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Sample records for clinical pharmacology section

  1. CLINICAL PHARMACOLOGY OF DIURETICS

    Directory of Open Access Journals (Sweden)

    I. V. Soldatenko

    2014-06-01

    Full Text Available Clinical pharmacology of diuretics in the international system of ATC (anatomic-therapeutic-chemical is presented. Classification of this group by the action mechanism and caused effects is provided. Pharmacokinetics and pharmacodynamics features, indications and principles of diuretics usage in clinics are considered. Contraindications, side effects and interaction with other drugs of this group are discussed in detail.

  2. Clinical pharmacology of homoharringtonine

    International Nuclear Information System (INIS)

    Savaraj, N.; Lu, K.; Dimery, I.; Feun, L.G.; Burgess, M.; Keating, M.; Loo, T.L.

    1986-01-01

    Clinical pharmacokinetics of homoharringtonine (HHT) were studied in eight patients who received uniformly labeled HHT at 3-4 mg/m2 (150 mu Ci) by continuous 6-hour infusion. The drug and metabolites were quantified by radiochemical and high-performance liquid chromatographic techniques. Computerized nonlinear least-square regression and curve stripping were used to characterize HHT and total [ 3 H]HHT equivalent pharmacokinetics. Unchanged HHT in the plasma declined biphasically, with an alpha-half-life of 0.5 +/- 0.1 hours and a beta-half-life of 9.3 +/- 1.4 hours. The total clearance of HHT was 177.4 +/- 27.7 ml X hour-1 X kg-1, and the apparent volume of distribution, estimated from the area under the drug concentration versus time curve, was 2.4 +/- 0.4 L X kg-1. Correspondingly, the total [ 3 H]HHT equivalent disappeared from the plasma in a triphasic manner. Compared with the pharmacokinetic parameters of unchanged HHT, the terminal half-life of total 3 H was 67.5 +/- 7.5 hours, 7.4 times longer; the total clearance was 30.9 +/- 3.1 ml X hour-1 X kg-1, 5.5 times slower; but the volume of distribution by area was 2.7 +/- 0.1 L X kg-1, nearly the same. The 72-hour cumulative urinary excretion of total tritium was 28.2% of the administered dose and only 38.3% of this resided in unchanged HHT. Thus, urinary excretion was not a major route of elimination of HHT. Moreover, HHT underwent extensive metabolism; one major and two minor unidentified products were detected in both plasma and urine

  3. Applications of stable isotopes in clinical pharmacology

    NARCIS (Netherlands)

    Schellekens, Reinout C A; Stellaard, Frans; Woerdenbag, Herman J; Frijlink, Henderik W; Kosterink, Jos G W

    2011-01-01

    This review aims to present an overview of the application of stable isotope technology in clinical pharmacology. Three main categories of stable isotope technology can be distinguished in clinical pharmacology. Firstly, it is applied in the assessment of drug pharmacology to determine the

  4. Pharmacology Portal: An Open Database for Clinical Pharmacologic Laboratory Services.

    Science.gov (United States)

    Karlsen Bjånes, Tormod; Mjåset Hjertø, Espen; Lønne, Lars; Aronsen, Lena; Andsnes Berg, Jon; Bergan, Stein; Otto Berg-Hansen, Grim; Bernard, Jean-Paul; Larsen Burns, Margrete; Toralf Fosen, Jan; Frost, Joachim; Hilberg, Thor; Krabseth, Hege-Merete; Kvan, Elena; Narum, Sigrid; Austgulen Westin, Andreas

    2016-01-01

    More than 50 Norwegian public and private laboratories provide one or more analyses for therapeutic drug monitoring or testing for drugs of abuse. Practices differ among laboratories, and analytical repertoires can change rapidly as new substances become available for analysis. The Pharmacology Portal was developed to provide an overview of these activities and to standardize the practices and terminology among laboratories. The Pharmacology Portal is a modern dynamic web database comprising all available analyses within therapeutic drug monitoring and testing for drugs of abuse in Norway. Content can be retrieved by using the search engine or by scrolling through substance lists. The core content is a substance registry updated by a national editorial board of experts within the field of clinical pharmacology. This ensures quality and consistency regarding substance terminologies and classification. All laboratories publish their own repertoires in a user-friendly workflow, adding laboratory-specific details to the core information in the substance registry. The user management system ensures that laboratories are restricted from editing content in the database core or in repertoires within other laboratory subpages. The portal is for nonprofit use, and has been fully funded by the Norwegian Medical Association, the Norwegian Society of Clinical Pharmacology, and the 8 largest pharmacologic institutions in Norway. The database server runs an open-source content management system that ensures flexibility with respect to further development projects, including the potential expansion of the Pharmacology Portal to other countries. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  5. The Dutch vision of clinical pharmacology

    NARCIS (Netherlands)

    Schellens, J H M; Grouls, R; Guchelaar, H J; Touw, D J; Rongen, G A; de Boer, A; Van Bortel, L M

    Recent position papers addressing the profession of clinical pharmacology have expressed concerns about the decline of interest in the field among clinicians and medical educators in the United Kingdom and other Western countries, whether clinical pharmacology is actually therapeutics, and whether

  6. Bioanalysis, metabolism & clinical pharmacology of antiretroviral drugs

    NARCIS (Netherlands)

    Heine, R. ter

    2009-01-01

    The aims of all studies described in this thesis were to develop new bioanalytical and more patient friendly methods for studying the clinical pharmacology of antiretroviral drugs and to ultimately improve antiretroviral treatment.

  7. Methods in Clinical Pharmacology Series

    Science.gov (United States)

    Beaumont, Claire; Young, Graeme C; Cavalier, Tom; Young, Malcolm A

    2014-01-01

    Human radiolabel studies are traditionally conducted to provide a definitive understanding of the human absorption, distribution, metabolism and excretion (ADME) properties of a drug. However, advances in technology over the past decade have allowed alternative methods to be employed to obtain both clinical ADME and pharmacokinetic (PK) information. These include microdose and microtracer approaches using accelerator mass spectrometry, and the identification and quantification of metabolites in samples from classical human PK studies using technologies suitable for non-radiolabelled drug molecules, namely liquid chromatography-mass spectrometry and nuclear magnetic resonance spectroscopy. These recently developed approaches are described here together with relevant examples primarily from experiences gained in support of drug development projects at GlaxoSmithKline. The advantages of these study designs together with their limitations are described. We also discuss special considerations which should be made for a successful outcome to these new approaches and also to the more traditional human radiolabel study in order to maximize knowledge around the human ADME properties of drug molecules. PMID:25041729

  8. Electronic cigarettes and nicotine clinical pharmacology

    OpenAIRE

    Schroeder, Megan J; Hoffman, Allison C

    2014-01-01

    Objective To review the available literature evaluating electronic cigarette (e-cigarette) nicotine clinical pharmacology in order to understand the potential impact of e-cigarettes on individual users, nicotine dependence and public health. Methods Literature searches were conducted between 1 October 2012 and 30 September 2013 using key terms in five electronic databases. Studies were included in the review if they were in English and publicly available; non-clinical studies, conference abst...

  9. Electronic cigarettes and nicotine clinical pharmacology.

    Science.gov (United States)

    Schroeder, Megan J; Hoffman, Allison C

    2014-05-01

    To review the available literature evaluating electronic cigarette (e-cigarette) nicotine clinical pharmacology in order to understand the potential impact of e-cigarettes on individual users, nicotine dependence and public health. Literature searches were conducted between 1 October 2012 and 30 September 2013 using key terms in five electronic databases. Studies were included in the review if they were in English and publicly available; non-clinical studies, conference abstracts and studies exclusively measuring nicotine content in e-cigarette cartridges were excluded from the review. Nicotine yields from automated smoking machines suggest that e-cigarettes deliver less nicotine per puff than traditional cigarettes, and clinical studies indicate that e-cigarettes deliver only modest nicotine concentrations to the inexperienced e-cigarette user. However, current e-cigarette smokers are able to achieve systemic nicotine and/or cotinine concentrations similar to those produced from traditional cigarettes. Therefore, user experience is critically important for nicotine exposure, and may contribute to the products' ability to support and maintain nicotine dependence. Knowledge about e-cigarette nicotine pharmacology remains limited. Because a user's e-cigarette experience may significantly impact nicotine delivery, future nicotine pharmacokinetic and pharmacodynamic studies should be conducted in experienced users to accurately assess the products' impact on public health.

  10. Electronic cigarettes and nicotine clinical pharmacology

    Science.gov (United States)

    Schroeder, Megan J; Hoffman, Allison C

    2014-01-01

    Objective To review the available literature evaluating electronic cigarette (e-cigarette) nicotine clinical pharmacology in order to understand the potential impact of e-cigarettes on individual users, nicotine dependence and public health. Methods Literature searches were conducted between 1 October 2012 and 30 September 2013 using key terms in five electronic databases. Studies were included in the review if they were in English and publicly available; non-clinical studies, conference abstracts and studies exclusively measuring nicotine content in e-cigarette cartridges were excluded from the review. Results Nicotine yields from automated smoking machines suggest that e-cigarettes deliver less nicotine per puff than traditional cigarettes, and clinical studies indicate that e-cigarettes deliver only modest nicotine concentrations to the inexperienced e-cigarette user. However, current e-cigarette smokers are able to achieve systemic nicotine and/or cotinine concentrations similar to those produced from traditional cigarettes. Therefore, user experience is critically important for nicotine exposure, and may contribute to the products’ ability to support and maintain nicotine dependence. Conclusions Knowledge about e-cigarette nicotine pharmacology remains limited. Because a user's e-cigarette experience may significantly impact nicotine delivery, future nicotine pharmacokinetic and pharmacodynamic studies should be conducted in experienced users to accurately assess the products’ impact on public health. PMID:24732160

  11. 21 CFR 320.28 - Correlation of bioavailability with an acute pharmacological effect or clinical evidence.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Correlation of bioavailability with an acute pharmacological effect or clinical evidence. 320.28 Section 320.28 Food and Drugs FOOD AND DRUG ADMINISTRATION... Correlation of bioavailability with an acute pharmacological effect or clinical evidence. Correlation of in...

  12. Only connect: the merger of BMC Pharmacology and BMC Clinical Pharmacology.

    Science.gov (United States)

    Moylan, Elizabeth C; Morrey, Christopher; Appleford-Cook, Joanne M

    2012-08-13

    This editorial celebrates the launch of BMC Pharmacology and Toxicology within the BMC series of journals published by BioMed Central. The scope of the journal is interdisciplinary encompassing toxicology, experimental and clinical pharmacology including clinical trials. In this editorial we discuss the origins of this new journal and the ethos and policies under which it will operate.

  13. Radioimmunoassay in basic and clinical pharmacology

    International Nuclear Information System (INIS)

    Patrono, C.; Peskar, B.A.

    1987-01-01

    The subject of the book is the development, validation and application of radioimmunoassay (RIA) techniques for the measurement of a variety of substances in animal and human body fluids. The book discusses methodological and conceptual issues related to the main classes of mediators of drug action and to drugs themselves, as assayed by this particular analytical technique. A number of introductory chapters provide basic information concerning production and characterization of antibodies, labeling techniques, statistical aspects and validation criteria, insight into problems related to the development and validation of RIA for the newly discovered mediator(s). In the following chapters, the emphasis is placed on the technical details relevant to each class of compounds and on specific aspects of their applications to basic and/or clinical pharmacological studies. New developments in this area, such as monoclonal antibodies and non-radioactive labeling techniques, are also covered

  14. Clinical pharmacology of atovaquone and proguanil hydrochloride.

    Science.gov (United States)

    Beerahee, M

    1999-05-01

    Atovaquone and proguanil hydrochloride is a new antimalarial combination that is used for treatment and prophylaxis of malaria. The clinical pharmacology of atovaquone and proguanil was reviewed. Atovaquone is a highly lipophilic compound with low aqueous solubility, the absorption of which is limited by the rate and extent of dissolution. Dietary fat increases the rate and extent of atovaquone absorption, increasing AUC two- to threefold and C(max) fivefold over fasting. Proguanil is rapidly and extensively absorbed regardless of food intake. Atovaquone is highly protein bound (> 99%) but does not displace other highly protein bound drugs in vitro, indicating significant drug interactions arising from displacement are unlikely. Atovaquone is predominantly eliminated unchanged in feces, with negligible excretion in urine. Proguanil is partially metabolized and partially excreted unchanged in urine. Its principal metabolite, cycloguanil, is also excreted in urine. Metabolism of proguanil is mediated in the liver by the cytochrome P450 3A and 2C subfamilies. The elimination half-life of atovaquone is 2 to 3 days in adults and 1 to 2 days in children. The elimination half-lives of proguanil and cycloguanil are 12 to 15 hours in adults and children. Dosage adjustments based on body weight categories in children (1/4 dose for 11-20 kg, 1/2 dose for > 20-30 kg, 3/4 dose for > 30-40 kg, and full dose for > 40 kg) achieve plasma concentrations that are safe and effective during prophylaxis and treatment of malaria. No dose adjustments for race, proguanil metabolizer status, gender, or elderly patients are needed, or for patients with mild to moderately impaired renal or hepatic function. The clinical pharmacology of atovaquone and proguanil provides a rationale for the dosing regimens recommended for treatment and prophylaxis of malaria.

  15. Clinical pharmacology in Russia-historical development and current state.

    Science.gov (United States)

    Zagorodnikova Goryachkina, Ksenia; Burbello, Aleksandra; Sychev, Dmitry; Frolov, Maxim; Kukes, Vladimir; Petrov, Vladimir

    2015-02-01

    Clinical pharmacology in Russia has long history and is currently active, but rather unrecognized internationally. It is governmentally approved as a teaching/scientific specialty since 1983 and as a medical specialty since 1997. Courses of clinical pharmacology are included in the undergraduate curricula in the 5th and/or 6th year of education at all medical schools in the Russian Federation. Postgraduate education includes initial specialization in internal medicine with further residency in clinical pharmacology. Governmental legislation recommends that every healthcare institution has either a department or a single position of clinical pharmacologist. Major routine duties include information about and monitoring of medication use, consultations in difficult clinical situations, pharmacogenetic counseling, therapeutic drug monitoring, pharmacovigilance, and participation in drug and therapeutics (formulary) committees. There are official experts in clinical pharmacology in Russia responsible for coordinating relevant legislative issues. The chief expert clinical pharmacologist represents the discipline directly at the Ministry of Health. Research in clinical pharmacology in Russia is extensive and variable, but only some of it is published internationally. Russia is a participant of international societies of clinical pharmacology and therapeutics and collaboration is actively ongoing. There are still certain problems related to the development of the discipline in Russia-some healthcare institutions do not see the need for clinical pharmacology. However, the number of clinical pharmacologists in Russia is increasing as well as their role in physicians' education, national healthcare, and research.

  16. Pharmacological Activity and Clinical Use of PDRN

    Directory of Open Access Journals (Sweden)

    Francesco Squadrito

    2017-04-01

    Full Text Available PDRN is a proprietary and registered drug that possesses several activities: tissue repairing, anti-ischemic, and anti-inflammatory. These therapeutic properties suggest its use in regenerative medicine and in diabetic foot ulcers. PDRN holds a mixture of deoxyribonucleotides with molecular weights ranging between 50 and 1,500 KDa, it is derived from a controlled purification and sterilization process of Oncorhynchus mykiss (Salmon Trout or Oncorhynchus keta (Chum Salmon sperm DNA. The procedure guarantees the absence of active protein and peptides that may cause immune reactions. In vitro and in vivo experiments have suggested that PDRN most relevant mechanism of action is the engagement of adenosine A2A receptors. Besides engaging the A2A receptor, PDRN offers nucleosides and nucleotides for the so called “salvage pathway.” The binding to adenosine A2A receptors is a unique property of PDRN and seems to be linked to DNA origin, molecular weight and manufacturing process. In this context, PDRN represents a new advancement in the pharmacotherapy. In fact adenosine and dipyridamole are non-selective activators of adenosine receptors and they may cause unwanted side effects; while regadenoson, the only other A2A receptor agonist available, has been approved by the FDA as a pharmacological stress agent in myocardial perfusion imaging. Finally, defibrotide, another drug composed by a mixture of oligonucleotides, has different molecular weight, a DNA of different origin and does not share the same wound healing stimulating effects of PDRN. The present review analyses the more relevant experimental and clinical evidences carried out to characterize PDRN therapeutic effects.

  17. Pharmacological Activity and Clinical Use of PDRN

    Science.gov (United States)

    Squadrito, Francesco; Bitto, Alessandra; Irrera, Natasha; Pizzino, Gabriele; Pallio, Giovanni; Minutoli, Letteria; Altavilla, Domenica

    2017-01-01

    PDRN is a proprietary and registered drug that possesses several activities: tissue repairing, anti-ischemic, and anti-inflammatory. These therapeutic properties suggest its use in regenerative medicine and in diabetic foot ulcers. PDRN holds a mixture of deoxyribonucleotides with molecular weights ranging between 50 and 1,500 KDa, it is derived from a controlled purification and sterilization process of Oncorhynchus mykiss (Salmon Trout) or Oncorhynchus keta (Chum Salmon) sperm DNA. The procedure guarantees the absence of active protein and peptides that may cause immune reactions. In vitro and in vivo experiments have suggested that PDRN most relevant mechanism of action is the engagement of adenosine A2A receptors. Besides engaging the A2A receptor, PDRN offers nucleosides and nucleotides for the so called “salvage pathway.” The binding to adenosine A2A receptors is a unique property of PDRN and seems to be linked to DNA origin, molecular weight and manufacturing process. In this context, PDRN represents a new advancement in the pharmacotherapy. In fact adenosine and dipyridamole are non-selective activators of adenosine receptors and they may cause unwanted side effects; while regadenoson, the only other A2A receptor agonist available, has been approved by the FDA as a pharmacological stress agent in myocardial perfusion imaging. Finally, defibrotide, another drug composed by a mixture of oligonucleotides, has different molecular weight, a DNA of different origin and does not share the same wound healing stimulating effects of PDRN. The present review analyses the more relevant experimental and clinical evidences carried out to characterize PDRN therapeutic effects. PMID:28491036

  18. Clinical pharmacology of novel anticancer drug formulations

    NARCIS (Netherlands)

    Stuurman, F.E.

    2013-01-01

    Studies outlined in this thesis describe the impact of drug formulations on pharmacology of anticancer drugs. It consists of four parts and starts with a review describing the mechanisms of low oral bioavailability of anti-cancer drugs and strategies for improvement of the bioavailability. The

  19. Clinical Pharmacology and Pharmacokinetics of Levetiracetam

    Directory of Open Access Journals (Sweden)

    Chanin Clark Wright

    2013-12-01

    Full Text Available Status epilepticus and acute repetitive seizures still pose a management challenge despite the recent advances in the field of epilepsy. Parenteral formulations of old anticonvulsants are still a cornerstone in acute seizure management and are approved by the FDA. Intravenous levetiracetam, a second generation anticonvulsant, is approved by the FDA as an adjunctive treatment in patients 16 years or older when oral administration is not available. Data have shown that it has a unique mechanism of action, linear pharmacokinetics and no known drug interactions with other anticonvulsants. In this paper, we will review the current literature about the pharmacology and pharmacokinetics of intravenous levetiracetam and the safety profile of this new anticonvulsant in acute seizure management of both adults and children.

  20. ORIGINAL ARTICLES Pharmacologically active: clinical trials and ...

    African Journals Online (AJOL)

    2008-01-22

    Jan 22, 2008 ... The US database, on the other hand, clearly identifies 172 ... operating within extended clinical trials R&D value chains. Companies often ... Source: CeSTII Survey Management and Results System internal database. Table III.

  1. Clinical Pharmacology of Chemotherapy Agents in Older People with Cancer

    Directory of Open Access Journals (Sweden)

    Xiaoye He

    2011-01-01

    Full Text Available Populations around the world are aging, and the associated increase in cancer incidence has led to the recognition of the importance of geriatric oncology. Chronological age is a poor determinant of pharmacological response to cancer chemotherapy agents. Age-associated changes in physiology and organ function have a significant impact on the clinical pharmacology of cancer chemotherapy agents used in cancer treatment. Altered response to medicines in older people is a consequence of changes in body composition, organ function, concomitant pathophysiology, multiple medications, genetic determinants of drug response, and patient's clinical status. These issues highlight the need to individualize the management of cancer in the older people with consideration of age-related changes in the clinical pharmacology of cancer drugs, analgesics, and adjunctive therapies.

  2. The internet as a tool in clinical pharmacology

    Science.gov (United States)

    Castel, Josep-Maria; Figueras, Albert; Vigo, Joan-Miquel

    2006-01-01

    The invention of the internet and the world-wide web was a landmark that has affected many aspects of everyday life, but is so recent and dynamic that many of its potential uses are still being explored. Aside from its purely commercial use as a virtual pharmacy (e-commerce), the internet is useful in at least three aspects related to clinical pharmacology: communication, training and research. In this paper we briefly review several internet applications related to clinical pharmacology and describe, as an example, the logistics of a multicentre research collaboration related to the promotion of rational drug use in the prevention of postpartum haemorrhage. PMID:16722847

  3. A Clinical Pharmacology Course for Veterinary Students.

    Science.gov (United States)

    Paulsen, Lynn Mulcahy

    1983-01-01

    A one-semester, two-credit course is described that was developed cooperatively by the colleges of pharmacy and veterinary medicine at Washington State University to help resolve an acute shortage of clinical pharmacologists in veterinary medicine and veterinary medical education. Course procedures, content, and evaluation are outlined (MSE)

  4. ORIGINAL ARTICLES Pharmacologically active: clinical trials and ...

    African Journals Online (AJOL)

    2008-01-22

    Jan 22, 2008 ... companies to manufacture pharmaceuticals, 24 to carry out quality control and ... represents a 3% real growth from 2004/2005, it represents a slight decline from ... manufacturer for the pharmas, or can it leverage strengths in medical ... increased clinical trials activity, R&D investment is too low to make it a ...

  5. Clinical Pharmacology Studies in Critically Ill Children

    Science.gov (United States)

    Thakkar, Nilay; Salerno, Sara; Hornik, Christoph P.; Gonzalez, Daniel

    2016-01-01

    Developmental and physiological changes in children contribute to variation in drug disposition with age. Additionally, critically ill children suffer from various life-threatening conditions that can lead to pathophysiological alterations that further affect pharmacokinetics (PK). Some factors that can alter PK in this patient population include variability in tissue distribution caused by protein binding changes and fluid shifts, altered drug elimination due to organ dysfunction, and use of medical interventions that can affect drug disposition (e.g., extracorporeal membrane oxygenation and continuous renal replacement therapy). Performing clinical studies in critically ill children is challenging because there is large inter-subject variability in the severity and time course of organ dysfunction; some critical illnesses are rare, which can affect subject enrollment; and critically ill children usually have multiple organ failure, necessitating careful selection of a study design. As a result, drug dosing in critically ill children is often based on extrapolations from adults or non-critically ill children. Dedicated clinical studies in critically ill children are urgently needed to identify optimal dosing of drugs in this population. This review will summarize the effect of critical illness on pediatric PK, the challenges associated with performing studies in this vulnerable subpopulation, and the clinical PK studies performed to date for commonly used drugs. PMID:27585904

  6. The Pharmacologic and Clinical Effects of Illicit Synthetic Cannabinoids.

    Science.gov (United States)

    White, C Michael

    2017-03-01

    This article presents information on illicitly used synthetic cannabinoids. Synthetic cannabinoids are structurally heterogeneous and commonly used drugs of abuse that act as full agonists of the cannabinoid type-1 receptor but have a variety of additional pharmacologic effects. There are numerous cases of patient harm and death in the United States, Europe, and Australia with many psychological, neurological, cardiovascular, pulmonary, and renal adverse events. Although most users prefer using cannabis, there are convenience, legal, and cost reasons driving the utilization of synthetic cannabinoids. Clinicians should be aware of pharmacologic and clinical similarities and differences between synthetic cannabinoid and cannabis use, the limited ability to detect synthetic cannabinoids in the urine or serum, and guidance to treat adverse events. © 2016, The American College of Clinical Pharmacology.

  7. Human pharmacology for addiction medicine: From evidence to clinical recommendations.

    Science.gov (United States)

    Quednow, Boris B; Herdener, Marcus

    2016-01-01

    Substance use disorders (SUD) are complex and often chronic diseases with negative health outcomes and social consequences. Pharmacological treatment options for SUD can be separated in medications for (i) intoxication, (ii) withdrawal, and (iii) reduction of use together with relapse prevention. This chapter will focus on approved or clinically established pharmacological strategies suited to manage symptoms of withdrawal, and to reduce substance use or to promote abstinence. Hereby SUD involving alcohol, nicotine, stimulants, and opioids are primarily discussed as these substances are considered most harmful for both the individual and the society. Moreover, the pharmacotherapy of SUD related to the use of cannabis, benzodiazepines, and gamma-hydroxybutyrate is also briefly reviewed. Since most approved pharmacological treatment options show only moderate effect sizes especially in the long term, the development of new treatment strategies including new drugs, new combinations of available compounds, and biomarkers for response prediction is still warranted. © 2016 Elsevier B.V. All rights reserved.

  8. Phytochemistry, pharmacology, and clinical trials of Morus alba.

    Science.gov (United States)

    Chan, Eric Wei-Chiang; Lye, Phui-Yan; Wong, Siu-Kuin

    2016-01-01

    The present review is aimed at providing a comprehensive summary on the botany, utility, phytochemistry, pharmacology, and clinical trials of Morus alba (mulberry or sang shu). The mulberry foliage has remained the primary food for silkworms for centuries. Its leaves have also been used as animal feed for livestock and its fruits have been made into a variety of food products. With flavonoids as major constituents, mulberry leaves possess various biological activities, including antioxidant, antimicrobial, skin-whitening, cytotoxic, anti-diabetic, glucosidase inhibition, anti-hyperlipidemic, anti-atherosclerotic, anti-obesity, cardioprotective, and cognitive enhancement activities. Rich in anthocyanins and alkaloids, mulberry fruits have pharmacological properties, such as antioxidant, anti-diabetic, anti-atherosclerotic, anti-obesity, and hepatoprotective activities. The root bark of mulberry, containing flavonoids, alkaloids and stilbenoids, has antimicrobial, skin-whitening, cytotoxic, anti-inflammatory, and anti-hyperlipidemic properties. Other pharmacological properties of M. alba include anti-platelet, anxiolytic, anti-asthmatic, anthelmintic, antidepressant, cardioprotective, and immunomodulatory activities. Clinical trials on the efficiency of M. alba extracts in reducing blood glucose and cholesterol levels and enhancing cognitive ability have been conducted. The phytochemistry and pharmacology of the different parts of the mulberry tree confer its traditional and current uses as fodder, food, cosmetics, and medicine. Overall, M. alba is a multi-functional plant with promising medicinal properties. Copyright © 2016 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

  9. Clinical pharmacology profile of care in Hepatology clinic

    Directory of Open Access Journals (Sweden)

    Talita Rocha Passos

    Full Text Available Summary Since 2010, the Clinical Gastroenterology and Hepatology Division of the Central Institute of Hospital das Clínicas of the University of São Paulo Medical School (HC-FMUSP, in the Portuguese acronym has been developing specialized electives assistance activities in the Outpatient Specialty Clinic, Secondary Level, in São Paulo NGA-63 Várzea do Carmo. The objective of this study was to analyze the pharmacotherapeutic profile of patients. This is a cross-sectional and retrospective study in which patients were seen at the Hepatology sector and the results were submitted to descriptive statistics. During the study period, 492 patients were treated at the clinic, with a mean age of 58.9 years and frequency of 61.2% female and 74.8% living in São Paulo. This population was served by various other medical specialties (cardiology and endocrine among others and the major liver diagnoses were: chronic hepatitis B and C and fatty liver. Comorbidities were also identified, such as diabetes, hypertension and dyslipidemia. Most patients took their medication in the Basic Health Units. We found that 30% of patients use of more than five medications and the most prescribed were omeprazole 208 (42.3%, metformin 132 (26.8% and losartan 80 (16.3%. Because it is an adult/elderly population, with several comorbidities and polymedication, it is important to be aware of the rational use of medication. The multidisciplinary team is important in applying correct conducts for the safe use of medicines, to reduce the burden on health spending and improving the quality of life of patients.

  10. 76 FR 38668 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2011-07-01

    ...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General.... In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and...

  11. 76 FR 38188 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2011-06-29

    ...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General..., 2011, the committee will discuss current strategies for FDA's Office of Pharmaceutical Science...

  12. 75 FR 11551 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-03-11

    ...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive...

  13. 78 FR 58315 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2013-09-23

    ...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... continuous manufacturing for pharmaceutical products. Speakers from the Agency, academia, and industry will...

  14. Clinical pharmacology profile of vorinostat, a histone deacetylase inhibitor.

    Science.gov (United States)

    Iwamoto, Marian; Friedman, Evan J; Sandhu, Punam; Agrawal, Nancy G B; Rubin, Eric H; Wagner, John A

    2013-09-01

    Vorinostat is a histone deacetylase inhibitor that has demonstrated preclinical activity in numerous cancer models. Clinical activity has been demonstrated in patients with a variety of malignancies. Vorinostat is presently indicated for the treatment of patients with advanced cutaneous T cell lymphoma (CTCL). Clinical investigation is ongoing for therapy of other solid tumors and hematological malignancies either as monotherapy or in combination with other chemotherapeutic agents. This review summarizes the pharmacokinetic properties of vorinostat. Monotherapy pharmacokinetic data across a number of pharmacokinetic studies were reviewed, and data are presented. In addition, literature review was performed to obtain published Phase I and II pharmacokinetic combination therapy data to identify and characterize potential drug interactions with vorinostat. Pharmacokinetic data in special populations were also reviewed. The clinical pharmacology profile of vorinostat is favorable, exhibiting dose-proportional pharmacokinetics and modest food effect. There appear to be no major differences in the pharmacokinetics of vorinostat in special populations, including varying demographics and hepatic dysfunction. Combination therapy pharmacokinetic data indicate that vorinostat has a low propensity for drug interactions. Vorinostat's favorable clinical pharmacology and drug interaction profile aid in the ease of administration of vorinostat for the treatment of advanced CTCL and will be beneficial in continued assessment for other oncologic indications. Although a number of studies have been conducted to elucidate the detailed pharmacokinetic profile of vorinostat, more rigorous assessment of vorinostat pharmacokinetics, including clinical drug interaction studies, will be informative.

  15. Clinical Pharmacology in Denmark in 2016 - 40 Years with the Danish Society of Clinical Pharmacology and 20 Years as a Medical Speciality

    DEFF Research Database (Denmark)

    Brøsen, Kim; Andersen, Stig Ejdrup; Borregaard, Jeanett

    2016-01-01

    new jobs and career opportunities for clinical pharmacologists. As of July 2016, the Danish Society of Clinical Pharmacology has 175 members, and 70 of these are specialists in clinical pharmacology corresponding to approximately 2.5 specialists per 1000 doctors (Denmark has in total 28,000 doctors...

  16. Amphetamine, past and present--a pharmacological and clinical perspective.

    Science.gov (United States)

    Heal, David J; Smith, Sharon L; Gosden, Jane; Nutt, David J

    2013-06-01

    Amphetamine was discovered over 100 years ago. Since then, it has transformed from a drug that was freely available without prescription as a panacea for a broad range of disorders into a highly restricted Controlled Drug with therapeutic applications restricted to attention deficit hyperactivity disorder (ADHD) and narcolepsy. This review describes the relationship between chemical structure and pharmacology of amphetamine and its congeners. Amphetamine's diverse pharmacological actions translate not only into therapeutic efficacy, but also into the production of adverse events and liability for recreational abuse. Accordingly, the balance of benefit/risk is the key challenge for its clinical use. The review charts advances in pharmaceutical development from the introduction of once-daily formulations of amphetamine through to lisdexamfetamine, which is the first d-amphetamine prodrug approved for the management of ADHD in children, adolescents and adults. The unusual metabolic route for lisdexamfetamine to deliver d-amphetamine makes an important contribution to its pharmacology. How lisdexamfetamine's distinctive pharmacokinetic/pharmacodynamic profile translates into sustained efficacy as a treatment for ADHD and its reduced potential for recreational abuse is also discussed.

  17. Amphetamine, past and present – a pharmacological and clinical perspective

    Science.gov (United States)

    Smith, Sharon L; Gosden, Jane; Nutt, David J

    2013-01-01

    Amphetamine was discovered over 100 years ago. Since then, it has transformed from a drug that was freely available without prescription as a panacea for a broad range of disorders into a highly restricted Controlled Drug with therapeutic applications restricted to attention deficit hyperactivity disorder (ADHD) and narcolepsy. This review describes the relationship between chemical structure and pharmacology of amphetamine and its congeners. Amphetamine’s diverse pharmacological actions translate not only into therapeutic efficacy, but also into the production of adverse events and liability for recreational abuse. Accordingly, the balance of benefit/risk is the key challenge for its clinical use. The review charts advances in pharmaceutical development from the introduction of once-daily formulations of amphetamine through to lisdexamfetamine, which is the first d-amphetamine prodrug approved for the management of ADHD in children, adolescents and adults. The unusual metabolic route for lisdexamfetamine to deliver d-amphetamine makes an important contribution to its pharmacology. How lisdexamfetamine’s distinctive pharmacokinetic/pharmacodynamic profile translates into sustained efficacy as a treatment for ADHD and its reduced potential for recreational abuse is also discussed. PMID:23539642

  18. Approach to pharmacological and clinical applications of Anisi aetheroleum

    Directory of Open Access Journals (Sweden)

    Khaled Mohamed Mohamed Koriem

    2015-01-01

    Full Text Available Anisi aetheroleum is the oil obtained from Pimpinella anisum L. (P. anisum by steam distillation. P. anisum seeds were air-dried, and then the dry seeds were crushed, pulverized, and weighed in sequence for anise oil preparation. P. anisum is one of the oldest medicinal plants that belong to family Apiaceae. The fruit of P. anisum is harvested in August and September. P. anisum is widespread in Asia, Africa and Europe. Local names of P. anisum include anise, anisoon, roomy, saunf, sweet cumin and yansoon. The anise oil odour is aromatic while the oil tastes sweet. The average daily dose of Anisi aetheroleum is 0.3 g. trans-Anethole is the major ingredient of the anise oil. Anisi aetheroleum also displays a protective action against neurotoxicity. In addition, Anisi aetheroleum increases glucose absorption and reduces urine output in the rat. The plant oil have pharmacological (antimicrobial, hepatoprotective, anticonvulsant, anti-inflammatory, antispasmodic, bronchodilator, estrogenic, expectorant and insecticidal effects and clinical effects on nausea, constipation, menopausal period, virus, diabetes, obesity and sedative action. Owing to the wide application of Anisi aetheroleum in pharmacological and clinical fields, it is recommended for more clinical trails to discover a new medication from the active constituents of the plant oil in the future to treat human diseases especially chronic ones.

  19. Pharmacological effect on pyeloureteric dynamics with a clinical perspective

    DEFF Research Database (Denmark)

    Jung, Helene U; Frimodt-Møller, Poul C; Osther, Palle J

    2006-01-01

    We searched to review experimental and clinical trials concerning the capabilities of impacting on the ureteric and pelvic activity by means of pharmacological stimulation. Ureteropyeloscopy may cause high renal pelvic pressure. The normal pressure is in the range of 5-15 mmHg whereas pressure...... an increased risk of several complications related to endourological procedures including bleeding, perforation and infection. In other words, means by which intrarenal pressure could be lowered during endourological procedures might be beneficial with respect to clinical outcomes. In vitro experiments support...... systemic side effects. In vivo human studies are necessary to clarify the exact dose-response relationship and the degree of urothelial absorption of a drug before clinical use may be adopted....

  20. Drug repurposing: translational pharmacology, chemistry, computers and the clinic.

    Science.gov (United States)

    Issa, Naiem T; Byers, Stephen W; Dakshanamurthy, Sivanesan

    2013-01-01

    The process of discovering a pharmacological compound that elicits a desired clinical effect with minimal side effects is a challenge. Prior to the advent of high-performance computing and large-scale screening technologies, drug discovery was largely a serendipitous endeavor, as in the case of thalidomide for erythema nodosum leprosum or cancer drugs in general derived from flora located in far-reaching geographic locations. More recently, de novo drug discovery has become a more rationalized process where drug-target-effect hypotheses are formulated on the basis of already known compounds/protein targets and their structures. Although this approach is hypothesis-driven, the actual success has been very low, contributing to the soaring costs of research and development as well as the diminished pharmaceutical pipeline in the United States. In this review, we discuss the evolution in computational pharmacology as the next generation of successful drug discovery and implementation in the clinic where high-performance computing (HPC) is used to generate and validate drug-target-effect hypotheses completely in silico. The use of HPC would decrease development time and errors while increasing productivity prior to in vitro, animal and human testing. We highlight approaches in chemoinformatics, bioinformatics as well as network biopharmacology to illustrate potential avenues from which to design clinically efficacious drugs. We further discuss the implications of combining these approaches into an integrative methodology for high-accuracy computational predictions within the context of drug repositioning for the efficient streamlining of currently approved drugs back into clinical trials for possible new indications.

  1. The impact of comorbid post-traumatic stress disorder in patients with major depressive disorder on clinical features, pharmacological treatment strategies, and treatment outcomes - Results from a cross-sectional European multicenter study.

    Science.gov (United States)

    Dold, Markus; Bartova, Lucie; Kautzky, Alexander; Souery, Daniel; Mendlewicz, Julien; Serretti, Alessandro; Porcelli, Stefano; Zohar, Joseph; Montgomery, Stuart; Kasper, Siegfried

    2017-07-01

    This international, multicenter, cross-sectional study comprising 1346 adult in- and outpatients with major depressive disorder (MDD) investigated the association between MDD as primary diagnosis and comorbid post-traumatic stress disorder (PTSD). In a cross-sectional data collection process, the presence of comorbid PTSD was determined by the Mini International Neuropsychiatric Interview (MINI) and the patients' socio-demographic, clinical, psychopharmacological, and response information were obtained. Clinical features between MDD with and without concurrent PTSD were compared using descriptive statistics, analyses of covariance (ANCOVA), and binary logistic regression analyses. 1.49% of the MDD patients suffered from comorbid PTSD. Significantly more MDD + comorbid PTSD patients exhibited atypical features, comorbid anxiety disorders (any comorbid anxiety disorder, panic disorder, agoraphobia, and social phobia), comorbid bulimia nervosa, current suicide risk, and augmentation treatment with low-dose antipsychotic drugs. In the binary logistic regression analyses, the presence of atypical features (odds ratio (OR) = 4.49, 95%CI:1.01-20.12; p≤.05), any comorbid anxiety disorder (OR = 3.89, 95%CI:1.60-9.44; p = .003), comorbid panic disorder (OR = 6.45, 95%CI:2.52-16.51; p = .001), comorbid agoraphobia (OR = 6.51, 95%CI:2.54-16.68; p≤.001), comorbid social phobia (OR = 6.16, 95%CI:1.71-22.17; p≤.001), comorbid bulimia nervosa (OR = 10.39, 95%CI:1.21-88.64; p = .03), current suicide risk (OR = 3.58, 95%CI:1.30-9.91; p = .01), and augmentation with low-potency antipsychotics (OR = 6.66, 95%CI:2.50-17.77; pdisorders, and (3.) the increased suicide risk due to concurrent PTSD. Copyright © 2017 Elsevier B.V. and ECNP. All rights reserved.

  2. World Antimalarial Resistance Network (WARN IV: Clinical pharmacology

    Directory of Open Access Journals (Sweden)

    Gbotosho Grace O

    2007-09-01

    Full Text Available Abstract A World Antimalarial Resistance Network (WARN database has the potential to improve the treatment of malaria, through informing current drug selection and use and providing a prompt warning of when treatment policies need changing. This manuscript outlines the contribution and structure of the clinical pharmacology component of this database. The determinants of treatment response are multi-factorial, but clearly providing adequate blood concentrations is pivotal to curing malaria. The ability of available antimalarial pharmacokinetic data to inform optimal dosing is constrained by the small number of patients studied, with even fewer (if any studies conducted in the most vulnerable populations. There are even less data relating blood concentration data to the therapeutic response (pharmacodynamics. By pooling all available pharmacokinetic data, while paying careful attention to the analytical methodologies used, the limitations of small (and thus underpowered individual studies may be overcome and factors that contribute to inter-individual variability in pharmacokinetic parameters defined. Key variables for pharmacokinetic studies are defined in terms of patient (or study subject characteristics, the formulation and route of administration of the antimalarial studied, the sampling and assay methodology, and the approach taken to data analysis. Better defining these information needs and criteria of acceptability of pharmacokinetic-pharmacodynamic (PK-PD studies should contribute to improving the quantity, relevance and quality of these studies. A better understanding of the pharmacokinetic properties of antimalarials and a more clear definition of what constitutes "therapeutic drug levels" would allow more precise use of the term "antimalarial resistance", as it would indicate when treatment failure is not caused by intrinsic parasite resistance but is instead the result of inadequate drug levels. The clinical pharmacology component

  3. Clinical and practical considerations in the pharmacologic management of narcolepsy.

    Science.gov (United States)

    Thorpy, Michael J; Dauvilliers, Yves

    2015-01-01

    Despite published treatment recommendations and the availability of approved and off-label pharmacologic therapies for narcolepsy, the clinical management of this incurable, chronic neurologic disorder remains challenging. While treatment is generally symptomatically driven, decisions regarding which drug(s) to use need to take into account a variety of factors that may affect adherence, efficacy, and tolerability. Type 1 narcolepsy (predominantly excessive daytime sleepiness with cataplexy) or type 2 narcolepsy (excessive daytime sleepiness without cataplexy) may drive treatment decisions, with consideration given either to a single drug that targets multiple symptoms or to multiple drugs that each treat a specific symptom. Other drug-related characteristics that affect drug choice are dosing regimens, tolerability, and potential drug-drug interactions. Additionally, the patient should be an active participant in treatment decisions, and the main symptomatic complaints, treatment goals, psychosocial setting, and use of lifestyle substances (ie, alcohol, nicotine, caffeine, and cannabis) need to be discussed with respect to treatment decisions. Although there is a lack of narcolepsy-specific instruments for monitoring therapeutic effects, clinically relevant subjective and objective measures of daytime sleepiness (eg, Epworth Sleepiness Scale and Maintenance of Wakefulness Test) can be used to provide guidance on whether treatment goals are being met. These considerations are discussed with the objective of providing clinically relevant recommendations for making treatment decisions that can enhance the effective management of patients with narcolepsy. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  4. Clinical pharmacology review of escitalopram for the treatment of depression.

    Science.gov (United States)

    Pastoor, Devin; Gobburu, Joga

    2014-01-01

    Depression is a serious and debilitating psychiatric condition with serious societal health and economic implications. Escitalopram , the S-enantiomer of racemic citalopram, is an effective treatment for major depressive disorder. This review covers the clinical pharmacology of escitalopram, with emphasis on regulatory approval. Its pharmacokinetics, pharmacodynamics and clinical efficacy for major depressive disorder are evaluated, along with data regarding safety and tolerability. Drug development of escitalopram was heavily guided by prior approval of citalopram. Select safety and efficacy studies for escitalopram in combination with supportive evidence from the results of prior citalopram studies allowed for regulatory approval for acute and maintenance claims in both adults and adolescents, while minimizing burden on the sponsor. Escitalopram has been shown to have better efficacy and safety profile than other selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor drugs, including racemic citalopram. The first generic escitalopram was approved in 2012, along with Abbreviated New Drug Applications. The associated cost savings have helped reduce the burden of weighing the benefits of escitalopram over less-expensive alternatives.

  5. 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

  6. Clinical Pharmacology of Furosemide in Neonates: A Review

    Directory of Open Access Journals (Sweden)

    Gian Maria Pacifici

    2013-09-01

    Full Text Available Furosemide is the diuretic most used in newborn infants. It blocks the Na+-K+-2Cl− symporter in the thick ascending limb of the loop of Henle increasing urinary excretion of Na+ and Cl−. This article aimed to review the published data on the clinical pharmacology of furosemide in neonates to provide a critical, comprehensive, authoritative and, updated survey on the metabolism, pharmacokinetics, pharmacodynamics and side-effects of furosemide in neonates. The bibliographic search was performed using PubMed and EMBASE databases as search engines; January 2013 was the cutoff point. Furosemide half-life (t1/2 is 6 to 20-fold longer, clearance (Cl is 1.2 to 14-fold smaller and volume of distribution (Vd is 1.3 to 6-fold larger than the adult values. t1/2 shortens and Cl increases as the neonatal maturation proceeds. Continuous intravenous infusion of furosemide yields more controlled diuresis than the intermittent intravenous infusion. Furosemide may be administered by inhalation to infants with chronic lung disease to improve pulmonary mechanics. Furosemide stimulates prostaglandin E2 synthesis, a potent dilator of the patent ductus arteriosus, and the administration of furosemide to any preterm infants should be carefully weighed against the risk of precipitation of a symptomatic patent ductus arteriosus. Infants with low birthweight treated with chronic furosemide are at risk for the development of intra-renal calcifications.

  7. Clinical Pharmacology of Fentanyl in Preterm Infants. A Review

    Directory of Open Access Journals (Sweden)

    Gian Maria Pacifici

    2015-06-01

    Full Text Available Fentanyl is a synthetic opioid that is very important in anesthetic practice because of its relatively short time to peak analgesic effect and the rapid termination of action after small bolus doses. The objective of this survey is to review the clinical pharmacology of fentanyl in preterm infants. The bibliographic search was performed using PubMed and EMBASE databases as search engines. In addition, the books Neofax: A manual of drugs used in neonatal care and Neonatal formulary were consulted. Fentanyl is N-dealkylated by CYP3A4 into the inactive norfentanyl. Fentanyl may be administered as bolus doses or as a continuous infusion. In neonates, there is a remarkable interindividual variability in the kinetic parameters. In neonates, fentanyl half-life ranges from 317 minutes to 1266 minutes and in adults it is 222 minutes. Respiratory depression occurs when fentanyl doses are >5 μg/kg. Chest wall rigidity may occur in neonates and occasionally is associated with laryngospasm. Tolerance to fentanyl may develop after prolonged use of this drug. Significant withdrawal symptoms have been reported in infants treated with continuous infusion for 5 days or longer. Fentanyl is an extremely potent analgesic and is the opioid analgesic most frequently used in the neonatal intensive care unit.

  8. 75 FR 10488 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  9. 76 FR 3912 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  10. 78 FR 42966 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2013-07-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  11. 77 FR 41790 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-07-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  12. 77 FR 42746 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  13. 78 FR 58314 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2013-09-23

    ...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... session, the Office of Pharmaceutical Science and the Office of Compliance will discuss with the committee...

  14. 77 FR 1696 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  15. 75 FR 8368 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-02-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  16. Post-stroke Movement Disorders: Clinical Manifestations and Pharmacological Management.

    Science.gov (United States)

    Siniscalchi, Antonio; Gallelli, Luca; Labate, Angelo; Malferrari, Giovanni; Palleria, Caterina; Sarro, Giovambattista De

    2012-09-01

    Involuntary abnormal movements have been reported after ischaemic and haemorrhagic stroke. Post stroke movement disorders can appear as acute or delayed sequel. At the moment, for many of these disorders the knowledge of pharmacological treatment is still inadequate. Dopaminergic and GABAergic systems may be mainly involved in post-stroke movement disorders. This article provides a review on drugs commonly used in post-stroke movement disorders, given that some post-stroke movement disorders have shown a partial benefit with pharmacological approach.

  17. Mephedrone (4-methylmethcathinone; 'meow meow'): chemical, pharmacological and clinical issues.

    Science.gov (United States)

    Schifano, Fabrizio; Albanese, Antonio; Fergus, Suzanne; Stair, Jackie L; Deluca, Paolo; Corazza, Ornella; Davey, Zoe; Corkery, John; Siemann, Holger; Scherbaum, Norbert; Farre', Magi'; Torrens, Marta; Demetrovics, Zsolt; Ghodse, A Hamid

    2011-04-01

    Recently, those substances deriving from the active ingredient of the Khat plant, cathinone, have been rising in popularity. Indeed, 4-methylmethcathinone (mephedrone; 'meow meow' and others) has been seen by some as a cheaper alternative to other classified recreational drugs. We aimed here at providing a state-of-the-art review on mephedrone history and prevalence of misuse, chemistry, pharmacology, legal status, product market appearance, clinical/management and related fatalities. Because of the limited evidence, some of the information here presented has been obtained from user reports/drug user-orientated web sites. The most common routes for mephedrone recreational use include insufflation and oral ingestion. It elicits stimulant and empathogenic effects similar to amphetamine, methylamphetamine, cocaine and MDMA. Due to its sympathomimetic actions, mephedrone may be associated with a number of both physical and psychopathological side effects. Recent preliminary analysis of recent UK data carried out in 48 related cases have provided positive results for the presence of mephedrone at postmortem. Within the UK, diffusion of mephedrone may have been associated with an unprecedented combination of a particularly aggressive online marketing policy and a decreasing availability/purity of both ecstasy and cocaine. Mephedrone has been recently classified in both the UK and in a number of other countries as a measure to control its availability. Following this, a few other research psychoactives have recently entered the online market as yet unregulated substances that may substitute for mephedrone. Only international collaborative efforts may be able to tackle the phenomenon of the regular offer of novel psychoactive drugs.

  18. An Endocrine Pharmacology Course for the Clinically-Oriented Pharmacy Curriculum

    Science.gov (United States)

    Rahwan, Ralf G.

    1976-01-01

    In view of trends in clinical pharmacy education, the role of the traditional basic sciences has to be reassessed. An endocrine pharmacology course comprised of 49 clock-hours and open for professional undergraduate and graduate credit is described that blends basic and applied pharmacology. (LBH)

  19. A review of the pharmacology and clinical efficacy of brivaracetam

    Directory of Open Access Journals (Sweden)

    Klein P

    2018-01-01

    Full Text Available Pavel Klein,1 Anyzeila Diaz,2 Teresa Gasalla,3 John Whitesides4 1Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA; 2Neurology Patient Value Unit, UCB Pharma, Smyrna, GA, USA; 3Neurology Patient Value Unit, UCB Pharma, Monheim am Rhein, Germany; 4Asset Development, UCB Pharma, Raleigh, NC, USA Abstract: Brivaracetam (BRV; Briviact is a new antiepileptic drug (AED approved for adjunctive treatment of focal (partial-onset seizures in adults. BRV is a selective, high-affinity ligand for synaptic vesicle 2A (SV2A with 15- to 30-fold higher affinity than levetiracetam, the first AED acting on SV2A. It has high lipid solubility and rapid brain penetration, with engagement of the target molecule, SV2A, within minutes of administration. BRV has potent broad-spectrum antiepileptic activity in animal models. Phase I studies indicated BRV was well tolerated and showed a favorable pharmacokinetic profile over a wide dose range following single (10–1,000 mg and multiple (200–800 mg/day oral dosing. Three pivotal Phase III studies have demonstrated promising efficacy and a good safety and tolerability profile across doses of 50–200 mg/day in the adjunctive treatment of refractory focal seizures. Long-term data indicate that the response to BRV is sustained, with good tolerability and retention rate. BRV is highly effective in patients experiencing secondarily generalized tonic–clonic seizures. Safety data to date suggest a favorable psychiatric adverse effect profile in controlled studies, although limited postmarketing data are available. BRV is easy to use, with no titration and little drug–drug interaction. It can be initiated at target dose with no titration. Efficacy is seen on day 1 of oral use in a significant percentage of patients. Intravenous administration in a 2-minute bolus and 15-minute infusion is well tolerated. Here, we review the pharmacology, pharmacokinetics, and clinical data of BRV. Keywords: brivaracetam, efficacy

  20. Post-stroke Movement Disorders: Clinical Manifestations and Pharmacological Management

    OpenAIRE

    Siniscalchi, Antonio; Gallelli, Luca; Labate, Angelo; Malferrari, Giovanni; Palleria, Caterina; Sarro, Giovambattista De

    2012-01-01

    Involuntary abnormal movements have been reported after ischaemic and haemorrhagic stroke. Post stroke movement disorders can appear as acute or delayed sequel. At the moment, for many of these disorders the knowledge of pharmacological treatment is still inadequate. Dopaminergic and GABAergic systems may be mainly involved in post-stroke movement disorders. This article provides a review on drugs commonly used in post-stroke movement disorders, given that some post-stroke movement disorders ...

  1. Clinical Pharmacology of Kinase Inhibitors in Oncology : Personalized and Optimzed Dosing

    NARCIS (Netherlands)

    Verheijen, Remy B.

    2017-01-01

    Kinase inhibitors are an important category of molecularly targeted therapies used for cancer. Verheijen’s doctoral thesis describes several clinical pharmacological studies to optimize and personalize the treatment of cancer with kinase inhibitors, using pharmacokinetics, molecular imaging and

  2. Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications.

    Science.gov (United States)

    Derendorf, H; Meltzer, E O

    2008-10-01

    Intranasal corticosteroids (INSs) are effective treatments for allergic rhinitis, rhinosinusitis, and nasal polyposis. In recent years, increased understanding of corticosteroid and glucocorticoid receptor pharmacology has enabled the development of molecules designed specifically to achieve potent, localized activity with minimal risk of systemic exposure. Pharmacologic potency studies using affinity and other assessments have produced similar rank orders of potency, with the most potent being mometasone furoate, fluticasone propionate, and its modification, fluticasone furoate. The furoate and propionate ester side chains render these agents highly lipophilic, which may facilitate their absorption through nasal mucosa and uptake across phospholipid cell membranes. These compounds demonstrate negligible systemic absorption. Systemic absorption rates are higher among the older corticosteroids (flunisolide, beclomethasone dipropionate, triamcinolone acetonide, and budesonide), which have bioavailabilities in the range of 34-49%. Studies, including 1-year studies with mometasone furoate, fluticasone propionate, and budesonide that evaluated potential systemic effects of INSs in children have generally found no adverse effects on hypothalamic-pituitary-adrenal axis function or growth. Clinical data suggest no significant differences in efficacy between the INSs. Theoretically, newer agents with lower systemic availability may be preferable, and may come closer to the pharmacokinetic/pharmacologic criteria for the ideal therapeutic choice.

  3. The pharmacologic and clinical effects of medical cannabis.

    Science.gov (United States)

    Borgelt, Laura M; Franson, Kari L; Nussbaum, Abraham M; Wang, George S

    2013-02-01

    Cannabis, or marijuana, has been used for medicinal purposes for many years. Several types of cannabinoid medicines are available in the United States and Canada. Dronabinol (schedule III), nabilone (schedule II), and nabiximols (not U.S. Food and Drug Administration approved) are cannabis-derived pharmaceuticals. Medical cannabis or medical marijuana, a leafy plant cultivated for the production of its leaves and flowering tops, is a schedule I drug, but patients obtain it through cannabis dispensaries and statewide programs. The effect that cannabinoid compounds have on the cannabinoid receptors (CB(1) and CB(2) ) found in the brain can create varying pharmacologic responses based on formulation and patient characteristics. The cannabinoid Δ(9) -tetrahydrocannabinol has been determined to have the primary psychoactive effects; the effects of several other key cannabinoid compounds have yet to be fully elucidated. Dronabinol and nabilone are indicated for the treatment of nausea and vomiting associated with cancer chemotherapy and of anorexia associated with weight loss in patients with acquired immune deficiency syndrome. However, pain and muscle spasms are the most common reasons that medical cannabis is being recommended. Studies of medical cannabis show significant improvement in various types of pain and muscle spasticity. Reported adverse effects are typically not serious, with the most common being dizziness. Safety concerns regarding cannabis include the increased risk of developing schizophrenia with adolescent use, impairments in memory and cognition, accidental pediatric ingestions, and lack of safety packaging for medical cannabis formulations. This article will describe the pharmacology of cannabis, effects of various dosage formulations, therapeutics benefits and risks of cannabis for pain and muscle spasm, and safety concerns of medical cannabis use. © 2013 Pharmacotherapy Publications, Inc.

  4. Clinical pharmacology in leishmaniasis: treatment optimization of a neglected disease

    NARCIS (Netherlands)

    Dorlo, T.P.C.

    2013-01-01

    This thesis presents various novel applications of clinical pharmacokinetics and pharmacodynamics in the treatment of leishmaniasis, by which diverse clinically relevant issues, mainly related to the efficacy and safety of miltefosine, could be elucidated. Throughout this thesis, the added value of

  5. Development of a Clinical Pharmacology Graduate Program at the University of Kentucky.

    Science.gov (United States)

    Blouin, Robert A.; And Others

    1994-01-01

    The structure, components, and anticipated outcomes of a University of Kentucky doctoral program in pharmacology are described. The program is designed to develop pharmacy-trained specialists who are interested in rigorous, intensive clinical experience, state-of-the-art coursework, and integrated laboratory-based and clinical dissertation…

  6. Pattern of Frequent But Nontargeted Pharmacologic Thromboprophylaxis for Hospitalized Patients With Cancer at Academic Medical Centers: A Prospective, Cross-Sectional, Multicenter Study

    Science.gov (United States)

    Zwicker, Jeffrey I.; Rojan, Adam; Campigotto, Federico; Rehman, Nadia; Funches, Renee; Connolly, Gregory; Webster, Jonathan; Aggarwal, Anita; Mobarek, Dalia; Faselis, Charles; Neuberg, Donna; Rickles, Frederick R.; Wun, Ted; Streiff, Michael B.; Khorana, Alok A.

    2014-01-01

    Purpose Hospitalized patients with cancer are considered to be at high risk for venous thromboembolism (VTE). Despite strong recommendations in numerous clinical practice guidelines, retrospective studies have shown that pharmacologic thromboprophylaxis is underutilized in hospitalized patients with cancer. Patients and Methods We conducted a prospective, cross-sectional study of hospitalized patients with cancer at five academic hospitals to determine prescription rates of thromboprophylaxis and factors influencing its use during hospitalization. Results A total of 775 patients with cancer were enrolled across five academic medical centers. Two hundred forty-seven patients (31.9%) had relative contraindications to pharmacologic prophylaxis. Accounting for contraindications to anticoagulation, the overall rate of pharmacologic thromboprophylaxis was 74.2% (95% CI, 70.4% to 78.0%; 392 of 528 patients). Among the patients with cancer without contraindications for anticoagulation, individuals hospitalized with nonhematologic malignancies were significantly more likely to receive pharmacologic thromboprophylaxis than those with hematologic malignancies (odds ratio [OR], 2.34; 95% CI, 1.43 to 3.82; P = .007). Patients with cancer admitted for cancer therapy were significantly less likely to receive pharmacologic thromboprophylaxis than those admitted for other reasons (OR, 0.37; 95% CI, 0.22 to 0.61; P < .001). Sixty-three percent of patients with cancer classified as low risk, as determined by the Padua Scoring System, received anticoagulant thromboprophylaxis. Among the 136 patients who did not receive anticoagulation, 58.8% were considered to be high risk by the Padua Scoring System. Conclusion We conclude that pharmacologic thromboprophylaxis is frequently administered to hospitalized patients with cancer but that nearly one third of patients are considered to have relative contraindications for prophylactic anticoagulation. Pharmacologic thromboprophylaxis in

  7. Anesthetic pharmacology

    National Research Council Canada - National Science Library

    Evers, Alex S; Maze, M; Kharasch, Evan D

    2011-01-01

    ...: Section 1 introduces the principles of drug action, Section 2 presents the molecular, cellular and integrated physiology of the target organ/functional system and Section 3 reviews the pharmacology...

  8. Clinical, molecular, and pharmacological aspects of FMR1 related disorders.

    Science.gov (United States)

    Pugin, A; Faundes, V; Santa María, L; Curotto, B; Aliaga, S; Salas, I; Soto, P; Bravo, P; Peña, M I; Alliende, M A

    2017-05-01

    Fragile X syndrome, the most common inherited cause of intellectual disability, is associated with a broad spectrum of disorders across different generations of a single family. This study reviews the clinical manifestations of fragile X-associated disorders as well as the spectrum of mutations of the fragile X mental retardation 1 gene (FMR1) and the neurobiology of the fragile X mental retardation protein (FMRP), and also provides an overview of the potential therapeutic targets and genetic counselling. This disorder is caused by expansion of the CGG repeat (>200 repeats) in the 5 prime untranslated region of FMR1, resulting in a deficit or absence of FMRP. FMRP is an RNA-binding protein that regulates the translation of several genes that are important in synaptic plasticity and dendritic maturation. It is believed that CGG repeat expansions in the premutation range (55 to 200 repeats) elicit an increase in mRNA levels of FMR1, which may cause neuronal toxicity. These changes manifest clinically as developmental problems such as autism and learning disabilities as well as neurodegenerative diseases including fragile X-associated tremor/ataxia syndrome (FXTAS). Advances in identifying the molecular basis of fragile X syndrome may help us understand the causes of neuropsychiatric disorders, and they will probably contribute to development of new and specific treatments. Copyright © 2014 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. Pharmacological basis and clinical evidence of dabigatran therapy

    Directory of Open Access Journals (Sweden)

    Redondo Santiago

    2011-12-01

    Full Text Available Abstract Dabigatran is an emerging oral anticoagulant which is a direct inhibitor of thrombin activity. It has been approved in the European Union and the United States of America for the prevention of thrombosis after major orthopedic surgery. It has also been approved by the American Food and Drug Administration and the European Medicines Agency for the prevention of stroke in chronic atrial fibrillation. Dabigatran provides a stable anticoagulation effect without any need to perform periodical laboratory controls. Of note, there is a growing amount of clinical evidence which shows its safety and efficacy. For these reasons, dabigatran may suppose a revolution in oral anticoagulation. However, two important limitations remain. First, it is contraindicated in patients with end-stage renal disease. Second, there is no evidence of the prevention of thrombosis in mechanical heart valves.

  10. Preliminary clinical pharmacological investigations of tylosin and tiamulin in chickens.

    Science.gov (United States)

    Ziv, G

    1980-10-15

    The minimal inhibitory concentrations (MIC) of tiamulin and tylosin for mycoplasma, Gram-positive, and Gram-negative micro-organisms isolated from chickens were determinated by the agar dilution method. Median MIC values for tiamulin against Mycoplasma gallisepticum (0.05 microgram/ml) and Mycoplasma synoviae (0.10 microgram/ml) were 2 to 4 times lower than the corresponding values for tylosin. Tiamulin was also slightly more effective in vitro in inhibiting Escherichia coli, Pasteurella multocida, and beta-haemolytic streptococci than was tylosin. Groups of chicken were offered tiamulin medicated drinking water at rates of 125 and 250 mg/litre for 48 hours. Average serum tiamulin concentrations were 0.38 and 0.78 microgram/ml, respectively. When tylosin tartrate was added to the drinking water at 500 and 700 mg/litre, average serum drug levels were 0.12 and 0.17 microgram/ml, respectively. Tiamulin was 45% bound in chicken serum, as against 30% serum protein binding for tylosin. Correlations were made between free (non protein bound) serum drug levels and the MIC values of the two drugs. Such comparisons suggest that when tiamulin is given in the drinking water at rates of 125 to 250 mg/litre, better antimycoplasmal activity is to be expected in vivo than by giving tylosin tartrate in the drinking water at 500 to 700 mg/litre. Based on these data, no clinical efficacy of these dose rates can be expected in flocks infected by gram-negative micro-organisms such as E. coli or P. multocida. The tylosin tartrate rate of 500 to 700 mg/litre, may be clinical ineffective the treatment of Staphylococcus aureus infections.

  11. Chaste tree (Vitex agnus-castus)--pharmacology and clinical indications.

    Science.gov (United States)

    Wuttke, W; Jarry, H; Christoffel, V; Spengler, B; Seidlová-Wuttke, D

    2003-05-01

    Extracts of the fruits of chaste tree (Vitex agnus castus = AC) are widely used to treat premenstrual symptoms. Double-blind placebo-controlled studies indicate that one of the most common premenstrual symptoms, i.e. premenstrual mastodynia (mastalgia) is beneficially influenced by an AC extract. In addition, numerous less rigidly controlled studies indicate that AC extracts have also beneficial effects on other psychic and somatic symptoms of the PMS. Premenstrual mastodynia is most likely due to a latent hyperprolactinemia, i.e. patients release more than physiologic amounts of prolactin in response to stressful situations and during deep sleep phases which appear to stimulate the mammary gland. Premenstrually this unphysiological prolactin release is so high that the serum prolactin levels often approach heights which are misinterpreted as prolactinomas. Since AC extracts were shown to have beneficial effects on premenstrual mastodynia serum prolactin levels in such patients were also studied in one double-blind, placebo-controlled clinical study. Serum prolactin levels were indeed reduced in the patients treated with the extract. The search for the prolactin-suppressive principle(s) yielded a number of compounds with dopaminergic properties: they bound to recombinant DA2-receptor protein and suppressed prolactin release from cultivated lactotrophs as well as in animal experiments. The search for the chemical identity of the dopaminergic compounds resulted in isolation of a number of diterpenes of which some clerodadienols were most important for the prolactin-suppressive effects. They were almost identical in their prolactin-suppressive properties than dopamine itself. Hence, it is concluded that dopaminergic compounds present in Vitex agnus castus are clinically the important compounds which improve premenstrual mastodynia and possibly also other symptoms of the premenstrual syndrome.

  12. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Blom, M T; van Hoeijen, D A; Bardai, A

    2014-01-01

    INTRODUCTION: Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Recognising the complexity of the underlying causes of OHCA in the community, we aimed to establish the clinical, pharmacological, environmental and genetic factors and their interactions that may cause OHCA. ME......-reviewed journals and presented at relevant scientific symposia....

  13. Review of the pharmacology and clinical studies of micafungin

    Directory of Open Access Journals (Sweden)

    Alison M Bormann

    2009-12-01

    Full Text Available Alison M Bormann1, Vicki A Morrison21Division of Infectious Diseases, University of Minnesota, Minneapolis, MN, USA; 2Division of Hematology/Oncology and Infectious Disease, Minneapolis Veterans Affairs Medical Center, Minneapolis, MN, USAAbstract: Micafungin, like other members of the echinocandin class, has a unique mechanism of action that inhibits the synthesis of 1,3-β-D glucans in the fungal cell wall. It has been approved for treatment of esophageal candidiasis, invasive candidiasis including candidemia, and for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. Although efficacy and safety have also been demonstrated in pediatric populations, micafungin is approved for this indication in Europe and Japan, but not in the United States. It has demonstrated activity against Candida spp. including those that are azole-resistant as well as Aspergillus and a few other clinically important molds. It is administered intravenously as a once daily infusion and does not require dose adjustments for renal or moderate hepatic dysfunction. Its safety record, favorable tolerability profile, and few drug interactions make it an important agent for the treatment of invasive fungal infections.Keywords: micafungin, antifungal therapy, echinocandins, fungal infections, Candida, Aspergillus

  14. Clinical Pharmacology of Phenobarbital in Neonates: Effects, Metabolism and Pharmacokinetics.

    Science.gov (United States)

    Pacifici, Gian M

    2016-01-01

    Phenobarbital is an effective and safe anticonvulsant drug introduced in clinical use in 1904. Its mechanism of action is the synaptic inhibition through an action on GABAA. The loading dose of phenobarbital is 20 mg/kg intravenously and the maintenance dose is 3 to 4 mg/kg by mouth. The serum concentration of phenobarbital is up to 40 µg/ml. Nonresponders should receive additional doses of 5 to 10 mg/kg until seizures stop. Infants with refractory seizures may have a serum concentration of phenobarbital of 100 µg/ml. Phenobarbital is metabolized in the liver by CYP2C9 with minor metabolism by CYP2C19 and CYP2E1. A quarter of the dose of phenobarbital is excreted unchanged in the urine. In adults, the half-life of phenobarbital is 100 hours and in term and preterm infants is 103 and 141 hours, respectively. The half-life of phenobarbital decreases 4.6 hours per day and it is 67 hours in infants 4 week old.

  15. Evaluation of a filmed clinical scenario as a teaching resource for an introductory pharmacology unit for undergraduate health students: A pilot study.

    Science.gov (United States)

    East, Leah; Hutchinson, Marie

    2015-12-01

    Simulation is frequently being used as a learning and teaching resource for both undergraduate and postgraduate students, however reporting of the effectiveness of simulation particularly within the pharmacology context is scant. The aim of this pilot study was to evaluate a filmed simulated pharmacological clinical scenario as a teaching resource in an undergraduate pharmacological unit. Pilot cross-sectional quantitative survey. An Australian university. 32 undergraduate students completing a healthcare degree including nursing, midwifery, clinical science, health science, naturopathy, and osteopathy. As a part of an undergraduate online pharmacology unit, students were required to watch a filmed simulated pharmacological clinical scenario. To evaluate student learning, a measurement instrument developed from Bloom's cognitive domains (knowledge, comprehension, application, analysis, synthesis and evaluation) was employed to assess pharmacological knowledge conceptualisation and knowledge application within the following fields: medication errors; medication adverse effects; medication interactions; and, general pharmacology. The majority of participants were enrolled in an undergraduate nursing or midwifery programme (72%). Results demonstrated that the majority of nursing and midwifery students (56.52%) found the teaching resource complementary or more useful compared to a lecture although less so compared to a tutorial. Students' self-assessment of learning according to Bloom's cognitive domains indicated that the filmed scenario was a valuable learning tool. Analysis of variance indicated that health science students reported higher levels of learning compared to midwifery and nursing. Students' self-report of the learning benefits of a filmed simulated clinical scenario as a teaching resource suggest enhanced critical thinking skills and knowledge conceptualisation regarding pharmacology, in addition to being useful and complementary to other teaching and

  16. A review on Pharmacological and clinical aspects of Linum usitatissimum L.

    Science.gov (United States)

    Ansari, Ramin; Zarshenas, Mohammad Mehdi; Dadbakhsh, Amir Hossein

    2018-05-20

    Linum usitatissimum L., known as common Flax or linseed, from the family Linnaceae, has long been cultivated in different nations due to its applications in medicine and industry. The present study aims to collect nearly all available information about chemical constituents of Flax, as well as pharmacological properties and confirmed clinical usages of it. We searched through databases such as Scopus and PubMed for relevant literatures using the keywords: (Linum usitatissimum), (pharmacology) and (phytochemical) from the beginning to 13 Aug 2017. Nearly 60 relevant papers, relating to pharmacological and phytochemical constituent of L. usitatissimum were selected. According to our researches, various properties were attributed to L. usitatisimum including: antioxidant, immunomodulatory, anti-inflammatory, antimicrobial, Antiprotozoal, insecticidal, Analgesic, anti-hyperlipidemia, Anti-hyperglycemic, Anti-tumor, wound healing and Feticidal activities. There were also many reports to the disease preventive and healing properties of the flax. Diseases like: GI disorders, cardiovascular, urogenital, respiratory diseases and some neurological syndromes were mentioned to be treated by Flax. The application of Flax in drug formulations was also investigated. Despite so much animal studies that have been accomplished, there haven't been enough clinical trials done on pharmacological properties of L. usitatissimum. Therefore this study could be considered as a concise and up to date overview for further facile studies and clinical trials over the valuable plant, L. usitatissimum. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  17. Avanafil for erectile dysfunction in elderly and younger adults: differential pharmacology and clinical utility

    Directory of Open Access Journals (Sweden)

    Katz EG

    2014-08-01

    Full Text Available Eric G Katz,1 Ronny BW Tan,2 Daniel Rittenberg,1 Wayne J Hellstrom3 1Tulane University School of Medicine, New Orleans, LA, USA; 2Department of Urology, Tan Tock Seng Hospital, Singapore; 3Section of Andrology, Department of Urology, Tulane University School of Medicine, New Orleans, LA, USA Abstract: The treatment modalities of erectile dysfunction range from oral pharmacotherapy to intracavernosal injections, intraurethral pellets, vacuum erectile devices, and the surgical option of penile prosthesis insertion. Oral phosphodiesterase 5 inhibitors still remain the preferred treatment for patients since they are the least invasive, not to mention that they can be prescribed by non-urologists. Due to these factors, there has been development of newer drugs with fewer side effects. This is a review of the second generation phosphodiesterase 5 inhibitor, avanafil, looking into its pharmacology as well as its clinical utility. Avanafil's faster onset and shorter duration of action has made it preferred as compared to other PDE5 inhibitors for patients with multiple comorbidities. Keywords: phosphodiesterase 5 inhibitors, impotence, sildenafil, sexual dysfunction, nitric oxide

  18. [Note on the epistemology of clinical pharmacology: comparison with the approach of Karl Popper].

    Science.gov (United States)

    Boissel, J P

    1999-01-01

    Is clinical pharmacology a science or only an application of science? Karl Popper suggested a method to identify science and to sort it out from other logical activities such as metaphysics, whereby the falsification criterion he proposed can apply to the theory in such a way that the theory could be refuted. The clinical pharmacologist's approach requires the build-up of a therapeutic model on the basis of two other models: the physiopathologic and the pharmacological. The three-model construct is a theory. Is it scientific in the Popperian sense? From the therapeutic model, one can predict the efficacy of a drug, and the corresponding statement is tested by a clinical trial. Whatever the original statement, it is modified into a refutable one because of the use of the statistical approach in clinical trials. Furthermore, the predicate represents a hypothesis of the model validity, which will then be confronted with 'reality' through clinical experiment. As the therapeutic model is refutable, clinical pharmacology is a science in the Popperian sense.

  19. A Blended Learning Course Design in Clinical Pharmacology for Post-graduate Dental Students

    Science.gov (United States)

    Rosenbaum, Paul-Erik Lillholm; Mikalsen, Øyvind; Lygre, Henning; Solheim, Einar; Schjøtt, Jan

    2012-01-01

    Postgraduate courses in clinical pharmacology are important for dentists to be updated on drug therapy and information related to their clinical practice, as well as knowledge of relevant adverse effects and interactions. A traditional approach with classroom delivery as the only method to teaching and learning has shortcomings regarding flexibility, individual learning preferences, and problem based learning (PBL) activities compared to online environments. This study examines a five week postgraduate course in clinical pharmacology with 15 hours of lectures and online learning activities, i.e. blended course design. Six postgraduate dental students participated and at the end of the course they were interviewed. Our findings emphasize that a blended learning course design can be successfully used in postgraduate dental education. Key matters for discussion were time flexibility and location convenience, change in teacher’s role, rein-forced learning strategies towards professional needs, scarcity in online communication, and proposed future utilization of e-learning components. PMID:23248716

  20. Optimizing oncology therapeutics through quantitative translational and clinical pharmacology: challenges and opportunities.

    Science.gov (United States)

    Venkatakrishnan, K; Friberg, L E; Ouellet, D; Mettetal, J T; Stein, A; Trocóniz, I F; Bruno, R; Mehrotra, N; Gobburu, J; Mould, D R

    2015-01-01

    Despite advances in biomedical research that have deepened our understanding of cancer hallmarks, resulting in the discovery and development of targeted therapies, the success rates of oncology drug development remain low. Opportunities remain for objective dose selection informed by exposure-response understanding to optimize the benefit-risk balance of novel therapies for cancer patients. This review article discusses the principles and applications of modeling and simulation approaches across the lifecycle of development of oncology therapeutics. Illustrative examples are used to convey the value gained from integration of quantitative clinical pharmacology strategies from the preclinical-translational phase through confirmatory clinical evaluation of efficacy and safety. © 2014 American Society for Clinical Pharmacology and Therapeutics.

  1. Development of innovative teaching materials: clinical pharmacology problem-solving (CPPS) units: comparison with patient-oriented problem-solving units and problem-based learning--a 10-year review.

    Science.gov (United States)

    Lathers, Claire M; Smith, Cedric M

    2002-05-01

    The First Teaching Clinic in Clinical Pharmacology, sponsored by the American College of Clinical Pharmacology in September 1992, was designed for the preparation and development of new clinical pharmacology problem-solving (CPPS) units. CPPS units are case histories that illustrate pertinent principles in clinical pharmacology. Each unit consists of the following sections: introduction, learning objectives, pretest, four clinical pharmacology scenarios, posttest, answers to pre- and posttest questions, and selected references. The clinical pharmacology content of the CPPS units place greater emphasis on clinical information, drug selection, and risk/benefit analyses, and thus they complement the basic pharmacology presented in the patient-oriented problem-solving (POPS) units. In general, the CPPS units are intended for use by students more advanced in clinical pharmacology than first- and second-year medical students. The CPPS unit "Clinical Pharmacology of Antiepileptic Drug Use: Clinical Pearls about the Perils of Patty" was developed for use by third- and fourth-year medical students doing rotations in neurology or clinical pharmacology; advanced pharmacy students; residents in neurology, pediatrics, internal medicine, and family practice; fellows in clinical pharmacology, and those taking the board examination in clinical pharmacology. The CPPS unit titled "Geriatric Clinical Psychopharmacology" was written for third- and fourth-year medical students; residents in psychiatry, family practice, and internal medicine;fellows in clinical pharmacology; and those studying for boards in clinical pharmacology. The CPPS unit "Anisocoria and Glaucoma" was written for more advanced students of clinical pharmacology. The CPPS unit titled "Antiepileptic Drugs" was intended for second-year medical students. The second teaching clinic was held in November 1993 and focused on the development and editing of the CPPS units and their evaluations by faculty and students from

  2. Blended learning for reinforcing dental pharmacology in the clinical years: A qualitative analysis.

    Science.gov (United States)

    Eachempati, Prashanti; Kiran Kumar, K S; Sumanth, K N

    2016-10-01

    Blended learning has become the method of choice in educational institutions because of its systematic integration of traditional classroom teaching and online components. This study aims to analyze student's reflection regarding blended learning in dental pharmacology. A cross-sectional study was conducted in Faculty of Dentistry, Melaka-Manipal Medical College among 3 rd and 4 th year BDS students. A total of 145 dental students, who consented, participate in the study. Students were divided into 14 groups. Nine online sessions followed by nine face-to-face discussions were held. Each session addressed topics related to oral lesions and orofacial pain with pharmacological applications. After each week, students were asked to reflect on blended learning. On completion of 9 weeks, reflections were collected and analyzed. Qualitative analysis was done using thematic analysis model suggested by Braun and Clarke. The four main themes were identified, namely, merits of blended learning, skill in writing prescription for oral diseases, dosages of drugs, and identification of strengths and weakness. In general, the participants had a positive feedback regarding blended learning. Students felt more confident in drug selection and prescription writing. They could recollect the doses better after the online and face-to-face sessions. Most interestingly, the students reflected that they are able to identify their strength and weakness after the blended learning sessions. Blended learning module was successfully implemented for reinforcing dental pharmacology. The results obtained in this study enable us to plan future comparative studies to know the effectiveness of blended learning in dental pharmacology.

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

  5. Pharmacology of dextromethorphan: Relevance to dextromethorphan/quinidine (Nuedexta®) clinical use.

    Science.gov (United States)

    Taylor, Charles P; Traynelis, Stephen F; Siffert, Joao; Pope, Laura E; Matsumoto, Rae R

    2016-08-01

    Dextromethorphan (DM) has been used for more than 50years as an over-the-counter antitussive. Studies have revealed a complex pharmacology of DM with mechanisms beyond blockade of N-methyl-d-aspartate (NMDA) receptors and inhibition of glutamate excitotoxicity, likely contributing to its pharmacological activity and clinical potential. DM is rapidly metabolized to dextrorphan, which has hampered the exploration of DM therapy separate from its metabolites. Coadministration of DM with a low dose of quinidine inhibits DM metabolism, yields greater bioavailability and enables more specific testing of the therapeutic properties of DM apart from its metabolites. The development of the drug combination DM hydrobromide and quinidine sulfate (DM/Q), with subsequent approval by the US Food and Drug Administration for pseudobulbar affect, led to renewed interest in understanding DM pharmacology. This review summarizes the interactions of DM with brain receptors and transporters and also considers its metabolic and pharmacokinetic properties. To assess the potential clinical relevance of these interactions, we provide an analysis comparing DM activity from in vitro functional assays with the estimated free drug DM concentrations in the brain following oral DM/Q administration. The findings suggest that DM/Q likely inhibits serotonin and norepinephrine reuptake and also blocks NMDA receptors with rapid kinetics. Use of DM/Q may also antagonize nicotinic acetylcholine receptors, particularly those composed of α3β4 subunits, and cause agonist activity at sigma-1 receptors. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  6. [History of clinical pharmacology in France: adaptation, evaluation, defense and illustration of drug in France 1978-1981].

    Science.gov (United States)

    Montastruc, Paul

    2014-01-01

    This text illustrates some unknown aspects of the history and beginnings of clinical pharmacology in France in the late 1970s and early 1980s From the current situation, development and objectives of clinical pharmacology are recalled as well as obstacles necessary to overcome to change the paradigm in the field of drug evaluation and appropriate use in France. The text recalls this important moment where French medicine and medical pharmacology entered the modern era. © 2014 Société Française de Pharmacologie et de Thérapeutique.

  7. Overview of clinical efficacy and safety of pharmacologic strategies for blood conservation.

    Science.gov (United States)

    Levy, Jerrold H

    2005-09-15

    The pharmacologic management of hemostasis in patients undergoing surgery with cardiopulmonary bypass is discussed. Nearly 45 studies involving 7,000 patients have reported efficacy of aprotinin in blood conservation. Both in primary coronary artery bypass graft (CABG) surgeries and in repeat surgeries, aprotinin treatment significantly reduces the incidence of blood transfusions and the number of units of blood transfused. These effects have been observed for red blood cell, platelet, and other blood products. The safety of aprotinin treatment has been extensively evaluated in randomized clinical trials, in postmarketing databases, and in systematic reviews of the literature. Overall, data do not indicate that aprotinin treatment increases mortality, myocardial infarction, or renal failure. These findings are supported by the results of a recent meta-analysis of 35 studies in patients undergoing CABG surgery. In addition, the meta-analysis suggests that aprotinin treatment was associated with a reduced incidence of stroke and a trend toward a reduced incidence of atrial fibrillation. Although lysine analogs, desmopressin, and recombinant factor VIIa are sometimes used to reduce bleeding, only aprotinin is indicated for use during CABG surgery. The future of cardiac surgery will be marked by an increasingly complex, high-risk group of patients and a greater need for multiple pharmacologic options for reducing bleeding. Pharmacologic approaches that attenuate the activation of the hemostatic system and inflammation need to be employed to decrease coagulopathies and the need for allogeneic blood administration.

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

    Directory of Open Access Journals (Sweden)

    Jem D. Lane

    2017-11-01

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

  9. Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories.

    Science.gov (United States)

    DiFrancesco, Robin; Rosenkranz, Susan L; Taylor, Charlene R; Pande, Poonam G; Siminski, Suzanne M; Jenny, Richard W; Morse, Gene D

    2013-10-01

    Among National Institutes of Health HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals. Drug assay data are, in turn, entered into study-specific data sets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis, and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semiannual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1) assess the precision and accuracy of concentrations reported by individual CPLs and (2) determine factors associated with round-specific and long-term assay accuracy, precision, and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21) drug concentration results reported for clinical trial samples by multiple CPLs). Using the Clinical Laboratory Improvement Act acceptance of meeting criteria for ≥2/3 consecutive rounds, all 10 laboratories that participated in 3 or more rounds per analyte maintained Clinical Laboratory Improvement Act proficiency. Significant associations were present between magnitude of error and CPL (Kruskal-Wallis P Kruskal-Wallis P < 0.001).

  10. Differential clinical pharmacology of rolapitant in delayed chemotherapy-induced nausea and vomiting (CINV

    Directory of Open Access Journals (Sweden)

    Rashad N

    2017-03-01

    Full Text Available Noha Rashad,1 Omar Abdel-Rahman2 1Medical Oncology Department, Maadi Armed Forces Hospital, 2Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt Abstract: Rolapitant is a highly selective neurokinin-1 receptor antagonist, orally administered for a single dose of 180 mg before chemotherapy with granisetron D1, dexamethasone 8 mg BID on day 2–4. It has a unique pharmacological characteristic of a long plasma half-life (between 163 and 183 hours; this long half-life makes a single use sufficient to cover the delayed emesis risk period. No major drug–drug interactions between rolapitant and dexamethasone or other cytochrome P450 inducers or inhibitors were observed. The clinical efficacy of rolapitant was studied in two phase III trials in highly emetogenic chemotherapy and in one clinical trial in moderately emetogenic chemotherapy. The primary endpoint was the proportion of patients achieving a complete response (defined as no emesis or use of rescue medication in the delayed phase (>24–120 hours after chemotherapy. In comparison to granisetron (10 µg/kg intravenously and dexamethasone (20 mg orally on day 1, and dexamethasone (8 mg orally twice daily on days 2–4 and placebo, rolapitant showed superior efficacy in the control of delayed and overall emesis. This review aims at revising the pharmacological characteristics of rolapitant, offering an updated review of the available clinical efficacy and safety data of rolapitant in different clinical settings, highlighting the place of rolapitant in the management of chemotherapy-induced nausea and vomiting (CINV among currently available guidelines, and exploring the future directions of CINV management. Keywords: nausea, vomiting, chemotherapy, rolapitant, CINV

  11. Evolving paradigms in clinical pharmacology and therapeutics for the treatment of Duchenne muscular dystrophy.

    Science.gov (United States)

    Huard, J; Mu, X; Lu, A

    2016-08-01

    Progressive muscle weakness and degeneration due to the lack of dystrophin eventually leads to the loss of independent ambulation by the middle of the patient's second decade, and a fatal outcome due to cardiac or respiratory failure by the third decade. More specifically, loss of sarcolemmal dystrophin and the dystrophin-associated glycoprotein (DAG) complex promotes muscle fiber damage during muscle contraction. This process results in an efflux of creatine kinase (CK), an influx of calcium ions, and the recruitment of T cells, macrophages, and mast cells to the damaged muscle, causing progressive myofiber necrosis. For the last 20 years, the major goal in the development of therapeutic approaches to alleviate muscle weakness in DMD has been centered on the restoration of dystrophin or proteins that are analogous to dystrophin, such as utrophin, through a variety of modalities including cell therapy, gene therapy, gene correction, and the highly promising techniques utilizing CRISPR/Cas9 technology. Despite the development of new therapeutic options, there still exist numerous challenges that we must face with regard to these new strategies and, consequently, we still do not have any feasible options available to ultimately slow the progression of this devastating disease. The purpose of this article is to highlight the current knowledge and advancements in the evolving paradigms in clinical pharmacology and therapeutics for this devastating musculoskeletal disease. © 2016 American Society for Clinical Pharmacology and Therapeutics.

  12. The mollusks in zootherapy: traditional medicine and clinical-pharmacological importance

    Directory of Open Access Journals (Sweden)

    Eraldo Medeiros Costa Neto

    2006-09-01

    Full Text Available The use of animals as sources of medicines is a cross-cultural phenomenon that is historically ancient and geographically widespread. This article reviews the use of mollusks in traditional medicine and discusses the clinical and pharmacological importance of these invertebrates. The roles that mollusks play in folk practices related to the healing and/or prevention of illnesses have been recorded in different social-cultural contexts worldwide. The clinical and therapeutic use of compounds coming from different species of mollusks is recorded in the literature. The chemistry of natural products provided by oysters, mussels, clams, sluggards, and snails has been substantially investigated, but the majority of these studies have focused on the subclasses Opistobranchia and Prosobranchia. Research into the knowledge and practices of folk medicine makes possible a better understanding of the interaction between human beings and the environment, in addition to allowing the elaboration of suitable strategies for the conservation of natural resources.

  13. CLINICAL AND PHARMACOLOGICAL PECULIARITIES OF CETIRIZINE USE FOR THE THERAPY OF ALLERGIC DISEASES IN CHILDREN

    Directory of Open Access Journals (Sweden)

    Yu. G. Levina

    2014-01-01

    Full Text Available The review is dedicated to treatment of allergic diseases in children, particularly to the use of the 2nd generation antihistamine. It demonstrates that mediator histamine has the crucial role in pathophysiology of the allergic reaction. Antihistamines block histamine action aimed at H1 receptors by way of competitive inhibition. The 2nd generation antihistamines are the drugs of choice for the treatment of allergic diseases due to the absence of sedative effect. The review presents clinical and pharmacological description of the selective 2nd generation antihistamine cetirizine, efficacy and safety of which have been appraised in numerous long-term clinical studies in children with allergic rhinitis, urticaria and atopic dermatitis. 

  14. Clinical pharmacology of CAR-T cells: Linking cellular pharmacodynamics to pharmacokinetics and antitumor effects.

    Science.gov (United States)

    Norelli, M; Casucci, M; Bonini, C; Bondanza, A

    2016-01-01

    Adoptive cell transfer of T cells genetically modified with tumor-reactive chimeric antigen receptors (CARs) is a rapidly emerging field in oncology, which in preliminary clinical trials has already shown striking antitumor efficacy. Despite these premises, there are still a number of open issues related to CAR-T cells, spanning from their exact mechanism of action (pharmacodynamics), to the factors associated with their in vivo persistence (pharmacokinetics), and, finally, to the relative contribution of each of the two in determining the antitumor effects and accompanying toxicities. In light of the unprecedented curative potential of CAR-T cells and of their predicted wide availability in the next few years, in this review we will summarize the current knowledge on the clinical pharmacology aspects of what is anticipated to be a brand new class of biopharmaceuticals to join the therapeutic armamentarium of cancer doctors. Copyright © 2015. Published by Elsevier B.V.

  15. Review of Clinical Pharmacology of Aloe vera L. in the Treatment of Psoriasis.

    Science.gov (United States)

    Miroddi, Marco; Navarra, Michele; Calapai, Fabrizio; Mancari, Ferdinando; Giofrè, Salvatore Vincenzo; Gangemi, Sebastiano; Calapai, Gioacchino

    2015-05-01

    Aloe vera L., is a plant used worldwide as folk remedy for the treatment of various ailments, including skin disorders. Its gel is present in cosmetics, medicinal products and food supplements. Psoriasis, an immune-mediated chronic inflammatory disease, involving mainly the skin, affects about the 2-3% of general population. Conventional pharmacological treatments for psoriasis can have limited effectiveness and can cause adverse reactions. For this reason often psoriatic patients look for alternative treatments based on natural products containing Aloe vera. We conducted a systematic review of clinical trials assessing effectiveness and safety of aloe for the treatment of psoriasis. Clinical studies published in English were considered; a total of four clinical trials met inclusion criteria. Studies were also evaluated by using the Jadad scale and Consort Statement in Reporting Clinical trials of Herbal Medicine Intervention. Quality and methodological accuracy of considered studies varied considerably, and some crucial information to reproduce clinical results was missing. We conclude that administration of aloe as cutaneous treatment is generally well tolerated, as no serious side effects were reported. Results on the effectiveness of Aloe vera are contradictory; our analysis reveals the presence of methodological gaps preventing to reach final conclusions. Copyright © 2015 John Wiley & Sons, Ltd.

  16. Methamphetamine: An Update on Epidemiology, Pharmacology, Clinical Phenomenology, and Treatment Literature

    Science.gov (United States)

    Courtney, Kelly E.; Ray, Lara A.

    2014-01-01

    Background Despite initial reports of a decline in use in the early 2000s, methamphetamine remains a significant public health concern with known neurotoxic and neurocognitive effects to the user. The goal of this review is to update the literature on methamphetamine use and addiction since its assent to peak popularity in 1990s. Methods Specifically, we first review recent epidemiological reports with a focus on methamphetamine accessibility, changes in use and disorder prevalence rates over time, and accurate estimates of the associated burden of care to the individual and society. Second, we review methamphetamine pharmacology literature with emphasis on the structural and functional neurotoxic effects associated with repeated use of the drug. Third, we briefly outline the findings on methamphetamine-related neurocognitive deficits as assessed via behavioral and neuroimaging paradigms. Lastly, we review the clinical presentation of methamphetamine addiction and the evidence supporting the available psychosocial and pharmacological treatments within the context of an addiction biology framework. Conclusion Taken together, this review provides a broad-based update of the available literature covering methamphetamine research over the past two decades and concludes with recommendations for future research. PMID:25176528

  17. Carthami flos: a review of its ethnopharmacology, pharmacology and clinical applications

    Directory of Open Access Journals (Sweden)

    Yanhua Tu

    Full Text Available ABSTRACTCarthami flos, the dried floret of Carthamus tinctorius L., Asteraceae (safflower, has been widely used in traditional Chinese medicine to treat a broad range of ailments, such as coronary heart disease, angina pectoris, gynecologic disease, stroke, and hypertension. However, although several studies on Carthami flos have been done consecutively, the results are usually scattered across various documents. This review aims to provide up-to-date information on the traditional uses, pharmacology, clinical applications, and toxicology of Carthami flos in China and thereby to provide a basis for further investigation of its use to treat dissimilar diseases. Various ethnomedical uses of Carthami flos have been documented in many ancient Chinese books. Crude extracts and isolated compounds from Carthami flos show a broad range of pharmacological properties, such as protective effects on brain tissue, on osteoblasts, and in myocardial ischemia, as well as anti-inflammatory, antithrombotic, antitumor, and antidiabetic activities. To date, safflower and safflor yellow injections have been used to treat coronary heart disease, chronic pulmonary heart disease, cerebrovascular diseases, orthopedic diseases, and diabetes mellitus. Regarding the toxicology of Carthami flos, among the side effects that have been observed are allergic reaction, spermatogenetic failure, fatty liver, and nephrotoxicity.

  18. Cato Guldberg and Peter Waage, the history of the Law of Mass Action, and its relevance to clinical pharmacology.

    Science.gov (United States)

    Ferner, Robin E; Aronson, Jeffrey K

    2016-01-01

    We have traced the historical link between the Law of Mass Action and clinical pharmacology. The Law evolved from the work of the French chemist Claude Louis Berthollet, was first formulated by Cato Guldberg and Peter Waage in 1864 and later clarified by the Dutch chemist Jacobus van 't Hoff in 1877. It has profoundly influenced our qualitative and quantitative understanding of a number of physiological and pharmacological phenomena. According to the Law of Mass Action, the velocity of a chemical reaction depends on the concentrations of the reactants. At equilibrium the concentrations of the chemicals involved bear a constant relation to each other, described by the equilibrium constant, K. The Law of Mass Action is relevant to various physiological and pharmacological concepts, including concentration-effect curves, dose-response curves, and ligand-receptor binding curves, all of which are important in describing the pharmacological actions of medications, the Langmuir adsorption isotherm, which describes the binding of medications to proteins, activation curves for transmembrane ion transport, enzyme inhibition and the Henderson-Hasselbalch equation, which describes the relation between pH, as a measure of acidity and the concentrations of the contributory acids and bases. Guldberg and Waage recognized the importance of dynamic equilibrium, while others failed to do so. Their ideas, over 150 years old, are embedded in and still relevant to clinical pharmacology. Here we explain the ideas and in a subsequent paper show how they are relevant to understanding adverse drug reactions. © 2015 The British Pharmacological Society.

  19. CLINICAL-PHARMACOLOGICAL VALUE OF TREATMENT EFFICIENCY OF BHP-PATIENTS BY ANTITHROMBOTIC THERAPY

    Directory of Open Access Journals (Sweden)

    A.A. Svistunov

    2007-09-01

    Full Text Available Patients with BHP need in pharmacological treatment of thrombosis the most often in the first 3 cases because has dysfunctions of platelets and coagulation. According to results of analysis of efficiency antithrombotic therapy in BHP-patients confirmed clinical and biochemical influence antithrombotic therapy by Ticlid 250 mg twice on the day in comparison with Aspirin 100 mg and Dipiridomol 25 mg on the basic therapy of the BHP by Permixon 160 mg. The received results have had statistically meant differences. Manifestation of BHP and value QOL and others urodynamic complications most often appear on the basic specific monotherapy of BHP and lost after antithrombotic therapy for 1-3 months. The important complications of antithrombotic therapy of BHP-patients did not observe.

  20. Clinical inertia in the pharmacological management of hypertension: A systematic review and meta-analysis.

    Science.gov (United States)

    Milman, Tal; Joundi, Raed A; Alotaibi, Naif M; Saposnik, Gustavo

    2018-06-01

    Clinical Inertia is defined as "failure of health care providers to initiate or intensify therapy according to current guidelines". This phenomenon is gaining increasing attention as a major cause of clinicians' failure to adequately manage hypertension, thus leading to an increased incidence of cardiovascular events. We performed a systematic review and meta-analysis of randomized controlled trials to determine whether interventions aimed at reducing clinical inertia in the pharmacological treatment of hypertension improve blood pressure (BP) control. MEDLINE, Embase, and Cochrane Database of Systematic Reviews were searched from the start of their database until October 3, 2017 for the MESH terms "Hypertension" or "Blood Pressure", their subheadings, and the keywords "Therapeutic Inertia" or "Clinical Inertia". Studies were included if they addressed pharmacologic hypertension management, clinical inertia, were randomized controlled trials, reported an outcome describing prescriber behavior, and were available in English. Data for the included studies was extracted by two independent observers. Quality of studies was analyzed using the Cochrane Risk of Bias Assessment. Data was pooled for statistical analysis using both fixed- and random-effects models. The primary study outcome was the percentage of patients achieving blood pressure control as defined by the Joint National Committee guidelines or study authors. Of 474 citations identified, ten met inclusion criteria comprising a total of 26,871 patients, and eight were selected for meta-analysis. Interventions included Physician Education, Physician Reminders, Patient Education, Patient Reminders, Ambulatory BP Monitoring, Digital Medication Offerings, Physician Peer Visits, and Pharmacist-led Counselling. Pooled event rates revealed more patients with controlled BP in the intervention group versus control (55%, 95% CI 46-63% versus 45%, 95% CI 37-53%) and interventions significantly improved the odds of BP

  1. Clinically Relevant Pharmacological Strategies That Reverse MDMA-Induced Brain Hyperthermia Potentiated by Social Interaction.

    Science.gov (United States)

    Kiyatkin, Eugene A; Ren, Suelynn; Wakabayashi, Ken T; Baumann, Michael H; Shaham, Yavin

    2016-01-01

    MDMA-induced hyperthermia is highly variable, unpredictable, and greatly potentiated by the social and environmental conditions of recreational drug use. Current strategies to treat pathological MDMA-induced hyperthermia in humans are palliative and marginally effective, and there are no specific pharmacological treatments to counteract this potentially life-threatening condition. Here, we tested the efficacy of mixed adrenoceptor blockers carvedilol and labetalol, and the atypical antipsychotic clozapine, in reversing MDMA-induced brain and body hyperthermia. We injected rats with a moderate non-toxic dose of MDMA (9 mg/kg) during social interaction, and we administered potential treatment drugs after the development of robust hyperthermia (>2.5 °C), thus mimicking the clinical situation of acute MDMA intoxication. Brain temperature was our primary focus, but we also simultaneously recorded temperatures from the deep temporal muscle and skin, allowing us to determine the basic physiological mechanisms of the treatment drug action. Carvedilol was modestly effective in attenuating MDMA-induced hyperthermia by moderately inhibiting skin vasoconstriction, and labetalol was ineffective. In contrast, clozapine induced a marked and immediate reversal of MDMA-induced hyperthermia via inhibition of brain metabolic activation and blockade of skin vasoconstriction. Our findings suggest that clozapine, and related centrally acting drugs, might be highly effective for reversing MDMA-induced brain and body hyperthermia in emergency clinical situations, with possible life-saving results.

  2. Pharmacological profile of β3-adrenoceptor agonists in clinical development for the treatment of overactive bladder syndrome

    NARCIS (Netherlands)

    Igawa, Yasuhiko; Michel, Martin C.

    2013-01-01

    β(3)-Adrenoceptor agonists are an emerging drug class for the treatment of the overactive bladder syndrome, and clinical proof-of-concept data have been obtained for three representatives of this class, mirabegron, ritobegron, and solabegron. We review here the pharmacological profile of these three

  3. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment

    DEFF Research Database (Denmark)

    Roessner, Veit; Plessen, Kerstin J; Rothenberger, Aribert

    2011-01-01

    provide the first comprehensive overview of all reports on pharmacological treatment options for TS through a MEDLINE, PubMed, and EMBASE search for all studies that document the effect of pharmacological treatment of TS and other tic disorders between 1970 and November 2010. We present a summary...

  4. Guanidino-containing drugs in cancer chemotherapy: biochemical and clinical pharmacology.

    Science.gov (United States)

    Ekelund, S; Nygren, P; Larsson, R

    2001-05-15

    The pharmacology and clinical application of three guanidino-containing compounds are reviewed in this commentary with special focus on a new member of this group of drugs, CHS 828 [N-(6-(4-chlorophenoxy)hexyl)-N'-cyano-N"-4-pyridylguanidine]. m-Iodobenzylguanidine (MIBG) and methylglyoxal bis(guanylhydrazone) (MGBG) have been extensively studied, preclinically as well as clinically, and have established use as anticancer agents. MIBG has structural similarities to the neurotransmitter, norepinephrine, and MGBG is a structural analog of the natural polyamine spermidine. CHS 828 is a pyridyl cyanoguanidine newly recognized as having cytotoxic effects when screening antihypertensive compounds. Apart from having the guanidino groups in common, there are many differences between these drugs in both structure and their mechanisms of action. However, they all inhibit mitochondrial function, a seemingly unique feature among chemotherapeutic drugs. In vitro in various cell lines and primary cultures of patient tumor cells and in vivo in various tumor models, CHS 828 has cytotoxic properties unlike any of the standard cytotoxic drugs with which it has been compared. Among these are non-cross-resistance to standard drugs and pronounced activity in tumor models acknowledged to be highly drug-resistant. Similar to MIBG, CHS 828 induces an early increase in extracellular acidification, due to stimulation of the glycolytic flux. Furthermore, ATP levels decrease, and the syntheses of DNA and protein are shut off after approximately 30 hr of exposure, indicating active cell death. CHS 828 is now in early clinical trials, the results of which are eagerly awaited.

  5. Differential pharmacology and clinical utility of rolapitant in chemotherapy-induced nausea and vomiting

    Directory of Open Access Journals (Sweden)

    Rapoport BL

    2017-02-01

    Full Text Available Bernardo Leon Rapoport The Medical Oncology Centre of Rosebank, Johannesburg, South Africa Abstract: Chemotherapy-induced nausea and vomiting (CINV is a debilitating side effect of many cytotoxic chemotherapy regimens. CINV typically manifests during two well-defined time periods (acute and delayed phases. The acute phase is the first 24 hours after chemotherapy and is largely managed with 5-hydroxytryptamine 3 receptor antagonists. The delayed phase, a 5-day at-risk period during which patients are not often in direct contact with their health care provider, remains a significant unmet medical need. Neurokinin-1 (NK-1 receptor antagonists have demonstrated protection against acute and delayed CINV in patients treated with highly emetogenic chemotherapy and moderately emetogenic chemotherapy when used in combination with a 5-hydroxytryptamine 3 receptor antagonist and dexamethasone. Furthermore, recent data indicate that this protection is maintained over multiple treatment cycles. Rolapitant, a selective and long-acting NK-1 receptor antagonist, is approved as oral formulation for the prevention of delayed CINV in adults. This review discusses the differential pharmacology and clinical utility of rolapitant in preventing CINV compared with other NK-1 receptor antagonists. Keywords: antiemetics, highly emetogenic chemotherapy, moderately emetogenic chemotherapy, delayed chemotherapy-induced nausea and vomiting, emesis, neurokinin-1 receptor antagonists

  6. [Clinical subtypes of essential tremor and their electrophysiological and pharmacological differences].

    Science.gov (United States)

    Koguchi, Y; Nakajima, M; Kawamura, M; Hirayama, K

    1995-02-01

    We divided 19 patients with essential tremor into two subtypes according to clinical characteristics of the tremor. Ten patients had pure postural tremor distributed in the hand(s), head, and face (group A). Nine patients had tremor extending to the voice or leg(s), associated with resting tremor and/or hyperkinesie volitionnelle of the hand(s) (group B). Their ages, the age of onset, and the duration of illness were not different between the two groups. Electrophysiologically, the tremor of group A patients had higher frequencies than that of group B patients, and had synchronized activities for antagonistic muscles. Four of group B patients had reciprocal antagonistic activities of the tremor. Inactive phase of tremor induced by an electrically-evoked muscle twitch was invariably within the range of the physiological silent period for group A patients, and prolonged beyond the range for four of group B patients. Pharmacologically, 78% of group A patients responded well to beta-blocker, which was effective for 25% of group B patients. Sixty per cent of beta-blocker-resistant group B patients responded well to phenobarbital. In conclusion, a peripheral mechanism, presumably beta-adrenergic drive, is important for the tremor in group A patients, while central pathogenic mechanisms are more important for the tremor of group B patients.

  7. The retinoids. A review of their clinical pharmacology and therapeutic use.

    Science.gov (United States)

    Orfanos, C E; Ehlert, R; Gollnick, H

    1987-10-01

    With the introduction of the synthetic retinoids, oral therapy with an acceptable risk/benefit ratio became possible for a variety of skin diseases including severe acne, psoriasis and numerous genodermatoses. This article reviews the clinical pharmacology, mechanisms of action and therapeutic use of the retinoids, particularly isotretinoin (13-cis-retinoic acid) and etretinate. The free aromatic acid of etretinate, etretin, and the new polyaromatic retinoid compounds (arotinoids) are also discussed. Isotretinoin is used clinically for oral therapy of severe acne, but is also recommended for severe Gram-negative folliculitis and rosacea not responding to traditional therapy. The results of several studies have established that acne therapy should be started with 1.0 mg/kg/day for 2 to 3 months after which the daily dosage should be lowered to 0.2 to 0.5 mg/kg/day for another 2 to 3 months. This therapeutic regimen of isotretinoin has proven to be the most successful in preventing relapses. Etretinate is particularly useful for oral therapy of widespread plaque-like, pustular and erythrodermic psoriasis, and of generalised lichen planus, Darier's disease and severe congenital ichthyoses. Whereas pustular forms of psoriasis require a high daily dosage of 1.0 mg/kg/day, erythrodermic psoriasis should be treated with a lower dosage of 0.25 to 0.35 mg/kg/day. In chronic plaque-like psoriasis, a mean daily dosage of 0.5 mg/kg/day over several weeks to months, usually combined with photo(chemo)therapy, tar or dithranol, is recommended. Other indications for oral etretinate therapy are adequately treated with a moderate dosage of 0.4 to 0.75 mg/kg/day. Etretin differs from etretinate in having a much shorter elimination half-life of 2 to 3 days, in contrast to 80 to 100 days after long term administration of etretinate. Moreover, it has not been shown to increase serum cholesterol levels. However, its clinical efficacy is not yet clearly established. Among the arotinoids

  8. Non-pharmacological modification of endothelial function: An important lesson for clinical practice

    Directory of Open Access Journals (Sweden)

    Monika Szulińska

    2018-03-01

    The impact of endothelial function in the complex pathology of cardiovascular diseases reflects a number of scientific proofs showing favorable effects of non-pharmacological interventions in endothelial dysfunction treatment.

  9. Clinical benefit from pharmacological elevation of high-density lipoprotein cholesterol: meta-regression analysis.

    Science.gov (United States)

    Hourcade-Potelleret, F; Laporte, S; Lehnert, V; Delmar, P; Benghozi, Renée; Torriani, U; Koch, R; Mismetti, P

    2015-06-01

    Epidemiological evidence that the risk of coronary heart disease is inversely associated with the level of high-density lipoprotein cholesterol (HDL-C) has motivated several phase III programmes with cholesteryl ester transfer protein (CETP) inhibitors. To assess alternative methods to predict clinical response of CETP inhibitors. Meta-regression analysis on raising HDL-C drugs (statins, fibrates, niacin) in randomised controlled trials. 51 trials in secondary prevention with a total of 167,311 patients for a follow-up >1 year where HDL-C was measured at baseline and during treatment. The meta-regression analysis showed no significant association between change in HDL-C (treatment vs comparator) and log risk ratio (RR) of clinical endpoint (non-fatal myocardial infarction or cardiac death). CETP inhibitors data are consistent with this finding (RR: 1.03; P5-P95: 0.99-1.21). A prespecified sensitivity analysis by drug class suggested that the strength of relationship might differ between pharmacological groups. A significant association for both statins (p<0.02, log RR=-0.169-0.0499*HDL-C change, R(2)=0.21) and niacin (p=0.02, log RR=1.07-0.185*HDL-C change, R(2)=0.61) but not fibrates (p=0.18, log RR=-0.367+0.077*HDL-C change, R(2)=0.40) was shown. However, the association was no longer detectable after adjustment for low-density lipoprotein cholesterol for statins or exclusion of open trials for niacin. Meta-regression suggested that CETP inhibitors might not influence coronary risk. The relation between change in HDL-C level and clinical endpoint may be drug dependent, which limits the use of HDL-C as a surrogate marker of coronary events. Other markers of HDL function may be more relevant. 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.

  10. Pharmacological versus microvascular decompression approaches for the treatment of trigeminal neuralgia: clinical outcomes and direct costs

    Directory of Open Access Journals (Sweden)

    Almeida A

    2011-08-01

    therapies, while after MDV surgery several patients showed important side effects. Data reinforce that, (1 TN patients should be carefully evaluated before choosing therapy for pain control, (2 different pharmacological approaches are available to initiate pain control at low costs, and (3 criteria for surgical interventions should be clearly defined due to important side effects, with the initial higher costs being strongly reduced with time.Keywords: trigeminal neuralgia, carbamazepine, gabapentin associated with ropivacaine, microvascular decompression, clinical outcomes, direct costs 

  11. A new generation of antipsychotics: pharmacology and clinical utility of cariprazine in schizophrenia

    Directory of Open Access Journals (Sweden)

    Caccia S

    2013-08-01

    Full Text Available Silvio Caccia, Roberto William Invernizzi, Alessandro Nobili, Luca Pasina IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy Abstract: Cariprazine is a potential antipsychotic awaiting approval from the US Food and Drug Administration. It is a dopamine D2- and D3-receptor partial agonist, with higher affinity for D3 receptors, as opposed to the D2 antagonism of most older antipsychotic agents. Like most lipophilic antipsychotics, it undergoes extensive hepatic metabolism by cytochrome P450 (CYP, mainly the highly variable 3A4, with the formation of active metabolites. However, the parent compound – particularly its active didesmethyl derivative – is cleared very slowly, with elimination half-lives in schizophrenic patients ranging from 2–5 days for cariprazine to 2–3 weeks for didesmethyl-cariprazine. Exposure to the latter was several times that for cariprazine, although didesmethyl-cariprazine did not reach steady state within the 3 weeks of 12.5 mg/day dosing. Preliminary information on its therapeutic role comes from press releases and a few abstracts presented at scientific meetings. In short-term controlled trials, it was more effective than placebo in reducing positive and negative symptoms of schizophrenia, with an effective dose range of 1.5–12 mg/day. Although cariprazine was associated with a higher incidence of akathisia and extrapyramidal side effects than placebo, it did not cause weight gain, metabolic abnormalities, prolactin increase, or corrected QT prolongation. Similarly, cariprazine's efficacy and tolerability for the treatment of bipolar disorder (manic/mixed and depressive episodes was established in the dose range of 3–12 mg/day, although again no long-term data are available. Well-designed clinical trials, mainly direct "head-to-head" comparisons with other second-generation antipsychotic agents, are needed to define the therapeutic role and safety profile of cariprazine in schizophrenia and

  12. Bringing stability to the COPD patient: clinical and pharmacological considerations for frequent exacerbators

    Science.gov (United States)

    Gulati, Swati

    2017-01-01

    Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are critical events associated with accelerated loss of lung function, increased morbidity, and excess mortality. AECOPD are heterogeneous in nature and this may directly impact clinical decision making, specifically in patients with frequent exacerbations. A “frequent exacerbator” is a sub-phenotype of COPD that is defined as an individual who experiences ≥2 moderate to severe exacerbations per year. This distinct subgroup has higher mortality and account for more than half of COPD-related hospitalizations annually. Thus, it is imperative to identify individuals at risk for frequent exacerbations and choose optimal strategies to minimize risk for these events. New paradigms for utilizing combination inhalers and the introduction of novel oral compounds provide expanded treatment options to reduce the risk and frequency of exacerbations. The goals of managing frequent exacerbators or patients at risk for AECOPD are: 1) maximizing bronchodilation, 2) reducing inflammation, and 3) targeting specific molecular pathways implicated in COPD and AECOPD pathogenesis. Novel inhaler therapies include combination long acting muscarinic agents (LAMA) plus long acting beta agonists (LABA) show promising results compared to monotherapy or LABA inhaled corticosteroid (ICS) combination in reducing exacerbation risk among individuals at risk for exacerbations and among frequent exacerbators. Likewise, oral medications including macrolides and phosphodiesterase (PDE4) inhibitors reduce the risk for AECOPD in select groups of individuals at high risk for exacerbation. Future direction in COPD management is based on identification of various subtypes or “endotypes” and targeting therapies based on their pathophysiology. This review aims to describe the impact of AECOPD, challenges posed by frequent exacerbators, and explores the rationale for different pharmacologic approaches to preventing AECOPD in these

  13. Pharmacological and clinical dilemmas of prescribing in co-morbid adult attention-deficit/hyperactivity disorder and addiction

    Science.gov (United States)

    Pérez de los Cobos, José; Siñol, Núria; Pérez, Víctor; Trujols, Joan

    2014-01-01

    The present article reviews whether available efficacy and safety data support the pharmacological treatment of adult attention-deficit/hyperactivity disorder (ADHD) in patients with concurrent substance use disorders (SUD). Arguments for and against treating adult ADHD with active SUD are discussed. Findings from 19 large open studies and controlled clinical trials show that the use of atomoxetine or extended-release methylphenidate formulations, together with psychological therapy, yield promising though inconclusive results about short term efficacy of these drugs in the treatment of adult ADHD in patients with SUD and no other severe mental disorders. However, the efficacy of these drugs is scant or lacking for treating concurrent SUD. No serious safety issues have been associated with these drugs in patients with co-morbid SUD-ADHD, given their low risk of abuse and favourable side effect and drug–drug interaction profile. The decision to treat adult ADHD in the context of active SUD depends on various factors, some directly related to SUD-ADHD co-morbidity (e.g. degree of diagnostic uncertainty for ADHD) and other factors related to the clinical expertise of the medical staff and availability of adequate resources (e.g. the means to monitor compliance with pharmacological treatment). Our recommendation is that clinical decisions be individualized and based on a careful analysis of the advantages and disadvantages of pharmacological treatment for ADHD on a case-by-case basis in the context of active SUD. PMID:23216449

  14. Pharmacology and Therapeutics Education in the European Union Needs Harmonization and Modernization: A Cross-sectional Survey Among 185 Medical Schools in 27 Countries.

    Science.gov (United States)

    Brinkman, D J; Tichelaar, J; Okorie, M; Bissell, L; Christiaens, T; Likic, R; Mačìulaitis, R; Costa, J; Sanz, E J; Tamba, B I; Maxwell, S R; Richir, M C; van Agtmael, M A

    2017-11-01

    Effective teaching in pharmacology and clinical pharmacology and therapeutics (CPT) is necessary to make medical students competent prescribers. However, the current structure, delivery, and assessment of CPT education in the European Union (EU) is unknown. We sent an online questionnaire to teachers with overall responsibility for CPT education in EU medical schools. Questions focused on undergraduate teaching and assessment of CPT, and students' preparedness for prescribing. In all, 185 medical schools (64%) from 27 EU countries responded. Traditional learning methods were mainly used. The majority of respondents did not provide students with the opportunity to practice real-life prescribing and believed that their students were not well prepared for prescribing. There is a marked difference in the quality and quantity of CPT education within and between EU countries, suggesting that there is considerable scope for improvement. A collaborative approach should be adopted to harmonize and modernize the undergraduate CPT education across the EU. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  15. Clinical pharmacology of indomethacin in preterm infants: implications in patent ductus arteriosus closure.

    Science.gov (United States)

    Pacifici, Gian Maria

    2013-10-01

    Indomethacin is a non-steroidal anti-inflammatory drug that is a potent inhibitor of prostaglandin E(2) synthesis. After birth, the ductus arteriosus closes spontaneously within 2-4 days in term infants. The major factor closing the ductus arteriosus is the tension of oxygen, which increases significantly after birth. Prostaglandin E(2) has the opposite effect to that of oxygen; it relaxes smooth muscle and tends to inhibit the closure of the ductus arteriosus. In preterm infants with respiratory distress syndrome, the ductus arteriosus fails to close (patent ductus arteriosus [PDA]) because the concentration of prostaglandin E2 is relatively high. PDA occurs in more than 70 % of neonates weighing less than 1,500 g at birth. The aim of this article was to review the published data on the clinical pharmacology of indomethacin in preterm infants in order to provide a critical analysis of the literature and a useful tool for physicians. The bibliographic search was performed electronically using the PubMed and EMBASE databases as search engines and February 2012 was the cutoff point. A remarkable interindividual variability was observed for the half-life (t(½)), clearance (CL), and volume of distribution (V(d)) of indomethacin. Prophylactic indomethacin consists of a continuous infusion of low levels of indomethacin and may be useful in preterm infants. Extremely preterm infants are less likely to respond to indomethacin. Infants with a postnatal age of 2 months do not respond to treatment with indomethacin. Indomethacin has several adverse effects, the most common of which is renal failure. An increase in serum creatinine of ≥0.5 % mg/dL after indomethacin was observed in about 10-15 % of the patients and creatinine returns to a normal level about 1 week after cessation of therapy. Indomethacin should be administered intravenously by syringe pump for at least 30 min to minimize adverse effects on cerebral, gastrointestinal, and renal blood flow velocities. A

  16. Incretin-based therapies– review of the physiology, pharmacology and emerging clinical experience

    DEFF Research Database (Denmark)

    Martin, JH; Deacon, Carolyn F.; Gorrell, MD

    2011-01-01

    in type 2 diabetes, leading to development of strategies aimed at redressing this abnormality. These strategies include pharmacological inhibition of dipeptidyl peptidase-4, the enzyme responsible for the short half-life of endogenous incretins, and administration of long-acting dipeptidyl peptidase-4...

  17. Inconsistencies in clinical guidelines for obstetric anaesthesia for Caesarean section

    DEFF Research Database (Denmark)

    Winther, Lars; Mitchell, A U; Møller, Ann

    2013-01-01

    Anaesthetists need evidence-based clinical guidelines, also in obstetric anaesthesia. We compared the Danish, English, American, and German national guidelines for anaesthesia for Caesarean section. We focused on assessing the quality of guideline development and evaluation of the guidelines...

  18. Treatment of post-partum depression: a review of clinical, psychological and pharmacological options

    Directory of Open Access Journals (Sweden)

    Elizabeth Fitelson

    2010-12-01

    Full Text Available Elizabeth Fitelson1, Sarah Kim4, Allison Scott Baker3, Kristin Leight21Director, 2Attending Psychiatrist, TheWomen's Program, 3Child and Adolescent Psychiatry Fellow, Division of Child Psychiatry, 4PGY-I Resident in Psychiatry, Department of Psychiatry, Columbia University Medical Center, New York, NY, USAAbstract: Postpartum depression (PPD is a common complication of childbearing, and has increasingly been identified as a major public health problem. Untreated maternal depression has multiple potential negative effects on maternal-infant attachment and child development. Screening for depression in the perinatal period is feasible in multiple primary care or obstetric settings, and can help identify depressed mothers earlier. However, there are multiple barriers to appropriate treatment, including concerns about medication effects in breastfeeding infants. This article reviews the literature and recommendations for the treatment of postpartum depression, with a focus on the range of pharmacological, psychotherapeutic, and other non-pharmacologic interventions. Keywords: postpartum depression, postnatal depression, lactation, antidepressant, hormone therapy, psychotherapy, bright light therapy, omega-3

  19. Experimental and Clinical Pharmacology of Andrographis paniculata and Its Major Bioactive Phytoconstituent Andrographolide

    Directory of Open Access Journals (Sweden)

    Thanasekaran Jayakumar

    2013-01-01

    Full Text Available Andrographis paniculata (Burm. F Nees, generally known as “king of bitters,” is an herbaceous plant in the family Acanthaceae. In China, India, Thailand, and Malaysia, this plant has been widely used for treating sore throat, flu, and upper respiratory tract infections. Andrographolide, a major bioactive chemical constituent of the plant, has shown anticancer potential in various investigations. Andrographolide and its derivatives have anti-inflammatory effects in experimental models asthma, stroke, and arthritis. In recent years, pharmaceutical chemists have synthesized numerous andrographolide derivatives, which exhibit essential pharmacological activities such as those that are anti-inflammatory, antibacterial, antitumor, antidiabetic, anti-HIV, antifeedant, and antiviral. However, what is noteworthy about this paper is summarizing the effects of andrographolide against cardiovascular disease, platelet activation, infertility, and NF-κB activation. Therefore, this paper is intended to provide evidence reported in relevant literature on qualitative research to assist scientists in isolating and characterizing bioactive compounds.

  20. Experimental and Clinical Pharmacology of Andrographis paniculata and Its Major Bioactive Phytoconstituent Andrographolide

    Science.gov (United States)

    Jayakumar, Thanasekaran; Hsieh, Cheng-Ying; Lee, Jie-Jen; Sheu, Joen-Rong

    2013-01-01

    Andrographis paniculata (Burm. F) Nees, generally known as “king of bitters,” is an herbaceous plant in the family Acanthaceae. In China, India, Thailand, and Malaysia, this plant has been widely used for treating sore throat, flu, and upper respiratory tract infections. Andrographolide, a major bioactive chemical constituent of the plant, has shown anticancer potential in various investigations. Andrographolide and its derivatives have anti-inflammatory effects in experimental models asthma, stroke, and arthritis. In recent years, pharmaceutical chemists have synthesized numerous andrographolide derivatives, which exhibit essential pharmacological activities such as those that are anti-inflammatory, antibacterial, antitumor, antidiabetic, anti-HIV, antifeedant, and antiviral. However, what is noteworthy about this paper is summarizing the effects of andrographolide against cardiovascular disease, platelet activation, infertility, and NF-κB activation. Therefore, this paper is intended to provide evidence reported in relevant literature on qualitative research to assist scientists in isolating and characterizing bioactive compounds. PMID:23634174

  1. A Brief Review of the Pharmacology of Amitriptyline and Clinical Outcomes in Treating Fibromyalgia

    Directory of Open Access Journals (Sweden)

    Kim Lawson

    2017-05-01

    Full Text Available Fibromyalgia is a complex chronic condition characterized by pain, physical fatigue, sleep disorder and cognitive impairment. Evidence-based guidelines recommend antidepressants as treatments of fibromyalgia where tricyclics are often considered to have the greatest efficacy, with amitriptyline often being a first-line treatment. Amitriptyline evokes a preferential reduction in pain and fatigue of fibromyalgia, and in the Fibromyalgia Impact Questionnaire (FIQ score, which is a quality of life assessment. The multimodal profile of the mechanisms of action of amitriptyline include monoamine reuptake inhibition, receptor modulation and ion channel modulation. Several of the actions of amitriptyline on multiple nociceptive and sensory processes at central and peripheral locations have the potential to act cumulatively to suppress the characteristic symptoms of fibromyalgia. Greater understanding of the role of these mechanisms of action of amitriptyline could provide further clues to the pathophysiology of fibromyalgia and to a preferable pharmacological profile for future drug development.

  2. A Brief Review of the Pharmacology of Amitriptyline and Clinical Outcomes in Treating Fibromyalgia

    Science.gov (United States)

    Lawson, Kim

    2017-01-01

    Fibromyalgia is a complex chronic condition characterized by pain, physical fatigue, sleep disorder and cognitive impairment. Evidence-based guidelines recommend antidepressants as treatments of fibromyalgia where tricyclics are often considered to have the greatest efficacy, with amitriptyline often being a first-line treatment. Amitriptyline evokes a preferential reduction in pain and fatigue of fibromyalgia, and in the Fibromyalgia Impact Questionnaire (FIQ) score, which is a quality of life assessment. The multimodal profile of the mechanisms of action of amitriptyline include monoamine reuptake inhibition, receptor modulation and ion channel modulation. Several of the actions of amitriptyline on multiple nociceptive and sensory processes at central and peripheral locations have the potential to act cumulatively to suppress the characteristic symptoms of fibromyalgia. Greater understanding of the role of these mechanisms of action of amitriptyline could provide further clues to the pathophysiology of fibromyalgia and to a preferable pharmacological profile for future drug development. PMID:28536367

  3. Trace Amines and the Trace Amine-Associated Receptor 1: Pharmacology, Neurochemistry and Clinical Implications

    Directory of Open Access Journals (Sweden)

    Yue ePei

    2016-04-01

    Full Text Available Biogenic amines are a collection of endogenous molecules that play pivotal roles as neurotransmitters and hormones. In addition to the classical biogenic amines resulting from decarboxylation of aromatic acids, including dopamine (DA, norepinephrine, epinephrine, serotonin (5-HT and histamine, other biogenic amines, present at much lower concentrations in the central nervous system (CNS, and hence referred to as trace amines (TAs, are now recognized to play significant neurophysiological and behavioural functions. At the turn of the century, the discovery of the trace amine-associated receptor 1 (TAAR1, a phylogenetically conserved G protein-coupled receptor that is responsive to both TAs, such as β-phenylethylamine, octopamine and tyramine, and structurally-related amphetamines, unveiled mechanisms of action for TAs other than interference with aminergic pathways, laying the foundations for deciphering the functional significance of TAs and its mammalian CNS receptor, TAAR1. Although its molecular interactions and downstream targets have not been fully elucidated, TAAR1 activation triggers accumulation of intracellular cAMP, modulates PKA and PKC signalling and interferes with the β-arrestin2-dependent pathway via G protein-independent mechanisms. TAAR1 is uniquely positioned to exert direct control over DA and 5-HT neuronal firing and release, which has profound implications for understanding the pathophysiology of, and therefore designing more efficacious therapeutic interventions for, a range of neuropsychiatric disorders that involve aminergic dysregulation, including Parkinson’s disease, schizophrenia, mood disorders and addiction. Indeed, the recent development of novel pharmacological tools targeting TAAR1 has uncovered the remarkable potential of TAAR1-based medications as new generation pharmacotherapies in neuropsychiatry. This review summarizes recent developments in the study of TAs and TAAR1, their intricate neurochemistry and

  4. FDG PET in non-pharmacological therapy in Alzheimer's disease; cerebral metabolic increase correlates with clinical improvement after cognitive therapy

    International Nuclear Information System (INIS)

    Na, Hae Ri; Kim, Yu Kyeong; Park, Seong Min; Lee, Seung Hyun; Park, Eun Kyung; Lee, Jung Seok; Kim, Sang Yun; Kim, Sang Eun

    2007-01-01

    In management of AD, pharmacological treatment alone using acetylcholinesterase inhibitor (AChEI) is general consensus, and provides beneficial effect to prolong their progression. Combined non-pharmacological therapy, especially cognitive therapy is recently having attention with expectation of improvement in cognitive ability. This study examined the effect of combined cognitive therapy in AD patients who were maintaining AChEI using FDG PET. Four patients (689 yrs) who diagnosed as probable Alzheimer's disease based on the NINCDS-ADRDA criteria participated in this study. 12-week cognitive therapy comprised seven fields to enhance orientation, memory, recall, visuo-motor organization, categorization and behavior modification/sequencing. They received 45-minute sessions twice per week with maintaining their previous medication. Clinical improvement was assessed by comprehensive neuropsychological tests. Two FDG PET studies were performed before cognitive therapy and in the middle of the therapy, and compared to evaluate the effect of cognitive therapy to cerebral metabolism. Two of 4 patients whose initial cognitive impairment was milder had clinical improvement after 12 weeks, the rest who were more severely impaired failed to have clinical improvement. Regional cerebral hypometabolism on initial PET was correlated with their functional status. Follow up PET of two responders demonstrated the increases in regional metabolism in the temporal and/or frontal cortex, which was associated their functional improvement. Cerebral metabolism in poor responders were minimally increased or no changed. This preliminary data suggests that cognitive therapy is potentially useful to stabilize or improve cognitive and functional performance in AD patients with relatively mild cognitive dysfunction. And FDG PET could demonstrate possible candidates for cognitive therapy and the effect of the therapy

  5. A feasibility study of a new approach to clinical radiosensitisation: hypothermia and hyperbaric oxygen in combination with pharmacological vasodilatation

    International Nuclear Information System (INIS)

    Sealy, R.; Harrison, G.G.; Morrell, D.; Cape Town Univ.

    1986-01-01

    It is proposed that hyperbaric oxygen fails in the clinical situation due to a high proportion (greater than 33%) of hypoxic cells in human tumours. The means of overcoming this problem are reviewed. Additional to hyperbaric oxygenation, moderate hypothermia (30 0 C) to allow redistribution of oxygen in the tumour is proposed. A system of externally controlled intravenous anaesthesia has been developed for the single-subject hypervaric cylinder. Pharmacological vasodilatation is induced in the anaesthetised patient who is then fluid loaded and cooled. Initial single-sensitising treatments are advocated. Twenty-nine patients with advanced mouth cancer have completed a course of this treatment, of whom five of nine were free of disease after 2 years and 10 of 21 at 1 year, with three intercurrent deaths. Fifteen have experienced local failure. This approach would appear to be practical, safe and promising. (author)

  6. Prescribing knowledge in the light of undergraduate clinical pharmacology and therapeutics teaching in India: views of first-year postgraduate students

    Directory of Open Access Journals (Sweden)

    Upadhyaya P

    2012-06-01

    Full Text Available Prerna Upadhyaya,1 Vikas Seth,2 Monika Sharma,1 Mushtaq Ahmed,1 Vijay Vasant Moghe,1 Zafar Yab Khan,1 Vinay Kumar Gupta,1 Shipra Vikram Jain,1 Utkarsh Soni,1 Manohar Bhatia,1 Kumar Abhijit,1 Jaswant Goyal11Department of Pharmacology, Mahatma Gandhi Medical College, Jaipur, 2Department of Pharmacology, Hind Institute of Medical Sciences, Lucknow, IndiaObjectives: The study aimed to review the prescribing knowledge of first-year postgraduate doctors in a medical college in India, using the principles of good prescribing, to suggest strategies to improve rational prescribing, and to recommend what curriculum planners can do to accomplish this objective.Methods: Fifty first-year postgraduate doctors were asked to fill in a structured questionnaire that sought information regarding their undergraduate training in clinical pharmacology and therapeutics, prescribing habits, and commonly consulted drug information sources. Also, the questionnaire assessed any perceived deficiencies in their undergraduate clinical pharmacology teaching and sought feedback regarding improvement in the teaching.Results: Eighty-eight percent of residents said that they were taught prescription writing in undergraduate pharmacology teaching; 48% of residents rated their prescribing knowledge at graduation as average, 28% good, 4% excellent, 14% poor, and 4% very poor; 58% felt that their undergraduate training did not prepare them to prescribe safely, and 62% felt that their training did not prepare them to prescribe rationally. Fifty-eight percent of residents felt that they had some specific problems with writing a prescription during their internship training, while 92% thought that undergraduate teaching should be improved. Their suggestions for improving teaching methods were recorded.Conclusions: This study concludes that efforts are needed to develop a curriculum that encompasses important aspects of clinical pharmacology and therapeutics along with incorporation of

  7. Impact of clinical audits on cesarean section rate.

    Science.gov (United States)

    Peng, Fu-Shiang; Lin, Hsien-Ming; Lin, Ho-Hsiung; Tu, Fung-Chao; Hsiao, Chin-Fen; Hsiao, Sheng-Mou

    2016-08-01

    Many countries have noted a substantial increase in the cesarean section rate (CSR). Several methods for lowering the CSR have been described. Understanding the impact of clinical audits on the CSR may aid in lowering CSR. Thus, our aim is to elucidate the effect of clinical audits on the CSR. We retrospectively analyzed 3781 pregnant women who gave birth in a medical center between January 2008 and January 2011. Pregnant women who delivered between January 2008 and July 2009 were enrolled as the pre-audit group (n = 1592). After August 2009, all cesarean section cases that were audited were enrolled in the audit group (n = 2189). The CSR was compared between groups. The overall CSR (34.5% vs. 31.1%, adjusted odds ratio [OR] = 0.83, p = 0.008) and the cesarean section rate due to dystocia (9.6% vs. 6.2%, p strategy for reducing the CSR. Therefore, we recommend strict monitoring of the indications in dystocia for cesarean section to reduce the CSR. Copyright © 2016. Published by Elsevier B.V.

  8. Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas

    Directory of Open Access Journals (Sweden)

    Jain S

    2017-03-01

    Full Text Available Sachin Jain,1 Ruolan Song,2 Jingwu Xie2 1Indiana University School of Medicine, 2Department of Pediatrics, Herman B Wells Center for Pediatric Research, Indianapolis, IN, USA Abstract: The Hedgehog (Hh pathway is critical for cell differentiation, tissue polarity, and stem cell maintenance during embryonic development, but is silent in adult tissues under normal conditions. However, aberrant Hh signaling activation has been implicated in the development and promotion of certain types of cancer, including basal cell carcinoma (BCC, medulloblastoma, and gastrointestinal cancers. In 2015, the US Food and Drug Administration (FDA approved sonidegib, a smoothened (SMO antagonist, for treatment of advanced BCC (aBCC after a successful Phase II clinical trial. Sonidegib, also named Odomzo, is the second Hh signaling inhibitor approved by the FDA to treat BCCs following approval of the first SMO antagonist vismodegib in 2012. What are the major features of sonidegib (mechanism of action; metabolic profiles, clinical efficacy, safety, and tolerability profiles? Will the sonidegib experience help other clinical trials using Hh signaling inhibitors in the future? In this review, we will summarize current understanding of BCCs and Hh signaling. We will focus on sonidegib and its use in the clinic, and we will discuss ways to improve its clinical application in cancer therapeutics. Keywords: Hedgehog, smoothened, inhibitor, cancer, basal cell carcinoma, sonidegib

  9. [Clinical and pharmacological aspects of rifaximin, local antibiotic therapy in intestinal disorders].

    Science.gov (United States)

    Gasztonyi, Beáta; Hunyady, Béla

    2004-10-24

    The authors report pharmacokinetics and indications of rifaximin and the results of clinical studies. Rifaximin has a large antibacterial spectrum with a good therapeutic effect on both gram positive and gram negative aerob and anaerob bacteria. Practically there is no absorption (< 1%) following oral administration with a high concentration in gastrointestinal mucosa (8000 microg/g). No increase in absorption can be detected in intestinal damage caused by inflammatory bowel disease. The remarkable safety profile of rifaximin is due to its negligible quality of absorption. According to the clinical studies rifaximin could be an adequate therapeutic approach in all gastrointestinal diseases and interventions when antibacterial therapy is needed.

  10. Systematic review of clinical trials assessing pharmacological properties of Salvia species on memory, cognitive impairment and Alzheimer's disease.

    Science.gov (United States)

    Miroddi, Marco; Navarra, Michele; Quattropani, Maria C; Calapai, Fabrizio; Gangemi, Sebastiano; Calapai, Gioacchino

    2014-06-01

    Salvia officinalis L. and Salvia lavandulaefolia L. have a longstanding use as traditional herbal remedies that can enhance memory and improve cognitive functions. Pharmacological actions of S. officinalis and S. lavandulaefolia on healthy subjects and on patients suffering of cognitive decline have been investigated. Aim of this review was to summarize published clinical trials assessing effectiveness and safety of S. officinalis and S. lavandulaefolia in the enhancement of cognitive performance in healthy subjects and neurodegenerative illnesses. Furthermore, to purchase a more complete view on safety of S. officinalis and S. lavandulaefolia, we collected and discussed articles regarding toxicity and adverse reactions. Eight clinical studies investigating on acute effects of S. officinalis on healthy subjects were included in the review. Six studies investigated on the effects of S. officinalis and S. lavandaeluaefolia on cognitive performance in healthy subjects. The two remaining were carried out to study the effects of sage on Azheimer's disease. Our review shows that S. officinalis and S. lavandulaefolia exert beneficial effects by enhancing cognitive performance both in healthy subjects and patients with dementia or cognitive impairment and is safe for this indication. Unfortunately, promising beneficial effects are debased by methodological issues, use of different herbal preparations (extracts, essential oil, use of raw material), lack of details on herbal products used. We believe that sage promising effects need further higher methodological standard clinical trials. © 2014 John Wiley & Sons Ltd.

  11. Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders

    Directory of Open Access Journals (Sweden)

    Jost WH

    2015-04-01

    Full Text Available Wolfgang H Jost,1 Reiner Benecke,2 Dieter Hauschke,3 Joseph Jankovic,4 Petr Kaňovský,5 Peter Roggenkämper,6 David M Simpson,7 Cynthia L Comella81Department of Neurology, University of Freiburg, Freiburg, Germany; 2Clinic and Policlinic for Neurology, University of Rostock, Rostock, Germany; 3Institute of Medical Biometry and Medical Informatics, University of Freiburg, Freiburg, Germany; 4Department of Neurology, Baylor College of Medicine, Houston, TX, USA; 5Department of Neurology, Palacky University Olomouc, Faculty of Medicine and Dentistry and University Hospital, Olomouc, Czech Republic; 6University Eye Clinic of Bonn, Bonn, Germany; 7Icahn School of Medicine at Mount Sinai, New York, NY, USA; 8Rush University Medical Center, Chicago, IL, USABackground: IncobotulinumtoxinA (Xeomin® is a purified botulinum neurotoxin type A formulation, free from complexing proteins, with proven efficacy and good tolerability for the treatment of neurological conditions such as blepharospasm, cervical dystonia (CD, and post-stroke spasticity of the upper limb. This article provides a comprehensive overview of incobotulinumtoxinA based on randomized controlled trials and prospective clinical studies.Summary: IncobotulinumtoxinA provides clinical efficacy in treating blepharospasm, CD, and upper-limb post-stroke spasticity based on randomized, double-blind, placebo-controlled trials with open-label extension periods (total study duration up to 89 weeks. Adverse events were generally mild or moderate. The most frequent adverse events, probably related to the injections, included eyelid ptosis and dry eye in the treatment of blepharospasm, dysphagia, neck pain, and muscular weakness in patients with CD, and injection site pain and muscular weakness when used for treating spasticity. In blepharospasm and CD, incobotulinumtoxinA was investigated in clinical trials permitting flexible intertreatment intervals based on the individual patient’s clinical need

  12. Thuja occidentalis (Arbor vitae): A Review of its Pharmaceutical, Pharmacological and Clinical Properties

    OpenAIRE

    Naser, Belal; Bodinet, Cornelia; Tegtmeier, Martin; Lindequist, Ulrike

    2005-01-01

    Arbor vitae (Thuja occidentalis L.) is a native European tree widely used in homeopathy and evidence-based phytotherapy. Many reviews and monographs have been published on the herbal substance's description, mode of action and clinical use. However, no comprehensive evidence-based review is available. Therefore, our aim was to search MEDLINE databases and survey manufacturers for further details or unpublished data. This review presents the botany, ethnobotany and phytochemistry, especial...

  13. Thuja occidentalis (Arbor vitae: A Review of its Pharmaceutical, Pharmacological and Clinical Properties

    Directory of Open Access Journals (Sweden)

    Belal Naser

    2005-01-01

    Full Text Available Arbor vitae (Thuja occidentalis L. is a native European tree widely used in homeopathy and evidence-based phytotherapy. Many reviews and monographs have been published on the herbal substance's description, mode of action and clinical use. However, no comprehensive evidence-based review is available. Therefore, our aim was to search MEDLINE databases and survey manufacturers for further details or unpublished data. This review presents the botany, ethnobotany and phytochemistry, especially the different contents of essential oil (Thujone in relation to different extraction procedures of this medicinal plant. Thuja's antiviral action and immunopharmacological potential, such as stimulatory and co-stimulatory effects on cytokine and antibody production and activation of macrophages and other immunocompetent cells, have been evaluated in numerous in vitro and in vivo investigations. Although no controlled trials have been conducted on Thuja occ alone, many clinical studies have been performed with a herbal medicinal product containing a special extract of Thuja occ and other immunostimulants, demonstrating its therapeutic efficacy and safety in respiratory tract infections.

  14. Improving the Clinical Pharmacologic Assessment of Abuse Potential: Part 1: Regulatory Context and Risk Management.

    Science.gov (United States)

    Sellers, Edward M

    2018-02-01

    This article brings to the attention of drug developers the Food and Drug Administration's (FDA's) recent final Guidance to Industry on Assessment of Abuse Potential and provides practical suggestions about compliance with the Guidance. The Guidance areas are reviewed, analyzed, and placed in the context of current scientific knowledge and best practices to mitigate regulatory risk. The Guidance provides substantial new detail on what needs to be done at all stages of drug development for central nervous system-active drugs. However, because many psychopharmacologic agents have unique preclinical and clinical features, the plan for each agent needs to be not only carefully prepared but also reviewed and approved by the FDA. Examples are provided where assumptions about interpretation of the Guidance can delay development. If the expertise and experience needed for assessing abuse potential during drug development do not exist within a company, external preclinical and clinical expert should be involved. Consultation with the FDA is encouraged and important because the specific requirements for each drug will vary.

  15. Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility

    Directory of Open Access Journals (Sweden)

    Davis-Ajami ML

    2014-04-01

    Full Text Available Mary Lynn Davis-Ajami,1 Jun Wu,2 Katherine Downton,3 Emilie Ludeman,3 Virginia Noxon4 1Organizational Systems and Adult Health, University of Maryland School of Nursing, Baltimore, MD, USA; 2South Carolina College of Pharmacy, University of South Carolina, Greenville, SC, USA; 3Health Sciences and Human Services Library, University of Maryland, Baltimore, MD, USA; 4Department of Clinical Pharmacy and Outcomes Science, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA Abstract: Epoetin zeta was granted marketing authorization in October 2007 by the European Medicines Agency as a recombinant human erythropoietin erythropoiesis-stimulating agent to treat symptomatic anemia of renal origin in adult and pediatric patients on hemodialysis and adults on peritoneal dialysis, as well as for symptomatic renal anemia in adult patients with renal insufficiency not yet on dialysis. Currently, epoetin zeta can be administered either subcutaneously or intravenously to correct for hemoglobin concentrations ≤10 g/dL (6.2 mmol/L or with dose adjustment to maintain hemoglobin levels at desired levels not in excess of 12 g/dL (7.5 mmol/L. This review article focuses on epoetin zeta indications in chronic kidney disease, its use in managing anemia of renal origin, and discusses its pharmacology and clinical utility. Keywords: biosimilar, chronic kidney disease, epoetin alfa, erythropoiesis, renal anemia, Retacrit®

  16. Trends in qualifying biomarkers in drug safety. Consensus of the 2011 meeting of the spanish society of clinical pharmacology.

    Science.gov (United States)

    Agúndez, José A G; Del Barrio, Jaime; Padró, Teresa; Stephens, Camilla; Farré, Magí; Andrade, Raúl J; Badimon, Lina; García-Martín, Elena; Vilahur, Gemma; Lucena, M Isabel

    2012-01-01

    In this paper we discuss the consensus view on the use of qualifying biomarkers in drug safety, raised within the frame of the XXIV meeting of the Spanish Society of Clinical Pharmacology held in Málaga (Spain) in October, 2011. The widespread use of biomarkers as surrogate endpoints is a goal that scientists have long been pursuing. Thirty years ago, when molecular pharmacogenomics evolved, we anticipated that these genetic biomarkers would soon obviate the routine use of drug therapies in a way that patients should adapt to the therapy rather than the opposite. This expected revolution in routine clinical practice never took place as quickly nor with the intensity as initially expected. The concerted action of operating multicenter networks holds great promise for future studies to identify biomarkers related to drug toxicity and to provide better insight into the underlying pathogenesis. Today some pharmacogenomic advances are already widely accepted, but pharmacogenomics still needs further development to elaborate more precise algorithms and many barriers to implementing individualized medicine exist. We briefly discuss our view about these barriers and we provide suggestions and areas of focus to advance in the field.

  17. Clinical evaluation of a nutraceutical diet as an adjuvant to pharmacological treatment in dogs affected by Keratoconjunctivitis sicca.

    Science.gov (United States)

    Destefanis, Simona; Giretto, Daniela; Muscolo, Maria Cristina; Di Cerbo, Alessandro; Guidetti, Gianandrea; Canello, Sergio; Giovazzino, Angela; Centenaro, Sara; Terrazzano, Giuseppe

    2016-09-22

    Canine keratoconjunctivitis sicca (cKCS) is an inflammatory eye condition related to a deficiency in the tear aqueous fraction. Etiopathogenesis of such disease is substantially multifactorial, combining the individual genetic background with environmental factors that contribute to the process of immunological tolerance disruption and, as a consequence, to the emergence of autoimmunity disease. In this occurrence, it is of relevance the role of the physiological immune-dysregulation that results in immune-mediated processes at the basis of cKCS. Current therapies for this ocular disease rely on immunosuppressive treatments. Clinical response to treatment frequently varies from poor to good, depending on the clinical-pathological status of eyes at diagnosis and on individual response to therapy. In the light of the variability of clinical response to therapies, we evaluated the use of an anti-inflammatory/antioxidant nutraceutical diet with potential immune-modulating activity as a therapeutical adjuvant in cKCS pharmacological treatment. Such combination was administered to a cohort of dogs affected by cKCS in which the only immunosuppressive treatment resulted poorly responsive or ineffective in controlling the ocular symptoms. Fifty dogs of different breeds affected by immune-mediated cKCS were equally distributed and randomly assigned to receive either a standard diet (control, n = 25) or the nutraceutical diet (treatment group, n = 25) both combined with standard immunosuppressive therapy over a 60 days period. An overall significant improvement of all clinical parameters (tear production, conjunctival inflammation, corneal keratinization, corneal pigment density and mucus discharge) and the lack of food-related adverse reactions were observed in the treatment group (p metabolic changes could affect the immune response orchestration in a model of immune-mediated ocular disease, as represented by cKCS.

  18. Educational Paper: Aspects of clinical pharmacology in children--pharmacovigilance and safety.

    Science.gov (United States)

    Choonara, Imti

    2013-05-01

    Adverse drug reactions (ADRs) are a significant problem in children, affecting one in ten children in hospital. Within the community, one in 500 children will experience an adverse drug reaction each year. Pharmacovigilance has been useful in detecting suspected ADRs. However, most ADRs are unreported and often not suspected. Education of health professionals in relation to drug toxicity improves the reporting rate of suspected ADRs. Clinical trials are useful to evaluate the efficacy of drugs. They are, however, not the best way of looking at ADRs where surveillance following the widespread use of a drug is more appropriate. Alongside work by the regulatory agencies, independent investigators have helped collate data. This information has been useful in developing guidelines to prevent further cases of drug toxicity. Greater awareness and understanding of drug toxicity in children should result in more rational prescribing.

  19. [Pharmacology of local anesthetics and clinical aspects of segmental blocking. II. Spinal anesthesia].

    Science.gov (United States)

    Kozlov, S P; Svetlov, V A; Luk'ianov, M V

    1998-01-01

    Clinical picture of development of segmental blocking after subarachnoidal injection of hyperbaric solutions of 0.75% bupivacaine, 5% ultracaine, and isobaric 0.5% bupivacaine is studied. A total of 152 patients operated on the lower part of the body and the lower limbs were examined under conditions of single, prolonged subarachnoidal, and combined spinal epidural anesthesia. Ultracaine and bupivacaine in different concentrations with different barism provided anesthesia equivalent by the efficacy, depth, and dissemination of sensory block. Segmental blocking with 5% ultracaine was characterized by the shortest latent period (3.14 +/- 0.16 min, p anesthesia in comparison with a single injection, and combined spinal epidural anesthesia shortened the latent period of segmental blocking and ensured intraoperative anesthesia and postoperative analgesia at the expense of the epidural component.

  20. Verapamil for cluster headache. Clinical pharmacology and possible mode of action

    DEFF Research Database (Denmark)

    Tfelt-Hansen, Peer; Tfelt-Hansen, Jacob

    2009-01-01

    is therefore limited. The clinical use of verapamil in cluster headache is reviewed and several relevant drug interactions are mentioned. Finally, its possible mode of action in cluster headache is discussed. The effect of verapamil in cluster headache most likely takes place in the hypothalamus......Verapamil is used mainly in cardiovascular diseases. High-dose verapamil (360-720 mg) is, however, currently the mainstay in the prophylactic treatment of cluster headache. The oral pharmacokinetics are variable. The pharmacodynamic effect of verapamil, the effect on blood pressure, also varies.......Verapamil is an L-type calcium channel blocker but it is also a blocker of other calcium channels (T-, P-, and possibly N- and Q-type Ca(2+) channels) and the human ether-a-go-go-related gene potassium channel. With so many different actions of verapamil, it is impossible at the present time to single out a certain...

  1. CLINICAL AND PHARMACOLOGICAL APPROACHES TO OPTIMIZE THE DOSING REGIMEN OF ANTIBACTERIAL DRUGS IN PEDIATRICS

    Directory of Open Access Journals (Sweden)

    Natal’ya B. Lazareva

    2018-01-01

    Full Text Available The rational use of antibacterial drugs in children implies an adequate choice of the necessary medication, its dosing regimen, and the duration of treatment in order to achieve maximum efficacy and minimize toxic effects. The knowledge of pharmacokinetic and pharmacodynamic profiles of the antibacterial drug plays a crucial role for optimizing the dosing regimen. The strategy of individual choice of the dosing regimen, taking into account the principles of pharmacokinetics and pharmacodynamics, can be especially effective in patients with the expectedly changed parameters of pharmacokinetics and in infections caused by bacteria strains with low sensitivity to antibiotics. The review presents a contemporary view of pharmacokinetic and pharmacodynamic profiles of antibacterial drugs most commonly used in pediatrics and their relationship to the clinical efficacy of the administered therapy.

  2. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest : rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

    NARCIS (Netherlands)

    Blom, M T; van Hoeijen, D A; Bardai, A; Berdowski, J; Souverein, P C; De Bruin, M L; Koster, R W; de Boer, A; Tan, H L

    2014-01-01

    INTRODUCTION: Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Recognising the complexity of the underlying causes of OHCA in the community, we aimed to establish the clinical, pharmacological, environmental and genetic factors and their interactions that may cause OHCA.

  3. Treatment outcomes of a Numeric Rating Scale (NRS)-guided pharmacological pain management strategy in symptomatic knee and hip osteoarthritis in daily clinical practice.

    NARCIS (Netherlands)

    Snijders, G.F.; Ende, C.H.M. van den; Bemt, B.J.F van den; Riel, P.L.C.M. van; Hoogen, F.H.J. van den; Broeder, A. den

    2012-01-01

    OBJECTIVES: To describe the results of a Numeric Rating Scale (NRS)-guided pharmacological pain management strategy in symptomatic knee and hip osteoarthritis (OA) in daily clinical practice. METHODS: In this observational cohort study, standardised conservative treatment was offered to patients

  4. Recent developments in the clinical pharmacology of rolapitant: subanalyses in specific populations

    Directory of Open Access Journals (Sweden)

    Rapoport BL

    2017-09-01

    Full Text Available Bernardo Leon Rapoport,1 Matti Aapro,2 Martin R Chasen,3 Karin Jordan,4 Rudolph M Navari,5 Ian Schnadig,6 Lee Schwartzberg7 1The Medical Oncology Centre of Rosebank, Johannesburg, South Africa; 2Breast Center, Genolier Cancer Center, Genolier, Switzerland; 3Palliative Care, William Osler Health Services, Brampton, ON, Canada; 4Department of Medicine V, University of Heidelberg, Heidelberg, Germany; 5Division of Hematology Oncology, University of Alabama School of Medicine, Birmingham, AL, USA; 6Compass Oncology, US Oncology Research, Tualatin, OR, USA; 7West Clinic, Memphis, TN, USA Abstract: Knowledge of the involvement of the neurokinin substance P in emesis has led to the development of the neurokinin-1 receptor antagonists (NK-1 RAs for control of chemotherapy-induced nausea and vomiting (CINV, in combination with serotonin type 3 receptor antagonists and corticosteroids. The NK-1 RA rolapitant, recently approved in oral formulation, has nanomolar affinity for the NK-1 receptor, as do the other commercially available NK-1 RAs, aprepitant and netupitant. Rolapitant is rapidly absorbed and has a long half-life in comparison to aprepitant and netupitant. All three NK-1 RAs undergo metabolism by cytochrome P450 (CYP 3A4, necessitating caution with the concomitant use of CYP3A4 inhibitors, but in contrast to aprepitant and netupitant, rolapitant does not inhibit or induce CYP3A4. However, rolapitant is a moderate inhibitor of CYP2D6, and concomitant use with CYP2D6 substrates with narrow therapeutic indices should be avoided. Aprepitant, netupitant, and rolapitant have all demonstrated efficacy in the control of delayed CINV in patients receiving moderately and highly emetogenic chemotherapy in randomized controlled trials, including over multiple cycles of chemotherapy. We reviewed recent post hoc analyses of clinical trial data demonstrating that rolapitant is efficacious in the control of CINV in patient populations with specific tumor types

  5. Behavioral and pharmacological treatment methods for pregnant smokers: issues for clinical practice.

    Science.gov (United States)

    Windsor, R; Oncken, C; Henningfield, J; Hartmann, K; Edwards, N

    2000-01-01

    Active and passive exposure to tobacco smoke are the most serious and preventable causes of poor maternal, fetal, and infant outcomes in the United States. Unfortunately, the majority of pregnant smokers do not quit smoking before or during pregnancy or after childbirth. We describe a standardized behavioral counseling model and discuss issues to consider in recommending the use of pharmacotherapy during pregnancy. Although the Food and Drug Administration no longer classifies nicotine replacement therapy (NRT) as contraindicated during pregnancy, precautions should be carefully considered for use in this population. This paper provides a synopsis of the risks of exposure to tobacco smoke during pregnancy and the postpartum; estimates the population at risk and the potential for increased cessation if effective health education methods during pregnancy were routinely provided; presents a meta-analysis of "best practice" patient education methods for pregnant smokers; and estimates the number of pregnant heavy smokers who might be eligible for NRT. We suggest five issues for the physician to consider before recommending NRT medications to pregnant patients who are heavy smokers. The judicious use of NRT medications may significantly reduce harm to the infants of heavy smokers. More evidence derived from large population-based research, however, is needed to provide guidance to the physician about NRT eligibility, dose, scheduling, and effectiveness in clinical practice.

  6. Medicinal Chemistry, Pharmacology, and Clinical Implications of TRPV1 Receptor Antagonists.

    Science.gov (United States)

    Aghazadeh Tabrizi, Mojgan; Baraldi, Pier Giovanni; Baraldi, Stefania; Gessi, Stefania; Merighi, Stefania; Borea, Pier Andrea

    2017-07-01

    Transient receptor potential vanilloid 1 (TRPV1) is an ion channel expressed on sensory neurons triggering an influx of cations. TRPV1 receptors function as homotetramers responsive to heat, proinflammatory substances, lipoxygenase products, resiniferatoxin, endocannabinoids, protons, and peptide toxins. Its phosphorylation increases sensitivity to both chemical and thermal stimuli, while desensitization involves a calcium-dependent mechanism resulting in receptor dephosphorylation. TRPV1 functions as a sensor of noxious stimuli and may represent a target to avoid pain and injury. TRPV1 activation has been associated to chronic inflammatory pain and peripheral neuropathy. Its expression is also detected in nonneuronal areas such as bladder, lungs, and cochlea where TRPV1 activation is responsible for pathology development of cystitis, asthma, and hearing loss. This review offers a comprehensive overview about TRPV1 receptor in the pathophysiology of chronic pain, epilepsy, cough, bladder disorders, diabetes, obesity, and hearing loss, highlighting how drug development targeting this channel could have a clinical therapeutic potential. Furthermore, it summarizes the advances of medicinal chemistry research leading to the identification of highly selective TRPV1 antagonists and their analysis of structure-activity relationships (SARs) focusing on new strategies to target this channel. © 2016 Wiley Periodicals, Inc.

  7. Clinical pharmacology of sibutramine hydrochloride (BTS 54524), a new antidepressant, in healthy volunteers.

    Science.gov (United States)

    King, D J; Devaney, N

    1988-01-01

    The cardiovascular, anticholinergic and central effects of single doses of 30, 45 and 60 mg of sibutramine hydrochloride (BTS 54524), a new potential antidepressant, were compared with amitriptyline (50 mg) and placebo given at weekly intervals in a randomised design to six healthy male volunteers. Sibutramine was associated with increases in both supine heart rate and systolic blood pressure at 1, 2 and 6 h after 60 mg (P less than 0.05). Amitriptyline caused a significant 50-60% decrease in salivation compared with placebo at 2 and 6 h but there were no changes with sibutramine. No significant changes in pupil size were detected with either drug. Visual analogue rating scales (VARS) revealed significant drowsiness with amitriptyline but neither sedative nor stimulant effects with sibutramine. Impairments of simple auditory and visual reaction times, visual two-choice reaction time, finger tapping and trail making, measured using an automated test battery, occurred with amitriptyline compared with sibutramine. If sibutramine proves to be an effective antidepressant it should be devoid of anticholinergic or central depressant effects. Chronic dosage studies are indicated to evaluate the clinical significance of its cardiovascular effects. PMID:3207566

  8. Delafloxacin: Place in Therapy and Review of Microbiologic, Clinical and Pharmacologic Properties.

    Science.gov (United States)

    Jorgensen, Sarah C J; Mercuro, Nicholas J; Davis, Susan L; Rybak, Michael J

    2018-03-31

    Delafloxacin (formerly WQ-3034, ABT492, RX-3341) is a novel fluoroquinolone chemically distinct from currently marketed fluoroquinolones with the absence of a protonatable substituent conferring a weakly acidic character to the molecule. This property results in increased intracellular penetration and enhanced bactericidal activity under acidic conditions that characterize the infectious milieu at a number of sites. The enhanced potency and penetration in low pH environments contrast what has been observed for other zwitterionic fluoroquinolones, which tend to lose antibacterial potency under acidic conditions, and may be particularly advantageous against methicillin-resistant Staphylococcus aureus, for which the significance of the intracellular mode of survival is increasingly being recognized. Delafloxacin is also unique in its balanced target enzyme inhibition, a property that likely explains the very low frequencies of spontaneous mutations in vitro. Delafloxacin recently received US Food and Drug Administration approval for the treatment of acute bacterial skin and skin structure infections and is currently being evaluated in a phase 3 trial among patients with community-acquired pneumonia. In the current era of a heightened awareness pertaining to collateral ecologic damage, safety issues and antimicrobial stewardship principles, it is critical to describe the unique properties of delafloxacin and define its potential role in therapy. The purpose of this article is to review available data pertaining to delafloxacin's biochemistry, pharmacokinetic/pharmacodynamics characteristics, in vitro activity and potential for resistance selection as well as current progress in clinical trials to ultimately assist clinicians in selecting patients who will benefit most from the distinctive properties of this agent.

  9. Mucuna pruriens in Parkinson's disease: a double blind clinical and pharmacological study

    Science.gov (United States)

    Katzenschlager, R; Evans, A; Manson, A; Patsalos, P; Ratnaraj, N; Watt, H; Timmermann, L; Van der Giessen, R; Lees, A

    2004-01-01

    Background: The seed powder of the leguminous plant, Mucuna pruriens has long been used in traditional Ayurvedic Indian medicine for diseases including parkinsonism. We have assessed the clinical effects and levodopa (L-dopa) pharmacokinetics following two different doses of mucuna preparation and compared them with standard L-dopa/carbidopa (LD/CD). Methods: Eight Parkinson's disease patients with a short duration L-dopa response and on period dyskinesias completed a randomised, controlled, double blind crossover trial. Patients were challenged with single doses of 200/50 mg LD/CD, and 15 and 30 g of mucuna preparation in randomised order at weekly intervals. L-Dopa pharmacokinetics were determined, and Unified Parkinson's Disease Rating Scale and tapping speed were obtained at baseline and repeatedly during the 4 h following drug ingestion. Dyskinesias were assessed using modified AIMS and Goetz scales. Results: Compared with standard LD/CD, the 30 g mucuna preparation led to a considerably faster onset of effect (34.6 v 68.5 min; p = 0.021), reflected in shorter latencies to peak L-dopa plasma concentrations. Mean on time was 21.9% (37 min) longer with 30 g mucuna than with LD/CD (p = 0.021); peak L-dopa plasma concentrations were 110% higher and the area under the plasma concentration v time curve (area under curve) was 165.3% larger (p = 0.012). No significant differences in dyskinesias or tolerability occurred. Conclusions: The rapid onset of action and longer on time without concomitant increase in dyskinesias on mucuna seed powder formulation suggest that this natural source of L-dopa might possess advantages over conventional L-dopa preparations in the long term management of PD. Assessment of long term efficacy and tolerability in a randomised, controlled study is warranted. PMID:15548480

  10. Pharmacological and clinical evidence of nevirapine immediate- and extended-release formulations

    Directory of Open Access Journals (Sweden)

    Ena J

    2012-11-01

    extended release, efficacy, safety, resistance, clinical practice

  11. A HUMANIZED CLINICALLY CALIBRATED QUANTITATIVE SYSTEMS PHARMACOLOGY MODEL FOR HYPOKINETIC MOTOR SYMPTOMS IN PARKINSON’S DISEASE

    Directory of Open Access Journals (Sweden)

    Hugo eGeerts

    2016-02-01

    Full Text Available The current treatment of Parkinson’s disease with dopamine-centric approaches such as L-DOPA and dopamine agonists, although very succesfull, is in need of alternative treatment strategies, both in terms of disease modification and symptom management. Various non-dopaminergic treatment approaches did not result in a clear clinical benefit, despite showing a clear effect in preclinical animal models. In addition, polypharmacy is common, sometimes leading to unintended effects on non-motor symptoms such as in cognitive and psychiatric domains. To explore novel targets for symptomatic treatment and possible synergistic pharmacodynamic effects between different drugs, we developed a Quantitative Systems Pharmacology (QSP platform of the closed cortico-striatal-thalamic-cortical basal ganglia loop of the dorsal motor circuit. This mechanism-based simulation platform is based on the known neuro-anatomy and neurophysiology of the basal ganglia and explicitly incorporates domain expertise in a formalized way. The calculated beta/gamma power ratio of the local field potential in the subthalamic nucleus correlates well (R2=0.71 with clinically observed extra-pyramidal symptoms triggered by antipsychotics during schizophrenia treatment (43 drug-dose combinations. When incorporating Parkinsonian (PD pathology and reported compensatory changes, the computer model suggests a major increase in b/g ratio (corresponding to bradykinesia and rigidity from a dopamine depletion of 70% onwards. The correlation between the outcome of the QSP model and the reported changes in UPDRS III Motor Part for 22 placebo-normalized drug-dose combinations is R2=0.84. The model also correctly recapitulates the lack of clinical benefit for perampanel, MK-0567 and flupirtine and offers a hypothesis for the translational disconnect. Finally, using human PET imaging studies with placebo response, the computer model predicts well the placebo response for chronic treatment, but not

  12. Modafinil : A Review of its Pharmacology and Clinical Efficacy in the Management of Narcolepsy.

    Science.gov (United States)

    McClellan, K J; Spencer, C M

    1998-04-01

    Modafinil promotes wakefulness through an as yet unknown mechanism of action. It significantly increases daytime sleep latency and reduces excessive daytime sleepiness (EDS) compared with placebo in patients with narcolepsy. However, the drug does not suppress cataplexy. Although direct comparative data are lacking, modafinil offers advantages over amphetamines and methylphenidate in patients with narcolepsy because of its lack of rebound phenomena after treatment withdrawal and its low abuse potential. Clinical trials have shown modafinil to be well tolerated in patients with narcolepsy. Except for headache, which was reported with a significantly greater frequency in modafinil recipients, the tolerability profile of modafinil 200 to 400 mg/day was similar to that of placebo in patients treated for 9 weeks. Preliminary data suggest that the tolerability of modafinil is maintained long term (40 weeks). Thus, modafinil is effective in the treatment of EDS in patients with narcolepsy, although it is not effective against cataplexy. Preliminary findings indicate that, unlike other psychostimulants, the drug is unlikely to be abused and is not associated with withdrawal phenomena. Therefore, modafinil is likely to be an effective therapeutic option for the treatment of EDS in patients with narcolepsy. The mechanism of action of modafinil has not been clearly established. However, it may indirectly increase wakefulness, at least in part, through inhibition of cortical γ-aminobutyric acid (GABA) release via serotonergic mechanisms. Modafinil induces wakefulness and increases locomotor activity in a variety of animal species without causing stereotyped behaviour. In rhesus monkeys, the effects of oral modafinil were not associated with changes in blood pressure or heart rate. In contrast to dexamphetamine 20mg, single night-time doses of modafinil 100 or 200mg had no significant effects on objective sleep variables or sleep structure in young or elderly healthy

  13. Comparison of the pharmacologic and clinical profiles of new combined oral contraceptives containing estradiol

    Directory of Open Access Journals (Sweden)

    Jensen JT

    2013-11-01

    Full Text Available Jeffrey T Jensen,1 Johannes Bitzer,2 Marco Serrani3 1Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, USA; 2Department of Social Medicine and Psychosomatics, Women’s Hospital, University Hospital of Basel, Basel, Switzerland; 3Global Medical Affairs, Women’s Healthcare, Bayer HealthCare Pharmaceuticals, Berlin, Germany Abstract: Three estradiol (E2-containing oral contraceptives, estradiol valerate/cyproterone acetate (E2V/CPA, Femilar®, estradiol valerate/dienogest (E2V/DNG, Qlaira®/Natazia™, and estradiol/nomegestrol acetate (E2/NOMAC; Zoely®, have received approval for use in general practice. Only Finnish women currently have access to all three E2-based formulations. E2/NOMAC is currently approved only in Europe, while E2V/DNG is approved globally. To assist clinicians counseling women considering use of one of these formulations, we conducted a review of the published information about the current E2-containing oral contraceptives. A literature search was conducted using the Ovid interface and a combination of free search terms relevant to estradiol and oral contraception to identify suitable articles for inclusion in this review. The available data show that E2V/DNG, E2/NOMAC, and E2V/CPA are all effective oral contraceptives. While direct comparisons are lacking, indirect evidence suggests that E2V/DNG and E2/NOMAC may have better bleeding profiles than E2V/CPA. E2V/DNG is also approved for the treatment of heavy menstrual bleeding. Both E2V/DNG and E2/NOMAC have minimal influence on hemostatic, lipid, and carbohydrate metabolism parameters, or induce less change in these parameters relative to ethinylestradiol-based oral contraceptives. However, the predictive value of these surrogate parameters is a matter of debate, and whether these differences can be translated into meaningful clinical outcomes needs to be established in large-scale, post-marketing, prospective, Phase IV cohort

  14. Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study.

    Science.gov (United States)

    Hunt, Hazel; Donaldson, Kirsteen; Strem, Mark; Zann, Vanessa; Leung, Pui; Sweet, Suzanne; Connor, Alyson; Combs, Dan; Belanoff, Joseph

    2018-05-01

    CORT125134 is an orally active, high-affinity, selective antagonist of the glucocorticoid receptor that is being developed for indications that may benefit from the modulation of cortisol activity. This first-in-human study was conducted to evaluate the dose-related safety, tolerability, pharmacokinetics and pharmacological effects of CORT125134 and its active metabolite CORT125201. Eighty-one healthy male or female subjects received a single dose of 5 to 500 mg CORT125134 or matching placebo across 9 cohorts; 1 cohort received 150 mg CORT125134 after a high-fat breakfast; and 46 subjects received 50 to 500 mg CORT125134 or matching placebo once daily for up to 14 days across 4 cohorts. CORT125134 was well tolerated at doses up to 250 mg per day for 14 days. CORT125134 was absorbed rapidly and eliminated with a mean half-life ranging from 11 to 19 hours. Steady state was achieved by day 7. Exposure increased in a greater than proportional manner, particularly at lower doses. Exposure to CORT125201 at steady state was less than 5% that of parent CORT125134. Evidence for the desired pharmacological effect (glucocorticoid receptor antagonism) was demonstrated by the ability of CORT125134 to prevent several effects of the glucocorticoid receptor agonist prednisone. © 2018 The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

  15. Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

    Science.gov (United States)

    Sateia, Michael J.; Buysse, Daniel J.; Krystal, Andrew D.; Neubauer, David N.; Heald, Jonathan L.

    2017-01-01

    Introduction: The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations: The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of

  16. The pharmacology of neuroplasticity induced by non-invasive brain stimulation: building models for the clinical use of CNS active drugs

    Science.gov (United States)

    Nitsche, Michael A; Müller-Dahlhaus, Florian; Paulus, Walter; Ziemann, Ulf

    2012-01-01

    The term neuroplasticity encompasses structural and functional modifications of neuronal connectivity. Abnormal neuroplasticity is involved in various neuropsychiatric diseases, such as dystonia, epilepsy, migraine, Alzheimer's disease, fronto-temporal degeneration, schizophrenia, and post cerebral stroke. Drugs affecting neuroplasticity are increasingly used as therapeutics in these conditions. Neuroplasticity was first discovered and explored in animal experimentation. However, non-invasive brain stimulation (NIBS) has enabled researchers recently to induce and study similar processes in the intact human brain. Plasticity induced by NIBS can be modulated by pharmacological interventions, targeting ion channels, or neurotransmitters. Importantly, abnormalities of plasticity as studied by NIBS are directly related to clinical symptoms in neuropsychiatric diseases. Therefore, a core theme of this review is the hypothesis that NIBS-induced plasticity can explore and potentially predict the therapeutic efficacy of CNS-acting drugs in neuropsychiatric diseases. We will (a) review the basics of neuroplasticity, as explored in animal experimentation, and relate these to our knowledge about neuroplasticity induced in humans by NIBS techniques. We will then (b) discuss pharmacological modulation of plasticity in animals and humans. Finally, we will (c) review abnormalities of plasticity in neuropsychiatric diseases, and discuss how the combination of NIBS with pharmacological intervention may improve our understanding of the pathophysiology of abnormal plasticity in these diseases and their purposeful pharmacological treatment. PMID:22869014

  17. Epidemio-Clinical Factors Associated with Caesarean Section in ...

    African Journals Online (AJOL)

    Abstract Caesarean section incurs significant cost and poses a hindrance to healthcare. The aim of the study was to determine maternal, foetal outcomes and cost. This was a cross sectional study conducted at the two health facilities. The study covered an eight month period. The rate of caesarean section was 5.69% and ...

  18. Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.

    Science.gov (United States)

    Sateia, Michael J; Buysse, Daniel J; Krystal, Andrew D; Neubauer, David N; Heald, Jonathan L

    2017-02-15

    The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading

  19. Lifestyle-oriented non-pharmacological treatments for fibromyalgia: a clinical overview and applications with home-based technologies

    Directory of Open Access Journals (Sweden)

    Friedberg F

    2012-10-01

    Full Text Available Fred Friedberg,1 David A Williams,2 William Collinge31Department of Psychiatry and Behavioral Science, Stony Brook University, Stony Brook, New York; 2Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, 3Collinge and Associates, Kittery, Maine, USAAbstract: Fibromyalgia (FM is a persistent and disabling widespread pain condition often accompanied by chronic fatigue, cognitive problems, sleep disturbance, depression, anxiety, and headache. To date, the most thoroughly studied non-pharmacological approaches to managing FM are those with a focus on changing patient activities and beliefs that affect the illness. These interventions are intended to facilitate enduring improvement in pain and functional status. Lifestyle-oriented treatments include patient education, aerobic or other physical exercise, and cognitive-behavioral therapy (CBT. These interventions in FM can be delivered in medical or behavioral health care settings by trained professionals, through patient-oriented treatment manuals, or via remote-access technologies. Non-pharmacological treatments, in particular exercise and CBT, have yielded effect sizes and cost–benefit ratios comparable to medications. This paper describes lifestyle-oriented non-pharmacological treatments for FM and highlights selected literature reviews of these interventions. In addition, behavioral and practical issues are addressed that may affect these non-pharmacological treatments, including patient expectations, participant burden, and treatment availability. Recommendations are made to facilitate these interventions and potentially improve outcomes. In particular, the increasing availability of convenient home-based mobile technologies to deliver these non-pharmacological treatments is described.Keywords: cognitive-behavior therapy, exercise, education, mobile technology

  20. Clinical management of the induction of labor in intrauterine fetal death: evaluation of incidence of cesarean section and related conditions

    Directory of Open Access Journals (Sweden)

    Maria Isabel do Nascimento

    2014-03-01

    Full Text Available OBJECTIVE: To assess the incidence and conditions associated with cesarean section in a cohort of pregnant women with intrauterine fetal death (IUFD, and clinical management to anticipate the childbirth. METHODS: It was a retrospective cohort study with 163 mothers with IUFD, at the second half of pregnancy, who were managed to anticipate childbirth using pharmacological preparations and/or a mechanical method (Foley catheter in a teaching hospital in Rio de Janeiro State, Brazil. Cox regression was used to evaluate the effect of the clinical methods on the kind of delivery. RESULTS: The Subgroups A (misoprostol or Oxytocin, B (misoprostol and Oxytocin, and C (Foley catheter alone or combined with misoprostol and/or Oxytocin were formed according to the applied methods. Nine out of 163 cases ended with cesarean section. The incidence of cesarean section was 3.5 per 1,000 people-hours, meaning that a pregnant woman with IUFD had a 15.6% risk of cesarean section during the first 48 hours of clinical management to anticipate childbirth. The conditions significantly associated with the mode of delivery were placental abruption (HR: 44.97, having two or more previous cesarean deliveries (HR: 10.03, and mechanical method with Foley catheter (HR: 5.01. CONCLUSION: Cesarean section was an essential conduct in this cohort and followed previous cesarean delivery and placental abruption. The effect of the mechanical method on the abdominal route suggests that the Foley catheter method was used in the most difficult cases and that the surgery was performed to ensure maternal health.

  1. Clinical Policy Recommendations from the VHA State-of-the-Art Conference on Non-Pharmacological Approaches to Chronic Musculoskeletal Pain.

    Science.gov (United States)

    Kligler, Benjamin; Bair, Matthew J; Banerjea, Ranjana; DeBar, Lynn; Ezeji-Okoye, Stephen; Lisi, Anthony; Murphy, Jennifer L; Sandbrink, Friedhelm; Cherkin, Daniel C

    2018-05-01

    As a large national healthcare system, Veterans Health Administration (VHA) is ideally suited to build on its work to date and develop a safe, evidence-based, and comprehensive approach to the care of chronic musculoskeletal pain conditions that de-emphasizes opioid use and emphasizes non-pharmacological strategies. The VHA Office of Health Services Research and Development (HSR&D) held a state-of-the-art (SOTA) conference titled "Non-pharmacological Approaches to Chronic Musculoskeletal Pain Management" in November 2016. Goals of the conference were (1) to establish consensus on the current state of evidence regarding non-pharmacological approaches to chronic musculoskeletal pain to inform VHA policy in this area and (2) to begin to identify priorities for the future VHA research agenda. Workgroups were established and asked to reach consensus recommendations on clinical and research priorities for the following treatment strategies: psychological/behavioral therapies, exercise/movement therapies, manual therapies, and models for delivering multimodal pain care. Participants in the SOTA identified nine non-pharmacological therapies with sufficient evidence to be implemented across the VHA system as part of pain care. Participants further recommended that effective integration of these non-pharmacological approaches across the VHA and especially into VHA primary care, pain care, and mental health settings should be a priority, and that these treatments should be offered early in the course of pain treatment and delivered in a team-based, multimodal treatment setting concurrently with active self-care and self-management approaches. In addition, we recommend that VHA leadership and policy makers systematically address the barriers to implementation of these approaches by expanding opportunities for clinician and veteran education on the effectiveness of these strategies; supporting and funding further research to determine optimal dosage, duration, sequencing

  2. Pharmacologic Treatment of Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians.

    Science.gov (United States)

    Wilt, Timothy J; MacDonald, Roderick; Brasure, Michelle; Olson, Carin M; Carlyle, Maureen; Fuchs, Erika; Khawaja, Imran S; Diem, Susan; Koffel, Erin; Ouellette, Jeannine; Butler, Mary; Kane, Robert L

    2016-07-19

    Pharmacologic interventions are often prescribed for insomnia disorder. To assess the benefits, harms, and comparative effectiveness of pharmacologic treatments for adults with insomnia disorder. Several electronic databases (2004-September 2015), reference lists, and U.S. Food and Drug Administration (FDA) documents. 35 randomized, controlled trials of at least 4 weeks' duration that evaluated pharmacotherapies available in the United States and that reported global or sleep outcomes; 11 long-term observational studies that reported harm information; FDA review data for nonbenzodiazepine hypnotics and orexin receptor antagonists; and product labels for all agents. Data extraction by single investigator confirmed by a second reviewer; dual-investigator assessment of risk of bias; consensus determination of strength of evidence. Eszopiclone, zolpidem, and suvorexant improved short-term global and sleep outcomes compared with placebo, although absolute effect sizes were small (low- to moderate-strength evidence). Evidence for benzodiazepine hypnotics, melatonin agonists, and antidepressants, and for most pharmacologic interventions in older adults, was insufficient or low strength. Evidence was also insufficient to compare efficacy within or across pharmacotherapy classes or versus behavioral therapy. Harms evidence reported in trials was judged insufficient or low strength; observational studies suggested that use of hypnotics for insomnia was associated with increased risk for dementia, fractures, and major injury. The FDA documents reported that most pharmacotherapies had risks for cognitive and behavioral changes, including driving impairment, and other adverse effects, and they advised dose reduction in women and in older adults. Most trials were small and short term and enrolled individuals meeting stringent criteria. Minimum important differences in outcomes were often not established or reported. Data were scant for many treatments. Eszopiclone, zolpidem, and

  3. Gingival recession: a cross-sectional clinical investigation.

    Science.gov (United States)

    Goutoudi, P; Koidis, P T; Konstantinidis, A

    1997-06-01

    In this cross-sectional study, risk and potentially causative factors of gingival recession were examined and their relationship to apical migration of the gingival margin evaluated. Thirty eight patients (18-60 years), displaying one or more sites with gingival recession but without any significant periodontal disease participated. A total of 28 parameters were evaluated in both 'test' teeth (50 teeth with gingival recession) and 'control' teeth (50 contralateral teeth). The results revealed that gingival margin recession was associated with both high inflammatory and plaque scores, with decreased widths of keratinized and attached gingiva and with the subjects' toothbrush bristle hardness.

  4. [Pharmacological treatment].

    Science.gov (United States)

    Arriola Manchola, Enrique; Álaba Trueba, Javier

    2016-06-01

    Alzheimer's disease (AD) is a chronic degenerative and inflammatory process leading to synapticdysfunction and neuronal death. A review about the pharmacological treatment alternatives is made: acetylcholinesterase inhibitors (AChEI), a nutritional supplement (Souvenaid) and Ginkgo biloba. A special emphasis on Ginkgo biloba due to the controversy about its use and the approval by the European Medicines Agency is made. Copyright © 2016 Sociedad Española de Geriatría y Gerontología. Publicado por Elsevier España, S.L.U. All rights reserved.

  5. Cerebral blood flow: Physiologic and clinical aspects

    International Nuclear Information System (INIS)

    Wood, J.H.

    1987-01-01

    This book contains 46 chapters divided among nine sections. The section titles are: Historical Perspectives; Cerebrovascular Anatomy; Cerebrovascular Physiology; Methods of Clinical Measurement; Experimental Methods; Imaging of Cerebral Circulation; Cerebrovascular Pathophysiology; Cerebrovascular Pharmacology; and Surgical and Interventional Augmentation

  6. THE INCIDENCE OF CAESAREAN SECTIONS IN THE UNIVERSITY CLINICAL CENTER OF KOSOVO

    OpenAIRE

    Elshani, Brikene; Daci, Armond; Gashi, Sanije; Lulaj, Shefqet

    2012-01-01

    Introduction: As in most countries of the world also at Kosovo the rate of Cesarean section from year to year is increasing. Aim: The main purpose of this paper was to present the incidence of births completed by Caesarean section at the Clinic of Gynecology and Obstetrics of University Clinical Center of Kosovo in Prishtin?. Material and methods: This study is retrospective, namely its made by collecting epidemiological data from patients? histories that completed birth by Caesarean section ...

  7. Pharmacology of basimglurant (RO4917523, RG7090), a unique metabotropic glutamate receptor 5 negative allosteric modulator in clinical development for depression.

    Science.gov (United States)

    Lindemann, Lothar; Porter, Richard H; Scharf, Sebastian H; Kuennecke, Basil; Bruns, Andreas; von Kienlin, Markus; Harrison, Anthony C; Paehler, Axel; Funk, Christoph; Gloge, Andreas; Schneider, Manfred; Parrott, Neil J; Polonchuk, Liudmila; Niederhauser, Urs; Morairty, Stephen R; Kilduff, Thomas S; Vieira, Eric; Kolczewski, Sabine; Wichmann, Juergen; Hartung, Thomas; Honer, Michael; Borroni, Edilio; Moreau, Jean-Luc; Prinssen, Eric; Spooren, Will; Wettstein, Joseph G; Jaeschke, Georg

    2015-04-01

    Major depressive disorder (MDD) is a serious public health burden and a leading cause of disability. Its pharmacotherapy is currently limited to modulators of monoamine neurotransmitters and second-generation antipsychotics. Recently, glutamatergic approaches for the treatment of MDD have increasingly received attention, and preclinical research suggests that metabotropic glutamate receptor 5 (mGlu5) inhibitors have antidepressant-like properties. Basimglurant (2-chloro-4-[1-(4-fluoro-phenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl]-pyridine) is a novel mGlu5 negative allosteric modulator currently in phase 2 clinical development for MDD and fragile X syndrome. Here, the comprehensive preclinical pharmacological profile of basimglurant is presented with a focus on its therapeutic potential for MDD and drug-like properties. Basimglurant is a potent, selective, and safe mGlu5 inhibitor with good oral bioavailability and long half-life supportive of once-daily administration, good brain penetration, and high in vivo potency. It has antidepressant properties that are corroborated by its functional magnetic imaging profile as well as anxiolytic-like and antinociceptive features. In electroencephalography recordings, basimglurant shows wake-promoting effects followed by increased delta power during subsequent non-rapid eye movement sleep. In microdialysis studies, basimglurant had no effect on monoamine transmitter levels in the frontal cortex or nucleus accumbens except for a moderate increase of accumbal dopamine, which is in line with its lack of pharmacological activity on monoamine reuptake transporters. These data taken together, basimglurant has favorable drug-like properties, a differentiated molecular mechanism of action, and antidepressant-like features that suggest the possibility of also addressing important comorbidities of MDD including anxiety and pain as well as daytime sleepiness and apathy or lethargy. Copyright © 2015 by The American Society for

  8. Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

    Science.gov (United States)

    Reginster, Jean-Yves L; Arden, Nigel K; Haugen, Ida K; Rannou, Francois; Cavalier, Etienne; Bruyère, Olivier; Branco, Jaime; Chapurlat, Roland; Collaud Basset, Sabine; Al-Daghri, Nasser M; Dennison, Elaine M; Herrero-Beaumont, Gabriel; Laslop, Andrea; Leeb, Burkhard F; Maggi, Stefania; Mkinsi, Ouafa; Povzun, Anton S; Prieto-Alhambra, Daniel; Thomas, Thierry; Uebelhart, Daniel; Veronese, Nicola; Cooper, Cyrus

    2017-12-07

    To gather expert opinion on the conduct of clinical trials that will facilitate regulatory review and approval of appropriate efficacious pharmacological treatments for hand osteoarthritis (OA), an area of high unmet clinical need. The European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) organized a working group under the auspices of the International Osteoporosis Foundation (IOF) and the World Health Organization (WHO). This consensus guideline is intended to provide a reference tool for practice, and should allow for better standardization of the conduct of clinical trials in hand OA. Hand OA is a heterogeneous disease affecting different, and often multiple, joints of the thumb and fingers. It was recognized that the various phenotypes and limitations of diagnostic criteria may make the results of hand OA trials difficult to interpret. Nonetheless, practical recommendations for the conduct of clinical trials of both symptom and structure modifying drugs are outlined in this consensus statement, including guidance on study design, execution, and analysis. While the working group acknowledges that the methodology for performing clinical trials in hand OA will evolve as knowledge of the disease increases, it is hoped that this guidance will support the development of new pharmacological treatments targeting hand OA. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  9. Pharmacological management of panic disorder

    Directory of Open Access Journals (Sweden)

    Carlo Marchesi

    2008-03-01

    Full Text Available Carlo MarchesiPsychiatric Section, Department of Neuroscience, University of Parma, Parma, ItalyAbstract: Panic disorder (PD is a disabling condition which appears in late adolescence or early adulthood and affects more frequently women than men. PD is frequently characterized by recurrences and sometimes by a chronic course and, therefore, most patients require longterm treatments to achieve remission, to prevent relapse and to reduce the risks associated with comorbidity. Pharmacotherapy is one of the most effective treatments of PD. In this paper, the pharmacological management of PD is reviewed. Many questions about this effective treatment need to be answered by the clinician and discussed with the patients to improve her/his collaboration to the treatment plan: which is the drug of choice; when does the drug become active; which is the effective dose; how to manage the side effects; how to manage nonresponse; and how long does the treatment last. Moreover, the clinical use of medication in women during pregnancy and breastfeeding or in children and adolescents was reviewed and its risk-benefit balance discussed.Keywords: panic disorder, pharmacological treatment, treatment guidelines

  10. A 1 year retrospective audit of quality indicators of clinical pharmacological advice for personalized linezolid dosing: one stone for two birds?

    Science.gov (United States)

    Pea, Federico; Cojutti, Piergiorgio; Dose, Lucia; Baraldo, Massimo

    2016-02-01

    This study explored the clinical and economic impact of clinical pharmacological advice (CPA) (based on therapeutic drug monitoring [TDM] results, and on patients' characteristics and co-medications) on personalized linezolid therapy in a tertiary care hospital. A 1 year retrospective analysis of quality indicators of CPA (clinicians' adherence rate to CPA, pre-post rate of linezolid trough concentrations within the desired range and cost balance analysis) was conducted. Five hundred and forty-four CPAs were provided to clinicians during 2014 for personalizing linezolid therapy in 168 patients. Clinicians' adherence to CPAs was very high (94.7%). The pre-post rate of linezolid Cmin distribution showed a favourable impact of CPA on patient care (pre-post ratio of Cmin within the desired range + 23.4%, pre, 51.2% vs. post, 74.6%). Overall, linezolid dosage was mainly reduced (56.9% of cases), whereas dose augmentation was needed only in a minority of cases (7.7%). Cost balance analysis showed that overall 1258 standard doses of linezolid (unitary dose 600 mg) were spared for treating 168 patients with a personalized dosage for a median duration of 11 days (range 3-128 days) with a cost saving of 60038.05 €. Active computerized advice elaborated by the clinical pharmacologist on the basis of TDM results and of patient's pathophysiological data and co-medications may be cost-effective for personalizing linezolid treatment. © 2015 The British Pharmacological Society.

  11. The pharmacology of regenerative medicine.

    Science.gov (United States)

    Christ, George J; Saul, Justin M; Furth, Mark E; Andersson, Karl-Erik

    2013-07-01

    Regenerative medicine is a rapidly evolving multidisciplinary, translational research enterprise whose explicit purpose is to advance technologies for the repair and replacement of damaged cells, tissues, and organs. Scientific progress in the field has been steady and expectations for its robust clinical application continue to rise. The major thesis of this review is that the pharmacological sciences will contribute critically to the accelerated translational progress and clinical utility of regenerative medicine technologies. In 2007, we coined the phrase "regenerative pharmacology" to describe the enormous possibilities that could occur at the interface between pharmacology, regenerative medicine, and tissue engineering. The operational definition of regenerative pharmacology is "the application of pharmacological sciences to accelerate, optimize, and characterize (either in vitro or in vivo) the development, maturation, and function of bioengineered and regenerating tissues." As such, regenerative pharmacology seeks to cure disease through restoration of tissue/organ function. This strategy is distinct from standard pharmacotherapy, which is often limited to the amelioration of symptoms. Our goal here is to get pharmacologists more involved in this field of research by exposing them to the tools, opportunities, challenges, and interdisciplinary expertise that will be required to ensure awareness and galvanize involvement. To this end, we illustrate ways in which the pharmacological sciences can drive future innovations in regenerative medicine and tissue engineering and thus help to revolutionize the discovery of curative therapeutics. Hopefully, the broad foundational knowledge provided herein will spark sustained conversations among experts in diverse fields of scientific research to the benefit of all.

  12. Targeting poly(ADP-ribose)polymerase1 in neurological diseases: A promising trove for new pharmacological interventions to enter clinical translation.

    Science.gov (United States)

    Sriram, Chandra Shekhar; Jangra, Ashok; Kasala, Eshvendar Reddy; Bodduluru, Lakshmi Narendra; Bezbaruah, Babul Kumar

    2014-10-01

    The highly conserved abundant nuclear protein poly(ADP-ribose)polymerase1 (PARP1) functions at the center of cellular stress response and is mainly implied in DNA damage repair mechanism. Apart from its involvement in DNA damage repair, it does sway multiple vital cellular processes such as cell death pathways, cell aging, insulator function, chromatin modification, transcription and mitotic apparatus function. Since brain is the principal organ vulnerable to oxidative stress and inflammatory responses, upon stress encounters robust DNA damage can occur and intense PARP1 activation may result that will lead to various CNS diseases. In the context of soaring interest towards PARP1 as a therapeutic target for newer pharmacological interventions, here in the present review, we are attempting to give a silhouette of the role of PARP1 in the neurological diseases and the potential of its inhibitors to enter clinical translation, along with its structural and functional aspects. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. Caesarean section in a patient with varicella: Anaesthesia considerations and clinical relevance

    Directory of Open Access Journals (Sweden)

    Nandini M Dave

    2007-01-01

    Full Text Available A primigravida with chicken pox was posted for an emergency caesarean section. General anaesthesia was administered. Key issues in anaesthesia management and the clinical implications are discussed.

  14. Vernakalant (RSD1235) in the management of atrial fibrillation: a review of pharmacological properties, clinical efficacy and safety

    DEFF Research Database (Denmark)

    Weeke, Peter; Andersson, Charlotte; Brendorp, Bente

    2008-01-01

    Vernakalant (RSD1235) is a novel antiarrhythmic agent for conversion of rapid onset atrial fibrillation (AF). It is an atria-selective multichannel ion blocker (blocks I(Kur), I(Na), I(Ca, L), I(to) and I(Kr)), with a small effect on ventricular repolarization. In clinical Phase II and III studie...... effect, with no reported cases of torsades de pointes in direct relation to vernakalant administration in Phase II and III studies. Overall, there are few reported serious adverse events.......Vernakalant (RSD1235) is a novel antiarrhythmic agent for conversion of rapid onset atrial fibrillation (AF). It is an atria-selective multichannel ion blocker (blocks I(Kur), I(Na), I(Ca, L), I(to) and I(Kr)), with a small effect on ventricular repolarization. In clinical Phase II and III studies...

  15. A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

    Science.gov (United States)

    Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

    2018-03-01

    To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

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

    Directory of Open Access Journals (Sweden)

    Marta Sacchetti

    2015-01-01

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

  17. Pharmacological interactions of vasoconstrictors.

    Science.gov (United States)

    Gómez-Moreno, Gerardo; Guardia, Javier; Cutando, Antonio; Calvo-Guirado, José Luis

    2009-01-01

    This article is the first of a series on pharmacological interactions involving medicaments commonly prescribed and/or used in odontology: vasoconstrictors in local anaesthetics and anti-inflammatory and anti-microbial analgesics. The necessity for the odontologist to be aware of adverse reactions as a result of the pharmacological interactions is due to the increase in medicament consumption by the general population. There is a demographic change with greater life expectancy and patients have increased chronic health problems and therefore have increased medicament intake. The presence of adrenaline (epinephrine) and other vasoconstrictors in local odontological anaesthetics is beneficial in relation to the duration and depth of anaesthesia and reduces bleeding and systemic toxicity of the local anaesthetic. However, it might produce pharmacological interactions between the injected vasoconstrictors and the local anaesthetic and adrenergic medicament administered exogenically which the odontologist should be aware of, especially because of the risk of consequent adverse reactions. Therefore the importance of conducting a detailed clinical history of the general state of health and include all medicaments, legal as well as illegal, taken by the patient.

  18. Vernakalant (RSD1235) in the management of atrial fibrillation: a review of pharmacological properties, clinical efficacy and safety

    DEFF Research Database (Denmark)

    Weeke, Peter; Andersson, Charlotte; Brendorp, Bente

    2008-01-01

    Vernakalant (RSD1235) is a novel antiarrhythmic agent for conversion of rapid onset atrial fibrillation (AF). It is an atria-selective multichannel ion blocker (blocks I(Kur), I(Na), I(Ca, L), I(to) and I(Kr)), with a small effect on ventricular repolarization. In clinical Phase II and III studie...... effect, with no reported cases of torsades de pointes in direct relation to vernakalant administration in Phase II and III studies. Overall, there are few reported serious adverse events....

  19. Recognition and Evaluation of Clinical Section Headings in Clinical Documents Using Token-Based Formulation with Conditional Random Fields

    Directory of Open Access Journals (Sweden)

    Hong-Jie Dai

    2015-01-01

    Full Text Available Electronic health record (EHR is a digital data format that collects electronic health information about an individual patient or population. To enhance the meaningful use of EHRs, information extraction techniques have been developed to recognize clinical concepts mentioned in EHRs. Nevertheless, the clinical judgment of an EHR cannot be known solely based on the recognized concepts without considering its contextual information. In order to improve the readability and accessibility of EHRs, this work developed a section heading recognition system for clinical documents. In contrast to formulating the section heading recognition task as a sentence classification problem, this work proposed a token-based formulation with the conditional random field (CRF model. A standard section heading recognition corpus was compiled by annotators with clinical experience to evaluate the performance and compare it with sentence classification and dictionary-based approaches. The results of the experiments showed that the proposed method achieved a satisfactory F-score of 0.942, which outperformed the sentence-based approach and the best dictionary-based system by 0.087 and 0.096, respectively. One important advantage of our formulation over the sentence-based approach is that it presented an integrated solution without the need to develop additional heuristics rules for isolating the headings from the surrounding section contents.

  20. Space Pharmacology

    CERN Document Server

    Wotring, Virginia E

    2012-01-01

    “Space Pharmacology” is a review of the current knowledge regarding the use of pharmaceuticals during spaceflights. It is a comprehensive review of the literature, addressing each area of pharmacokinetics and each major physiological system in turn. Every section begins with a topic overview, and is followed by a discussion of published data from spaceflight, and from ground experiments meant to model the spaceflight situation. Includes a discussion looking forward to the new medical challenges we are likely to face on longer duration exploration missions. This book is a snapshot of our current knowledge that also highlights areas of unknown.

  1. The antiprogesterone steroid RU 486: a short pharmacological and clinical review, with emphasis on the interruption of pregnancy.

    Science.gov (United States)

    Garfield, R E; Baulieu, E E

    1987-02-01

    In this review we have briefly outlined the clinical applications and mechanism of action of the progesterone antagonist RU 486. RU 486 has been successfully used in a variety of conditions to regulate the reproductive cycle and to control fertility in women. We suggest that the mechanism by which RU 486 acts during the cycle and early pregnancy is probably by affecting mainly the endometrium. During late pregnancy, the compound has significant effects on the myometrium including the induction of gap junctions between myometrium cells, which is required for muscle contractility during labour. The use of RU 486 has helped to demonstrate that progesterone is required for maintenance of the late stages of pregnancy in women.

  2. Information technology for clinical, translational and comparative effectiveness research. Findings from the section clinical research informatics.

    Science.gov (United States)

    Daniel, C; Choquet, R

    2013-01-01

    To summarize advances of excellent current research in the new emerging field of Clinical Research Informatics. Synopsis of four key articles selected for the IMIA Yearbook 2013. The selection was performed by querying PubMed and Web of Science with predefined keywords. From the original set of 590 papers, a first subset of 461 articles which was in the scope of Clinical Research Informatics was refined into a second subset of 79 relevant articles from which 15 articles were retained for peer-review. The four selected articles exemplify current research efforts conducted in the areas of data representation and management in clinical trials, secondary use of EHR data for clinical research, information technology platforms for translational and comparative effectiveness research and implementation of privacy control. The selected articles not only illustrate how innovative information technology supports classically organized randomized controlled trials but also demonstrate that the long promised benefits of electronic health care data for research are becoming a reality through concrete platforms and projects.

  3. Impact of amyloid-beta changes on cognitive outcomes in Alzheimer's disease: analysis of clinical trials using a quantitative systems pharmacology model.

    Science.gov (United States)

    Geerts, Hugo; Spiros, Athan; Roberts, Patrick

    2018-02-02

    Despite a tremendous amount of information on the role of amyloid in Alzheimer's disease (AD), almost all clinical trials testing this hypothesis have failed to generate clinically relevant cognitive effects. We present an advanced mechanism-based and biophysically realistic quantitative systems pharmacology computer model of an Alzheimer-type neuronal cortical network that has been calibrated with Alzheimer Disease Assessment Scale, cognitive subscale (ADAS-Cog) readouts from historical clinical trials and simulated the differential impact of amyloid-beta (Aβ40 and Aβ42) oligomers on glutamate and nicotinic neurotransmission. Preclinical data suggest a beneficial effect of shorter Aβ forms within a limited dose range. Such a beneficial effect of Aβ40 on glutamate neurotransmission in human patients is absolutely necessary to reproduce clinical data on the ADAS-Cog in minimal cognitive impairment (MCI) patients with and without amyloid load, the effect of APOE genotype effect on the slope of the cognitive trajectory over time in placebo AD patients and higher sensitivity to cholinergic manipulation with scopolamine associated with higher Aβ in MCI subjects. We further derive a relationship between units of Aβ load in our model and the standard uptake value ratio from amyloid imaging. When introducing the documented clinical pharmacodynamic effects on Aβ levels for various amyloid-related clinical interventions in patients with low Aβ baseline, the platform predicts an overall significant worsening for passive vaccination with solanezumab, beta-secretase inhibitor verubecestat and gamma-secretase inhibitor semagacestat. In contrast, all three interventions improved cognition in subjects with moderate to high baseline Aβ levels, with verubecestat anticipated to have the greatest effect (around ADAS-Cog value 1.5 points), solanezumab the lowest (0.8 ADAS-Cog value points) and semagacestat in between. This could explain the success of many amyloid

  4. PHARMACOLOGICAL IN VITRO MODELS IN PRE-CLINICAL DRUG TESTING - EXAMPLE OF hSERT TRANSFECTED HUMAN EMBRYONIC KIDNEY CELLS

    Directory of Open Access Journals (Sweden)

    Mihajlo Jakovljević

    2012-06-01

    Full Text Available Preclinical drug testing should be considered an important stage during examinations of its efficiency and safety in any likely indication observed. Purpose of the process is acquisition of substantial amount of particular drug-related data before approaching clinical trials in humans. Historical preclinical testing relied on available testing in microbe cultures and animal models. During recent decades laboratory techniques of human cell lines cultivation have been developed and improved. These provide unique possibility of drug acting mechanism testing in a simplified environment lacking basic homeostatic mechanisms. Some examples of these are measuring drug impact to biochemical transport, signaling or anabolic processes. Humane cell lines of embrional kidney 293 are an example of easy-to-grow and disseminate and quite endurable cell line. This methodological article notices some of the details of HEK293 cells cultivation and breading. We took transfection as an example of in vitro model creation for drug testing. Transfection refers to gene introduction into HEK293 cellular genome in order to achieve membrane expression of coded protein. In our case it would be human serotonin transporter. Article contains description of one particular methodological approach in measuring human serotonin transporter expression. The role and importance of serotonin pump in affective disorders genesis was already widely recognized. Aim of the paper was to emphasize feasibility of cell cultivation and its advantages in comparison with alternative traditional methods.

  5. Theoretical overview of clinical and pharmacological aspects of the use of etelcalcetide in diabetic patients undergoing hemodialysis

    Directory of Open Access Journals (Sweden)

    Ye J

    2018-04-01

    Full Text Available Jianzhen Ye,1 Guangrui Deng,1 Feng Gao2 1Department of Endocrinology, Huangzhou District People’s Hospital, Huanggang, People’s Republic of China; 2Department of Endocrinology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People’s Republic of China Abstract: Etelcalcetide is the first intravenous calcimimetic agent authorized for the treatment of secondary hyperparathyroidism (sHPT in patients undergoing hemodialysis in Europe, the US, and Japan. The relationship between sHPT and diabetes resides on complex, bidirectional effects and largely unknown homeostatic mechanisms. Although 30% or more patients with end-stage renal disease are diabetics and about the same percentage of those patients suffer from sHPT associated with hemodialysis, no data on the specificities of the use of etelcalcetide in such patients are available yet. Regarding pharmacokinetic interactions, etelcalcetide may compete with oral hypoglycemics recommended for use in patients undergoing hemodialysis and insulins detemir and degludec, causing unexpected hypocalcemia or hypoglycemia. More importantly, hypocalcemia, a common side effect of etelcalcetide, may cause decompensation of preexisting cardiac insufficiency in diabetic patients or worsen dialysis-related hypotension and lead to hypotension-related cardiac events, such as myocardial ischemia. In diabetic patients, hypocalcemia may lead to dangerous ventricular arrhythmias, as both insulin-related hypoglycemia and hemodialysis prolong QT interval. Patients with diabetes, therefore, should be strictly monitored for hypocalcemia and associated effects. Due to an altered parathormone activity in this patient group, plasma calcium should be the preferred indicator of etelcalcetide effects. Until more clinical experience with etelcalcetide is available, the clinicians should be cautious when using this calcimimetic in patients with diabetes. Keywords: glucose intolerance

  6. The incidence of caesarean sections in the university clinical center of kosovo.

    Science.gov (United States)

    Elshani, Brikene; Daci, Armond; Gashi, Sanije; Lulaj, Shefqet

    2012-12-01

    As in most countries of the world also at Kosovo the rate of Cesarean section from year to year is increasing. The main purpose of this paper was to present the incidence of births completed by Caesarean section at the Clinic of Gynecology and Obstetrics of University Clinical Center of Kosovo in Prishtinë. This study is retrospective, namely its made by collecting epidemiological data from patients' histories that completed birth by Caesarean section for the period 2000-2006 in this clinic. During this period, 14 maternal deaths were recorded during or after Caesarean section. Besides this, 14 lethal outcomes, the object of our study was 84 mothers which completed birth by Caesarean section and which are best used as a control group. The average age of mothers who died during or after Caesarean section was 32.1 years (SD ± 4.9). Youngest in this group was 24 years old and oldest 42 years. While the average age of mothers from the control group was 30.6 years (SD ± 5.9). Youngest was 19 and oldest 43 years, without significant difference. Most mothers included in the survey had more than one indication for Caesarean section. The most frequent indication was PIH syndrome with 33.7% and previous Caesarean section in 32.7%. Then with the participation of 12.2% were abruption of the placenta and disproportio feto pelvinea, 11.2% pelvinea and placenta praevia presentation, 10.2% parturiens while other indications were much rarer with less than 10% participation. Based on this we can conclude that the risk of the Caesarean section is high.

  7. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest: rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

    Science.gov (United States)

    Blom, M T; van Hoeijen, D A; Bardai, A; Berdowski, J; Souverein, P C; De Bruin, M L; Koster, R W; de Boer, A; Tan, H L

    2014-01-01

    Introduction Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Recognising the complexity of the underlying causes of OHCA in the community, we aimed to establish the clinical, pharmacological, environmental and genetic factors and their interactions that may cause OHCA. Methods and analysis We set up a large-scale prospective community-based registry (AmsteRdam Resuscitation Studies, ARREST) in which we prospectively include all resuscitation attempts from OHCA in a large study region in the Netherlands in collaboration with Emergency Medical Services. Of all OHCA victims since June 2005, we prospectively collect medical history (through hospital and general practitioner), and current and previous medication use (through community pharmacy). In addition, we include DNA samples from OHCA victims with documented ventricular tachycardia/fibrillation during the resuscitation attempt since July 2007. Various study designs are employed to analyse the data of the ARREST registry, including case–control, cohort, case only and case-cross over designs. Ethics and dissemination We describe the rationale, outline and potential results of the ARREST registry. The design allows for a stable and reliable collection of multiple determinants of OHCA, while assuring that the patient, lay-caregiver or medical professional is not hindered in any way. Such comprehensive data collection is required to unravel the complex basis of OHCA. Results will be published in peer-reviewed journals and presented at relevant scientific symposia. PMID:25332818

  8. A clinical evaluation of interventional embolization in hemorrhage after cesarean section followed by DIC

    International Nuclear Information System (INIS)

    Yang Kui; Yin Jun; Luo Jun; Jin Xueguang; Liu Zaijie; Liang Yong; Huang Lexiu

    2005-01-01

    Objective: To investigate the clinical characteristics of cesarean section (C-section) complicating with DIC and evaluate the interventional embolization as a treatment of post-C-section hemorrhage. Methods: In total 12 cases of post-C-section massive hemorrhage and DIC were retrospectively studied. Results: Hemostasia was successfully obtained after intervention in all patients. Bleeding was immediately ceased after the procedure in 10 cases out of 12, and bleeding was significantly decreased after intervention, which stop gradually within 3 and 7 days in other 2 cases. Excellent prognosis was arcbieved in all cases. Conclusion: Post-C-section bleeding with DIC is characterized by massive blood loss and progressive deterioration of the patients condition. Interventional embolization provides a quick, thorough, lasting, safe and reliable control of the bleeding, with which uterectomy is able to be avoid. (authors)

  9. Cesarean section rates and indications at our clinic between 2001 and 2005

    Directory of Open Access Journals (Sweden)

    Ertan Uzun

    2006-12-01

    Full Text Available OBJECTIVE: Cesarean section has increased risks for maternal mortality and morbidity, and perinatal morbidity. The purpose of this study was to analyze the annual distribution of indications and rates of cesarean sections in all deliveries that happened between 2001 and 2005.\tMATERIAL-METHODS: We evaluated retrospectively the hospital records of 1806 patients who underwent cesarean section among 2416 deliveries at Suleyman Demirel University, School of Medicine, Department of Obstetrics and Gynecology, between 2001- 2005. The annual distribution of patients with cesarean section were analyzed with respect to age, parity, vaginal birth rate and cesarean section indications.\tRESULTS: The rate of cesarean section is between 58.1% and 85.2%. This rate increased by years. The most increased indications of cesarean section were previous cesarean, cephalo-pelvic disproportion, and fetal distress. While the rate of previous cesarean\twas 18.3 % in 2001, it increased to 29.6 % in 2005. In a same manner, the rates of cephalo-pelvic disproportion was raised from 2.8% to 21.4%.. The indications of fetal distress and desire of contraception were decreased during this period (p CONCLUSION: The cesarean rate has increased by years in our clinic. This increase was attributed to the increased rate of previous cesarean section, the increased number of primigravid women over 35 year old, and the management of breech presentations. The widespread use of antenatal diagnostic techniques also caused an increase in the rate of cesarean section.

  10. Aspergillus pragensis sp nov discovered during molecular reidentification of clinical isolates belonging to Aspergillus section Candidi

    DEFF Research Database (Denmark)

    Lyskova, Pavlina; Hubka, Vit; Kolarik, Miroslav

    2014-01-01

    The identity of nine clinical isolates recovered from Czech patients and presumptively identified as Aspergillus sp. section Candidi based on colony morphology was revised using sequences of beta-tubulin, calmodulin gene sequence, and internal transcribed spacer rDNA. Six isolates were from suspe...

  11. Antenatal Sonographic Diagnosis and Clinical Significance of Placenta Previa Accreta after Cesarean Section.

    Science.gov (United States)

    Liu, Zhen-Zhen; Wei, Yao; Wang, Ruo-Jiao; Xu, Wen; Shi, Zhi-Min; Dai, Qing

    2017-10-30

    Objective To investigate the clinical and antenatal sonographic characteristics of placenta previa accreta after cesarean section. Methods The data of 21 inpatients diagnosed as placenta previa accreta after cesarean section in PUMC Hospital from 2006 to 2016 were retrospectively reviewed. The clinical and ultrasound features were recorded and compared among three placental accreta groups,including placenta accrete group(n=5),increta group(n=12),and percreta group(n=4). The relationship between the placental thickness at the uterine anterior lower segment level and the blood loss of the following cesarean section was tested. Results Of 21 patients,placenta previa was diagnosed by ultrasound in 20 cases(95.2%) and placenta previa accreta was diagnosed in 9 cases(42.9%). Antenatal ultrasound findings included following signs:loss of "clear zone"(15/18,83.3%),myometrial thinning(12/18,66.7%),abnormal placental lacunae(12/19,63.2%),bladder wall interruption(2/18,11.1%),and uterovesical hypervascularity(4/9,44.4%). Myometrial thinning(J-T=64.000,P=0.036),abnormal placental lacunae(J-T=74.500,P=0.032) and the placental thickness at the uterine anterior lower segment level(U=83.000,P=0.010) showed significant difference among different placenta accreta groups. Placental thickness at the uterine anterior lower segment level showed linear correlation with the blood loss of the following cesarean section(r=0.669,P=0.002). The blood loss of the following cesarean section showed significant difference among different placenta accreta groups(U=118.500,P=0.000). Conclusions The clinical and sonographic manifestations of placenta previa accreta after cesarean section show a spectrum of demographic characteristics. The measurement of thickness of placenta at the anterior lower segment may help the evaluation of the clinical prognosis of this special pathology.

  12. 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...

  13. Effects of Recitation of Holy Quran on Anxiety of Women before Cesarean Section: A Randomize Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ranjbar N

    2010-03-01

    Full Text Available Background and Objectives: Anxiety is a kind of agitation and concern stemming from the feeling of threat or hazard in human. It can decrease or increase the understanding ability of individuals. Most clinical patients have anxiety in confronting a new and unknown environment such as hospitals. A non-pharmacological method such as pleasant sound of Holy Quran recitation can be used as a useful and effective procedure to decrease the anxiety. The aim of this research was to study the recitation effects of Holy Quran on anxiety of woman before cesarean.Methods: In this quasi-experimental study, 80 women expecting cesarean section were randomly selected regarding their characteristics and divided into two groups: control group (30 members and experimental group (50 members. Data collection instrument was a two-part questionnaire including demographic characteristics, and Spilburge’s state-trait anxiety inventory. The degree of anxiety for the two groups was evaluated before cesarean, then before innate cesarean, the Holy Quran recitation was played for experimental group for 20 minutes by the sound of famous recite, Abdol Basset. Data were analyzed using Chi-Square, single sample & paired T-test, and a Pvalue of 0<0.05 was considered as statistically significant.Results: The results showed that the degree of anxiety decreased in experimental group after intervention (P=0.0001, but not in the control group.(P=0.98 Comparison of the two groups showed a significant difference after intervention (P=0.002.Conclusion: According to the results of this research and because of the agreeable rhythmic intonation of the Quran as gnostic music and its miracle aspect, we can use its tone as a non medicinal method for reducing anxiety before cesarean women.

  14. Teaching efficacy of nurses in clinical practice education: A cross-sectional study.

    Science.gov (United States)

    Kim, Eun-Kyeung; Shin, Sujin

    2017-07-01

    Clinical nurses play a vital role in clinical practice education; thus, it is necessary to help clinical nurses have teaching efficacy through the development and application of systematic education programs. To identify nurses' teaching efficacy for clinical education and analyze the influencing factors of teaching efficacy. The study used a cross-sectional design. We used a convenience sample of 263 nurses from two hospitals. Teaching efficacy, general characteristics, and perception of clinical practice education were collected via self-reported questionnaires. Teaching efficacy was measured using Hwang's (2006) questionnaire, while perception of clinical practice education was measured using the Clinical Nurse Teacher Survey developed by Nishioka et al. (2014). Participants completed the questionnaire directly. The collected data were then analyzed using descriptive statistics, t-tests, ANOVAs, and multiple regression analysis with PASW Statistics 18.0. The mean total score of teaching efficacy was 72.5 (range 21-105). The leadership for students subscale had the highest score (3.56±0.59). The factors influencing teaching efficacy were length of clinical career (β=0.26, pteaching efficacy in nurses. Based on these results, nursing educators might need to develop greater confidence in their knowledge and enhance control of their teaching strategies. Nursing schools and hospitals might need to provide greater support and educational opportunities to nurse clinical practice instructors. Furthermore, constructing a system of cooperation between these colleges and educational hospitals, developing programs to enhance teaching efficacy, and identifying the clinical instructor's role are all necessary to promote clinical practice education. Copyright © 2017. Published by Elsevier Ltd.

  15. Healthcare students' evaluation of the clinical learning environment and supervision - a cross-sectional study.

    Science.gov (United States)

    Pitkänen, Salla; Kääriäinen, Maria; Oikarainen, Ashlee; Tuomikoski, Anna-Maria; Elo, Satu; Ruotsalainen, Heidi; Saarikoski, Mikko; Kärsämänoja, Taina; Mikkonen, Kristina

    2018-03-01

    The purpose of clinical placements and supervision is to promote the development of healthcare students´ professional skills. High-quality clinical learning environments and supervision were shown to have significant influence on healthcare students´ professional development. This study aimed to describe healthcare students` evaluation of the clinical learning environment and supervision, and to identify the factors that affect these. The study was performed as a cross-sectional study. The data (n = 1973) were gathered through an online survey using the Clinical Learning Environment, Supervision and Nurse Teacher scale during the academic year 2015-2016 from all healthcare students (N = 2500) who completed their clinical placement at a certain university hospital in Finland. The data were analysed using descriptive statistics and binary logistic regression analysis. More than half of the healthcare students had a named supervisor and supervision was completed as planned. The students evaluated the clinical learning environment and supervision as 'good'. The students´ readiness to recommend the unit to other students and the frequency of separate private unscheduled sessions with the supervisor were the main factors that affect healthcare students` evaluation of the clinical learning environment and supervision. Individualized and goal-oriented supervision in which the student had a named supervisor and where supervision was completed as planned in a positive environment that supported learning had a significant impact on student's learning. The clinical learning environment and supervision support the development of future healthcare professionals' clinical competence. The supervisory relationship was shown to have a significant effect on the outcomes of students' experiences. We recommend the planning of educational programmes for supervisors of healthcare students for the enhancement of supervisors' pedagogical competencies in supervising students in

  16. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  17. Pharmacology education in North American dental schools: the basic science survey series.

    Science.gov (United States)

    Gautam, Medha; Shaw, David H; Pate, Ted D; Lambert, H Wayne

    2013-08-01

    As part of the Basic Science Survey Series (BSSS) for Dentistry, members of the American Dental Education Association (ADEA) Physiology, Pharmacology, and Therapeutics Section surveyed course directors of basic pharmacology courses in North American dental schools. The survey was designed to assess, among other things, faculty affiliation and experience of course directors, teaching methods, general course content and emphasis, extent of interdisciplinary (shared) instruction, and impact of recent curricular changes. Responses were received from forty-nine of sixty-seven (73.1 percent) U.S. and Canadian dental schools. The findings suggest the following: 1) substantial variation exists in instructional hours, faculty affiliation, placement within curriculum, class size, and interdisciplinary nature of pharmacology courses; 2) pharmacology course content emphasis is similar among schools; 3) the number of contact hours in pharmacology has remained stable over the past three decades; 4) recent curricular changes were often directed towards enhancing the integrative and clinically relevant aspects of pharmacology instruction; and 5) a trend toward innovative content delivery, such as use of computer-assisted instruction applications, is evident. Data, derived from this study, may be useful to pharmacology course directors, curriculum committees, and other dental educators with an interest in integrative and interprofessional education.

  18. Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance.

    Science.gov (United States)

    Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane A; Hasbani, Divina Justina; Abou-Jaoude, Elias A; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Zein; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A

    2017-10-05

    To provide a detailed and current characterisation of funding of a representative sample clinical trials. We also aimed to develop guidance for standardised reporting of funding information. We addressed the extent to which clinical trials published in 2015 in any of the 119 Core Clinical Journals included a statement on the funding source (eg, whether a not-for-profit organisation was supported by a private-for-profit organisation), type of funding, amount and role of funder. We used a stepwise approach to develop a guidance and an instrument for standardised reporting of funding information. Of 200 trials, 178 (89%) included a funding statement, of which 171 (96%) reported being funded. Funding statements in the 171 funded trials indicated the source in 100%, amount in 1% and roles of funders in 50%. The most frequent sources were governmental (58%) and private-for-profit (40%). Of 54 funding statements in which the source was a not-for-profit organisation, we found evidence of undisclosed support of those from private-for-profit organisation(s) in 26 (48%). The most frequently reported roles of funders in the 171 funded trials related to study design (42%) and data analysis, interpretation or management (41%). Of 139 randomised controlled trials (RCTs) addressing pharmacological or surgical interventions, 29 (21%) reported information on the supplier of the medication or device. The proposed guidance addresses both the funding information that RCTs should report and the reporting process. Attached to the guidance is a fillable PDF document for use as an instrument for standardised reporting of funding information. Although the majority of RCTs report funding, there is considerable variability in the reporting of funding source, amount and roles of funders. A standardised approach to reporting of funding information would address these limitations. Future research should explore the implications of funding by not-for-profit organisations that are supported by for

  19. Continuity Between DSM-5 Section II and III Personality Disorders in a Dutch Clinical Sample.

    Science.gov (United States)

    Orbons, Irene M J; Rossi, Gina; Verheul, Roel; Schoutrop, Mirjam J A; Derksen, Jan L L; Segal, Daniel L; van Alphen, Sebastiaan P J

    2018-05-14

    The goal of this study was to evaluate the continuity across the Section II personality disorders (PDs) and the proposed Section III model of PDs in the Diagnostic and Statistical Manual of Mental Disorders (5th ed. [DSM-5]; American Psychiatric Association, 2013a ). More specifically, we analyzed association between the DSM-5 Section III pathological trait facets and Section II PDs among 110 Dutch adults (M age = 35.8 years, range = 19-60 years) receiving mental health care. We administered the Structured Clinical Interview for DSM-IV Axis II Disorders to all participants. Participants also completed the self-report Personality Inventory for DSM-5 (PID-5) as a measure of pathological trait facets. The distributions underlying the dependent variable were modeled as criterion counts, using negative binomial regression. The results provided some support for the validity of the PID-5 and the DSM-5 Section III Alternative Model, although analyses did not show a perfect match. Both at the trait level and the domain level, analyses showed mixed evidence of significant relationships between the PID-5 trait facets and domains with the traditional DSM-IV PDs.

  20. Clinical learning environment and supervision of international nursing students: A cross-sectional study.

    Science.gov (United States)

    Mikkonen, Kristina; Elo, Satu; Miettunen, Jouko; Saarikoski, Mikko; Kääriäinen, Maria

    2017-05-01

    Previously, it has been shown that the clinical learning environment causes challenges for international nursing students, but there is a lack of empirical evidence relating to the background factors explaining and influencing the outcomes. To describe international and national students' perceptions of their clinical learning environment and supervision, and explain the related background factors. An explorative cross-sectional design was used in a study conducted in eight universities of applied sciences in Finland during September 2015-May 2016. All nursing students studying English language degree programs were invited to answer a self-administered questionnaire based on both the clinical learning environment, supervision and nurse teacher scale and Cultural and Linguistic Diversity scale with additional background questions. Participants (n=329) included international (n=231) and Finnish (n=98) nursing students. Binary logistic regression was used to identify background factors relating to the clinical learning environment and supervision. International students at a beginner level in Finnish perceived the pedagogical atmosphere as worse than native speakers. In comparison to native speakers, these international students generally needed greater support from the nurse teacher at their university. Students at an intermediate level in Finnish reported two times fewer negative encounters in cultural diversity at their clinical placement than the beginners. To facilitate a successful learning experience, international nursing students require a sufficient level of competence in the native language when conducting clinical placements. Educational interventions in language education are required to test causal effects on students' success in the clinical learning environment. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Efficacy and safety of a novel pharmacological stress test agent-higenamine in radionuclide myocardial perfusion imaging: phase Ⅱ clinical trial

    International Nuclear Information System (INIS)

    Du Yanrong; Li Fang; Wang Qian; Li Dianfu; Long Mingqing; Liu Yimin; Li Bilu

    2014-01-01

    of diastolic blood pressure. Either HG or Ad induced significantly increased HR during administration and 5 min after administration. The clinical laboratory profile (hematology,serum chemistry, and urinalysis) was either normal or with no significant change. A total of 176 side effects (e.g, dyspnea, short breath, palpitation, dizziness,headache) were found related to HG (69.2%, 83/120) and Ad (77.5%, 93/120) administration (χ 2 =2.1307, P>0.05), which were mostly mild and transient. Conclusion: HG is a safe and effective pharmacological stress test agent as compared to adenosine for the detection of CAD with SPECT perfusion imaging. (authors)

  2. The thin-section CT, pathological and clinical findings of peripheral small squamous cell lung carcinomas

    International Nuclear Information System (INIS)

    Yamamoto, Takahito; Saito, Haruhiro; Kondo, Tetsuro

    2010-01-01

    We analyzed thin-section CT, pathological, and clinical findings of peripheral lung squamous cell carcinomas, with diameters of less than 20 mm and compared these findings with solid type adenocarcinomas. CT findings of polygonal shapes, notches, pleural thickness, and cavities are more frequently found in squamous cell carcinomas than in adenocarcinomas. The pathological types can be classified in two groups: Solid types, Scirrhous types. The 5 year survival rate after resection is 64.5%, which is poorer than survival rate for solid type adenocarcinomas. It is vital to diagnose and treat peripheral squamous cell carcinomas as early as possible. (author)

  3. Improving clinical cognitive testing: report of the AAN Behavioral Neurology Section Workgroup.

    Science.gov (United States)

    Daffner, Kirk R; Gale, Seth A; Barrett, A M; Boeve, Bradley F; Chatterjee, Anjan; Coslett, H Branch; D'Esposito, Mark; Finney, Glen R; Gitelman, Darren R; Hart, John J; Lerner, Alan J; Meador, Kimford J; Pietras, Alison C; Voeller, Kytja S; Kaufer, Daniel I

    2015-09-08

    To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. © 2015 American Academy of Neurology.

  4. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  5. Posterior pharyngeal candidiasis in the absence of clinically overt oral involvement: a cross-sectional study.

    Science.gov (United States)

    Glavey, Siobhan V; Keane, Niamh; Power, Maria; O'Regan, Anthony W

    2013-12-01

    Although oropharyngeal candidiasis is associated with inhaled corticosteroid (ICS) usage, there is sparse data on the prevalence of posterior pharyngeal candidiasis in those without any detectable oral candidiasis on clinical examination. We systematically investigated the relationship between oral candidiasis on clinical examination and the presence of posterior pharyngeal candidiasis at bronchoscopy. We conducted a cross-sectional study on a convenience sample of 100 patients undergoing bronchoscopy at our institution. Patients were assessed for symptoms of and risk factors for candida infection and had an examination of their oropharynx for evidence of candidiasis before bronchoscopy. They subsequently had a detailed assessment for posterior candidiasis at bronchoscopy. We performed a posteriori subgroup analysis, which focused solely on those patients on ICS maintenance therapy. Median age was 54.7 (27-84) years, and 55 patients were male; 47 % of patients were on ICS, and 20 % of this cohort received recent oral corticosteroids. Twenty-eight percent of this convenience sample had posterior pharyngeal candidiasis; however, only 10.7 % (3/28) of these patients had clinically detectable oral candidiasis on clinical examination before bronchoscopy. Factors that were independently associated with the presence of pharyngeal candidiasis at bronchoscopy were OR (95 % CI) ICS usage 6.9 (2.5-19.2), particularly fluticasone usage 6.8 (2.62-17.9) and the presence of dysphonia 3.2 (1.3-8.0). In the subgroup analysis of ICS usage, posterior pharyngeal candidiasis was correlated with the presence of dysphonia but was not independently associated with fluticasone or budesonide dosage. This study demonstrates that posterior pharyngeal candidiasis in the absence of clinically overt oral candidiasis is frequent amongst ICS users. A history of ICS use, particularly fluticasone usage, as well as the presence of dysphonia are associated with posterior pharyngeal candidiasis at

  6. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Directory of Open Access Journals (Sweden)

    Joseph S Ross

    2009-09-01

    Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

  7. A comparison of medical and pharmacy students' knowledge and skills of pharmacology and pharmacotherapy.

    Science.gov (United States)

    Keijsers, Carolina J P W; Brouwers, Jacobus R B J; de Wildt, Dick J; Custers, Eugene J F M; Ten Cate, Olle Th J; Hazen, Ankie C M; Jansen, Paul A F

    2014-10-01

    Pharmacotherapy might be improved if future pharmacists and physicians receive a joint educational programme in pharmacology and pharmacotherapeutics. This study investigated whether there are differences in the pharmacology and pharmacotherapy knowledge and skills of pharmacy and medical students after their undergraduate training. Differences could serve as a starting point from which to develop joint interdisciplinary educational programmes for better prescribing. In a cross-sectional design, the knowledge and skills of advanced pharmacy and medical students were assessed, using a standardized test with three domains (basic pharmacology knowledge, clinical or applied pharmacology knowledge and pharmacotherapy skills) and eight subdomains (pharmacodynamics, pharmacokinetics, interactions and side-effects, Anatomical Therapeutic Chemical Classification groups, prescribing, prescribing for special groups, drug information, regulations and laws, prescription writing). Four hundred and fifty-one medical and 151 pharmacy students were included between August 2010 and July 2012. The response rate was 81%. Pharmacy students had better knowledge of basic pharmacology than medical students (77.0% vs. 68.2% correct answers; P students had better skills than pharmacy students in writing prescriptions (68.6% vs. 50.7%; P students had similar knowledge of applied pharmacology (73.8% vs. 72.2%, P = 0.124, δ = 0.15). Pharmacy students have better knowledge of basic pharmacology, but not of the application of pharmacology knowledge, than medical students, whereas medical students are better at writing prescriptions. Professional differences in knowledge and skills therefore might well stem from their undergraduate education. Knowledge of these differences could be harnessed to develop a joint interdisciplinary education for both students and professionals. © 2014 The British Pharmacological Society.

  8. Effects of Recitation of Holy Quran on Anxiety of Women before Cesarean Section: A Randomize Clinical Trial

    Directory of Open Access Journals (Sweden)

    N Mir Bagher AjorPaz

    2012-05-01

    Full Text Available

    Background and Objectives: Anxiety is a kind of agitation and concern stemming from the feeling of threat or hazard in human. It can decrease or increase the understanding ability of individuals. Most clinical patients have anxiety in confronting a new and unknown environment such as hospitals. A non-pharmacological method such as pleasant sound of Holy Quran recitation can be used as a useful and effective procedure to decrease the anxiety. The aim of this research was to study the recitation effects of Holy Quran on anxiety of woman before cesarean.

    Methods: In this quasi-experimental study, 80 women expecting cesarean section were randomly selected regarding their characteristics and divided into two groups: control group (30 members and experimental group (50 members. Data collection instrument was a two-part questionnaire including demographic characteristics, and Spilburge’s state-trait anxiety inventory. The degree of anxiety for the two groups was evaluated before cesarean, then before innate cesarean, the Holy Quran recitation was played for experimental group for 20 minutes by the sound of famous recite, Abdol Basset. Data were analyzed using Chi-Square, single sample & paired T-test, and a Pvalue of 0<0.05 was considered as statistically significant.

    Results: The results showed that the degree of anxiety decreased in experimental group after intervention (P=0.0001, but not in the control group.(P=0.98 Comparison of the two groups showed a significant difference after intervention (P=0.002.

    Conclusion: According to the results of this research and because of the agreeable rhythmic intonation of the Quran as gnostic music and its miracle aspect, we can use its tone as a non medicinal method for reducing anxiety before cesarean women.

  9. Clinical and pulmonary thin-section CT findings in acute Klebsiella Pneumoniae pneumonia

    Energy Technology Data Exchange (ETDEWEB)

    Okada, Fumito [Oita University Faculty of Medicine, Department of Diagnostic and Interventional Radiology, Oita (Japan); Oita University Faculty of Medicine, Department of Radiology, Oita (Japan); Ando, Yumiko; Honda, Koichi; Nakayama, Tomoko; Kiyonaga, Maki; Ono, Asami; Tanoue, Shuichi; Maeda, Toru; Mori, Hiromu [Oita University Faculty of Medicine, Department of Diagnostic and Interventional Radiology, Oita (Japan)

    2009-04-15

    The aim of this study was to assess the clinical and pulmonary thin-section CT findings in patients with acute Klebsiella pneumoniae pneumonia. We retrospectively evaluated thin-section CT examinations performed between January 1991 and December 2007 from 962 patients with acute Klebsiella pneumoniae pneumonia. Seven hundred and sixty-four cases with concurrent infectious diseases were excluded. Thus, our study group comprised 198 patients (118 male, 80 female; age range 18-97 years, mean age 61.5). Underlying diseases and clinical findings were assessed. Parenchymal abnormalities were evaluated along with the presence of enlarged lymph nodes and pleural effusion. CT findings in patients with acute Klebsiella pneumoniae pneumonia consisted mainly of ground-glass attenuation (100%), consolidation (91.4%), and intralobular reticular opacity (85.9%), which were found in the periphery (96%) of both sides of the lungs (72.2%) and were often associated with pleural effusion (53%). The underlying conditions in patients with Klebsiella pneumoniae pneumonia were alcoholism or smoking habit. (orig.)

  10. Clinical and pulmonary thin-section CT findings in acute Klebsiella Pneumoniae pneumonia

    International Nuclear Information System (INIS)

    Okada, Fumito; Ando, Yumiko; Honda, Koichi; Nakayama, Tomoko; Kiyonaga, Maki; Ono, Asami; Tanoue, Shuichi; Maeda, Toru; Mori, Hiromu

    2009-01-01

    The aim of this study was to assess the clinical and pulmonary thin-section CT findings in patients with acute Klebsiella pneumoniae pneumonia. We retrospectively evaluated thin-section CT examinations performed between January 1991 and December 2007 from 962 patients with acute Klebsiella pneumoniae pneumonia. Seven hundred and sixty-four cases with concurrent infectious diseases were excluded. Thus, our study group comprised 198 patients (118 male, 80 female; age range 18-97 years, mean age 61.5). Underlying diseases and clinical findings were assessed. Parenchymal abnormalities were evaluated along with the presence of enlarged lymph nodes and pleural effusion. CT findings in patients with acute Klebsiella pneumoniae pneumonia consisted mainly of ground-glass attenuation (100%), consolidation (91.4%), and intralobular reticular opacity (85.9%), which were found in the periphery (96%) of both sides of the lungs (72.2%) and were often associated with pleural effusion (53%). The underlying conditions in patients with Klebsiella pneumoniae pneumonia were alcoholism or smoking habit. (orig.)

  11. Ethnic Variation in the Cross-sectional Association between Domains of Depressive Symptoms and Clinical Depression

    Directory of Open Access Journals (Sweden)

    Shervin eAssari

    2016-04-01

    Full Text Available BackgroundThe degree by which depressive symptoms and clinical depression reflect each other may vary across populations. The present study compared Blacks and Whites for the magnitude of the cross-sectional associations between various domains of depressive symptoms and endorsement of clinical disorders of depression. MethodsData came from the National Survey of American Life (NSAL, 2001–2003. We included 3,570 Black (African Americans, and 891 Non-Hispanic Whites. Predictors were positive affect, negative affect, and interpersonal problems measured using the 12-item Center for Epidemiologic Studies Depression Scale (CES-D. Outcomes were lifetime MDD, lifetime MDE, 12 month MDE, 30 days MDE, and 30 days MDDH based on the Composite International Diagnostic Interview (CIDI. Logistic regression models were applied in the pooled sample, as well as Blacks and Whites.ResultsRegarding CES-D, Blacks had lower total scores, positive affect, negative affect, and interpersonal problems compared to Whites (p < 0.05 for all comparisons. Blacks also had lower odds of meeting criteria for lifetime MDD and MDE, 12 month MDE, and 30 days MDE and MDDH (p < 0.05 for all comparisons. For most depressive diagnoses, ethnicity showed a positive and significant interaction with the negative affect and interpersonal domains, suggesting stronger associations for Blacks compared to Whites. CES-D total and CES-D positive affect did not interact with ethnicity on CIDI based diagnoses.ConclusionStronger associations between multiple domains of depressive symptoms and clinical MDD may be due to higher severity of depression among Blacks, when they endorse the disorder. This finding may explain some of previously observed ethnic differences in social, psychological, and medical correlates of depressive symptoms and clinical depression in the general population as well as clinical settings.

  12. Responses to clinical uncertainty in Australian general practice trainees: a cross-sectional analysis.

    Science.gov (United States)

    Cooke, Georga; Tapley, Amanda; Holliday, Elizabeth; Morgan, Simon; Henderson, Kim; Ball, Jean; van Driel, Mieke; Spike, Neil; Kerr, Rohan; Magin, Parker

    2017-12-01

    Tolerance for ambiguity is essential for optimal learning and professional competence. General practice trainees must be, or must learn to be, adept at managing clinical uncertainty. However, few studies have examined associations of intolerance of uncertainty in this group. The aim of this study was to establish levels of tolerance of uncertainty in Australian general practice trainees and associations of uncertainty with demographic, educational and training practice factors. A cross-sectional analysis was performed on the Registrar Clinical Encounters in Training (ReCEnT) project, an ongoing multi-site cohort study. Scores on three of the four independent subscales of the Physicians' Reaction to Uncertainty (PRU) instrument were analysed as outcome variables in linear regression models with trainee and practice factors as independent variables. A total of 594 trainees contributed data on a total of 1209 occasions. Trainees in earlier training terms had higher scores for 'Anxiety due to uncertainty', 'Concern about bad outcomes' and 'Reluctance to disclose diagnosis/treatment uncertainty to patients'. Beyond this, findings suggest two distinct sets of associations regarding reaction to uncertainty. Firstly, affective aspects of uncertainty (the 'Anxiety' and 'Concern' subscales) were associated with female gender, less experience in hospital prior to commencing general practice training, and graduation overseas. Secondly, a maladaptive response to uncertainty (the 'Reluctance to disclose' subscale) was associated with urban practice, health qualifications prior to studying medicine, practice in an area of higher socio-economic status, and being Australian-trained. This study has established levels of three measures of trainees' responses to uncertainty and associations with these responses. The current findings suggest differing 'phenotypes' of trainees with high 'affective' responses to uncertainty and those reluctant to disclose uncertainty to patients. More

  13. Polysomnographic Findings and Clinical Correlates in Huntington Disease: A Cross-Sectional Cohort Study

    Science.gov (United States)

    Piano, Carla; Losurdo, Anna; Della Marca, Giacomo; Solito, Marcella; Calandra-Buonaura, Giovanna; Provini, Federica; Bentivoglio, Anna Rita; Cortelli, Pietro

    2015-01-01

    Study Objectives: To evaluate the sleep pattern and the motor activity during sleep in a cohort of patients affected by Huntington disease (HD). Design: Cross-sectional cohort study. Setting: Sleep laboratory. Patients: Thirty HD patients, 16 women and 14 men (mean age 57.3 ± 12.2 y); 30 matched healthy controls (mean age 56.5 ± 11.8 y). Interventions: Subjective sleep evaluation: Epworth Sleepiness Scale (ESS); Berlin's Questionnaire, interview for restless legs syndrome (RLS), questionnaire for REM sleep behavior disorder (RBD). Clinical evaluation: disease duration, clinical severity (unified Huntington disease motor rating scale [UHDMRS]), genetic tests. Laboratory-based full-night attended video-polysomnography (V-PSG). Measurements and Results: The duration of the disease was 9.4 ± 4.4 y, UHMDRS score was 55.5 ± 23.4, CAG repeats were 44.3 ± 4.1. Body mass index was 21.9 ± 4.0 kg/m2. No patients or caregivers reported poor sleep quality. Two patients reported symptoms of RLS. Eight patients had an ESS score ≥ 9. Eight patients had high risk of obstructive sleep apnea. At the RBD questionnaire, two patients had a pathological score. HD patients, compared to controls, showed shorter sleep, reduced sleep efficiency index, and increased arousals and awakenings. Four patients presented with sleep disordered breathing (SDB). Periodic limb movements (PLMs) during wake and sleep were observed in all patients. No episode of RBD was observed in the V-PSG recordings, and no patients showed rapid eye movement (REM) sleep without atonia. The disease duration correlated with ESS score (P Marca G, Solito M, Calandra-Buonaura G, Provini F, Bentivoglio AR, Cortelli P. Polysomnographic findings and clinical correlates in Huntington disease: a cross-sectional cohort study. SLEEP 2015;38(9):1489–1495. PMID:25845698

  14. Pharmacological approach to acute pancreatitis

    DEFF Research Database (Denmark)

    Bang, U.C.; Semb, S.; Nøjgaard, Camilla

    2008-01-01

    The aim of the present review is to summarize the current knowledge regarding pharmacological prevention and treatment of acute pancreatitis (AP) based on experimental animal models and clinical trials. Somatostatin (SS) and octreotide inhibit the exocrine production of pancreatic enzymes and may...... be useful as prophylaxis against post endoscopic retrograde cholangiopancreatography pancreatitis (PEP). The protease inhibitor gabexate mesilate (GM) is used routinely as treatment to AP in some countries, but randomized clinical trials and a meta-analysis do not support this practice. Nitroglycerin (NGL...

  15. Pharmacological therapy of spondyloarthritis.

    Science.gov (United States)

    Palazzi, Carlo; D'Angelo, Salvatore; Gilio, Michele; Leccese, Pietro; Padula, Angela; Olivieri, Ignazio

    2015-01-01

    The current pharmacological therapy of spondyloarthritis (SpA) includes several drugs: Non-steroidal anti-inflammatory drugs, corticosteroids, traditional disease-modifying antirheumatic drugs and biologic drugs. A systematic literature search was completed using the largest electronic databases (Medline, Embase and Cochrane), starting from 1995, with the aim to review data on traditional and biologic agents commercialised for SpA treatment. Randomised controlled trials and large observational studies were considered. In addition, studies performed in SpA patients treated with other, still unapproved, drugs (rituximab, anti-IL6 agents, apremilast, IL17 inhibitors and anakinra) were also taken into account. Biologic agents, especially anti-TNF drugs, have resulted in significant progress in improving clinical symptoms and signs, reducing inflammatory features in laboratory tests and imaging findings, and recovering all functional indexes. Anti-TNF drugs have radically changed the evolution of radiographic progression in peripheral joints; the first disappointing data concerning their efficacy on new bone formation of axial SpA has been recently challenged by studies enrolling patients who have been earlier diagnosed and treated. The opportunity to extend the interval of administration or to reduce the doses of anti-TNF agents can favourably influence the costs. Ustekinumab, the first non-anti-TNF biologic drug commercialised for psoriatic arthritis, offers new chances to patients that are unresponsive to anti-TNF.

  16. Domestic violence in a UK abortion clinic: anonymous cross-sectional prevalence survey.

    Science.gov (United States)

    Motta, Silvia; Penn-Kekana, Loveday; Bewley, Susan

    2015-04-01

    To measure the prevalence of domestic violence (DV) experienced by women seeking termination of pregnancy (TOP) in a UK abortion clinic. A cross-sectional anonymous questionnaire survey of all women aged over 16 years accessing a TOP clinic in inner London between 20 May 2012 and 2 July 2012. The main outcome measures were: distribution of questionnaires, response rate, lifetime prevalence of abuse, past-year prevalence of physical and sexual abuse, prevalence of physical abuse during current pregnancy, relationship of lifetime abuse to number of terminations, and receptivity to DV services. Questionnaires were distributed to 46% (383/828) of women accessing the clinic. Response rate was 50% (190/383). Lifetime prevalence of abuse was 16%. Past-year prevalence of physical abuse was 11% and sexual abuse was 4%. Prevalence of physical abuse during the current pregnancy was 4%. Prevalence of lifetime abuse was lower in women having a first termination (12%) versus one (20%) or two or more previous terminations (24%), although this was not statistically significant (p=0.192). The majority (75%) of participants expressing an opinion on the possibility of having a support service for DV in the abortion clinic setting were positive, unrelated to their personal experience, but some concerns were raised about implementation. In order to provide effective support for women, services require a needs assessment of their local population. Asking women presenting for abortion about DV, even anonymously, is challenging but feasible. Future work should be directed to women's unmet safety needs. 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.

  17. Neuropathological diagnoses and clinical correlates in older adults in Brazil: A cross-sectional study.

    Directory of Open Access Journals (Sweden)

    Claudia K Suemoto

    2017-03-01

    Full Text Available Clinicopathological studies are important in determining the brain lesions underlying dementia. Although almost 60% of individuals with dementia live in developing countries, few clinicopathological studies focus on these individuals. We investigated the frequency of neurodegenerative and vascular-related neuropathological lesions in 1,092 Brazilian admixed older adults, their correlation with cognitive and neuropsychiatric symptoms, and the accuracy of dementia subtype diagnosis.In this cross-sectional study, we describe clinical and neuropathological variables related to cognitive impairment in 1,092 participants (mean age = 74 y, 49% male, 69% white, and mean education = 4 y. Cognitive function was investigated using the Clinical Dementia Rating (CDR and the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE; neuropsychiatric symptoms were evaluated using the Neuropsychiatric Inventory (NPI. Associations between neuropathological lesions and cognitive impairment were investigated using ordinal logistic regression. We developed a neuropathological comorbidity (NPC score and compared it to CDR, IQCODE, and NPI scores. We also described and compared the frequency of neuropathological diagnosis to clinical diagnosis of dementia subtype. Forty-four percent of the sample met criteria for neuropathological diagnosis. Among these participants, 50% had neuropathological diagnoses of Alzheimer disease (AD, and 35% of vascular dementia (VaD. Neurofibrillary tangles (NFTs, hippocampal sclerosis, lacunar infarcts, hyaline atherosclerosis, siderocalcinosis, and Lewy body disease were independently associated with cognitive impairment. Higher NPC scores were associated with worse scores in the CDR sum of boxes (β = 1.33, 95% CI 1.20-1.46, IQCODE (β = 0.14, 95% CI 0.13-0.16, and NPI (β = 1.74, 95% CI = 1.33-2.16. Compared to neuropathological diagnoses, clinical diagnosis had high sensitivity to AD and high specificity to dementia with

  18. International Union of Basic and Clinical Pharmacology. C. Nomenclature and Properties of Calcium-Activated and Sodium-Activated Potassium Channels.

    Science.gov (United States)

    Kaczmarek, Leonard K; Aldrich, Richard W; Chandy, K George; Grissmer, Stephan; Wei, Aguan D; Wulff, Heike

    2017-01-01

    A subset of potassium channels is regulated primarily by changes in the cytoplasmic concentration of ions, including calcium, sodium, chloride, and protons. The eight members of this subfamily were originally all designated as calcium-activated channels. More recent studies have clarified the gating mechanisms for these channels and have documented that not all members are sensitive to calcium. This article describes the molecular relationships between these channels and provides an introduction to their functional properties. It also introduces a new nomenclature that differentiates between calcium- and sodium-activated potassium channels. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

  19. Perinatal pharmacology: applications for neonatal neurology.

    Science.gov (United States)

    Smits, Anne; Allegaert, Karel

    2011-11-01

    The principles of clinical pharmacology also apply to neonates, but their characteristics warrant a tailored approach. We focus on aspects of both developmental pharmacokinetics (concentration/time relationship) and developmental pharmacodynamics (concentration/effect relationship) in neonates. We hereby aimed to link concepts used in clinical pharmacology with compound-specific observations (anti-epileptics, analgosedatives) in the field of neonatal neurology. Although in part anecdotal, we subsequently illustrate the relevance of developmental pharmacology in the field of neonatal neurology by a specific intervention (e.g. whole body cooling), specific clinical presentations (e.g. short and long term outcome following fetal exposure to antidepressive agents, the development of new biomarkers for fetal alcohol syndrome) and specific clinical needs (e.g. analgosedation in neonates, excitocytosis versus neuro-apoptosis/impaired synaptogenesis). Copyright © 2011 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

  20. Use of oxytocin during Caesarean section at Princess Marina Hospital, Botswana: An audit of clinical practice

    Directory of Open Access Journals (Sweden)

    Billy M. Tsima

    2013-02-01

    Full Text Available Background: Oxytocin is widely used for the prevention of postpartum haemorrhage. In the setting of Caesarean section (CS, the dosage and mode of administrating oxytocin differs according to different guidelines. Inappropriate oxytocin doses have been identified ascontributory to some cases of maternal deaths. The main aim of this study was to audit the current standard of clinical practice with regard to the use of oxytocin during CS at a referral hospital in Botswana.Methods: A clinical audit of pregnant women having CS and given oxytocin at the time of the operation was conducted over a period of three months. Data included indications for CS, oxytocin dose regimen, prescribing clinician’s designation, type of anaesthesia for the CS and estimated blood loss.Results: A total of 139 case records were included. The commonest dose was 20 IU infusion (31.7%. The potentially dangerous regimen of 10 IU intravenous bolus of oxytocin was used in 12.9% of CS. Further doses were utilized in 57 patients (41%. The top three indications forCS were fetal distress (36 patients, 24.5%, dystocia (32 patients, 21.8% and a previous CS (25 patients, 17.0%. Estimated blood loss ranged from 50 mL – 2000 mL.Conclusion: The use of oxytocin during CS in the local setting does not follow recommended practice. This has potentially harmful consequences. Education and guidance through evidencebased national guidelines could help alleviate the problem.

  1. Patient satisfaction with TB care clinical consultations in Kampala: a cross sectional study.

    Science.gov (United States)

    Ssengooba, Willy; Kirenga, Bruce; Muwonge, Catherine; Kyaligonza, Steven; Kasozi, Samuel; Mugabe, Frank; Boeree, Martin; Joloba, Moses; Okwera, Alphonse

    2016-12-01

    Patient satisfaction towards care during encounter with clinicians is key for better treatment outcomes. We assessed patient satisfaction with TB clinical care consultations in Kampala, Uganda. This was a facility-based cross sectional study done between September 2012 and February 2013 using qualitative method of data collection. Participants consecutively completed a pre-tested structured satisfaction questionnaire. A criteria of the rating as good; >75% was considered acceptable, (50-75%) as more effort is needed and patient satisfaction, were: time spent with clinician (85.4%), explanation of what was done (87.6%), technical skills (91.6%), personal manner of the clinician seen (91.6%). Factors for low satisfaction were; waiting time before getting an appointment (61.8%), convenience of location of consultation office (53.4%), getting through to the office by phone (21.3%) and length of time waiting at the office (61.2%). Tuberculosis patients in Kampala are satisfied with TB clinical care consultations. Addressing factors with low patient satisfaction may significantly impact on treatment outcome.

  2. Paramedic student exposure to workplace violence during clinical placements - A cross-sectional study.

    Science.gov (United States)

    Boyle, Malcolm; McKenna, Lisa

    2017-01-01

    Paramedic students are hesitant to formally report exposure to acts of workplace violence as they feel it may jeopardise their chance of getting a job. The objective of this study was to identify the type and number of workplace violence acts experienced by undergraduate paramedic students whilst on an ambulance clinical placement. This was a cross-sectional study using the Paramedic Workplace Violence Exposure Questionnaire to obtain student exposure to acts of workplace violence which occurred whilst on ambulance clinical placements. The survey response rate was 29.8%. The students' average age was 24.1 years, median age of 23 years, range 18-47 years. There were 32.6% of students who were exposed to at least one act of workplace violence with 56% of these being females. Verbal abuse 18%, and intimidation 17% were the common acts of workplace violence students were exposed to. One female, a nursing/paramedic student, was exposed to sexual harassment on more than one occasion. The findings from this study suggest that paramedic students are exposed to similar rates of workplace violence as full time practising paramedics. Further research is required into workplace violence against students from all professions and what detrimental effect this may have on them. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Biological and Pharmacological properties

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Biological and Pharmacological properties. NOEA inhibits Ceramidase. Anandamide inhibits gap junction conductance and reduces sperm fertilizing capacity. Endogenous ligands for Cannabinoid receptors (anandamide and NPEA). Antibacterial and antiviral ...

  4. EORTC recommended protocol for melanoma sentinel lymph node sectioning misclassifies up to 50% of the patients compared with complete step sectioning. Danish Society for Pathological Anatomy and Clinical Cytology

    DEFF Research Database (Denmark)

    Riber-Hansen, Rikke; Hastrup, N; Clemmensen, O.

    2010-01-01

    EORTC recommended protocol for melanoma sentinel lymph node sectioning misclassifies up to 50% of the patients compared with complete step sectioning. Danish Society for Pathological Anatomy and Clinical Cytology......EORTC recommended protocol for melanoma sentinel lymph node sectioning misclassifies up to 50% of the patients compared with complete step sectioning. Danish Society for Pathological Anatomy and Clinical Cytology...

  5. Clinical trial registration in physical therapy journals: a cross-sectional study.

    Science.gov (United States)

    Babu, Abraham Samuel; Veluswamy, Sundar Kumar; Rao, Pratiksha Tilak; Maiya, Arun G

    2014-01-01

    Clinical trial registration has become an important part of editorial policies of various biomedical journals, including a few physical therapy journals. However, the extent to which editorial boards enforce the need for trial registration varies across journals. The purpose of this study was to identify editorial policies and reporting of trial registration details in MEDLINE-indexed English-language physical therapy journals. This study was carried out using a cross-sectional design. Editorial policies on trial registration of MEDLINE-indexed member journals of the International Society of Physiotherapy Journal Editors (ISPJE) (Journal of Geriatric Physical Therapy, Journal of Hand Therapy, Journal of Neurologic Physical Therapy, Journal of Orthopaedic and Sports Physical Therapy, Journal of Physiotherapy [formerly Australian Journal of Physiotherapy], Journal of Science and Medicine in Sport, Manual Therapy, Physical Therapy, Physical Therapy in Sport, Physiotherapy, Physiotherapy Research International, Physiotherapy Theory and Practice, and Revista Brasileira de Fisioterapia) were reviewed in April 2013. Full texts of reports of clinical trials published in these journals between January 1, 2008, and December 31, 2012, were independently assessed for information on trial registration. Among the 13 journals, 8 recommended trial registration, and 6 emphasized prospective trial registration. As of April 2013, 4,618 articles were published between January 2008 and December 2012, of which 9% (417) were clinical trials and 29% (121/417) of these reported trial registration details. A positive trend in reporting of trial registration was observed from 2008 to 2012. The study was limited to MEDLINE-indexed ISPJE member journals. Editorial policies on trial registration of physical therapy journals and a rising trend toward reporting of trial registration details indicate a positive momentum toward trial registration. Physical therapy journal editors need to show

  6. Pharmacologic therapy for acute pancreatitis

    Science.gov (United States)

    Kambhampati, Swetha; Park, Walter; Habtezion, Aida

    2014-01-01

    While conservative management such as fluid, bowel rest, and antibiotics is the mainstay of current acute pancreatitis management, there is a lot of promise in pharmacologic therapies that target various aspects of the pathogenesis of pancreatitis. Extensive review of preclinical studies, which include assessment of therapies such as anti-secretory agents, protease inhibitors, anti-inflammatory agents, and anti-oxidants are discussed. Many of these studies have shown therapeutic benefit and improved survival in experimental models. Based on available preclinical studies, we discuss potential novel targeted pharmacologic approaches that may offer promise in the treatment of acute pancreatitis. To date a variety of clinical studies have assessed the translational potential of animal model effective experimental therapies and have shown either failure or mixed results in human studies. Despite these discouraging clinical studies, there is a great clinical need and there exist several preclinical effective therapies that await investigation in patients. Better understanding of acute pancreatitis pathophysiology and lessons learned from past clinical studies are likely to offer a great foundation upon which to expand future therapies in acute pancreatitis. PMID:25493000

  7. The pharmacology of gynaecology.

    Science.gov (United States)

    Tothill, A

    1980-09-01

    Focus in this discussion of the pharmacology of gynecology is on the following: vaginal infections; genital herpes; genital warts; pelvic inflammatory disease; urinary infections; pruritus vulvae; menstrual problems; infertility; oral contraception; and hormone replacement therapy. Doctors in England working in Local Authority Family Planning Clinics are debarred from prescribing, and any patient with a vaginal infection has to be referred either to a special clinic or to her general practitioner which is often preferable as her medical history will be known. Vaginal discharge is a frequent complaint, and it is necessary to obtain full details. 1 of the most common infections is vaginal candidosis. Nystatin pessaries have always been a useful 1st-line treatment and are specific for this type of infection. Trichomonas infection also occurs frequently and responds well to metronidazole in a 200 mg dosage, 3 times daily for 7 days. It is necessary to treat the consort at the same time. Venereal diseases such as syphilis and gonorrhea always require vigorous treatment. Patients are now presenting with herpes genitalis far more often. The only treatment which is currently available, and is as good as any, is the application of warm saline to the vaginal area. Genital warts may be discovered on routine gynecological examination or may be reported to the doctor by the patient. 1 application of a 20% solution of podophyllum, applied carefully to each wart, usually effects a cure. Pelvic inflammatory disease seems to be on the increase. Provided any serious disease is ruled out a course of systemic antibiotics is often effective. Urinary infections are often seen in the gynecologic clinic, and many of these will respond well to 2 tablets of co-trimoxazole, 2 times daily for 14 days. In pruritus vulvae it is important to determine whether the cause is general or local. Menstrual problems regularly occur and have been increased by the IUD and the low-dose progesterone pill

  8. Post graduate clinical placements: evaluating benefits and challenges with a mixed methods cross sectional design.

    Science.gov (United States)

    Yiend, Jenny; Tracy, Derek K; Sreenan, Brian; Cardi, Valentina; Foulkes, Tina; Koutsantoni, Katerina; Kravariti, Eugenia; Tchanturia, Kate; Willmott, Lucy; Shergill, Sukhi; Reedy, Gabriel

    2016-02-16

    Systematic evaluations of clinical placements are rare, especially when offered alongside academic postgraduate courses. An evidence-based approach is important to allow pedagogically-driven provision, rather than that solely governed by opinion or market demand. Our evaluation assessed a voluntary clinical placement scheme allied to a mental health course. Data were collected over academic years 2010/11- 2013/14, from participating students (n = 20 to 58) and clinician supervisors (n = 10-12), using a mixed-methods cross-sectional design. Quantitative evaluation captured information on uptake, dropout, resource use, attitudes and experience, using standardized (the Placement Evaluation Questionnaire; the Scale To Assess the Therapeutic Relationship - Clinical version and the University of Toronto Placement Supervisor Evaluation) and bespoke questionnaires and audit data. Qualitative evaluation comprised two focus groups (5 clinicians, 5 students), to investigate attitudes, experience, perceived benefits, disadvantages and desired future developments. Data were analysed using framework analysis to identify a priori and emergent themes. High uptake (around 70 placements per annum), low dropout (2-3 students per annum; 5 %) and positive focus group comments suggested placements successfully provided added value and catered sufficiently to student demand. Students' responses confirmed that placements met expectations and the perception of benefit remained after completion with 70 % (n = 14) reporting an overall positive experience, 75 % (n = 15) reporting a pleasant learning experience, 60 % (n = 12) feeling that their clinical skills were enhanced and 85 % (n = 17) believing that it would benefit other students. Placements contributed the equivalent of seven full time unskilled posts per annum to local health care services. While qualitative data revealed perceived 'mutual benefit' for both students and clinicians, this was qualified by

  9. Bibliometric analysis of journal of clinical and diagnostic research (dentistry section; 2007-2014).

    Science.gov (United States)

    Jain, Swati; Basavaraj, P; Singla, Ashish; Singh, Khushboo; Kundu, Hansa; Vashishtha, Vaibhav; Pandita, Venisha; Malhi, Ravneet

    2015-04-01

    The role of scientific journals in diffusion of data concerning researches in the field of Public Health Dentistry is of premier importance. Bibliometric analysis involves analysis of publications reflecting the type of research work. The present study was conducted with an aim to determine the number and trends of published articles in Journal of Clinical and Diagnostic Research (JCDR) from Feb. 2007 to Oct.2014. A retrospective observational study was conducted for JCDR. All issues of JCDR were electronically searched for the parameters : study design, area of interest of research, state /college where research was conducted, authorship pattern, source of articles published each year, changing study trends, disease under study and publication bias. The data was organized and analyzed using software SPSS - version 21.0; descriptive statistics was used. Bibliometric analysis was done for 601 articles of JCDR published from Feb. 2007 to Oct. 2014. The total number of articles published under Dentistry section have tremendously increased from mere 2 articles in 2007 to 328 articles in 2014.Majority of the study designs published in both the journal were case reports (42.6%) followed by cross sectional studies (24.8%). 96.3% of the articles were from India. Majority of the articles published were of multi authors (65.2%) and from Educational institutes (98.4%). The trends of the articles published indicated that the case reports/series formed the major bulk (others=59.1%) followed by research studies (21.3%). It was concluded that most articles published were case reports followed by researches indicating an inclination towards better quality methodology. The SJR and the citation count of the articles published also indicated the quality of the scientific articles published.

  10. Iomazenil: pharmacological and animal data

    International Nuclear Information System (INIS)

    Beer, H.F.; Blaeuenstein, P.A.; Hasler, P.H.; Schubiger, P.A.; Hunkeler, W.; Bibettu, E.P.; Pieri, L.; Grayson Richards, J.

    1990-01-01

    The flumazenil analogue Ro 16-0154 (Iomazenil), a benzodiazepine partial inverse agonist, has been labelled by halogen exchange to enable SPECT investigations of central benzodiazepine receptors in human brain. The purified 123 I-Ro 16-0154 was found to be stable in rat brain preparations and to be metabolized in rat liver preparations. Its pharmacological properties were comparable to those of flumazenil with the exception of the antagonism of diazepam versus pentylenetetrazol. Biodistribution in rats (1 h p.i.) resulted in a high brain to blood ratio of 16. Clinical studies revealed images of the bezodiazepine receptor density in the brain. (author) 9 figs., 3 tabs., 27 refs

  11. Pharmacological approach to acute pancreatitis

    DEFF Research Database (Denmark)

    Bang, Ulrich-Christian; Semb, Synne; Nojgaard, Camilla

    2008-01-01

    -steroidal anti-inflammatory drugs (NSAID) indomethacin and diclofenac have in randomized studies showed potential as prophylaxis against PEP. Interleukin 10 (IL-10) is a cytokine with anti-inflammatory properties but two trials testing IL-10 as prophylaxis to PEP have returned conflicting results. Antibodies...... pharmacological treatment of AP is limited and studies on the effect of potent anti-inflammatory drugs are warranted....... against tumor necrosis factor-alpha (TNF-alpha) have a potential as rescue therapy but no clinical trials are currently being conducted. The antibiotics beta-lactams and quinolones reduce mortality when necrosis is present in pancreas and may also reduce incidence of infected necrosis. Evidence based...

  12. Overlap between Headache, Depression, and Anxiety in General Neurological Clinics: A Cross-sectional Study

    Institute of Scientific and Technical Information of China (English)

    Cui-Bai Wei; Jian-Ping Jia; Fen Wang; Ai-Hong Zhou; Xiu-Mei Zuo; Chang-Biao Chu

    2016-01-01

    Background:Many studies have reported that depression and anxiety have bidirectional relationship with headache.However,few researches investigated the roles of depression or anxiety in patients with headache.We surveyed the prevalence of depression and anxiety as a complication or cause of headache among outpatients with a chief complaint of headache at neurology clinics in general hospitals.Additional risk factors for depression and anxiety were also analyzed.Methods:A cross-sectional study was conducted at 11 general neurological clinics.All consecutive patients with a chief complaint of headache were enrolled.Diagnoses of depression and anxiety were made using the Chinese version of the Mini International Neuropsychiatric Interview,and those for headache were made according to the International Classification of Headache Disorders,2nd Edition.The headache impact test and an 11-point verbal rating scale were applied to assess headache severity and intensity.Logistic regression was used to analyze risk factors of patients with headache for depression or anxiety.Results:A total of 749 outpatients with headache were included.Among them,148 (19.7%) were diagnosed with depression and 103 (13.7%) with anxiety.Further analysis showed that 114 (15.2%) patients complaining headache due to somatic symptoms of psychiatric disorders and 82 (10.9%) had a depression or anxiety comorbidity with headache.Most patients with depression or anxiety manifested mild to moderate headaches.Poor sleep and severe headache-related disabilities were predictors for either depression or anxiety.Conclusion:Clinicians must identify the etiology of headache and recognize the effects of depression or anxiety on headache to develop specific treatments.

  13. Clinical features of depression in Asia: results of a large prospective, cross-sectional study.

    Science.gov (United States)

    Srisurapanont, Manit; Hong, Jin Pyo; Tian-Mei, Si; Hatim, Ahmad; Liu, Chia-Yih; Udomratn, Pichet; Bae, Jae Nam; Fang, Yiru; Chua, Hong Choon; Liu, Shen-Ing; George, Tom; Bautista, Dianne; Chan, Edwin; Rush, A John

    2013-12-01

    The objective of this study was to investigate the clinical features of depression in Asian patients. It was a cross-sectional, observational study of depression in China, Korea, Malaysia, Singapore, Taiwan, and Thailand. Participants were drug-free outpatients with depressed mood and/or anhedonia. Symptoms and clinical features were assessed using the Montgomery-Asberg Depression Rating Scale, Symptoms Checklist 90-Revised (SCL-90-R), and the Fatigue Severity Scale. Other measures included the Medical Outcome Survey 36-Item Short-Form Health Survey (SF-36), the Sheehan Disability Scale, and the Multidimensional Scale of Perceived Social Support (MSPSS). A total of 547 outpatients with major depressive disorder were included in the analyses. Among the Montgomery-Asberg Depression Rating Scale symptoms, "reported sadness" and "reduced sleep" had the highest severity, with means (SDs) of 3.4 (1.2) and 3.4 (1.6), respectively. Apart from the SCL-90-R depression and anxiety domains, the SCL-90-R obsession-compulsion syndrome had the highest domain score, with a mean (SD) of 1.9 (0.9). Among eight domains, the mean (SD) SF-36 pain subscale score of 58.4 (27.7) was only second to that for the SF-36 physical function. In comparison to other disability domains, the Sheehan Disability Scale work/school had the highest subscale score, with a mean (SD) of 6.5 (2.9). The mean (SD) MSPSS "family" subscale score of 4.7 (1.7) was higher than the MSPSS "friends" and "significant others" subscale scores. This study suggests that pain has a minimal impact on the quality of life in Asian patients with depression. Noteworthy issues in this population may include insomnia, obsessive-compulsive symptoms, working/school disability, and family support. Copyright © 2013 Wiley Publishing Asia Pty Ltd.

  14. Scaling down of a clinical three-dimensional perfusion multicompartment hollow fiber liver bioreactor developed for extracorporeal liver support to an analytical scale device useful for hepatic pharmacological in vitro studies.

    Science.gov (United States)

    Zeilinger, Katrin; Schreiter, Thomas; Darnell, Malin; Söderdahl, Therese; Lübberstedt, Marc; Dillner, Birgitta; Knobeloch, Daniel; Nüssler, Andreas K; Gerlach, Jörg C; Andersson, Tommy B

    2011-05-01

    Within the scope of developing an in vitro culture model for pharmacological research on human liver functions, a three-dimensional multicompartment hollow fiber bioreactor proven to function as a clinical extracorporeal liver support system was scaled down in two steps from 800 mL to 8 mL and 2 mL bioreactors. Primary human liver cells cultured over 14 days in 800, 8, or 2 mL bioreactors exhibited comparable time-course profiles for most of the metabolic parameters in the different bioreactor size variants. Major drug-metabolizing cytochrome P450 activities analyzed in the 2 mL bioreactor were preserved over up to 23 days. Immunohistochemical studies revealed tissue-like structures of parenchymal and nonparenchymal cells in the miniaturized bioreactor, indicating physiological reorganization of the cells. Moreover, the canalicular transporters multidrug-resistance-associated protein 2, multidrug-resistance protein 1 (P-glycoprotein), and breast cancer resistance protein showed a similar distribution pattern to that found in human liver tissue. In conclusion, the down-scaled multicompartment hollow fiber technology allows stable maintenance of primary human liver cells and provides an innovative tool for pharmacological and kinetic studies of hepatic functions with small cell numbers.

  15. Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

    Science.gov (United States)

    Sivaramakrishnan, Gowri; Sridharan, Kannan

    2016-06-01

    Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

  16. Relationship between reflection ability and clinical performance: a cross-sectional and retrospective-longitudinal correlational cohort study in midwifery.

    Science.gov (United States)

    Embo, M; Driessen, E; Valcke, M; van der Vleuten, C P M

    2015-01-01

    increasingly, reflection is highlighted as integral to core practice competencies but empirical research into the relationship between reflection and performance in the clinical workplace is scarce. this study investigated the relationship between reflection ability and clinical performance. we designed a cross-sectional and a retrospective-longitudinal cohort study. Data from first, second and third year midwifery students were collected to study the variables 'clinical performance' and 'reflection ability'. Data were analysed with SPSS for Windows, Release 20.0. Descriptive statistics, Pearson׳s Product Moment Correlation Coefficients (r) and r² values were computed to investigate associations between the research variables. the results showed a moderate observed correlation between reflection ability and clinical performance scores. When adopting a cross-sectional perspective, all correlation values were significant (p0.6). The results based on the retrospective-longitudinal data set explained a moderate proportion of the variance after correction for attenuation. Finally, the results indicate that 'reflection ability' scores of earlier years are significant related with 'clinical performance' scores of subsequent years. These results suggest that (1) reflection ability is linked to clinical performance; (2) that written reflections are an important, but not the sole way to assess professional competence and that (3) reflection is a contributor to clinical performance improvement. the data showed a moderate but significant relationship between 'reflection ability' and 'clinical performance' scores in clinical practice of midwifery students. Reflection therefore seems an important component of professional competence. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Quantitative Systems Pharmacology: A Case for Disease Models.

    Science.gov (United States)

    Musante, C J; Ramanujan, S; Schmidt, B J; Ghobrial, O G; Lu, J; Heatherington, A C

    2017-01-01

    Quantitative systems pharmacology (QSP) has emerged as an innovative approach in model-informed drug discovery and development, supporting program decisions from exploratory research through late-stage clinical trials. In this commentary, we discuss the unique value of disease-scale "platform" QSP models that are amenable to reuse and repurposing to support diverse clinical decisions in ways distinct from other pharmacometrics strategies. © 2016 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of The American Society for Clinical Pharmacology and Therapeutics.

  18. Clinical Differences between Subtypes of Atrial Fibrillation and Flutter: Cross-Sectional Registry of 407 Patients

    Directory of Open Access Journals (Sweden)

    Eduardo Dytz Almeida

    2015-01-01

    Full Text Available Introduction: Atrial fibrillation and atrial flutter account for one third of hospitalizations due to arrhythmias, determining great social and economic impacts. In Brazil, data on hospital care of these patients is scarce. Objective: To investigate the arrhythmia subtype of atrial fibrillation and flutter patients in the emergency setting and compare the clinical profile, thromboembolic risk and anticoagulants use. Methods: Cross-sectional retrospective study, with data collection from medical records of every patient treated for atrial fibrillation and flutter in the emergency department of Instituto de Cardiologia do Rio Grande do Sul during the first trimester of 2012. Results: We included 407 patients (356 had atrial fibrillation and 51 had flutter. Patients with paroxysmal atrial fibrillation were in average 5 years younger than those with persistent atrial fibrillation. Compared to paroxysmal atrial fibrillation patients, those with persistent atrial fibrillation and flutter had larger atrial diameter (48.6 ± 7.2 vs. 47.2 ± 6.2 vs. 42.3 ± 6.4; p < 0.01 and lower left ventricular ejection fraction (66.8 ± 11 vs. 53.9 ± 17 vs. 57.4 ± 16; p < 0.01. The prevalence of stroke and heart failure was higher in persistent atrial fibrillation and flutter patients. Those with paroxysmal atrial fibrillation and flutter had higher prevalence of CHADS2 score of zero when compared to those with persistent atrial fibrillation (27.8% vs. 18% vs. 4.9%; p < 0.01. The prevalence of anticoagulation in patients with CHA2DS2-Vasc ≤ 2 was 40%. Conclusions: The population in our registry was similar in its comorbidities and demographic profile to those of North American and European registries. Despite the high thromboembolic risk, the use of anticoagulants was low, revealing difficulties for incorporating guideline recommendations. Public health strategies should be adopted in order to improve these rates.

  19. Clinical preventive services in Guatemala: a cross-sectional survey of internal medicine physicians.

    Directory of Open Access Journals (Sweden)

    Juan E Corral

    Full Text Available Guatemala is currently undergoing an epidemiologic transition. Preventive services are key to reducing the burden of non-communicable diseases, and smoking counseling and cessation are among the most cost-effective and wide-reaching strategies. Internal medicine physicians are fundamental to providing such services, and their knowledge is a cornerstone of non-communicable disease control.A national cross-sectional survey was conducted in 2011 to evaluate knowledge of clinical preventive services for non-communicable diseases. Interns, residents, and attending physicians of the internal medicine departments of all teaching hospitals in Guatemala completed a self-administered questionnaire. Participants' responses were contrasted with the Guatemalan Ministry of Health (MoH prevention guidelines and the US Preventive Services Task Force (USPSTF recommendations. Analysis compared knowledge of recommendations within and between hospitals.In response to simulated patient scenarios, all services were recommended by more than half of physicians regardless of MoH or USPSTF recommendations. Prioritization was adequate according to the MoH guidelines but not including other potentially effective services (e.g. colorectal cancer and lipid disorder screenings. With the exception of colorectal and prostate cancer screening, less frequently recommended by interns, there was no difference in recommendation rates by level.Guatemalan internal medicine physicians' knowledge on preventive services recommendations for non-communicable diseases is limited, and prioritization did not reflect cost-effectiveness. Based on these data we recommend that preventive medicine training be strengthened and development of evidence-based guidelines for low-middle income countries be a priority.

  20. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study.

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    Martina Kollmann

    Full Text Available Early bonding by skin-to-skin contact (SSC has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC after cesarean section on neonatal adaptation, maternal pain and stress response.This prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria between September 2013 and January 2014. Women were randomly assigned to intraoperative ("early" SCC (n = 17 versus postoperative ("late" SCC (n = 18. Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature, maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase.There was no evidence for differences in parameters reflecting neonatal transition or stress response between the 'Early SSC Group' and the 'Late SSC Group'. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group' (p = 0.004.This study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group', which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial.ClinicalTrials.gov NCT01894880.

  1. Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

    Directory of Open Access Journals (Sweden)

    S. Kannan

    2016-03-01

    Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

  2. Developmental paediatric anaesthetic pharmacology

    DEFF Research Database (Denmark)

    Hansen, Tom Giedsing

    2015-01-01

    Safe and effective drug therapy in neonates, infants and children require detailed knowledge about the ontogeny of drug disposition and action as well how these interact with genetics and co-morbidity of children. Recent advances in developmental pharmacology in children follow the increased...

  3. Eliciting students′ perceptions of integrated clinical dental education in Saudi Arabia: A cross-sectional study

    Directory of Open Access Journals (Sweden)

    Mahmoud Al-Dajani

    2016-01-01

    Conclusion: In the integrated curriculum, our study highlights the importance of clinical training not only in making dental students competent but also in increasing their confidence in performing clinical procedures.

  4. A validated HPLC-MS/MS assay for quantifying unstable pharmacologically active metabolites of clopidogrel in human plasma: application to a clinical pharmacokinetic study.

    Science.gov (United States)

    Furlong, Michael T; Savant, Ishani; Yuan, Moucun; Scott, Laura; Mylott, William; Mariannino, Thomas; Kadiyala, Pathanjali; Roongta, Vikram; Arnold, Mark E

    2013-05-01

    Clopidogrel is prescribed for the treatment of Acute Coronary Syndrome and recent myocardial infarction, recent stroke, or established peripheral arterial disease. A sensitive and reliable high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) assay was developed and validated to enable reliable quantification of four diastereomeric and chemically reactive thiol metabolites, two of which are pharmacologically active, in human plasma. The metabolites were stabilized by alkylation of their reactive thiol moieties with 2-bromo-3'-methoxyacetophenone (MPB). Following organic solvent mediated-protein precipitation in a 96-well plate format, chromatographic separation was achieved by gradient elution on an Ascentis Express RP-amide column. Chromatographic conditions were optimized to ensure separation of the four derivatized active metabolites. Derivatized metabolites and stable isotope-labeled internal standards were detected by positive ion electrospray tandem mass spectrometry. The HPLC-MS/MS assay was validated over concentration ranges of 0.125-125 ng/mL for metabolites H1-H3 and 0.101-101 ng/mL for H4. Intra- and inter-assay precision values for replicate quality control samples were within 14.3% for all analytes during the assay validation. Mean quality control accuracy values were within ±6.3% of nominal values for all analytes. Assay recoveries were high (>79%). The four derivatized analytes were stable in human blood for at least 2 h at room temperature and on ice. The analytes were also stable in human plasma for at least 25 h at room temperature, 372 days at -20 °C and -70 °C, and following at least five freeze-thaw cycles. The validated assay was successfully applied to the quantification of all four thiol metabolites in human plasma in support of a human pharmacokinetic study. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Serum levels of brain-derived neurotrophic factor in major depressive disorder: state-trait issues, clinical features and pharmacological treatment

    NARCIS (Netherlands)

    Molendijk, M.L.; Bus, B.A.A.; Spinhoven, P.; Penninx, B.W.J.H.; Kenis, G.; Prickaerts, J.; Voshaar, R.C.O.; Elzinga, B.M.

    2011-01-01

    Recent evidence supports 'the neurotrophin hypothesis of depression' in its prediction that brain-derived neurotrophic factor (BDNF) is involved in depression. However, some key questions remain unanswered, including whether abnormalities in BDNF persist beyond the clinical state of depression,

  6. Is medical perspective on clinical governance practices associated with clinical units’ performance and mortality? A cross-sectional study through a record-linkage procedure

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    Guido Sarchielli

    2016-07-01

    Full Text Available Objective: Assessment of the knowledge and application as well as perceived utility by doctors of clinical governance tools in order to explore their impact on clinical units’ performance measured through mortality rates and efficiency indicators. Methods: This research is a cross-sectional study with a deterministic record-linkage procedure. The sample includes n = 1250 doctors (n = 249 chiefs of clinical units; n = 1001 physicians working in six public hospitals located in the Emilia-Romagna Region in Italy. Survey instruments include a checklist and a research-made questionnaire which were used for data collection about doctors’ knowledge and application as well as perceived utility of clinical governance tools. The analysis was based on clinical units’ performance indicators which include patients’ mortality, extra-region active mobility rate, average hospital stay, bed occupancy, rotation and turnover rates, and the comparative performance index as efficiency indicators. Results: The clinical governance tools are known and applied differently in all the considered clinical units. Significant differences emerged between roles and organizational levels at which the medical leadership is carried out. The levels of knowledge and application of clinical governance practices are correlated with the clinical units’ efficiency indicators (bed occupancy rate, bed turnover interval, and extra-region mobility. These multiple linear regression analyses highlighted that the clinical governance knowledge and application is correlated with clinical units’ mortality rates (odds ratio, −8.677; 95% confidence interval, −16.654, −0.700. Conclusion: The knowledge and application, as well as perceived utility by medical professionals of clinical governance tools, are associated with the mortality rates of their units and with some efficiency indicators. However, the medical frontline staff seems to not consider homogeneously useful

  7. [Pharmacological therapy of obesity].

    Science.gov (United States)

    Pagotto, Uberto; Vanuzzo, Diego; Vicennati, Valentina; Pasquali, Renato

    2008-04-01

    Obesity is reaching epidemic proportions worldwide and it is correlated with various comorbidities, among which the most relevant are diabetes mellitus, arterial hypertension, and cardiovascular diseases. Obesity management is a modern challenge because of the rapid evolution of unfavorable lifestyles and unfortunately there are no effective treatments applicable to the large majority of obese/overweight people. The current medical attitude is to treat the complications of obesity (e.g. dyslipidemia, hypertension, diabetes, and cardiovascular diseases). However, the potential of treating obesity is enormous, bearing in mind that a volitional weight loss of 10 kg is associated with important risk factor improvement: blood pressure -10 mmHg, total cholesterol -10%, LDL cholesterol -15%, triglycerides -30%, fasting glucose -50%, HDL cholesterol +8%. Drug treatment for obesity is an evolving branch of pharmacology, burdened by severe side effects and consequences of the early drugs, withdrawn from the market, and challenged by the lack of long-term data on the effect of medications on obesity-related morbidity and mortality, first of all cardiovascular diseases. In Europe three antiobesity drugs are currently licensed: sibutramine, orlistat, and rimonabant; important trials with clinical endpoints are ongoing for sibutramine and rimonabant. While waiting for their results, it is convenient to evaluate these drugs for their effects on body weight and cardiometabolic risk factors. Sibutramine is a centrally acting serotonin/noradrenaline reuptake inhibitor that mainly increases satiety. At the level of brown adipose tissue, sibutramine can also facilitate energy expenditure by increasing thermogenesis. The long-term studies (five) documented a mean differential weight reduction of 4.45 kg for sibutramine vs placebo. Considering the principal studies, attrition rate was 43%. This drug not only reduces body weight and waist circumference, but it decreases triglycerides and

  8. Multilocus phylogeny and antifungal susceptibility of Aspergillus section Circumdati from clinical samples and description of A. pseudosclerotiorum sp. nov.

    Science.gov (United States)

    A multilocus phylogenetic study was carried out to assess the species distribution in a set of 34 clinical isolates of Aspergillus section Circumdati from the USA and their in vitro antifungal susceptibility were determined against eight antifungal drugs. The genetic markers used were ITS, BenA, CaM...

  9. An Integrated Approach to Instruction in Pharmacology and Therapeutics

    Science.gov (United States)

    Talbert, Robert L.; Walton, Charles A.

    1976-01-01

    The impact of the clinical faculty on the content of the pharmacology course is described in a discussion of trends in pharmacology instruction. Interfaculty communication and development of course objectives are reviewed, and descriptions of two baccalaureate courses at the University of Texas College of Pharmacy are appended. (LBH)

  10. Traumatic brain injury pharmacological treatment: recommendations

    Directory of Open Access Journals (Sweden)

    Renato Anghinah

    Full Text Available ABSTRACT This article presents the recommendations on the pharmacological treatment employed in traumatic brain injury (TBI at the outpatient clinic of the Cognitive Rehabilitation after TBI Service of the Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil. A systematic assessment of the consensus reached in other countries, and of articles on TBI available in the PUBMED and LILACS medical databases, was carried out. We offer recommendations of pharmacological treatments in patients after TBI with different symptoms.

  11. Pharmacological effects of biotin.

    Science.gov (United States)

    Fernandez-Mejia, Cristina

    2005-07-01

    In the last few decades, more vitamin-mediated effects have been discovered at the level of gene expression. Increasing knowledge on the molecular mechanisms of these vitamins has opened new perspectives that form a connection between nutritional signals and the development of new therapeutic agents. Besides its role as a carboxylase prosthetic group, biotin regulates gene expression and has a wide repertoire of effects on systemic processes. The vitamin regulates genes that are critical in the regulation of intermediary metabolism: Biotin has stimulatory effects on genes whose action favors hypoglycemia (insulin, insulin receptor, pancreatic and hepatic glucokinase); on the contrary, biotin decreases the expression of hepatic phosphoenolpyruvate carboxykinase, a key gluconeogenic enzyme that stimulates glucose production by the liver. The findings that biotin regulates the expression of genes that are critical in the regulation of intermediary metabolism are in agreement with several observations that indicate that biotin supply is involved in glucose and lipid homeostasis. Biotin deficiency has been linked to impaired glucose tolerance and decreased utilization of glucose. On the other hand, the diabetic state appears to be ameliorated by pharmacological doses of biotin. Likewise, pharmacological doses of biotin appear to decrease plasma lipid concentrations and modify lipid metabolism. The effects of biotin on carbohydrate metabolism and the lack of toxic effects of the vitamin at pharmacological doses suggest that biotin could be used in the development of new therapeutics in the treatment of hyperglycemia and hyperlipidemia, an area that we are actively investigating.

  12. Sectional mandibular complete denture for a total maxillectomy patient with trismus: a clinical report.

    Science.gov (United States)

    Celakil, Tamer; Demir, Azize; Keskin, Haluk

    2017-01-01

    This report presents the case of a 60-year-old male patient with trismus induced by radiotherapy and fabrication of a sectional mandibular complete denture to allow the insertion of the denture into the mouth. A mandibular sectional denture was designed in two pieces with a locking mechanism by using mini anchor and ball abutment housing with cap. Patients who have undergone maxillectomy often have constricted mouth openings, as a result of surgical intervention and radiotherapy, and complain of an inability to insert or remove dentures. A new approach is vital for sectional dentures because existing sectional denture fabrication techniques cannot meet the ongoing needs of trismus patients. The mini anchor system with ball abutment housing has better mechanical retention in acrylic resin and can provide favorable stabilization during masticatory function; thus, additional framework is not required for assisting in stabilization and retention.

  13. SECTIONAL MANDIBULAR COMPLETE DENTURE FOR A TOTAL MAXILLECTOMY PATIENT WITH TRISMUS: A CLINICAL REPORT

    Directory of Open Access Journals (Sweden)

    Tamer ÇELAKIL

    2017-10-01

    Full Text Available This report presents the case of a 60-year-old male patient with trismus induced by radiotherapy and fabrication of a sectional mandibular complete denture to allow the insertion of the denture into the mouth. A mandibular sectional denture was designed in two pieces with a locking mechanism by using mini anchor and ball abutment housing with cap. Patients who have undergone maxillectomy often have constricted mouth openings, as a result of surgical intervention and radiotherapy, and complain of an inability to insert or remove dentures. A new approach is vital for sectional dentures because existing sectional denture fabrication techniques cannot meet the ongoing needs of trismus patients. The mini anchor system with ball abutment housing has better mechanical retention in acrylic resin and can provide favorable stabilization during masticatory function; thus, additional framework is not required for assisting in stabilization and retention.

  14. Carotenoids: biochemistry, pharmacology and treatment.

    Science.gov (United States)

    Milani, Alireza; Basirnejad, Marzieh; Shahbazi, Sepideh; Bolhassani, Azam

    2017-06-01

    Carotenoids and retinoids have several similar biological activities such as antioxidant properties, the inhibition of malignant tumour growth and the induction of apoptosis. Supplementation with carotenoids can affect cell growth and modulate gene expression and immune responses. Epidemiological studies have shown a correlation between a high carotenoid intake in the diet with a reduced risk of breast, cervical, ovarian, colorectal cancers, and cardiovascular and eye diseases. Cancer chemoprevention by dietary carotenoids involves several mechanisms, including effects on gap junctional intercellular communication, growth factor signalling, cell cycle progression, differentiation-related proteins, retinoid-like receptors, antioxidant response element, nuclear receptors, AP-1 transcriptional complex, the Wnt/β-catenin pathway and inflammatory cytokines. Moreover, carotenoids can stimulate the proliferation of B- and T-lymphocytes, the activity of macrophages and cytotoxic T-cells, effector T-cell function and the production of cytokines. Recently, the beneficial effects of carotenoid-rich vegetables and fruits in health and in decreasing the risk of certain diseases has been attributed to the major carotenoids, β-carotene, lycopene, lutein, zeaxanthin, crocin (/crocetin) and curcumin, due to their antioxidant effects. It is thought that carotenoids act in a time- and dose-dependent manner. In this review, we briefly describe the biological and immunological activities of the main carotenoids used for the treatment of various diseases and their possible mechanisms of action. This article is part of a themed section on Principles of Pharmacological Research of Nutraceuticals. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v174.11/issuetoc. © 2016 The British Pharmacological Society.

  15. Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study

    Directory of Open Access Journals (Sweden)

    González-Saldivar G

    2016-04-01

    Full Text Available Gerardo González-Saldivar,1 René Rodríguez-Gutiérrez,2 José Luis Viramontes-Madrid,3 Alejandro Salcido-Montenegro,2 Kevin Erick Gabriel Carlos-Reyna,2 Andrés Marcelo Treviño-Alvarez,2 Neri Alejandro Álvarez-Villalobos,4 José Gerardo González-González2 1Ophthalmology Department, 2Endocrinology Division, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, 3Instituto Nacional de Salud Pública, Cuernavaca, Morelos, 4Medical Statistics Department, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico Background: There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials.Methods: To assess the perception that 604 trial participants (cases and 604 nonparticipants (controls of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico.Results: Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4% than controls (50.7% perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%. We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk

  16. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 2. Psychological Treatments.

    Science.gov (United States)

    Parikh, Sagar V; Quilty, Lena C; Ravitz, Paula; Rosenbluth, Michael; Pavlova, Barbara; Grigoriadis, Sophie; Velyvis, Vytas; Kennedy, Sidney H; Lam, Raymond W; MacQueen, Glenda M; Milev, Roumen V; Ravindran, Arun V; Uher, Rudolf

    2016-09-01

    The Canadian Network for Mood and Anxiety Treatments (CANMAT) has revised its 2009 guidelines for the management of major depressive disorder (MDD) in adults by updating the evidence and recommendations. The target audiences for these 2016 guidelines are psychiatrists and other mental health professionals. Using the question-answer format, we conducted a systematic literature search focusing on systematic reviews and meta-analyses. Evidence was graded using CANMAT-defined criteria for level of evidence. Recommendations for lines of treatment were based on the quality of evidence and clinical expert consensus. "Psychological Treatments" is the second of six sections of the 2016 guidelines. Evidence-informed responses were developed for 25 questions under 5 broad categories: 1) patient characteristics relevant to using psychological interventions; 2) therapist and health system characteristics associated with optimizing outcomes; 3) descriptions of major psychotherapies and their efficacy; 4) additional psychological interventions, such as peer interventions and computer- and technology-delivered interventions; and 5) combining and/or sequencing psychological and pharmacological interventions. First-line psychological treatment recommendations for acute MDD include cognitive-behavioural therapy (CBT), interpersonal therapy (IPT), and behavioural activation (BA). Second-line recommendations include computer-based and telephone-delivered psychotherapy. Where feasible, combining psychological treatment (CBT or IPT) with antidepressant treatment is recommended because combined treatment is superior to either treatment alone. First-line psychological treatments for maintenance include CBT and mindfulness-based cognitive therapy (MBCT). Patient preference, in combination with evidence-based treatments and clinician/system capacity, will yield the optimal treatment strategies for improving individual outcomes in MDD. © The Author(s) 2016.

  17. Vaginal Birth After Caesarean Section in Low Resource Settings: The Clinical and Ethical Dilemma.

    Science.gov (United States)

    Wanyonyi, Sikolia; Muriithi, Francis G

    2015-10-01

    Vaginal birth after Caesarean section (VBAC) has long been practised in low resource settings using unconventional methods. This not only poses danger to the woman and her baby, but could also have serious legal and ethical implications. The adoption of this practice has been informed by observational studies with many deficiencies; this is so despite other studies from settings in which the standard of care is much better that show that elective repeat Caesarean section (ERCS) may actually be safer than VBAC. This raises questions about whether we should insist on a dangerous practice when there are safer alternatives. We highlight some of the challenges faced in making this decision, and discuss why the fear of ERCS may not be justified after all in low resource settings. Since a reduction in rates of Caesarean section may not be applicable in these regions, because their rates are already low, the emphasis should instead be on adequate birth spacing and safer primary operative delivery.

  18. Are activity limitations associated with lower urinary tract symptoms in stroke patients? A cross-sectional, clinical survey

    DEFF Research Database (Denmark)

    Tibaek, Sigrid; Gard, Gunvor; Klarskov, Peter

    2009-01-01

    stroke patients were invited to complete four activity limitations measurements: Barthel Index, mobility velocity, mobility distance, mobility aids and one LUTS measurement: the Danish Prostatic Symptom Score (DAN-PSS-1) questionnaire. Of 519 stroke patients, 482 subjects were eligible. Results......Objective. To assess self-reported activity limitations in a clinical sample of stroke patients and to identify their association with prevalence, severity and impact on daily life of lower urinary tract symptoms (LUTS). Material and methods. A cross-sectional, clinical survey was initiated whereby...... time that activity limitations are closely related to LUTS in stroke patients and that rehabilitation should also be directed towards the treatment of LUTS....

  19. Arformoterol Tartrate: A Review of Pharmacology, Analysis and ...

    African Journals Online (AJOL)

    Erah

    suggest the potentially enhanced efficacy of this drug in the treatment of COPD including ... pharmacology, pharmacokinetics, clinical studies, analytical techniques, drug-drug interactions, ..... accordance with the United States Food and. Drug ...

  20. Integrated quantitative pharmacology for treatment optimization in oncology

    NARCIS (Netherlands)

    Hasselt, J.G.C. van

    2014-01-01

    This thesis describes the development and application of quantitative pharmacological models in oncology for treatment optimization and for the design and analysis of clinical trials with respect to pharmacokinetics, toxicity, efficacy and cost-effectiveness. A recurring theme throughout this

  1. 3D-MICE: integration of cross-sectional and longitudinal imputation for multi-analyte longitudinal clinical data.

    Science.gov (United States)

    Luo, Yuan; Szolovits, Peter; Dighe, Anand S; Baron, Jason M

    2018-06-01

    A key challenge in clinical data mining is that most clinical datasets contain missing data. Since many commonly used machine learning algorithms require complete datasets (no missing data), clinical analytic approaches often entail an imputation procedure to "fill in" missing data. However, although most clinical datasets contain a temporal component, most commonly used imputation methods do not adequately accommodate longitudinal time-based data. We sought to develop a new imputation algorithm, 3-dimensional multiple imputation with chained equations (3D-MICE), that can perform accurate imputation of missing clinical time series data. We extracted clinical laboratory test results for 13 commonly measured analytes (clinical laboratory tests). We imputed missing test results for the 13 analytes using 3 imputation methods: multiple imputation with chained equations (MICE), Gaussian process (GP), and 3D-MICE. 3D-MICE utilizes both MICE and GP imputation to integrate cross-sectional and longitudinal information. To evaluate imputation method performance, we randomly masked selected test results and imputed these masked results alongside results missing from our original data. We compared predicted results to measured results for masked data points. 3D-MICE performed significantly better than MICE and GP-based imputation in a composite of all 13 analytes, predicting missing results with a normalized root-mean-square error of 0.342, compared to 0.373 for MICE alone and 0.358 for GP alone. 3D-MICE offers a novel and practical approach to imputing clinical laboratory time series data. 3D-MICE may provide an additional tool for use as a foundation in clinical predictive analytics and intelligent clinical decision support.

  2. Learning by playing: A cross-sectional descriptive study of nursing students' experiences of learning clinical reasoning.

    Science.gov (United States)

    Koivisto, Jaana-Maija; Multisilta, Jari; Niemi, Hannele; Katajisto, Jouko; Eriksson, Elina

    2016-10-01

    Clinical reasoning is viewed as a problem-solving activity; in games, players solve problems. To provide excellent patient care, nursing students must gain competence in clinical reasoning. Utilising gaming elements and virtual simulations may enhance learning of clinical reasoning. To investigate nursing students' experiences of learning clinical reasoning process by playing a 3D simulation game. Cross-sectional descriptive study. Thirteen gaming sessions at two universities of applied sciences in Finland. The prototype of the simulation game used in this study was single-player in format. The game mechanics were built around the clinical reasoning process. Nursing students from the surgical nursing course of autumn 2014 (N=166). Data were collected by means of an online questionnaire. In terms of the clinical reasoning process, students learned how to take action and collect information but were less successful in learning to establish goals for patient care or to evaluate the effectiveness of interventions. Learning of the different phases of clinical reasoning process was strongly positively correlated. The students described that they learned mainly to apply theoretical knowledge while playing. The results show that those who played digital games daily or occasionally felt that they learned clinical reasoning by playing the game more than those who did not play at all. Nursing students' experiences of learning the clinical reasoning process by playing a 3D simulation game showed that such games can be used successfully for learning. To ensure that students follow a systematic approach, the game mechanics need to be built around the clinical reasoning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Diabetes quality management in Dutch care groups and outpatient clinics: a cross-sectional study.

    Science.gov (United States)

    Campmans-Kuijpers, Marjo J E; Baan, Caroline A; Lemmens, Lidwien C; Rutten, Guy E H M

    2014-08-07

    In recent years, most Dutch general practitioners started working under the umbrella of diabetes care groups, responsible for the organisation and coordination of diabetes care. The quality management of these new organisations receives growing interest, although its association with quality of diabetes care is yet unclear. The best way to measure quality management is unknown and it has not yet been studied at the level of outpatient clinics or care groups. We aimed to assess quality management of type 2 diabetes care in care groups and outpatient clinics. Quality management was measured with online questionnaires, containing six domains (see below). They were divided into 28 subdomains, with 59 (care groups) and 57 (outpatient clinics) questions respectively. The mean score of the domains reflects the overall score (0-100%) of an organisation. Two quality managers of all Dutch care groups and outpatient clinics were invited to fill out the questionnaire.Sixty care groups (response rate 61.9%) showed a mean score of 59.6% (CI 57.1-62.1%). The average score in 52 outpatient clinics (response rate 50.0%) was 61.9% (CI 57.5-66.8%).Mean scores on the six domains for care groups and outpatient clinics respectively were: 'organisation of care' 71.9% (CI 68.8-74.9%), 76.8% (CI 72.8-80.7%); 'multidisciplinary teamwork' 67.1% (CI 62.4-71.9%), 71.5% (CI 65.3-77.8%); 'patient centeredness' 46.7% (CI 42.6-50.7%), 62.5% (CI 57.7-67.2%); 'performance management' 63.3% (CI 61.2-65.3%), 50.9% (CI 44.2-57.5%); 'quality improvement policy' 52.6% (CI 49.2-56.1%), 50.9% (CI 44.6-57.3%); and 'management strategies' 56.0% (CI 51.4-60.7%), 59.0% (CI 52.8-65.2%). On subdomains, care groups scored highest on 'care program' (83.3%) and 'measured outcomes' (98.3%) and lowest on 'patient safety' (15.1%) and 'patient involvement' (17.7%). Outpatient clinics scored high on the presence of a 'diabetic foot team' (81.6%) and the support in 'self-management' (81.0%) and low on 'patient

  4. Pharmacological Profile of Quinoxalinone

    Directory of Open Access Journals (Sweden)

    Youssef Ramli

    2014-01-01

    Full Text Available Quinoxalinone and its derivatives are used in organic synthesis for building natural and designed synthetic compounds and they have been frequently utilized as suitable skeletons for the design of biologically active compound. This review covers updated information on the most active quinoxalinone derivatives that have been reported to show considerable pharmacological actions such as antimicrobial, anti-inflammatory, antidiabetic, antiviral, antitumor, and antitubercular activity. It can act as an important tool for chemists to develop newer quinoxalinone derivatives that may prove to be better agents in terms of efficacy and safety.

  5. Knowledge and attitude about relining of complete dentures in clinical practice: A cross-sectional study

    Directory of Open Access Journals (Sweden)

    Akhil Rathi

    2018-01-01

    Conclusion: Awareness and scientific knowledge about the relining materials and procedure should be enhanced within general dental practitioners through CDE program and workshops. Steps should be taken to include relining procedure as a part of undergraduate clinical curriculum as well as internship program.

  6. Remifentanil at induction of general anesthesia for cesarean section: Double blind,randomized clinical trial

    OpenAIRE

    Behdad, Shekoufeh; Ayatollahi, Vida; Harrazi, Hamid; Nazemian, Naderali; Heiranizadeh, Najmeh; Baghianimoghadam, Behnam

    2013-01-01

    Introduction: Remifentanil, with its rapid activity onset and short duration of action, may be more effective than other opioids for providing hemodynamic stability during obstetric anesthesia. However, there is some evidence of adverse effects on neonatal respiratory function. We investigated maternal and fetal effects of Remifentanil during cesarean section surgery. Methods: Eighteen women with singleton term pregnancies, and physical class status of I or II as defined by the American Socie...

  7. Citation of prior research has increased in introduction and discussion sections with time: A survey of clinical trials in physiotherapy.

    Science.gov (United States)

    Hoderlein, Xenia; Moseley, Anne M; Elkins, Mark R

    2017-08-01

    Many clinical trials are reported without reference to the existing relevant high-quality research. This study aimed to investigate the extent to which authors of reports of clinical trials of physiotherapy interventions try to use high-quality clinical research to (1) help justify the need for the trial in the introduction and (2) help interpret the trial's results in the discussion. Data were extracted from 221 clinical trials that were randomly selected from the Physiotherapy Evidence Database: 70 published in 2001 (10% sample) and 151 published in 2015 (10% sample). The Physiotherapy Evidence Database score (which rates methodological quality and completeness of reporting) for each trial was also downloaded. Overall 41% of trial reports cited a systematic review or the results of a search for other evidence in the introduction section: 20% for 2001 and 50% for 2015 (relative risk = 2.3, 95% confidence interval = 1.5-3.8). For the discussion section, only 1 of 221 trials integrated the results of the trial into an existing meta-analysis, but citation of a relevant systematic review did increase from 17% in 2001 to 34% in 2015. There was no relationship between citation of existing research and the total Physiotherapy Evidence Database score. Published reports of clinical trials of physiotherapy interventions increasingly cite a systematic review or the results of a search for other evidence in the introduction, but integration with existing research in the discussion section is very rare. To encourage the use of existing research, stronger recommendations to refer to existing systematic reviews (where available) could be incorporated into reporting checklists and journal editorial guidelines.

  8. Atomoxetine in patients with ADHD: A clinical and pharmacological review of the onset, trajectory, duration of response and implications for patients.

    Science.gov (United States)

    Clemow, David B; Bushe, Chris J

    2015-12-01

    This article reviews data providing new insight into the trajectory of response and maintenance of response of atomoxetine in the treatment of child and adult attention-deficit hyperactivity disorder (ADHD). This nonsystematic review includes: onset of action and duration of effect, response rate, effect size, time to optimal response and norepinephrine transporter blockade biomarker data. Atomoxetine can have an onset of action within 1-2 weeks of starting treatment, but there is an incrementally increasing response for up to 24 weeks or longer. Responder rates and effect sizes are similar to methylphenidate. Upon treatment discontinuation, relapse rates are lower than expected. In adults, 50% maintain their response for at least 6 months after stopping atomoxetine, following 6 months of treatment. Single-dose atomoxetine can provide 24-hour efficacy, despite a 5-hour plasma half-life. Hypotheses can be generated relating to neuroadaptive changes, to explain these findings. Atomoxetine has a trajectory of response that is incremental over a long period of time, with a greater than expected maintenance of response. This has implications for physician atomoxetine dosing and efficacy assessment, patient education and outcomes, and for clinical trial design and assessment of comparative efficacy with stimulant medications. © The Author(s) 2015.

  9. Socio demographic and clinical predictors of absenteeism A cross sectional study of urban industrial employees

    OpenAIRE

    Suhash Chakraborty; Anantha H. C. Subramanya

    2013-01-01

    Context: Public sector undertakings are facing a threat of privatization due to unsatisfactory performance putting pressure on management and in turn to employees. There is an increasing trend of absenteeism observed amongst employees citing job stress. Aim: To find an association between job stress and absenteeism in relation to socio-demographic and clinical profile. Materials and Methods: The study was conducted in an urban aeronautical industry with 68 employees who mentioned stress at wo...

  10. Psychiatric and clinical correlates of rapid cycling bipolar disorder: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Alexandre D. Gigante

    2016-01-01

    Full Text Available Objective: Rapid cycling (RC is a feature of bipolar disorder (BD that has been associated with worse outcome and more severe disability. Our goal was to investigate the association of demographic and clinical factors with RC. Methods: We compared RC and non-rapid cycling (NRC BD patients from the Brazilian Research Network in Bipolar Disorder (BRN-BD regarding age at onset of BD; total number of episodes; previous number of manic, depressive, mixed, and hypomanic episodes; polarity of the first episode; gender; number of suicide attempts; number of lifetime hospitalizations and lifetime history of at least one hospitalization; family history of mood disorder; clinical comorbidities such as hypothyroidism, hyperthyroidism, seizures; and current use of medications such as lithium, anticonvulsants, antipsychotics, and antidepressants. Results: We studied 577 patients and found that 100 (17.3% met the criteria for RC in the year before the investigation. RC patients had earlier age at onset, longer duration of disease, more lifetime depressive and manic episodes, higher number of suicide attempts, and higher rate antidepressant use. Conclusion: The presence of RC in the previous year was associated with specific clinical characteristics closely related to worse outcome in the course of BD.

  11. A semi-quantitative translational pharmacology analysis to understand the relationship between in vitro ENT1 inhibition and the clinical incidence of dyspnoea and bronchospasm

    Energy Technology Data Exchange (ETDEWEB)

    Rosenbrier Ribeiro, Lyn, E-mail: Lyn.Rosenbrierribeiro@AstraZeneca.com; Ian Storer, R.

    2017-02-15

    Adenosine contributes to the pathophysiology of respiratory disease, and adenosine challenge leads to bronchospasm and dyspnoea in patients. The equilibrative nucleoside transporter 1 (ENT1) terminates the action of adenosine by removal from the extracellular environment. Therefore, it is proposed that inhibition of ENT1 in respiratory disease patients leads to increased adenosine concentrations, triggering bronchospasm and dyspnoea. This study aims to assess the translation of in vitro ENT1 inhibition to the clinical incidence of bronchospasm and dyspnoea in respiratory disease, cardiovascular disease and healthy volunteer populations. Four marketed drugs with ENT1 activity were assessed; dipyridamole, ticagrelor, draflazine, cilostazol. For each patient population, the relationship between in vitro ENT1 [{sup 3}H]-NBTI binding affinity (K{sub i}) and [{sup 3}H]-adenosine uptake (IC{sub 50}) to the incidence of: (1) bronchospasm/severe dyspnoea; (2) tolerated dyspnoea and; (3) no adverse effects, was evaluated. A high degree of ENT1 inhibition (≥ 13.3x K{sub i}, ≥ 4x IC{sub 50}) associated with increased incidence of bronchospasm/severe dyspnoea for patients with respiratory disease only, whereas a lower degree of ENT1 inhibition (≥ 0.1x K{sub i}, ≥ 0.05x IC{sub 50}) associated with a tolerable level of dyspnoea in both respiratory and cardiovascular disease patients. ENT1 inhibition had no effect in healthy volunteers. Furthermore, physicochemical properties correlative with ENT1 binding were assessed using a set of 1625 diverse molecules. Binding to ENT1 was relatively promiscuous (22% compounds K{sub i} < 1 μM) especially for neutral or basic molecules, and greater incidence tracked with higher lipophilicity (clogP > 5). This study rationalises inclusion of an assessment of ENT1 activity during early safety profiling for programs targeting respiratory disorders. - Highlights: • ENT1 inhibition causes bronchospasm and severe dyspnoea in respiratory

  12. A semi-quantitative translational pharmacology analysis to understand the relationship between in vitro ENT1 inhibition and the clinical incidence of dyspnoea and bronchospasm

    International Nuclear Information System (INIS)

    Rosenbrier Ribeiro, Lyn; Ian Storer, R.

    2017-01-01

    Adenosine contributes to the pathophysiology of respiratory disease, and adenosine challenge leads to bronchospasm and dyspnoea in patients. The equilibrative nucleoside transporter 1 (ENT1) terminates the action of adenosine by removal from the extracellular environment. Therefore, it is proposed that inhibition of ENT1 in respiratory disease patients leads to increased adenosine concentrations, triggering bronchospasm and dyspnoea. This study aims to assess the translation of in vitro ENT1 inhibition to the clinical incidence of bronchospasm and dyspnoea in respiratory disease, cardiovascular disease and healthy volunteer populations. Four marketed drugs with ENT1 activity were assessed; dipyridamole, ticagrelor, draflazine, cilostazol. For each patient population, the relationship between in vitro ENT1 [ 3 H]-NBTI binding affinity (K i ) and [ 3 H]-adenosine uptake (IC 50 ) to the incidence of: (1) bronchospasm/severe dyspnoea; (2) tolerated dyspnoea and; (3) no adverse effects, was evaluated. A high degree of ENT1 inhibition (≥ 13.3x K i , ≥ 4x IC 50 ) associated with increased incidence of bronchospasm/severe dyspnoea for patients with respiratory disease only, whereas a lower degree of ENT1 inhibition (≥ 0.1x K i , ≥ 0.05x IC 50 ) associated with a tolerable level of dyspnoea in both respiratory and cardiovascular disease patients. ENT1 inhibition had no effect in healthy volunteers. Furthermore, physicochemical properties correlative with ENT1 binding were assessed using a set of 1625 diverse molecules. Binding to ENT1 was relatively promiscuous (22% compounds K i < 1 μM) especially for neutral or basic molecules, and greater incidence tracked with higher lipophilicity (clogP > 5). This study rationalises inclusion of an assessment of ENT1 activity during early safety profiling for programs targeting respiratory disorders. - Highlights: • ENT1 inhibition causes bronchospasm and severe dyspnoea in respiratory patients. • Neutral or basic

  13. Prevalence and clinical features of celiac disease in patients with autoimmune thyroiditis: cross-sectional study

    Directory of Open Access Journals (Sweden)

    Aline Ventura

    Full Text Available CONTEXT AND OBJECTIVE: Celiac disease is an autoimmune disorder with an average prevalence of 1% in Europe and the United States. Because of strong European ancestry in southern Brazil, this study aimed to evaluate the seroprevalence of celiac disease among autoimmune thyroiditis patients.DESIGN AND SETTING: Cross-sectional study in a public university hospital.METHODS: This cross-sectional prevalence study included autoimmune thyroiditis patients who were tested for anti-endomysial and anti-transglutaminase antibodies between August 2010 and July 2011.RESULTS: Fifty-three patients with autoimmune thyroiditis were included; 92.5% were women, with mean age of 49.0 ± 13.5 years. Five patients (9.3% were serologically positive for celiac disease: three of them (5.6% were reactive for anti-endomysial antibodies and two (3.7% for anti-transglutaminase. None of them exhibited anemia and one presented diarrhea. Endoscopy was performed on two patients: one with normal histology and the other with lymphocytic infiltrate and villous atrophy.CONCLUSION: The prevalence of celiac disease among patients with autoimmune thyroid disease was 9.3%; one patient complained of diarrhea and none presented anemia. Among at-risk populations, like autoimmune thyroiditis patients, the presence of diarrhea or anemia should not be used as a criterion for indicating celiac disease investigation. This must be done for all autoimmune thyroiditis patients because of its high prevalence.

  14. International Union of Basic and Clinical Pharmacology Review: WNT/Frizzled signalling: receptor–ligand selectivity with focus on FZD-G protein signalling and its physiological relevance: IUPHAR Review 3

    Science.gov (United States)

    Dijksterhuis, J P; Petersen, J; Schulte, G

    2014-01-01

    The wingless/int1 (WNT)/Frizzled (FZD) signalling pathway controls numerous cellular processes such as proliferation, differentiation, cell-fate decisions, migration and plays a crucial role during embryonic development. Nineteen mammalian WNTs can bind to 10 FZDs thereby activating different downstream pathways such as WNT/β-catenin, WNT/planar cell polarity and WNT/Ca2+. However, the mechanisms of signalling specification and the involvement of heterotrimeric G proteins are still unclear. Disturbances in the pathways can lead to various diseases ranging from cancer, inflammatory diseases to metabolic and neurological disorders. Due to the presence of seven-transmembrane segments, evidence for coupling between FZDs and G proteins and substantial structural differences in class A, B or C GPCRs, FZDs were grouped separately in the IUPHAR GPCR database as the class FZD within the superfamily of GPCRs. Recently, important progress has been made pointing to a direct activation of G proteins after WNT stimulation. WNT/FZD and G protein coupling remain to be fully explored, although the basic observation supporting the nature of FZDs as GPCRs is compelling. Because the involvement of different (i) WNTs; (ii) FZDs; and (iii) intracellular binding partners could selectively affect signalling specification, in this review we present the current understanding of receptor/ligand selectivity of FZDs and WNTs. We pinpoint what is known about signalling specification and the physiological relevance of these interactions with special emphasis on FZD–G protein interactions. LINKED ARTICLESThis article is part of a themed section on Molecular Pharmacology of GPCRs. To view the other articles in this section visit http://dx.doi.org/10.1111/bph.2014.171.issue-5 PMID:24032637

  15. Nursing students' perceptions of using the Clinical Education Assessment tool AssCE and their overall perceptions of the clinical learning environment - A cross-sectional correlational study.

    Science.gov (United States)

    Engström, Maria; Löfmark, Anna; Vae, Karen Johanne Ugland; Mårtensson, Gunilla

    2017-04-01

    Clinical education is a vital part of nursing students' learning; the importance of assessment tools and feedback in stimulating student learning has been stressed, but this needs to be studied in more detail. To examine relationships between nursing students' perceptions of using an Assessment tool in Clinical Education (AssCE) during their mid-course discussion and final assessment, the content discussed during these meetings between the student, preceptor and nurse teacher and the students' overall perception of the clinical learning environment. A cross-sectional, correlational design was used. A convenience sample of 110 nursing students from one Norwegian university college with two campuses. Data were collected with self-developed questionnaires and analysed using logistic regression with SPSS and the PROCESS macro for mediation analysis. There was a positive relationship between nursing students' perceptions of using the assessment tool AssCE and their overall perception of the clinical learning environment. This relationship was, in turn, mediated by the content discussed during the formative mid-course discussion and summative final assessment. Our conclusion is that the assessment tool AssCE supported students' clinical learning and that this relationship, in turn, was mediated by the degree to which the conversation during the assessment meeting focused on the student's knowledge, skills and professional judgement. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. The contribution of traditional healers' clinics to public health care system in Addis Ababa, Ethiopia: a cross-sectional study.

    Science.gov (United States)

    Birhan, Wubet; Giday, Mirutse; Teklehaymanot, Tilahun

    2011-12-02

    Ethiopian people have been using traditional medicine since time immemorial with 80% of its population dependent on traditional medicines. However, the documentation of traditional healers' clinics contribution to modern public health system in cosmopolitan cities is scanty. Studies conducted so far are limited and focused on the perceptions and practices of modern and traditional health practitioners about traditional medicine. Thus, a cross sectional study was conducted from February to May 2010 to assess the contribution of traditional healers' clinics to public health care system in Addis Ababa. Ten traditional healers who were willing to participate in the study and 306 patients who were visiting these traditional healers' clinics were interviewed using two types of semi-structured questionnaires. Data were summarized using percentages, tables and bar chart. The diseases mostly treated by traditional healers were wound, inflammation, herpes zoster, hemorrhoids, fracture, paralysis, back-pain, liver diseases, cancer and eczema. This study showed that traditional healers' clinics considerably contribute to public health care in Addis Ababa. Fifty two percent of patients reported that traditional healers' clinics were their first choice when they faced health problems. The reasons for visiting these clinics were 175 (57.2%) efficacy, 109 (35.6%) dissatisfaction with modern medicine, 10 (3.3%) dissatisfaction with modern medicine and efficacy, 6 (2.0%) cost and 6 (2.0%) dissatisfaction and cost. Females (55.2%), young age (20-40 years, 65.0%), never married (56.9%), orthodox (73.9%), Amhara (52.3%), educational status above grade 12 (34.6%) and government employees (29.4%) were frequent visitors. Healers reported that there was no form of cooperation with modern health professionals. The reasons were lack of motivation to collaborate and communicate with modern health service workers. Family based apprenticeship was the sources of knowledge for majority of the

  17. The contribution of traditional healers' clinics to public health care system in Addis Ababa, Ethiopia: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Birhan Wubet

    2011-12-01

    Full Text Available Abstract Background Ethiopian people have been using traditional medicine since time immemorial with 80% of its population dependent on traditional medicines. However, the documentation of traditional healers' clinics contribution to modern public health system in cosmopolitan cities is scanty. Studies conducted so far are limited and focused on the perceptions and practices of modern and traditional health practitioners about traditional medicine. Thus, a cross sectional study was conducted from February to May 2010 to assess the contribution of traditional healers' clinics to public health care system in Addis Ababa. Materials and methods Ten traditional healers who were willing to participate in the study and 306 patients who were visiting these traditional healers' clinics were interviewed using two types of semi-structured questionnaires. Data were summarized using percentages, tables and bar chart. Results The diseases mostly treated by traditional healers were wound, inflammation, herpes zoster, hemorrhoids, fracture, paralysis, back-pain, liver diseases, cancer and eczema. This study showed that traditional healers' clinics considerably contribute to public health care in Addis Ababa. Fifty two percent of patients reported that traditional healers' clinics were their first choice when they faced health problems. The reasons for visiting these clinics were 175 (57.2% efficacy, 109 (35.6% dissatisfaction with modern medicine, 10 (3.3% dissatisfaction with modern medicine and efficacy, 6 (2.0% cost and 6 (2.0% dissatisfaction and cost. Females (55.2%, young age (20-40 years, 65.0%, never married (56.9%, orthodox (73.9%, Amhara (52.3%, educational status above grade 12 (34.6% and government employees (29.4% were frequent visitors. Healers reported that there was no form of cooperation with modern health professionals. The reasons were lack of motivation to collaborate and communicate with modern health service workers. Family based

  18. Awareness and utilization of community clinic services among women in rural areas in Bangladesh: A cross-sectional study.

    Directory of Open Access Journals (Sweden)

    Sanni Yaya

    Full Text Available In recent years, Bangladesh government has accomplished the ambitious project of establishing hospitals 18,000 Community Health Clinics in sub-districts across the country. Operating under the affiliation of the government hospitals, these community health clinics aim to provide free healthcare services and to increase health-awareness among the extreme poor communities in the rural areas. However, a great proportion of the people are still not well aware of the services offered by the community health clinics. Thus, it is imperative to identify the factors of awareness regarding the community clinics. Research-based evidence is necessary to improve the efficacy and service coverage of community clinics among key population.Cross-sectional data of size 11,673 women aged 15 to 49 years living in rural settings across seven divisions were extracted from the latest Bangladesh Demographic and Health Survey 2014. The main outcome measures of our study were awareness and utilization of Community Clinic Services (CCs. Descriptive statistics were used to present the baseline socio-demographic and economic characteristics; Chi-square test and logistic regression were performed to identify the factors associated with awareness of community clinics.About one-third (36.7% of the women were aware of community clinics. Geographical location, level of education, household wealth status and frequency of reading newspaper were found to be significantly associated with awareness about community clinic services. Services reported to be obtained in the community clinics include family planning, immunization, tetanus, antenatal care, vitamin A, and health care for children and child growth monitoring. In the multivariate logistic regression, the odds of awareness among participants with primary education [p<0.001, AOR = 1.255, 95%CI = 1.107-1.357], secondary qualification [p<0.001, AOR = 1.370, 95%CI = 1.242-1.510] and tertiary [p<0.001, AOR = 1.526, 95%CI = 1

  19. Use of the internet by patients attending specialist clinics in Sri Lanka: a cross sectional study

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    Kommalage Mahinda

    2009-02-01

    Full Text Available Abstract Background The internet is a relatively new medium of disseminating health information. Studies on Internet usage for health information are mainly done in developed countries and very few studies have been carried out in developing countries. Methods The Internet usage of patients who were attending specialist clinics in Teaching Hospital Karapitiya and Southern Hospital in Galle, Sri Lanka was investigated. The study was carried out on the following specialities; General Medicine, Pediatrics, General Surgery and Cardiothoracic surgery. Information was collected using an investigator-administered questionnaire while patients were waiting for a consultation. Results Three hundred and fifty five patients (or guardians in the Pediatric clinic participated in the study. One hundred seventy two (48.3% participants have heard about the Internet. There was a relationship between awareness of the Internet and age, educational level and the clinic attended. There was no difference of awareness depending on the gender or the hospital. Only three participants (0.97% have used the Internet to find information about their disease conditions. Close relatives searched the Internet about the conditions of two participants. Altogether, the Internet was used to search information on the disease condition of five participants (1.4%. Conclusion Very low usage of the Internet for health information retrieval in this study is probably due to low awareness of the Internet and low educational level. This low usage of Internet and the associated reasons shown in this study can be generalized to Sri Lanka and probably to other low-income countries that have lower educational level than Sri Lanka.

  20. Prevalence of Lower Urinary Tract Symptoms (LUTS) in Stroke Patients. A cross-sectional, clinical survey

    DEFF Research Database (Denmark)

    Tibæk, Sigrid; Gard, Gunvor; Klarskov, Peter

    2008-01-01

    AIMS: The aims of this study were primarily to investigate the prevalence, severity and impact on daily life of Lower Urinary Tract Symptoms (LUTS) in a clinical sample of stroke patients and secondly to identify factors associated with LUTS. MATERIALS AND METHODS: This was a cross......, symptoms of urinary incontinence on admission, and use of analgesics were significantly associated with severity, whereas the prevalence and bother of LUTS could not be associated with other patient characteristics. CONCLUSION: LUTS are highly prevalent in stroke patients and have a major impact on daily...

  1. Temporal trends in pharmacology publications by pharmacy institutes: A deeper dig

    OpenAIRE

    Bhatt, Parloop Amit; Patel, Zarana

    2016-01-01

    Objective: Publications in Indian Journal of Pharmacology (IJP) are the face of contemporary pharmacology practices followed in health-care profession - a knowledge-based profession. It depicts trends in terms of quantity (proportions), quality, type (preclinical/clinical), thrust areas, etc., of pharmacology followed by biomedical community professions both nationally and internationally. This article aims to establish temporal trends in pharmacology research by pharmacy institutes in light ...

  2. Pharmacological therapy for amblyopia

    Directory of Open Access Journals (Sweden)

    Anupam Singh

    2017-01-01

    Full Text Available Amblyopia is the most common cause of preventable blindness in children and young adults. Most of the amblyopic visual loss is reversible if detected and treated at appropriate time. It affects 1.0 to 5.0% of the general population. Various treatment modalities have been tried like refractive correction, patching (both full time and part time, penalization and pharmacological therapy. Refractive correction alone improves visual acuity in one third of patients with anisometropic amblyopia. Various drugs have also been tried of which carbidopa & levodopa have been popular. Most of these agents are still in experimental stage, though levodopa-carbidopa combination therapy has been widely studied in human amblyopes with good outcomes. Levodopa therapy may be considered in cases with residual amblyopia, although occlusion therapy remains the initial treatment choice. Regression of effect after stoppage of therapy remains a concern. Further studies are therefore needed to evaluate the full efficacy and side effect profile of these agents.

  3. Pharmacological therapy for amblyopia

    Science.gov (United States)

    Singh, Anupam; Nagpal, Ritu; Mittal, Sanjeev Kumar; Bahuguna, Chirag; Kumar, Prashant

    2017-01-01

    Amblyopia is the most common cause of preventable blindness in children and young adults. Most of the amblyopic visual loss is reversible if detected and treated at appropriate time. It affects 1.0 to 5.0% of the general population. Various treatment modalities have been tried like refractive correction, patching (both full time and part time), penalization and pharmacological therapy. Refractive correction alone improves visual acuity in one third of patients with anisometropic amblyopia. Various drugs have also been tried of which carbidopa & levodopa have been popular. Most of these agents are still in experimental stage, though levodopa-carbidopa combination therapy has been widely studied in human amblyopes with good outcomes. Levodopa therapy may be considered in cases with residual amblyopia, although occlusion therapy remains the initial treatment choice. Regression of effect after stoppage of therapy remains a concern. Further studies are therefore needed to evaluate the full efficacy and side effect profile of these agents. PMID:29018759

  4. Extended phenotype and clinical subgroups in unilateral Meniere disease: A cross-sectional study with cluster analysis.

    Science.gov (United States)

    Frejo, L; Martin-Sanz, E; Teggi, R; Trinidad, G; Soto-Varela, A; Santos-Perez, S; Manrique, R; Perez, N; Aran, I; Almeida-Branco, M S; Batuecas-Caletrio, A; Fraile, J; Espinosa-Sanchez, J M; Perez-Guillen, V; Perez-Garrigues, H; Oliva-Dominguez, M; Aleman, O; Benitez, J; Perez, P; Lopez-Escamez, J A

    2017-12-01

    To define clinical subgroups by cluster analysis in patients with unilateral Meniere disease (MD) and to compare them with the clinical subgroups found in bilateral MD. A cross-sectional study with a two-step cluster analysis. A tertiary referral multicenter study. Nine hundred and eighty-eight adult patients with unilateral MD. best predictors to define clinical subgroups with potential different aetiologies. We established five clusters in unilateral MD. Group 1 is the most frequently found, includes 53% of patients, and it is defined as the sporadic, classic MD without migraine and without autoimmune disorder (AD). Group 2 is found in 8% of patients, and it is defined by hearing loss, which antedates the vertigo episodes by months or years (delayed MD), without migraine or AD in most of cases. Group 3 involves 13% of patients, and it is considered familial MD, while group 4, which includes 15% of patients, is linked to the presence of migraine in all cases. Group 5 is found in 11% of patients and is defined by a comorbid AD. We found significant differences in the distribution of AD in clusters 3, 4 and 5 between patients with uni- and bilateral MD. Cluster analysis defines clinical subgroups in MD, and it extends the phenotype beyond audiovestibular symptoms. This classification will help to improve the phenotyping in MD and facilitate the selection of patients for randomised clinical trials. © 2017 John Wiley & Sons Ltd.

  5. Relationship between esophageal clinical symptoms and manometry findings in patients with esophageal motility disorders: a cross-sectional study.

    Science.gov (United States)

    FakhreYaseri, Hashem; FakhreYaseri, Ali Mohammad; Baradaran Moghaddam, Ali; Soltani Arabshhi, Seyed Kamran

    2015-01-01

    Manometry is the gold-standard diagnostic test for motility disorders in the esophagus. The development of high-resolution manometry catheters and software displays of manometry recordings in color-coded pressure plots have changed the diagnostic assessment of esophageal disease. The diagnostic value of particular esophageal clinical symptoms among patients suspected of esophageal motor disorders (EMDs) is still unknown. The aim of this study was to explore the sensitivity, specificity, and predictive accuracy of presenting esophageal symptoms between abnormal and normal esophageal manometry findings. We conducted a cross-sectional study of 623 patients aged 11-80 years. Data were collected from clinical examinations as well as patient questionnaires. The sensitivity, specificity, and accuracy were calculated after high-resolution manometry plots were reviewed according to the most recent Chicago Criteria. The clinical symptoms were not sensitive enough to discriminate between EMDs. Nevertheless, dysphagia, noncardiac chest pain, hoarseness, vomiting, and weight loss had high specificity and high accuracy to distinguish EMDs from normal findings. Regurgitation and heartburn did not have good accuracy for the diagnosis of EMDs. Clinical symptoms are not reliable enough to discriminate between EMDs. Clinical symptoms can, however, discriminate between normal findings and EMDs, especially achalasia.

  6. Systems Pharmacology in Small Molecular Drug Discovery

    Directory of Open Access Journals (Sweden)

    Wei Zhou

    2016-02-01

    Full Text Available Drug discovery is a risky, costly and time-consuming process depending on multidisciplinary methods to create safe and effective medicines. Although considerable progress has been made by high-throughput screening methods in drug design, the cost of developing contemporary approved drugs did not match that in the past decade. The major reason is the late-stage clinical failures in Phases II and III because of the complicated interactions between drug-specific, human body and environmental aspects affecting the safety and efficacy of a drug. There is a growing hope that systems-level consideration may provide a new perspective to overcome such current difficulties of drug discovery and development. The systems pharmacology method emerged as a holistic approach and has attracted more and more attention recently. The applications of systems pharmacology not only provide the pharmacodynamic evaluation and target identification of drug molecules, but also give a systems-level of understanding the interaction mechanism between drugs and complex disease. Therefore, the present review is an attempt to introduce how holistic systems pharmacology that integrated in silico ADME/T (i.e., absorption, distribution, metabolism, excretion and toxicity, target fishing and network pharmacology facilitates the discovery of small molecular drugs at the system level.

  7. Assessment of service quality of public antiretroviral treatment (ART clinics in South Africa: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Kinkel Hans F

    2012-07-01

    Full Text Available Abstract Background In South Africa the ever increasing demand for antiretroviral treatment (ART runs the risk of leading to sub-optimal care in public sector ART clinics that are overburdened and under resourced. This study assessed the quality of ART services to identify service areas that require improvement. Methods A cross-sectional study was carried out at 16 of 17 public ART clinics in the target area in greater Pretoria, South Africa. Trained participant observers presented as ART qualifying HIV positive patients that required a visit to assess treatment readiness. They evaluated each facility on five different occasions between June and November 2009, assessing the time it took to get an appointment, the services available and accessed, service quality and the duration of the visit. Services (reception area, clinician’s consultation, HIV counselling, pharmacy, nutrition counselling and social worker’s assessment were assessed against performance standards that apply to all clinics. Service quality was expressed as scores for clinic performance (CPS and service performance (SPS, defined as the percentage of performance standards met per clinic and service area. Results In most of the clinics (62.5% participant observers were able to obtain an appointment within one week, although on the day of their visit essential services could not always be accessed. The median CPS of the assessed facilities was 68.5 with four clinics not meeting minimum standards (CPS > 60. The service areas that performed least well were the clinician’s consultation (SPS 67.3 and HIV counselling (SPS 70.7. Most notably, clinicians performed a physical examination in only 41.1% of the visits and rarely did a complete TB symptom screening. Counsellors frequently failed to address prevention of HIV transmission. Conclusions Overall public sector ART clinics in greater Pretoria were easily accessible and their services were of an acceptable quality. However

  8. Prevention of cardiovascular disease guided by total risk estimations - challenges and opportunities for practical implementation: highlights of a CardioVascular Clinical Trialists (CVCT) Workshop of the ESC Working Group on CardioVascular Pharmacology and Drug Therapy.

    LENUS (Irish Health Repository)

    Zannad, Faiez

    2011-11-03

    This paper presents a summary of the potential practical and economic barriers to implementation of primary prevention of cardiovascular disease guided by total cardiovascular risk estimations in the general population. It also reviews various possible solutions to overcome these barriers. The report is based on discussion among experts in the area at a special CardioVascular Clinical Trialists workshop organized by the European Society of Cardiology Working Group on Cardiovascular Pharmacology and Drug Therapy that took place in September 2009. It includes a review of the evidence in favour of the \\'treat-to-target\\' paradigm, as well as potential difficulties with this approach, including the multiple pathological processes present in high-risk patients that may not be adequately addressed by this strategy. The risk-guided therapy approach requires careful definitions of cardiovascular risk and consideration of clinical endpoints as well as the differences between trial and \\'real-world\\' populations. Cost-effectiveness presents another issue in scenarios of finite healthcare resources, as does the difficulty of documenting guideline uptake and effectiveness in the primary care setting, where early modification of risk factors may be more beneficial than later attempts to manage established disease. The key to guideline implementation is to improve the quality of risk assessment and demonstrate the association between risk factors, intervention, and reduced event rates. In the future, this may be made possible by means of automated data entry and various other measures. In conclusion, opportunities exist to increase guideline implementation in the primary care setting, with potential benefits for both the general population and healthcare resources.

  9. Socio demographic and clinical predictors of absenteeism A cross sectional study of urban industrial employees

    Directory of Open Access Journals (Sweden)

    Suhash Chakraborty

    2013-01-01

    Full Text Available Context: Public sector undertakings are facing a threat of privatization due to unsatisfactory performance putting pressure on management and in turn to employees. There is an increasing trend of absenteeism observed amongst employees citing job stress. Aim: To find an association between job stress and absenteeism in relation to socio-demographic and clinical profile. Materials and Methods: The study was conducted in an urban aeronautical industry with 68 employees who mentioned stress at workplace during evaluation. Job stress was assessed using Professional Life Stress Scale (David Fontana. Those who scored more than 30 (n = 43 were taken up for the study after an informed consent. A semi-structured questionnaire was administered to find socio-demographic and clinical profile. Employees who reported taking leave in last six months just to avoid work or workplace constitute the "absenteeism" group. The absenteeism group was compared to non-absenteeism group using Fisher exact/Chi-square test or independent t-test depending on type of variables. Results: Out of 43 subjects, 18 had absenteeism while 25 did not have absenteeism. Comparing the two groups, interstate migration, having more than one previous job, commuting time more than an hour, co-morbid anxiety/depression, and alcohol abuse were significantly associated with absenteeism (P 0.05. Conclusion: In absenteeism research, one of the widely accepted models is Steer and Rhode′s "Process model of absenteeism." The model postulates job stress as one of the barriers for attendance. Thus, knowing the factors for absenteeism would help in preventing absenteeism.

  10. Sequential compression pump effect on hypotension due to spinal anesthesia for cesarean section: A double blind clinical trial

    Science.gov (United States)

    Zadeh, Fatemeh Javaherforoosh; Alqozat, Mostafa; Zadeh, Reza Akhond

    2017-01-01

    Background Spinal anesthesia (SA) is a standard technique for cesarean section. Hypotension presents an incident of 80–85% after SA in pregnant women. Objective To determine the effect of intermittent pneumatic compression of lower limbs on declining spinal anesthesia induced hypotension during cesarean section. Methods This double-blind clinical prospective study was conducted on 76 non-laboring parturient patients, aged 18–45 years, with the American Society of Anesthesiologist physical status I or II who were scheduled for elective cesarean section at Razi Hospital, Ahvaz, Iran from December 21, 2015 to January 20, 2016. Patients were divided into treatment mechanical pump (Group M) or control group (Group C) with simple random sampling. Fetal presentation, birth weight, Apgar at 1 and 5 min, time taken for pre-hydration (min), pre-hydration to the administration of spinal anesthesia (min), initiation of spinal to the delivery (min) and total volume of intravenous fluids, total dose of ephedrine and metoclopramide were recorded. Data were analyzed by SPSS version 19, using repeated measures of ANOVA and Chi square test. Results Heart rate, MPA, DAP and SAP changes were significantly higher in off-pump group in the baseline and 1st-minute (p<0.05), and in the other times, this change was significantly different with control groups. Conclusion This research showed the suitability of the use of Sequential Compression Device (SCD) in reducing hypotension after spinal anesthesia for cesarean section, also this method can cause reducing vasopressor dosage for increased blood pressure, but the approval of its effectiveness requires repetition of the study with a larger sample size. Trial registration The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the IRCT ID: IRCT2015011217742N3. Funding The authors received no financial support for the research, authorship, and/or publication of this article. PMID:28713516

  11. Use of oxytocin during Caesarean section at Princess Marina Hospital, Botswana: An audit of clinical practice

    Directory of Open Access Journals (Sweden)

    Billy M. Tsima

    2013-02-01

    Methods: A clinical audit of pregnant women having CS and given oxytocin at the time of the operation was conducted over a period of three months. Data included indications for CS, oxytocin dose regimen, prescribing clinician’s designation, type of anaesthesia for the CS and estimated blood loss. Results: A total of 139 case records were included. The commonest dose was 20 IU infusion (31.7%. The potentially dangerous regimen of 10 IU intravenous bolus of oxytocin was used in 12.9% of CS. Further doses were utilized in 57 patients (41%. The top three indications for CS were fetal distress (36 patients, 24.5%, dystocia (32 patients, 21.8% and a previous CS (25 patients, 17.0%. Estimated blood loss ranged from 50 mL – 2000 mL. Conclusion: The use of oxytocin during CS in the local setting does not follow recommended practice. This has potentially harmful consequences. Education and guidance through evidence based national guidelines could help alleviate the problem.

  12. Clinical indications and determinants of the rise of cesarean section in three hospitals in rural China.

    Science.gov (United States)

    Qin, Cheng; Zhou, Min; Callaghan, William M; Posner, Samuel F; Zhang, Jun; Berg, Cynthia J; Zhao, Gengli

    2012-10-01

    This study investigated changes in cesarean delivery rate and cesarean indications in 3 county-level hospitals in rural China. Hospital delivery records in 1997 and 2003 were used to examine the reasons behind the changes. In Chengde County Hospital, the cesarean delivery rate increased from 28% in 1997 to 54% in 2003. The rate increased from 43% in 1997 to 65% in 2003 in Anxian County Hospital and Anxian Maternal and Child Health Hospital. The dramatic increase in cesarean delivery in the study hospitals was associated with a shift from more severe to mild or no clinical indications. The ratio of mild to moderate to severe hypertension increased substantially. More than half of the cephalopelvic disproportion cases were diagnosed prior to labor. The majority of nuchal cord cases were diagnosed without fetal distress. Maternal/family request was the number one cesarean indication in Anxian County Hospital and Anxian MCH Hospital in 2003. Ultrasound evidence of nuchal cord moved from the ninth ranked indication in 1997 to the second in 2003 in Chengde County Hospital.

  13. Process Pharmacology: A Pharmacological Data Science Approach to Drug Development and Therapy.

    Science.gov (United States)

    Lötsch, Jörn; Ultsch, Alfred

    2016-04-01

    A novel functional-genomics based concept of pharmacology that uses artificial intelligence techniques for mining and knowledge discovery in "big data" providing comprehensive information about the drugs' targets and their functional genomics is proposed. In "process pharmacology", drugs are associated with biological processes. This puts the disease, regarded as alterations in the activity in one or several cellular processes, in the focus of drug therapy. In this setting, the molecular drug targets are merely intermediates. The identification of drugs for therapeutic or repurposing is based on similarities in the high-dimensional space of the biological processes that a drug influences. Applying this principle to data associated with lymphoblastic leukemia identified a short list of candidate drugs, including one that was recently proposed as novel rescue medication for lymphocytic leukemia. The pharmacological data science approach provides successful selections of drug candidates within development and repurposing tasks. © 2016 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  14. Pharmacologic and non-pharmacologic treatments for chronic pain in individuals with HIV: a systematic review

    Science.gov (United States)

    Merlin, Jessica S.; Bulls, Hailey W.; Vucovich, Lee A.; Edelman, E. Jennifer; Starrels, Joanna L.

    2016-01-01

    Chronic pain occurs in as many as 85% of individuals with HIV and is associated with substantial functional impairment. Little guidance is available for HIV providers seeking to address their patients’ chronic pain. We conducted a systematic review to identify clinical trials and observational studies that examined the impact of pharmacologic or non-pharmacologic interventions on pain and/or functional outcomes among HIV-infected individuals with chronic pain in high-development countries. Eleven studies met inclusion criteria and were mostly low or very low quality. Seven examined pharmacologic interventions (gabapentin, pregabalin, capsaicin, analgesics including opioids) and four examined non-pharmacologic interventions (cognitive behavioral therapy, self-hypnosis, smoked cannabis). The only controlled studies with positive results were of capsaicin and cannabis, and had short-term follow-up (≤12 weeks). Among the seven studies of pharmacologic interventions, five had substantial pharmaceutical industry sponsorship. These findings highlight several important gaps in the HIV/chronic pain literature that require further research. PMID:27267445

  15. Clinical pharmacology of ifosfamide and metabolites

    NARCIS (Netherlands)

    Kerbusch, T.

    2000-01-01

    Introduction Ifosfamide is an alkylating agent, which is used in the treatment of various types of malignant diseases in adults and childeren. Its use, however, can be accompanied by severe haematological, neuro- and nephrotoxicities. Since its development in the middle of the 1960’s, most of its

  16. Pharmacology and clinical experience with risperidone.

    Science.gov (United States)

    Love, R C; Nelson, M W

    2000-12-01

    Risperidone (Risperdal, Janssen Pharmaceutica) is a second generation antipsychotic (SGA) for the treatment of schizophrenia and other psychotic disorders. It is a potent antagonist of serotonin-2 (5-HT2) and dopamine-2 (D2) receptors in the brain. In comparison to conventional antipsychotics, risperidone demonstrates superior efficacy against the positive and negative symptoms of schizophrenia and a decreased occurrence of extrapyramidal side effects (EPS). Risperidone causes less weight gain than other marketed SGAs, but can increase prolactin levels and cause EPS in a dose-related manner. In a variety of pharmacoeconomic analyses, it has proven to be a cost-effective addition to the antipsychotic armamentarium. As the first SGA available for front line use, risperidone has established a new standard of care for the treatment of individuals with psychotic disorders.

  17. Clinical pharmacology of tiamulin in ruminants.

    Science.gov (United States)

    Ziv, G; Levisohn, S L; Bar-Moshe, B; Bor, A; Soback, S

    1983-03-01

    Median values for the minimum inhibitory concentrations (MIC) of tiamulin for Mycoplasma and Acholeplasma isolated from ruminants were 0.05 micrograms/ml and 0.025 micrograms/ml, respectively. These values were close to the MIC values of tylosin and considerably lower than the respective values for spectinomycin, Spiramycin and oxytetracycline. The serum concentration--time profile of tiamulin after intramuscular (i.m.) injection to goats, ewes, cows and calves, and after oral administration to preruminant calves was characterized by a rapid absorption phase (absorption t1/2 of less than 30 min.), a short plateau phase, an elimination t1/2 ranging between 3 and 6 h, and low peak serum drug levels. The serum elimination t1/2 of the drug after intravenous (i.v.) injection was 25 min. It appears that tiamulin is extensively metabolized in ruminants and is well distributed throughout the body. Drug concentrations in the lungs, liver, and the kidneys 1 h after i.v. injection were four to seven times higher than in blood. The drug penetrated very rapidly into the milk after i.m. administration; mean peak drug concentrations in normal milk and in milk secreted from inflamed glands of cows were 7.5 times and 1.2 times higher respectively, than the mean peak serum drug concentrations. Concentrations of tiamulin of potential therapeutic value in the treatment of mycoplasmal infections can be maintained in the lungs for at least 12 h after i.m. injection at 10 mg/kg, and in preruminant calves after an oral dose of 20 mg/kg. However, tiamulin possesses several very serious side-effects and the i.v. route of administration is definitely contraindicated.

  18. Clinical pharmacology of methadone in dogs.

    Science.gov (United States)

    Ingvast-Larsson, Carina; Holgersson, Anja; Bondesson, Ulf; Lagerstedt, Anne-Sofie; Olsson, Kerstin

    2010-01-01

    To investigate the pharmacokinetics and effects of methadone on behaviour and plasma concentrations of cortisol and vasopressin in healthy dogs. Randomized, cross-over, experimental trial. Nine adult dogs (beagle and beagle cross breeds), four males and five females. Methadone hydrochloride, 0.4 mg kg(-1), was administered intravenously (IV) and subcutaneously (SC) with a crossover design. Drug and hormone analyses in plasma were performed using Liquid Chromatography-Electrospray Ionization-Tandem Mass Spectrometry and radioimmunoassay respectively. Behavioural data were collected using a standardized protocol. After IV administration, the plasma concentration of methadone at 10 minutes was 82.1 +/- 9.2 ng mL(-1) (mean +/- SD), the terminal half-life was 3.9 +/- 1.0 hours, the volume of distribution 9.2 +/- 3.3 L kg(-1) and plasma clearance 27.9 +/- 7.6 mL minute(-1) kg(-1). After SC administration, time to maximal plasma concentration was 1.26 +/- 1.04 hours and maximal plasma concentration of methadone was 23.9 +/- 14.4 ng mL(-1), the terminal half-life was 10.7 +/- 4.3 hours and bioavailability was 79 +/- 22%. Concentrations of both cortisol and vasopressin were increased for an hour following IV methadone. The observed behavioural effects of methadone were decreased licking and swallowing and an increase in whining after SC administration. The latter finding is notable as it can be misinterpreted as pain when methadone is used as an analgesic. When methadone was administered by the SC route, the half-life was longer, but the individual variation in plasma concentrations was greater compared with IV administration. Increased frequency of whining occurred after administration of methadone and may be a drug effect and not a sign of pain. Cortisol and vasopressin concentrations in plasma may not be suitable for evaluating analgesia after methadone treatment.

  19. Pharmacological and clinical aspects of thyroid blocking

    International Nuclear Information System (INIS)

    Eickstedt, K.W. von

    1983-01-01

    The paper discusses the risk of uptake of radioactive iodine into the human body. Prevention of iodine - especially 131 I - uptake by the thyroid is a necessary measure in case of reactor accidents, accidental contamination of laboratory staff, and as a preventive measure in patients whose organic functions are studied using 131 I, i.e. in the field of medical diagnostics. The best known thyroid-blocking substance is potassium perchlorate. Perchlorate must be applied in high doses; it is administered when fixed doses of 131 I are applied for a given period of time for diagnostic purposes. In case of reactor accidents, when 131 I is released in uncombined form, potassium iodide is recommended as it has less undesirable side-effects than perchlorate. Further, nothing is known about the effects of short-term high doses of perchlorate. The authors state that the risk of iodine-induced hyperthyroidism is lower with high doses of iodide than with low doses. (orig./MG) [de

  20. Fluoxetine: clinical pharmacology and physiologic disposition

    International Nuclear Information System (INIS)

    Lemberger, L.; Bergstrom, R.F.; Wolen, R.L.; Farid, N.A.; Enas, G.G.; Aronoff, G.R.

    1985-01-01

    Fluoxetine (30 mg), administered for 7 days to normal volunteers, produced a 66% inhibition of tritiated serotonin uptake into platelets. Plasma concentrations of fluoxetine correlated positively with inhibition of serotonin uptake. Fluoxetine is well absorbed after oral administration in both the fed and fasted states and demonstrates dose proportionality. Fluoxetine disappears from plasma with a half-life of 1-3 days; its metabolite norfluoxetine has a plasma half-life of 7-15 days. After administration of 14 C-fluoxetine, approximately 65% of the administered dose of radioactivity is recovered in urine and about 15% in feces. Fluoxetine, given as a single dose or in multiple doses over 8 days, did not produce significant effects on the plasma disappearance of warfarin, diazepam, tolbutamide, or chlorothiazide. Coadministration of fluoxetine and ethanol did not result in an increase from control values in the blood ethanol levels, nor did it produce significant changes in physiologic, psychometric, or psychomotor activity. Pharmacokinetics of fluoxetine in the elderly and normal volunteers appear to be similar. In addition, pharmacokinetic analyses in patients with varying degrees of renal impairment did not show significant differences from healthy subjects

  1. Stressors and Coping Strategies of the Saudi Nursing Students in the Clinical Training: A Cross-Sectional Study

    Directory of Open Access Journals (Sweden)

    Salman H. Alsaqri

    2017-01-01

    Full Text Available Nursing students often encounter high levels of stress through clinical practice that may cause psychological or emotional problems during their professional life eventually affecting the quality of patient care they provide. The aims of the current study were to identify the level and types of stress perceived by nursing students in their clinical practice and to identify the coping strategies that students used to relieve their stress. A descriptive, cross-sectional design was used in this study. A total of 200 students who were enrolled in the nursing program were taken as study respondents. Research data were collected using the Perceived Stress Scale (PSS and the Coping Behavior Inventory (CBI. Data was analyzed using one-way ANOVA test, Pearson’s test, and independent sample t-test on SPSS version 22. Findings indicated that nursing students experienced a high level of stress. The most common coping strategy utilized by the students was problem solving, while avoidance was the least frequently used one. Saudi nursing students experienced stress levels above the mean in clinical training. The most common stressors were related to assignments and workload. The study recommends that clinical curriculum requirements and the workload of nursing students should be reviewed.

  2. From Learning to Decision-Making: A Cross-Sectional Survey of a Clinical Pharmacist-Steered Journal Club

    Directory of Open Access Journals (Sweden)

    Sherine Ismail

    2017-01-01

    Full Text Available Journal clubs have been traditionally incorporated into academic training programs to enhance competency in the interpretation of literature. We designed a structured journal club (JC to improve skills in the interpretation of literature; however, we were not aware of how learners (interns, residents, clinical pharmacists, etc. would perceive it. We aimed to assess the perception of learners at different levels of pharmacy training. A cross-sectional design was used. A self-administered online survey was emailed to JC attendees from 2010–2014 at King Abdulaziz Medical City, Jeddah, Saudi Arabia. The survey questions included: introduction sessions, topic selection, JC layout, interaction with the moderator, and decision-making skills by clinical pharmacists. The response rate was 58/89 (65%; 52/54 (96% respondents believed that JC adds to their knowledge in interpreting literature. Topic selection met the core curriculum requirements for credentials exams for 16/36 (44.4%, while 16/22 (73% presenters had good to excellent interaction with the moderator. JC facilitated decision-making for 10/12 (83% of clinical pharmacists. The results suggest that clinical pharmacist-steered JC may serve as an effective tool to empower learners at different levels of pharmacy practice, with evidence-based principles for interpretation of literature and guide informed decision-making.

  3. Pharmacological Aspects of Neuro-Immune Interactions.

    Science.gov (United States)

    Tarasov, Vadim V; Kudryashov, Nikita V; Chubarev, Vladimir N; Kalinina, Tatiana S; Barreto, George E; Ashraf, Ghulam Md; Aliev, Gjumrakch

    2018-01-01

    The use of systematic approach for the analysis of mechanism of action of drugs at different levels of biological organization of organisms is an important task in experimental and clinical pharmacology for drug designing and increasing the efficacy and safety of drugs. The analysis of published data on pharmacological effects of psychotropic drugs possessing immunomodulatory and/or antiviral properties have shown a correlation between central effects of examined drugs associated with the impact on the processes of neurogenesis of adult brain and survival of neurons, and their ability to alter levels of key proinflammatory cytokines. The changes that occur as a result of the influence of pharmacological agents at one of the systems should inevitably lead to the functional reorganization at another. Integrative mechanisms underlying the neuro-immune interactions may explain the "pleiotropic" pharmacological effects of some antiviral and immunomodulatory drugs. Amantadine, which was originally considered as an antiviral agent, was approved as anti-parkinsonic drug after its wide medical use. The prolonged administration of interferon alpha caused depression in 30-45% of patients, thus limiting its clinical use. The antiviral drug "Oseltamivir" may provoke the development of central side effects, including abnormal behavior, delirium, impaired perception and suicides. Anti-herpethetical drug "Panavir" shows pronounced neuroprotective properties. The purpose of this review is to analyze the experimental and clinical data related to central effects of drugs with antiviral or/and immunotropic activity, and to discover the relationship of these effects with changes in reactivity of immune system and proinflammatory response. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  4. General practitioners' views of clinically led commissioning: cross-sectional survey in England.

    Science.gov (United States)

    Moran, Valerie; Checkland, Kath; Coleman, Anna; Spooner, Sharon; Gibson, Jonathan; Sutton, Matt

    2017-06-08

    Involving general practitioners (GPs) in the commissioning/purchasing of services has been an important element in English health policy for many years. The Health and Social Care Act 2012 handed responsibility for commissioning of the majority of care for local populations to GP-led Clinical Commissioning Groups (CCGs). In this paper, we explore GP attitudes to involvement in commissioning and future intentions for engagement. Survey of a random sample of GPs across England in 2015. The Eighth National GP Worklife Survey was distributed to GPs in spring 2015. Responses were received from 2611 respondents (response rate = 46%). We compared responses across different GP characteristics and conducted two sample tests of proportions to identify statistically significant differences in responses across groups. We also used multivariate logistic regression to identify the characteristics associated with wanting a formal CCG role in the future. While GPs generally agree that they can add value to aspects of commissioning, only a minority feel that this is an important part of their role. Many current leaders intend to quit in the next 5 years, and there is limited appetite among those not currently in a formal role to take up such a role in the future. CCGs were set up as 'membership organisations' but only a minority of respondents reported feeling that they had 'ownership' of their local CCG and these were often GPs with formal CCG roles. However, respondents generally agree that the CCG has a legitimate role in influencing the work that they do. CCGs need to engage in active succession planning to find the next generation of GP leaders. GPs believe that CCGs have a legitimate role in influencing their work, suggesting that there may be scope for CCGs to involve GPs more fully in roles short of formal leadership. © 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

  5. General practitioners’ views of clinically led commissioning: cross-sectional survey in England

    Science.gov (United States)

    Moran, Valerie; Checkland, Kath; Coleman, Anna; Spooner, Sharon; Gibson, Jonathan; Sutton, Matt

    2017-01-01

    Objectives Involving general practitioners (GPs) in the commissioning/purchasing of services has been an important element in English health policy for many years. The Health and Social Care Act 2012 handed responsibility for commissioning of the majority of care for local populations to GP-led Clinical Commissioning Groups (CCGs). In this paper, we explore GP attitudes to involvement in commissioning and future intentions for engagement. Design and setting Survey of a random sample of GPs across England in 2015. Method The Eighth National GP Worklife Survey was distributed to GPs in spring 2015. Responses were received from 2611 respondents (response rate = 46%). We compared responses across different GP characteristics and conducted two sample tests of proportions to identify statistically significant differences in responses across groups. We also used multivariate logistic regression to identify the characteristics associated with wanting a formal CCG role in the future. Results While GPs generally agree that they can add value to aspects of commissioning, only a minority feel that this is an important part of their role. Many current leaders intend to quit in the next 5 years, and there is limited appetite among those not currently in a formal role to take up such a role in the future. CCGs were set up as ‘membership organisations’ but only a minority of respondents reported feeling that they had ‘ownership’ of their local CCG and these were often GPs with formal CCG roles. However, respondents generally agree that the CCG has a legitimate role in influencing the work that they do. Conclusion CCGs need to engage in active succession planning to find the next generation of GP leaders. GPs believe that CCGs have a legitimate role in influencing their work, suggesting that there may be scope for CCGs to involve GPs more fully in roles short of formal leadership. PMID:28596217

  6. Porphyromonas endodontalis in chronic periodontitis: a clinical and microbiological cross-sectional study.

    Science.gov (United States)

    Lombardo Bedran, Telma Blanca; Marcantonio, Rosemary Adriana C; Spin Neto, Rubens; Alves Mayer, Marcia Pinto; Grenier, Daniel; Spolidorio, Luis Carlos; Spolidorio, Denise Palomari

    2012-01-01

    Although previous studies have shown the presence of Porphyromonas endodontalis in chronic periodontitis associated with periapical lesions, the occurrence of this pathogen in diseased periodontal sites without periapical lesions has been poorly investigated. The aims of this study were to quantify P. endodontalis in patients with chronic periodontitis without periapical lesions, to evaluate the potential correlation of P. endodontalis with Porphyromonas gingivalis and Tannerella forsythia, and to evaluate the ability of periodontal treatment to reduce these pathogens. Patients with generalized chronic periodontitis were selected by recording clinical attachment level (CAL), probing depth (PD), and bleeding on probing (BOP). Subgingival samples from 30 diseased nonadjacent sites (CAL≥5 mm, PD between 5 and 7 mm and positive BOP) and 30 healthy nonadjacent sites (PD≤3 mm and negative BOP) were collected and subjected to microbial analysis by quantitative polymerase chain reaction (qPCR) The variables of age, PD, CAL and BOP of all individuals were analyzed using the paired t-test (GrapPad Prism5(®)). Data of bacteria quantification were subjected to a normality test (D'Agostino-Pearson Test). For bacterial correlation analysis, the Spearman correlation was used. Our results showed that diseased sites had significantly higher levels of P. endodontalis compared to healthy sites, similar to the results obtained for P. gingivalis and T. forsythia. The numbers of all bacterial species were reduced significantly after mechanical periodontal treatment. P. endodontalis was significantly correlated with the presence of T. forsythia and P. gingivalis in the diseased group. Our results suggest that there is a high prevalence of P. endodontalis, P. gingivalis and T. forsythia in periodontitis sites and that mechanical periodontal treatment is effective at reducing the pathogens studied.

  7. Porphyromonas endodontalis in chronic periodontitis: a clinical and microbiological cross-sectional study

    Science.gov (United States)

    Lombardo Bedran, Telma Blanca; Marcantonio, Rosemary Adriana C.; Spin Neto, Rubens; Alves Mayer, Marcia Pinto; Grenier, Daniel; Spolidorio, Luis Carlos; Spolidorio, Denise Palomari

    2012-01-01

    Background Although previous studies have shown the presence of Porphyromonas endodontalis in chronic periodontitis associated with periapical lesions, the occurrence of this pathogen in diseased periodontal sites without periapical lesions has been poorly investigated. Objective The aims of this study were to quantify P. endodontalis in patients with chronic periodontitis without periapical lesions, to evaluate the potential correlation of P. endodontalis with Porphyromonas gingivalis and Tannerella forsythia, and to evaluate the ability of periodontal treatment to reduce these pathogens. Design Patients with generalized chronic periodontitis were selected by recording clinical attachment level (CAL), probing depth (PD), and bleeding on probing (BOP). Subgingival samples from 30 diseased nonadjacent sites (CAL≥5 mm, PD between 5 and 7 mm and positive BOP) and 30 healthy nonadjacent sites (PD≤3 mm and negative BOP) were collected and subjected to microbial analysis by quantitative polymerase chain reaction (qPCR) The variables of age, PD, CAL and BOP of all individuals were analyzed using the paired t-test (GrapPad Prism5®). Data of bacteria quantification were subjected to a normality test (D'Agostino-Pearson Test). For bacterial correlation analysis, the Spearman correlation was used. Results Our results showed that diseased sites had significantly higher levels of P. endodontalis compared to healthy sites, similar to the results obtained for P. gingivalis and T. forsythia. The numbers of all bacterial species were reduced significantly after mechanical periodontal treatment. P. endodontalis was significantly correlated with the presence of T. forsythia and P. gingivalis in the diseased group. Conclusion Our results suggest that there is a high prevalence of P. endodontalis, P. gingivalis and T. forsythia in periodontitis sites and that mechanical periodontal treatment is effective at reducing the pathogens studied. PMID:22232719

  8. Porphyromonas endodontalis in chronic periodontitis: a clinical and microbiological cross-sectional study

    Directory of Open Access Journals (Sweden)

    Telma Blanca Lombardo Bedran

    2012-01-01

    Full Text Available Although previous studies have shown the presence of Porphyromonas endodontalis in chronic periodontitis associated with periapical lesions, the occurrence of this pathogen in diseased periodontal sites without periapical lesions has been poorly investigated.The aims of this study were to quantify P. endodontalis in patients with chronic periodontitis without periapical lesions, to evaluate the potential correlation of P. endodontalis with Porphyromonas gingivalis and Tannerella forsythia, and to evaluate the ability of periodontal treatment to reduce these pathogens.Patients with generalized chronic periodontitis were selected by recording clinical attachment level (CAL, probing depth (PD, and bleeding on probing (BOP. Subgingival samples from 30 diseased nonadjacent sites (CAL ≥ 5 mm, PD between 5 and 7 mm and positive BOP and 30 healthy nonadjacent sites (PD ≤ 3 mm and negative BOP were collected and subjected to microbial analysis by quantitative polymerase chain reaction (qPCR The variables of age, PD, CAL and BOP of all individuals were analyzed using the paired t-test (GrapPad Prism5®. Data of bacteria quantification were subjected to a normality test (D'Agostino-Pearson Test. For bacterial correlation analysis, the Spearman correlation was used.Our results showed that diseased sites had significantly higher levels of P. endodontalis compared to healthy sites, similar to the results obtained for P. gingivalis and T. forsythia. The numbers of all bacterial species were reduced significantly after mechanical periodontal treatment. P. endodontalis was significantly correlated with the presence of T. forsythia and P. gingivalis in the diseased group.Our results suggest that there is a high prevalence of P. endodontalis, P. gingivalis and T. forsythia in periodontitis sites and that mechanical periodontal treatment is effective at reducing the pathogens studied.

  9. Methodologies for Quantitative Systems Pharmacology (QSP) Models: Design and Estimation.

    Science.gov (United States)

    Ribba, B; Grimm, H P; Agoram, B; Davies, M R; Gadkar, K; Niederer, S; van Riel, N; Timmis, J; van der Graaf, P H

    2017-08-01

    With the increased interest in the application of quantitative systems pharmacology (QSP) models within medicine research and development, there is an increasing need to formalize model development and verification aspects. In February 2016, a workshop was held at Roche Pharma Research and Early Development to focus discussions on two critical methodological aspects of QSP model development: optimal structural granularity and parameter estimation. We here report in a perspective article a summary of presentations and discussions. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  10. Non-pharmacological approaches to alleviate distress in dementia care.

    Science.gov (United States)

    Mitchell, Gary; Agnelli, Joanne

    2015-11-25

    Distress is one of the most common clinical manifestations associated with dementia. Pharmacological intervention may be appropriate in managing distress in some people. However, best practice guidelines advocate non-pharmacological interventions as the preferred first-line treatment. The use of non-pharmacological interventions encourages healthcare professionals to be more person-centred in their approach, while considering the causes of distress. This article provides healthcare professionals with an overview of some of the non-pharmacological approaches that can assist in alleviating distress for people living with dementia including: reminiscence therapy, reality orientation, validation therapy, music therapy, horticultural therapy, doll therapy and pet therapy. It provides a summary of their use in clinical practice and links to the relevant literature.

  11. [Pharmacological treatment of obesity].

    Science.gov (United States)

    Gomis Barbará, R

    2004-01-01

    The pharmacological treatment of obesity should be considered when cannot be achieved a 10% weight loss with diet therapy and physical activity. The drugs effective in obesity treatment may act by different mechanisms such as reduction in food intake, inhibition of fat absorption, increase of thermogenesis and stimulation of adipocyte apoptosis. At present, we only have two marketed drugs for obesity treatment. Sibutramine is an inhibitor of norepinephrine, dopamine and serotonina reuptake which inhibits food intake and increases thermogenesis. Sibutramine administration for a year can induce a weight loss of 4-7%. Its main side effects are hypertension, headache, insomnia and constipation. Orlistat is an inhibitor of pancreatic lipase which is able to block the absorption of 30% of ingested fat. Its administration induces weight loss and reduction of ulterior weight regain. Also, this drug improves hypertension dyslipdaemia and helps to prevent diabetes in 52% of cases when administered over four years. The increase in frequency of stools and interference with vitamin absorption are its main side effects. Glucagon-like peptide 1, which increases insulin sensitivity and satiety, adiponectin and PPAR-gamma agonists which reduce insulin resistance and modulates adipocyte generation are the basis for future therapeutic approaches of obesity. Phosphatase inhibitors induce PPAR-gamma phosphorylation and UCP-1 expression leading to an increase in thermogenesis and reduction in appetite.

  12. Pharmacology of midazolam.

    Science.gov (United States)

    Pieri, L; Schaffner, R; Scherschlicht, R; Polc, P; Sepinwall, J; Davidson, A; Möhler, H; Cumin, R; Da Prada, M; Burkard, W P; Keller, H H; Müller, R K; Gerold, M; Pieri, M; Cook, L; Haefely, W

    1981-01-01

    8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine (midazolam, Ro 21-3981, Dormicum) is an imidazobenzodiazepine whose salts are soluble and stable in aqueous solution. It has a quick onset and, due to rapid metabolic inactivation, a rather short duration of action in all species studied. Midazolam has a similar pharmacologic potency and broad therapeutic range as diazepam. It produces all the characteristic effects of the benzodiazepine class, i.e., anticonvulsant, anxiolytic, sleep-inducing, muscle relaxant, and "sedative" effects. The magnitude of the anticonflict effect of midazolam is smaller than that of diazepam in rats and squirrel monkeys, probably because a more pronounced sedative component interferes with the increase of punished responses. In rodents, surgical anaesthesia is not attained with midazolam alone even in high i.v. doses, whereas this state is obtained in monkeys. The drug potentiates the effect of various central depressant agents. Midazolam is virtually free of effects on the cardiovascular system in conscious animals and produces only slight decreases in cardiac performance in dogs anaesthetized with barbiturates. No direct effects of the drugs on autonomic functions were found, however, stress-induced autonomic disturbances are prevented, probably by an effect on central regulatory systems. All animal data suggest the usefulness of midazolam as a sleep-inducer and i.v. anaesthetic of rapid onset and short duration.

  13. Pharmacology of pediatric resuscitation.

    Science.gov (United States)

    Ushay, H M; Notterman, D A

    1997-02-01

    The resuscitation of children from cardiac arrest and shock remains a challenging goal. The pharmacologic principles underlying current recommendations for intervention in pediatric cardiac arrest have been reviewed. Current research efforts, points of controversy, and accepted practices that may not be most efficacious have been described. Epinephrine remains the most effective resuscitation adjunct. High-dose epinephrine is tolerated better in children than in adults, but its efficacy has not received full analysis. The preponderance of data continues to point toward the ineffectiveness and possible deleterious effects of overzealous sodium bicarbonate use. Calcium chloride is useful in the treatment of ionized hypocalcemia but may harm cells that have experienced asphyxial damage. Atropine is an effective agent for alleviating bradycardia induced by increased vagal tone, but because most bradycardia in children is caused by hypoxia, improved oxygenation is the intervention of choice. Adenosine is an effective and generally well-tolerated agent for the treatment of supraventricular tachycardia. Lidocaine is the drug of choice for ventricular dysrhythmias, and bretylium, still relatively unexplored, is in reserve. Many pediatricians use dopamine for shock in the postresuscitative period, but epinephrine is superior. Most animal research on cardiac arrest is based on models with ventricular fibrillation that probably are not reflective of cardiac arrest situations most often seen in pediatrics.

  14. Measurement of DSM-5 section II personality disorder constructs using the MMPI-2-RF in clinical and forensic samples.

    Science.gov (United States)

    Anderson, Jaime L; Sellbom, Martin; Pymont, Carly; Smid, Wineke; De Saeger, Hilde; Kamphuis, Jan H

    2015-09-01

    In the current study, we evaluated the associations between the Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-RF; Ben-Porath & Tellegen, 2008) scale scores and the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; American Psychiatric Association, 2013) Section II personality disorder (PD) criterion counts in inpatient and forensic psychiatric samples from The Netherlands using structured clinical interviews to operationalize PDs. The inpatient psychiatric sample included 190 male and female patients and the forensic sample included 162 male psychiatric patients. We conducted correlation and count regression analyses to evaluate the utility of relevant MMPI-2-RF scales in predicting PD criterion count scores. Generally, results from these analyses emerged as conceptually expected and provided evidence that MMPI-2-RF scales can be useful in assessing PDs. At the zero-order level, most hypothesized associations between Section II disorders and MMPI-2-RF scales were supported. Similarly, in the regression analyses, a unique set of predictors emerged for each PD that was generally in line with conceptual expectations. Additionally, the results provided general evidence that PDs can be captured by dimensional psychopathology constructs, which has implications for both DSM-5 Section III specifically and the personality psychopathology literature more broadly. (c) 2015 APA, all rights reserved.

  15. The Effect of Honey Gel on Abdominal Wound Healing in Cesarean Section: A Triple Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Maryam Nikpour

    2014-07-01

    Full Text Available Objective: To assess whether honey can accelerate the wound healing in women undergoing cesarean section. Methods: This was a triple blinded randomized prospective clinical trial. Women with cesarean section were randomly designated as drug (37 cases and placebo (38 cases groups. The drug group received local honey gel 25% while the placebo group received similar free-honey gel on abdominal cesarean incision twice a day for 14 days. REEDA scale (Redness, Edema, Ecchymosis, Discharge and Approximation of wound edges was used to assess wound healing. Results: The mean REEDA was 2.27 ± 2.46 and 3.91 ± 2.74 (p=0.008 on the 7th day and 0.47 ± 0.84 and 1.59± 1.95 (p=0.002 on the 14th day for the drug and placebo groups, respectively. Redness, edema and hematoma in the drug group were significantly lower on the 7th and 14th days. Conclusion: Honey was effective in healing the cesarean section incision. Using topical honey is suggested as a natural product with rare side effects in order to reduce the complications of cesarean wounds.

  16. Future pharmacological therapy in hypertension.

    Science.gov (United States)

    Stewart, Merrill H; Lavie, Carl J; Ventura, Hector O

    2018-04-26

    Hypertension (HTN) is a widespread and growing disease, with medication intolerance and side-effect present among many. To address these obstacles novel pharmacotherapy is an active area of drug development. This review seeks to explore future drug therapy for HTN in the preclinical and clinical arenas. The future of pharmacological therapy in HTN consists of revisiting old pathways to find new targets and exploring wholly new approaches to provide additional avenues of treatment. In this review, we discuss the current status of the most recent drug therapy in HTN. New developments in well trod areas include novel mineralocorticoid antagonists, aldosterone synthase inhibitors, aminopeptidase-A inhibitors, natriuretic peptide receptor agonists, or the counter-regulatory angiotensin converting enzyme 2/angiotensin (Ang) (1-7)/Mas receptor axis. Neprilysin inhibitors popularized for heart failure may also still hold HTN potential. Finally, we examine unique systems in development never before used in HTN such as Na/H exchange inhibitors, vasoactive intestinal peptide agonists, and dopamine beta hydroxylase inhibitors. A concise review of future directions of HTN pharmacotherapy.

  17. [History and pharmacology of trazodone].

    Science.gov (United States)

    Agnoli, A

    1986-10-01

    Trazodone, a non-tricyclic molecule, represents the first of a new generation of antidepressants. It is currently marketed in a number of European countries, in the United States and in Latin America. The pharmacological and biochemical data, the mechanism of action and the preferential indications of trazodone are presented and compared to those of imipramine and other tricyclics. Unlike imipramine, trazodone inhibits the adrenergic system. The two molecules have anti-nociceptive properties, similar effects on the serotoninergic system and, after repeated administrations, they both reduce the density of beta-receptors. The clinical implications of the alpha-blocking activity of trazodone are reported. Trazodone is preferable to tricyclic anti-depressants in the treatment of depression in elderly subjects in general, and especially when they present closed angle glaucoma, prostatic hypertrophy, tremor or cardiovascular problems due to hyperactivity of the adrenergic system, as well as in organic depressions and in depression secondary to schizophrenia, alcoholism and in patients with Parkinson's disease.

  18. Pharmacological challenges in chronic pancreatitis.

    Science.gov (United States)

    Olesen, Anne Estrup; Brokjaer, Anne; Fisher, Iben Wendelboe; Larsen, Isabelle Myriam

    2013-11-14

    Drug absorption in patients with chronic pancreatitis might be affected by the pathophysiology of the disease. The exocrine pancreatic insufficiency is associated with changes in gastrointestinal intraluminal pH, motility disorder, bacterial overgrowth and changed pancreatic gland secretion. Together these factors can result in malabsorption and may also affect the efficacy of pharmacological intervention. The lifestyle of chronic pancreatitis patients may also contribute to gastrointestinal changes. Many patients limit their food intake because of the pain caused by eating and in some cases food intake is more or less substituted with alcohol, tobacco and coffee. Alcohol and drug interaction are known to influence the pharmacokinetics by altering either drug absorption or by affecting liver metabolism. Since patients suffering from chronic pancreatitis experience severe pain, opioids are often prescribed as pain treatment. Opioids have intrinsic effects on gastrointestinal motility and hence can modify the absorption of other drugs taken at the same time. Furthermore, the increased fluid absorption caused by opioids will decrease water available for drug dissolution and may hereby affect absorption of the drug. As stated above many factors can influence drug absorption and metabolism in patients with chronic pancreatitis. The factors may not have clinical relevance, but may explain inter-individual variations in responses to a given drug, in patients with chronic pancreatitis.

  19. Pharmacologic management of chronic neuropathic pain

    Science.gov (United States)

    Mu, Alex; Weinberg, Erica; Moulin, Dwight E.; Clarke, Hance

    2017-01-01

    Abstract Objective To provide family physicians with a practical clinical summary of the Canadian Pain Society (CPS) revised consensus statement on the pharmacologic management of neuropathic pain. Quality of evidence A multidisciplinary interest group within the CPS conducted a systematic review of the literature on the current treatments of neuropathic pain in drafting the revised consensus statement. Main message Gabapentinoids, tricyclic antidepressants, and serotonin-norepinephrine reuptake inhibitors are the first-line agents for treating neuropathic pain. Tramadol and other opioids are recommended as second-line agents, while cannabinoids are newly recommended as third-line agents. Other anticonvulsants, methadone, tapentadol, topical lidocaine, and botulinum toxin are recommended as fourth-line agents. Conclusion Many pharmacologic analgesics exist for the treatment of neuropathic pain. Through evidence-based recommendations, the CPS revised consensus statement helps guide family physicians in the management of patients with neuropathic pain. PMID:29138154

  20. The presence of comorbidity in Tourette syndrome increases the need for pharmacological treatment

    DEFF Research Database (Denmark)

    Debes, Nanette M M M; Hjalgrim, Helle; Skov, Liselotte

    2009-01-01

    to a better insight into the common practice in Scandinavia. Furthermore, we wanted to elaborate the influence of the presence of comorbidities and of the severity of tics on pharmacological treatment. We have examined the frequency, art, and reason for pharmacological treatment in a Danish clinical cohort...... of 314 children with Tourette syndrome. In total, 60.5% of the children once had received pharmacological treatment. Mostly, the treatment was started because of tics or ADHD. If ADHD or obsessive-compulsive disorder were present, more children received pharmacological treatment and more different agents...... were tried. The children who received pharmacological treatment had more severe tics than those without medication....

  1. Enhancing predictive accuracy and reproducibility in clinical evaluation research: Commentary on the special section of the Journal of Evaluation in Clinical Practice.

    Science.gov (United States)

    Bryant, Fred B

    2016-12-01

    This paper introduces a special section of the current issue of the Journal of Evaluation in Clinical Practice that includes a set of 6 empirical articles showcasing a versatile, new machine-learning statistical method, known as optimal data (or discriminant) analysis (ODA), specifically designed to produce statistical models that maximize predictive accuracy. As this set of papers clearly illustrates, ODA offers numerous important advantages over traditional statistical methods-advantages that enhance the validity and reproducibility of statistical conclusions in empirical research. This issue of the journal also includes a review of a recently published book that provides a comprehensive introduction to the logic, theory, and application of ODA in empirical research. It is argued that researchers have much to gain by using ODA to analyze their data. © 2016 John Wiley & Sons, Ltd.

  2. Internet health seeking behaviour of parents attending a general paediatric outpatient clinic: A cross-sectional observational study.

    Science.gov (United States)

    Sebelefsky, Christian; Karner, Denise; Voitl, Jasmin; Klein, Frederic; Voitl, Peter; Böck, Andreas

    2015-10-01

    Our aim was to examine the internet health seeking behaviour of parents attending a general paediatric outpatient clinic. For this purpose, the proportion of parents going online to obtain child health information, the most commonly used online resources, and factors having an influence on internet usage were identified. This cross-sectional observational study was conducted at a general paediatric outpatient clinic in Vienna, Austria. Data collection was done by means of an anonymous questionnaire containing 14 items. A total number of 500 questionnaires were collected. Among parents visiting the outpatient clinic, 94.4% use the internet to obtain child health information in general and 21% to be informed about the reason for consultation. Most commonly used online resources are Google (91.4%), websites run by doctors (84.8%), Wikipedia (84.7%), health portals (76.4%), the outpatient clinic's homepage (76.4%), as well as health forums and communities (61.9%). Younger parents (p = 0.022) and parents of younger children (p parents with different completed educational levels (mothers: p = 0.078; fathers: p = 0.388) do not differ in this behaviour. Important reasons for high internet use might be the inexperience of young parents regarding child health as well as the frequent infections, vaccinations, and preventive check-ups which are associated with young age of children. In contrast to former findings relating to health seekers in general, internet usage of parents is independent of their sex and educational level. © The Author(s) 2015.

  3. The prevalence and correlations of medical student burnout in the pre-clinical years: a cross-sectional study.

    Science.gov (United States)

    Mazurkiewicz, Rebecca; Korenstein, Deborah; Fallar, Robert; Ripp, Jonathan

    2012-01-01

    Burnout is a psychological syndrome of emotional exhaustion, depersonalization, and impaired personal accomplishment induced by repeated workplace stressors. Current research suggests that physician burnout may have its origins in medical school. The consequences of medical student burnout include both personal and professional distress, loss of empathy, and poor health. We hypothesized that burnout occurs prior to the initiation of the clinical years of medical education. This was a cross-sectional survey administered to third-year medical students at the Mount Sinai School of Medicine (MSSM) in New York, New York (a traditional-style medical school with a marked division between pre-clinical and clinical training occurring at the beginning of the third year). Survey included an instrument used to measure job burnout, a sleep deprivation screen, and questions related to demographic information, current rotation, psychiatric history, time spent working/studying, participation in extracurricular activities, social support network, autonomy and isolation. Of the 86 medical students who participated, 71% met criteria for burnout. Burnt out students were significantly more likely to suffer from sleep deprivation (p = 0.0359). They were also more likely to disagree with the following statements: "I have control over my daily schedule" (p = 0.0286) and "I am confident that I will have the knowledge and skills necessary to become an intern when I graduate" (p = 0.0263). Our findings show that burnout is present at the beginning of the third year of medical school, prior to the initiation of the clinical years of medical training. Medical student burnout is quite common, and early efforts should be made to empower medical students to both build the knowledge and skills necessary to become capable physicians, as well as withstand the emotional, mental, and physical challenges inherent to medical school.

  4. Fuzzy pharmacology: theory and applications.

    Science.gov (United States)

    Sproule, Beth A; Naranjo, Claudio A; Türksen, I Burhan

    2002-09-01

    Fuzzy pharmacology is a term coined to represent the application of fuzzy logic and fuzzy set theory to pharmacological problems. Fuzzy logic is the science of reasoning, thinking and inference that recognizes and uses the real world phenomenon that everything is a matter of degree. It is an extension of binary logic that is able to deal with complex systems because it does not require crisp definitions and distinctions for the system components. In pharmacology, fuzzy modeling has been used for the mechanical control of drug delivery in surgical settings, and work has begun evaluating its use in other pharmacokinetic and pharmacodynamic applications. Fuzzy pharmacology is an emerging field that, based on these initial explorations, warrants further investigation.

  5. Pharmacological imaging as a tool to visualise dopaminergic neurotoxicity.

    Science.gov (United States)

    Schrantee, A; Reneman, L

    2014-09-01

    Dopamine abnormalities underlie a wide variety of psychopathologies, including ADHD and schizophrenia. A new imaging technique, pharmacological magnetic resonance imaging (phMRI), is a promising non-invasive technique to visualize the dopaminergic system in the brain. In this review we explore the clinical potential of phMRI in detecting dopamine dysfunction or neurotoxicity, assess its strengths and weaknesses and identify directions for future research. Preclinically, phMRI is able to detect severe dopaminergic abnormalities quite similar to conventional techniques such as PET and SPECT. phMRI benefits from its high spatial resolution and the possibility to visualize both local and downstream effects of dopaminergic neurotransmission. In addition, it allows for repeated measurements and assessments in vulnerable populations. The major challenge is the complex interpretation of phMRI results. Future studies in patients with dopaminergic abnormalities need to confirm the currently reviewed preclinical findings to validate the technique in a clinical setting. Eventually, based on the current review we expect that phMRI can be of use in a clinical setting involving vulnerable populations (such as children and adolescents) for diagnosis and monitoring treatment efficacy. This article is part of the Special Issue Section entitled 'Neuroimaging in Neuropharmacology'. Copyright © 2013 Elsevier Ltd. All rights reserved.

  6. Pharmacological Overview of Galactogogues

    Directory of Open Access Journals (Sweden)

    Felipe Penagos Tabares

    2014-01-01

    Full Text Available Galactogogues are substances used to induce, maintain, and increase milk production, both in human clinical conditions (like noninfectious agalactias and hypogalactias and in massification of production in the animal dairy industry. This paper aims to report the state of the art on the possible mechanisms of action, effectiveness, and side effects of galactogogues, including potential uses in veterinary and human medicine. The knowledge gaps in veterinary clinical practice use of galactogogues, especially in the standardization of the lactogenic dose in some pure drugs and herbal preparations, are reviewed.

  7. Comparing Different Epinephrine Concentrations for Spinal Anesthesia in Cesarean Section: A Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Arash Hamzei

    2015-07-01

    Full Text Available Background: Although various anesthetic techniques can be used in different kinds of surgeries, spinal anesthesia has received considerable attention for the lower abdomen and lower extremities surgeries and cesarean section. This study aimed at comparing the effect of adding epinephrine 1:1000 and 1:10000 to lidocaine and fentanyl in spinal anesthesia on the prolongation of paralysis, analgesia and hemodynamic changes in pregnant women candidate for cesarean section. Methods: A double blind randomized clinical trial was carried out on 66 pregnant women (equally sized control and treatment groups of 33 in 2011. After randomizing the participants into two groups of recipients of epinephrine 1:1000 plus lidocaine 5% and fentanyl (control group and recipients of epinephrine 1:10000 with lidocaine 5% and fentanyl, (treatment group, the participants’ systolic and diastolic blood pressure and heart rate were recorded before and 1, 3, 5, 10, 15 minutes after procedure. Besides the prolongation of paralysis and analgesia, the presence of postoperative nausea and vomiting were evaluated. The outcome of the study was analyzed using SPSS software and via t test, χ2 test and RMANOVA. Results: The mean age (standard deviation of the participants was 29.3 (4.4 and 28.2 (4.5 in the treatment and control groups, respectively. There were no statistical significance between the participants’ prolongation of paralysis, analgesia, the frequency of nausea and vomiting, and the average values of hemodynamic variables between the two groups. Conclusion: The use of epinephrine 1:10000 along with lidocaine and fentanyl is recommended in spinal anesthesia in pregnant women candidate for cesarean section. Trial Registration Number: IRCT201012225445N1.

  8. Socio-demographic and clinical features of Irish iatrogenic hepatitis C patients: a cross-sectional survey.

    LENUS (Irish Health Repository)

    McKenna, Olivia

    2009-01-01

    BACKGROUND: A discrete sub-group of iatrogenically-acquired hepatitis C virus (HCV)-infected individuals exists in the Irish population on whom limited current research data is available. The aim of this study was to establish a current profile of the socio-demographic and clinical characteristics of the Irish iatrogenic hepatitis C population and to determine factors predicting symptoms experienced. METHODS: An anonymous, national, cross-sectional survey was conducted to explore this populations\\' self-reported health and social attributes. Data were collected on 290 respondents. RESULTS: Mean time since infection was 26 years. Eighty-four percent (n = 237) of respondents were female (mean age = 55.9 +\\/- 9.6 years). Hepatic and extra-hepatic symptoms were common (62% and 99% respectively). Fatigue and pain were frequent complaints while 89% reported diagnosed co-morbid disease. On logistic regression, female gender, age and co-morbid disease emerged as independent predictors of self-reported symptoms. CONCLUSION: This study describes the current status of the iatrogenically infected patient cohort in Ireland, adding to existing knowledge regarding the clinical course and consequences of HCV infection. Changing healthcare needs were shown by comparison with earlier surveys in this same population, in terms of disease progression, development of co-morbid disease and ageing.

  9. MMPI-2 Profile of French Transsexuals: The Role of Sociodemographic and Clinical Factors. A cross-sectional design.

    Science.gov (United States)

    Bonierbale, Mireille; Baumstarck, Karine; Maquigneau, Aurélie; Gorin-Lazard, Audrey; Boyer, Laurent; Loundou, Anderson; Auquier, Pascal; Lançon, Christophe

    2016-04-12

    The assessment of co-existing psychological and psychiatric disorders is advocated in the Standards of Care for the health of transsexual people. This study aimed to determine the psychopathological characteristics of transsexuals based on a large sample of French individuals and to identify whether these characteristics differed according to the individual's sociodemographic or clinical characteristics. The aim of this study was to determine the psychopathological characteristics of transsexuals from a large sample of French individuals and whether these differed by sociodemographic or clinical characteristics. This cross-sectional study was conducted in a French public university hospital. The inclusion criteria were 18 years or older, diagnosis of gender dysphoria, and eligibility for a standardized sex reassignment procedure. Personality characteristics were assessed using the Minnesota Multiphasic Personality Inventory 2 (MMPI-2). A total of 108 individuals provided a valid MMPI-2 between January 2007 and December 2010. The final sample had a median age of 31 years and included 54 (50%) Female-to-Male individuals. In multivariate models, hormonal therapy status was significantly related to the scales of MMPI-2 (Psychasthenia and Masculinity/Femininity). Personality assessment can help a multidisciplinary gender dysphoria team detect potential psychopathological factors of vulnerability.

  10. ENLIST 1: An International Multi-centre Cross-sectional Study of the Clinical Features of Erythema Nodosum Leprosum.

    Directory of Open Access Journals (Sweden)

    Stephen L Walker

    Full Text Available Erythema nodosum leprosum (ENL is a severe multisystem immune mediated complication of borderline lepromatous leprosy and lepromatous leprosy. ENL is associated with skin lesions, neuritis, arthritis, dactylitis, eye inflammation, osteitis, orchitis, lymphadenitis and nephritis. The treatment of ENL requires immunosuppression, which is often required for prolonged periods of time and may lead to serious adverse effects. ENL and its treatment is associated with increased mortality and economic hardship. Improved, evidence-based treatments for ENL are needed; however, defining the severity of ENL and outcome measures for treatment studies is difficult because of the multiple organ systems involved. A cross-sectional study was performed, by the members of the Erythema Nodosum Leprosum International STudy (ENLIST Group, of patients with ENL attending seven leprosy referral centres in Brazil, Ethiopia, India, Nepal, the Philippines and the United Kingdom. We systematically documented the clinical features and type of ENL, its severity and the drugs used to treat it. Patients with chronic ENL were more likely to be assessed as having severe ENL. Pain, the most frequent symptom, assessed using a semi-quantitative scale was significantly worse in individuals with "severe" ENL. Our findings will determine the items to be included in a severity scale of ENL which we are developing and validating. The study also provides data on the clinical features of ENL, which can be incorporated into a definition of ENL and used for outcome measures in treatment studies.

  11. Clinical patterns of vitiligo and its associated co morbidities: A prospective controlled cross-sectional study in South India

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    D S Krupa Shankar

    2012-01-01

    Full Text Available Aim: The purpose of this study is to assess the clinical patterns and associations of vitiligo, audiometric functions, and ocular involvement and to correlate the morphology, clinical behaviour and comorbidities associated with vitiligo. Settings and Design: For this prospective and cross-sectional study 80 self-reporting patients in the age group 7-75 years with vitiligo attending the outpatient department of Manipal hospital during the period August 2008 to February 2010 were selected and the data was analysed. Materials and Methods: The patients were subjected to detailed history, clinical examination and investigations [complete blood count (CBC, absolute eosinophil count (AEC, erythrocyte sedimentation rate (ESR, thyroid stimulating hormone (TSH, vitamin B12 estimation, fasting blood sugar (FBS, and post prandial blood sugar (PPBS,antibody titre estimations that is antithyroid peroxidase (ATPA, antithyroglobulin (ATA, antinuclear antibodies (ANA,urine analysis], audiometric evaluation and ophthalmic examination. Statistical Analysis Used: The Fisher exact test has been used to find the significance of study parameters on categorical scale between two or more groups. Results: In the present series of 80 cases, 41 (51.25% were males and 39 (48.75% were females. The male to female ratio was 1.05:1. In our study 20% cases gave definite family history of vitiligo and patients in the age group of 20 - 30 years were the most commonly affected. Generalized vitiligo (31.3% was the most common type followed by segmental (30%, focal (18.8%, acrofacial (8.8%, and mucosal vitiligo (11.3%. In the present study there was a high incidence of autoantibodies (22.5%, vitamin B12 deficiency (30%, hypothyroidism (11.3%, elevated absolute eosinophil count (16.3%, hypoacusis (10% and retinal changes (8.8%. This suggests multisystem autoimmunity in vitiligo.

  12. Requirements of Clinical Journals for Authors’ Disclosure of Financial and Non-Financial Conflicts of Interest: A Cross Sectional Study

    Science.gov (United States)

    Shawwa, Khaled; Kallas, Romy; Koujanian, Serge; Agarwal, Arnav; Neumann, Ignacio; Alexander, Paul; Tikkinen, Kari A. O.; Guyatt, Gordon; Akl, Elie A.

    2016-01-01

    Importance It is unclear how medical journals address authors’ financial and non-financial conflict of interest (COI). Objective To assess the policies of clinical journals for disclosure of financial and non-financial COI. Methods Cross sectional study that included both review of public documents as well as a simulation of a manuscript submission for the National Library of Medicine’s “core clinical journals”. The study did not involve human subjects. Investigators who abstracted the data, reviewed “instructions for authors” on the journal website and, in order to reflect the actual implementation of the COI disclosure policy, simulated the submission of a manuscript. Two individuals working in duplicate and independently to abstract information using a standardized data abstraction form, resolved disagreements by discussion or with the help of a third person. Results All but one of 117 core clinical journals had a COI policy. All journals required disclosure of financial COI pertaining to the authors and a minority (35%) asked for financial COI disclosure pertaining to the family members or authors' institution (29%). Over half required the disclosure of at least one form of non-financial COI (57%), out of which only two (3%) specifically referred to intellectual COI. Small minorities of journals (17% and 24% respectively) described a potential impact of disclosed COI and of non-disclosure of COI on the editorial process. Conclusion While financial COI disclosure was well defined by the majority of the journals, many did not have clear policies on disclosure of non-financial COI, disclosure of financial COI of family members and institutions of the authors, and effect of disclosed COI or non-disclosure of COI on editorial policies. PMID:27030966

  13. Requirements of Clinical Journals for Authors' Disclosure of Financial and Non-Financial Conflicts of Interest: A Cross Sectional Study.

    Science.gov (United States)

    Shawwa, Khaled; Kallas, Romy; Koujanian, Serge; Agarwal, Arnav; Neumann, Ignacio; Alexander, Paul; Tikkinen, Kari A O; Guyatt, Gordon; Akl, Elie A

    2016-01-01

    It is unclear how medical journals address authors' financial and non-financial conflict of interest (COI). To assess the policies of clinical journals for disclosure of financial and non-financial COI. Cross sectional study that included both review of public documents as well as a simulation of a manuscript submission for the National Library of Medicine's "core clinical journals". The study did not involve human subjects. Investigators who abstracted the data, reviewed "instructions for authors" on the journal website and, in order to reflect the actual implementation of the COI disclosure policy, simulated the submission of a manuscript. Two individuals working in duplicate and independently to abstract information using a standardized data abstraction form, resolved disagreements by discussion or with the help of a third person. All but one of 117 core clinical journals had a COI policy. All journals required disclosure of financial COI pertaining to the authors and a minority (35%) asked for financial COI disclosure pertaining to the family members or authors' institution (29%). Over half required the disclosure of at least one form of non-financial COI (57%), out of which only two (3%) specifically referred to intellectual COI. Small minorities of journals (17% and 24% respectively) described a potential impact of disclosed COI and of non-disclosure of COI on the editorial process. While financial COI disclosure was well defined by the majority of the journals, many did not have clear policies on disclosure of non-financial COI, disclosure of financial COI of family members and institutions of the authors, and effect of disclosed COI or non-disclosure of COI on editorial policies.

  14. Breaking bad news in clinical setting - health professionals' experience and perceived competence in Southwestern Nigeria: a cross sectional study.

    Science.gov (United States)

    Adebayo, Philip Babatunde; Abayomi, Olukayode; Johnson, Peter O; Oloyede, Taofeeq; Oyelekan, Abimbola A A

    2013-01-01

    Communication skills are vital in clinical settings because the manner in which bad news is delivered could be a huge determinant of responses to such news; as well as compliance with beneficial treatment option. Information on training, institutional guidelines and protocols for breaking bad news (BBN) is scarce in Nigeria. We assessed the training, experience and perceived competence of BBN among medical personnel in southwestern Nigeria. The study was a cross-sectional descriptive study conducted out among doctors and nurses in two healthcare institutions in southwestern Nigeria using an anonymous questionnaire (adapted from the survey by Horwitz et al.), which focused on the respondents training, awareness of protocols in BBN; and perceived competence (using a Five-Point Likert Scale) in five clinical scenarios. We equally asked the respondents about an instance of BBN they have recently witnessed. A total of 113 of 130 selected (response rate 86.9%) respondents were studied. Eight (7.1%) of the respondents knew of the guidelines on BBN in the hospital in which they work. Twenty-three (20.3%) respondents claimed knowledge of a protocol. The median perceived competence rating was 4 out of 5 in all the clinical scenarios. Twenty-five (22.1%) respondents have had a formal training in BBN and they generally had significant higher perceived competence rating (P = 0.003-0.021). There is poor support from fellow workers during instances of BBN. It appears that the large proportion of the respondents in this study were unconsciously incompetent in BBN in view of the low level of training and little or no knowledge of well known protocols for BBN even though self-rated competence is high. Continuous medical education in communication skills among health personnel in Nigeria is advocated.

  15. Clinical and cognitive correlates of employment among patients with schizophrenia: a cross-sectional study in Malaysia

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    Radzi Rozhan SM

    2011-05-01

    Full Text Available Abstract Background Gainful employment is one major area of functioning which is becoming an important goal in psychiatric rehabilitation of patients with schizophrenia. Studies in western countries are pointing to evidence that certain sociodemographic and clinical factors may contribute to employment outcomes in this group of people. However, the area is still largely unexplored in Malaysia. The aim of this study was to examine the sociodemographic, clinical and cognitive correlates of employment status among patients with Schizophrenia. Methods This was a cross-sectional study. All participants who fulfilled the requirements of the study according to the inclusion and exclusion criteria were enrolled. Study instruments included a demographic data questionnaire, Positive and Negative Symptom Scale (PANSS, Trail Making Tests, Rey's Auditory Verbal Learning Test (RAVLT and Digit Span. Bivariate analyses were done using chi-square for categorical data and t-test for continuous data and multiple logistic regression analysis was done to identify predictors of employment status. Results A total of 95 participants who fulfilled the inclusion criteria were enrolled into the study. Among the sociodemographic, clinical and cognitive variables studied marital status, educational level, mean scores of negative symptoms, Digit Span and RAVLT and Trail Making Tests were found to show significant association with employment status on bivariate analyses. However, when entered into a logistic regression model, only cognitive variables ie. Trail A and B, Digit Span and RAVLT were significant predictors of employment status. Conclusions The results from this study support the role of cognitive function, particularly, attention, working memory and executive functioning on attaining and maintaining employment in persons with schizophrenia as measured by the RAVLT, Digit Span and Trail Making Tests. These findings may act as preliminary evidence suggesting the

  16. Financial Relationships between Organizations That Produce Clinical Practice Guidelines and the Biomedical Industry: A Cross-Sectional Study.

    Science.gov (United States)

    Campsall, Paul; Colizza, Kate; Straus, Sharon; Stelfox, Henry T

    2016-05-01

    Financial relationships between organizations that produce clinical practice guidelines and biomedical companies are vulnerable to conflicts of interest. We sought to determine whether organizations that produce clinical practice guidelines have financial relationships with biomedical companies and whether there are associations between organizations' conflict of interest policies and recommendations and disclosures provided in guidelines. We conducted a cross-sectional survey and review of websites of 95 national/international medical organizations that produced 290 clinical practice guidelines published on the National Guideline Clearinghouse website from January 1 to December 31, 2012. Survey responses were available for 68% (65/95) of organizations (167/290 guidelines, 58%), and websites were reviewed for 100% (95/95) of organizations (290/290 guidelines, 100%). In all, 63% (60/95) of organizations producing clinical practice guidelines reported receiving funds from a biomedical company; 80% (76/95) of organizations reported having a policy for managing conflicts of interest. Disclosure statements (disclosing presence or absence of financial relationships with biomedical companies) were available in 65% (188/290) of clinical practice guidelines for direct funding sources to produce the guideline, 51% (147/290) for financial relationships of the guideline committee members, and 1% (4/290) for financial relationships of the organizations producing the guidelines. Among all guidelines, 6% (18/290) disclosed direct funding by biomedical companies, 40% (117/290) disclosed financial relationships between committee members and biomedical companies (38% of guideline committee members, 773/2,043), and 1% (4/290) disclosed financial relationships between the organizations producing the guidelines and biomedical companies. In the survey responses, 60 organizations reported the procedures that they included in their conflict of interest policies (158 guidelines

  17. Neuropathic pain in people with cancer (part 2): pharmacological and non-pharmacological management.

    Science.gov (United States)

    Taverner, Tarnia

    2015-08-01

    The aim of this paper is to provide an overview of the management of neuropathic pain associated with cancer and to provide helpful clinical advice for nurses working with patients who may have neuropathic pain. While cancer pain is a mixed-mechanism pain, this article will focus only on neuropathic pain management. The impact of neuropathic pain on patients' quality of life is great and while many patients recover from their cancer, a significant number continue to suffer from a neuropathic pain syndrome. Management of neuropathic pain is significantly different from management of nociceptive pain with respect to pharmacological and non-pharmacological strategies. Neuropathic pain is complex, and as such requires complex management using pharmacological as well as non-pharmacological approaches. Specific drugs for neuropathic pain may be effective for some patients, but not all; therefore, ongoing and comprehensive assessment and management are required. Furthermore, these patients may require trials of several drugs before they find one that works for them. It is important for nurses to understand neuropathic pain, its manifestation, impact on quality of life and management when nursing patients with neuropathic pain associated with cancer.

  18. Factors Affecting the Pharmacology of Antibody–Drug Conjugates

    Directory of Open Access Journals (Sweden)

    Andrew T. Lucas

    2018-02-01

    Full Text Available Major advances in therapeutic proteins, including antibody–drug conjugates (ADCs, have created revolutionary drug delivery systems in cancer over the past decade. While these immunoconjugate agents provide several advantages compared to their small-molecule counterparts, their clinical use is still in its infancy. The considerations in their development and clinical use are complex, and consist of multiple components and variables that can affect the pharmacologic characteristics. It is critical to understand the mechanisms employed by ADCs in navigating biological barriers and how these factors affect their biodistribution, delivery to tumors, efficacy, and toxicity. Thus, future studies are warranted to better understand the complex pharmacology and interaction between ADC carriers and biological systems, such as the mononuclear phagocyte system (MPS and tumor microenvironment. This review provides an overview of factors that affect the pharmacologic profiles of ADC therapies that are currently in clinical use and development.

  19. PHARMACOLOGY OF CANNABINOIDS

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    Ilonka Ferjan

    2015-06-01

    Full Text Available The discovery of cannabinoid receptors and endocannabinoid system has led to the potential therapeutic use of cannabis derivatives. Cannabinoids acting through the CB1 receptors modulate the release of other neurotransmitters in central nervous system, whereas the activation of peripheral CB2 receptors results in decreased inflammatory response and increased apoptosis of some tumor cells populations. The cannabinoids have been authorized for chemotherapy-induced nausea and vomiting; stimulation of appetite; to alleviate neuropathic pain and spasticity in multiple sclerosis, and to reduce pain in cancer patients. Efficacy in other diseases and clinical conditions should be proven in ongoing or future clinical trials. Isolation and identification of different cannabinoids from cannabis and synthesis of novel, more selective, derivatives widens their therapeutic potential. However, there are numerous adverse effects reported, especially when cannabinoids formulations with unknown quantitative and qualitative composition are used. Addiction, tolerance, withdrawal symptoms, increased risk of acute myocardial re-infarction, and increased risk of psychosis or worsening of psychosis are the most common adverse effects of cannabinoids. Acute adverse effects e. g. severe central nervous system depression, are more pronounced in children than in adults. Potential cannabinoid medicines should be subject to the same regulations as other potential drugs. Safety and efficacy of any potential drug candidate, regardless whether it is plant-derived or synthesized, should be proven in non-clinical studies and clinical trials, as well as the marketing authorization must be issued by the appropriate drug authority. Patients deserve a quality manufactured product, which always contains the specified amount of "Remedium cardinale."

  20. [Pharmacological aspects of pain research in Germany].

    Science.gov (United States)

    Niederberger, E; Kuner, R; Geißlinger, G

    2015-10-01

    In spite of several approved analgesics, the therapy of pain still constitutes a challenge due to the fact that the drugs do not exert sufficient efficacy or are associated with severe side effects. Therefore, the development of new and improved painkillers is still of great importance. A number of highly qualified scientists in Germany are investigating signal transduction pathways in pain, effectivity of new drugs and the so far incompletely investigated mechanisms of well-known analgesics in preclinical and clinical studies. The highlights of pharmacological pain research in Germany are summarized in this article.

  1. The pharmacological management of metabolic syndrome.

    Science.gov (United States)

    Rask Larsen, Julie; Dima, Lorena; Correll, Christoph U; Manu, Peter

    2018-04-01

    The metabolic syndrome includes a constellation of several well-established risk factors, which need to be aggressively treated in order to prevent overt type 2 diabetes and cardiovascular disease. While recent guidelines for the treatment of individual components of the metabolic syndrome focus on cardiovascular benefits as resulted from clinical trials, specific recent recommendations on the pharmacological management of metabolic syndrome are lacking. The objective of present paper was to review the therapeutic options for metabolic syndrome and its components, the available evidence related to their cardiovascular benefits, and to evaluate the extent to which they should influence the guidelines for clinical practice. Areas covered: A Medline literature search was performed to identify clinical trials and meta-analyses related to the therapy of dyslipidemia, arterial hypertension, glucose metabolism and obesity published in the past decade. Expert commentary: Our recommendation for first-line pharmacological are statins for dyslipidemia, renin-angiotensin-aldosteron system inhibitors for arterial hypertension, metformin or sodium/glucose cotransporter 2 inhibitors or glucagon-like peptide 1 receptor agonists (GLP-1RAs) for glucose intolerance, and the GLP-1RA liraglutide for achieving body weight and waist circumference reduction.

  2. Comparison of maternal and fetal outcomes among patients undergoing cesarean section under general and spinal anesthesia: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Anıl İçel Saygı

    Full Text Available CONTEXT AND OBJECTIVE: As the rates of cesarean births have increased, the type of cesarean anesthesia has gained importance. Here, we aimed to compare the effects of general and spinal anesthesia on maternal and fetal outcomes in term singleton cases undergoing elective cesarean section.DESIGN AND SETTING: Prospective randomized controlled clinical trial in a tertiary-level public hospital.METHODS: Our study was conducted on 100 patients who underwent cesarean section due to elective indications. The patients were randomly divided into general anesthesia (n = 50 and spinal anesthesia (n = 50 groups. The maternal pre and postoperative hematological results, intra and postoperative hemodynamic parameters and perinatal results were compared between the groups.RESULTS: Mean bowel sounds (P = 0.036 and gas discharge time (P = 0.049 were significantly greater and 24th hour hemoglobin difference values (P = 0.001 were higher in the general anesthesia group. The mean hematocrit and hemoglobin values at the 24th hour (P = 0.004 and P < 0.001, respectively, urine volume at the first postoperative hour (P < 0.001 and median Apgar score at the first minute (P < 0.0005 were significantly higher, and the time that elapsed until the first requirement for analgesia was significantly longer (P = 0.042, in the spinal anesthesia group.CONCLUSION: In elective cases, spinal anesthesia is superior to general anesthesia in terms of postoperative comfort. In pregnancies with a risk of fetal distress, it would be appropriate to prefer spinal anesthesia by taking the first minute Apgar score into account.

  3. A Multi-Level Analysis of World Scientific Output in Pharmacology

    OpenAIRE

    Olmeda-Gómez, Carlos; Ovalle-Perandones, María Antonia; Perianes-Rodríguez, Antonio

    2012-01-01

    The purpose of this chapter is to analyse international research in “pharmacology, toxicology and pharmaceutics” (hereafter pharmacology) on the basis of the scientific papers listed in the Scopus multidisciplinary database. This primary objective is reached by answering the following questions (in the section on results). What weight does the subject area “pharmacology, toxicology and pharmaceutics” carry in world-wide science? What is the percentage contribution made by the various regions ...

  4. Clinical efficiency in a simulated emergency and relationship to team behaviours: a multisite cross-sectional study.

    Science.gov (United States)

    Siassakos, D; Bristowe, K; Draycott, T J; Angouri, J; Hambly, H; Winter, C; Crofts, J F; Hunt, L P; Fox, R

    2011-04-01

    To identify specific aspects of teamworking associated with greater clinical efficiency in simulated obstetric emergencies. Cross-sectional secondary analysis of video recordings from the Simulation & Fire-drill Evaluation (SaFE) randomised controlled trial. Six secondary and tertiary maternity units. A total of 114 randomly selected healthcare professionals, in 19 teams of six members. Two independent assessors, a clinician and a language communication specialist identified specific teamwork behaviours using a grid derived from the safety literature. Relationship between teamwork behaviours and the time to administration of magnesium sulfate, a validated measure of clinical efficiency, was calculated. More efficient teams were likely to (1) have stated (recognised and verbally declared) the emergency (eclampsia) earlier (Kendall's rank correlation coefficient τ(b) = -0.53, 95% CI from -0.74 to -0.32, P=0.004); and (2) have managed the critical task using closed-loop communication (task clearly and loudly delegated, accepted, executed and completion acknowledged) (τ(b) = 0.46, 95% CI 0.17-0.74, P=0.022). Teams that administered magnesium sulfate within the allocated time (10 minutes) had significantly fewer exits from the labour room compared with teams who did not: a median of three (IQR 2-5) versus six exits (IQR 5-6) (P=0.03, Mann-Whitney U-test). Using administration of an essential drug as a valid surrogate of team efficiency and patient outcome after a simulated emergency, we found that more efficient teams were more likely to exhibit certain team behaviours relating to better handover and task allocation. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

  5. Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2016-01-01

    The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients' associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value. Cross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested. Latin America. To assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries' minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs. We found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries' income per capita or minimum wage. The implementation of clinical trials in Latin America results in the commercialization of medicines with questionable safety

  6. A cross-sectional exploration of the clinical characteristics of disengaged (NEET) young people in primary mental healthcare.

    Science.gov (United States)

    O'Dea, Bridianne; Glozier, Nicholas; Purcell, Rosemary; McGorry, Patrick D; Scott, Jan; Feilds, Kristy-Lee; Hermens, Daniel F; Buchanan, John; Scott, Elizabeth M; Yung, Alison R; Killacky, Eoin; Guastella, Adam J; Hickie, Ian B

    2014-12-23

    Youth with mental health problems often have difficulties engaging in education and employment. In Australia, youth mental health services have been widely established with a key aim of improving role functioning; however, there is little knowledge of those who are not engaged in employment, education or training (NEET) and the factors which may influence this. This study aimed to examine NEET status and its correlates in a sample of such youth. Cross-sectional data from a longitudinal cohort study. Between January 2011 and August 2012, young people presenting to one of the four primary mental health centres in Sydney or Melbourne were invited to participate. Young adults (N=696) aged between 15 and 25 years (M=19.0, SD=2.8), 68% female, 58% (n=404) attended headspace in Sydney. Individuals 'Not in any type of Education, Employment or Training' in the past month were categorised as NEET. Demographic, psychological and clinical factors alongside disability and functioning were assessed using clinical interview and self-report. A total of 19% (n=130/696) were NEET. NEETs were more likely to be male, older, have a history of criminal charges, risky cannabis use, higher level of depression, poorer social functioning, greater disability and economic hardship, and a more advanced stage of mental illness than those engaged in education, training or work. Demographics such as postsecondary education, immigrant background and indigenous background, were not significantly associated with NEET status in this sample. One in five young people seeking help for mental health problems were not in any form of education, employment and training. The commonly observed risk factors did not appear to influence this association, instead, behavioural factors such as criminal offending and cannabis use appeared to require targeted intervention. 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.

  7. Postgraduate nurses' self-assessment of clinical competence and need for further training. A European cross-sectional survey.

    Science.gov (United States)

    Wangensteen, Sigrid; Finnbakk, Elisabeth; Adolfsson, Annsofie; Kristjansdottir, Gudrun; Roodbol, Petrie; Ward, Helen; Fagerström, Lisbeth

    2018-03-01

    Nursing practice requires application of knowledge, skills and values in various combinations and has undergone substantial changes the last decades. An increased focus on inter-professional collaboration and possible new and more independent roles for nurses are described. A variety of programs have been developed in order to educate registered nurses (RN) to meet the changes and demands in health and nursing care throughout the world. The aims were to 1) describe nurses' self-assessment of clinical competence and need for further training, and 2) explore possible differences between nurses in specialist vs master's programs. A cross-sectional survey design was applied. 97 nurses in postgraduate programs from five countries responded (response rate 45%). A revised version of the Professional Nurse Self-Assessment Scale of clinical core competencies (PROFFNurseSASII) was used for data collection. Independent student t-test and regression analyses were carried out. The respondents rated their competence highest in taking full responsibility, cooperation with other health professionals and in acting ethically. Items where they considered themselves needing further training most were competence on medications, interaction and side effects and differential diagnoses. For all items, nurses in master's programs rated their competence higher than nurses in the specialist programs. Nurses in specialist programs rated their need for more training for all items higher than nurses in master's degree programs, and for 47 out of the 50 items these differences were statistically significant. Even though the nurses rated their competence high for important competence aspects such as taking responsibility and cooperation with other health professionals, it is worrying that their need for further training was highest for effects and interaction of various types of medications. Further studies are needed to conclude if and how master's education improves patient outcome. Copyright

  8. Non-pharmacological treatment of ankylosing spondylitis: Barriers to effective implementation of recommendations in Morocco

    Directory of Open Access Journals (Sweden)

    Abderrazak Hajjioui

    2014-01-01

    Full Text Available This cross-sectional study aimed to describe non-pharmacological treatment modalities in Moroccan patients with ankylosing spondylitis (AS, and to approach physical therapy implementation barriers. 61 patients with AS according to New York classification criteria were included in the study. Socio-demographic data and clinical characteristics were collected and different therapeutic modalities, including physical therapy were investigated. The mean age of the patients was 38.20 (SD 12.36 years with a male/female ratio of 1.5. 55 (90% patients received pharmacological therapy, 37 (60.7% received physical therapy, 5(8.2% underwent surgery and 36 (59% tried at least one type of complementary medicine (medicine plants, sand baths, acupuncture, fire needles, and cupping. Patients’ major expectations from physical therapy were improving their functional status (86.5%, and reducing their pain (59.5%. Most patients (86.49% were satisfied of their physical therapy and 56.8% practiced home exercises. Reasons for nonattendance to physical therapy for the remaining 24 patients were nonprescription (58.3%, lack of financial resources (20.8%, geographical remoteness from rehabilitation centers (4% and lack of motivation (17%. Non-pharmacological treatment, especially based on exercise and education, is an integral part of the comprehensive management of AS. However, it is not efficiently implemented in Morocco and more effort should be made to develop this both efficient and relatively inexpensive component of AS treatment.

  9. A Cross-Sectional Clinic-Based Study in Patients With Side-Locked Unilateral Headache and Facial Pain.

    Science.gov (United States)

    Prakash, Sanjay; Rathore, Chaturbhuj; Makwana, Prayag; Dave, Ankit

    2016-07-01

    To undertake the epidemiological evaluation of the patients presenting with side-locked headache and facial pain in a tertiary neurology outpatient clinic. Side-locked unilateral headache and facial pain include a large number of primary and secondary headaches and cranial neuropathies. A diagnostic approach for the patients presenting with strictly unilateral headaches is important as many of these headache disorders respond to a highly selective drug. Epidemiological data may guide us to formulate a proper approach for such patients. However, the literature is sparse on strictly unilateral headache and facial pain. We prospectively recruited 307 consecutive adult patients (>18 years) with side-locked headache and facial pain presenting to a neurology outpatient clinic between July 2014 and December 2015. All patients were subjected to MRI brain and other investigations to find out the different secondary causes. The diagnosis was carried out by at least two headache specialists together. All patients were classified according to the International Classification of Headache Disorder-third edition (ICHD-3β). The mean age at the time of examination was 42.4 ± 13.6 years (range 18-80 years). Forty-eight percent of patients were male. Strictly unilateral headaches accounted for 19.2% of the total headaches seen in the clinic. Headaches were classified as primary in 58%, secondary in 18%, and cranial neuropathies and other facial pain in 16% patients. Five percent of patients could not be classified. Three percent of patients were classified as per the Appendix section of ICHD-3β. The prevalence of secondary headaches and painful cranial neuropathies increased with age. A total of 36 different diagnoses were made. Only two diseases (migraine and cluster headache) had a prevalence of more than 10%. The prevalence of 13 diseases varied between 6 and 9%. The prevalence of other 14 groups was ≤1%. Migraine was the most common diagnosis (15%). Cervicogenic headache

  10. Actinic keratosis: a cross-sectional study of disease characteristics and treatment patterns in Danish dermatology clinics.

    Science.gov (United States)

    Erlendsson, Andrés M; Egekvist, Henrik; Lorentzen, Henrik F; Philipsen, Peter A; Stausbøl-Grøn, Birgitte; Stender, Ida M; Haedersdal, Merete

    2016-03-01

    The incidence of actinic keratosis (AK) is increasing, and several treatment options are available. The aim of this study was to describe clinical characteristics and treatment patterns in patients with AK treated by Danish dermatologists. A multicenter, non-interventional, cross-sectional study was conducted. Three dermatology hospital departments and seven private dermatology clinics enrolled eligible AK patients consecutively during one week. A total of 312 patients were included. Non-melanoma skin cancer (NMSC) was previously reported in 51.0% of patients and currently suspected in 9.4% of AK-affected anatomical regions. Lesions of AK were located primarily on the face (38.6%), scalp (12.8%), and hands (11.2%). Actinic keratosis commonly presented with multiple AK lesions (38.6%) and field cancerization (38.5%). The treatments used most frequently were cryotherapy (57.7%) and photodynamic therapy (PDT) with methyl aminolevulinate (17.1%) and imiquimod (11.2%). The likelihood of receiving cryotherapy was higher for men (odds ratio [OR] 1.65, 95% confidence interval [CI] 1.10-2.47) and increased with age (2.2% per year, 0.4-4.0%). PDT represented the most frequently applied treatment for severe actinic damage and was more likely to be prescribed to women (OR 4.08, 95% CI 2.22-7.47) and young patients (OR 0.97 per year, 95% CI 0.95-0.99). The prevalence of severe actinic damage (17.3% versus 9.6%) and intake of immunosuppressive medication (29.0 versus 2.0) were higher among hospital patients compared with those treated in private practices (P AK patients in Danish dermatology clinics have a history of skin cancer, and NMSC is suspected in almost 10% of AK-affected regions. Cryotherapy is the most frequently used treatment overall, except in instances of severe actinic damage, in which PDT is the first-choice treatment. © 2015 The International Society of Dermatology.

  11. Risk factors and pre-travel healthcare of international travellers attending a Dutch travel clinic: a cross-sectional analysis.

    Science.gov (United States)

    Wieten, Rosanne W; van der Schalie, Maurice; Visser, Benjamin J; Grobusch, Martin P; van Vugt, Michèle

    2014-01-01

    The number of international travellers is currently estimated to exceed one billion annually. To address travel related health risks and facilitate risk reduction strategies, detailed knowledge of travellers' characteristics is important. In this cross-sectional study, data of a 20% sample of travellers visiting the Academic Medical Center (AMC) travel clinic Amsterdam from July 2011 to July 2012 was collected. Itineraries and protection versus exposure rates of preventable infectious diseases were mapped and reported according to STROBE guidelines. 1749 travellers were included. South-Eastern Asia, South-America and West-Africa were most frequently visited. 26.2% of the population had pre-existing medical conditions (often cardiovascular). Young and VFR travellers had a longer median travel time (28 and 30 days) compared to the overall population (21 days). Young adult travellers were relatively often vaccinated against hepatitis B (43.9% vs. 20.5%, p travellers. Pre-travel guidelines were well adhered to. Young adult travellers had high-risk itineraries but were adequately protected. Improvement of hepatitis B and rabies protection would be desirable, specifically for VFRs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Preventive health services implemented by family physicians in Portugal—a cross-sectional study based on two clinical scenarios

    Science.gov (United States)

    Martins, Carlos; Azevedo, Luís Filipe; Santos, Cristina; Sá, Luísa; Santos, Paulo; Couto, Maria; Pereira, Altamiro; Hespanhol, Alberto

    2014-01-01

    Objectives To assess whether Portuguese family physicians perform preventive health services in accordance with scientific evidence, based on the recommendations of the United States Preventive Services Task Force (USPSTF). Design Cross-sectional study. Setting Primary healthcare, Portuguese National Health Service. Participants 255 Portuguese family physicians selected by a stratified cluster sampling design were invited to participate in a computer-assisted telephone survey. Outcomes Prevalence of compliance with USPSTF recommendations for screening, given a male and female clinical scenario and a set of proposed medical interventions, including frequency of the intervention and performance in their own daily practice. Results A response rate of 95.7% was obtained (n=244). 98–100% of family physicians answered according to the USPSTF recommendations in most interventions. In the male scenario, the lowest concordance was observed in the evaluation of prostate-specific antigen with 37% of family physicians answering according to the USPSTF recommendations. In the female scenario, the lowest concordance was for cholesterol testing with 2% of family physicians complying. Family physicians younger than 50 years had significantly better compliance scores than older ones (mean 77% vs 72%; p<0.001). Conclusions We found a high degree of agreement with USPSTF recommendations among Portuguese family physicians. However, we also found results suggesting excessive use of some medical interventions, raising concerns related to possible harm associated with overdiagnosis and overtreatment. PMID:24861550

  13. A cross-sectional multicenter study of osteogenesis imperfecta in North America - results from the linked clinical research centers.

    Science.gov (United States)

    Patel, R M; Nagamani, S C S; Cuthbertson, D; Campeau, P M; Krischer, J P; Shapiro, J R; Steiner, R D; Smith, P A; Bober, M B; Byers, P H; Pepin, M; Durigova, M; Glorieux, F H; Rauch, F; Lee, B H; Hart, T; Sutton, V R

    2015-02-01

    Osteogenesis imperfecta (OI) is the most common skeletal dysplasia that predisposes to recurrent fractures and bone deformities. In spite of significant advances in understanding the genetic basis of OI, there have been no large-scale natural history studies. To better understand the natural history and improve the care of patients, a network of Linked Clinical Research Centers (LCRC) was established. Subjects with OI were enrolled in a longitudinal study, and in this report, we present cross-sectional data on the largest cohort of OI subjects (n = 544). OI type III subjects had higher prevalence of dentinogenesis imperfecta, severe scoliosis, and long bone deformities as compared to those with OI types I and IV. Whereas the mean lumbar spine area bone mineral density (LS aBMD) was low across all OI subtypes, those with more severe forms had lower bone mass. Molecular testing may help predict the subtype in type I collagen-related OI. Analysis of such well-collected and unbiased data in OI can not only help answering questions that are relevant to patient care but also foster hypothesis-driven research, especially in the context of 'phenotypic expansion' driven by next-generation sequencing. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. A Cross-sectional Multicenter Study of Osteogenesis Imperfecta in North America – Results from the Linked Clinical Research Centers

    Science.gov (United States)

    Patel, Ronak M; Nagamani, Sandesh CS; Cuthbertson, David; Campeau, Philippe M; Krischer, Jeffrey P; Shapiro, Jay R; Steiner, Robert D; Smith, Peter A; Bober, Michael B; Byers, Peter H; Pepin, Melanie; Durigova, Michaela; Glorieux, Francis H; Rauch, Frank; Lee, Brendan H; Smith, Tracy; Sutton, V. Reid

    2017-01-01

    Osteogenesis Imperfecta (OI) is the most common skeletal dysplasia that predisposes to recurrent fractures and bone deformities. In spite of significant advances in understanding the genetic basis of OI, there have been no large-scale natural history studies. To better understand the natural history and improve the care of patients, a network of Linked Clinical Research Centers (LCRC) was established. Subjects with OI were enrolled in a longitudinal study, and in this report, we present cross-sectional data on the largest cohort of OI subjects (n=544). OI type III subjects had higher prevalence of dentinogenesis imperfecta, severe scoliosis, and long bone deformities as compared to those with OI types I and IV. Whereas the mean LS aBMD was low across all OI subtypes, those with more severe forms had lower bone mass. Molecular testing may help predict the subtype in type I collagen-related OI. Analysis of such well-collected and unbiased data in OI can not only help answer questions that are relevant to patient care but also foster hypothesis-driven research, especially in the context of “phenotypic expansion” driven by next-generation sequencing. PMID:24754836

  15. Correlation between the Severity of Female Urinary Incontinence and Concomitant Morbidities: A Multi-Center Cross-Sectional Clinical Study

    Directory of Open Access Journals (Sweden)

    Ji Seon Kim

    2010-12-01

    Full Text Available Purpose The aim of this study was to identify the relationship between urinary incontinence (UI and low back pain (LBP discomfort and disability, static balance, and demographic factors. Methods A total of 348 women aged 20-80 years were included in this cross-sectional study. The general characteristics of the subjects and the main outcome (UI condition, LBP discomfort, LBP disability, and static balance ability were assessed by using clinical questionnaires and assessment tools. Results Of all the subjects, 22.8% had experienced UI. Women with UI showed a significantly higher relationship of LBP and disability, and static balance ability (P<0.01. We found a significant correlation between UI, age, LBP and disability, and static balance ability (P<0.01. Conclusions These findings suggest that UI correlates negatively with LBP discomfort, LBP disability, and static balance ability. Further studies should focus on the identification of the precise mechanisms underlying UI and its related physical symptoms and on the development of therapeutic strategies to manage this condition.

  16. Prevention of influenza among travellers attending at a UK travel clinic: beliefs and perceptions. A cross-sectional study.

    Science.gov (United States)

    Masuet-Aumatell, Cristina; Toovey, Stephen; Zuckerman, Jane N

    2013-07-01

    Travellers' compliance with measures to prevent influenza through the use of antivirals and influenza vaccine remains very poor despite influenza being one of the commonest travel and vaccine-preventable diseases. A study was undertaken to assess travellers' beliefs, perceptions and intentions to take antivirals for the treatment and prevention of influenza during the H1N1 pandemic. A cross-sectional survey (n = 96) of travellers who attended the Royal Free Travel Health Centre, London, UK was undertaken in September 2009. A self-administered questionnaire was completed by a traveller in advance of their pre-travel health consultation. Logistic regression identified variables independently associated with compliance. Influenza vaccination uptake for the 5 years preceding the study was found to be 20·8%. This was statistically significantly higher for older travellers and those with underlying health conditions (P study identifies some beliefs and perceptions travellers consider with regard to the therapeutic and preventive influenza use of antivirals during the H1N1 pandemic; it underscores the importance of travellers receiving hemisphere appropriate influenza vaccination. The external validity of these study findings requires further corroboration involving other travel clinics and different cohorts of travellers during seasonal activity or outbreaks of influenza. These findings could guide the development of future strategies for the prevention of influenza in travellers. © 2012 John Wiley & Sons Ltd.

  17. Acanthopanax senticosus: review of botany, chemistry and pharmacology.

    Science.gov (United States)

    Huang, Linzhang; Zhao, Hongfang; Huang, Baokang; Zheng, Chengjian; Peng, Wei; Qin, Luping

    2011-02-01

    Acanthopanax senticosus (Rupr. et Maxim) Harms (Araliaceae), also called Siberian Ginseng, Eleutherococcus senticosus, and Ciwujia in Chinese, is a widely used traditional Chinese herb that could invigorate qi, strengthen the spleen, and nourish kidney in the theory of Traditional Chinese Medicine. With high medicinal value, Acanthopanax senticosus (AS, thereafter) is popularly used as an "adaptogen" like Panax ginseng. In recent decades, a great number of chemical, pharmacological, and clinical studies on AS have been carried out worldwide. Several kinds of chemical compounds have been reported, including triterpenoid saponins, lignans, coumarins, and flavones, among which, phenolic compounds such as syringin and eleutheroside E, were considered to be the most active components. Considerable pharmacological experiments both in vitro and in vivo have persuasively demonstrated that AS possessed anti-stress, antiulcer, anti-irradiation, anticancer, anti-inflammatory and hepatoprotective activities, etc. The present review is an up-to-date and comprehensive analysis of the botany, chemistry, pharmacology, toxicity and clinical trials of AS.

  18. Pharmacology of anabolic steroids.

    Science.gov (United States)

    Kicman, A T

    2008-06-01

    Athletes and bodybuilders have recognized for several decades that the use of anabolic steroids can promote muscle growth and strength but it is only relatively recently that these agents are being revisited for clinical purposes. Anabolic steroids are being considered for the treatment of cachexia associated with chronic disease states, and to address loss of muscle mass in the elderly, but nevertheless their efficacy still needs to be demonstrated in terms of improved physical function and quality of life. In sport, these agents are performance enhancers, this being particularly apparent in women, although there is a high risk of virilization despite the favourable myotrophic-androgenic dissociation that many xenobiotic steroids confer. Modulation of androgen receptor expression appears to be key to partial dissociation, with consideration of both intracellular steroid metabolism and the topology of the bound androgen receptor interacting with co-activators. An anticatabolic effect, by interfering with glucocorticoid receptor expression, remains an attractive hypothesis. Behavioural changes by non-genomic and genomic pathways probably help motivate training. Anabolic steroids continue to be the most common adverse finding in sport and, although apparently rare, designer steroids have been synthesized in an attempt to circumvent the dope test. Doping with anabolic steroids can result in damage to health, as recorded meticulously in the former German Democratic Republic. Even so, it is important not to exaggerate the medical risks associated with their administration for sporting or bodybuilding purposes but to emphasize to users that an attitude of personal invulnerability to their adverse effects is certainly misguided.

  19. Contemporary pharmacological obesity treatments

    Directory of Open Access Journals (Sweden)

    Kaszubska Katarzyna

    2016-06-01

    Full Text Available In the last few years, obesity has become a global epidemic. Consequently, worldwide costs associated with managing obesity and obesity-related comorbidities are huge. Numerous studies have focused on discerning the appropriate proper treatment of weight related problems such as overweight and obesity. Moreover, many clinical trials have been conducted for many years in order to introduce effective anti-obesity drugs. The aim of the present review is to provide an overview of current and future pharmacotherapy for obesity, and to provide the reader with a determination of the concentration and composition of long and short term anti-obesity drugs, doing so by placing emphasis on pharmacotherapy and up-to-day solutions. It should be noted that, currently, the worldwide pharmacotherapy is represented by phendimetrazine, benzphetamine and diethylpropion, as well as by orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion and liraglutide. In our paper, individual cases of patients’ needs are thoroughly illustrated by way of examples. Medical prescriptions and contraindications are also described.

  20. Factors associated to clinical learning in nursing students in primary health care: an analytical cross-sectional study.

    Science.gov (United States)

    Serrano-Gallardo, Pilar; Martínez-Marcos, Mercedes; Espejo-Matorrales, Flora; Arakawa, Tiemi; Magnabosco, Gabriela Tavares; Pinto, Ione Carvalho

    2016-09-09

    to identify the students' perception about the quality of clinical placements and asses the influence of the different tutoring processes in clinical learning. analytical cross-sectional study on second and third year nursing students (n=122) about clinical learning in primary health care. The Clinical Placement Evaluation Tool and a synthetic index of attitudes and skills were computed to give scores to the clinical learning (scale 0-10). Univariate, bivariate and multivariate (multiple linear regression) analyses were performed. the response rate was 91.8%. The most commonly identified tutoring process was "preceptor-professor" (45.2%). The clinical placement was assessed as "optimal" by 55.1%, relationship with team-preceptor was considered good by 80.4% of the cases and the average grade for clinical learning was 7.89. The multiple linear regression model with more explanatory capacity included the variables "Academic year" (beta coefficient = 1.042 for third-year students), "Primary Health Care Area (PHC)" (beta coefficient = 0.308 for Area B) and "Clinical placement perception" (beta coefficient = - 0.204 for a suboptimal perception). timeframe within the academic program, location and clinical placement perception were associated with students' clinical learning. Students' perceptions of setting quality were positive and a good team-preceptor relationship is a matter of relevance. identificar a percepção dos estudantes de enfermagem sobre a qualidade das Práticas Clínicas em Atenção Primária à Saúde e avaliar a influência dos diferentes processos de tutoria na aprendizagem clínica. um estudo analítico transversal realizado com alunos do segundo e do terceiro ano de enfermagem (n = 122) na aprendizagem clínica nos serviços de Atenção Primária à Saúde. A Ferramenta de Avaliação de Práticas Clínicas (Clinical Placement Evaluation Tool) e um índice sintético de atitudes e habilidades (escala de 0 a 10) foram calculados para marcar a

  1. Pharmacology Experiments on the Computer.

    Science.gov (United States)

    Keller, Daniel

    1990-01-01

    A computer program that replaces a set of pharmacology and physiology laboratory experiments on live animals or isolated organs is described and illustrated. Five experiments are simulated: dose-effect relationships on smooth muscle, blood pressure and catecholamines, neuromuscular signal transmission, acetylcholine and the circulation, and…

  2. Pharmacology of Marihuana (Cannabis sativa)

    Science.gov (United States)

    Maickel, Roger P.

    1973-01-01

    A detailed discussion of marihuana (Cannabis sativa) providing the modes of use, history, chemistry, and physiologic properties of the drug. Cites research results relating to the pharmacologic effects of marihuana. These effects are categorized into five areas: behavioral, cardiovascular-respiratory, central nervous system, toxicity-toxicology,…

  3. Chemotaxonomy and pharmacology of Gentianaceae

    DEFF Research Database (Denmark)

    Jensen, Søren Rosendal; Schripsema, Jan

    2002-01-01

    the remaining six are members of the Gentianeae. Based on the above results, a tentative list of chemical characteristics for the tribes of the Gentianaceae is presented. Finally, some pharmacologically interesting properties of plant extracts or compounds from taxa within Gentianaceae are listed....

  4. A Review of Pharmacologic Treatment for Compulsive Buying Disorder.

    Science.gov (United States)

    Soares, Célia; Fernandes, Natália; Morgado, Pedro

    2016-04-01

    At present, no treatment recommendations can be made for compulsive buying disorder. Recent studies have found evidence for the efficacy of psychotherapeutic options, but less is known regarding the best pharmacologic treatment. The purpose of this review is to present and analyze the available published evidence on the pharmacological treatment of compulsive buying disorder. To achieve this, we conducted a review of studies focusing on the pharmacological treatment of compulsive buying by searching the PubMed/MEDLINE database. Selection criteria were applied, and 21 studies were identified. Pharmacological classes reported included antidepressants, mood stabilizers, opioid antagonists, second-generation antipsychotics, and N-methyl-D-aspartate receptor antagonists. We found only placebo-controlled trials for fluvoxamine; none showed effectiveness against placebo. Three open-label trials reported clinical improvement with citalopram; one was followed by a double-blind discontinuation. Escitalopram was effective in an open-label trial but did not show efficacy in the double-blind phase. Memantine was identified as effective in a pilot open-label study. Fluoxetine, bupropion, nortriptyline, clomipramine, topiramate and naltrexone were only reported to be effective in clinical cases. According to the available literature, there is no evidence to propose a specific pharmacologic agent for compulsive buying disorder. Future research is required for a better understanding of both pathogenesis and treatment of this disorder.

  5. Pharmacological management of spasticity in multiple sclerosis

    DEFF Research Database (Denmark)

    Otero-Romero, Susana; Sastre-Garriga, Jaume; Comi, Giancarlo

    2016-01-01

    Background and objectives: Treatment of spasticity poses a major challenge given the complex clinical presentation and variable efficacy and safety profiles of available drugs. We present a systematic review of the pharmacological treatment of spasticity in multiple sclerosis (MS) patients. Methods...... improvement is seen with the previous drugs. Nabiximols has a positive effect when used as add-on therapy in patients with poor response and/or tolerance to first-line oral treatments. Despite limited evidence, intrathecal baclofen and intrathecal phenol show a positive effect in severe spasticity...... and suboptimal response to oral drugs. Conclusion: The available studies on spasticity treatment offer some insight to guide clinical practice but are of variable methodological quality. Large, well-designed trials are needed to confirm the effectiveness of antispasticity agents and to produce evidence...

  6. Oral mucosal lesions in skin diseased patients attending a dermatologic clinic: a cross-sectional study in Sudan

    Directory of Open Access Journals (Sweden)

    Salman Hussein

    2011-09-01

    Full Text Available Abstract Background So far there have been no studies focusing on the prevalence of a wide spectrum of oral mucosal lesions (OML in patients with dermatologic diseases. This is noteworthy as skin lesions are strongly associated with oral lesions and could easily be neglected by dentists. This study aimed to estimate the frequency and socio-behavioural correlates of OML in skin diseased patients attending outpatient's facility of Khartoum Teaching Hospital - Dermatology Clinic, Sudan. Methods A cross-sectional hospital-based study was conducted in Khartoum from October 2008 to January 2009. A total of 588 patients (mean age 37.2 ± 16 years, 50.3% females completed an oral examination and a personal interview of which 544 patients (mean age 37.1 ± 15.9 years, 50% females with confirmed skin disease diagnosis were included for further analyses. OML were recorded using the World Health Organization criteria (WHO. Biopsy and smear were used as adjuvant techniques for confirmation. Data were analysed using the Statistical Package for Social Science (Version 15.0.1. Cross tabulation and Chi-square with Fisher's exact test were used. Results A total of 438 OML were registered in 315 (57.9%, males: 54.6% versus females: 45.6%, p Tongue lesions were the most frequently diagnosed OML (23.3%, followed in descending order by white lesions (19.1%, red and blue lesions (11% and vesiculobullous diseases (6%. OML in various skin diseases were; vesiculobullous reaction pattern (72.2%, lichenoid reaction pattern (60.5%, infectious lesions (56.5%, psoriasiform reaction pattern (56.7%, and spongiotic reaction pattern (46.8%. Presence of OML in skin diseased patients was most frequent in older age groups (62.4% older versus 52.7% younger, p Conclusions OML were frequently diagnosed in skin diseased patients and varied systematically with age, gender, systemic condition and use of toombak. The high prevalence of OML emphasizes the importance of routine examination

  7. [Human papillomavirus infection and its correlates with clinically relevant gynecological and obstetric conditions: A cross-sectional study].

    Science.gov (United States)

    López-Hernández, Daniel; Beltrán-Lagunes, Luis; Brito-Aranda, Leticia; López-Hernández, Maria de la Luz

    2016-08-05

    To analyze the prevalence of human papillomavirus (HPV) infection and the possible epidemiological association with conditions of clinical relevance in women. A cross-sectional study from Mexico City was conducted from January 2012 to December 2014. HPV molecular detection was performed on cervical samples. Data were analyzed with appropriated statistic tests. A total of 1,604 females (median 47, interquartile range 38-54) were analyzed. Global prevalence of infection for any HPV is 9.91% (95% CI 8.6-11.3). An association between infection with 16-HPV and number of abortions (NA) (OR=1.427; 95% CI 1.091-1.866), by univariate regression model (UVRM) was estimated. Moreover, menarche (OR=1.566; 95% CI 1.079-2.272), NA (OR=1.570; 95% CI 1.106-2.227) and number of pregnancies (NP) (OR=0.461; 95% CI 0.260-0.818) have a direct and inverse association with infection by genotype 18 of HPV, respectively. Also, infection with HR-HPV genotypes has an inverse association with NP (OR=0.791; 95% CI 0.707-0.884) by normal labor (OR=0.867; 95% CI 0.767-0.979) and NA (OR=0.715; 95% CI 0.534-0.959) (UVRM), and a direct association with number of sexual partners (OR=1.082; 95% CI 1.015-1.154). Onset of sexual activity has an inverse association with infection by genotype 16- (UVRM: OR=0.814; 95% CI 0.715-0.926; multinomial regression model (MNRM): OR=0.803; 95% CI 0.702-0.918) and HR-HPV (UVRM: OR=0.933; 95% CI 0.889-0.980, and MNRM: OR=0.912; 95% CI 0.867-0.959), all P values were lower than .03. Prevalence of HPV cervical infection is different according to age and it is associated with several medical conditions of clinical relevance in women. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  8. Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2016-01-01

    Introduction The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients’ associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value. Design and Objectives Cross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested. Setting Latin America. Measures To assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries’ minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs. Results We found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries’ income per capita or minimum wage. Conclusion The implementation of clinical trials in Latin America

  9. Numbness in clinical and experimental pain--a cross-sectional study exploring the mechanisms of reduced tactile function.

    Science.gov (United States)

    Geber, Christian; Magerl, Walter; Fondel, Ricarda; Fechir, Marcel; Rolke, Roman; Vogt, Thomas; Treede, Rolf-Detlef; Birklein, Frank

    2008-09-30

    Pain patients often report distinct numbness of the painful skin although no structural peripheral or central nerve lesion is obvious. In this cross-sectional study we assessed the reduction of tactile function and studied underlying mechanisms in patients with chronic pain and in healthy participants exposed to phasic and tonic experimental nociceptive stimulation. Mechanical detection (MDT) and pain thresholds (MPT) were assessed in the painful area and the non-painful contralateral side in 10 patients with unilateral musculoskeletal pain. Additionally, 10 healthy participants were exposed to nociceptive stimulation applied to the volar forearms (capsaicin; electrical stimulation, twice each). Areas of tactile hypaesthesia and mechanical hyperalgesia were assessed. MDT and MPT were quantified adjacent to the stimulation site. Tactile hypaesthesia in pain patients and in experimental pain (MDT-z-scores: -0.66+/-0.30 and -0.42+/-0.15, respectively, both p<0.01) was paralleled by mechanical hyperalgesia (MPT-z-scores: +0.51+/-0.27, p<0.05; and +0.48+/-0.10, p<0.001). However, hypaesthesia and hyperalgesia were not correlated. Although 9 patients reported numbness, only 3 of them were able to delineate circumscript areas of tactile hypaesthesia. In experimental pain, the area of tactile hypaesthesia could be mapped in 31/40 experiments (78%). Irrespective of the mode of nociceptive stimulation (phasic vs. tonic) tactile hypaesthesia and hyperalgesia developed with a similar time course and disappeared within approximately 1 day. Hypaesthesia (numbness) often encountered in clinical pain can be reproduced by experimental nociceptive stimulation. The time course of effects suggests a mechanism involving central plasticity.

  10. A cross-sectional MRI study of brain regional atrophy and clinical characteristics of temporal lobe epilepsy with hippocampal sclerosis.

    LENUS (Irish Health Repository)

    2012-02-01

    PURPOSE: Applying a cross-sectional design, we set out to further characterize the significance of extrahippocampal brain atrophy in a large sample of \\'sporadic\\' mesial temporal lobe epilepsy with hippocampal sclerosis (MTLE+HS). By evaluating the influence of epilepsy chronicity on structural atrophy, this work represents an important step towards the characterization of MRI-based volumetric measurements as genetic endophenotypes for this condition. METHODS: Using an automated brain segmentation technique, MRI-based volume measurements of several brain regions were compared between 75 patients with \\'sporadic\\' MTLE+HS and 50 healthy controls. Applying linear regression models, we examined the relationship between structural atrophy and important clinical features of MTLE+HS, including disease duration, lifetime number of partial and generalized seizures, and history of initial precipitating insults (IPIs). RESULTS: Significant volume loss was detected in ipsilateral hippocampus, amygdala, thalamus, and cerebral white matter (WM). In addition, contralateral hippocampal and bilateral cerebellar grey matter (GM) volume loss was observed in left MTLE+HS patients. Hippocampal, amygdalar, and cerebral WM volume loss correlated with duration of epilepsy. This correlation was stronger in patients with prior IPIs history. Further, cerebral WM, cerebellar GM, and contralateral hippocampal volume loss correlated with lifetime number of generalized seizures. CONCLUSION: Our findings confirm that multiple brain regions beyond the hippocampus are involved in the pathogenesis of MTLE+HS. IPIs are an important factor influencing the rate of regional atrophy but our results also support a role for processes related to epilepsy chronicity. The consequence of epilepsy chronicity on candidate brain regions has important implications on their application as genetic endophenotypes.

  11. Production and quality of clinical practice guidelines in Argentina (1994–2004: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Dieguez Marcelo

    2008-10-01

    Full Text Available Abstract Background In the last decades, a sustained increment of Clinical Practice Guidelines (CPG production in the world has been accompanied by a growing concern about their quality. Many studies related to quality assessment of guidelines produced in High Income Countries were published; however, evidence on this topic is scarce in Low and Middle Income Countries (LMIC. The objectives of this research were: a to describe guideline production in Argentina at different levels of the health system (macro, meso and micro from 1994 to 2004; and b to assess their quality by using the AGREE instrument. Methods A cross-sectional study was undertaken to describe guidelines production in Argentina between 1994 and 2004. CPG were identified through Internet and electronic databases (MEDLINE and LILACS. Explicit inclusion and exclusion criteria were used to select guidelines. Each CPG was independently assessed by two reviewers using the AGREE instrument. Domain scores were calculated as recommended by the AGREE Collaboration. The internal consistency of each domain was evaluated using Cronbach's alpha and inter-observer agreement by the Intraclass Correlation Coefficient (ICC. Results A total amount of 431 potential CPG were identified, but only 144 were considered CPG. At the end, 101 CPG were included for further assessment. Median standardized score for each domain were: scope = 39%; stakeholder involvement = 13%; rigour of development = 10%; clarity = 42%; applicability = 6%; editorial independence = 0%. Only 22 CPG were recommended with modifications by both appraisers. ICC and Cronbach's alpha for each domain were in all cases moderate or high (greater than 0.40, except for editorial independence. Conclusion This study has systematically employed the AGREE instrument for the critical assessment of guidelines produced in a LMIC. Guideline development and diffusion in Argentina from 1994 to 2004 shows a constant increment, although quality of

  12. Examination of the Section III DSM-5 diagnostic system for personality disorders in an outpatient clinical sample

    Science.gov (United States)

    Few, Lauren R.; Miller, Joshua D.; Rothbaum, Alex; Meller, Suzanne; Maples, Jessica; Terry, Douglas P.; Collins, Brittany; MacKillop, James

    2014-01-01

    The DSM-5 includes a novel approach to the diagnosis of personality disorders (PDs) in Section III, in order to stimulate further research with the possibility that this proposal will be included more formally in future DSM iterations. The current study provides the first test of this proposal in a clinical sample by simultaneously examining its two primary components: a system for rating personality impairment and a newly developed dimensional model of pathological personality traits. Participants were community adults currently receiving outpatient mental health treatment who completed a semi-structured interview for DSM-IV PDs and were then rated in terms of personality impairment and pathological traits. Data on the pathological traits were also collected via self-reports using the Personality Inventory for DSM-5 (PID-5). Both sets of trait scores were compared to self-report measures of general personality traits, internalizing symptoms, and externalizing behaviors. Inter-rater reliabilities for the clinicians’ ratings of impairment and the pathological traits were fair. The impairment ratings manifested substantial correlations with symptoms of depression and anxiety, DSM-5 PDs, and DSM-5 pathological traits. The clinician and self-reported personality trait scores demonstrated good convergence with one another, both accounted for substantial variance in DSM-IV PD constructs, and both manifested expected relations with the external criteria. The traits but not the impairment ratings demonstrated incremental validity in the prediction of the DSM-IV PDs. Overall, the current results support the general validity of several of the components of this new PD diagnostic system and point to areas that may require further modification. PMID:24364607

  13. High-Throughput Screening of Ototoxic and Otoprotective Pharmacological Drugs

    Science.gov (United States)

    Kalinec, Federico

    2005-01-01

    Drug ototoxicity research has relied traditionally on animal models for the discovery and development of therapeutic interventions. More than 50 years of research, however, has delivered few--if any--successful clinical strategies for preventing or ameliorating the ototoxic effects of common pharmacological drugs such as aminoglycoside…

  14. Integrated quantitative pharmacology for treatment optimization in oncology

    NARCIS (Netherlands)

    van Hasselt, J.G.C.

    2014-01-01

    This thesis describes the development and application of quantitative pharmacological models in oncology for treatment optimization and for the design and analysis of clinical trials with respect to pharmacokinetics, toxicity, efficacy and cost-effectiveness. A recurring theme throughout this thesis

  15. Pharmacological interventions for acute pancreatitis.

    Science.gov (United States)

    Moggia, Elisabetta; Koti, Rahul; Belgaumkar, Ajay P; Fazio, Federico; Pereira, Stephen P; Davidson, Brian R; Gurusamy, Kurinchi Selvan

    2017-04-21

    the remaining comparisons in these outcomes or for any of the remaining primary outcomes (the proportion of participants experiencing at least one serious adverse event and the occurrence of infected pancreatic necrosis). None of the trials reported heath-related quality of life. Very low-quality evidence suggests that none of the pharmacological treatments studied decrease short-term mortality in people with acute pancreatitis. However, the confidence intervals were wide and consistent with an increase or decrease in short-term mortality due to the interventions. We did not find consistent clinical benefits with any intervention. Because of the limitations in the prognostic scoring systems and because damage to organs may occur in acute pancreatitis before they are clinically manifest, future trials should consider including pancreatitis of all severity but power the study to measure the differences in the subgroup of people with severe acute pancreatitis. It may be difficult to power the studies based on mortality. Future trials in participants with acute pancreatitis should consider other outcomes such as complications or health-related quality of life as primary outcomes. Such trials should include health-related quality of life, costs, and return to work as outcomes and should follow patients for at least three months (preferably for at least one year).

  16. Preparedness of HIV care and treatment clinics for the management of concomitant non–communicable diseases: a cross–sectional survey

    OpenAIRE

    Leung, Claudia; Aris, Eric; Mhalu, Aisa; Siril, Hellen; Christian, Beatrice; Koda, Happiness; Samatta, Talumba; Maghimbi, Martha Tsere; Hirschhorn, Lisa R.; Chalamilla, Guerino; Hawkins, Claudia

    2016-01-01

    Abstract Background In Sub-Saharan Africa, epidemiological studies have reported an increasing burden of non-communicable diseases (NCD) among people living with HIV. NCD management can be feasibly integrated into HIV care; however, clinic readiness to provide NCD services in these settings should first be assessed and gaps in care identified. Methods A cross-sectional survey conducted in July 2013 assessed the resources available for NCD care at 14 HIV clinics in Dar es Salaam, Tanzania. Sur...

  17. Noradrenergic augmentation strategies in the pharmacological treatment of depression and schizophrenia : An experimental study

    OpenAIRE

    Linnér, Love

    2002-01-01

    The pharmacological treatment of depression and schizophrenia, two major psychiatric disorders, is largely based on modulation of central monoaminergic neurotransmission. However, currently available pharmacological treatment alternatives possess a relatively modest clinical efficacy, making them less than optimal. The present series of studies, using in vivo electrophysiological, biochemical and behavioral techniques in rats, aim at the disclosure of mechanisms whereby an ...

  18. Multiple sclerosis: general features and pharmacologic approach

    International Nuclear Information System (INIS)

    Nielsen Lagumersindez, Denis; Martinez Sanchez, Gregorio

    2009-01-01

    Multiple sclerosis is an autoimmune, inflammatory and desmyelinization disease central nervous system (CNS) of unknown etiology and critical evolution. There different etiological hypotheses talking of a close interrelation among predisposing genetic factors and dissimilar environmental factors, able to give raise to autoimmune response at central nervous system level. Hypothesis of autoimmune pathogeny is based on study of experimental models, and findings in biopsies of affected patients by disease. Accumulative data report that the oxidative stress plays a main role in pathogenesis of multiple sclerosis. Oxygen reactive species generated by macrophages has been involved as mediators of demyelinization and of axon damage, in experimental autoimmune encephalomyelitis and strictly in multiple sclerosis. Disease diagnosis is difficult because of there is not a confirmatory unique test. Management of it covers the treatment of acute relapses, disease modification, and symptoms management. These features require an individualized approach, base on evolution of this affection, and tolerability of treatments. In addition to diet, among non-pharmacologic treatments for multiple sclerosis it is recommended physical therapy. Besides, some clinical assays have been performed in which we used natural extracts, nutrition supplements, and other agents with promising results. Pharmacology allowed neurologists with a broad array of proved effectiveness drugs; however, results of research laboratories in past years make probable that therapeutical possibilities increase notably in future. (Author)

  19. Pharmacological treatment of diabetic neuropathic pain.

    Science.gov (United States)

    Smith, Howard S; Argoff, Charles E

    2011-03-26

    Neuropathic pain continues to be a difficult and challenging clinical issue to deal with effectively. Painful diabetic polyneuropathy is a complex pain condition that occurs with reasonable frequency in the population and it may be extremely difficult for clinicians to provide patients with effective analgesia. Chronic neuropathic pain may occur in approximately one of every four diabetic patients. The pain may be described as burning or a deep-seated ache with sporadic paroxysms of lancinating painful exacerbations. The pain is often constant, moderate to severe in intensity, usually primarily involves the feet and generally tends to worsen at night. Treatment may be multimodal but largely involves pharmacological approaches. Pharmacological therapeutic options include antidepressants (tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors), α2δ ligands and topical (5%) lidocaine patch. Other agents may be different antiepileptic drugs (carbamazepine, lamotrigine, topiramate), topical capsaicin, tramadol and other opioids. Progress continues with respect to understanding various mechanisms that may contribute to painful diabetic neuropathy. Agents that may hold some promise include neurotrophic factors, growth factors, immunomodulators, gene therapy and poly (adenosine diphosphate-ribose) polymerase inhibitors. It is hoped that in the future clinicians will be able to assess patient pathophysiology, which may help them to match optimal therapeutic agents to target individual patient aberrant mechanisms.

  20. Harnessing Big Data for Systems Pharmacology.

    Science.gov (United States)

    Xie, Lei; Draizen, Eli J; Bourne, Philip E

    2017-01-06

    Systems pharmacology aims to holistically understand mechanisms of drug actions to support drug discovery and clinical practice. Systems pharmacology modeling (SPM) is data driven. It integrates an exponentially growing amount of data at multiple scales (genetic, molecular, cellular, organismal, and environmental). The goal of SPM is to develop mechanistic or predictive multiscale models that are interpretable and actionable. The current explosions in genomics and other omics data, as well as the tremendous advances in big data technologies, have already enabled biologists to generate novel hypotheses and gain new knowledge through computational models of genome-wide, heterogeneous, and dynamic data sets. More work is needed to interpret and predict a drug response phenotype, which is dependent on many known and unknown factors. To gain a comprehensive understanding of drug actions, SPM requires close collaborations between domain experts from diverse fields and integration of heterogeneous models from biophysics, mathematics, statistics, machine learning, and semantic webs. This creates challenges in model management, model integration, model translation, and knowledge integration. In this review, we discuss several emergent issues in SPM and potential solutions using big data technology and analytics. The concurrent development of high-throughput techniques, cloud computing, data science, and the semantic web will likely allow SPM to be findable, accessible, interoperable, reusable, reliable, interpretable, and actionable.

  1. Pharmacological Treatment for Atrial Fibrillation

    Directory of Open Access Journals (Sweden)

    Kaoru Sugi, MD PhD

    2005-01-01

    Full Text Available Pharmacological treatment for atrial fibrillation has a variety of purposes, such as pharmacological defibrillation, maintenance of sinus rhythm, heart rate control to prevent congestive heart failure and prevention of both cerebral infarction and atrial remodeling. Sodium channel blockers are superior to potassium channel blockers for atrial defibrillation, while both sodium and potassium channel blockers are effective in the maintenance of sinus rhythm. In general, digitalis or Ca antagonists are used to control heart rate during atrial fibrillation to prevent congestive heart failure, while amiodarone or bepridil also reduce heart rates during atrial fibrillation. Anticoagulant therapy with warfarin is recommended to prevent cerebral infarction and angiotensin converting enzyme antagonists or angiotensin II receptor blockers are also used to prevent atrial remodeling. One should select appropriate drugs for treatment of atrial fibrillation according to the patient's condition.

  2. Knowledge, attitudes and practices among people with chronic hepatitis B attending a hepatology clinic in Malaysia: A cross sectional study

    Directory of Open Access Journals (Sweden)

    Mohamed Rosmawati

    2012-08-01

    Full Text Available Abstract Background Hepatitis B (HBV is the leading cause of cirrhosis and hepatocellular carcinoma worldwide. This study assessed the knowledge, attitudes and practices of people with chronic HBV and the associated factors. Methods This cross-sectional study was conducted at an outpatient adult hepatology clinic at a tertiary hospital in Kuala Lumpur. A self-administered questionnaire was administered on a one-to-one basis to assess knowledge, attitudes, and lifestyle practices of people with chronic HBV. Results The response rate was 89% (n = 483/543. Participants had a mean age of 46.3 (±14.7 years and the mean duration of HBV from time of diagnosis was 12.2 (±8.8 years. The mean knowledge score was 12.57/20 (standard deviation: ±4.4, range: 0–19. Participants aged 30–39 years, with higher educational attainment, employed in professional jobs, longer duration of diagnosis and those without cirrhosis had significantly higher knowledge scores. Age, education level and duration of diagnosis were significant predictors of the knowledge score on standard multiple regression analysis. More than half of the participants were worried of spreading HBV infection to family and friends and worried since the diagnosis. A third of the participants (33.5% were embarrassed to reveal their diagnosis to the public but most of them (93.6% would inform their family. Those who reported feeling worried since their diagnosis were more likely to be middle-aged, of Malay ethnicity, have shorter duration of diagnosis of less than 10 years and have received therapy. About half of the participants (50.6% did not share dining utensils and the majority (93.2% believed that HBV can be transmitted by sharing of eating and drinking utensils. Older patients were significantly less likely to share utensils. Those who felt worried since diagnosis had significant higher knowledge of HBV. Conclusion The findings highlight the stigma and misconceptions that still

  3. Feeding practices among children attending child welfare clinics in Ragama MOH area: a descriptive cross-sectional study

    Directory of Open Access Journals (Sweden)

    Perera Priyantha J

    2011-11-01

    Full Text Available Abstract Background Feeding during early childhood is important for normal physical and mental growth as well as for health in later life. Currently, Sri Lanka has adopted the WHO recommendation of exclusive breastfeeding for six months, followed by addition of complementary feeds thereafter, with continuation of breastfeeding up to or beyond two years. This study was conducted to evaluate the current feeding practices among Sri Lankan children during early childhood. Methods This study was a descriptive cross-sectional study conducted in the Ragama Medical Officer of Health (MOH area. It was conducted between 10 August 2010 and 30 October 2010. Children between the ages of 24 and 60 months, attending child welfare clinics, were included in the study on consecutive basis. An interviewer-administered questionnaire was used to collect data regarding sociodemographic characteristics and feeding practices. Results There were 208 boys and 202 girls in the study population. Of them, 255 (62.2% were exclusively breastfed up to 6 months. Younger children had a statistically significant, higher rate of exclusive breastfeeding compared to older children. Three hundred and fifty one (85.6% children had received infant formula, and it was started before the age of 6 months in 61 children, and in 212 before one year. Sugar was added to infant formula in 330 (80.4% children, and out of them 144 had sugar added within first year of life. Complementary foods were started before 4 months in 29 (7% children. Of the 410 children, 294 (71.7% were breastfed beyond 2 years and 41.6% of them were breastfed at regular intervals throughout the day. Three hundred and thirty eight (82.6% children were receiving overnight feeding of either breast milk or infant formula even after 2 years. Conclusions Though a high rate of exclusive breastfeeding was observed in this study population, there are many other issues related to feeding during the early years of life that need

  4. Contraceptive use by Palestine refugee mothers of young children attending UNRWA clinics: a cross-sectional follow-up study.

    Science.gov (United States)

    Hababeh, Majed; Zeidan, Wafaa; El-Kader, Mariam Abdel; Thaher, Anwar Al; Kassim, Nimer; Habash, Elias; Arab, Hasan; Khader, Ali; Seita, Akihiro

    2018-02-21

    UNRWA introduced family planning services in 1994 as an integral part of its expanded maternal and child health-care programme. The main objective of UNRWA's family planning programme is to promote the health of mothers, children, and their families. The aim of this follow-up study was to assess contraceptive practices in the target population 5 years after the 2010 follow-up study and to identify future programme needs. This cross-sectional survey was a done by trained nurses from June 1 to Dec 31, 2015. Participants were Palestinian refugee mothers who attended Well Baby Clinics at all UNRWA health centres with their youngest child (aged 2 months to 5 years). A sample size of 10 478 participants was calculated on the basis of contraceptive use in 2010, using Epi Info sample size calculation. Women were interviewed, and retrospective data from health records were used as supplementary data. We did a multiple logistic regression to test if maternal age and parity predicted contraceptive use. We used the χ 2 test to analyse the relation between previous contraceptive use and birth interval, birth weight, and gestational age. All participants provided verbal informed consent. The study was approved by the ethical committee in the UNRWA Health Department. Data were obtained from 9860 mothers (mean age 29·8 years [range 29·4-30·1]). 5849 (59%) women were using modern contraceptives at the time of the survey, 1745 (18%) were using traditional methods, and 2265 (23%) were not using any contraceptive method. The most common modern contraceptive was an intrauterine device (2186 [37%] women), and UNRWA was the main provider for 4827 (83%) women using modern contraceptives. The most common reasons for not using contraceptives were a wish to have a child (873 [22%] women), pregnancy (747 [19%]), and a husband's opposition (775 [20%]). Using women with less than three pregnancies as the reference category, use of contraceptives was most likely in women with three to six

  5. Knowledge, attitudes and practices among people with chronic hepatitis B attending a hepatology clinic in Malaysia: a cross sectional study.

    Science.gov (United States)

    Mohamed, Rosmawati; Ng, Chirk Jenn; Tong, Wen Ting; Abidin, Suraya Zainol; Wong, Li Ping; Low, Wah Yun

    2012-08-03

    Hepatitis B (HBV) is the leading cause of cirrhosis and hepatocellular carcinoma worldwide. This study assessed the knowledge, attitudes and practices of people with chronic HBV and the associated factors. This cross-sectional study was conducted at an outpatient adult hepatology clinic at a tertiary hospital in Kuala Lumpur. A self-administered questionnaire was administered on a one-to-one basis to assess knowledge, attitudes, and lifestyle practices of people with chronic HBV. The response rate was 89% (n = 483/543). Participants had a mean age of 46.3 (±14.7) years and the mean duration of HBV from time of diagnosis was 12.2 (±8.8) years. The mean knowledge score was 12.57/20 (standard deviation: ±4.4, range: 0-19). Participants aged 30-39 years, with higher educational attainment, employed in professional jobs, longer duration of diagnosis and those without cirrhosis had significantly higher knowledge scores. Age, education level and duration of diagnosis were significant predictors of the knowledge score on standard multiple regression analysis. More than half of the participants were worried of spreading HBV infection to family and friends and worried since the diagnosis. A third of the participants (33.5%) were embarrassed to reveal their diagnosis to the public but most of them (93.6%) would inform their family. Those who reported feeling worried since their diagnosis were more likely to be middle-aged, of Malay ethnicity, have shorter duration of diagnosis of less than 10 years and have received therapy. About half of the participants (50.6%) did not share dining utensils and the majority (93.2%) believed that HBV can be transmitted by sharing of eating and drinking utensils. Older patients were significantly less likely to share utensils. Those who felt worried since diagnosis had significant higher knowledge of HBV. The findings highlight the stigma and misconceptions that still exist among the HBV patients. More patient and public education about

  6. Pharmacological challenges in chronic pancreatitis

    OpenAIRE

    Olesen, Anne Estrup; Brokjaer, Anne; Fisher, Iben Wendelboe; Larsen, Isabelle Myriam

    2013-01-01

    Drug absorption in patients with chronic pancreatitis might be affected by the pathophysiology of the disease. The exocrine pancreatic insufficiency is associated with changes in gastrointestinal intraluminal pH, motility disorder, bacterial overgrowth and changed pancreatic gland secretion. Together these factors can result in malabsorption and may also affect the efficacy of pharmacological intervention. The lifestyle of chronic pancreatitis patients may also contribute to gastrointestinal ...

  7. Pharmacological properties of Salvia officinalis and its components

    Directory of Open Access Journals (Sweden)

    Ahmad Ghorbani

    2017-10-01

    Full Text Available Salvia officinalis (Sage is a plant in the family of Labiatae/Lamiaceae. It is native to Middle East and Mediterranean areas, but today has been naturalized throughout the world. In folk medicine, S. officinalis has been used for the treatment of different kinds of disorders including seizure, ulcers, gout, rheumatism, inflammation, dizziness, tremor, paralysis, diarrhea, and hyperglycemia. In recent years, this plant has been a subject of intensive studies to document its traditional use and to find new biological effects. These studies have revealed a wide range of pharmacological activities for S. officinalis. Present review highlights the up-to-date information on the pharmacological findings that have been frequently reported for S. officinalis. These findings include anticancer, anti-inflammatory, antinociceptive, antioxidant, antimicrobial, antimutagenic, antidementia, hypoglycemic, and hypolipidemic effects. Also, chemical constituents responsible for pharmacological effects of S. officinalis and the clinical studies on this plant are presented and discussed.

  8. Current trends and future development in pharmacologic stress testing

    International Nuclear Information System (INIS)

    Bae, Jin Ho; Lee, Jae Tae

    2005-01-01

    Pharmacologic stress testing for myocardial perfusion imaging is a widely used noninvasive method for the evaluation of known or suspected coronary artery disease. The use of exercise for cardiac stress has been practiced for over 60 years and clinicians are familiar with its using. However, there are inevitable situations in which exercise stress is inappropriate. A large number of patients with cardiac problems are unable to exercise to their full potential due to comorbidity such as osteoarthritis, vascular disease and pulmonary disease and a standard exercise stress test for myocardial perfusion imaging is suboptimal means for assessment of coronary artery disease. This problem has led to the development of the pharmacologic stress test and to a great increase in its popularity. All of the currently used pharmacologic agents have well-documented diagnostic value. This review deals the physiological actions, clinical protocols, safety, nuclear imaging applications of currently available stress agents and future development of new vasodilating agents

  9. FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study

    OpenAIRE

    Douglas H. Marin dos Santos; Álvaro N. Atallah

    2015-01-01

    The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the ...

  10. FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Douglas H. Marin dos Santos

    2015-06-01

    Full Text Available The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA, aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov. We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.

  11. FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study.

    Science.gov (United States)

    Marin Dos Santos, Douglas H; Atallah, Álvaro N

    2015-01-01

    The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.

  12. Pharmacological chaperoning: a primer on mechanism and pharmacology.

    Science.gov (United States)

    Leidenheimer, Nancy J; Ryder, Katelyn G

    2014-05-01

    Approximately forty percent of diseases are attributable to protein misfolding, including those for which genetic mutation produces misfolding mutants. Intriguingly, many of these mutants are not terminally misfolded since native-like folding, and subsequent trafficking to functional locations, can be induced by target-specific, small molecules variably termed pharmacological chaperones, pharmacoperones, or pharmacochaperones (PCs). PC targets include enzymes, receptors, transporters, and ion channels, revealing the breadth of proteins that can be engaged by ligand-assisted folding. The purpose of this review is to provide an integrated primer of the diverse mechanisms and pharmacology of PCs. In this regard, we examine the structural mechanisms that underlie PC rescue of misfolding mutants, including the ability of PCs to act as surrogates for defective intramolecular interactions and, at the intermolecular level, overcome oligomerization deficiencies and dominant negative effects, as well as influence the subunit stoichiometry of heteropentameric receptors. Not surprisingly, PC-mediated structural correction of misfolding mutants normalizes interactions with molecular chaperones that participate in protein quality control and forward-trafficking. A variety of small molecules have proven to be efficacious PCs and the advantages and disadvantages of employing orthostatic antagonists, active-site inhibitors, orthostatic agonists, and allosteric modulator PCs are considered. Also examined is the possibility that several therapeutic agents may have unrecognized activity as PCs, and this chaperoning activity may mediate/contribute to therapeutic action and/or account for adverse effects. Lastly, we explore evidence that pharmacological chaperoning exploits intrinsic ligand-assisted folding mechanisms. Given the widespread applicability of PC rescue of mutants associated with protein folding disorders, both in vitro and in vivo, the therapeutic potential of PCs is vast

  13. Safety pharmacology--current and emerging concepts.

    Science.gov (United States)

    Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor; Alfirevic, Ana; Alhaidari, Mohammad; Atkinson, Jeffrey; Ayala, Mimieveshiofuo; Box, Helen; Cross, Michael; Delaunois, Annie; Dermody, Ailsa; Govindappa, Karthik; Guillon, Jean-Michel; Jenkins, Rosalind; Kenna, Gerry; Lemmer, Björn; Meecham, Ken; Olayanju, Adedamola; Pestel, Sabine; Rothfuss, Andreas; Sidaway, James; Sison-Young, Rowena; Smith, Emma; Stebbings, Richard; Tingle, Yulia; Valentin, Jean-Pierre; Williams, Awel; Williams, Dominic; Park, Kevin; Goldring, Christopher

    2013-12-01

    Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. Targeting HIV latency: pharmacologic strategies toward eradication

    Science.gov (United States)

    Xing, Sifei; Siliciano, Robert F.

    2013-01-01

    The latent reservoir for HIV-1 in resting CD4+ T cells remains a major barrier to HIV-1 eradication, even though highly active antiretroviral therapy (HAART) can successfully reduce plasma HIV-1 levels to below the detection limit of clinical assays and reverse disease progression. Proposed eradication strategies involve reactivation of this latent reservoir. Multiple mechanisms are believed to be involved in maintaining HIV-1 latency, mostly through suppression of transcription. These include cytoplasmic sequestration of host transcription factors and epigenetic modifications such as histone deacetylation, histone methylation and DNA methylation. Therefore, strategies targeting these mechanisms have been explored for reactivation of the latent reservoir. In this review, we discuss current pharmacological approaches toward eradication, focusing on small molecule latency-reversing agents, their mechanisms, advantages and limitations. PMID:23270785

  15. Clinical experience with a C-section surgical technique in patients with morbid obesity: a case series

    Directory of Open Access Journals (Sweden)

    Mayra Elena Hernández Carrazco

    2014-07-01

    Full Text Available Obesity is a public health challenge that has crossed into the area of reproductive health. An obese pregnant woman has multiple complications before, during, and after pregnancy. Likewise, cesarean section is more difficult and has slower recovery times in this group of patients. This paper proposes a surgical technique adapted to the morbidly obese pregnant patient that aims to reduce cesarean section complications

  16. Clinical use of sensory gardens and outdoor environments in norwegian nursing homes: a cross-sectional e-mail survey.

    Science.gov (United States)

    Gonzalez, Marianne Thorsen; Kirkevold, Marit

    2015-01-01

    Gardens and outdoor environments offer multiple therapeutic possibilities for the residents in nursing homes. Web-based questionnaires were sent to 488 nursing home leaders and 121 leaders responded. The clinical impressions of the leaders and staff regarding the benefits of sensory gardens (SGs) to the residents were consistent with previous research. SGs facilitated taking residents outdoors, offered convenient topics for communication and facilitated social privacy for relatives. For improved clinical use of SGs and outdoor environments, systematic assessment of residents' interests, performance and experiences when outdoors, implementation of seasonal clinical programmes and educational programmes for leaders and staff are recommended.

  17. Review of pharmacological interactions of oral anticancer drugs provided at pharmacy department

    Directory of Open Access Journals (Sweden)

    E. Sánchez Gómez

    2014-07-01

    Full Text Available Abstract: Objective: To identify the pharmacologic interactions of oral anti-cancer drugs provided at an outpatient clinic. Material and methods: Anti-cancer drugs included in the Phamacotherapeutic Guideline of the Hospital were identified. A literature search was carried out on the pharmacologic interactions in MEDLINE® and EMBASE® (with the filer language English or Spanish, and the descriptors: “name of the anti-cancer drug” AND (“drug interactions” OR “pharmacokinetic”, Up-to-date®, MICROMEDEX® and the drug information sheet for the EMA and the FDA. Information was also gathered from the abstract presented to European and Spanish scientific meetings for the last 4 years. When an interaction was analyzed and had clinical relevance, the best pharmacotherapeutic interaction-free alternative was sought. Results: Twenty-three drugs were identified, of which Chlorambucil, Fludarabine, Lenalidomide, Melphalan, and Thalidomide were the active compounds with the lowest likelihood of producing a pharmacologic interaction. Tyrosine kinase inhibitors (particularly Erlotinib, Imatinib, Lapatinib, and Pazopanib are the drugs with highest number of pharmacologic interactions described, many of them with severe clinical consequences, with increases and decreases of the plasma levels of anti-cancer drugs. The active compounds identified that may have pharmacologic interactions with anticancer drugs were mainly: Allopurinol, Amiodarone, Carbamazepine, Dabigatran, Digoxin, Spironolactone, Phenytoin, Itraconazol, Repaglinide, Silodosin, Tamoxifen, Verapamil, and Warfarin. Pharmacologic interactions through the cytochrome P450 1A2, 2D6, 2C8, 2C9, 3A4 were the most important for tyrosine kinase inhibitors. Other non-pharmacologic compounds, with an important potential of producing relevant pharmacologic interaction were immunomodulators (Echinacea extracts and Hypericum perforatum. Conclusions: Oral anticancer drugs have numerous pharmacologic

  18. Identification of non-tuberculous mycobacteria isolated from clinical specimens at a tertiary care hospital: a cross-sectional study.

    Science.gov (United States)

    Ahmed, Imran; Jabeen, Kauser; Hasan, Rumina

    2013-10-22

    Non-tuberculous mycobacteria (NTM) are opportunistic pathogens in immuno-compromised patients. They are also increasingly recognized as pathogens in immuno-competent individuals. Globally, an increase in NTM isolation is being reported with a varied geographic prevalence of different species around the world. There is lack of data on species distribution of these organisms from Pakistan. Treatment options differ according to the species isolated and its susceptibility profile. Knowledge of local species variation would help targeted therapy. This study was performed to determine frequencies of different NTM species isolated from various clinical specimens submitted at a tertiary care hospital laboratory. NTM isolated from 25955 clinical specimens over a period of two years (2010 to 2011) were included. All NTM were identified using conventional tests. Drug susceptibility testing (DST) was performed by broth microdilution and interpreted according to Clinical and Laboratory Standards Institute's document M24-A2. A total of 104 NTM were included in the study. Of these, 76% (54/71) rapidly growing mycobacteria (RGM) and 57.6% (19/33) slow growing mycobacteria (SGM) could be further identified. Mycobacterium fortuitum (21/54) was the commonest NTM identified among RGM followed by M. mucogenicum (12/54) and M. smegmatis (11/54). Among SGM, M. avium complex (MAC) was the most frequent (14/19). Clinical significance could be assessed in a limited number (52/104) of NTM isolates and MAC appeared to be the commonest significant NTM. Three extra-pulmonary cases were found to be healthcare associated infections. DST results for RGM showed susceptibility to amikacin (100%), clarithromycin (100%, except M. fortuitum where it is not reportable), linezolid (90%) and moxifloxacin (75%). Whereas SGM were susceptible to clarithromycin (100%), linezolid (58.8%) and moxifloxacin (64.7%). This is the first study reporting NTM species and their clinical significance isolated from

  19. Antibiotic prescribing in public and private practice: a cross-sectional study in primary care clinics in Malaysia.

    Science.gov (United States)

    Ab Rahman, Norazida; Teng, Cheong Lieng; Sivasampu, Sheamini

    2016-05-17

    Antibiotic overuse is driving the emergence of antibiotic resistance worldwide. Good data on prescribing behaviours of healthcare providers are needed to support antimicrobial stewardship initiatives. This study examined the differences in antibiotic prescribing rates of public and private primary care clinics in Malaysia. We used data from the National Medical Care Survey (NMCS), a nationwide cluster sample of Malaysian public and private primary care clinics in 2014. NMCS contained demographic, diagnoses and prescribing from 129 public clinics and 416 private clinics. We identified all encounters who were prescribed antibiotic and analyse the prescribing rate, types of antibiotics, and diagnoses that resulted in antibiotic. Five thousand eight hundred ten encounters were prescribed antibiotics; antibiotic prescribing rate was 21.1 % (public clinics 6.8 %, private clinics 30.8 %). Antibiotic prescribing was higher in private clinics where they contributed almost 87 % of antibiotics prescribed in primary care. Upper respiratory tract infection (URTI) was the most frequent diagnosis in patients receiving antibiotic therapy and accounted for 49.2 % of prescriptions. Of the patients diagnosed with URTI, 46.2 % received antibiotic treatment (public 16.8 %, private 57.7 %). Penicillins, cephalosporins and macrolides were the most commonly prescribed antibiotics and accounted for 30.7, 23.6 and 16.0 % of all antibiotics, respectively. More recently available broad-spectrum antibiotics such as azithromycin and quinolones were more frequently prescribed in private clinics. Antibiotic prescribing rates are high in both public and private primary care settings in Malaysia, especially in the latter. This study provides evidence of excessive and inappropriate antibiotic prescribing for self-limiting conditions. These data highlights the needs for more concerted interventions targeting both prescribers and public. Improvement strategies should focus on reducing

  20. Gender bias in clinical case reports: A cross-sectional study of the "big five" medical journals.

    Directory of Open Access Journals (Sweden)

    Pascale Allotey

    Full Text Available Gender bias in medical journals can affect the science and the benefit to patients. It has never been investigated in clinical case reports. The oversight is important because of the role clinical case reports play in hypothesis generation and medical education. We investigated contemporary gender bias in case reports for the highest ranked journals in general and internal medicine.PubMed case reports data from 2011 to 2016 were extracted for the Annals of Internal Medicine, British Medical Journal, the Journal of the American Medical Association, The Lancet, and New England Journal of Medicine. The gender of the patients were identified and a text analysis of the Medical Subject Headings conducted.A total of 2,742 case reports were downloaded and 2,582 (95.6% reports contributed to the final analysis. A pooled analysis showed a statistically significant gender bias against female case reports (0.45; 95%CI: 0.43-0.47. The Annals of Internal Medicine was the only journal with a point estimate (non significant in the direction of a bias against male patients. The text analysis identified no substantive difference in the focus of the case reports and no obvious explanation for the bias.Gender bias, previously identified in clinical research and in clinical authorship, extends into the patients presented in clinical case reports. Whether it is driven by authors or editors is not clear, but it likely contributes to and supports an overall male bias of clinical medicine.

  1. The Role of Pharmacology in Ureteral Physiology and Expulsive Therapy

    Science.gov (United States)

    Jerde, Travis J.; Nakada, Stephen Y.

    2007-04-01

    Research in the field of ureteral physiology and pharmacology has traditionally been directed toward relaxation of ureteral spasm as a mechanism of analgesia during painful ureteral obstruction, most often stone-induced episodes. However, interest in this field has expanded greatly in recent years with the expanded use of alpha-blocker therapy for inducing stone passage, a usage now termed "medical expulsive therapy". While most clinical reports involving expulsive therapy have focused on alpha receptor or calcium channel blockade, there are diverse studies investigating pharmacological ureteral relaxation with novel agents including cyclooxygenase inhibitors, small molecule beta receptor agonists, neurokinin antagonists, and phosphodiesterase inhibitors. In addition, cutting edge molecular biology research is revealing promising potential therapeutic targets aimed at specific molecular changes that occur during the acute obstruction that accompanies stone disease. The purpose of this report is to review the use of pharmacological agents as ureteral smooth muscle relaxants clinically, and to look into the future of expulsive therapy by reviewing the available literature of ureteral physiology and pharmacology research.

  2. Gaultheria: Phytochemical and Pharmacological Characteristics

    Directory of Open Access Journals (Sweden)

    Ren-Bing Shi

    2013-09-01

    Full Text Available The genus Gaultheria, comprised of approximately 134 species, is mostly used in ethnic drugs to cure rheumatism and relieve pain. Phytochemical investigations of the genus Gaultheria have revealed the presence of methyl salicylate derivatives, C6-C3 constituents, organic acids, terpenoids, steroids, and other compounds. Methyl salicylate glycoside is considered as a characteristic ingredient in this genus, whose anti-rheumatic effects may have a new mechanism of action. In this review, comprehensive information on the phytochemistry, volatile components and the pharmacology of the genus Gaultheria is provided to explore its potential and advance research.

  3. O tratamento farmacológico do transtorno bipolar: uma revisão sistemática e crítica dos aspectos metodológicos dos estudos clínicos modernos The pharmacological treatment of bipolar disorder: a systematic and critical review of the methodological aspects of modern clinical trials

    Directory of Open Access Journals (Sweden)

    Elie Cheniaux

    2011-03-01

    Full Text Available OBJETIVO: Revisar sistematicamente os principais estudos clínicos sobre o tratamento farmacológico do transtorno bipolar e fazer uma análise crítica de seus aspectos metodológicos. MÉTODO: Realizou-se uma busca nas bases de dados Medline, ISI e PsycINFO, utilizando-se os seguintes termos de busca: "bipolar", "randomized", "placebo" e "controlled". Foram selecionados estudos clínicos randomizados, duplo-cegos e controlados por placebo sobre o tratamento farmacológico do transtorno bipolar. Além disso, de acordo com os nossos critérios, as amostras deveriam ser de no mínimo 100 pacientes e a substância testada deveria ser usada como monoterapia. RESULTADOS: 34 artigos se adequaram aos critérios de seleção. Todas as substâncias atualmente indicadas para mania, depressão bipolar e para o tratamento de manutenção foram mais eficazes que o placebo em pelo menos um estudo. Todavia, esses estudos tiveram amostras altamente selecionadas, altas taxas de abandono e baixas taxas de resposta clínica. CONCLUSÃO: Os modernos estudos clínicos sobre o tratamento farmacológico do transtorno bipolar apresentam algumas importantes limitações metodológicas. Assim, seus resultados devem ser considerados com cautela.OBJECTIVE: To review systematically the main clinical trials on the pharmacological treatment of bipolar disorder and to make a critical analysis of their methodological aspects. METHOD: A search in Medline, ISI and PsycINFO databases was conducted, using the following search terms: "bipolar", "randomized", "placebo" e "controlled". Randomized, double-blind, placebo-controlled clinical trials on the pharmacological treatment of bipolar disorder were selected. Besides, according to our criteria, samples had to consist of at least 100 patients and experimental drug had to be used as monotherapy. RESULTS: 34 articles met our selection criteria. All drugs currently indicated for mania, bipolar depression and maintenance treatment of

  4. Targeting Adenosine Signaling in Parkinson's Disease: From Pharmacological to Non-pharmacological Approaches

    Directory of Open Access Journals (Sweden)

    Luiza R. Nazario

    2017-11-01

    Full Text Available Parkinson's disease (PD is one of the most prevalent neurodegenerative disease displaying negative impacts on both the health and social ability of patients and considerable economical costs. The classical anti-parkinsonian drugs based in dopaminergic replacement are the standard treatment, but several motor side effects emerge during long-term use. This mini-review presents the rationale to several efforts from pre-clinical and clinical studies using adenosine receptor antagonists as a non-dopaminergic therapy. As several studies have indicated that the monotherapy with adenosine receptor antagonists reaches limited efficacy, the usage as a co-adjuvant appeared to be a promising strategy. The formulation of multi-targeted drugs, using adenosine receptor antagonists and other neurotransmitter systems than the dopaminergic one as targets, have been receiving attention since Parkinson's disease presents a complex biological impact. While pharmacological approaches to cure or ameliorate the conditions of PD are the leading strategy in this area, emerging positive aspects have arisen from non-pharmacological approaches and adenosine function inhibition appears to improve both strategies.

  5. Pharmacological treatment of cardiac glycoside poisoning.

    Science.gov (United States)

    Roberts, Darren M; Gallapatthy, Gamini; Dunuwille, Asunga; Chan, Betty S

    2016-03-01

    Cardiac glycosides are an important cause of poisoning, reflecting their widespread clinical usage and presence in natural sources. Poisoning can manifest as varying degrees of toxicity. Predominant clinical features include gastrointestinal signs, bradycardia and heart block. Death occurs from ventricular fibrillation or tachycardia. A wide range of treatments have been used, the more common including activated charcoal, atropine, β-adrenoceptor agonists, temporary pacing, anti-digoxin Fab and magnesium, and more novel agents include fructose-1,6-diphosphate (clinical trial in progress) and anticalin. However, even in the case of those treatments that have been in use for decades, there is debate regarding their efficacy, the indications and dosage that optimizes outcomes. This contributes to variability in use across the world. Another factor influencing usage is access. Barriers to access include the requirement for transfer to a specialized centre (for example, to receive temporary pacing) or financial resources (for example, anti-digoxin Fab in resource poor countries). Recent data suggest that existing methods for calculating the dose of anti-digoxin Fab in digoxin poisoning overstate the dose required, and that its efficacy may be minimal in patients with chronic digoxin poisoning. Cheaper and effective medicines are required, in particular for the treatment of yellow oleander poisoning which is problematic in resource poor countries. © 2015 The British Pharmacological Society.

  6. Safety pharmacology — Current and emerging concepts

    International Nuclear Information System (INIS)

    Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor; Alfirevic, Ana; Alhaidari, Mohammad; Atkinson, Jeffrey; Ayala, Mimieveshiofuo; Box, Helen; Cross, Michael; Delaunois, Annie; Dermody, Ailsa; Govindappa, Karthik; Guillon, Jean-Michel; Jenkins, Rosalind; Kenna, Gerry; Lemmer, Björn; Meecham, Ken; Olayanju, Adedamola; Pestel, Sabine; Rothfuss, Andreas

    2013-01-01

    Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. - Highlights: • SP — mandatory non-clinical risk assessments performed during drug development. • SP organ system studies ensure the safety of clinical participants in FiH trials. • Frontloading in SP facilitates lead candidate drug selection. • Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests

  7. Safety pharmacology — Current and emerging concepts

    Energy Technology Data Exchange (ETDEWEB)

    Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor; Alfirevic, Ana; Alhaidari, Mohammad [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Atkinson, Jeffrey [Lorraine University Pharmacolor Consultants Nancy PCN (France); Ayala, Mimieveshiofuo; Box, Helen; Cross, Michael [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Delaunois, Annie [UCB Pharma (Belgium); Dermody, Ailsa; Govindappa, Karthik [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Guillon, Jean-Michel [Sanofi-aventis (France); Jenkins, Rosalind [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Kenna, Gerry [Astra-Zeneca (United Kingdom); Lemmer, Björn [Ruprecht-Karls-Universität Heidelberg (Germany); Meecham, Ken [Huntingdon Life Sciences (United Kingdom); Olayanju, Adedamola [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Pestel, Sabine [Boehringer-Ingelheim (Germany); Rothfuss, Andreas [Roche (Switzerland); and others

    2013-12-01

    Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. - Highlights: • SP — mandatory non-clinical risk assessments performed during drug development. • SP organ system studies ensure the safety of clinical participants in FiH trials. • Frontloading in SP facilitates lead candidate drug selection. • Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests.

  8. Systematic Reviews Published in Emergency Medicine Journals Do Not Routinely Search Clinical Trials Registries: A Cross-Sectional Analysis.

    Science.gov (United States)

    Keil, Lukas G; Platts-Mills, Timothy F; Jones, Christopher W

    2015-10-01

    Publication bias compromises the validity of systematic reviews. This problem can be addressed in part through searching clinical trials registries to identify unpublished studies. This study aims to determine how often systematic reviews published in emergency medicine journals include clinical trials registry searches. We identified all systematic reviews published in the 6 highest-impact emergency medicine journals between January 1 and December 31, 2013. Systematic reviews that assessed the effects of an intervention were further examined to determine whether the authors described searching a clinical trials registry and whether this search identified relevant unpublished studies. Of 191 articles identified through PubMed search, 80 were confirmed to be systematic reviews. Our sample consisted of 41 systematic reviews that assessed a specific intervention. Eight of these 41 (20%) searched a clinical trials registry. For 4 of these 8 reviews, the registry search identified at least 1 relevant unpublished study. Systematic reviews published in emergency medicine journals do not routinely include searches of clinical trials registries. By helping authors identify unpublished trial data, the addition of registry searches may improve the validity of systematic reviews. Copyright © 2014 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  9. Patterns of Hepatosplenic Brucella Abscesses on Cross-Sectional Imaging: A Review of Clinical and Imaging Features

    NARCIS (Netherlands)

    Heller, Tom; Bélard, Sabine; Wallrauch, Claudia; Carretto, Edoardo; Lissandrin, Raffaella; Filice, Carlo; Brunetti, Enrico

    2015-01-01

    While diffuse involvement of liver and spleen is frequently seen in brucellosis, suppurative abscesses caused by Brucella are less common but well described. With the increased availability of cross-sectional imaging techniques, reports have become more frequent. Four patients with hepatosplenic

  10. Risk factors and pre-travel healthcare of international travellers attending a Dutch travel clinic: a cross-sectional analysis

    NARCIS (Netherlands)

    Wieten, Rosanne W.; van der Schalie, Maurice; Visser, Benjamin J.; Grobusch, Martin P.; van Vugt, Michèle

    2014-01-01

    The number of international travellers is currently estimated to exceed one billion annually. To address travel related health risks and facilitate risk reduction strategies, detailed knowledge of travellers' characteristics is important. In this cross-sectional study, data of a 20% sample of

  11. Êxtase (MDMA: efeitos farmacológicos e tóxicos, mecanismo de ação e abordagem clínica Ecstasy (MDMA: pharmacological and toxic effects, mechanism of action and clinical management

    Directory of Open Access Journals (Sweden)

    Caroline Addison Carvalho Xavier

    2008-01-01

    Full Text Available CONTEXTO: O 3,4-metilenodioximetanfetamina (MDMA, êxtase é um derivado da anfetamina, cujo consumo por jovens tem aumentado. OBJETIVOS: Conduzir uma revisão de literatura sobre os aspectos farmacológicos e fisiopatológicos do MDMA, incluindo o mecanismo de ação que possa explicar os efeitos neurotóxicos e a toxicidade aguda e a longo prazo. MÉTODOS: Revisão da literatura usando as palavras-chave: 3,4-methylenedioxymethamphetamine, ecstasy, neurotoxicity, intoxication, drug abuse, por intermédio do MEDLINE e LILACS. A busca incluiu todos os artigos publicados no período entre 1985 e 2007. RESULTADOS: Ainda existem muitas questões sem respostas sobre a farmacologia do êxtase e a fisiopatologia dos efeitos tóxicos dessa substância. A simples descrição do mecanismo de ação é insuficiente para explicar todos os efeitos induzidos pelo êxtase. O mecanismo exato responsável por mediar os efeitos tóxicos do MDMA sobre os neurônios da serotonina precisa ser elucidado. CONCLUSÕES: Existem poucas informações na literatura sobre a farmacologia e o mecanismo de ação do MDMA que possam explicar os efeitos neurotóxicos e outros efeitos fisiopatológicos. São necessários mais estudos para que o profissional de saúde possa obter informações e conhecimentos a fim de combater os efeitos terríveis do êxtase na população jovem vulnerável.BACKGROUND: The consumption of the amphetamine derivative 3,4-methylenedioxymethamphetamine (MDMA, ecstasy by young people increased in the past years. OBJECTIVES: To conduct a literature review on the pharmacology of MDMA and particularly with respect to the putative mechanism of action implicated in the acute and long-term toxicity and neurotoxic effects. METHODS: A literature review using the key words: 3,4-methylenedioxymethamphetamine, ecstasy, neurotoxicity, intoxication, abuse drugs was performed in the databases MEDLINE and LILACS. The search covered all articles published between 1985

  12. Does carbetocin for prevention of postpartum haemorrhage at caesarean section provide clinical or financial benefit compared with oxytocin?

    Science.gov (United States)

    Higgins, L; Mechery, J; Tomlinson, A J

    2011-11-01

    Postpartum haemorrhage is a major cause of maternal morbidity and mortality worldwide. A recent Cochrane review of carbetocin (long-acting oxytocin analogue) concluded that its use decreased additional uterotonic requirements, however, no included studies compared its use against intravenous bolus oxytocin. The majority of studies of carbetocin have considered its use in vaginal delivery; no studies have examined the economic implications of its use. This study describes a clinical and financial evaluation undertaken at a United Kingdom District General Hospital surrounding the introduction of carbetocin for prophylaxis against postpartum haemorrhage at caesarean deliveries. A range of clinical outcomes were observed including frequency of postpartum haemorrhage, estimated blood loss, transfusion requirements, change in haemoglobin or haemodynamics, use of additional uterotonics and perioperative recovery. Finally, a composite financial analysis was performed. No clinically significant benefit was found, however associated costs increased by £18.52/patient.

  13. Radioimmunoassay in clinical practice

    Energy Technology Data Exchange (ETDEWEB)

    Ametov, A S

    1982-01-01

    A wide application of radioimmunoassay in clinical practice is shown. The main theoretical aspects of radioimmunoassay and the fields of application in clinical practice - endocrinology, oncology, allergology, cardiology, pharmacology, pediatrics, hematology, obstetrics and gynecology, are presented.

  14. The Effectiveness of Pharmacological and Non-Pharmacological Interventions for Improving Glycaemic Control in Adults with Severe Mental Illness: A Systematic Review and Meta-Analysis

    OpenAIRE

    Taylor, Johanna; Stubbs, Brendon; Hewitt, Catherine; Ajjan, Ramzi A.; Alderson, Sarah L.; Gilbody, Simon; Holt, Richard I. G.; Hosali, Prakash; Hughes, Tom; Kayalackakom, Tarron; Kellar, Ian; Lewis, Helen; Mahmoodi, Neda; McDermid, Kirstine; Smith, Robert D.

    2017-01-01

    People with severe mental illness (SMI) have reduced life expectancy compared with the general population, which can be explained partly by their increased risk of diabetes. We conducted a meta-analysis to determine the clinical effectiveness of pharmacological and non-pharmacological interventions for improving glycaemic control in people with SMI (PROSPERO registration: CRD42015015558). A systematic literature search was performed on 30/10/2015 to identify randomised controlled trials (RCTs...

  15. Expanding the Aperture of Psychological Assessment: Introduction to the Special Section on Innovative Clinical Assessment Technologies and Methods

    Science.gov (United States)

    Trull, Timothy J.

    2007-01-01

    Contemporary psychological assessment is dominated by tried-and-true methods like clinical interviewing, self-report questionnaires, intellectual assessment, and behavioral observation. These approaches have served as the mainstays of psychological assessment for decades. To be sure, these methods have survived over the years because clinicians…

  16. Depression and heart failure associated with clinical COPD questionnaire outcome in primary care COPD patients : A cross-sectional study

    NARCIS (Netherlands)

    Urff, Manon; Van Den Berg, Jan Willem K; Uil, Steven M.; Chavannes, Niels H.; Damoiseaux, Roger Amj

    2014-01-01

    BACKGROUND: Improvement in health-related quality of life (HRQoL) is one of the main goals in treating chronic obstructive pulmonary disease (COPD). Impaired HRQoL in COPD is associated with increased morbidity and mortality, hospitalisations and burden on our health-care system. The Clinical COPD

  17. Knowledge and Practices of Toxoplasmosis among Clinical Laboratory Professionals: A Cross-Sectional Study in Durango, Mexico.

    Science.gov (United States)

    Alvarado-Esquivel, Cosme; Sánchez-Anguiano, Luis Francisco; Berumen-Segovia, Luis Omar; Hernández-Tinoco, Jesús; Rico-Almochantaf, Yazmin Del Rosario; Cisneros-Camacho, Alfredo; Cisneros-Martínez, Jorge Arturo

    2017-11-18

    Background : The aim of this study was to determine the level of knowledge and practices about toxoplasmosis in a sample of clinical laboratory professionals in Mexico. Methods : 192 clinical laboratory professionals were surveyed. They were asked about (1) Toxoplasma gondii ; (2) clinical manifestations, diagnosis, treatment, and epidemiology of toxoplasmosis; and (3) their practices with respect to toxoplasmosis. Results : The range of animals infected by T. gondii was known by 44.8% of participants. Clinical aspects of toxoplasmosis were known by up to 44.3% of subjects. Correct answers about the interpretation of serological markers of T. gondii infection were provided by up to 32.8% of participants. A minority (32.2%) of participants knew about a high number of false positive results of anti- T. gondii IgM antibody tests. Most participants (90.1%) did not know what the anti- T. gondii IgG avidity test was. Up to 55.7% of participants provided incorrect answers about the interpretation of serology tests for the treatment of pregnant women. Common routes of T. gondii infection were known by toxoplasmosis and a limited practice of laboratory tests among the professionals surveyed.

  18. Mindfulness training for medical students in their clinical clerkships: two cross-sectional studies exploring interest and participation

    NARCIS (Netherlands)

    Dijk, I. van; Lucassen, P.L.B.J.; Speckens, A.E.M.

    2015-01-01

    BACKGROUND: So far, studies investigating Mindfulness Based Stress Reduction (MBSR) training in medical students are conducted in self-selected, pre-clinical samples, with modest response rates without collecting data on non-participants. This study first examines interest and participation rates of

  19. Pharmacological and non- pharmacological treatment of hypertension: A review article

    Directory of Open Access Journals (Sweden)

    Marjan Seyedmazhari

    2013-01-01

    Full Text Available BACKGROUND: Hypertension is a worldwide epidemic disease. It is more common and more severe in elderly persons. Various studies however have estimated 41.9 million men and 27.8 million women to have prehypertension. Diagnosis and early treatment of prehypertension are of utmost importance. Although hypertension is usually divided into 2 general categories of essential (primary and secondary hypertension, the initial treatment for hypertension often depends on its stage which is determined by systolic and diastolic blood pressure. Lifestyle modification is the first step in treating stage one hypertension. Pharmaceutical treatments including diuretics, angiotensin converting enzyme (ACE inhibitors, calcium blockers, beta blockers, and angiotensin receptor blockers will be recommended if lifestyle modification fails to control blood pressure.    METHODS: The PubMed database was searched by a number of keywords including hypertension, pharmaceutical treatment, and non-pharmaceutical treatment. The results were limited by determining a date range of 2008-11.    RESULTS: High blood pressure causes major health problems for many people around the world. It should be controlled because of its high mortality and morbidity. However, in order to select an appropriate treatment modality, it is initially important to diagnose the kinds and stages of hypertension. Pharmaceutical or non-pharmaceutical treatments can then be employed to control this serious disease.    CONCLUSION: Treating hypertension depends on the kinds and stages of this disease. Several tips should be considered when selecting a method of treatment.       Keywords: Hypertension, Pharmacological treatment, Non-pharmacological treatment

  20. Dentists' perception, knowledge, and clinical management of molar-incisor-hypomineralisation in Kuwait: a cross-sectional study.

    Science.gov (United States)

    Alanzi, Abrar; Faridoun, Anfal; Kavvadia, Katerina; Ghanim, Aghareed

    2018-03-07

    Molar-incisor Hypomineralisation (MIH) is considered as a global dental problem. There is little knowledge of general dental practitioners (GDPs) and dental specialists (DSs) about this condition in different parts of the world, particularly in Gulf Cooperation Council (GCC) countries. Hence, this study has been carried out to assess the knowledge of GDPS and DSs in Kuwait about MIH condition, its clinical presentation and management. Findings would help national school oral health program (SOHP) to promote good oral healthcare. A structured questionnaire was distributed to 310 attendees of the 18th Kuwait Dental Association Scientific Conference, Kuwait. Data concerning demographic variables, prevalence, diagnosis, severity, training demands and clinical management of MIH were collected. A response rate of 71.3% (221/310) was reported. 94% of respondents noticed MIH in their practice. Yellow/brown demarcation has been observed as a common clinical presentation (> 50%). Almost 10-20% of MIH prevalence has been reported by the participants. Resin composite was the dental material often used in treating MIH teeth (~ 65%), and fewer than half would use it for treating moderately affected molars. Most respondents would use preformed metal crowns for severe MIH (63%). Dental journals were the information source for DSs; whereas, the internet was the information source for GDPs. Child's behaviour was the main reported barrier for treatment of MIH affected children. Many GDPs felt unconfident when diagnosing MIH compared to dental specialists. Respondents supported the need to investigate MIH prevalence and to receive a clinical training. Molar incisor hypomineralisation is a recognised dental condition by practitioners in Kuwait. Yellow/brown demarcated opacities were the most reported clinical presentation, and the composite resin was the most preferred dental material for restoring MIH teeth. Most GDPs and dental specialists would use preformed metal crowns for

  1. Clinical Observation on Termination of Early Pregnancy of 213 Cases after Caesarian Section with Repeated Use of Mifepristone and Misoprostol

    Institute of Scientific and Technical Information of China (English)

    高佩佩; 汪平

    1999-01-01

    Objective To investigate the efficacy and safety in women after caesarian section for termination of early pregnancies by treatment, or repeated treatment with mifepristone and misoprostot.Subjects and Methods A total of 213 pregnant women with amenorrhea of 34-69d after caesarian section who asked for medical abortion were recruited,including 63 cases undergoing their second medical abortion.A total amount of mi feprisstone of 150 mg given in separate doses(25 mg×4 and 50 mg at the first time)was administered orally within 3d, followed by misoprostot of 0.6 mg orally in the morning of d 3.Results The complete abortion rate was 92.5%,incomplete abortion was 4.7% and failure was 2.8%.Conclusion The sequential use of mifepristone and misoprostol could be successfully and repeatedly used for induced abortion in those women with a caesarian section histo-ry.Its efficacy was similar to that for ordinary population.Its safety and effec-tiveness were satisfactory.

  2. Non-­‐pharmacological treatment of ankylosing spondylitis: Barriers to effective implementation of recommendations in Morocco

    Directory of Open Access Journals (Sweden)

    Abderrazak Hajjioui

    2014-05-01

    Full Text Available This cross-sectional study aimed to describe non--‐pharmacological treatment modalities in Moroccan patients with ankylosing spondylitis (AS, and to approach physical therapy implementation barriers. 61 patients with AS according to New York classification criteria were included in the study. Socio-demographic data and clinical characteristics were collected and different therapeutic modalities, including physical therapy were investigated. The mean age of the patients was 38.20 (SD 12.36 years with a male/female ratio of 1.5. 55 (90% patients received pharmacological therapy, 37 (60.7% received physical therapy, 5(8.2% underwent surgery and 36 (59% tried at least one type of complementary medicine (medicine plants, sand baths, acupuncture, fire needles, and cupping. Patients’ major expectations from physical therapy were improving their functional status (86.5%, and reducing their pain (59.5%. Most patients (86.49% were satisfied of their physical therapy and 56.8% practiced home exercises. Reasons for nonattendance to physical therapy for the remaining 24 patients were nonprescription (58.3%, lack of financial resources (20.8%, geographical remoteness from rehabilitation centers (4% and lack of motivation (17%. Non-pharmacological treatment, especially based on exercise and education, is an integral part of the comprehensive management of AS. However, it is not efficiently implemented in Morocco and more effort should be made to develop this both efficient and relatively inexpensive component of AS treatment.

  3. Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis.

    Science.gov (United States)

    Pradhan, Richeek; Singh, Sonal

    2018-04-11

    Inconsistencies in data on serious adverse events (SAEs) and mortality in ClinicalTrials.gov and corresponding journal articles pose a challenge to research transparency. The objective of this study was to compare data on SAEs and mortality from clinical trials reported in ClinicalTrials.gov and corresponding journal articles with US Food and Drug Administration (FDA) medical reviews. We conducted a cross-sectional study of a randomly selected sample of new molecular entities approved during the study period 1 January 2013 to 31 December 2015. We extracted data on SAEs and mortality from 15 pivotal trials from ClinicalTrials.gov and corresponding journal articles (the two index resources), and FDA medical reviews (reference standard). We estimated the magnitude of deviations in rates of SAEs and mortality between the index resources and the reference standard. We found deviations in rates of SAEs (30% in ClinicalTrials.gov and 30% in corresponding journal articles) and mortality (72% in ClinicalTrials.gov and 53% in corresponding journal articles) when compared with the reference standard. The intra-class correlation coefficient between the three resources was 0.99 (95% confidence interval [CI] 0.98-0.99) for SAE rates and 0.99 (95% CI 0.97-0.99) for mortality rates. There are differences in data on rates of SAEs and mortality in randomized clinical trials in both ClinicalTrials.gov and journal articles compared with FDA reviews. Further efforts should focus on decreasing existing discrepancies to enhance the transparency and reproducibility of data reporting in clinical trials.

  4. Spatial distribution of clinical computer systems in primary care in England in 2016 and implications for primary care electronic medical record databases: a cross-sectional population study.

    Science.gov (United States)

    Kontopantelis, Evangelos; Stevens, Richard John; Helms, Peter J; Edwards, Duncan; Doran, Tim; Ashcroft, Darren M

    2018-02-28

    UK primary care databases (PCDs) are used by researchers worldwide to inform clinical practice. These databases have been primarily tied to single clinical computer systems, but little is known about the adoption of these systems by primary care practices or their geographical representativeness. We explore the spatial distribution of clinical computing systems and discuss the implications for the longevity and regional representativeness of these resources. Cross-sectional study. English primary care clinical computer systems. 7526 general practices in August 2016. Spatial mapping of family practices in England in 2016 by clinical computer system at two geographical levels, the lower Clinical Commissioning Group (CCG, 209 units) and the higher National Health Service regions (14 units). Data for practices included numbers of doctors, nurses and patients, and area deprivation. Of 7526 practices, Egton Medical Information Systems (EMIS) was used in 4199 (56%), SystmOne in 2552 (34%) and Vision in 636 (9%). Great regional variability was observed for all systems, with EMIS having a stronger presence in the West of England, London and the South; SystmOne in the East and some regions in the South; and Vision in London, the South, Greater Manchester and Birmingham. PCDs based on single clinical computer systems are geographically clustered in England. For example, Clinical Practice Research Datalink and The Health Improvement Network, the most popular primary care databases in terms of research outputs, are based on the Vision clinical computer system, used by <10% of practices and heavily concentrated in three major conurbations and the South. Researchers need to be aware of the analytical challenges posed by clustering, and barriers to accessing alternative PCDs need to be removed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  5. Physiological and Pharmacological Aspects of the Vas Deferens - an Update

    Directory of Open Access Journals (Sweden)

    David Stewart Koslov

    2013-08-01

    Full Text Available The vas deferens, a muscular conduit conveying spermatozoa from the epididymis to the urethra, has been used as a model tissue for smooth muscle pharmacological and physiological advancements. Many drugs, notably α-adrenergic antagonists, have effects on contractility and thus normal ejaculation, incurring significant side effects for patients that may interfere with compliance. A more thorough understanding of the innervation and neurotransmitter pharmacology of the vas has indicated that this is a highly complex structure and a model for co-transmission at the synapse. Recent models have shown clinical scenarios that alter the vas contraction. This review covers structure, receptors, neurotransmitters, smooth muscle physiology, and clinical implications of the vas deferens.

  6. Perceptions of clinical safety climate of the multicultural nursing workforce in Saudi Arabia: a cross-sectional survey.

    Science.gov (United States)

    Almutairi, Adel F; Gardner, Glenn; McCarthy, Alexandra

    2013-01-01

    The purpose of this study is to explore the safety climate perceptions of the multicultural nursing workforce, and to investigate the influence of diversity of the multicultural nursing workforce on clinical safety in a large tertiary hospital in Saudi Arabia. Working in a multicultural environment is challenging. Each culture has its own unique characteristics and dimensions that shape the language, lifestyle, beliefs, values, customs, traditions, and patterns of behaviour, which expatriate nurses must come to terms with. However, cultural diversity in the health care environment can potentially affect the quality of care and patient safety. A mixed-method case study (survey, interview and document analysis) was employed. A primary study phase entailed the administration of the Safety Climate Survey (SCS). A population sampling strategy was used and 319 nurses participated, yielding a 76.8% response rate. Descriptive and inferential statistics (Kruskal-Wallis test) were used to analyse survey data. The data revealed the nurses' perceptions of the clinical safety climate in this multicultural environment was unsafe, with a mean score of 3.9 out of 5. No significant difference was found between the age groups, years of nursing experience and their perceptions of the safety climate in this context. A significant difference was observed between the national background categories of nurses and perceptions of safety climate. Cultural diversity within the nursing workforce could have a significant influence on perceptions of clinical safety. These findings have the potential to inform policy and practice related to cultural diversity in Saudi Arabia.

  7. Pharmacological challenges in chronic pancreatitis

    DEFF Research Database (Denmark)

    Olesen, Anne Estrup; Brokjaer, Anne; Fischer, Iben Wendelboe Deleuran

    2014-01-01

    food intake is more or less substituted with alcohol, tobacco and coffee. Alcohol and drug interaction are known to influence the pharmacokinetics by altering either drug absorption or by affecting liver metabolism. Since patients suffering from chronic pancreatitis experience severe pain, opioids......Drug absorption in patients with chronic pancreatitis might be affected by the pathophysiology of the disease. The exocrine pancreatic insufficiency is associated with changes in gastrointestinal intraluminal pH, motility disorder, bacterial overgrowth and changed pancreatic gland secretion....... Together these factors can result in malabsorption and may also affect the efficacy of pharmacological intervention. The lifestyle of chronic pancreatitis patients may also contribute to gastrointestinal changes. Many patients limit their food intake because of the pain caused by eating and in some cases...

  8. Pharmacological challenges in chronic pancreatitis

    DEFF Research Database (Denmark)

    Olesen, Anne Estrup; Brokjaer, Anne; Fischer, Iben Wendelboe Deleuran

    2014-01-01

    food intake is more or less substituted with alcohol, tobacco and coffee. Alcohol and drug interaction are known to influence the pharmacokinetics by altering either drug absorption or by affecting liver metabolism. Since patients suffering from chronic pancreatitis experience severe pain, opioids....... Together these factors can result in malabsorption and may also affect the efficacy of pharmacological intervention. The lifestyle of chronic pancreatitis patients may also contribute to gastrointestinal changes. Many patients limit their food intake because of the pain caused by eating and in some cases......Drug absorption in patients with chronic pancreatitis might be affected by the pathophysiology of the disease. The exocrine pancreatic insufficiency is associated with changes in gastrointestinal intraluminal pH, motility disorder, bacterial overgrowth and changed pancreatic gland secretion...

  9. The main directions of pharmacological correction of radioinduced scleroses

    International Nuclear Information System (INIS)

    Dubrovskaya, V.F.

    1991-01-01

    Results of clinical and experimental research on pharmacological correction of radiationinduced sclerosis were summarized. Efficiency of prophylaxis main trends and drug therapy was analyzed. Application of specific pharmaceuticals (preparations directly affecting certain chains of collagen metabolism) and nonspecific pharmaceuticals (preparations of indirect affect on collagen metabolism) was given. Further research of specific pharmaceuticals was shown to be expedient. Analysis of nonspecific pharmaceuticals used in complex therapy revealed problems in evaluating their efficiency at various stages of sclerosis development

  10. Tinnitus: Network pathophysiology-network pharmacology

    Directory of Open Access Journals (Sweden)

    Ana Belen eElgoyhen

    2012-01-01

    Full Text Available Tinnitus, the phantom perception of sound, is a prevalent disorder. One in 10 adults has clinically significant subjective tinnitus, and for 1 in 100, tinnitus severely affects their quality of life. Despite the significant unmet clinical need for a safe and effective drug targeting tinnitus relief, there is currently not a single FDA-approved drug on the market. The search for drugs that target tinnitus is hampered by the lack of a deep knowledge of the underlying neural substrates of this pathology. Recent studies are increasingly demonstrating that, as described for other central nervous system disorders, tinnitus is a pathology of brain networks. The application of graph theoretical analysis to brain networks has recently provided new information concerning their topology, their robustness and their vulnerability to attacks. Moreover, the philosophy behind drug design and pharmacotherapy in central nervous system pathologies is changing from that of magic bullets that target individual chemoreceptors or disease-causing genes into that of magic shotguns, promiscuous or dirty drugs that target disease-causing networks, also known as network pharmacology. In the present work we provide some insight into how this knowledge could be applied to tinnitus pathophysiology and pharmacotherapy.

  11. Tinnitus: network pathophysiology-network pharmacology.

    Science.gov (United States)

    Elgoyhen, Ana B; Langguth, Berthold; Vanneste, Sven; De Ridder, Dirk

    2012-01-01

    Tinnitus, the phantom perception of sound, is a prevalent disorder. One in 10 adults has clinically significant subjective tinnitus, and for one in 100, tinnitus severely affects their quality of life. Despite the significant unmet clinical need for a safe and effective drug targeting tinnitus relief, there is currently not a single Food and Drug Administration (FDA)-approved drug on the market. The search for drugs that target tinnitus is hampered by the lack of a deep knowledge of the underlying neural substrates of this pathology. Recent studies are increasingly demonstrating that, as described for other central nervous system (CNS) disorders, tinnitus is a pathology of brain networks. The application of graph theoretical analysis to brain networks has recently provided new information concerning their topology, their robustness and their vulnerability to attacks. Moreover, the philosophy behind drug design and pharmacotherapy in CNS pathologies is changing from that of "magic bullets" that target individual chemoreceptors or "disease-causing genes" into that of "magic shotguns," "promiscuous" or "dirty drugs" that target "disease-causing networks," also known as network pharmacology. In the present work we provide some insight into how this knowledge could be applied to tinnitus pathophysiology and pharmacotherapy.

  12. Pharmacology of human experimental anxiety

    Directory of Open Access Journals (Sweden)

    F.G. Graeff

    2003-04-01

    Full Text Available This review covers the effect of drugs affecting anxiety using four psychological procedures for inducing experimental anxiety applied to healthy volunteers and patients with anxiety disorders. The first is aversive conditioning of the skin conductance responses to tones. The second is simulated public speaking, which consists of speaking in front of a video camera, with anxiety being measured with psychometric scales. The third is the Stroop Color-Word test, in which words naming colors are painted in the same or in a different shade, the incongruence generating a cognitive conflict. The last test is a human version of a thoroughly studied animal model of anxiety, fear-potentiated startle, in which the eye-blink reflex to a loud noise is recorded. The evidence reviewed led to the conclusion that the aversive conditioning and potentiated startle tests are based on classical conditioning of anticipatory anxiety. Their sensitivity to benzodiazepine anxiolytics suggests that these models generate an emotional state related to generalized anxiety disorder. On the other hand, the increase in anxiety determined by simulated public speaking is resistant to benzodiazepines and sensitive to drugs affecting serotonergic neurotransmission. This pharmacological profile, together with epidemiological evidence indicating its widespread prevalence, suggests that the emotional state generated by public speaking represents a species-specific response that may be related to social phobia and panic disorder. Because of scant pharmacological data, the status of the Stroop Color-Word test remains uncertain. In spite of ethical and economic constraints, human experimental anxiety constitutes a valuable tool for the study of the pathophysiology of anxiety disorders.

  13. A Cross-sectional Survey and Cross-sectional Clinical Trial to Determine the Prevalence and Management of Eye Movement Disorders and Vestibular Dysfunction in Post-Stroke Patients in the Sub-Acute Phase: Protocol.

    Science.gov (United States)

    van Wyk, Andoret; Eksteen, Carina A; Becker, Piet J; Heinze, Barbara M

    2016-01-01

    Visual impairment, specifically eye movement disorders and vestibular dysfunction may have a negative influence on the functional recovery in post-stroke patients. This type of sensory dysfunction may further be associated with poor functional outcome in patients' post-stroke. In phase 1, a cross-sectional survey ( n  = 100) will be conducted to determine the prevalence of eye movement disorders and vestibular dysfunction in patients who sustained a stroke. A cross-sectional clinical trial ( n  = 60) will be conducted during phase 2 of the study to determine the effect of the combination of vestibular rehabilitation therapy (VRT) and visual scanning exercises (VSE) (experimental group) integrated with task-specific activities compared with the effect of task-specific activities as an intervention (control group) on patients who present with eye movement impairment and central vestibular dysfunction post-stroke. An audiologist will assess (a) visual acuity (static and dynamic), (b) nystagmus, (c) saccadic eye movements, (d) smooth pursuit eye movements, (e) vestibulo-ocular reflex, and (f) saccular, utricular, and vestibular nerve function. An independent physiotherapist will assess (1) cognitive function, (2) residual oculomotor visual performance, (3) visual-perceptual system, (4) functional balance, (5) gait, (6) functional ability, (7) presence of anxiety and/or depression, and (8) level of participation in physical activity. Ethics approval has been obtained from the Ethics Committee of the Faculty of Health Sciences at the University of Pretoria (UP) (374/2015). The study will be submitted as fulfillment for the PhD degree at UP. Dissemination will include submission to peer-reviewed professional journals and presentation at congresses. Training of rehabilitation team members on the integration of VSE and VRT into task-specific activities in rehabilitation will be done if the outcome of the experimental group's functional performance is clinically and

  14. Clinically Significant Prostate Cancer Local Recurrence After Radiation Therapy Occurs at the Site of Primary Tumor: Magnetic Resonance Imaging and Step-Section Pathology Evidence

    International Nuclear Information System (INIS)

    Pucar, Darko; Hricak, Hedvig; Shukla-Dave, Amita; Kuroiwa, Kentaro; Drobnjak, Marija; Eastham, James; Scardino, Peter T.; Zelefsky, Michael J.

    2007-01-01

    Purpose: To determine whether prostate cancer local recurrence after radiation therapy (RT) occurs at the site of primary tumor by retrospectively comparing the tumor location on pre-RT and post-RT magnetic resonance imaging (MRI) and using step-section pathology after salvage radical prostatectomy (SRP) as the reference standard. Methods and Materials: Nine patients with localized prostate cancer were treated with intensity modulated RT (69-86.4 Gy), and had pre-RT and post-RT prostate MRI, biopsy-proven local recurrence, and SRP. The location and volume of lesions on pre-RT and post-RT MRI were correlated with step-section pathology findings. Tumor foci >0.2 cm 3 and/or resulting in extraprostatic disease on pathology were considered clinically significant. Results: All nine significant tumor foci (one in each patient; volume range, 0.22-8.63 cm 3 ) were detected both on pre-RT and post-RT MRI and displayed strikingly similar appearances on pre-RT and post-RT MRI and step-section pathology. Two clinically insignificant tumor foci (≤0.06 cm 3 ) were not detected on imaging. The ratios between tumor volumes on pathology and on post-RT MRI ranged from 0.52 to 2.80. Conclusions: Our study provides a direct visual confirmation that clinically significant post-RT local recurrence occurs at the site of primary tumor. Our results are in agreement with reported clinical and pathologic results and support the current practice of boosting the radiation dose within the primary tumor using imaging guidance. They also suggest that monitoring of primary tumor with pre-RT and post-RT MRI could lead to early detection of local recurrence amenable to salvage treatment

  15. A cross-sectional study of HIV and STIs among male sex workers attending Australian sexual health clinics.

    Science.gov (United States)

    Callander, Denton; Read, Phillip; Prestage, Garrett; Minichiello, Victor; Chow, Eric P F; Lewis, David A; McNulty, Anna; Ali, Hammad; Hellard, Margaret; Guy, Rebecca; Donovan, Basil

    2017-06-01

    Although sex work is frequently characterised as a practice with high risk for HIV and other STIs, little is known about the epidemiology of these infections among men who sell sex in Australia. This study reports the prevalence of chlamydia, gonorrhoea, infectious syphilis and HIV among men who have sex with men attending Australian publicly funded sexual health clinics and compares prevalence between sex workers and non-sex workers. From 2011 to 2014, de-identified patient data were extracted from 40 sexual health clinics in four Australian jurisdictions. The χ 2 and multiple logistic regression analyses were used to compare the prevalence of HIV and STIs among men attending these services who did and did not report sex work in the 12 months prior to consultation. All analyses were restricted to men who reported sex with other men and to each patient's first consultation at participating services. In total, 27 469 gay, bisexual and other men who have sex with men attended participating clinics; 443 (1.6%) reported sex work. At first consultation, 18% of sex workers and 17% of non-sex workers were diagnosed with HIV or an STI (p=0.4): 13% of sex workers were newly diagnosed with chlamydia, 15% with gonorrhoea, 0.5% with infectious syphilis and 0.6% with HIV. After controlling for demographic and behavioural factors, sex work was not independently associated with an HIV or STI diagnosis. These findings provide estimates of HIV and STI prevalence among men who sell sex in Australia and they challenge assumptions of sex work as inherently risky to the sexual health of gay bisexual and other men who have sex with men. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. Pharmacological therapy for analgesia and sedation in the newborn.

    Science.gov (United States)

    Anand, K J S; Hall, R W

    2006-11-01

    Rapid advances have been made in the use of pharmacological analgesia and sedation for newborns requiring neonatal intensive care. Practical considerations for the use of systemic analgesics (opioids, non-steroidal anti-inflammatory agents, other drugs), local and topical anaesthetics, and sedative or anaesthetic agents (benzodiazepines, barbiturates, other drugs) are summarised using an evidence-based medicine approach, while avoiding mention of the underlying basic physiology or pharmacology. These developments have inspired more humane approaches to neonatal intensive care. Despite these advances, little is known about the clinical effectiveness, immediate toxicity, effects on special patient populations, or long-term effects after neonatal exposure to analgesics or sedatives. The desired or adverse effects of drug combinations, interactions with non-pharmacological interventions or use for specific conditions also remain unknown. Despite the huge gaps in our knowledge, preliminary evidence for the use of neonatal analgesia and sedation is available, but must be combined with a clear definition of clinical goals, continuous physiological monitoring, evaluation of side effects or tolerance, and consideration of long-term clinical outcomes.

  17. Holistic Management of Schizophrenia Symptoms Using Pharmacological and Non-pharmacological Treatment.

    Science.gov (United States)

    Ganguly, Pronab; Soliman, Abdrabo; Moustafa, Ahmed A

    2018-01-01

    Individuals with schizophrenia lead a poor quality of life, due to poor medical attention, homelessness, unemployment, financial constraints, lack of education, and poor social skills. Thus, a review of factors associated with the holistic management of schizophrenia is of paramount importance. The objective of this review is to improve the quality of life of individuals with schizophrenia, by addressing the factors related to the needs of the patients and present them in a unified manner. Although medications play a role, other factors that lead to a successful holistic management of schizophrenia include addressing the following: financial management, independent community living, independent living skill, relationship, friendship, entertainment, regular exercise for weight gained due to medication administration, co-morbid health issues, and day-care programmes for independent living. This review discusses the relationship between different symptoms and problems individuals with schizophrenia face (e.g., homelessness and unemployment), and how these can be managed using pharmacological and non-pharmacological methods. Thus, the target of this review is the carers of individuals with schizophrenia, public health managers, counselors, case workers, psychiatrists, and clinical psychologists aiming to enhance the quality of life of individuals with schizophrenia.

  18. Electroencephalography as a clinical tool for diagnosing and monitoring attention deficit hyperactivity disorder: a cross-sectional study

    Science.gov (United States)

    Helgadóttir, Halla; Gudmundsson, Ólafur Ó; Baldursson, Gísli; Magnússon, Páll; Blin, Nicolas; Brynjólfsdóttir, Berglind; Emilsdóttir, Ásdís; Gudmundsdóttir, Gudrún B; Lorange, Málfrídur; Newman, Paula K; Jóhannesson, Gísli H; Johnsen, Kristinn

    2015-01-01

    Objectives The aim of this study was to develop and test, for the first time, a multivariate diagnostic classifier of attention deficit hyperactivity disorder (ADHD) based on EEG coherence measures and chronological age. Setting The participants were recruited in two specialised centres and three schools in Reykjavik. Participants The data are from a large cross-sectional cohort of 310 patients with ADHD and 351 controls, covering an age range from 5.8 to 14 years. ADHD was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) criteria using the K-SADS-PL semistructured interview. Participants in the control group were reported to be free of any mental or developmental disorders by their parents and had a score of less than 1.5 SDs above the age-appropriate norm on the ADHD Rating Scale-IV. Other than moderate or severe intellectual disability, no additional exclusion criteria were applied in order that the cohort reflected the typical cross section of patients with ADHD. Results Diagnostic classifiers were developed using statistical pattern recognition for the entire age range and for specific age ranges and were tested using cross-validation and by application to a separate cohort of recordings not used in the development process. The age-specific classification approach was more accurate (76% accuracy in the independent test cohort; 81% cross-validation accuracy) than the age-independent version (76%; 73%). Chronological age was found to be an important classification feature. Conclusions The novel application of EEG-based classification methods presented here can offer significant benefit to the clinician by improving both the accuracy of initial diagnosis and ongoing monitoring of children and adolescents with ADHD. The most accurate possible diagnosis at a single point in time can be obtained by the age-specific classifiers, but the age-independent classifiers are also useful as they enable longitudinal

  19. Perioperative warming with a thermal gown prevents maternal temperature loss during elective cesarean section. A randomized clinical trial.

    Science.gov (United States)

    de Bernardis, Ricardo Caio Gracco; Siaulys, Monica Maria; Vieira, Joaquim Edson; Mathias, Lígia Andrade Silva Telles

    2016-01-01

    Decrease in body temperature is common during general and regional anesthesia. Forced-air warming intraoperative during cesarean section under spinal anesthesia seems not able to prevent it. The hypothesis considers that active warming before the intraoperative period avoids temperature loss during cesarean. Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia received active warming from a thermal gown in the preoperative care unit 30min before spinal anesthesia and during surgery (Go, n=20), or no active warming at any time (Ct, n=20). After induction of spinal anesthesia, the thermal gown was replaced over the chest and upper limbs and maintained throughout study. Room temperature, hemoglobin saturation, heart rate, arterial pressure, and tympanic body temperature were registered 30min before (baseline) spinal anesthesia, right after it (time zero) and every 15min thereafter. There was no difference for temperature at baseline, but they were significant throughout the study (p<0.0001; repeated measure ANCOVA). Tympanic temperature baseline was 36.6±0.3°C, measured 36.5±0.3°C at time zero and reached 36.1±0.2°C for gown group, while control group had baseline temperature of 36.4±0.4°C, measured 36.3±0.3°C at time zero and reached 35.4±0.4°C (F=32.53; 95% CI 0.45-0.86; p<0.001). Hemodynamics did not differ throughout the study for both groups of patients. Active warming 30min before spinal anesthesia and during surgery prevented a fall in body temperature in full-term pregnant women during elective cesarean delivery. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  20. [Perioperative warming with a thermal gown prevents maternal temperature loss during elective cesarean section. A randomized clinical trial].

    Science.gov (United States)

    Bernardis, Ricardo Caio Gracco de; Siaulys, Monica Maria; Vieira, Joaquim Edson; Mathias, Lígia Andrade Silva Telles

    2016-01-01

    Decrease in body temperature is common during general and regional anesthesia. Forced-air warming intraoperative during cesarean section under spinal anesthesia seems not able to prevent it. The hypothesis considers that active warming before the intraoperative period avoids temperature loss during cesarean. Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia received active warming from a thermal gown in the preoperative care unit 30min before spinal anesthesia and during surgery (Go, n=20), or no active warming at any time (Ct, n=20). After induction of spinal anesthesia, the thermal gown was replaced over the chest and upper limbs and maintained throughout study. Room temperature, hemoglobin saturation, heart rate, arterial pressure, and tympanic body temperature were registered 30min before (baseline) spinal anesthesia, right after it (time zero) and every 15min thereafter. There was no difference for temperature at baseline, but they were significant throughout the study (p<0.0001; repeated measure ANCOVA). Tympanic temperature baseline was 36.6±0.3°C, measured 36.5±0.3°C at time zero and reached 36.1±0.2°C for gown group, while control group had baseline temperature of 36.4±0.4°C, measured 36.3±0.3°C at time zero and reached 35.4±0.4°C (F=32.53; 95% CI 0.45-0.86; p<0.001). Hemodynamics did not differ throughout the study for both groups of patients. Active warming 30min before spinal anesthesia and during surgery prevented a fall in body temperature in full-term pregnant women during elective cesarean delivery. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  1. Effects of intrathecal dexmedetomidine on shivering after spinal anesthesia for cesarean section: a double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Nasseri K

    2017-04-01

    Full Text Available Karim Nasseri,1,2 Negin Ghadami,1 Bijan Nouri2 1Department of Anesthesiology, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran; 2Social Determinants of Health Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran Background: Shivering is among the common troublesome complications of spinal anesthesia (SA, and causes discomfort and discontentment in parturients undergoing cesarean sections (CSs. The aim of this study was to investigate the effects of intrathecal dexmedetomidine in the prevention of shivering in those who underwent CS under SA.Subjects and methods: Fifty parturients planned for elective CSs under SA were enrolled in this prospective, double-blinded, controlled study and randomly divided into two equal groups. Spinal block was achieved with 12.5 mg 0.5% heavy bupivacaine plus 5 µg dexmedetomidine (BD group or 0.5 mL 0.9% normal saline (BN group. The incidence and intensity of shivering, peripheral and core body temperature, hemodynamic parameters, and adverse events was recorded.Results: The incidence of shivering was significantly higher in the BN group (52% than the BD group (24% (P=0.04. Likewise, the intensity of shivering was significantly higher in the BN group than the BD group (P=0.04. The incidence of adverse events, such as hypotension, nausea/vomiting, and bradycardia, was not significantly different between the two groups, although the grade of sedation was higher in the BD group than the BN group (P=0.004.Conclusion: We conclude that intrathecal dexmedetomidine is effective in lowering the incidence and intensity of shivering in parturients undergoing CSs under SA without major adverse effects. Keywords: dexmedetomidine, shivering, spinal anesthesia, cesarean sections, bupivacaine

  2. Home-based HIV testing for men preferred over clinic-based testing by pregnant women and their male partners, a nested cross-sectional study.

    Science.gov (United States)

    Osoti, Alfred Onyango; John-Stewart, Grace; Kiarie, James Njogu; Barbra, Richardson; Kinuthia, John; Krakowiak, Daisy; Farquhar, Carey

    2015-07-30

    Male partner HIV testing and counseling (HTC) is associated with enhanced uptake of prevention of mother-to-child HIV transmission (PMTCT), yet male HTC during pregnancy remains low. Identifying settings preferred by pregnant women and their male partners may improve male involvement in PMTCT. Participants in a randomized clinical trial (NCT01620073) to improve male partner HTC were interviewed to determine whether the preferred male partner HTC setting was the home, antenatal care (ANC) clinic or VCT center. In this nested cross sectional study, responses were evaluated at baseline and after 6 weeks. Differences between the two time points were compared using McNemar's test and correlates of preference were determined using logistic regression. Among 300 pregnant female participants, 54% preferred home over ANC clinic testing (34.0%) or VCT center (12.0%). Among 188 male partners, 68% preferred home-based HTC to antenatal clinic (19%) or VCT (13%). Men who desired more children and women who had less than secondary education or daily income Pregnant women and their male partners preferred home-based compared to clinic or VCT-center based male partner HTC. Home-based HTC during pregnancy appears acceptable and may improve male testing and involvement in PMTCT.

  3. AWARENESS ABOUT HIV/AIDS IN CLIENTS ATTENDING STI CLINIC: A CROSS SECTIONAL STUDY FROM SOUTH-EAST RAJASTHAN, INDIA

    Directory of Open Access Journals (Sweden)

    Atul

    2015-12-01

    Full Text Available BACKGROUND India bears a large burden of HIV/AIDS on globe. Major weapons against HIV/AIDS are treatment which is not curative, vaccine which is far from reality and accurate & adequate information about the disease which is practically acceptable and cost effective way of prevention in form of social vaccine and is a good tool for HIV/AIDS in developing countries like India. In India there is inadequate & inaccurate knowledge about the disease in general population. AIM In present study we tried to analyze the knowledge & awareness about HIV/AIDS in clients attending the STI clinic at Jhalawar Hospital and Medical College at south east part of Rajasthan, India. MATERIAL & METHODS We assessed 500 clients at STI clinic by using a predesigned questionnaire which gathers their knowledge regarding HIV/AIDS. All the clients above the age of 18 years who attended the STI clinic were enrolled for the study voluntarily. Participants were finally assessed as good/poor or unaware according to their level of knowledge. STATISTICAL ANALYSIS SPSS version 20.0 (trial was used to analyze all the data. Chi square test was used to find association between knowledge and their literacy level & occupation. RESULTS 142(28.4% of the participants had never heard about HIV/AIDS among them females were significantly more than males. Both low level of literacy and unemployment or house wives were associated with unawareness about HIV/AIDS. For the 358(71.6% participants who had heard about HIV/AIDS, mass media was the main source of information (53.07% in which television contributes the major part, followed by friends and colleagues (24.02%. While the knowledge about HIV transmission and prevention was good but the extent of misconceptions was also high (64.8%. CONCLUSION Our study is highly suggestive of the strong need to increase the level of HIV awareness among Indian population via proper education and through various resources on information.

  4. A cross-sectional study of 329 farms in England to identify risk factors for ovine clinical mastitis.

    Science.gov (United States)

    Cooper, S; Huntley, S J; Crump, R; Lovatt, F; Green, L E

    2016-03-01

    The aims of this study were to estimate the incidence rate of clinical mastitis (IRCM) and identify risk factors for clinical mastitis in suckler ewes to generate hypotheses for future study. A postal questionnaire was sent to 999 randomly selected English sheep farmers in 2010 to gather data on farmer reported IRCM and flock management practices for the calendar year 2009, of which 329 provided usable information. The mean IRCM per flock was 1.2/100 ewes/year (CI:1.10:1.35). The IRCM was 2.0, 0.9 and 1.3/100 ewes/year for flocks that lambed indoors, outdoors and a combination of both, respectively. Farmers ran a variety of managements before, during and after lambing that were not comparable within one model, therefore six mixed effects over-dispersed Poisson regression models were developed. Factors significantly associated with increased IRCM were increasing percentage of the flock with poor udder conformation, increasing mean number of lambs reared/ewe and when some or all ewes lambed in barns compared with outdoors (Model 1). For ewes housed in barns before lambing (Model 2), concrete, earth and other materials were associated with an increase in IRCM compared with hardcore floors (an aggregate of broken bricks and stones). For ewes in barns during lambing (Model 3), an increase in IRCM was associated with concrete compared with hardcore flooring and where bedding was stored covered outdoors or in a building compared with bedding stored outdoors uncovered. For ewes in barns after lambing (Model 4), increased IRCM was associated with earth compared with hardcore floors, and when fresh bedding was added once per week compared with at a frequency of ≤2 days or twice/week. The IRCM was lower for flocks where some or all ewes remained in the same fields before, during and after lambing compared with flocks that did not (Model 5). Where ewes and lambs were turned outdoors after lambing (Model 6), the IRCM increased as the age of the oldest lambs at turnout

  5. 2011 Annual Meeting of the Safety Pharmacology Society: an overview.

    Science.gov (United States)

    Cavero, Icilio

    2012-03-01

    The keynote address of 2011 Annual Meeting of the Safety Pharmacology Society examined the known and the still to be known on drug-induced nephrotoxicity. The nominee of the Distinguished Service Award Lecture gave an account of his career achievements particularly on the domain of chronically instrumented animals for assessing cardiovascular safety. The value of Safety Pharmacology resides in the benefits delivered to Pharma organizations, regulators, payers and patients. Meticulous due diligence concerning compliance of Safety Pharmacology studies to best practices is an effective means to ensure that equally stringent safety criteria are applied to both in-licensed and in-house compounds. Innovative technologies of great potential for Safety Pharmacology presented at the meeting are organs on chips (lung, heart, intestine) displaying mechanical and biochemical features of native organs, electrical field potential (MEA) or impedance (xCELLigence Cardio) measurements in human induced pluripotent stem cell-derived cardiomyocytes for unveiling cardiac electrophysiological and mechanical liabilities, functional human airway epithelium (MucilAir™) preparations with unique 1-year shelf-life for acute and chronic in vitro evaluation of drug efficacy and toxicity. Custom-designed in silico and in vitro assay platforms defining the receptorome space occupied by chemical entities facilitate, throughout the drug discovery phase, the selection of candidates with optimized safety profile on organ function. These approaches can now be complemented by advanced computational analysis allowing the identification of compounds with receptorome, or clinically adverse effect profiles, similar to those of the drug candidate under scrutiny for extending the safety assessment to potential liability targets not captured by classical approaches. Nonclinical data supporting safety can be quite reassuring for drugs with a discovered signal of risk. However, for marketing authorization

  6. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.

    Directory of Open Access Journals (Sweden)

    Andrew Schumacher

    Full Text Available Informed consent forms (ICFs for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies.We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics.Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials were significantly longer (P < .0001 and had lower Flesch ease-of-reading scores (P = .003 than investigator-initiated trials (N = 11. At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011. The scores did not differ significantly by type of cancer therapy (P = .12 or trial sponsor (P = .38.Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups.Clinicaltrials.gov NCT01772511.

  7. Dental caries among children visiting a mobile dental clinic in South Central Kentucky: a pooled cross-sectional study.

    Science.gov (United States)

    Dawkins, Erika; Michimi, Akihiko; Ellis-Griffith, Gregory; Peterson, Tina; Carter, Daniel; English, Gary

    2013-05-02

    Dental caries is one of the most common chronic childhood diseases affecting a large portion of children in the United States. The prevalence of childhood dental caries in Kentucky is among the highest in the nation. The purposes of this study are to (1) compare sociodemographic differences between caries and no caries groups and (2) investigate factors associated with untreated dental caries among children who visited a mobile dental clinic in South Central Kentucky. Study subjects were children aged 6 to 15 years who participated in the school-based dental sealant program through the mobile dental clinic operated by the Institute for Rural Health at Western Kentucky University between September 2006 and May 2011 (n = 2,453). Descriptive statistics were calculated for sociodemographic factors (age, gender, race/ethnicity, insurance status, and urban versus rural residential location) and caries status. We used chi-square tests to compare sociodemographic differences of children stratified by caries and no caries status as well as three levels of caries severity. We developed a logistic regression model to investigate factors associated with untreated dental caries while controlling for sociodemographic characteristics. The proportion of children having untreated dental caries was 49.7% and the mean number of untreated dental caries was 2.0. The proportion of untreated dental caries was higher in older children, children with no insurance and living in rural residential locations, and caries severity was also higher in these groups. Odds ratio indicated that older ages, not having private insurance (having only public, government-sponsored insurance or no insurance at all) and rural residential location were associated with having untreated dental caries after controlling for sociodemographic characteristics of children. Untreated dental caries was more likely to be present in older children living in rural areas without insurance. Health interventionists may use

  8. Socio-demographic and clinical predictors of absenteeism - A cross-sectional study of urban industrial employees.

    Science.gov (United States)

    Chakraborty, Suhash; Subramanya, Anantha H C

    2013-01-01

    Public sector undertakings are facing a threat of privatization due to unsatisfactory performance putting pressure on management and in turn to employees. There is an increasing trend of absenteeism observed amongst employees citing job stress. To find an association between job stress and absenteeism in relation to socio-demographic and clinical profile. The study was conducted in an urban aeronautical industry with 68 employees who mentioned stress at workplace during evaluation. Job stress was assessed using Professional Life Stress Scale (David Fontana). Those who scored more than 30 (n = 43) were taken up for the study after an informed consent. A semi-structured questionnaire was administered to find socio-demographic and clinical profile. Employees who reported taking leave in last six months just to avoid work or workplace constitute the "absenteeism" group. The absenteeism group was compared to non-absenteeism group using Fisher exact/Chi-square test or independent t-test depending on type of variables. Out of 43 subjects, 18 had absenteeism while 25 did not have absenteeism. Comparing the two groups, interstate migration, having more than one previous job, commuting time more than an hour, co-morbid anxiety/depression, and alcohol abuse were significantly associated with absenteeism (P Absentees complained more about fatigue and relationship problem with colleagues than non-absentees (P absenteeism (P > 0.05). In absenteeism research, one of the widely accepted models is Steer and Rhode's "Process model of absenteeism." The model postulates job stress as one of the barriers for attendance. Thus, knowing the factors for absenteeism would help in preventing absenteeism.

  9. Health and nutrition knowledge, attitudes and practices of pregnant women attending and not-attending ANC clinics in Western Kenya: a cross-sectional analysis.

    Science.gov (United States)

    Perumal, Nandita; Cole, Donald C; Ouédraogo, Hermann Z; Sindi, Kirimi; Loechl, Cornelia; Low, Jan; Levin, Carol; Kiria, Christine; Kurji, Jaameeta; Oyunga, Mary

    2013-07-11

    Antenatal care (ANC) is a key strategy to decreasing maternal mortality in low-resource settings. ANC clinics provide resources to improve nutrition and health knowledge and promote preventive health practices. We sought to compare the knowledge, attitude and practices (KAP) among women seeking and not-seeking ANC in rural Kenya. Data from a community-based cross-sectional survey conducted in Western Province, Kenya were used. Nutrition knowledge (NKS), health knowledge (HKS), attitude score (AS), and dietary diversity score (DDS) were constructed indices. χ2 test and Student's t-test were used to compare proportions and means, respectively, to assess the difference in KAP among pregnant women attending and not-attending ANC clinics. Multiple regression analyses were used to assess the impact of the number of ANC visits (none, ANC clinics while 39% had not. The mean (±SD) NKS was 4.6 (1.9) out of 11, HKS was 6.2 (1.7) out of 12, DDS was 4.9 (1.4) out of 12, and AS was 7.4 (2.2) out of 10. Nutrition knowledge, attitudes, and DDS were not significantly different between ANC clinic attending and non-attending women. Among women who attended ANC clinics, 82.6% received malaria and/or antihelmintic treatment, compared to 29.6% of ANC clinic non-attendees. Higher number of ANC clinic visits and higher maternal education level were significantly positively associated with maternal health knowledge. Substantial opportunities exist for antenatal KAP improvement among women in Western Kenya, some of which could occur with greater ANC attendance. Further research is needed to understand multi-level factors that may affect maternal knowledge and practices.

  10. Analysis of the relationship between periodontal disease and atherosclerosis within a local clinical system: a cross-sectional observational pilot study.

    Science.gov (United States)

    Kudo, Chieko; Shin, Wee Soo; Minabe, Masato; Harai, Kazuo; Kato, Kai; Seino, Hiroaki; Goke, Eiji; Sasaki, Nobuhiro; Fujino, Takemasa; Kuribayashi, Nobuichi; Pearce, Youko Onuki; Taira, Masato; Maeda, Hiroshi; Takashiba, Shogo

    2015-09-01

    It has been revealed that atherosclerosis and periodontal disease may have a common mechanism of "chronic inflammation". Several reports have indicated that periodontal infection is related to atherosclerosis, but none have yet reported such an investigation through the cooperation of local clinics. This study was performed in local Japanese clinics to examine the relationship between periodontal disease and atherosclerosis under collaborative medical and dental care. A pilot multicenter cross-sectional study was conducted on 37 medical patients with lifestyle-related diseases under consultation in participating medical clinics, and 79 periodontal patients not undergoing medical treatment but who were seen by participating dental clinics. Systemic examination and periodontal examination were performed at baseline, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed. There was a positive correlation between LDL-C level and plasma IgG antibody titer to Porphyromonas gingivalis. According to the analysis under adjusted age, at a cut-off value of 5.04 for plasma IgG titer to Porphyromonas gingivalis, the IgG titer was significantly correlated with the level of low-density lipoprotein cholesterol (LDL-C). This study suggested that infection with periodontal bacteria (Porphyromonas gingivalis) is associated with the progression of atherosclerosis. Plasma IgG titer to Porphyromonas gingivalis may be useful as the clinical risk marker for atherosclerosis related to periodontal disease. Moreover, the application of the blood examination as a medical check may lead to the development of collaborative medical and dental care within the local medical clinical system for the purpose of preventing the lifestyle-related disease.

  11. Pharmacologic treatment of depression in multiple sclerosis

    NARCIS (Netherlands)

    Koch, Marcus W.; Glazenborg, Arjon; Uyttenboogaart, Maarten; Mostert, Jop; De Keyser, Jacques

    2011-01-01

    Background Depression is a common problem in patients with multiple sclerosis (MS). It is unclear which pharmacologic treatment is the most effective and the least harmful. Objectives To investigate the efficacy and tolerability of pharmacologic treatments for depression in patients with MS. Search

  12. Complex Pharmacology of Free Fatty Acid Receptors

    DEFF Research Database (Denmark)

    Milligan, Graeme; Shimpukade, Bharat; Ulven, Trond

    2017-01-01

    pharmacology have shaped understanding of the complex pharmacology of receptors that recognize and are activated by nonesterified or "free" fatty acids (FFAs). The FFA family of receptors is a recently deorphanized set of GPCRs, the members of which are now receiving substantial interest as novel targets...

  13. Subthreshold depression among diabetes patients in Beijing: Cross-sectional associations among sociodemographic, clinical, and behavior factors.

    Science.gov (United States)

    Wang, Dandan; Shi, Lintao; Li, Leling; Guo, Xiaohui; Li, Yufeng; Xu, Yuan; Yin, Shinan; Wu, Qiaozhen; Yang, Yu; Zhuang, Xiaoming; Gai, Yingli; Li, Quanmin; Liu, Yanjun

    2018-09-01

    This study explores the prevalence of subthreshold depression (SubD) and its association with factors in type 2 diabetes mellitus (T2DM) patients. This cross-sectional study involved 808 outpatients with T2DM from ten hospitals in Beijing between September 2015 and January 2016. All participants completed the Patient Health Questionnaire 9-item (PHQ-9) to evaluate depressive status, with scores between 5 and 14 considered SubD. Conditional logistic regression was conducted to investigate the variables associated with SubD in T2DM patients. T2DM patients with SubD comprised 11.6% (n = 94) of the sample. The odd ratios for the variables having significant positive associations with SubD were: being a women (OR = 1.90; 95%CI: 1.09-3.32), divorced/widowed (OR = 3.27; 95%CI: 1.46-7.30), comorbidity of cerebrovascular disease (OR = 2.00; 95%CI: 1.06-3.76), more diabetic complications (OR = 8.04; 95%CI: 2.77-23.31), and higher HbA1c in men (OR = 2.41; 95%CI: 1.25-4.64). Being older (OR = 0.78; 95%CI: 0.62-0.98), exercising more (OR = 0.44; 95%CI: 0.22-0.91) and poverty (OR = 0.36; 95%CI: 0.19-0.69) were negatively related to SubD. The sample was mainly recruited from hospital settings, which limits generalization. The study's cross-sectional design precludes making causal inferences. The proportion of SubD was estimated to be 11.6% among T2DM patients in Beijing. Having more diabetic complications and being divorced/widowed made the odds of having SubD 8-fold and 3-fold higher than not having it, respectively. The relationship between SubD and diabetes necessitates early screening for milder forms of depression, which can alleviate the social burden and individual impairment from major depression or other chronic diseases. Copyright © 2018. Published by Elsevier B.V.

  14. Work-related stress is associated with impaired neuropsychological test performance: a clinical cross-sectional study.

    Science.gov (United States)

    Eskildsen, Anita; Andersen, Lars Peter; Pedersen, Anders Degn; Vandborg, Sanne Kjær; Andersen, Johan Hviid

    2015-01-01

    Patients on sick leave due to work-related stress often complain about impaired concentration and memory. However, it is undetermined how widespread these impairments are, and which cognitive domains are most long-term stress sensitive. Previous studies show inconsistent results and are difficult to synthesize. The primary aim of this study was to examine whether patients with work-related stress complaints have cognitive impairments compared to a matched control group without stress. Our secondary aim was to examine whether the level of self-reported perceived stress is associated with neuropsychological test performance. We used a broad neuropsychological test battery to assess 59 outpatients with work-related stress complaints (without major depression) and 59 healthy controls. We matched the patients and controls pairwise by sex, age and educational level. Compared to controls, patients generally showed mildly reduced performance across all the measured domains of the neuropsychological test battery. However, only three comparisons reached statistical significance (p working memory. There were no statistical significant associations between self-reported perceived stress level and neuropsychological test performance. In conclusion, we recommend that cognitive functions should be considered when evaluating patients with work-related stress complaints, especially when given advice regarding return to work. Since this study had a cross-sectional design, it is still uncertain whether the impairments are permanent. Further study is required to establish causal links between work-related stress and cognitive deficits.

  15. Pharmacology of sexually compulsive behavior.

    Science.gov (United States)

    Codispoti, Victoria L

    2008-12-01

    In a meta-analysis on controlled outcomes evaluations of 22,000 sex offenders, Losel and Schmucker found 80 comparisons between treatment and control groups. The recidivism rate averaged 19% in treated groups, and 27% in controls. Most other reviews reported a lower rate of sexual recidivism in treated sexual offenders. Of 2039 citations in this study (including literature in five languages), 60 studies held independent comparisons. Problematic issues included the control groups; various hormonal, surgical, cognitive behavioral, and psychotherapeutic treatments; and sample sizes. In the 80 studies compared after the year 2000, 32% were reported after 2000, 45% originated in the United States, 45% were reported in journals, and 36% were unpublished. Treatment characteristics showed a significant lack of pharmacologic treatment (7.5%), whereas use cognitive and classical behavioral therapy was 64%. In 68% of the studies, no information was available on the integrity of the treatment implementation; 36% of the treatment settings were outpatient only, 31% were prison settings, and 12% were mixed settings (prison, hospital, and outpatient). Integrating research interpretations is complicated by the heterogeneity of sex offenders, with only 56% being adult men and 17.5% adolescents. Offense types reported included 74% child molestation, 48% incest, and 30% exhibitionism. Pedophilia was not singled out. Follow-up periods varied from 12 months to greater than 84 months. The definition of recidivism ran the gamut from arrest (24%), conviction (30%), charges (19%), and no indication (16%). Results were difficult to interpret because of the methodological problems with this type of study. Overall, a positive outcome was noted with sex offender treatment. Cognitive-behavioral and hormonal treatment were the most promising. Voluntary treatment led to a slightly better outcome than mandatory participation. When accounting for a low base rate of sexual recidivism, the reduction

  16. Problem-based learning in pharmacology:a survey of department heads in Taiwan, China

    Institute of Scientific and Technical Information of China (English)

    Ying-tung LAU

    2004-01-01

    Problem-based learning (PBL) requires active student participation and the use of clinical cases as a trigger to learn within a given area. It has gained much attention as a pedagogic alternative in the course of reform in medica education due to information overload. From discipline-based consideration, it is interesting to understand the views of department heads of pharmacology about implementing PBL for their medical students. According to a general survey from the heads of the department of pharmacology across medical schools in Taiwan, we found that although serious reservation about the approach remains, many departments indeed look forward to including PBL component in their pharmacology curriculum.

  17. α-Mangostin from Garcinia mangostana Linn: An updated review of its pharmacological properties

    Directory of Open Access Journals (Sweden)

    Mohamed Yousif Ibrahim

    2016-05-01

    Full Text Available Over the past decades, various studies have highlighted the pure natural compound, α-mangostin as their main topic. The compound’s pre-clinical and pharmacological properties have been recognized and defined in these studies. α-Mangostin shows strong pharmacological effects in in vitro and in vivo model systems by targeting a number of vital cellular factors through various mechanisms of action. Despite its important molecular versatility, the α-mangostin still has limited clinical application. In order to optimize the conditions of this compound as a chemotherapeutic and chemopreventive agent, for instance in diseases such as cancer, obesity, diabetes as well as inflammatory disorders, the recent tendency is to limit the range of its pharmacological properties. The present work reviews recent studies on the central and potential pharmacological principles as well as the preclinical applications of the α-mangostin.

  18. Illness Perception and Depressive Symptoms among Persons with Type 2 Diabetes Mellitus: An Analytical Cross-Sectional Study in Clinical Settings in Nepal.

    Science.gov (United States)

    Joshi, Suira; Dhungana, Raja Ram; Subba, Usha Kiran

    2015-01-01

    Background. This study aimed to assess the relationship between illness perception and depressive symptoms among persons with diabetes. Method. This was an analytical cross-sectional study conducted among 379 type 2 diabetic patients from three major clinical settings of Kathmandu, Nepal. Results. The prevalence of depressive symptoms was 44.1% (95% CI: 39.1, 49.1). Females (p perception and depressive symptoms among diabetic patients. Study finding indicated that persons living with diabetes in Nepal need comprehensive diabetes education program for changing poor illness perception, which ultimately helps to prevent development of depressive symptoms.

  19. Who are the children and adolescent patients of a national referral service of eating disorders in Brazil?: a cross-sectional study of a clinical sample

    OpenAIRE

    Pinzon,Vanessa Dentzien; Turkiewicz,Gizela; Monteiro,Denise Oliveira; Koritar,Priscila; Fleitlich-Bilyk,Bacy

    2013-01-01

    Objectives: To investigate the sociodemographic and clinical profile of patients receiving treatment at a specialized service for children and adolescents with eating disorders (ED) in São Paulo, Brazil, and to compare data with the relevant literature. Methods: This cross-sectional study assessed male and female patients with ED up to 18 years of age. All data were collected upon admission. Results: A total of 100 subjects were assessed. Mean age was 15.41±0.18 years, and mean age at ED onse...

  20. Correlation of skin changes with hormonal changes in polycystic ovarian syndrome: A cross-sectional study clinical study

    Directory of Open Access Journals (Sweden)

    B Vijaya Gowri

    2015-01-01

    Full Text Available Background: Polycystic ovarian syndrome (PCOS is a heterogenous collection of signs and symptoms that when gathered, form a spectrum of disorder with disturbance of reproductive, endocrine and metabolic functions. Aim: The aim of this study is to correlate the skin manifestations with hormonal changes and to know the incidence and prevalence of skin manifestations in patients with PCOS. Materials and Methods: A total of 40 patients with PCOS were examined during 1 year time period from May 2008 P to May 2009. Detailed clinical history was taken from each patient. PCOS was diagnosed on the basis of ultrasonography. Hormonal assays included fasting blood sugar, postprandial blood sugar, follicle-stimulating hormone, luteinizing hormone, thyroid stimulating hormone, dehydroepiandrostenedione, prolactin, free testosterone, fasting lipid profile and sex hormone binding globulin. The results obtained were statistically correlated. Results: In our study, the prevalence of cutaneous manifestations was 90%. Of all the cutaneous manifestations acne was seen in highest percentage (67.5%, followed by hirsutism (62.5%, seborrhea (52.5%, androgenetic alopecia (AGA (30%, acanthosis nigricans (22.5% and acrochordons (10%. Fasting insulin levels was the most common hormonal abnormality seen in both acne and hirsutism, whereas AGA was associated with high testosterone levels. Conclusion: The prevalence of cutaneous manifestations in PCOS was 90%. Hirsutism, acne, seborrhea, acanthosis nigricans and acrochordons were associated with increased levels of fasting insulin, whereas AGA showed higher levels of serum testosterone.

  1. Determining clinical practice of expert physiotherapy for patients undergoing lumbar spinal fusion: a cross-sectional survey study.

    Science.gov (United States)

    Janssen, Esther R C; Scheijen, Elle E M; van Meeteren, Nico L U; de Bie, Rob A; Lenssen, Anton F; Willems, Paul C; Hoogeboom, Thomas J

    2016-05-01

    To determine the content of current Dutch expert hospital physiotherapy practice for patients undergoing lumbar spinal fusion (LSF), to gain insight into expert-based clinical practice. At each hospital where LSF is performed, one expert physiotherapist received an e-mailed questionnaire, about pre- and postoperative physiotherapy and discharge after LSF. The level of uniformity in goals and interventions was graded on a scale from no uniformity (50-60 %) to very strong uniformity (91-100 %). LSF was performed at 34 of the 67 contacted hospitals. From those 34 hospitals, 28 (82 %) expert physiotherapists completed the survey. Twenty-one percent of the respondents saw patients preoperatively, generally to provide information. Stated postoperative goals and administered interventions focused mainly on performing transfers safely and keeping the patient informed. Outcome measures were scarcely used. There was no uniformity regarding advice on the activities of daily living. Dutch perioperative expert physiotherapy for patients undergoing LSF is variable and lacks structural outcome assessment. Studies evaluating the effectiveness of best-practice physiotherapy are warranted.

  2. Illness self-concept in Type 1 diabetes: a cross-sectional view on clinical, demographic, and psychosocial correlates.

    Science.gov (United States)

    Luyckx, Koen; Rassart, Jessica; Weets, Ilse

    2015-01-01

    The present study assessed the centrality of one's illness self-concept, or the degree to which chronic illness intrudes upon one's self, in a sample of 478 18-35-year-old patients with Type 1 diabetes. Confirmatory factor analysis indicated that illness self-concept centrality was a one-dimensional construct, despite the fact that three constituting components (i.e. pervasiveness, directionality, and illness self-consciousness) have been forwarded. Further, important demographic and clinical correlates of illness self-concept were identified: women, unemployed individuals, individuals with a lower educational level, and patients with an insulin pump had a more central illness self-concept. Finally, a series of correlation and regression analyses indicated that, despite the fact that illness self-concept centrality was negatively related to emotional stability, self-esteem, and diabetes integration, and positively to perceived consequences of diabetes, illness self-concept had unique predictive value over and above these variables for problem areas in diabetes and depressive symptoms. Implications and suggestions for future research are outlined.

  3. Frequency of bullying perceived in clinical practices of last year interns of a medicine school: cross sectional study

    Directory of Open Access Journals (Sweden)

    Nubia Fernanda Sánchez

    2016-07-01

    Full Text Available Introduction: During the medical internship year, students attend several hospitals and are observed and influenced by postgraduate students, general practitioners and other interns, who provide them with fundamental support regarding professional training. Bullying is defined as an aggressive behavior that occurs between a perpetrator and a victim in different scenarios and authority relationships, such as clinical practices at Medicine programs. Objective: To describe the perceived frequency of bullying among a group of interns of the Faculty of Medicine from Universidad Nacional de Colombia during internship. Materials and methods: A transversal analytical study was performed through a questionnaire applied to 82 medical interns of the School of Medicine from Universidad Nacional de Colombia. Results: The perceived frequency of bullying was 90%. Statistically significant differences were not found in the stratified analysis by sex or place of practice. In most cases, bullying was perpetrated by other interns, while residents and specialists showed a lower frequency. Conclusion: Perceived frequency of bullying was higher than expected according to the existing literature. These results can be used as a basis for new studies.

  4. Prevalence and patterns of prenatal use of traditional medicine among women at selected harare clinics: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Mureyi Dudzai D

    2012-09-01

    Full Text Available Abstract Background Prenatal use of traditional medicine or complementary and alternative medicine is widespread globally despite the lack of evidence of the effectiveness of these therapeutic options. Documentation on the prevalence and patterns of this maternal practice in the Zimbabwean setting was also lacking. Methods A cross sectional survey of 248 women at selected health centres in Harare was carried out to address the need for such data using an interviewer-administered questionnaire. Results Fifty-two (52% (95% C.I. 44%-60% of the participants reported to have used at least one traditional medicine intervention during the third trimester of their most recent pregnancy to induce labour, avoid perineal tearing and improve the safety of their delivery process. The study found prenatal use of traditional medicine to be significantly associated with nulliparity and nulligravidity. Such practice was also significant among participants residing in a particular high density suburb located in close proximity to informal traders of traditional medicines. Prenatal traditional medicine use was not significantly linked to experiencing an obstetrics-related adverse event. Instead, participants who reported not using any traditional medicine during pregnancy reported experiencing significantly more adverse events, mainly perineal tearing during delivery. Conclusions The practice of prenatal use of traditional medicine was significant in the study setting, with a prevalence of 52%. A variety of products were used in various dosage forms for differing indications. Nulliparity, nulligavidity and possible accessibility of these products were the factors significantly associated with prenatal use of traditional medicine. Prenatal use of traditional medicine was not significantly associated with any obstetric adverse event.

  5. Food security in a sample of clients attending HIV clinics in New South Wales: A cross-sectional study.

    Science.gov (United States)

    Langton, Angela; Moxham, Rosalind; Hirst, Sarah; Houtzager, Louise; Coutelas, Julie; Rider, Amanda; Yusuf, Christine

    2018-06-08

    The aim of this study was to determine the prevalence, demographics and location of food insecurity (FI) among people living with HIV at six health sites in Sydney, Australia and to identify the factors relating to FI. This was a cross-sectional study recruiting people living with HIV receiving HIV care from six sites across the Sydney metropolitan area. The United States Department of Agriculture abbreviated six-item Subset Food Insecurity Tool was used to assess FI and a demographic questionnaire was completed. Bivariate analysis was conducted to investigate differences between variables. Descriptive and frequency statistics were used to collate the demographic questionnaire and determine the prevalence of FI. All tests performed were two sided with a P-value of less than 0.05, or 95% confidence interval not overlapping, indicating a statistically significant association. Of the 162 participants 47% (n = 76) reported FI. The percentage of FI was found to be higher among the females (61%, n = 8 out of 13), unemployed (65%), receiving a government pension (63%), with a lower perceived health status (68%), a lower CD4 T cell count (60%), a detectable or unknown viral load (67%), and missed taking their antiretroviral therapy either in the last week or month (64%). All of the six participants who were Australian Aboriginal were food insecure. The study finds evidence of associations between FI, employment, lower immune function and poorer health outcomes for people living with HIV in Sydney. © 2018 State of New South Wales. Nutrition and Dietetics © 2018 Dietitians Association of Australia.

  6. Cardiovascular Safety Pharmacology of Sibutramine.

    Science.gov (United States)

    Yun, Jaesuk; Chung, Eunyong; Choi, Ki Hwan; Cho, Dae Hyun; Song, Yun Jeong; Han, Kyoung Moon; Cha, Hey Jin; Shin, Ji Soon; Seong, Won-Keun; Kim, Young-Hoon; Kim, Hyung Soo

    2015-07-01

    Sibutramine is an anorectic that has been banned since 2010 due to cardiovascular safety issues. However, counterfeit drugs or slimming products that include sibutramine are still available in the market. It has been reported that illegal sibutramine-contained pharmaceutical products induce cardiovascular crisis. However, the mechanism underlying sibutramine-induced cardiovascular adverse effect has not been fully evaluated yet. In this study, we performed cardiovascular safety pharmacology studies of sibutramine systemically using by hERG channel inhibition, action potential duration, and telemetry assays. Sibutramine inhibited hERG channel current of HEK293 cells with an IC50 of 3.92 μM in patch clamp assay and increased the heart rate and blood pressure (76 Δbpm in heart rate and 51 ΔmmHg in blood pressure) in beagle dogs at a dose of 30 mg/kg (per oral), while it shortened action potential duration (at 10 μM and 30 μM, resulted in 15% and 29% decreases in APD50, and 9% and 17% decreases in APD90, respectively) in the Purkinje fibers of rabbits and had no effects on the QTc interval in beagle dogs. These results suggest that sibutramine has a considerable adverse effect on the cardiovascular system and may contribute to accurate drug safety regulation.

  7. [Pharmacologic treatment of osteoporosis--2011].

    Science.gov (United States)

    Lakatos, Péter

    2011-08-14

    Osteoporosis affects approximately 9% of the population in Hungary resulting in about 100 000 osteoporotic fractures annually. Thirty-five percent of patients with hip fractures due to osteoporosis will die within 1 year. Direct costs of osteoporosis exceed 25 billion forints per year. Apparently, cost-effective reduction of bone loss and consequent fracture risk will add up to not only financial savings but improvement in quality of life, as well. A number of pharmacological modalities are available for this purpose. The mainstay of the treatment of osteoporosis is the bisphosphonate group that includes effective anti-resorptive compounds mitigating bone loss and fragility. The recently registered denosumab exhibits similar efficacy by neutralizing RANK ligand, however, marked differences can be observed between the two drug classes. Strontium has a unique mechanism of action by rebalancing bone turnover, and thus, providing an efficient treatment option for the not fast bone losers who are at high fracture risk. The purely anabolic teriparatide is available for the extremely severe osteoporotic patients and for those who do not respond to other types of therapy. Older treatment options such as hormone replacement therapy, raloxifene, tibolone or calcitonin may also have a restricted place in the management of osteoporosis.

  8. Pharmacological Fingerprints of Contextual Uncertainty.

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    Louise Marshall

    2016-11-01

    Full Text Available Successful interaction with the environment requires flexible updating of our beliefs about the world. By estimating the likelihood of future events, it is possible to prepare appropriate actions in advance and execute fast, accurate motor responses. According to theoretical proposals, agents track the variability arising from changing environments by computing various forms of uncertainty. Several neuromodulators have been linked to uncertainty signalling, but comprehensive empirical characterisation of their relative contributions to perceptual belief updating, and to the selection of motor responses, is lacking. Here we assess the roles of noradrenaline, acetylcholine, and dopamine within a single, unified computational framework of uncertainty. Using pharmacological interventions in a sample of 128 healthy human volunteers and a hierarchical Bayesian learning model, we characterise the influences of noradrenergic, cholinergic, and dopaminergic receptor antagonism on individual computations of uncertainty during a probabilistic serial reaction time task. We propose that noradrenaline influences learning of uncertain events arising from unexpected changes in the environment. In contrast, acetylcholine balances attribution of uncertainty to chance fluctuations within an environmental context, defined by a stable set of probabilistic associations, or to gross environmental violations following a contextual switch. Dopamine supports the use of uncertainty representations to engender fast, adaptive responses.

  9. A cross-sectional examination of psychological distress, positive mental health and their predictors in medical students in their clinical clerkships

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    Inge van Dijk

    2017-11-01

    Full Text Available Abstract Background Medical students can experience the transition from theory to clinical clerkships as stressful. Scientific literature on the mental health of clinical clerkship students is scarce and mental health is usually defined as absence of psychological distress without assessing psychological, emotional and social wellbeing, together called ‘positive mental health’. This cross-sectional study examines the prevalence of psychological distress and positive mental health and explores possible predictors in a Dutch sample of clinical clerkship students. Methods Fourth-year medical students in their first year of clinical clerkships were invited to complete an online questionnaire assessing demographics, psychological distress (Brief Symptom Inventory, positive mental health (Mental Health Continuum- SF, dysfunctional cognitions (Irrational Beliefs Inventory and dispositional mindfulness skills (Five Facet Mindfulness Questionnaire. Multiple linear regression analysis was used to explore relationships between psychological distress, positive mental health (dependent variables and demographics, dysfunctional cognitions and dispositional mindfulness skills (predictors. Results Of 454 eligible students, 406 (89% completed the assessment of whom 21% scored in the clinical range of psychological distress and 41% reported a flourishing mental health. These proportions partially overlap each other. Female students reported a significantly higher mean level of psychological distress than males. In the regression analysis the strongest predictors of psychological distress were ‘acting with awareness’ (negative and ‘worrying’ (positive. Strongest predictors of positive mental health were ‘problem avoidance’ (negative and ‘emotional irresponsibility’ (negative. Conclusions The prevalence of psychopathology in our sample of Dutch clinical clerkship students is slightly higher than in the general population. Our results support

  10. The evidence-based practice profiles of academic and clinical staff involved in pre-registration nursing students' education: a cross sectional survey of US and UK staff.

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    Upton, Penney; Scurlock-Evans, Laura; Williamson, Kathleen; Rouse, Joanne; Upton, Dominic

    2015-01-01

    Competency in evidence-based practice (EBP) is a requirement for graduate nurses. Despite a growing body of research exploring the EBP profiles of students, little research has explored the EBP profiles of nurse educators. To explore: the differences/similarities in the EBP profiles of US and UK clinical and academic faculty; the barriers nurse educators experience when teaching EBP; the impact of postgraduate education on EBP profile and; what nurse educators perceive "success" in implementing and teaching EBP to be. A cross-sectional online survey design was employed. Two Universities delivering undergraduate nursing education in the US and UK, in partnership with large hospital systems, small community hospitals, community settings, and independent sector health organisations. Eighty-one nurse educators working in academic and clinical contexts in the US and UK (US academic=12, US clinical=17, UK academic=9, UK clinical=43) were recruited opportunistically. Participants were emailed a weblink to an online survey, comprising demographic questions, the Evidence-Based Practice Questionnaire and open-ended questions about EBP barriers, facilitators and successes. Quantitative results indicated that academic faculty scored significantly higher on knowledge and skills of EBP, than clinical faculty, but revealed no other significant differences on EBP use or attitudes, or between US and UK professionals. Participants with postgraduate training scored significantly higher on EBP knowledge/skills, but not EBP attitudes or use. Qualitative findings identified key themes relating to EBP barriers and facilitators, including: Evidence-, organisational-, and teaching-related issues. Perceptions of successes in EBP were also described. Nurse educators working in the UK and US face similar EBP barriers to teaching and implementation, but view it positively and use it frequently. Clinical staff may require extra support to maintain their EBP knowledge and skills in

  11. Clinical and cytogenetic features of a Brazilian sample of patients with phenotype of oculo-auriculo-vertebral spectrum: a cross-sectional study

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    Alessandra Pawelec da Silva

    Full Text Available CONTEXT AND OBJECTIVE: Oculo-auriculo-vertebral spectrum (OAVS is considered to be a defect of embryogenesis involving structures originating from the first branchial arches. Our objective was to describe the clinical and cytogenetic findings from a sample of patients with the phenotype of OAVS.DESIGN AND SETTING: Cross-sectional study in a referral hospital in southern Brazil.METHODS: The sample consisted of 23 patients who presented clinical findings in at least two of these four areas: orocraniofacial, ocular, auricular and vertebral. The patients underwent a clinical protocol and cytogenetic evaluation through high-resolution karyotyping, fluorescence in situ hybridization for 5p and 22q11 microdeletions and investigation of chromosomal instability for Fanconi anemia.RESULTS: Cytogenetic abnormalities were observed in three cases (13% and consisted of: 47,XX,+mar; mos 47,XX,+mar/46,XX; and 46,XX,t(6;10(q13; q24. We observed cases of OAVS with histories of gestational exposition to fluoxetine, retinoic acid and crack. One of our patients was a discordant monozygotic twin who had shown asymmetrical growth restriction during pregnancy. Our patients with OAVS were characterized by a broad clinical spectrum and some presented atypical findings such as lower-limb reduction defect and a tumor in the right arm, suggestive of hemangioma/lymphangioma.CONCLUSIONS: We found a wide range of clinical characteristics among the patients with OAVS. Different chromosomal abnormalities and gestational expositions were also observed. Thus, our findings highlight the heterogeneity of the etiology of OAVS and the importance of these factors in the clinical and cytogenetic evaluation of these patients.

  12. A cross-sectional examination of psychological distress, positive mental health and their predictors in medical students in their clinical clerkships.

    Science.gov (United States)

    van Dijk, Inge; Lucassen, Peter L B J; van Weel, Chris; Speckens, Anne E M

    2017-11-17

    Medical students can experience the transition from theory to clinical clerkships as stressful. Scientific literature on the mental health of clinical clerkship students is scarce and mental health is usually defined as absence of psychological distress without assessing psychological, emotional and social wellbeing, together called 'positive mental health'. This cross-sectional study examines the prevalence of psychological distress and positive mental health and explores possible predictors in a Dutch sample of clinical clerkship students. Fourth-year medical students in their first year of clinical clerkships were invited to complete an online questionnaire assessing demographics, psychological distress (Brief Symptom Inventory), positive mental health (Mental Health Continuum- SF), dysfunctional cognitions (Irrational Beliefs Inventory) and dispositional mindfulness skills (Five Facet Mindfulness Questionnaire). Multiple linear regression analysis was used to explore relationships between psychological distress, positive mental health (dependent variables) and demographics, dysfunctional cognitions and dispositional mindfulness skills (predictors). Of 454 eligible students, 406 (89%) completed the assessment of whom 21% scored in the clinical range of psychological distress and 41% reported a flourishing mental health. These proportions partially overlap each other. Female students reported a significantly higher mean level of psychological distress than males. In the regression analysis the strongest predictors of psychological distress were 'acting with awareness' (negative) and 'worrying' (positive). Strongest predictors of positive mental health were 'problem avoidance' (negative) and 'emotional irresponsibility' (negative). The prevalence of psychopathology in our sample of Dutch clinical clerkship students is slightly higher than in the general population. Our results support conclusions of previous research that psychological distress and positive mental

  13. Preparedness of HIV care and treatment clinics for the management of concomitant non–communicable diseases: a cross–sectional survey

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    Claudia Leung

    2016-09-01

    Full Text Available Abstract Background In Sub-Saharan Africa, epidemiological studies have reported an increasing burden of non-communicable diseases (NCD among people living with HIV. NCD management can be feasibly integrated into HIV care; however, clinic readiness to provide NCD services in these settings should first be assessed and gaps in care identified. Methods A cross-sectional survey conducted in July 2013 assessed the resources available for NCD care at 14 HIV clinics in Dar es Salaam, Tanzania. Survey items related to staff training, protocols, and resources for cardiovascular disease risk factor screening, management, and patient education. Results 43 % of clinics reported treating patients with hypertension; however, only 21 % had a protocol for NCD management. ECHO International Health standards for essential clinical equipment were used to measure clinic readiness; 36 % met the standard for blood pressure cuffs, 14 % for glucometers. Available laboratory tests for NCD included blood glucose (88 %, urine dipsticks (78 %, and lipid panel (57 %. 21 % had a healthcare worker with NCD training. All facilities provided some form of patient education, but only 14 % included diabetes, 57 % tobacco cessation, and 64 % weight management. Conclusions A number of gaps were identified in this sample of HIV clinics that currently limit the ability of Tanzanian healthcare workers to diagnose and manage NCD in the context of HIV care. Integrated NCD and HIV care may be successfully achieved in these settings with basic measures incorporated into existing infrastructures at minimal added expense, i.e., improving access to basic functioning equipment, introducing standardized treatment guidelines, and improving healthcare worker education.

  14. Clinical inertia in poorly controlled elderly hypertensive patients: a cross-sectional study in Spanish physicians to ascertain reasons for not intensifying treatment.

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    Gil-Guillén, Vicente; Orozco-Beltrán, Domingo; Carratalá-Munuera, Concepción; Márquez-Contreras, Emilio; Durazo-Arvizu, Ramón; Cooper, Richard; Pertusa-Martínez, Salvador; Pita-Fernandez, Salvador; González-Segura, Diego; Martin-de-Pablo, José Luis; Pallarés, Vicente; Fernández, Antonio; Redón, Josep

    2013-06-01

    Clinical inertia, the failure of physicians to initiate or intensify therapy when indicated, is a major problem in the management of hypertension and may be more prevalent in elderly patients. Overcoming clinical inertia requires understanding its causes and evaluating certain factors, particularly those related to physicians. The objective of our study was to determine the rate of clinical inertia and t