are small, retrospective case-series that lack control groups. The authors aim to systematically review available literature to better illustrate the efficacy and safety of this new procedure. A systematic literature review performed using MEDLINE, Embase, PubMed, and Cochrane databases identified all published studies evaluating cryolipolysis for body contouring. A total of 34 articles up to February 2015 were identified. Nineteen articles matched the selection criteria and were included in the analysis. Sixteen were evaluated in the final analysis. A total of 1445 patients had reportable data for analysis of the safety profile. Twelve patients (0.82%) reported complications with the most common being diminished sensation lasting greater than 4 weeks. An aggregate total of 295 patients had objective data for evaluation of tissue reduction. The mean time from procedure to objective outcome evaluation was 3.83 months. The mean reduction of subcutaneous tissue was 19.55% with respect to a designated control site. Selective cryolipolysis appears, at short-term follow-up, to reliably decrease subcutaneous tissue deposits. Reported complications are uncommon and appear to resolve without intervention. Future studies should aim to optimize patient selection and treatment characteristics while obtaining long-term follow-up data. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  19. Deferasirox: appraisal of safety and efficacy in long-term therapy

    Directory of Open Access Journals (Sweden)

    Chaudhary P

    2013-08-01

    Full Text Available Preeti Chaudhary, Vinod PullarkatJane Ann Nohl Division of Hematology, University of Southern California Keck School of Medicine, Los Angeles, CA, USAAbstract: Deferasirox is a once-daily, oral iron chelator that is widely used in the management of patients with transfusional hemosiderosis. Several Phase II trials along with their respective extension studies as well as a Phase III trial have established the efficacy and safety of this novel agent in transfusion-dependent patients with β-thalassemia, sickle-cell disease and bone marrow-failure syndromes, including myelodysplastic syndrome and aplastic anemia. Data from various clinical trials show that a deferasirox dose of 20 mg/kg/day stabilizes serum ferritin levels and liver iron concentration, while a dose of 30–40 mg/kg/day reduces these parameters and achieves negative iron balance in red cell transfusion-dependent patients with iron overload. Across various pivotal clinical trials, deferasirox was well tolerated, with the most common adverse events being gastrointestinal disturbances, skin rash, nonprogressive increases in serum creatinine, and elevations in liver enzyme levels. Longer-term extension studies have also confirmed the efficacy and safety of deferasirox. However, it is essential that patients on deferasirox therapy are monitored regularly to ensure timely management for any adverse events that may occur with long-term therapy.Keywords: deferasirox, iron overload, thalassemia, sickle-cell disease, myelodysplastic syndrome

  20. Comparative instrumental evaluation of efficacy and safety between a binary and a ternary system in chemexfoliation.

    Science.gov (United States)

    Cameli, Norma; Mariano, Maria; Ardigò, Marco; Corato, Cristina; De Paoli, Gianfranco; Berardesca, Enzo

    2017-09-20

    To instrumentally evaluate the efficacy and the safety of a new ternary system chemo exfoliating formulation (water-dimethyl isosorbide-acid) vs traditional binary systems (water and acid) where the acid is maintained in both the systems at the same concentration. Different peelings (binary system pyruvic acid and trichloroacetic acid-TCA, and ternary system pyruvic acid and TCA) were tested on the volar forearm of 20 volunteers of both sexes between 28 and 50 years old. The outcomes were evaluated at the baseline, 10 minutes, 24 hours, and 1 week after the peeling by means of noninvasive skin diagnosis techniques. In vivo reflectance confocal microscopy was used for stratum corneum evaluation, transepidermal waterloss, and Corneometry for skin barrier and hydration, Laser Doppler velocimetry in association with colorimetry for irritation and erythema analysis. The instrumental data obtained showed that the efficacy and safety of the new ternary system peel compounds were significantly higher compared with the binary system formulations tested. The new formulation peels improved chemexfoliation and reduced complications such as irritation, redness, and postinflammatory pigmentation compared to the traditional aqueous solutions. The study showed that ternary system chemexfoliation, using a controlled delivery technology, was able to provide the same clinical effects in term of stratum corneum reduction with a significantly reduced barrier alteration, water loss, and irritation/erythema compared to traditional binary system peels. © 2017 Wiley Periodicals, Inc.

  1. Profile of vildagliptin in type 2 diabetes: efficacy, safety, and patient acceptability

    Directory of Open Access Journals (Sweden)

    Pan CY

    2013-05-01

    Full Text Available CY Pan,1 XL Wang21Chinese PLA General Hospital, Beijing, People's Republic of China; 2Medical Affairs Department, Beijing Novartis Pharma Co, Ltd, Beijing, People's Republic of ChinaAbstract: Vildagliptin is a selective and potent dipeptidyl peptidase-4 inhibitor that improves glycemic control by inhibiting the degradation of both endogenous glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. This article is a comprehensive review of the safety and efficacy of vildagliptin in patients with type 2 diabetes. Clinical evidence has proven that it effectively decreases hemoglobin A1c with a low risk of hypoglycemia and is weight neutral. The addition of vildagliptin to metformin improves glucose control and significantly reduces gastrointestinal adverse events, particularly in patients inadequately controlled with metformin monotherapy. Its long-term advantages include preservation of β-cell function, reduction in total cholesterol, decrease in fasting lipolysis in adipose tissue, and triglyceride storage in non-fat tissues. Vildagliptin is well tolerated with a low incidence of AEs, and it does not increase the risk of cardiovascular/cerebrovascular (CCV events. It can be taken before or after meals, and has little drug interaction, thus it will be well accepted.Keywords: dipeptidyl peptidase-4, incretin hormones, vildagliptin, efficacy, safety, patient acceptability

  2. Efficacy and safety of small intestinal submucosa in dural defect repair in a canine model

    Energy Technology Data Exchange (ETDEWEB)

    He, Shu-kun [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Guo, Jin-hai [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Department of Orthopedics, The Third People' s Hospital of Chengdu, Chengdu, Sichuan 610031 (China); Wang, Zhu-le [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Zhang, Yi [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Tu, Yun-hu [Department of Neurosurgery, Chengdu Military General Hospital, Chengdu, Sichuan 610083 (China); Wu, Shi-zhou [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Huang, Fu-guo [Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Xie, Hui-qi, E-mail: xiehuiqi@scu.edu.cn [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China)

    2017-04-01

    Dural defects are a common problem, and inadequate dural closure can lead to complications. Several types of dural substitute materials have recently been discarded or modified owing to poor biocompatibility or mechanical properties and adverse reactions. The small intestinal submucosa (SIS) is a promising material used in a variety of applications. Based on the limitations of previous studies, we conducted an animal study to evaluate the efficacy and safety of the SIS in preclinical trials. Twenty-four male beagle dogs were subjected to surgical resection to produce dural defects. SIS or autologous dural mater was patched on the dural defect. Gross and histological evaluations were carried out to evaluate the efficacy and safety of the therapy. Our findings demonstrated that the SIS, which stimulated connective and epithelial tissue responses for dural regeneration and functional recovery without immunological rejection, could provide prolonged defect repair and prevent complications. The mechanical properties of the SIS could be adjusted by application of multiple layers, and the biocompatibility of the material was appropriate. Thus, our data suggested that this material may represent an alternative option for clinical treatment of dural defects. - Highlights: • SIS stimulates dura regeneration without immunological rejection. • SIS has adjustable mechanical properties and appropriate biocompatibility. • SIS may be an effective alternative option for clinical treatment of dural defects.

  3. Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis

    Directory of Open Access Journals (Sweden)

    Gajofatto A

    2015-12-01

    Full Text Available Alberto Gajofatto,1,2 Marco Turatti,2 Salvatore Monaco,1,2 Maria Donata Benedetti2 1Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy; 2Division of Neurology B, Verona University Hospital, Verona, Italy Abstract: Fingolimod is a selective immunosuppressive agent approved worldwide for the treatment of relapsing-remitting multiple sclerosis (MS, a chronic and potentially disabling neurological condition. Randomized double-blind clinical trials have shown that fingolimod significantly reduces relapse rate and ameliorates a number of brain MRI measures, including cerebral atrophy, compared to both placebo and intramuscular interferon-1a. The effect on disability progression remains controversial, since one Phase III trial showed a significant benefit of treatment while two others did not. Although fingolimod has a very convenient daily oral dosing, the possibility of serious cardiac, ocular, infectious, and other rare adverse events justified the decision of the European Medicines Agency to approve the drug as a second-line treatment for MS patients not responsive to first-line therapy, or those with rapidly evolving course. In the United States, fingolimod is instead authorized as a first-line treatment. The aim of this review is to describe and discuss the characteristics of fingolimod concerning its efficacy, safety, and tolerability in the clinical context of multiple sclerosis management. Keywords: multiple sclerosis, fingolimod, safety, tolerability, efficacy

  4. Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals

    International Nuclear Information System (INIS)

    Kulkarni, R.D.; Gopal, N.G.S.

    1975-01-01

    Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)

  5. Efficacy and safety of topical Trikatu preparation in, relieving mosquito bite reactions: a randomized controlled trial.

    Science.gov (United States)

    Maenthaisong, Ratree; Chaiyakunapruk, Nathorn; Tiyaboonchai, Waree; Tawatsin, Apiwat; Rojanawiwat, Archawin; Thavara, Usavadee

    2014-02-01

    Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl, and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis, pain, and inflammation for a long time, there is no clinical evidence to confirm its efficacy and safety. Therefore, we performed a double-blind, within person-randomized controlled study of 30 healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions. All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule. The main outcome was the difference of papule size reduction at 30 min, measured by a caliper, between the Trikatu and reference arms. Pruritis, redness, pain, and patient satisfaction were assessed at 15, 30, 60, 180, and 360 min as secondary outcomes. There were no significant differences between treatment and reference arms on any outcome at any time of measurement. Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor, menthol, and eucalyptus. For further study, it is very important to consider a proper selection of subjects, comparator product, and concentration of extract when Trikatu preparation is investigated. Copyright © 2013 Elsevier Ltd. All rights reserved.

  6. Managing blood pressure control in Asian patients: safety and efficacy of losartan.

    Science.gov (United States)

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

    Hypertension is common in Asian populations and is a major cause of cardiovascular diseases. The prevalence of hypertension is increasing in many Asian countries. The overall prevalence of hypertension in India and the People's Republic of China has been estimated to be 20.6% in men and 22.6% in women. However, the rates of detection, treatment, and control of hypertension remain low in Asia. This reflects a low level of literacy and education, as well as a low level of access to medical care. To overcome these obstacles, strategies targeted at education, promotion, and optimization of medical care, are crucial to achieve target blood pressure control. Angiotensin receptor blockers are one of the first-line treatments for essential hypertension because they confer better cardiovascular outcomes. Losartan has been widely evaluated for the management of hypertension. Although some studies suggested that the blood pressure-lowering effect of losartan is perhaps lower than for other angiotensin receptor blockers, losartan has been demonstrated to be beneficial in terms of renal protection in patients with diabetes, heart failure resulting from either systolic or diastolic dysfunction, and diuretic-induced hyperuricemia. However, most of these data were obtained from Caucasian populations. The efficacy and safety of losartan in Asian populations may be different because of genetic and ethnic variations. Therefore, the efficacy and safety of losartan in Asian patients with hypertension warrant further study.

  7. Efficacy and safety of small intestinal submucosa in dural defect repair in a canine model

    International Nuclear Information System (INIS)

    He, Shu-kun; Guo, Jin-hai; Wang, Zhu-le; Zhang, Yi; Tu, Yun-hu; Wu, Shi-zhou; Huang, Fu-guo; Xie, Hui-qi

    2017-01-01

    Dural defects are a common problem, and inadequate dural closure can lead to complications. Several types of dural substitute materials have recently been discarded or modified owing to poor biocompatibility or mechanical properties and adverse reactions. The small intestinal submucosa (SIS) is a promising material used in a variety of applications. Based on the limitations of previous studies, we conducted an animal study to evaluate the efficacy and safety of the SIS in preclinical trials. Twenty-four male beagle dogs were subjected to surgical resection to produce dural defects. SIS or autologous dural mater was patched on the dural defect. Gross and histological evaluations were carried out to evaluate the efficacy and safety of the therapy. Our findings demonstrated that the SIS, which stimulated connective and epithelial tissue responses for dural regeneration and functional recovery without immunological rejection, could provide prolonged defect repair and prevent complications. The mechanical properties of the SIS could be adjusted by application of multiple layers, and the biocompatibility of the material was appropriate. Thus, our data suggested that this material may represent an alternative option for clinical treatment of dural defects. - Highlights: • SIS stimulates dura regeneration without immunological rejection. • SIS has adjustable mechanical properties and appropriate biocompatibility. • SIS may be an effective alternative option for clinical treatment of dural defects.

  8. Efficacy and safety of tofacitinib in older and younger patients with rheumatoid arthritis.

    Science.gov (United States)

    Curtis, Jeffrey R; Schulze-Koops, Hendrik; Takiya, Liza; Mebus, Charles A; Terry, Ketti K; Biswas, Pinaki; Jones, Thomas V

    2017-01-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the efficacy and safety of tofacitinib 5 or 10 mg twice daily (BID), in patients with moderate to severe RA, aged ≥65 and tofacitinib, or placebo (Phase 3 only), with/without conventional synthetic DMARDs (mainly methotrexate). Clinical efficacy outcomes from Phase 3 studies were evaluated at Month 3. Safety evaluations using pooled Phase 3 data (Month 12) and pooled LTE data (Month 24) compared exposure-adjusted incidence rates (IRs; with 95% confidence intervals [CIs]), in older versus younger patients. In Phase 3 and LTE studies, 15.3% (475/3111) and 16.1% (661/4102) of patients, respectively, were aged ≥65 years. Consequently, exposure to tofacitinib was lower in older versus younger patients in Phase 3 (259.2 vs. 1554.9 patient years [pt-yrs]) and LTE (962.1 vs. 5071.7 pt-yrs) studies. Probability ratios for ACR responses and HAQ-DI improvement from baseline ≥0.22 (Month 3) favoured tofacitinib and were similar in older and younger patients, with overlapping CIs. IRs for SAEs and discontinuations due to AEs were generally numerically higher in older versus younger patients, irrespective of treatment. Older patients receiving tofacitinib 5 or 10 mg BID had a similar probability of ACR20 or ACR50 response and, due to comorbidities, a numerically higher risk of SAEs and discontinuations due to AEs compared with younger patients.

  9. The Influence of Safety, Efficacy, and Medical Condition Severity on Natural versus Synthetic Drug Preference.

    Science.gov (United States)

    Meier, Brian P; Lappas, Courtney M

    2016-11-01

    Research indicates that there is a preference for natural v. synthetic products, but the influence of this preference on drug choice in the medical domain is largely unknown. We present 5 studies in which participants were asked to consider a hypothetical situation in which they had a medical issue requiring pharmacological therapy. Participants ( N = 1223) were asked to select a natural, plant-derived, or synthetic drug. In studies 1a and 1b, approximately 79% of participants selected the natural v. synthetic drug, even though the safety and efficacy of the drugs were identical. Furthermore, participants rated the natural drug as safer than the synthetic drug, and as that difference increased, the odds of choosing the natural over synthetic drug increased. In studies 2 and 3, approximately 20% of participants selected the natural drug even when they were informed that it was less safe (study 2) or less effective (study 3) than the synthetic drug. Finally, in study 4, approximately 65% of participants chose a natural over synthetic drug regardless of the severity of a specific medical condition (mild v. severe hypertension), and this choice was predicted by perceived safety and efficacy differences. Overall, these data indicate that there is a bias for natural over synthetic drugs. This bias could have implications for drug choice and usage. © The Author(s) 2015.

  10. A prospective case series evaluating the safety and efficacy of the Klox BioPhotonic System in venous leg ulcers

    Directory of Open Access Journals (Sweden)

    Nikolis A

    2016-09-01

    Full Text Available Andreas Nikolis,1 Doria Grimard,2 Yves Pesant,3 Giovanni Scapagnini,4 Denis Vézina5 1Division of Plastic Surgery, Victoria Park Research Centre, Montreal, 2Q&T Research Chicoutimi, Chicoutimi, 3St-Jerome Medical Research Inc., St-Jerome, Quebec, Canada; 4Department of Medicine and Health Sciences, School of Medicine, University of Molise, Campobasso, Italy; 5Klox Technologies, Laval, Quebec, Canada Purpose: To investigate the safety and efficacy of the BioPhotonic System developed by Klox Technologies in a case series of ten patients with venous leg ulcers.Patients and methods: Ten patients with chronic venous leg ulcers, having failed on at least one previous therapy, were enrolled into this case series.Results: Nine patients were evaluable for efficacy. A response (defined as decrease in wound surface area was observed in seven patients (77.8%. Of these, four patients (44.4% achieved wound closure on average 4 months (127.5 days following the beginning of the treatment. Two patients did not respond to the investigational treatment. Quality of life improved over time throughout the study. Compliance was excellent, with 93.2% of visits completed as per protocol. Safety was unremarkable, with only four treatment-emergent-related adverse events, for which no specific intervention was required.Conclusion: The BioPhotonic System was shown to be safe and extremely well tolerated. It also demonstrated potential in terms of wound closure, wound surface area decrease, and wound bed preparation. Keywords: biophotonics, light, photobiomodulation, venous leg ulcers

  11. National and foreign research of Anaferon Kid: efficacy, safety and experience of application (review

    Directory of Open Access Journals (Sweden)

    Yu. V. Lobzin

    2015-01-01

    Full Text Available Interest in acute respiratory viral infections (ARVI in children does not tend to decrease and is determined by their high prevalence, relatedness to «uncontrollable infections» in most cases and presence of age limits in the use of antiviral drugs. Presently, focus on the use of national drugs is made in the RF clinical practice. An innovative drug Anaferon for children was developed by the Russian pharmaceutical company OOO «NPF «Materia Medica Holding» and registered in Russia in 2002.The summary purpose is to classify and analyze national and international publications on the results of non-clinical and clinical investigation of Anaferon for children efficacy and safety in ARVI and other viral infections.Study method: exploratory and analytical.Results: the summary presents the data of non-clinical studies justifying the drug mechanism of action at molecular level ensuring its combined antiviral and immunomodulating efficacy. The results obtained in the experiment were verified by clinical studies and are reflected in numerous scientific publications including international ones. The summary contains analysis of the results of clinical studies of the drug in children with ARVI including influenza. Anaferon for children was found to reduce duration of the main clinical symptoms of ARVI and influenza, incidence of bacterial complications, it is well-tolerated and has high safety profile. The open-label randomized comparative study of Anaferon for children efficacy and safety vs. Oseltamivir in influenza demonstrated clinical efficacy of these drugs. Numerous publications evidence that Anaferon for children exerts antiviral effect against most viruses causing acute respiratory viral infections as well as herpes viruses, viruses causing intestinal infections and tick-borne encephalitis. The list of scientific publications on the drug consists of approximately 800 references including more than 50 articles in

  12. Safety and efficacy of extracorporeal shock wave myocardial revascularization therapy for refractory angina pectoris.

    Science.gov (United States)

    Cassar, Andrew; Prasad, Megha; Rodriguez-Porcel, Martin; Reeder, Guy S; Karia, Darshak; DeMaria, Anthony N; Lerman, Amir

    2014-03-01

    To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris. A single-arm multicenter prospective trial to assess safety and efficacy of the ESMR therapy in patients with refractory angina (class III/IV angina) was performed. Screening exercise treadmill tests and pharmacological single-photon emission computed tomography (SPECT) were performed for all patients to assess exercise capacity and ischemic burden. Patients were treated with 9 sessions of ESMR to ischemic areas over 9 weeks. Efficacy end points were exercise capacity by using treadmill test as well as ischemic burden on pharmacological SPECT at 4 months after the last ESMR treatment. Safety measures included electrocardiography, echocardiography, troponin, creatine kinase, and brain natriuretic peptide testing, and pain questionnaires. Fifteen patients with medically refractory angina and no revascularization options were enrolled. There was a statistically significant mean increase of 122.3±156.9 seconds (38% increase compared with baseline; P=.01) in exercise treadmill time from baseline (319.8±157.2 seconds) to last follow-up after the ESMR treatment (422.1±183.3 seconds). There was no improvement in the summed stress perfusion scores after pharmacologically induced stress SPECT at 4 months after the last ESMR treatment in comparison to that at screening; however, SPECT summed stress score revealed that untreated areas had greater progression in ischemic burden vs treated areas (3.69±6.2 vs 0.31±4.5; P=.03). There was no significant change in the mean summed echo score from baseline to posttreatment (0.4±5.1; P=.70). The ESMR therapy was performed safely without any adverse events in electrocardiography, echocardiography, troponins, creatine kinase, or brain natriuretic peptide. Pain during the ESMR treatment was minimal (a score of 0.5±1.2 to 1.1±1.2 out of 10). In this multicenter feasibility

  13. Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

    Science.gov (United States)

    Solis, Marina Yazigi; Hayashi, Ana Paula; Artioli, Guilherme Giannini; Roschel, Hamilton; Sapienza, Marcelo Tatit; Otaduy, Maria Concepción; De Sã Pinto, Ana Lucia; Silva, Clovis Artur; Sallum, Adriana Maluf Elias; Pereira, Rosa Maria R; Gualano, Bruno

    2016-01-01

    It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients. In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements. Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported. Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter. © 2015 Wiley Periodicals, Inc.

  14. The Efficacy and Safety of Tetrachlorodecaoxide in Comparison with Super-oxidised Solution in Wound Healing

    Directory of Open Access Journals (Sweden)

    Romil Parikh

    2016-09-01

    Full Text Available BackgroundSome of the relatively newer, more efficacious, and potent topical wound dressing solutions include tetrachlorodecaoxide and super-oxidised solution. This study compares the efficacy and safety of these two drugs.MethodsThis is a block-randomised, double blind, parallel-arm, post-marketing study. One hundred fifty patients with ulcers (75 blocks uniform for sex, ulcer aetiology, diabetes mellitus, and wound area score were randomised into the two treatment arms. Patients were observed for eight weeks with weekly assessments. One hundred and twenty patients completed the study. Wound healing was objectively assessed by measurement of wound area, scoring of wound exudation and tissue type, and using the pressure ulcer scale of healing Tool (validated for multiple wound aetiologies. Subjective improvement in pain was noted using a visual analogue scale. Both groups were compared using Mann–Whitney U test on all indicators.ResultsDifference in change in wound tissue type in the two groups was significant (α=0.05 by intention-to-treat (ITT and per-protocol (PP analysis at the end of week two (ITT and PP, P0.05. No study-related adverse events were observed.ConclusionsBoth drugs are efficacious. Tetrachlorodecaoxide yields healthy granulation tissue earlier. Both drugs appear to be safe for application.

  15. Efficacy and safety of tramadol/acetaminophen in the treatment of breakthrough pain in cancer patients

    International Nuclear Information System (INIS)

    Ming-Lin Ho; Chih-Yuan Chung

    2010-01-01

    We evaluated the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg combination tablet, for the treatment of breakthrough pain in cancer patients. This study was conducted at Changhua Christian Hospital, Changhua, Taiwan from January 2006 to February 2007. The single-center and open-label study enrolled 59 opioid-treated cancer patients with at least moderate breakthrough pain (visual analog scale [VAS] score >/=40mm on a 100-mm scale). The efficacy measures included VAS scores and adverse effect assessment 10, 30, and 60 minutes after the administration of tramadol/acetaminophen. Visual analog scale score at time of pain relief was reported. The mean VAS score when the breakthrough pain episode began (0 minute) was 77.8. Analysis showed significant better mean pain VAS scores at 10, 30, and 60 minutes after the administration of tramadol/acetaminophen (p Tramadol/acetaminophen might be efficacious and safe in the treatment of breakthrough pain in cancer (Author).

  16. Efficacy and safety of tramadol/acetaminophen in the treatment of breakthrough pain in cancer patients.

    Science.gov (United States)

    Ho, Ming-Lin; Chung, Chih-Yuan; Wang, Chuan-Cheng; Lin, Hsuan-Yu; Hsu, Nicholas C; Chang, Cheng-Shyong

    2010-12-01

    We evaluated the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg combination tablet, for the treatment of breakthrough pain in cancer patients. This study was conducted at Changhua Christian Hospital, Changhua, Taiwan from January 2006 to February 2007. The single-center and open-label study enrolled 59 opioid-treated cancer patients with at least moderate breakthrough pain (visual analog scale [VAS] score ≥40mm on a 100-mm scale). The efficacy measures included VAS scores and adverse effect assessment 10, 30, and 60 minutes after the administration of tramadol/acetaminophen. Visual analog scale score at time of pain relief was reported. The mean VAS score when the breakthrough pain episode began (0 minute) was 77.8. Analysis showed significant better mean pain VAS scores at 10, 30, and 60 minutes after the administration of tramadol/acetaminophen (p≤0.001 versus 0 min for all 3 time points). The mean time to pain relief was 597.2 seconds and the mean VAS score at time of relief was 43.4. The effective rates, defined by more than 30% reduction of the VAS score, after 10 minutes of administration was 74.6%, 30 minutes 86.4%, and one hour 94.9% (p≤0.001 versus 0 minute for all 3 time points). Two cases of drowsiness were reported. Tramadol/acetaminophen might be efficacious and safe in the treatment of breakthrough pain in cancer.

  17. American rural women's exercise self-efficacy and awareness of exercise benefits and safety during pregnancy.

    Science.gov (United States)

    Melton, Bridget; Marshall, Elaine; Bland, Helen; Schmidt, Michael; Guion, W Kent

    2013-12-01

    Though the positive link between physical activity and maternal health is well documented, physical activity declines during pregnancy and, internationally, rural mothers are less likely than urban mothers to engage in physical activity. Some evidence suggests that self-efficacy is related to sustained engagement in physical activity. The purpose of this study was to examine self-efficacy, perceived benefits, and knowledge of safe exercise among 88 rural pregnant women in a southeastern region of the United States. Exercise self-efficacy was significantly related to maternal age and gestation. Women over age 26 years, and those in the second and third trimesters, scored significantly higher than younger women or those in the first trimester. Fifty-two percent (n = 46) of participants perceived that activity would decrease energy levels, 37.5% (n = 33) did not know that exercise can decrease the risk of gestational diabetes, and 47.6% (n = 41) were unaware that a mother who is overweight is more likely to have an overweight child. Results confirm a need for education to improve women's knowledge about health benefits and safety information related to physical activity during pregnancy. © 2013 Wiley Publishing Asia Pty Ltd.

  18. Evaluating Performance of Safety Management and Occupational Health Using Total Quality Safety Management Model (TQSM

    Directory of Open Access Journals (Sweden)

    E Mohammadfam

    2015-11-01

    Full Text Available Introduction: All organizations, whether public or private, necessitate performance evaluation systems in regard with growth, stability, and development in the competitive fields. One of the existing models for performance evaluation of occupational health and safety management is Total Quality Safety Management model (TQSM. Therefore, the present study aimed to evaluate performance of safety management and occupational health utilizing TQSM model. Methods: In this descriptive-analytic study, the population consisted of 16 individuals, including managers, supervisors, and members of technical protection and work health committee. Then the participants were asked to respond to TQSM questionnaire before and after the implementation of Occupational Health & Safety Advisory Services 18001 (OHSAS18001. Ultimately, the level of each program as well as the TQSM status were determined before and after the implementation of OHSAS18001. Results: The study results showed that the scores obtained by the company before OHSAS 18001’s implementation, was 43.7 out of 312. After implementing OHSAS 18001 in the company and receiving the related certificate, the total score of safety program that company could obtain was 127.12 out of 312 demonstrating a rise of 83.42 scores (26.8%. The paired t-test revealed that mean difference of TQSM scores before and after OHSAS 18001 implementation was proved to be significant (p> 0.05. Conclusion: The study findings demonstrated that TQSM can be regarded as an appropriate model in order to monitor the performance of safety management system and occupational health, since it possesses the ability to quantitatively evaluate the system performance.

  19. Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.

    Science.gov (United States)

    Talukdar, Anjan; Wang, S Keisin; Czosnowski, Lauren; Mokraoui, Nassim; Gupta, Alok; Fajardo, Andres; Dalsing, Michael; Motaganahalli, Raghu

    2017-10-01

    Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. We report the safety and efficacy of rivaroxaban vs warfarin in patients undergoing peripheral arterial interventions. This single-institution retrospective study analyzed all sequential patients from December 2012 to August 2014 (21 months) who were prescribed rivaroxaban or warfarin after a peripheral arterial procedure. Our study population was then compared using American College of Chest Physicians guidelines with patients then stratified as low, medium, or high risk for bleeding complications. Statistical analyses were performed using the Student t-test and χ 2 test to compare demographics, readmissions because of bleeding, and the need for secondary interventions. Logistic regression models were used for analysis of variables associated with bleeding complications and secondary interventions. The Fisher exact test was used for power analysis. There were 44 patients in the rivaroxaban group and 50 patients in the warfarin group. Differences between demographics and risk factors for bleeding between groups or reintervention rate were not statistically significant (P = .297). However, subgroup evaluation of the safety profile suggests that patients who were aged ≤65 years and on warfarin had an overall higher incidence of major bleeding (P = .020). Patients who were aged >65 years, undergoing open operation, had a significant risk for reintervention (P = .047) when they received rivaroxaban. Real-world experience using rivaroxaban and warfarin in patients after peripheral arterial procedures suggests a comparable safety and efficacy profile. Subgroup analysis of those requiring an open operation demonstrated a decreased bleeding risk when rivaroxaban was used (in those aged <65

  20. 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

  1. Exposure-safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate.

    Science.gov (United States)

    Gidal, B E; Jacobson, M P; Ben-Menachem, E; Carreño, M; Blum, D; Soares-da-Silva, P; Falcão, A; Rocha, F; Moreira, J; Grinnell, T; Ludwig, E; Fiedler-Kelly, J; Passarell, J; Sunkaraneni, S

    2018-05-06

    Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) for focal-onset seizures (FOS). Pharmacokinetic (PK) and pharmacodynamic (PD) models were developed to assess dose selection, identify significant AED drug interactions, and quantitate relationships between exposure and safety and efficacy outcomes from Phase 3 trials of adjunctive ESL. Eslicarbazepine (the primary active metabolite of ESL) population PK was evaluated using data from 1351 subjects enrolled in 14 studies (11 Phase 1 and three Phase 3 studies) after multiple oral doses ranging from 400 to 1200 mg. Population PK and PD models related individual eslicarbazepine exposures to safety outcomes and efficacy responses. Eslicarbazepine PK was described by a one-compartment model with linear absorption and elimination. The probability of a treatment-emergent adverse event (TEAE; dizziness, headache, or somnolence) was higher with an initial dose of ESL 800 mg than with an initial dose of ESL 400 mg QD. Body weight, sex, region, and baseline use of carbamazepine (CBZ) or lamotrigine were also found to influence the probability of TEAEs. Eslicarbazepine exposure influenced serum sodium concentration, standardized seizure frequency, and probability of response; better efficacy outcomes were predicted in patients not from Western Europe (WE; vs WE patients) and those not taking CBZ (vs taking CBZ) at baseline. Pharmacokinetic and PK/PD modeling were implemented during the development of ESL for adjunctive treatment of FOS in adults. This quantitative approach supported decision-making during the development of ESL, and contributed to dosing recommendations and labeling information related to drug interactions. © 2018 The Authors. Acta Neurologica Scandinavica Published by John Wiley & Sons Ltd.

  2. Efficacy and Safety Extrapolation Analyses for Atomoxetine in Young Children with Attention-Deficit/Hyperactivity Disorder.

    Science.gov (United States)

    Upadhyaya, Himanshu; Kratochvil, Christopher; Ghuman, Jaswinder; Camporeale, Angelo; Lipsius, Sarah; D'Souza, Deborah; Tanaka, Yoko

    2015-12-01

    This extrapolation analysis qualitatively compared the efficacy and safety profile of atomoxetine from Lilly clinical trial data in 6-7-year-old patients with attention-deficit/hyperactivity disorder (ADHD) with that of published literature in 4-5-year-old patients with ADHD (two open-label [4-5-year-old patients] and one placebo-controlled study [5-year-old patients]). The main efficacy analyses included placebo-controlled Lilly data and the placebo-controlled external study (5-year-old patients) data. The primary efficacy variables used in these studies were the ADHD Rating Scale-IV Parent Version, Investigator Administered (ADHD-RS-IV-Parent:Inv) total score, or the Swanson, Nolan and Pelham (SNAP-IV) scale score. Safety analyses included treatment-emergent adverse events (TEAEs) and vital signs. Descriptive statistics (means, percentages) are presented. Acute atomoxetine treatment improved core ADHD symptoms in both 6-7-year-old patients (n=565) and 5-year-old patients (n=37) (treatment effect: -10.16 and -7.42). In an analysis of placebo-controlled groups, the mean duration of exposure to atomoxetine was ∼ 7 weeks for 6-7-year-old patients and 9 weeks for 5-year-old patients. Decreased appetite was the most common TEAE in atomoxetine-treated patients. The TEAEs observed at a higher rate in 5-year-old versus 6-7-year-old patients were irritability (36.8% vs. 3.6%) and other mood-related events (6.9% each vs. atomoxetine may improve ADHD symptoms, but possibly to a lesser extent than in older children, with some adverse events occurring at a higher rate in 5-year-old patients.

  3. Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.

    LENUS (Irish Health Repository)

    Ní Ainle, Fionnuala

    2008-10-01

    Low molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU\\/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU\\/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered

  4. CTLA-4 blockade with ipilimumab: biology, safety, efficacy, and future considerations

    International Nuclear Information System (INIS)

    Camacho, Luis H

    2015-01-01

    Melanoma remains a critical public health problem worldwide. Patients with stage IV disease have very poor prognosis and their 1-year survival rate is only 25%. Until recently, systemic treatments with a positive impact on overall survival (OS) had remained elusive. In recent years, the United States Food and Drug Administration (FDA) – approved several novel agents targeting the RAS/RAF/MEK/ERK pathway (vemurafenib, dabrafenib, and trametinib) – critical in cell division and proliferation of melanoma, and an immune checkpoint inhibitor (ipilimumab) directed against the cytotoxic T lymphocyte Antigen - (CTLA-4). Moreover, recent reports of clinical trials studying other immune checkpoint modulating agents will most likely result in their FDA approval within the next months. This review focuses on ipilimumab, its safety and efficacy, and future considerations. Ipilimumab has demonstrated a positive OS impact after a several-year follow-up. It is also recognized that due to its mechanism of action, the response patterns to ipilimumab can differ from those observed in patients following treatment with conventional cytotoxic agents and even the most recently approved BRAF inhibitors. Most patients (84.8%) experience drug-related adverse events (AEs) of any grade; most of these are mild to moderate and immune mediated. However, a minority of patients may also experience severe and life-threatening AEs. In clinical studies, AEs were managed according to guidelines that emphasized close clinical monitoring and early use of corticosteroids when appropriate. Preliminary results have taught us the potential greater toxicity when in combination with vemurafenib, and the greater antitumor efficacy when combined with nivolumab, a monoclonal antibody directed against programmed death receptor-1 (PD-1), another immune checkpoint inhibitor. Future challenges include the optimization of dosing and toxicities when used as a single agent, and studying the safety and efficacy of

  5. Field study on the safety and efficacy of intradermal versus intramuscular vaccination against Mycoplasma hyopneumoniae.

    Science.gov (United States)

    Beffort, Lisa; Weiß, Christine; Fiebig, Kerstin; Jolie, Rika; Ritzmann, Mathias; Eddicks, Matthias

    2017-09-30

    The present study compares the safety and efficacy of a needle-free, intradermal Mycoplasma hyopneumoniae vaccine to an intramuscular one. 420 piglets (21+3 days of age) were randomly assigned to two vaccination groups (intradermal vaccination V1 (n=138), intramuscular vaccination V2 (n=144)) and one unvaccinated control group (CG, n=138). As safety parameters clinical observations, local injection site reactions (ISR) and rectal temperatures were assessed. Average daily weight gain (ADWG) and pneumonic lung lesions (LL) were measured as efficacy parameters. ISRs were minor in V1. After both vaccinations, no adverse impact on appetite was observed and mean rectal temperatures remained within physiological range. ADWG during the fattening period was significantly higher in vaccinated groups (V1: 913.4 g, V2: 924.5 g) compared with CG (875.6 g). No differences in ADWG were observed between V1 and V2. Vaccinated pigs had a significantly reduced mean extent of LL compared with CG. V1 was superior in reducing the extent and prevalence of LL compared with V2. These results reveal that a needle-free intradermal vaccination is safe and efficacious in reducing both the prevalence and extent of lung lesions, as well as in improving performance parameters, in a farrow-to-finish farm with a late onset of M hyopneumonia e infection. © British Veterinary Association (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  6. AbobotulinumtoxinA Efficacy and Safety in Children With Equinus Foot Previously Treated With Botulinum Toxin.

    Science.gov (United States)

    Dabrowski, Edward; Bonikowski, Marcin; Gormley, Mark; Volteau, Magali; Picaut, Philippe; Delgado, Mauricio R

    2018-05-01

    The effects of botulinum toxin are transient, and repeat injections are required in children with lower-limb spasticity. However, the efficacy of botulinum toxin in patients who have received previous injections has remained largely unexplored. We present subgroup analyses of a phase III study conducted in ambulatory children (aged two to 17) with spastic equinus foot. Patients were randomized to single doses of abobotulinumtoxinA 10 U/kg/leg, 15 U/kg/leg, or placebo injected into the gastrocnemius-soleus complex (one or both legs). The first analysis was prespecified to review the effect of abobotulinumtoxinA in children previously treated with botulinum toxin versus those children new to the treatment; a second post hoc analysis evaluated the effect of abobotulinumtoxinA in children who changed botulinum toxin formulation. Of the 241 randomized patients, 113 had previously received botulinum toxin, including 86 who had been treated with another formulation. In both analyses, muscle tone (Modified Ashworth Scale) and the Physicians Global Assessment, at week 4, improved with abobotulinumtoxinA treatment versus placebo, regardless of baseline botulinum toxin status. Placebo responses in patients new to treatment were consistently higher than in the previously treated group. These results demonstrate similar abobotulinumtoxinA efficacy and safety profiles in children with spasticity who are new to botulinum toxin treatment and those children who were previously treated. The efficacy and safety of abobotulinumtoxinA treatment in these previously treated patients were comparable with the overall trial population, indicating that doses of 10 and 15 U/kg/leg are suitable starting doses for children with spasticity regardless of the previous botulinum toxin preparation used. Copyright © 2018 Elsevier Inc. All rights reserved.

  7. Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis.

    Science.gov (United States)

    Mei, Changlin; Chen, Nan; Ding, Xiaoqiang; Yu, Xueqing; Wang, Li; Qian, Jiaqi; Wang, Mei; Jiang, Gengru; Li, Xuemei; Hou, Fanfan; Zuo, Li; Wang, Niansong; Liu, Hong

    2016-10-01

    Introduction Secondary hyperparathyroidism (SHPT) develops in patients with chronic renal failure. Cinacalcet hydrochloride has been used successfully in U.S., Europe, and Japan in the treatment of SHPT, while maintaining serum levels of calcium and phosphorus. The efficacy and safety profile of Cinacalcet treatment vs. conventional treatments has been of great interest in clinical practice. In this recent phase III study conducted in China, efficacy and safety of a calcimimetic agent, Cinacalcet (Kyowa Hakko Kirin Co., Ltd.), were assessed for SHPT treatment in stable chronic renal disease patients on hemodialysis. Methods In this double-blind, multicenter, placebo-controlled, randomized phase III study, 238 subjects were enrolled in 12 centers and randomly divided into a Cinacalcet group and a placebo group. The percentage of patients achieving a serum parathyroid hormone (PTH) level ≤250 pg/mL was the primary efficacy end point. Serum calcium and phosphorus levels were measured. Adverse events and serious adverse events were recorded, and causal analysis performed. Findings In primary analysis, 25.4% of the Cinacalcet group and 3.5% of the placebo group achieved the primary end point (PTH ≤250 pg/mL). Calcium and phosphorus levels and calcium-phosphorus product were lower in the Cinacalcet group compared with the placebo group. Eleven serious adverse events were reported and considered to be not related to study drugs. Mild to moderate hypocalcemia and reduced calcium levels were reported and considered to be Cinacalcet related. Discussion This phase III study demonstrated that Cinacalcet is effective and well tolerated in treating SHPT in Chinese chronic kidney disease patients on hemodialysis, and in a patient population with much higher baseline PTH levels. © 2016 International Society for Hemodialysis.

  8. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery.

    Science.gov (United States)

    Lin, Zilan X; Woolf, Shane K

    2016-01-01

    Perioperative bleeding and postsurgical hemorrhage are common in invasive surgical procedures, including orthopedic surgery. Tranexamic acid (TXA) is a pharmacologic agent that acts through an antifibrinolytic mechanism to stabilize formed clots and reduce active bleeding. It has been used successfully in orthopedics to reduce perioperative blood loss, particularly in total hip and knee arthroplasty and spine surgery. Numerous research studies have reported favorable safety and efficacy in orthopedic cases, although there is no universal standard on its administration and its use has not yet become the standard of practice. Reported administration methods often depend on the surgeon's preference, with both topical and intravenous routes showing efficacy. The type and anatomic site of the surgery seem to influence the decision making but also result in conflicting opinions. Reported complication rates with TXA use are low. The incidence of both arterial and venous thromboembolic events, particularly deep venous thrombosis and pulmonary embolism, has not been found to be significantly different with TXA use for healthy patients. The route of administration and dosage do not appear to affect complication rates either. However, data on patients with higher-risk conditions are deficient. In addition, TXA has shown potential to reduce blood loss, transfusion rates and volumes, perioperative hemoglobin change, and hospital-related costs at various degrees among the published studies. Conservation of blood products, reduced laboratory costs, and shorter hospital stays are likely the major factors driving the cost savings associated with TXA use. This article reviews current data supporting the safety, efficacy, and cost-effectiveness of TXA in orthopedic surgery. Copyright 2016, SLACK Incorporated.

  9. Efficacy and safety of intermittent preventive treatment for malaria in schoolchildren: a systematic review.

    Science.gov (United States)

    Matangila, Junior R; Mitashi, Patrick; Inocêncio da Luz, Raquel A; Lutumba, Pascal T; Van Geertruyden, Jean-Pierre

    2015-11-14

    Intermittent preventive treatment (IPT) is a proven malaria control strategy in infants and pregnancy. School-aged children represent 26 % of the African population, and an increasing percentage of them are scholarized. Malaria is causing 50 % of deaths in this age group and malaria control efforts may shift the malaria burden to older age groups. Schools have been suggested as a platform for health interventions delivery (deworming, iron-folic acid, nutrients supplementation, (boost-)immunization) and as a possible delivery system for IPT in schoolchildren (IPTsc). However, the current evidence on the efficacy and safety of IPTsc is limited and the optimal therapeutic regimen remains controversial. A systematic search for studies reporting efficacy and safety of IPT in schoolchildren was conducted using PubMed, Web of Science, Clinicaltrials and WHO/ICTRP database, and abstracts from congresses with the following key words: intermittent, preventive treatment AND malaria OR Plasmodium falciparum AND schoolchildren NOT infant NOT pregnancy. Five studies were identified. Most IPTsc regimes demonstrated substantial protection against malaria parasitaemia, with dihydroartemisinin-piperaquine (DP) given monthly having the highest protective effect (PE) (94 %; 95 % CI 93-96). Contrarily, SP did not provide any PE against parasitaemia. However, no IPT regimen provided a PE above 50 % in regard to anaemia, and highest protection was provided by SP+ amodiaquine (AQ) given four-monthly (50 %; 95 % CI 41-53). The best protection against clinical malaria was observed in children monthly treated with DP (97 %; 95 % CI 87-98). However, there was no protection when the drug was given three-monthly. No severe adverse events were associated with the drugs used for IPTsc. IPTsc may reduce the malaria-related burden in schoolchildren. However, more studies assessing efficacy of IPT in particular against malaria-related anaemia and clinical malaria in schoolchildren must be conducted.

  10. Do Published Data in Trials Assessing Cancer Drugs Reflect the Real Picture of Efficacy and Safety?

    Science.gov (United States)

    Lv, Jia-Wei; Chen, Yu-Pei; Zhou, Guan-Qun; Liu, Xu; Guo, Ying; Mao, Yan-Ping; Ma, Jun; Sun, Ying

    2017-11-01

    Background: The reporting quality of publications is of vital importance to ensure accurate evidence dissemination. This study aimed to compare the consistency of results reporting between the ClinicalTrials.gov results database and the respective matching publications. Methods: We identified 323 phase III/IV cancer drug trials with a randomized controlled design and searched PubMed for publications in a 50% random sample (n=160). Data were extracted independently from ClinicalTrials.gov and publications. A scoring system was applied to determine characteristics associated with reporting quality. Results: Of 117 reviewed trials with publications, result reporting was significantly more complete in ClinicalTrials.gov for efficacy measurement (92.3% vs 90.6%), serious adverse events (SAEs; 100% vs 43.6%), and other adverse events (OAEs; 100% vs 62.4%). For trials with both posted and published results for design information (n=117), efficacy measurements (n=98), SAEs (n=51), and OAEs (n=73), discrepancies were found in 16 (13.7%), 38 (38.8%), 26 (51.0%), and 54 (74.0%) trials, respectively. Overreporting of treatment effects (7 trials) and alteration of primary end points favoring statistically significant outcomes (11 trials) were the major discrepancies in efficacy reporting; incomplete (66 trials) and underreporting (20 trials) of SAEs were the predominant issues in benefit/risk reporting. Median quality score was 21 (range, 14-28). Trials that had parallel assignment, were phase IV, had primary funding by industry, were completed after 2009, and had earlier results posted possessed better reporting quality. Conclusions: Although most trials showed reasonable completeness and consistency, some discrepancies are prevalent and persistent, jeopardizing evidence-based decision-making. Our findings highlight the need to consult results systematically from both ClinicalTrials.gov and publications. Copyright © 2017 by the National Comprehensive Cancer Network.

  11. Self-Efficacy and Quality of Life in People with Spinal Cord Injuries in China.

    Science.gov (United States)

    Hampton, Nan Zhang

    2000-01-01

    Explores the relationship between self-efficacy beliefs and the quality of life in Chinese individuals with spinal cord injuries. Also examines whether health status and demographic variables correlated with the quality of life in this population. Results are discussed in line with the Chinese culture and its influences on the psychosocial…

  12. Quality survey on efficacy of carboxytherapy for localized lipolysis.

    Science.gov (United States)

    Lee, Georgia S K

    2016-12-01

    A survey was conducted to ascertain the efficacy of carboxytherapy for localized lipolysis. Patients on physical, dietary, or drug concurrent therapy were excluded. Paired measurements (initial versus 8th course) between treated (right) and untreated (left) sides were compared for braline, upper arm, abdomen, and thigh. Ten women, age range 23-37 years, were reviewed. Weight and body mass index were unchanged. Significant reductions (P carboxytherapy is locally effective in reduction of subcutaneous fat. © 2016 The Author. Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc.

  13. Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

    Directory of Open Access Journals (Sweden)

    Moataz Alhaj

    2016-01-01

    Full Text Available Rift Valley Fever (RVF is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA, a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control.

  14. Efficacy and safety of acupuncture for dizziness and vertigo in emergency department: a pilot cohort study.

    Science.gov (United States)

    Chiu, Chih-Wen; Lee, Tsung-Chieh; Hsu, Po-Chi; Chen, Chia-Yun; Chang, Shun-Chang; Chiang, John Y; Lo, Lun-Chien

    2015-06-09

    Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department (ED). Pharmacological therapy is often applied for these symptoms, such as vestibular suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with unavoidable side-effects. There are several research articles providing evidence of acupuncture treating dizziness and vertigo but few studies of acupuncture as an emergent intervention in ED. We performed a pilot cohort study to evaluate the efficacy and safety of acupuncture in treating patients with dizziness and vertigo in ED. A total of 60 participants, recruited in ED, were divided into acupuncture and control group. Life-threatening conditions or central nervous system disorders were excluded to ensure participants' safety. The clinical effect of treating dizziness and vertigo was evaluated by performing statistical analyses on data collected from questionnaires of Dizziness Handicap Inventory (DHI), Visual Analog Scale (VAS) of dizziness and vertigo, and heart rate variability (HRV). The variation of VAS demonstrated a significant decrease (p-value: 0.001 and p-value: 0.037) between two groups after two different durations: 30 mins and 7 days. The variation of DHI showed no significant difference after 7 days. HRV revealed a significant increase in high frequency (HF) in the acupuncture group. No adverse event was reported in this study. Acupuncture demonstrates a significant immediate effect in reducing discomforts and VAS of both dizziness and vertigo. This study provides clinical evidence on the efficacy and safety of acupuncture to treat dizziness and vertigo in the emergency department. ClinicalTrials.gov ID: NCT02358239 . Registered 5 February 2015.

  15. Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

    Directory of Open Access Journals (Sweden)

    Huss M

    2017-07-01

    Full Text Available Michael Huss,1 Praveen Duhan,2 Preetam Gandhi,3 Chien-Wei Chen,4 Carsten Spannhuth,3 Vinod Kumar5 1Child and Adolescent Psychiatry, University Medicine, Mainz, Germany; 2Global Medical Affairs, Novartis Healthcare Pvt. Ltd., Hyderabad, India; 3Development Franchise, Established Medicine Neuroscience, Novartis Pharma AG, Basel, Switzerland; 4Biostatistics Cardio-Metabolic & Established Medicine, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 5Established Medicines, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Abstract: Attention-deficit/hyperactivity disorder (ADHD is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH, a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD. Keywords: methylphenidate, dose optimization, attention-deficit/hyperactivity disorder, ADHD

  16. A randomized trial of telemedicine efficacy and safety for nonacute headaches.

    Science.gov (United States)

    Müller, Kai I; Alstadhaug, Karl B; Bekkelund, Svein I

    2017-07-11

    To evaluate long-term treatment efficacy and safety of one-time telemedicine consultations for nonacute headaches. We randomized, allocated, and consulted nonacute headache patients via telemedicine (n = 200) or in a traditional manner (n = 202) in a noninferiority trial. Efficacy endpoints, assessed by questionnaires at 3 and 12 months, included change from baseline in Headache Impact Test-6 (HIT-6) (primary endpoint) and pain intensity (visual analogue scale [VAS]) (secondary endpoint). The primary safety endpoint, assessed via patient records, was presence of secondary headache within 12 months after consultation. We found no differences between telemedicine and traditional consultations in HIT-6 ( p = 0.84) or VAS ( p = 0.64) over 3 periods. The absolute difference in HIT-6 from baseline was 0.3 (95% confidence interval [CI] -1.26 to 1.82, p = 0.72) at 3 months and 0.2 (95% CI -1.98 to 1.58, p = 0.83) at 12 months. The absolute change in VAS was 0.4 (95% CI -0.93 to 0.22, p = 0.23) after 3 months and 0.3 (95% CI -0.94 to 0.29, p = 0.30) at 12 months. We found one secondary headache in each group at 12 months. The estimated number of consultations needed to miss one secondary headache with the use of telemedicine was 20,200. Telemedicine consultation for nonacute headache is as efficient and safe as a traditional consultation. NCT02270177. This study provides Class III evidence that a one-time telemedicine consultation for nonacute headache is noninferior to a one-time traditional consultation regarding long-term treatment outcome and safety. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  17. Marital quality and self-efficacy: influence on disease management among individuals with rheumatoid arthritis.

    Science.gov (United States)

    Tewary, Sweta; Farber, Naomi

    2014-01-01

    Individuals with rheumatoid arthritis (RA) struggle to maintain improved functional ability and reduced pain levels. Health education emphasizing self-efficacy helps individuals to adjust with the disease outcome and progression. As a basis to develop comprehensive evidence-based patient education programs, the aim of the study was to examine the role of marriage as a predictor of pain and functional self-efficacy among individuals with RA. Review of the regression analysis did not provide support for the relationships between marital quality and self-efficacy. Relationships were not observed between marital quality, length of marriage, and self-efficacy as predicted by the first hypothesis. Additional regression analysis examination found that marital quality, length of marriage, pain, and health assessment together reported significant variance in self-efficacy. However, only health assessment significantly predicted self-efficacy. Other nonexamined variables could have influenced the independent marital quality effects. Future longitudinal studies with larger sample sizes can further validate the current findings.

  18. Self-efficacy and quality of life in adults who stutter.

    Science.gov (United States)

    Carter, Alice; Breen, Lauren; Yaruss, J Scott; Beilby, Janet

    2017-12-01

    Self-efficacy has emerged as a potential predictor of quality of life for adults who stutter. Research has focused primarily on the positive relationship self-efficacy has to treatment outcomes, but little is known about the relationship between self-efficacy and quality of life for adults who stutter. The purpose of this mixed- methods study is to determine the predictive value of self-efficacy and its relationship to quality of life for adults who stutter. The Self-Efficacy Scale for Adult Stutterers and the Overall Assessment of the Speaker's Experience with Stuttering were administered to 39 adults who stutter, aged 18- 77. Percentage of syllables stuttered was calculated from a conversational speech sample as a measure of stuttered speech frequency. Qualitative interviews with semi-structured probes were conducted with 10 adults and analyzed using thematic analysis to explore the lived experience of adults who stutter. Self-efficacy emerged as a strong positive predictor of quality of life for adults living with a stuttered speech disorder. Stuttered speech frequency was a moderate negative predictor of self-efficacy. Major qualitative themes identified from the interviews with the participants were: encumbrance, self-concept, confidence, acceptance, life-long journey, treatment, and support. Results provide clarity on the predictive value of self-efficacy and its relationship to quality of life and stuttered speech frequency. Findings highlight that the unique life experiences of adults who stutter require a multidimensional approach to the assessment and treatment of stuttered speech disorders. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  19. Efficacy and Safety of Anti-Interleukin-5 Therapy in Patients with Asthma: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Fa-Ping Wang

    Full Text Available Recent trials have assessed the efficacy and safety of novel monoclonal antibodies such as reslizumab and benralizumab. However, the overall efficacy and safety anti-interleukin (IL 5 treatment in asthma have not been thoroughly assessed.Randomized controlled trials (RCTs of anti-IL-5 treatment on patients with asthma published up to October 2016 in PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL that reported pulmonary function, quality of life scores, asthmatic exacerbation rate, blood and sputum eosinophil counts, short-acting β-agonist (SABA rescue use, and adverse events were included. The pooled mean difference, and relative risks (RR, and 95% confidence intervals (CIs were calculated using random-effects models.Twenty studies involving 7100 patients were identified. Pooled analysis revealed significant improvements in FEV1 (first second forced expiratory volume (MD = 0.09, 95% CI: 0.06-0.12, I2 = 10%, FEV1% (MD = 3.75, 95% CI: 1.66-5.83, I2 = 19%, Asthma Quality of Life Questionnaire (AQLQ score (MD = 0.22, 95% CI: 0.15-0.30, I2 = 0%, decreased blood, sputum eosinophils and asthmatic exacerbation (RR = 0.66, 95% CI: 0.59-0.73, I2 = 51%; peak expiratory flow (PEF (MD = 5.45, 95% CI: -2.83-13.72, I2 = 0%, histamine PC20 (MD = -0.62, 95% CI: -1.92-0.68, I2 = 0% or SABA rescue use (MD = -0.11, 95% CI: -0.3-0.07, I2 = 30% were unaffected; adverse events were not increased (RR = 0.93, 95% CI: 0.89-0.98, I2 = 46%. No publication bias was observed (Egger's P = 0.78.Anti-interleukin 5 monoclonal therapies for asthma could be safe for slightly improving FEV1 (or FEV1% of predicted value, quality of life, and reducing exacerbations risk and blood and sputum eosinophils, but have no significant effect on PEF, histamine PC20, and SABA rescue use. Further trials required to establish to clarify the optimal antibody for different patients.

  20. EFFECTS OF FIRE FUMES ON ALMOND SAFETY AND QUALITY

    Directory of Open Access Journals (Sweden)

    Amanda Ramírez-Gandolfo

    2011-08-01

    Full Text Available A fire originated and burnt two cold chambers; the present study focused on almonds stored in adjacent chambers (4, 5, 6 and 13 and evaluated both their food safety and quality. Testing for polycyclic aromatic hydrocarbons, polychlorinated dibenzo-p-dioxins and dibenzofurans was carried out in affected facilities, packaging and almonds. Experimental results proved that fire fumes did not reach chambers 4-6, but traces were found in bin packaging of chamber 13; thus, packaging from this chamber were changed. Concentrations of benzo(apyrene were low enough to prove that fire fumes did not get in contact with the stored almonds. Later, only volatile compounds typical of nuts were identified in both raw and toasted almonds. Finally, a trained panel concluded that no sensory signal of fumes reaching almonds was found. This manuscript could be taken as a model protocol to establish whether fire fumes have reached and affected the safety and/or quality of foods. This information will be especially useful for insurance companies.

  1. Improving Quality and Occupational Safety on Automated Casting Lines

    Directory of Open Access Journals (Sweden)

    Kukla S.

    2017-09-01

    Full Text Available The paper presents a practical example of improving quality and occupational safety on automated casting lines. Working conditions on the line of box moulding with horizontal mould split were analysed due to low degree of automation at the stage of cores or filters installation as well as spheroidizing mortar dosing. A simulation analysis was carried out, which was related to the grounds of introducing an automatic mortar dispenser to the mould. To carry out the research, a simulation model of a line in universal Arena software for modelling and simulation of manufacturing systems by Rockwell Software Inc. was created. A simulation experiment was carried out on a model in order to determine basic parameters of the working system. Organization and working conditions in other sections of the line were also analysed, paying particular attention to quality, ergonomics and occupational safety. Ergonomics analysis was carried out on manual cores installation workplace and filters installation workplace, and changes to these workplaces were suggested in order to eliminate actions being unnecessary and onerous for employees.

  2. Quality assurance and radiation safety in positron emission tomography

    International Nuclear Information System (INIS)

    Kmetyuk, Ya.V.; Radosh, H.V.; Bezshyyko, O.A.; Golinka-Bezshyyko, L.O.; Kadenko, I.M.; Kazinova, O.A.; Nagai, A.O.

    2012-01-01

    Scientific studies, clinical experience and economic analysis have shown that the positron emission tomography (PET) is clinically and cost effective cancer diagnostics method. Combined PET and computed tomography (PET/CT) has proven clinical utility, particularly in the diagnosis, staging or restaging malignant disease and metastases, surgical planning, radiation therapy planning and evaluation of treatment response. The use of PET/CT has grown substantially in the past few years, with an increasing number of hospitals and installations of PET/CT imaging centers each year. In the same time combination of 2 procedures, each of which impart a radiation dose and, as a result, increases the deleterious influence for health, creates additional radiation safety issues. In these conditions the role of quality assurance (QA) and quality control (QC) programs is getting more and more important. We considered main QA and radiation safety requirements for whole PET technology chain from radio-pharmacy facilities to PET/CT scanning and patient release criteria. All these issues were considered and assessed having the example of PET facilities and technology chain of All-Ukrainian Center for Radiosurgery of the Clinical Hospital 'Feofania'

  3. Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants.

    Science.gov (United States)

    Phua, Kong Boo; Lim, Fong Seng; Quak, Seng Hock; Lee, Bee Wah; Teoh, Yee Leong; Suryakiran, Pemmaraju V; Han, Htay Htay; Bock, Hans L

    2016-02-01

    This was the first study conducted to evaluate the efficacy of 2 oral doses of the human rotavirus vaccine, RIX4414 in Singaporean infants during the first 3 years of life. Healthy infants, 11 to 17 weeks of age were enrolled in this randomised (1:1), double-blinded, placebo-controlled study to receive 2 oral doses of RIX4414 vaccine/placebo following a 0-, 1-month schedule. Vaccine efficacy against severe rotavirus (RV) gastroenteritis (Vesikari score ≥11) caused by wild-type RV strains from a period starting from 2 weeks post-Dose 2 until 2 and 3 years of age was calculated with 95% confidence interval (CI). Immunogenicity and safety of the vaccine were also assessed. Of 6542 infants enrolled, 6466 were included in the efficacy analysis and a subset of 100 infants was included in the immunogenicity analysis. Fewer severe RV gastroenteritis episodes were reported in the RIX4414 group when compared to placebo at both 2 and 3 year follow-up periods. Vaccine efficacy against severe RV gastroenteritis at the respective time points were 93.8% (95% CI, 59.9 to 99.9) and 95.2% (95% CI, 70.5 to 99.9). One to 2 months post-Dose 2 of RIX4414, 97.5% (95% CI, 86.8 to 99.9) of infants seroconverted for anti-RV IgA antibodies. The number of serious adverse events recorded from Dose 1 until 3 years of age was similar in both groups. Two oral doses of RIX4414 vaccine was immunogenic and provided high level of protection against severe RV gastroenteritis in Singaporean children, during the first 3 years of life when the disease burden is highest.

  4. The safety and efficacy of robotic image-guided radiosurgery system treatment for intra- and extracranial lesions: A systematic review of the literature

    International Nuclear Information System (INIS)

    Calcerrada Diaz-Santos, Nieves; Blasco Amaro, Juan Antonio; Cardiel, Gloria Ariza; Andradas Aragones, Elena

    2008-01-01

    Background: The CyberKnife is a new, frameless stereotactic radiosurgery system. This work reviews its safety and efficacy in the treatment of intra- and extracranial lesions. Methods: A literature search was made of the Medline, Embase, Pascal Biomed, CINAHL and Cancerlit databases. Health technology assessment reports on stereotactic radiosurgery systems were also consulted. All searches were made in June 2007. Data on efficacy and safety were extracted and then synthesized into the present review. Results: Thirty five clinical studies were identified, the majority of which included no patient comparison group. These studies assessed the use of the CyberKnife mainly in the treatment of primary and metastatic intracranial and spinal tumours. Conclusions: The CyberKnife system allows to carry out standard radiosurgical and fractionated stereotactic radiotherapy procedures. The use of this system offers an alternative for the treatment of inoperable tumours, and of lesions located close to critical structures that cannot be treated using other types of stereotactic radiosurgery system. Unfortunately, the quality of the reviewed papers still does not allow definite conclusions to be drawn regarding the safety and efficacy of these treatments

  5. Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer.

    Science.gov (United States)

    Lousberg, Laurence; Jerusalem, Guy

    2016-01-01

    Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus-exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile.

  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. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety management of radiation workers in medical institutions

    International Nuclear Information System (INIS)

    Han, Eun Ok

    2007-01-01

    Radiation safety managements in medical institutions are needed to protect certain radiation damages as a part of National Coalition. This study investigates the characteristics of self-efficacy that become the major factor on the knowledge, attitude, and behavior on the radiation safety management of radiation workers as an approach of educational aspects and analyzes the relationship between such factors to provide basic materials for improving the activity level of radiation safety managements. In order to implement the goal of this study, a survey was performed for 1,200 workers who were engaged in radiation treatments in medical centers, such as general hospital, university hospital, private hospital, and public health center for 42 days from July 23, 2006. Then, the results of the analysis can be summarized as follows: 1. Average scores on knowledge, attitude, and behavior in the radiation safety management were presented as 75.76±11.20, 90.55±8.59, 80.58±11.70, respectively. Also, the average score of self-efficacy was recorded as 73.55±9.82. 2. Knowledge levels in the radiation safety management showed significant differences according to the sex, age, marriage, education, and experience. Also, males of married, older, highly educated, and largely experienced represented high knowledge levels. Attitude levels in the radiation safety management showed certain significant differences according to the type of medical centers in which private hospitals showed a relatively low level compared to that of high levels in university hospitals. Behavior levels in the radiation safety management also represented significant differences according to the age, marriage, education, experience, and types of medical centers. Factors in married, general hospital, older, highly educated, and largely experienced showed high behavior levels. In addition, the self-efficacy showed certain differences according to the marriage and types of medical centers. Factors in married

  8. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety management of radiation workers in medical institutions

    Energy Technology Data Exchange (ETDEWEB)

    Han, Eun Ok [Daegu Health College, Daegu (Korea, Republic of)

    2007-06-15

    Radiation safety managements in medical institutions are needed to protect certain radiation damages as a part of National Coalition. This study investigates the characteristics of self-efficacy that become the major factor on the knowledge, attitude, and behavior on the radiation safety management of radiation workers as an approach of educational aspects and analyzes the relationship between such factors to provide basic materials for improving the activity level of radiation safety managements. In order to implement the goal of this study, a survey was performed for 1,200 workers who were engaged in radiation treatments in medical centers, such as general hospital, university hospital, private hospital, and public health center for 42 days from July 23, 2006. Then, the results of the analysis can be summarized as follows: 1. Average scores on knowledge, attitude, and behavior in the radiation safety management were presented as 75.76{+-}11.20, 90.55{+-}8.59, 80.58{+-}11.70, respectively. Also, the average score of self-efficacy was recorded as 73.55{+-}9.82. 2. Knowledge levels in the radiation safety management showed significant differences according to the sex, age, marriage, education, and experience. Also, males of married, older, highly educated, and largely experienced represented high knowledge levels. Attitude levels in the radiation safety management showed certain significant differences according to the type of medical centers in which private hospitals showed a relatively low level compared to that of high levels in university hospitals. Behavior levels in the radiation safety management also represented significant differences according to the age, marriage, education, experience, and types of medical centers. Factors in married, general hospital, older, highly educated, and largely experienced showed high behavior levels. In addition, the self-efficacy showed certain differences according to the marriage and types of medical centers. Factors in

  9. Efficacy and safety of Elevate® system on apical and anterior compartment prolapse repair with personal technique modification

    Directory of Open Access Journals (Sweden)

    Daniele Castellani

    Full Text Available ABSTRACT Aim: To evaluate the effectiveness and safety of Anterior Elevate® mesh kit system (AES in woman with symptomatic stage 3 or 4 anterior and/or apical pelvic organ prolapse (POP. Materials and Methods: This retrospective, monocentric, single surgeon study enrolled between May 2010 and January 2013 fifty-six woman experiencing symptomatic anterior vaginal prolapse with or without apical descent (POP-Q stage 3 or 4. All women received a AES and 7 (12.5% received a concomitant transvaginal hysterectomy. Primary endpoint was anatomic correction of prolapse; success was defined as POP-Q stage ≤ 1 or asymptomatic stage 2. Secondary endpoints were quality-of-life (QOL results and patients' safety outcomes, which were assessed by 3 validated self-reporting questionnaires at baseline and annually: ICIQ-UI short form, ICIQ-VS and P-QOL. All patients completed 2-years and 28 women 3-years of follow-up. Surgical approach was modified in women with uterus, moving the two-propylene strips anteriorly around the cervix itself crossing one another, so the left will take place in the right side and the right on the opposite. This modification was made in order to better support the uterus. Results: Vaginal mesh exposure was present in 3 (5,3% patients. Very good anatomical outcomes were seen, with one (1,8% failure at 6-months, 4 (7,1% at 1-year, 6 at 2-years (10,7%. Statistically significant improvements were seen in the ICIQ-VS and P-QOL questionnaires throughout follow-up. Conclusion: Our data suggest that AES is a minimally-invasive transvaginal procedure to repair anterior and apical POP, with good evidence related to mid-term safety and efficacy.

  10. 2011 John M. Eisenberg Patient Safety and Quality Awards. The effect of a novel Housestaff Quality Council on quality and patient safety. Innovation in patient safety and quality at the local level.

    Science.gov (United States)

    Fleischut, Peter M; Faggiani, Susan L; Evans, Adam S; Brenner, Samantha; Liebowitz, Richard S; Forese, Laura; Kerr, Gregory E; Lazar, Eliot J

    2012-07-01

    In 2008 New York-Presbyterian Hospital (NYP)/Weill Cornell Medical Center, New York City, the largest not-for-profit, nonsectarian hospital in the United States, created and implemented a novel approach--the Housestaff Quality Council (HQC)--to engaging house-staff in quality and patient safety activities. The HQC represented an innovative collaboration between the housestaff, the Department of Anesthesiology, the Division of Quality and Patient Safety, the Office of Graduate Medical Education, and senior leadership. As key managers of patient care, the housestaff sought to become involved in the quality and patient safety decision- and policy-making processes at the hospital. Its members were determined to decrease or minimize adverse events by facilitating multimodal communication, ensuring smart work flow, and measuring outcomes to determine best practices. The HQC, which also included frontline hospital staff or managers from areas such as nursing, pharmacy, and information technology, aligned its initiatives with those of the division of quality and patient safety and embarked on two projects--medication reconciliation and use of the electronic medical record. More than three years later, the resulting improvements have been sustained and three new projects--hand hygiene, central line-associated bloodstream infections, and patient handoffs--have been initiated. The HQC model is highly replicable at other teaching institutions as a complementary approach to their other quality and patient safety initiatives. However, the ability to sustain positive momentum is dependent on the ability of residents to invest time and effort in the face of a demanding residency training schedule and focus on specialty-specific clinical and research activities.

  11. Safety and clinical efficacy of tenvermectin, a novel antiparasitic 16-membered macrocyclic lactone antibiotics.

    Science.gov (United States)

    Fei, Chenzhong; She, Rufeng; Li, Guiyu; Zhang, Lifang; Fan, Wushun; Xia, Suhan; Xue, Feiqun

    2018-05-30

    Tenvermectin (TVM) is a novel 16-membered macrocyclic lactone antibiotics, which contains component TVM A and TVM B. However there is not any report on safety and clinical efficacy of TVM for developing as a potential drug. In order to understand the part of safety and clinical efficacy of TVM, we conducted the acute toxicity test, the standard bacterial reverse mutation (Ames) test and the clinical deworming test. In the acute toxicity studies, TVM, TVM A and ivermectin (IVM) were administrated once by oral gavage to mice and rats. Results showed that the oral LD 50 values of TVM, TVM A and IVM in mice were 74.41, 106.95 and 53.06 mg/kg respectively. The oral LD 50 values of TVM and TVM A in rats were determined to be 164.22 and 749.34 mg/kg respectively. TVM and IVM are moderately toxic substances, meanwhile the TVM A belongs to low toxic compounds, implying that the acute toxicity is highly related to the length of side chain of TVM at position C25. In the Ames test, results showed that TVM did not induce mutagenicity in Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without metabolic activation system, speculating that the mutagenicity is probably not related to the side chain at position C25 of 16-membered macrocyclic lactone antibiotics. In the efficacy trail of TVM against swine nematodes, growing pigs natural infection of Ascaris suum and Trichuris suis were treated with a single subcutaneous injection 0.3 mg/kg b.w.. Results showed that TVM and IVM had excellent effect in expelling Ascaris suum, and TVM had potential efficacy against Trichuris suis, however IVM had no effect on Trichuris suis. This study suggests that the side chain of TVM at position C25 may have important biological functions, which is one of the key sites of the studies on structure-activity relationship of 16-membered macrocyclic lactone compounds. TVM is a new compound exhibited some advantages worthy of developing. Copyright © 2018 Elsevier B.V. All

  12. The efficacy and safety of a novel posterior scleral reinforcement device in rabbits

    Energy Technology Data Exchange (ETDEWEB)

    Yuan, Yongguang; Zong, Yao; Zheng, Qishan [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Qian, Garrett [University of New South Wales (Australia); Qian, Xiaobin; Li, Yujie; Shao, Wanwen [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Gao, Qianying, E-mail: gaoqy@mail.sysu.edu.cn [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China)

    2016-05-01

    Purpose: To evaluate the efficacy and safety of posterior scleral reinforcement (PSR) device for myopia suppression in rabbits' eyes. Methods: PSR surgery was performed on the normal 12 8-week-old New Zealand white rabbits' right eyes. To determine efficacy of the device, ophthalmic examination would be taken at pre-operation and post-operation (1 week, 1 month, 3 months, 6 months, and 1 year), such as A-ultrasound, diopter and B-ultrasound. Evaluation of safety were based on the following indicators: intraocular pressure (IOP), slit lamp, fundus photography, fundus fluorescein angiography and pathological examination after surgery. The efficacy and safety of PSR device were evaluated by comparison (treated eyes and contralateral eyes) of pre and post-operation. Results: The novel PSR device could significantly shorten axial length (preoperative axial length: 16.36 ± 0.14 mm, postoperative 1 week, 1 month, 3 months, 6 months and 1 year axial lengths: 15.03 ± 0.28 mm, 15.23 ± 0.32 mm, 15.39 ± 0.31 mm, 15.45 ± 0.22 mm and 15.45 ± 0.22 mm; P = 0.00037 < 0.001) in the treated eyes (right eyes) after surgery. At different postoperative time points, the B-ultrasound images showed that the PSR located in appropriate position and supported the posterior sclera very well. At the same time, IOP of treated eyes kept a relatively stable level (preoperative IOP: 12.56 ± 2.01 mmHg, postoperative IOP: ranging from 11.33 ± 1.23 mmHg to 13.44 ± 2.19 mmHg, P > 0.05) post-operation 1 year. During observation period, there was no significant inflammatory reaction and complications such as anterior chamber flare, empyema, endophthalmitis, vitreous hemorrhage, retina detachment and retinal choroid neovascularization by slit lamp, fundus photography and fundus fluorescein angiography. In addition, there were no pathologic changes be found by comparison treated eyes group and contralateral group eyes based on pathological examinations. Conclusions: In vivo study

  13. Efficacy and safety of a new microneedle patch for skin brightening: A Randomized, split-face, single-blind study.

    Science.gov (United States)

    Park, Kui Young; Kwon, Hyun Jung; Lee, Changjin; Kim, Daegun; Yoon, Jun Jin; Kim, Myeong Nam; Kim, Beom Joon

    2017-09-01

    Although microneedles are one of the best transdermal drug delivery systems for active compounds, few clinical trials have examined the safety and efficacy of brightening microneedle patches. To determine the efficacy and safety of a newly developed whitening microneedle patch. A split-face study was designed for efficacy assessment with 34 Korean women applying the tested product (a whitening microneedle patch) on one cheek and a control whitening essence on the other. We objectively measured changes in melanin index values and skin brightness by mexameter and chromameter. Each participant also used global assessment to determine skin whitening. In addition, 55 participants were selected for primary skin irritation tests and repeated insult patch tests for safety assessments. Mean skin brightness and melanin indexes improved (Pmicroneedle patch was effective and safe for skin brightening and would be a promising functional cosmetic product. © 2017 Wiley Periodicals, Inc.

  14. Efficacy-mediated effects of spirituality and physical activity on quality of life: A path analysis

    Directory of Open Access Journals (Sweden)

    Konopack James F

    2012-05-01

    Full Text Available Abstract Background Physical activity has been established as an important determinant of quality of life, particularly among older adults. Previous research has suggested that physical activity’s influence on quality of life perceptions is mediated by changes in self-efficacy and health status. In the same vein, spirituality may be a salient quality of life determinant for many individuals. Methods In the current study, we used path analysis to test a model in which physical activity, spirituality, and social support were hypothesized to influence global quality of life in paths mediated by self-efficacy and health status. Cross-sectional data were collected from a sample of 215 adults (male, n = 51; female, n = 164 over the age of 50 (M age = 66.55 years. Results The analysis resulted in a model that provided acceptable fit to the data (χ2 = 33.10, df = 16, p  Conclusions These results support previous findings of an efficacy-mediated relationship between physical activity and quality of life, with the exception that self-efficacy in the current study was moderately associated with physical health status (.38 but not mental health status. Our results further suggest that spirituality may influence health and well-being via a similar, efficacy-mediated path, with strongest effects on mental health status. These results suggest that those who are more spiritual and physically active report greater quality of life, and the effects of these factors on quality of life may be partially mediated by perceptions of self-efficacy.

  15. Influence of motivation, self-efficacy and situational factors on the teaching quality of clinical educators.

    Science.gov (United States)

    Dybowski, Christoph; Sehner, Susanne; Harendza, Sigrid

    2017-05-08

    Being exposed to good teachers has been shown to enhance students' knowledge and their clinical performance, but little is known about the underlying psychological mechanisms that provide the basis for being an excellent medical teacher. Self-Determination Theory (SDT) postulates that more self-regulated types of motivation are associated with higher performance. Social Cognitive Theory (SCT) focuses on self-efficacy that has been shown to be positively associated with performance. To investigate the influences of different types of teaching motivation, teaching self-efficacy, and teachers' perceptions of students' skills, competencies and motivation on teaching quality. Before the winter semester 2014, physicians involved in bedside teaching in internal medicine at the University Medical Center Hamburg-Eppendorf completed a questionnaire with sociodemographic items and instruments measuring different dimensions of teaching motivation as well as teaching self-efficacy. During the semester, physicians rated their perceptions of the participating students who rated the teaching quality after each lesson. We performed a random intercept mixed-effects linear regression with students' ratings of teaching quality as the dependent variable and students' general interest in a subject as covariate. We explored potential associations between teachers' dispositions and their perceptions of students' competencies in a mixed-effects random intercept logistic regression. 94 lessons given by 55 teachers with 500 student ratings were analyzed. Neither teaching motivation nor teaching self-efficacy were directly associated with students' rating of teaching quality. Teachers' perceptions of students' competencies and students' general interest in the lesson's subject were positively associated with students' rating of teaching quality. Physicians' perceptions of their students' competencies were significantly positively predicted by their teaching self-efficacy. Teaching quality

  16. 30 CFR 250.806 - Safety and pollution prevention equipment quality assurance requirements.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Safety and pollution prevention equipment... Gas Production Safety Systems § 250.806 Safety and pollution prevention equipment quality assurance... install only certified safety and pollution prevention equipment (SPPE) in wells located on the OCS. SPPE...

  17. Documenting Quality Improvement and Patient Safety Efforts: The Quality Portfolio. A Statement from the Academic Hospitalist Taskforce

    OpenAIRE

    Taylor, Benjamin B.; Parekh, Vikas; Estrada, Carlos A.; Schleyer, Anneliese; Sharpe, Bradley

    2013-01-01

    Physicians increasingly investigate, work, and teach to improve the quality of care and safety of care delivery. The Society of General Internal Medicine Academic Hospitalist Task Force sought to develop a practical tool, the quality portfolio, to systematically document quality and safety achievements. The quality portfolio was vetted with internal and external stakeholders including national leaders in academic medicine. The portfolio was refined for implementation to include an outlined fr...

  18. Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology.

    Science.gov (United States)

    Manzoli, Lamberto; La Vecchia, Carlo; Flacco, Maria Elena; Capasso, Lorenzo; Simonetti, Valentina; Boccia, Stefania; Di Baldassarre, Angela; Villari, Paolo; Mezzetti, Andrea; Cicolini, Giancarlo

    2013-09-24

    While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety.We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking. From June to December 2013, we will enroll adult smokers of: (EC) e-cigarettes (self-reported inhaling ≥ 50 puffs per week since ≥ 6 months); (TC) traditional cigarettes (≥ 1 per day since ≥ 6 m); (Mixed) both electronic and traditional cigarettes (≥ 1 per day since ≥ 6 m). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate

  19. Male enhancement Nutraceuticals in the Middle East market: Claim, pharmaceutical quality and safety assessments.

    Science.gov (United States)

    ElAgouri, Ghada; ElAmrawy, Fatema; ElYazbi, Ahmed; Eshra, Ahmed; Nounou, Mohamed I

    2015-08-15

    The global market is invaded by male enhancement nutraceuticals claimed to be of natural origin sold with a major therapeutic claim. Most of these products have been reported by international systems like the Food and Drug Administration (FDA). We hypothesize that these products could represent a major threat to the health of the consumers. In this paper, pharmaceutical evaluation of some of these nutraceutical products sold in Egypt under the therapeutic claim of treating erectile dysfunction, are discussed along with pharmacological evaluation to investigate their safety and efficacy parameters. Samples were analyzed utterly using conventional methods, i.e.: HPLC, HPTLC, NIR, content uniformity and weight variation and friability. The SeDeM system was used for quality assessment. On the basis of the results of this research, the sampled products are adulterated and totally heterogeneous in their adulterant drug content and pharmaceutical quality. These products represent a major safety threat for the consumers in Egypt and the Middle East, especially; the target audience is mostly affected with heart and blood pressure problems seeking natural and safe alternatives to the well-established Phosphodiesterase 5 Inhibitors (PDE-5Is). Copyright © 2015 Elsevier B.V. All rights reserved.

  20. ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety

    Directory of Open Access Journals (Sweden)

    Plebani Mario

    2017-09-01

    Full Text Available Accreditation is a valuable resource for clinical laboratories and the development of an International Standard for their accreditation represented a milestone on the path towards improved quality and safety in laboratory medicine. The recent revision of the International Standard, ISO 15189, has further strengthened its value not only for improving the quality system of a clinical laboratory but also for better answering the request for competence, focus on customers’ needs and ultimate value of laboratory services. Although in some countries more general standards such as ISO 9001 for quality systems or ISO 17025 for testing laboratories are still used, there is increasing recognition of the value of ISO 15189 as the most appropriate and useful standard for the accreditation of medical laboratories. In fact, only this International Standard recognizes the importance of all steps of the total testing process, namely extra-analytical phases, the need to focus on technical competence in addition to quality systems, and the focus on customers’ needs. However, the number of accredited laboratories largely varies between European countries and also major differences affect the approaches to accreditation promoted by the national bodies. In particular, some national accreditation bodies perpetuate the use of fixed scopes, while the European co-operation for accreditation (EA and the European Federation of Laboratory Medicine (EFLM Working Group promote the use of flexible scopes. Major issues in clinical laboratory accreditation are the verification of examination procedures for imprecision, trueness and diagnostic accuracy and for estimating measurement uncertainty. In addition, quality indicators (QIs are a fundamental requirement of the ISO 15189 International Standard.

  1. Efficacy and safety of SOX chemotherapy with or without surgery in AFP-producing advanced gastric cancer

    OpenAIRE

    Li, Zhu; Hou, Xu; Chen, Juan; Sun, Huidong; Mi, Yuetang; Sui, Yongling; Li, Yuhong; Xie, Jiaping; Qiao, Yingli; Lei, Xiaofeng; Che, Xiaoshuang; Liu, Jun

    2017-01-01

    The present study investigated the clinical efficacy of S-1 plus oxaliplatin (SOX) regimen, with or without surgery in ?-fetoprotein-producing gastric cancer (APGC) with liver metastasis. A total of 24 patients with APGC treated at the Liaocheng People's Hospital between January 2011 and December 2013 were retrospectively reviewed. Clinical efficacy and patient safety were compared between the two groups. The median progression-free survival (PFS) and overall survival (OS) in the SOX group we...

  2. Long-term efficacy and safety of ExPress implantation for treatment of open angle glaucoma

    OpenAIRE

    Lee, Geun Young; Lee, Chong Eun; Lee, Kyoo Won; Seo, Sam

    2017-01-01

    AIM: To compare the long-term efficacy and safety of ExPress implantation and standard trabeculectomy in patients with primary open angle glaucoma (POAG). METHODS: In this retrospective study, we compared 17 eyes treated by ExPress implantation with 23 eyes treated by trabeculectomy. Efficacy was assessed according to the relevant intraocular pressure (IOP) values and success rates during the first year of follow-up. Postoperative corneal endothelial cell loss was also compared. RESULTS...

  3. Psychological Treatment of Depression in People Aged 65 Years and Over: A Systematic Review of Efficacy, Safety, and Cost-Effectiveness.

    Directory of Open Access Journals (Sweden)

    Ulf Jonsson

    Full Text Available Depression in elderly people is a major public health concern. As response to antidepressants is often unsatisfactory in this age group, there is a need for evidence-based non-pharmacological treatment options. Our objectives were twofold: firstly, to synthesize published trials evaluating efficacy, safety and cost-effectiveness of psychological treatment of depression in the elderly and secondly, to assess the quality of evidence.The electronic databases PubMed, EMBASE, Cochrane Library, CINAL, Scopus, and PsycINFO were searched up to 23 May 2016 for randomized controlled trials (RCTs of psychological treatment for depressive disorders or depressive symptoms in people aged 65 years and over. Two reviewers independently assessed relevant studies for risk of bias. Where appropriate, the results were synthesized in meta-analyses. The quality of the evidence was graded according to GRADE (Grading of Recommendations Assessment, Development and Evaluation.Twenty-two relevant RCTs were identified, eight of which were excluded from the synthesis due to a high risk of bias. Of the remaining trials, six evaluated problem-solving therapy (PST, five evaluated other forms of cognitive behavioural therapy (CBT, and three evaluated life review/reminiscence therapy. In frail elderly with depressive symptoms, the evidence supported the efficacy of PST, with large but heterogeneous effect sizes compared with treatment as usual. The results for life-review/reminiscence therapy and CBT were also promising, but because of the limited number of trials the quality of evidence was rated as very low. Safety data were not reported in any included trial. The only identified cost-effectiveness study estimated an incremental cost per additional point reduction in Beck Depression Inventory II score for CBT compared with talking control and treatment as usual.Psychological treatment is a feasible option for frail elderly with depressive symptoms. However, important questions

  4. Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.

    Science.gov (United States)

    Rudroju, Neelima; Bansal, Dipika; Talakokkula, Shiva Teja; Gudala, Kapil; Hota, Debasish; Bhansali, Anil; Ghai, Babita

    2013-01-01

    Anticonvulsants and antidepressants are mostly used in management of painful diabetic neuropathy (PDN). However there are few direct comparisons between drugs of these classes, making evidence-based decision-making in the treatment of painful diabetic neuropathy difficult. This study aimed to perform a network meta-analysis and benefit-risk analysis to evaluate the comparative efficacy and safety of these drugs in PDN treatment. Comparative effectiveness study. Medical Education and Research facility in India. A comprehensive data search was done in PubMed, Cochrane, and Embase up to August 2012. We then systematically reviewed the studies which compared any of 6 drugs for the management of PDN: amitriptyline, duloxetine, gabapentin, pregabalin, valproate, and venlafaxine or any of their combinations. We performed a random-effects network meta-analysis to rank treatments in terms of efficacy and safety. We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively. We also performed benefit-risk analysis, taking efficacy outcome as benefit and safety outcome as risk. Analysis was intention-to-treat. We included 21 published trials in the analysis. Duloxetine, gabapentin, pregabalin, and venlafaxine were shown to be significantly efficacious compared to placebo with odds ratios (OR) of 2.12, 3.98, 2.78, and 4.43, respectively. Amitriptyline (OR: 7.03, 95% confidence interval [CI]: 1.87, 29.05) and duloxetine (OR: 3.26, 95% CI: 1.04, 9.97) caused more withdrawals than gabapentin. The ranking order of efficacy was gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin, duloxetine, amitriptyline, and placebo and the ranking order of safety was placebo, gabapentin, pregabalin, venlafaxine, duloxetine/gabapentin combination, duloxetine, and amitriptyline. Benefit-risk balance favored the order: gabapentin, venlafaxine, pregabalin, duloxetine

  5. Safety-efficacy balance of S-ketamine and S-norketamine in acute and chronic pain

    OpenAIRE

    Noppers, Ingeborg Marieke

    2011-01-01

    The balance between safety and efficacy is important in pharmacotherapy. When the indication of a registered drug shifts to another disease or a different patient population, studies on safety and efficacy need to be performed. Ketamine is a relatively ‘old’ drug and used for almost 50 years as an anesthetic. Recently there has been a renewed interest for the treatment of therapy-resistant chronic pain with subanesthetic doses of ketamine. This thesis describes the effects of S-ketamine in pa...

  6. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women

    OpenAIRE

    Ángela María Ruiz-Sternberg; Edson D. Moreira, Jr; Jaime A. Restrepo; Eduardo Lazcano-Ponce; Robinson Cabello; Arnaldo Silva; Rosires Andrade; Francisco Revollo; Santos Uscanga; Alejandro Victoria; Ana María Guevara; Joaquín Luna; Manuel Plata; Claudia Nossa Dominguez; Edison Fedrizzi

    2018-01-01

    Background: A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine. Methods: Efficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16–26 years...

  7. Assessment of efficacy and safety of a fractionated bipolar radiofrequency device for the treatment of lower face wrinkles and laxity.

    Science.gov (United States)

    Jiang, Yueqi; Zhang, Xuting; Lu, Zhong; Gold, Michael H

    2018-04-18

    Skin aging, as a natural course, is a gradual process. It can be classified as either intrinsic or photo-aging. In recent years, as the attention to lower face wrinkles and laxity has raised significantly, the demands to facial rejuvenation also increased, along with a variety of technologies coming into being. Fractional bipolar RF as a novel means of rejuvenation has been used in clinical practice, but questions remain in terms of its efficacy and safety. Considering a large population in our country and huge demands for skin tightening, we did this research to evaluate the efficacy and safety of fractional bipolar radiofrequency.

  8. Efficacy and safety of icotinib in patients with brain metastases from lung adenocarcinoma.

    Science.gov (United States)

    Xu, Jianping; Liu, Xiaoyan; Yang, Sheng; Zhang, Xiangru; Shi, Yuankai

    2016-01-01

    The objective of this study was to evaluate the efficacy and safety of icotinib in patients with brain metastases (BMs) from lung adenocarcinoma. Clinical data of 28 cases with BMs from lung adenocarcinoma were retrospectively analyzed. All the patients took 125 mg icotinib orally three times a day. Progression of disease, intolerable adverse reactions, and number of deaths were recorded. For all the patients, the remission rate of icotinib was 67.8% and the disease control rate was 96.4%. The median overall survival time of patients was 21.2 months, and the median progression-free survival time of patients was 10.9 months. Only mild adverse events of grade 1/2 were observed during the treatment. Icotinib was an effective and safe strategy to treat patients with BMs from lung adenocarcinoma.

  9. Dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes: safety, tolerability, and efficacy

    Directory of Open Access Journals (Sweden)

    Mary Elizabeth Cox

    2010-01-01

    Full Text Available Mary Elizabeth Cox1, Jennifer Rowell1, Leonor Corsino1, Jennifer B Green1,21Department of Medicine, Division of Endocrinology, Metabolism, and Nutrition. Duke University Medical Center, Durham, NC, USA; 2Department of Medicine, Division of Endocrinology, Durham Veterans Affairs Medical Center, Durham, NC, USAAbstract: Although glycemic control is an important and effective way to prevent and minimize the worsening of diabetes-related complications, type 2 diabetes is a progressive disease which often proves difficult to manage. Most affected patients will eventually require therapy with multiple medications in order to reach appropriate glycemic targets. The dipeptidyl peptidase-4 (DPP-4 inhibitors constitute a relatively new class of oral medications for the treatment of type 2 diabetes, which has become widely incorporated into clinical practice. This review summarizes the available data on the efficacy, safety, and tolerability of these medications.Keywords: type 2 diabetes, pharmacotherapy, DPP-4 inhibitor, sitagliptin, vildagliptin, saxagliptin, alogliptin, linagliptin

  10. Efficacy and Safety of Tranexamic Acid in Melasma: A Meta-analysis and Systematic Review.

    Science.gov (United States)

    Kim, Hyun Jung; Moon, Seok Hoon; Cho, Sang Hyun; Lee, Jeong Deuk; Kim, Hei Sung

    2017-07-06

    Tranexamic acid is a novel treatment option for melasma; however, there is no consensus on its use. This systematic review searched major databases for relevant publications to March 2016. Eleven studies with 667 participants were included. Pooled data from tranexamic acid-only observational studies with pre- and post-treatment Melasma Area and Severity Index (MASI) showed a decrease of 1.60 in MASI (95% confidence interval (CI), 1.20-2.00; ptranexamic acid. The addition of tranexamic acid to routine treatment modalities resulted in a further decrease in MASI of 0.94 (95% CI 0.10-1.79; p = 0.03). Side-effects were minor, with a few cases reporting hypo-menorrhoea, mild abdominal discomfort, and transient skin irritation. These results support the efficacy and safety of tranexamic acid, either alone or as an adjuvant to routine treatment modalities for melasma.

  11. Efficacy and safety of PPC-5650 on experimental rectal pain in patients with irritable bowel syndrome

    DEFF Research Database (Denmark)

    Nielsen, Lecia Møller; Olesen, Anne Estrup; Andresen, Trine

    2015-01-01

    PPC-5650 is a new pharmacological agent that can modulate acid-sensing ion channel activity, leading to a reduction in the pain signal under up-regulated conditions. The non-clinical programme for PPC-5650 supported a role for this novel agent in the treatment of pain in patients with irritable...... bowel syndrome (IBS). In patients with IBS, the aims of the study were: (1) to assess the efficacy of a single bolus of PPC-5650 locally applied in the rectum using multi-modal stimulations of the recto sigmoid and (2) to assess the safety profile of PPC-5650. The study was a randomized, double......-blind, placebo-controlled, cross-over trial in patients with IBS, excluding females of child-bearing potential. The study consisted of a training visit, study visit 1 and 2 and a follow-up visit. Rectosigmoid electrical, thermal and mechanical stimulations were performed, pain perception was rated on a pain...

  12. Safety and efficacy of abciximab as an adjunct to percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Jennifer Vergara-Jimenez

    2010-03-01

    Full Text Available Jennifer Vergara-Jimenez, Pierluigi TricociDepartment of Medicine-Cardiology, Duke Clinical Research Institute, Durham, North Carolina, USAAbstract: Abciximab is a widely studied glycoprotein IIb/IIIa inhibitor, specifically in the setting of patients undergoing percutaneous coronary intervention (PCI. The populations studied have included patients with non-ST-segment acute coronary syndromes, ST-segment elevation myocardial infarction, and elective PCI. This large amount of information provides a clear efficacy and safety profile of the drug, although a few questions on the use of abciximab still exist, particularly on its use and preference in the setting of newer antiplatelet and antithrombotic medications. In this article we review the most relevant data from randomized clinical trials with abciximab in patients undergoing PCI and discuss the recent guideline recommendation on use during PCI.Keywords: abciximab, percutaneous coronary intervention, glycoprotein inhibitor

  13. Long-term efficacy, safety and tolerability of Remoxy for the management of chronic pain.

    Science.gov (United States)

    Pergolizzi, Joseph V; Zampogna, Gianpietro; Taylor, Robert; Raffa, Robert B

    2015-03-01

    Historically, chronic pain generally went under-treated for a variety of objective and subjective reasons, including difficulty to objectively diagnose and manage over a long period of time, potential serious adverse effects of commonly available medications, and patient, healthcare and societal concerns over opioid medications. More recently, in an effort to redress the under-treatment of pain, the number of prescriptions of opioid analgesics has risen dramatically. However, paralleling the increased legitimate use has been a concomitant increase in opioid abuse, misuse and diversion. Pharmaceutical companies have responded by developing a variety of opioid formulations designed to deter abuse by making the products more difficult to tamper with. One such product is Remoxy(®), an extended-release formulation of the strong opioid oxycodone. We review the efficacy, safety and tolerability of this formulation based on the available published literature.

  14. Ayurpharmacoepidemiology en Route to Safeguarding Safety and Efficacy of Ayurvedic Drugs in Global Outlook

    Science.gov (United States)

    Debnath, Parikshit; Banerjee, Subhadip; Adhikari, Anjan; Debnath, Pratip K.

    2016-01-01

    Ayurpharmacoepidemiology is a new field developed by synergy of the fields of clinical pharmacology, epidemiology, and ayurveda. It will use the effects of ayurvedic medicinal products on large populations to describe and analyze the practices, evaluate the safety and efficacy, and carry out medicoeconomic evaluations. Good pharmacoepidemiology practices in ayurveda is projected to assist with issues of ayurpharmacoepidemiologic research. The embraced good pharmacoepidemiology practices guideline in this viewpoint will be able to provide valuable evidence about the health effects of ayurvedic herbs/drugs and consider different fields like pharmacovigilance, pharmacoeconomics, and drug discovery with ayurvedic reverse pharmacology approach, also pass out significant data for further basic sciences study in ayurveda biology, ayurgenomics, ayurnutrigenomics, and systems biology. Several unanswered questions about ayurvedic drug use and informed interventions or policies that can be addressed by informatics database, which will eventually demonstrate the credibility and rationality of ayurceuticals in the future. PMID:26721554

  15. Safety and Efficacy of Argatroban in the Management of Heparin-Induced Thrombocytopenia

    Directory of Open Access Journals (Sweden)

    Bernd Saugel

    2011-01-01

    Full Text Available Heparin-induced thrombocytopenia (HIT is a life-threatening adverse reaction to heparin therapy that is characterized by thrombocytopenia and an increased risk of venous and arterial thrombosis. According to guidelines, in patients with strongly suspected or confirmed HIT all sources of heparin have to be discontinued and an alternative, nonheparin anticoagulant for HIT treatment must immediately be started. For both the prophylaxis of thrombembolic events in HIT and the treatment of HIT with thrombosis the direct thrombin inhibitor argatroban is approved in the United States. The objective of this review is to describe the mechanism of action and the pharmacokinetic profile of argatroban, to characterize argatroban regarding its safety and therapeutic efficacy and to discuss its place in therapy in HIT.

  16. Endovascular treatment of brain-stem arteriovenous malformations: safety and efficacy

    Energy Technology Data Exchange (ETDEWEB)

    Liu, H.M.; Wang, Y.H.; Chen, Y.F.; Huang, K.M. [Department of Medical Imaging, National Taiwan University Hospital, 7 Chung-Shan South Road, 10016, Taipei (Taiwan); Tu, Y.K. [Division of Neurosurgery, Department of Surgery, National Taiwan University Hospital, 7 Chung-Shan South Road, 1001, Taipei (Taiwan)

    2003-09-01

    Our purpose was to evaluate the safety and efficacy of endovascular treatment of brain-stem arteriovenous malformations (AVMs), reviewing six cases managed in the last 5 years. There were four patients who presented with bleeding, one with a progressive neurological deficit and one with obstructive hydrocephalus. Of the six patients, one showed 100%, one 90%, two 75% and two about 50% angiographic obliteration of the AVM after embolisation; the volume decreased about 75% on average. Five patients had a good outcome and one an acceptable outcome, with a mild postprocedure neurological deficit; none had further bleeding during midterm follow-up. Endovascular management of a brain-stem AVM may be an alternative to treatment such as radiosurgery and microsurgery in selected cases. It may be not as risky as previously thought. Embolisation can reduce the size of the AVM and possibly make it more treatable by radiosurgery and decrease the possibility of radiation injury. (orig.)

  17. Evaluation of the safety and efficacy of percutaneous radiofrequency ablation for treating multiple breast fibroadenoma.

    Science.gov (United States)

    Li, Ping; Xiao-Yin, Tang; Cui, Dan; Chi, Jia-Chang; Wang, Zhi; Wang, Tao; Qi, Xing-Xing; Zhai, Bo

    2016-12-01

    This study was conducted to evaluate the safety and efficacy of ultrasound (US)-guided percutaneous radiofrequency ablation (RFA) for multiple breast fibroadenoma as an alternative to surgical resection. Sixty-five patients with multiple breast fibroadenoma accepted general anesthesia and US-guided percutaneous RFA in our hospital from September 2014 to January 2016. Contrast-enhanced US (CEUS) was used immediately after operation to determine whether the tumor was ablated completely. The complete ablation rate (CAR) and the change of focal volume were evaluated by CEUS at the 1st month and the 3rd month after operation. All the patients were diagnosed by needle biopsy. Among all the patients, 256 nodules were found. Forty-six nodules (17.96%) were located fibroadenoma.

  18. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Christiansen, Evald Høj

    2016-01-01

    BACKGROUND: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. OBJECTIVES: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical...... rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR...... in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877)....

  19. Safety and efficacy of generic drugs with respect to brand formulation.

    Science.gov (United States)

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-12-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

  20. Association of SNPs with the efficacy and safety of immunosuppressant therapy after heart transplantation.

    Science.gov (United States)

    Sánchez-Lázaro, Ignacio; Herrero, María José; Jordán-De Luna, Consuelo; Bosó, Virginia; Almenar, Luis; Rojas, Luis; Martínez-Dolz, Luis; Megías-Vericat, Juan E; Sendra, Luis; Miguel, Antonio; Poveda, José L; Aliño, Salvador F

    2015-01-01

    Studying the possible influence of SNPs on efficacy and safety of calcineurin inhibitors upon heart transplantation. In 60 heart transplant patients treated with tacrolimus or cyclosporine, we studied a panel of 36 SNPs correlated with a series of clinical parameters during the first post-transplantation year. The presence of serious infections was correlated to ABCB1 rs1128503 (p = 0.012), CC genotype reduced the probability of infections being also associated with lower blood cyclosporine concentrations. Lower renal function levels were found in patients with rs9282564 AG (p = 0.003), related to higher blood cyclosporine blood levels. A tendency toward increased graft rejection (p = 0.05) was correlated to rs2066844 CC in NOD2/CARD15, a gene related to lymphocyte activation. Pharmacogenetics can help identify patients at increased risk of clinical complications. Original submitted 30 January 2015; revision submitted 27 March 2015.

  1. Off-label biologic regimens in psoriasis: a systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy.

    Directory of Open Access Journals (Sweden)

    Elizabeth A Brezinski

    Full Text Available OBJECTIVES: While off-label dosing of biologic treatments may be necessary in selected psoriasis patients, no systematic review exists to date that synthesizes the efficacy and safety of these off-label dosing regimens. The aim of this systematic review is to evaluate efficacy and safety of off-label dosing regimens (dose escalation, dose reduction, and interrupted treatment with etanercept, adalimumab, infliximab, ustekinumab, and alefacept for psoriasis treatment. DATA SOURCES AND STUDY SELECTION: We searched OVID Medline from January 1, 1990 through August 1, 2011 for prospective clinical trials that studied biologic therapy for psoriasis treatment in adults. Individual articles were screened for studies that examined escalated, reduced, or interrupted therapy with etanercept, adalimumab, infliximab, ustekinumab, or alefacept. DATA SYNTHESIS: A total of 23 articles with 12,617 patients matched the inclusion and exclusion criteria for the systematic review. Data were examined for primary and secondary efficacy outcomes and adverse events including infections, malignancies, cardiovascular events, and anti-drug antibodies. The preponderance of data suggests that continuous treatment with anti-TNF agents and anti-IL12/23 agent was necessary for maintenance of disease control. Among non-responders, dose escalation with etanercept, adalimumab, ustekinumab, and alefacept typically resulted in greater efficacy than standard dosing. Dose reduction with etanercept and alefacept resulted in reduced efficacy. Withdrawal of the examined biologics led to an increase in disease activity; efficacy from retreatment did not result in equivalent initial response rates for most biologics. Safety data on off-label dosing regimens are limited. CONCLUSION: Dose escalation in non-responders generally resulted in increased efficacy in the examined biologics used to treat moderate-to-severe psoriasis. Continuous treatment with anti-TNF agents and anti-IL12/23 agent

  2. A Comparative Study of Natural Antimicrobial Delivery Systems for Microbial Safety and Quality of Fresh-Cut Lettuce.

    Science.gov (United States)

    Hill, Laura E; Oliveira, Daniela A; Hills, Katherine; Giacobassi, Cassie; Johnson, Jecori; Summerlin, Harvey; Taylor, T Matthew; Gomes, Carmen L

    2017-05-01

    Nanoencapsulation can provide a means to effectively deliver antimicrobial compounds and enhance the safety of fresh produce. However, to date there are no studies which directly compares how different nanoencapsulation systems affect fresh produce safety and quality. This study compared the effects on quality and safety of fresh-cut lettuce treated with free and nanoencapsulated natural antimicrobial, cinnamon bark extract (CBE). A challenge study compared antimicrobial efficacy of 3 different nanoencapsulated CBE systems. The most effective antimicrobial treatment against Listeria monocytogenes was chitosan-co-poly-N-isopropylacrylamide (chitosan-PNIPAAM) encapsulated CBE, with a reduction on bacterial load up to 2 log 10 CFU/g (P lettuce was stored at 5 °C and 10 °C for 15 d. Subsequently, chitosan-PNIPAAM-CBE nanoparticles (20, 40, and 80 mg/mL) were compared to a control and free CBE (400, 800, and 1600 μg/mL) for its effects on fresh-cut lettuce quality over 15 d at 5 °C. By the 10th day, the most effective antimicrobial concentration was 80 mg/mL for chitosan-PNIPAAM-CBE, up to 2 log 10 CFU/g reduction (P lettuce shelf-life. Overall, nanoencapsulation provided a method to effectively deliver essential oil and enhanced produce safety, while creating little to no detrimental quality changes on the fresh-cut lettuce. © 2017 Institute of Food Technologists®.

  3. Quality assurance of radiotherapy in cancer treatment. Toward improvement of patient safety and quality of care

    International Nuclear Information System (INIS)

    Ishikura, Satoshi

    2008-01-01

    The process of radiotherapy (RT) is complex and involves understanding of the principles of medical physics, radiobiology, radiation safety, dosimetry, radiation treatment planning, simulation and interaction of radiation with other treatment modalities. Each step in the integrated process of RT needs quality control and quality assurance (QA) to prevent errors and to give high confidence that patients will receive the prescribed treatment correctly. Recent advances in RT, including intensity-modulated and image-guided RT, focus on the need for a systematic RTQA program that balances patient safety and quality with available resources. It is necessary to develop more formal error mitigation and process analysis methods, such as failure mode and effect analysis, to focus available QA resources optimally on process components. External audit programs are also effective. The International Atomic Energy Agency has operated both an on-site and off-site postal dosimetry audit to improve practice and to assure the dose from RT equipment. Several countries have adopted a similar approach for national clinical auditing. In addition, clinical trial QA has a significant role in enhancing the quality of care. The Advanced Technology Consortium has pioneered the development of an infrastructure and QA method for advanced technology clinical trials, including credentialing and individual case review. These activities have an impact not only on the treatment received by patients enrolled in clinical trials, but also on the quality of treatment administered to all patients treated in each institution, and have been adopted globally; by the USA, Europe and Japan also. (author)

  4. Quality assurance of radiotherapy in cancer treatment: toward improvement of patient safety and quality of care.

    Science.gov (United States)

    Ishikura, Satoshi

    2008-11-01

    The process of radiotherapy (RT) is complex and involves understanding of the principles of medical physics, radiobiology, radiation safety, dosimetry, radiation treatment planning, simulation and interaction of radiation with other treatment modalities. Each step in the integrated process of RT needs quality control and quality assurance (QA) to prevent errors and to give high confidence that patients will receive the prescribed treatment correctly. Recent advances in RT, including intensity-modulated and image-guided RT, focus on the need for a systematic RTQA program that balances patient safety and quality with available resources. It is necessary to develop more formal error mitigation and process analysis methods, such as failure mode and effect analysis, to focus available QA resources optimally on process components. External audit programs are also effective. The International Atomic Energy Agency has operated both an on-site and off-site postal dosimetry audit to improve practice and to assure the dose from RT equipment. Several countries have adopted a similar approach for national clinical auditing. In addition, clinical trial QA has a significant role in enhancing the quality of care. The Advanced Technology Consortium has pioneered the development of an infrastructure and QA method for advanced technology clinical trials, including credentialing and individual case review. These activities have an impact not only on the treatment received by patients enrolled in clinical trials, but also on the quality of treatment administered to all patients treated in each institution, and have been adopted globally; by the USA, Europe and Japan also.

  5. A systematic review on the safety and efficacy of percutaneous edge-to-edge mitral valve repair with the MitraClip system for high surgical risk candidates

    DEFF Research Database (Denmark)

    Munkholm-Larsen, Stine; Wan, Benjamin; Tian, David H

    2014-01-01

    BACKGROUND: MitraClip implantation has emerged as a viable option in high surgical risk patients with severe mitral regurgitation (MR). We performed the present systematic review to assess the safety and efficacy of the MitraClip system for high surgical risk candidates with severe organic and....../or functional MR. METHODS: Six electronic databases were searched for original published studies from January 2000 to March 2013. Two reviewers independently appraised studies, using a standard form, and extracted data on methodology, quality criteria, and outcome measures. All data were extracted and tabulated...

  6. Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: a contemporary evaluation

    Directory of Open Access Journals (Sweden)

    Mary E. Westerman

    Full Text Available ABSTRACT Introduction: Hemorrhagic cystitis (HC represents a challenging clinical entity. While various intravesical agents have been utilized in this setting, limited data exist regarding safety or efficacy. Herein, then, we evaluated the effectiveness and complications associated with intravesical alum instillation for HC in a contemporary cohort. Materials and Methods: We identified 40 patients treated with intravesical alum for HC between 1997-2014. All patients had failed previous continuous bladder irrigation with normal saline and clot evacuation. Treatment success was defined as requiring no additional therapy beyond normal saline irrigation after alum instillation. Results: Median patient age was 76.5 years (IQR 69, 83. Pelvic radiation was the most common etiology for HC (n=38, 95%. Alum use decreased patient's transfusion requirement, with 82% (32/39 receiving a transfusion within 30 days before alum instillation (median 4 units versus 59% (23/39 within 30 days after completing alum (median 3 units (p=0.05. In total, 24 patients (60% required no additional therapy prior to hospital discharge. Moreover, at a median follow-up of 17 months (IQR 5, 38.5, 13 patients (32.5% remained without additional treatment for HC. Adverse effects were reported in 15 patients (38%, with bladder spasms representing the most common event (14/40; 35%. No clinical evidence of clinically significant systemic absorption was detected. Conclusion: Intravesical alum therapy is well-tolerated, with resolution of HC in approximately 60% of patients, and a durable response in approximately one-third. Given its favorable safety/efficacy profile, intravesical alum may be considered as a first-line treatment option for patients with HC.

  7. Tenofovir alafenamide versus tenofovir disoproxil fumarate: is there a true difference in efficacy and safety?

    Science.gov (United States)

    Hill, Andrew; Hughes, Sophie L; Gotham, Dzintars; Pozniak, Anton L

    2018-04-01

    Higher plasma tenofovir concentrations are associated with higher risks of renal and bone adverse events. The pharmacokinetic boosters ritonavir (RTV) and cobicistat (COBI) significantly increase plasma area under the curve (AUC) concentrations of tenofovir disoproxil fumarate (TDF), by 25-37%. When combined with RTV or COBI, the dose of tenofovir alafenamide (TAF) is lowered from 25 mg to 10 mg daily, but the TDF dose is maintained at 300 mg daily. To assess the differences in safety and efficacy between tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) in regimens with and without the pharmacokinetic boosters RTV and COBI. A PubMed/Embase search inclusive of dates up to 17 July 2017 identified 11 randomised head-to-head trials (8111 patients) of TDF versus TAF. The Mantel-Haenszel method was used to calculate pooled risk differences and 95% confidence intervals using random-effects models. A pre-defined sub-group analysis compared TAF with TDF, either when boosted with RTV or COBI, or when unboosted. Nine clinical trials compared TAF and TDF for treatment of HIV-1 and two were for hepatitis B treatment. The eleven clinical trials documented 4574 patients with boosting RTV or COBI in both arms, covering 7198 patient-years of follow-up. Some 3537 patients received unboosted regimens, totalling 3595 patient-years of follow-up. Boosted TDF-treated patients showed borderline lower HIV RNA suppression TAF and unboosted TDF. TDF boosted with RTV or COBI was associated with higher risks of bone and renal adverse events, and lower HIV RNA suppression rates, compared with TAF. By contrast, when ritonavir and cobicistat were not used, there were no efficacy differences between TAF and TDF, and marginal differences in safety. The health economic value of TAF versus low-cost generic TDF may be limited when these drugs are used without cobicistat or ritonavir.

  8. Silodosin for the treatment of clinical benign prostatic hyperplasia: safety, efficacy, and patient acceptability

    Directory of Open Access Journals (Sweden)

    Cho HJ

    2014-09-01

    Full Text Available Hee Ju Cho, Tag Keun Yoo Department of Urology, Eulji Hospital, Eulji University School of Medicine, Seoul, KoreaAbstract: α1-Adrenergic receptor antagonists are commonly used to treat male lower urinary tract symptoms and benign prostatic hyperplasia (BPH. We performed a literature search using PubMed, Medline via Ovid, Embase, and the Cochrane Library databases to identify studies on the treatment of BPH by silodosin. Silodosin is a novel α1-adrenergic receptor antagonist whose affinity for the α1A-adrenergic receptor is greater than that for the α1B-adrenergic receptor. Therefore, silodosin does not increase the incidence of blood pressure-related side effects, which may result from the inhibition of the α1B-adrenergic receptor. Patients receiving silodosin at a daily dose of 8 mg showed a significant improvement in the International Prostate Symptom Score and maximum urinary flow rate compared with those receiving a placebo. Silodosin also improved both storage and voiding symptoms, indicating that silodosin is effective, even during early phases of BPH treatment. Follow-up extension studies performed in the United States, Europe, and Asia demonstrated its long-term safety and efficacy. In the European study, silodosin significantly reduced nocturia compared to the placebo. Although retrograde or abnormal ejaculation was the most commonly reported symptom in these studies, only a few patients discontinued treatment. The incidence of adverse cardiovascular events was also very low. Evidence showing solid efficacy and cardiovascular safety profiles of silodosin will provide a good solution for the treatment of lower urinary tract symptoms associated with BPH in an increasingly aging society. Keywords: α1A-adrenoceptor antagonist, silodosin, benign prostatic hyperplasia, lower urinary tract symptoms

  9. Efficacy and safety of oral sildenafil in children with Down syndrome and pulmonary hypertension.

    Science.gov (United States)

    Beghetti, Maurice; Rudzinski, Andrzej; Zhang, Min

    2017-07-04

    Despite the increased risk for pulmonary hypertension in children with Down syndrome, the response to treatment with targeted therapies for pulmonary hypertension in these patients is not well characterized. The Sildenafil in Treatment-naive children, Aged 1-17 years, with pulmonary arterial hypertension (STARTS-1) trial was a dose-ranging study of the short-term efficacy and safety of oral sildenafil in children with pulmonary arterial hypertension. We assessed the safety and efficacy of oral sildenafil in children with Down syndrome and pulmonary arterial hypertension. This was a post-hoc analysis of children with Down syndrome and pulmonary arterial hypertension enrolled in the STARTS-1 trial. Mean pulmonary arterial pressure (mPAP), pulmonary vascular resistance index (PVRI), and cardiac index (CI) were assessed at baseline and following 16 weeks of treatment with sildenafil. Of 234 patients randomized and treated in the STARTS-1 trial, 48 (20.5%) had Down syndrome. Although sildenafil produced dose-related reductions in PVRI and mPAP, compared with placebo, in non-Down syndrome patients and children developmentally able to exercise, this was not satisfactorily marked in patients with Down syndrome. The dose-related reductions in PVRI, compared with placebo, occurred in all subgroups, with the exception of the Down syndrome subgroup. Sildenafil appeared to be well tolerated in the Down syndrome subpopulation and the most frequently reported AEs were similar to those reported for the entire STARTS-1 population. Sildenafil treatment for 16 weeks had no effect on PVRI or mPAP in children with Down syndrome and pulmonary arterial hypertension. The results suggest that children with Down syndrome may be less responsive to sildenafil for pulmonary arterial hypertension, but the incomplete work-up for the etiology of pulmonary arterial hypertension may have introduced a potential bias. Study received, September 8, 2005 (retrospectively registered); Study start

  10. Chronic electrical stimulation with a suprachoroidal retinal prosthesis: a preclinical safety and efficacy study.

    Directory of Open Access Journals (Sweden)

    David A X Nayagam

    Full Text Available To assess the safety and efficacy of chronic electrical stimulation of the retina with a suprachoroidal visual prosthesis.Seven normally-sighted feline subjects were implanted for 96-143 days with a suprachoroidal electrode array and six were chronically stimulated for 70-105 days at levels that activated the visual cortex. Charge balanced, biphasic, current pulses were delivered to platinum electrodes in a monopolar stimulation mode. Retinal integrity/function and the mechanical stability of the implant were assessed monthly using electroretinography (ERG, optical coherence tomography (OCT and fundus photography. Electrode impedances were measured weekly and electrically-evoked visual cortex potentials (eEVCPs were measured monthly to verify that chronic stimuli were suprathreshold. At the end of the chronic stimulation period, thresholds were confirmed with multi-unit recordings from the visual cortex. Randomized, blinded histological assessments were performed by two pathologists to compare the stimulated and non-stimulated retina and adjacent tissue.All subjects tolerated the surgical and stimulation procedure with no evidence of discomfort or unexpected adverse outcomes. After an initial post-operative settling period, electrode arrays were mechanically stable. Mean electrode impedances were stable between 11-15 kΩ during the implantation period. Visually-evoked ERGs & OCT were normal, and mean eEVCP thresholds did not substantially differ over time. In 81 of 84 electrode-adjacent tissue samples examined, there were no discernible histopathological differences between stimulated and unstimulated tissue. In the remaining three tissue samples there were minor focal fibroblastic and acute inflammatory responses.Chronic suprathreshold electrical stimulation of the retina using a suprachoroidal electrode array evoked a minimal tissue response and no adverse clinical or histological findings. Moreover, thresholds and electrode impedance remained

  11. Drug Repositioning of Proton Pump Inhibitors for Enhanced Efficacy and Safety of Cancer Chemotherapy

    Directory of Open Access Journals (Sweden)

    Kenji Ikemura

    2017-12-01

    Full Text Available Proton pump inhibitors (PPIs, H+/K+-ATPase inhibitors, are the most commonly prescribed drugs for the treatment of gastroesophageal reflux and peptic ulcer diseases; they are highly safe and tolerable. Since PPIs are frequently used in cancer patients, studies investigating interactions between PPIs and anticancer agents are of particular importance to achieving effective and safe cancer chemotherapy. Several studies have revealed that PPIs inhibit not only the H+/K+-ATPase in gastric parietal cells, but also the vacuolar H+-ATPase (V-ATPase overexpressed in tumor cells, as well as the renal basolateral organic cation transporter 2 (OCT2 associated with pharmacokinetics and/or renal accumulation of various drugs, including anticancer agents. In this mini-review, we summarize the current knowledge regarding the impact of PPIs on the efficacy and safety of cancer chemotherapeutics via inhibition of targets other than the H+/K+-ATPase. Co-administration of clinical doses of PPIs protected kidney function in patients receiving cisplatin and fluorouracil, presumably by decreasing accumulation of cisplatin in the kidney via OCT2 inhibition. In addition, co-administration or pretreatment with PPIs could inhibit H+ transport via the V-ATPase in tumor cells, resulting in lower extracellular acidification and intracellular acidic vesicles to enhance the sensitivity of the tumor cells to the anticancer agents. In the present mini-review, we suggest that PPIs enhance the efficacy and safety of anticancer agents via off-target inhibition (e.g., of OCT2 and V-ATPase, rather than on-target inhibition of the H+/K+-ATPase. The present findings should provide important information to establish novel supportive therapy with PPIs during cancer chemotherapy.

  12. Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria.

    Science.gov (United States)

    Hide, Michihiro; Park, Hae-Sim; Igarashi, Atsuyuki; Ye, Young-Min; Kim, Tae-Bum; Yagami, Akiko; Roh, Jooyoung; Lee, Jae-Hyun; Chinuki, Yuko; Youn, Sang Woong; Lee, Soo-Keol; Inomata, Naoko; Choi, Jeong-Hee; Fukunaga, Atsushi; Wang, Junyi; Matsushima, Soichiro; Greenberg, Steve; Khalil, Sam

    2017-07-01

    Many patients with chronic spontaneous/idiopathic urticaria (CSU/CIU) do not respond adequately to treatment with non-sedating H1 antihistamines (H1AH). There are limited studies on use of omalizumab as add-on therapy for treatment of CSU in an Asian population. The POLARIS study (NCT02329223), representing the first randomized, double-blind, placebo-controlled phase III trial of omalizumab for CSU in an Eastern Asian population, evaluated efficacy and safety of omalizumab as add-on therapy for treatment of CSU. This 26-week multicenter (41 Japanese/Korean sites) study enrolled patients (12-75 years) who were symptomatic despite H1AH treatment. Eligible participants (N=218) were randomized 1:1:1 to receive three subcutaneous injections of omalizumab 300mg, 150mg, or placebo every 4 weeks, followed by 12 weeks of follow-up. Primary outcome was change from baseline to Week 12 (Wk12) in weekly itch severity score (ISS7). Safety was assessed through the summary of adverse events (AEs). Baseline demographics and disease characteristics were generally well balanced across treatment groups. At Wk12, statistically significant decreases from baseline were observed in ISS7 with omalizumab vs placebo (mean changes -10.22, -8.80, and -6.51 for omalizumab 300mg, 150mg and placebo; pomalizumab 300mg, 150mg, and placebo groups, respectively); nasopharyngitis was the most frequently reported AE in all treatment arms. The POLARIS study demonstrates that omalizumab is an efficacious and well-tolerated add-on therapy in Japanese and Korean H1AH-refractory patients with CSU. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  13. Efficacy and safety of combined ethinyl estradiol/drospirenone oral contraceptives in the treatment of acne

    Directory of Open Access Journals (Sweden)

    Jerry KL Tan

    2009-11-01

    Full Text Available Jerry KL Tan1, Chemanthi Ediriweera21University of Western Ontario and Windsor Clinical Research Inc., Windsor, Ontario, Canada; 2University of Western Ontario, Southwest Ontario Medical Education Network, Windsor, Ontario, CanadaAbstract: Acne is a common disorder affecting the majority of adolescents and often extends into adulthood. The central pathophysiological feature of acne is increased androgenic stimulation and/or end-organ sensitivity of pilosebaceous units leading to sebum hypersecretion and infundibular hyperkeratinization. These events lead to Propionibacterium acnes proliferation and subsequent inflammation. Hormonal therapy, including combined oral contraceptives (OCs, can attenuate the proximate androgenic trigger of this sequence. For many women, hormonal therapy is a rational option for acne treatment as it may be useful across the spectrum of severity. Drospirenone (DRSP is a unique progestin structurally related to spironolactone with progestogenic, antimineralocorticoid, and antiandrogenic properties. It is available in 2 combined OC preparations (30 µg EE/3 mg DRSP; Yasmin® in a 21/7 regimen; and 20 µg EE/3 mg DRSP; Yaz® in a 24/4 regimen. These preparations are bereft of the fluid retentional side effects typical of other progestins and their safety has been demonstrated in large epidemiological studies in which no increased risk of vascular thromboembolic disease or arrhythmias was observed. In acne, the efficacy of DRSP-containing OCs has been shown in placebo-controlled superiority trials and in active-comparator non-inferiority trials.Keywords: acne vulgaris, combined oral contraceptives, drosperinone, ethinyl estradiol, efficacy, safety, treatment

  14. Safety and efficacy of fenproporex for obesity treatment: a systematic review.

    Science.gov (United States)

    Paumgartten, Francisco José Roma; Pereira, Sabrina Schaaf Teixeira Costa; de Oliveira, Ana Cecilia Amado Xavier

    2016-01-01

    To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals) were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year), 3.8 kg (six months) and 1.55 kg (two months) in average, in relation to diet and exercise only (three trials). Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern.

  15. Clinical efficacy, safety and tolerance of the Kerawort (imiquimod cream used for treatment of anogenital warts

    Directory of Open Access Journals (Sweden)

    M. R. Rakhmatulina

    2015-01-01

    Full Text Available Goal of the study. To assess the efficacy and safety of Kerawort (Imiquimod, 5% cream for topical administration vs. placebo used for treatment of anogenital warts. Methods and materials. The single-blind comparative placebo-controlled study involved 90 patients (44 female and 46 male with anogenital warts. The patients were randomized into two groups: the main group (n = 45 receiving treatment with Kerawort (Imiquimod, 5% cream and the control group (n = 45 receiving placebo. The diagnosis was confirmed by the identification of human papillomavirus by the polymerase chain reaction method. The patients received treatment three times a week until clinical signs disappeared but for not more than 16 weeks. Results. In 95.6% of patients from the main group and 8.9% of patients from the control group, anogenital warts disappeared completely or the quantity/area of pathological eruptions reduced at least by 70% as compared to the baseline. No relapses occurred during the treatment and follow-up period (28 days after the completion of treatment in patients from the main group. An increase in the size and/or area of anogenital warts and/or development of new eruptions on the skin and mucous membrane of the genitals were recorded in 11.1% of patients from the control group. No serious adverse events were revealed during the study. Conclusion. Higher efficacy (р < 0.0000001 and comparable safety of Kerawort (Imiquimod, 5% cream for topical administration used for treatment of anogenital warts vs. placebo were reliably established.

  16. Safety and efficacy outcome of mentor alpha-1 inflatable penile prosthesis implantation for impotence treatment.

    Science.gov (United States)

    Goldstein, I; Newman, L; Baum, N; Brooks, M; Chaikin, L; Goldberg, K; McBride, A; Krane, R J

    1997-03-01

    We investigated safety and efficacy outcome pertaining to the Mentor Alpha-1, 3-piece inflatable penile prosthesis for impotence treatment. A 2-phase, multi-institutional, large scale retrospective study, with independently analyzed medical record (phase I) and questionnaire (phase II) data from consecutive eligible patients of 7 physician investigators was performed from March to October 1993. In phase I there were no morbidities of any type in 394 of the 434 patients (90.8%) (mean age 61 years, range 24 to 88) who underwent Alpha-1 implantation (mean followup 22.2 months, range 0.67 to 44.5). The risk of prosthesis malfunction (fluid leak and auto-inflation) was 2.5%. No cylinder aneurysms were reported. A total of 93.1% of Alpha-1 devices was free from explantation (4.4%) or revision surgery (2.5%) for approximately 2 years from the original implant date. Kaplan-Meier actuarial analyses revealed that cumulative survival of the Alpha-1 prostheses at 12, 24 and 36 months was 98 +/- 1%, 93 +/- 2% and 85 +/- 7% until device malfunction, and 91 +/- 2% 83 +/- 4% and 75 +/- 7% until surgical intervention (revision or explantation). In phase II 89% of the men claimed fulfilled expectations with the Alpha-1 prosthesis as impotence treatment. Satisfaction responses 80% or greater were noted with regard to intercourse ability and confidence, and device rigidity and function. Implantation did not result in greater than 80% satisfaction in partner relationships or feelings (as judged by the patient), social or work confidence, or intercourse frequency. Factors adversely affecting satisfaction included partner feelings of dissatisfaction (as judged by the patient), specific physician investigators and need for explantation/revision surgery. In 1 of the largest multi-institutional implant outcome studies thus far performed, safety and efficacy data concerning the Alpha-1 contemporary inflatable device were found markedly improved over earlier inflatable prostheses and now

  17. [Efficacy and safety profile of cranberry in infants and children with recurrent urinary tract infection].

    Science.gov (United States)

    Fernández-Puentes, V; Uberos, J; Rodríguez-Belmonte, R; Nogueras-Ocaña, M; Blanca-Jover, E; Narbona-López, E

    2015-06-01

    Cranberry prophylaxis of recurrent urinary tract infection in infants has proven effective in the experimental model of the adult. There are few data on its efficacy, safety and recommended dose in the pediatric population. A controlled, double-blind Phase III clinical trial was conducted on children older than 1 month of age to evaluate the efficacy and safety of cranberry in recurrent urinary tract infection. The assumption was of the non-inferiority of cranberry versus trimethoprim. Statistical analysis was performed using Kaplan Meier analysis. A total of 85 patients under 1 year of age and 107 over 1 year were recruited. Trimethoprim was prescribed to 75 patients and 117 received cranberry. The cumulative rate of urinary infection associated with cranberry prophylaxis in children under 1 year was 46% (95% CI; 23-70) in children and 17% (95% CI; 0-38) in girls, effectively at doses inferior to trimethoprim. In children over 1 year-old cranberry was not inferior to trimethoprim, with a cumulative rate of urine infection of 26% (95% CI; 12-41). The cranberry was well tolerated and with no new adverse effects. Our study confirms that cranberry is safe and effective in the prophylaxis of recurrent urinary tract infection in infants and children. With the doses used, their efficiency is not less than that observed for trimethoprim among those over 1 year-old. (Clinical Trials Registry ISRCTN16968287). Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

  18. Safety and efficacy of fenproporex for obesity treatment: a systematic review

    Directory of Open Access Journals (Sweden)

    Francisco José Roma Paumgartten

    2016-01-01

    Full Text Available ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. RESULTS Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year, 3.8 kg (six months and 1.55 kg (two months in average, in relation to diet and exercise only (three trials. Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. CONCLUSIONS There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern.

  19. Efficacy, Safety, and Pharmacokinetics of Coadministered Diethylcarbamazine, Albendazole, and Ivermectin for Treatment of Bancroftian Filariasis.

    Science.gov (United States)

    Thomsen, Edward K; Sanuku, Nelly; Baea, Manasseh; Satofan, Samson; Maki, Elit; Lombore, Bart; Schmidt, Mark S; Siba, Peter M; Weil, Gary J; Kazura, James W; Fleckenstein, Lawrence L; King, Christopher L

    2016-02-01

    Available treatments for lymphatic filariasis (LF) are limited in their longterm clearance of microfilaria from the blood. The safety and efficacy of a single-dose triple-drug therapy of the antifilarial drugs diethylcarbamazine (DEC), ivermectin (IVM), and albendazole (ALB) for LF are unknown. We performed a pilot study to test the efficacy, safety, and pharmacokinetics of single-dose DEC, IVM, and ALB in Wuchereria bancrofti-infected Papua New Guineans. Adults were randomized into 2 treatment arms, DEC 6 mg/kg + ALB 400 mg (N = 12) or DEC 6 mg/kg + ALB 400 mg + IVM 200 μg/kg (N = 12), and monitored for microfilaria, parasite antigenemia, adverse events (AEs), and serum drug levels. Triple-drug therapy induced >2-log reductions in microfilaria levels at 36 and 168 hours after treatment compared with approximately 1-log reduction with 2 drugs. All 12 individuals who received 3 drugs were microfilaria negative 1 year after treatment, whereas 11 of 12 individuals in the 2-drug regimen were microfilaria positive. In 6 participants followed 2 years after treatment, those who received 3 drugs remained microfilaria negative. AEs, particularly fever, myalgias, pruritus, and proteinuria/hematuria, occurred in 83% vs 50% of those receiving triple-drug compared to 2-drug treatment respectively (P = .021); all resolved within 7 days after treatment. No serious AEs were observed in either group. There was no significant effect of IVM on DEC or ALB drug levels. Triple-drug therapy is safe and more effective than DEC + ALB for Bancroftian filariasis and has the potential to accelerate elimination of lymphatic filariasis. NCT01975441. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  20. Dietary self-efficacy predicts AHEI diet quality in women with previous gestational diabetes.

    Science.gov (United States)

    Ferranti, Erin Poe; Narayan, K M Venkat; Reilly, Carolyn M; Foster, Jennifer; McCullough, Marjorie; Ziegler, Thomas R; Guo, Ying; Dunbar, Sandra B

    2014-01-01

    The purpose of this study was to examine the association of intrapersonal influences of diet quality as defined by the Health Belief Model constructs in women with recent histories of gestational diabetes. A descriptive, correlational, cross-sectional design was used to analyze relationships between diet quality and intrapersonal variables, including perceptions of threat of type 2 diabetes mellitus development, benefits and barriers of healthy eating, and dietary self-efficacy, in a convenience sample of 75 community-dwelling women (55% minority; mean age, 35.5 years; SD, 5.5 years) with previous gestational diabetes mellitus. Diet quality was defined by the Alternative Healthy Eating Index (AHEI). Multiple regression was used to identify predictors of AHEI diet quality. Women had moderate AHEI diet quality (mean score, 47.6; SD, 14.3). Only higher levels of education and self-efficacy significantly predicted better AHEI diet quality, controlling for other contributing variables. There is a significant opportunity to improve diet quality in women with previous gestational diabetes mellitus. Improving self-efficacy may be an important component to include in nutrition interventions. In addition to identifying other important individual components, future studies of diet quality in women with previous gestational diabetes mellitus are needed to investigate the scope of influence beyond the individual to potential family, social, and environmental factors. © 2014 The Author(s).

  1. Efficacy, acceptability, and safety of adjunctive aripiprazole in treatment-resistant depression: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Luan SX

    2018-02-01

    Full Text Available Shuxin Luan,1,2 Hongquan Wan,2 Lei Zhang,3 Hua Zhao1,4 1Department of Physiology, College of Basic Medical Sciences, Jilin University, Changchun, China; 2Department of Mental Health, The First Hospital of Jilin University, Changchun, China; 3Department of Radiology, The First Hospital of Jilin University, Changchun, China; 4Neuroscience Research Center, The First Hospital of Jilin University, Changchun, China Background: Treatment-resistant depression (TRD is common and potentially life-threatening in adults, and the benefits and risks of adjunctive aripiprazole in these patients remain controversial. Therefore, we conducted a meta-analysis of randomized controlled trials (RCTs to assess the efficacy, acceptability, safety, and quality of life of adjunctive aripiprazole in patients with TRD.Methods: RCTs published in PubMed, Web of Science, and Embase were systematically reviewed to evaluate the efficacy and safety profiles of TRD patients who were treated with adjunctive aripiprazole. The main outcome measures included response rate, remission rate, changes from baseline in Montgomery–Asberg Depression Rating Scale (MADRS, Clinical Global Impression-severity (CGI-S, Clinical Global Impression-improvement (CGI-I, 17-Item Hamilton Rating Scale for Depression (HAM-D17, Sheehan Disability scale (SDS, and Inventory of Depressive Symptomatology Self-Report Scale (IDS-SR, discontinuation due to adverse events, and adverse events. Risk ratio (RR or weight mean difference with 95% confidence intervals (CIs were pooled using a fixed-effects or random-effects model according to the heterogeneity among studies.Results: A total of 8 RCTs involving 2,260 patients were included in this meta-analysis. Adjunctive aripiprazole was associated with a significantly higher remission rate (RR =1.64, 95% CI: 1.42 to 1.89; P<0.001 and response rate (RR =1.45, 95% CI: 1.13 to 1.87; P=0.004 than other treatments. Moreover, adjunctive aripiprazole had greater changes in

  2. Efficacy and safety of regenerative cell therapy for pulmonary arterial hypertension in animal models: a preclinical systematic review protocol.

    Science.gov (United States)

    Suen, Colin M; Zhai, Alex; Lalu, Manoj M; Welsh, Christopher; Levac, Brendan M; Fergusson, Dean; McIntyre, Lauralyn; Stewart, Duncan J

    2016-05-25

    Pulmonary arterial hypertension (PAH) is a rare disease (15 cases per million) that is characterized by widespread loss of the pulmonary microcirculation and elevated pulmonary vascular resistance leading to pathological right ventricular remodeling and ultimately right heart failure. Regenerative cell therapies (i.e., therapies involving cells with stem or progenitor-like properties) could potentially restore the effective lung microcirculation and provide a curative therapy for PAH. Preclinical evidence suggests that regenerative cell therapy using endothelial progenitor cells or mesenchymal stem cells may be beneficial in the treatment of PAH. These findings have led to the completion of a small number of human clinical trials, albeit with modest effect compared to animal studies. The objective of this systematic review is to compare the efficacy and safety of regenerative cell therapies in preclinical models of PAH as well as assess study quality to inform future clinical studies. We will include preclinical studies of PAH in which a regenerative cell type was administered and outcomes compared to a disease control. The primary outcome will be pulmonary hemodynamics as assessed by measurement of right ventricular systolic pressure and/or mean pulmonary arterial pressure. Secondary outcomes will include mortality, survival, right ventricular remodeling, pulmonary vascular resistance, cardiac output, cardiac index, pulmonary acceleration time, tricuspid annular systolic excursion, and right ventricular wall thickness. Electronic searches of MEDLINE and EMBASE databases will be constructed and reviewed by the Peer Review of Electronic Search Strategies (PRESS) process. Search results will be screened independently in duplicate. Data from eligible studies will be extracted, pooled, and analyzed using random effects models. Risk of bias will be assessed using the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool, and

  3. Safety and efficacy of tiotropium Respimat versus HandiHaler in patients naive to treatment with inhaled anticholinergics

    DEFF Research Database (Denmark)

    Wise, Robert; Calverley, Peter Ma; Dahl, Ronald

    2015-01-01

    BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) who were naive to anticholinergics before the TIOtropium Safety and Performance In Respimat (TIOSPIR) trial may reflect patients seen in practice, in particular in primary care. In addition, investigating safety...... in these patients avoids the potential bias in patients who previously received anticholinergics and may be tolerant of their effects. AIMS: The aim of this study was to evaluate whether patients naive to anticholinergic therapy who were treated with tiotropium Respimat 2.5 or 5 μg had different safety and efficacy...... the Respimat and HandiHaler groups. Rates of exacerbations in the subgroup of patients with moderate disease were similar across the Respimat and HandiHaler groups. CONCLUSIONS: Tiotropium Respimat and HandiHaler have similar safety and efficacy profiles in patients who are naive to anticholinergic therapy....

  4. Safety and Efficacy of Paliperidone Extended-Release in Acute and Maintenance Treatment of Schizophrenia

    Directory of Open Access Journals (Sweden)

    Edoardo Spina

    2011-01-01

    Full Text Available Paliperidone, the major active metabolite of risperidone, is a second-generation antipsychotic that has been developed as an extended-release (ER tablet formulation that minimizes peak-trough fluctuations in plasma concentrations, allowing once-daily administration and constant drug delivery. Paliperidone ER has demonstrated efficacy in the reduction of acute schizophrenia symptoms in 6-week, placebo-controlled, double-blind trials and clinical benefits were maintained in the longer-term according to extension studies of up to 52 weeks in duration. Compared with quetiapine, paliperidone ER was associated with a more rapid symptom improvement. In addition, it was more effective than placebo in the prevention of symptom recurrence. Paliperidone ER is generally well tolerated with a predictable adverse event profile. Like risperidone, it is associated with a dose-dependent risk of extrapyramidal symptoms and prolactin elevation. Short-and longer-term studies have indicated a low liability for paliperidone ER to cause metabolic (ie, weight gain, hyperglycaemia and lipid dysregulation or cardiovascular adverse effects. Available safety data from elderly patients appear to be promising. Due to negligible hepatic biotransformation, paliperidone ER is unlikely to be involved in clinically significant metabolic drug-drug interactions. Additional active comparator trials evaluating efficacy, tolerability and cost-effectiveness are required to better define the role of paliperidone ER in the treatment of schizophrenia in relation to other currently available second-generation antipsychotics, particularly risperidone.

  5. Efficacy and safety of prucalopride for chronic constipation: A meta-analysis

    Directory of Open Access Journals (Sweden)

    Hui-jun TANG

    2014-08-01

    Full Text Available Objective To evaluate the efficacy and safety of prucalopride in the treatment of chronic constipation (CC. Methods Articles regarding treatment of constipation were retrieved from PubMed, EMBASE, Web of Science, The Cochrane Central Register of Controlled Trials, Chinese Journals Full-text Database (CNKI, China National Knowledge Infrastructure, Wan Fang Digital Journal Full-text Database, and Database for Chinese Technical Periodical (VIP to collect clinical randomized controlled trials for CC treated by prucalopride. Meta analysis was performed by using Review Manager 5.0. Results A total of eleven randomized controlled trials including 3278 patients met the inclusion criteria, and ten of them were analyzed to compare the effect of prucalopride with placebo, and another group of articles were analyzed to compare the effect or prucalopride with that of PEG 3350+electrolytes. Mete-analysis showed that the efficacy rate was significantly higher in prucalopride group (29.2% than in the placebo group (12.6%, RR=2.37, 95% CI 2.02-2.79, P0.05. Conclusion Prucalopride is effective in the treatment of CC, with relatively milder and lower incidence of adverse reaction, and it could be a new choice for the treatment of CC. DOI: 10.11855/j.issn.0577-7402.2014.06.10

  6. Unraveling the Effect of Immunogenicity on the PK/PD, Efficacy, and Safety of Therapeutic Proteins

    Directory of Open Access Journals (Sweden)

    Alison Smith

    2016-01-01

    Full Text Available Biologics have emerged as a powerful and diverse class of molecular and cell-based therapies that are capable of replacing enzymes, editing genomes, targeting tumors, and more. As this complex array of tools arises a distinct set of challenges is rarely encountered in the development of small molecule therapies. Biotherapeutics tend to be big, bulky, polar molecules comprised of protein and/or nucleic acids. Compared to their small molecule counterparts, they are fragile, labile, and heterogeneous. Their biodistribution is often limited by hydrophobic barriers which often restrict their administration to either intravenous or subcutaneous entry routes. Additionally, their potential for immunogenicity has proven to be a challenge to developing safe and reliably efficacious drugs. Our discussion will emphasize immunogenicity in the context of therapeutic proteins, a well-known class of biologics. We set out to describe what is known and unknown about the mechanisms underlying the interplay between antigenicity and immune response and their effect on the safety, efficacy, pharmacokinetics, and pharmacodynamics of these therapeutic agents.

  7. Management of advanced pancreatic cancer with gemcitabine plus erlotinib: efficacy and safety results in clinical practice.

    Science.gov (United States)

    Diaz Beveridge, Robert; Alcolea, Vicent; Aparicio, Jorge; Segura, Ángel; García, Jose; Corbellas, Miguel; Fonfría, María; Giménez, Alejandra; Montalar, Joaquin

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