Science.gov

Sample records for a-abo dysport clinical

  1. Conversion Ratio between Botox(®), Dysport(®), and Xeomin(®) in Clinical Practice.

    PubMed

    Scaglione, Francesco

    2016-01-01

    Botulinum neurotoxin has revolutionized the treatment of spasticity and is now administered worldwide. There are currently three leading botulinum neurotoxin type A products available in the Western Hemisphere: onabotulinum toxin-A (ONA) Botox(®), abobotulinum toxin-A (ABO), Dysport(®), and incobotulinum toxin A (INCO, Xeomin(®)). Although the efficacies are similar, there is an intense debate regarding the comparability of various preparations. Here we will address the clinical issues of potency and conversion ratios, as well as safety issues such as toxin spread and immunogenicity, to provide guidance for BoNT-A use in clinical practice. INCO was shown to be as effective as ONA with a comparable adverse event profile when a clinical conversion ratio of 1:1 was used. The available clinical and preclinical data suggest that a conversion ratio ABO:ONA of 3:1-or even lower-could be appropriate for treating spasticity, cervical dystonia, and blepharospasm or hemifacial spasm. A higher conversion ratio may lead to an overdosing of ABO. While uncommon, distant spread may occur; however, several factors other than the pharmaceutical preparation are thought to affect spread. Finally, whereas the three products have similar efficacy when properly dosed, ABO has a better cost-efficacy profile. PMID:26959061

  2. Conversion Ratio between Botox®, Dysport®, and Xeomin® in Clinical Practice

    PubMed Central

    Scaglione, Francesco

    2016-01-01

    Botulinum neurotoxin has revolutionized the treatment of spasticity and is now administered worldwide. There are currently three leading botulinum neurotoxin type A products available in the Western Hemisphere: onabotulinum toxin-A (ONA) Botox®, abobotulinum toxin-A (ABO), Dysport®, and incobotulinum toxin A (INCO, Xeomin®). Although the efficacies are similar, there is an intense debate regarding the comparability of various preparations. Here we will address the clinical issues of potency and conversion ratios, as well as safety issues such as toxin spread and immunogenicity, to provide guidance for BoNT-A use in clinical practice. INCO was shown to be as effective as ONA with a comparable adverse event profile when a clinical conversion ratio of 1:1 was used. The available clinical and preclinical data suggest that a conversion ratio ABO:ONA of 3:1—or even lower—could be appropriate for treating spasticity, cervical dystonia, and blepharospasm or hemifacial spasm. A higher conversion ratio may lead to an overdosing of ABO. While uncommon, distant spread may occur; however, several factors other than the pharmaceutical preparation are thought to affect spread. Finally, whereas the three products have similar efficacy when properly dosed, ABO has a better cost-efficacy profile. PMID:26959061

  3. Does Reduction of Number of Intradetrusor Injection Sites of aboBoNTA (Dysport®) Impact Efficacy and Safety in a Rat Model of Neurogenic Detrusor Overactivity?

    PubMed Central

    Huynh Le Maux, Amélie; Pignol, Bernadette; Behr-Roussel, Delphine; Blachon, Jean-Luc; Chabrier, Pierre-Etienne; Compagnie, Sandrine; Picaut, Philippe; Bernabé, Jacques; Giuliano, François; Denys, Pierre

    2015-01-01

    Intradetrusor injections of Botulinum toxin A—currently onabotulinumtoxinA—is registered as a second-line treatment to treat neurogenic detrusor overactivity (NDO). The common clinical practice is 30 × 1 mL injections in the detrusor; however, protocols remain variable and standardization is warranted. The effect of reducing the number of injection sites of Dysport® abobotulinumtoxinA (aboBoNTA) was assessed in the spinal cord-injured rat (SCI). Nineteen days post-spinalization, female rats received intradetrusor injections of saline or aboBoNTA 22.5 U distributed among four or eight sites. Two days after injection, continuous cystometry was performed in conscious rats. Efficacy of aboBoNTA 22.5 U was assessed versus aggregated saline groups on clinically-relevant parameters: maximal pressure, bladder capacity, compliance, voiding efficiency, as well as amplitude, frequency, and volume threshold for nonvoiding contractions (NVC). AboBoNTA 22.5 U significantly decreased maximal pressure, without affecting voiding efficiency. Injected in four sites, aboBoNTA significantly increased bladder capacity and compliance while only the latter when in eight sites. AboBoNTA significantly reduced NVC frequency and amplitude. This preclinical investigation showed similar inhibiting effects of aboBoNTA despite the number of sites reduction. Further studies are warranted to optimize dosing schemes to improve the risk-benefit ratio of BoNTA-based treatment modalities for NDO and further idiopathic overactive bladder. PMID:26694464

  4. Does Reduction of Number of Intradetrusor Injection Sites of aboBoNTA (Dysport®) Impact Efficacy and Safety in a Rat Model of Neurogenic Detrusor Overactivity?

    PubMed

    Huynh Le Maux, Amélie; Pignol, Bernadette; Behr-Roussel, Delphine; Blachon, Jean-Luc; Chabrier, Pierre-Etienne; Compagnie, Sandrine; Picaut, Philippe; Bernabé, Jacques; Giuliano, François; Denys, Pierre

    2015-12-01

    Intradetrusor injections of Botulinum toxin A-currently onabotulinumtoxinA-is registered as a second-line treatment to treat neurogenic detrusor overactivity (NDO). The common clinical practice is 30 × 1 mL injections in the detrusor; however, protocols remain variable and standardization is warranted. The effect of reducing the number of injection sites of Dysport(®) abobotulinumtoxinA (aboBoNTA) was assessed in the spinal cord-injured rat (SCI). Nineteen days post-spinalization, female rats received intradetrusor injections of saline or aboBoNTA 22.5 U distributed among four or eight sites. Two days after injection, continuous cystometry was performed in conscious rats. Efficacy of aboBoNTA 22.5 U was assessed versus aggregated saline groups on clinically-relevant parameters: maximal pressure, bladder capacity, compliance, voiding efficiency, as well as amplitude, frequency, and volume threshold for nonvoiding contractions (NVC). AboBoNTA 22.5 U significantly decreased maximal pressure, without affecting voiding efficiency. Injected in four sites, aboBoNTA significantly increased bladder capacity and compliance while only the latter when in eight sites. AboBoNTA significantly reduced NVC frequency and amplitude. This preclinical investigation showed similar inhibiting effects of aboBoNTA despite the number of sites reduction. Further studies are warranted to optimize dosing schemes to improve the risk-benefit ratio of BoNTA-based treatment modalities for NDO and further idiopathic overactive bladder. PMID:26694464

  5. Efficacy of Onabotulinum Toxin A (Botox) versus Abobotulinum Toxin A (Dysport) Using a Conversion Factor (1 : 2.5) in Treatment of Primary Palmar Hyperhidrosis

    PubMed Central

    El Kahky, Hanan Mohamed; Diab, Heba Mahmoud; Aly, Dalia Gamal; Farag, Nehal Magdi

    2013-01-01

    Background. Two preparations of botulinum A toxin (BTX-A) are commercially available for the treatment of palmar hyperhidrosis (PPH): Botox (Allergan; 100 U/vial) and Dysport (Ipsen Limited; 500 U/vial), which are not bioequivalent. Results regarding an appropriate conversion factor between them are controversial. Objectives. This paper aims to compare the efficacy of Botox and Dysport in PPH using a conversion factor of 1 : 2.5. Methods. Eight patients with severe PPH received intradermal injections of Botox in one palm and Dysport in the other in the same session. Clinical assessment was performed at baseline and posttreatment for 8 months using Minor's iodine starch test, Hyperhidrosis Disease Severity Scale (HDSS), and Dermatology Life Quality Index (DLQI) test. Results. At 3 weeks, a significant decrease in sweating for both preparations was noted which was more pronounced with Dysport compared with Botox. At 8 weeks, this difference turned insignificant. Continued evaluation showed similar improvement in both palms with a nonsignificant difference. Patients with longer disease duration were more liable to relapse. Conclusion. The efficacy and safety of Botox and Dysport injections were similar using a conversion factor of 1 : 2.5. There was a trend towards a more rapid action after Dysport treatment but without significant importance. PMID:24250334

  6. AbobotulinumtoxinA (Dysport) dosing in cervical dystonia: an exploratory analysis of two large open-label extension studies.

    PubMed

    Hauser, Robert A; Truong, Daniel; Hubble, Jean; Coleman, Chandra; Beffy, Jean-Luc; Chang, Stephen; Picaut, Philippe

    2013-02-01

    Treatment with botulinum toxin-A is recommended as first-line treatment for cervical dystonia (CD). In clinical practice many factors appear to influence dose adjustment and the retreatment regimen; however, there is little information available in the literature regarding the evolution of dosing over treatment cycles. We report on two similarly designed, long-term, multicenter, open-label extension studies of Dysport for the treatment of CD, which followed 500 U fixed-dose placebo-controlled trials. Both studies specified a fixed 500 U dose for the first open-label treatment cycle, with dose adjustment in subsequent treatment cycles according to the clinical response. These analyses include 218 patients who entered the two studies; doses in the subsequent treatment cycles ranged between 250 and 1,000 U. During open-label treatment, all treatment cycles resulted in improvements in mean Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores. However, increasing the dose of Dysport above the initial 500 U dose was not observed to result in an incremental improvement in response as measured by the TWSTRS. No individual patient characteristic was found to reliably predict the use of higher doses at each treatment cycle. Dysport was generally well tolerated with no major differences in the incidence of adverse events (AEs) observed with different doses. Dysphagia was considered an AE of special interest and dysphagia data from the open-label studies were combined with two Phase II studies. Analysis of this enhanced database indicates that unilateral injections of >150 U into the sternocleidomastoid muscle is associated with a higher dysphagia risk. Thus, limiting the dose in the sternocleidomastoid may help reduce the incidence of dysphagia. PMID:22878514

  7. Dysport and Botox at a Ratio of 2.5:1 Units in Cervical Dystonia: A Double-Blind, Randomized Study

    PubMed Central

    Yun, Ji Young; Kim, Jae Woo; Kim, Hee-Tae; Chung, Sun Ju; Kim, Jong-Min; Cho, Jin Whan; Lee, Jee-Young; Lee, Ha Neul; You, Sooyeoun; Oh, Eungseok; Jeong, Heejeong; Kim, Young Eun; Kim, Han-Joon; Lee, Won Yong; Jeon, Beom S

    2015-01-01

    We aimed to compare Dysport (abobotulinumtoxinA, Ipsen Biopharm, Slough, UK) and Botox (onabotulinumtoxinA, Allergan, Irvine, CA, USA) at a 2.5:1 ratio in the treatment of cervical dystonia (CD). A Dysport/Botox ratio of lower than 3:1 was suggested as a more appropriate conversion ratio, considering its higher efficacy and more frequent incidence of adverse effects not only in the treatment of CD but also in other focal movement disorders. A randomized, double-blind, multicenter, non-inferiority, two-period crossover study was done in CD, with a duration of at least 18 months. Patients were randomly assigned to treatment for the first period with Dysport or Botox, and they were followed up for 16 weeks after the injection. After a 4-week washout period, they were switched to the other formulation and then followed up for 16 weeks. The primary outcome was the changes in the Tsui scale between the baseline value and that at 1 month after each injection. A total of 103 patients were enrolled, and 94 completed the study. Mean changes in the Tsui scale between baseline and 4 weeks after each injection tended to favor Botox; however, this was not statistically significant (4.0 ± 3.9 points for the Dysport treatment vs. 4.8 ± 4.1 points for Botox; 95% confidence interval, −0.1-1.7; P = 0.091). The mean change of the Toronto western spasmodic torticollis rating scale score, the proportion of improvement in clinical global impression and patient global impression, and the incidences of adverse events were not significantly different between the two treatments. With regard to safety and efficacy, Dysport was not inferior to Botox in patients with CD at a conversion factor of 2.5:1. [http//clinicaltrial.gov: NCT00950664] © The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. PMID:25476727

  8. Clinical differences between botulinum neurotoxin type A and B.

    PubMed

    Bentivoglio, Anna Rita; Del Grande, Alessandra; Petracca, Martina; Ialongo, Tamara; Ricciardi, Lucia

    2015-12-01

    In humans, the therapeutic use of botulinum neurotoxin A (BoNT/A) is well recognized and continuously expanding. Four BoNTs are widely available for clinical practice: three are serotype A and one is serotype B: onabotulinumtoxinA (A/Ona), abobotulinumtoxinA (A/Abo) and incobotulinumtoxinA (A/Inco), rimabotulinumtoxinB (B/Rima). A/Abo, A/Inco, A/Ona and B/Rima are all licensed worldwide for cervical dystonia. In addition, the three BoNT/A products are approved for blepharospasm and focal dystonias, spasticity, hemifacial spasm, hyperhidrosis and facial lines, with remarkable regional differences. These toxin brands differ for specific activity, packaging, constituents, excipient, and storage. Comparative literature assessing the relative safety and efficacy of different BoNT products is limited, most data come from reports on small samples, and only a few studies meet criteria of evidence-based medicine. One study compared the effects of BoNT/A and BoNT/B on muscle activity of healthy volunteers, showing similar neurophysiological effects with a dose ratio of 1:100. In cervical dystonia, when comparing the effects of BoNT/A and BoNT/B, results are more variable, some studies reporting roughly similar peak effect and overall duration (at a ratio of 1:66, others reporting substantially shorter duration of BoNT/B than BoNT/A (at a ratio 1/24). Although the results of clinical studies are difficult to compare for methodological differences (dose ratio, study design, outcome measures), it is widely accepted that: BoNT/B is clinically effective using appropriate doses as BoNT/A (1:40-50), injections are generally more painful, in most of the studies on muscular conditions, efficacy is shorter, and immunogenicity higher. Since the earliest clinical trials, it has been reported that autonomic side effects are more frequent after BoNT/B injections, and this observation encouraged the use of BoNT/B for sialorrhea, hyperhidrosis and other non-motor symptoms. In these indications the efficacy of toxins A and B are comparable and dose ratio is 1:25-30. PMID:26260691

  9. Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Blepharospasm and Hemifacial Spasm

    PubMed Central

    Dashtipour, Khashayar; Chen, Jack J.; Frei, Karen; Nahab, Fatta; Tagliati, Michele

    2015-01-01

    Background The aim was to elucidate clinical trial efficacy, safety, and dosing practices of abobotulinumtoxinA (ABO) treatment in adult patients with blepharospasm and hemifacial spasm. To date, most literature reviews for blepharospasm and hemifacial spasm have examined the effectiveness of all botulinum neurotoxin type A products as a class. However, differences in dosing units and recommended schemes provide a clear rationale for reviewing each product separately. Methods A systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of ABO in the treatment of blepharospasm and hemifacial spasm published in English between January 1991 and March 2015. Medical literature databases (PubMed, Cochrane library, EMBASE) were searched. A total of five primary publications that evaluated ABO for the management of blepharospasm and hemifacial spasm were identified and summarized. Results Data included 374 subjects with blepharospasm and 172 subjects with hemifacial spasm treated with ABO. Total ABO doses ranged between 80 and 340 U for blepharospasm and 25 and 85 U for hemifacial spasm, depending on the severity of the clinical condition. All studies showed statistically significant benefits for the treatment of blepharospasm and hemifacial spasm. ABO was generally well tolerated across the individual studies. Adverse events considered to be associated with ABO treatment included: ptosis, tearing, blurred vision, double vision, dry eyes, and facial weakness. Discussion These data from 5 randomized clinical studies represents the available evidence base of ABO in blepharospasm and hemifacial spasm. Future studies in this area will add to this evidence base. PMID:26566457

  10. Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Lower Limb Spasticity

    PubMed Central

    Dashtipour, Khashayar; Chen, Jack J.; Walker, Heather W.; Lee, Michael Y.

    2016-01-01

    Abstract To elucidate clinical trial efficacy, safety, and dosing practices of AbobotulinumtoxinA (ABO) treatment in adult patients with lower limb spasticity. A systematic literature review was performed to identify randomized controlled trials of ABO in the treatment of adult lower limb spasticity. Of the 295 records identified, 6 primary publications evaluated ABO for the management of lower limb spasticity of various etiologies and were evaluated. Total ABO doses ranged between 500 and 2000 U for lower limb spasticity, depending on the muscles injected. All studies in lower limb spasticity showed statistically significant reduction in muscle tone based on Modified Ashworth Scale of ABO versus placebo. Significant effects on active movement and pain were demonstrated albeit less consistently. ABO was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Treatment-related adverse events included but not limited to fatigue, local pain at injection site, hypertonia, dry mouth, weakness of the noninjected muscle, abnormal gait, and urinary tract infection. These data from 6 randomized clinical studies provide the beginnings of an evidence base for the use of ABO to reduce lower limb spasticity. Ongoing studies in this area will add to this evidence base. PMID:26765447

  11. Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Lower Limb Spasticity.

    PubMed

    Dashtipour, Khashayar; Chen, Jack J; Walker, Heather W; Lee, Michael Y

    2016-01-01

    To elucidate clinical trial efficacy, safety, and dosing practices of AbobotulinumtoxinA (ABO) treatment in adult patients with lower limb spasticity.A systematic literature review was performed to identify randomized controlled trials of ABO in the treatment of adult lower limb spasticity.Of the 295 records identified, 6 primary publications evaluated ABO for the management of lower limb spasticity of various etiologies and were evaluated. Total ABO doses ranged between 500 and 2000 U for lower limb spasticity, depending on the muscles injected. All studies in lower limb spasticity showed statistically significant reduction in muscle tone based on Modified Ashworth Scale of ABO versus placebo. Significant effects on active movement and pain were demonstrated albeit less consistently. ABO was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Treatment-related adverse events included but not limited to fatigue, local pain at injection site, hypertonia, dry mouth, weakness of the noninjected muscle, abnormal gait, and urinary tract infection.These data from 6 randomized clinical studies provide the beginnings of an evidence base for the use of ABO to reduce lower limb spasticity. Ongoing studies in this area will add to this evidence base. PMID:26765447

  12. Clinical Research

    MedlinePlus

    ... a Clinical Trial Breadcrumb Navigation Home Our Research Clinical Trials Share Facebook Twitter Email Permalink This is an exciting time in cystic fibrosis clinical research. Not only are there several clinical trials ...

  13. Clinical Research and Clinical Trials

    MedlinePlus

    ... of Health A-Z Topics | Directory Connect with us: Toggle navigation Health & Research A-Z Topics Symptoms, treatments, research, articles, clinical trials, resources Clinical Trials & Clinical Research Find clinical trials, ...

  14. CLINICAL BIOCHEMISTRY

    EPA Science Inventory

    Assessment of the health status of animals through measurement of cellular, biochemical, and macromolecular constituents in blood, secretions, and excretions has been variously referred to as clinical chemistry, clinical biochemistry, or clinical pathology. he genesis of this dis...

  15. Clinical Trials

    MedlinePlus

    Women in CLINICAL TRIALS Make a Difference For Yourself and For Women Like You. Clinical trials are research studies that help to show ... other trials, you take a new drug. Some clinical trials use healthy people. Others use people who ...

  16. Clinical Competence/Clinical Credibility.

    ERIC Educational Resources Information Center

    Goorapah, David

    1997-01-01

    In interviews with 10 nurse teachers and 10 clinicians, respondents could describe clinical competence more fluently than clinical credibility. Responses raised the question of whether nursing teachers must be clinically competent/credible to teach nursing. (SK)

  17. Clinical Trials

    MedlinePlus

    Clinical Trials What is a clinical trial? A clinical trial is a study carried out in human volunteers to help doctors learn more about the human body ... medicines and treatments. The information gained from a clinical study is added to the results from lab ...

  18. Clinical Trials

    MedlinePlus

    Clinical trials are research studies that test how well new medical approaches work in people. Each study ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to ...

  19. Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

    PubMed Central

    Rodgers, Helen; Shaw, Lisa; Price, Christopher; van Wijck, Frederike; Barnes, Michael; Graham, Laura; Ford, Gary; Shackley, Phil; Steen, Nick

    2008-01-01

    Background Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear. The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group). Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy. Randomisation : A web based central independent randomisation service. Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between intervention and control groups. Treatment success is defined as improvement of 3 points for those with a baseline ARAT of 0–3 and 6 points for those with ARAT of 4–56. Trial registration ISRCTN78533119 EudraCT 2004-002427-40 CTA 17136/0230/001 Funding National Institute for Health Research, Health Technology Assessment Programme. Ipsen Ltd provide botulinum toxin type A (Dysport®). PMID:18947418

  20. Clinical medicine

    PubMed Central

    Rockman, Howard A.

    2012-01-01

    With the December issue of the Journal of Clinical Investigation, I announce the launch of a new category of manuscript called “Clinical Medicine,” along with new editorial board members to adjudicate the peer-review process. With this initiative, the journal aims to publish the highest quality human research that reports early-stage, effective new therapies that impact disease outcomes.

  1. Preoperative Clinics.

    PubMed

    Edwards, Angela F; Slawski, Barbara

    2016-03-01

    Preoperative evaluation clinics have been shown to enhance operating room efficiency, decrease day-of-surgery cancellations, reduce hospital costs, and improve the quality of patient care. Although programs differ in staffing, structure, financial support, and daily operations, they share the common goal of preoperative risk reduction in order for patients to proceed safely through the perioperative period. Effective preoperative evaluation occurs if processes are standardized to ensure clinical, regulatory, and accreditation guidelines are met while keeping medical optimization and patient satisfaction at the forefront. Although no universally accepted standard model exists, there are key components to a successful preoperative process. PMID:26927735

  2. Clinical cytometry

    SciTech Connect

    Andreeff, M.

    1986-01-01

    This book contains papers presented at the Clinical Cytometry Conference of the Engineering Foundation and the Society for Analytical Cytology. Topics covered include: instrumentation, cell cycle analysis and drugs, hematology-immunology, lymphomas, leukemias, solid tumor, and bacteria, chromosomes and sperm.

  3. Clinical Research Operations

    Cancer.gov

    Clinical Research Operations  The Office of the Clinical Director serves as the interface between CCR clinical investigators and the NIH Clinical Center where CCR clinical trials take place. The Clinical Director, Dr. William L. Dahut, oversees and assure

  4. Clinical Research Operations

    Cancer.gov

    Clinical Trials - Research Resources CCR Clinical Trials at NIH - CCR conducts more than 150 cancer clinical trials at the NIH Clinical Center in Bethesda, Maryland. NCI Clinical Trials - Search NCI's list of 10,000+ clinical trials now accepting particip

  5. Clinical biochemistry

    NASA Technical Reports Server (NTRS)

    Alexander, W. C.; Leach, C. S.; Fischer, C. L.

    1975-01-01

    The objectives of the biochemical studies conducted for the Apollo program were (1) to provide routine laboratory data for assessment of preflight crew physical status and for postflight comparisons; (2) to detect clinical or pathological abnormalities which might have required remedial action preflight; (3) to discover as early as possible any infectious disease process during the postflight quarantine periods following certain missions; and (4) to obtain fundamental medical knowledge relative to man's adjustment to and return from the space flight environment. The accumulated data presented suggest that these requirements were met by the program described. All changes ascribed to the space flight environment were subtle, whereas clinically significant changes were consistent with infrequent illnesses unrelated to the space flight exposure.

  6. Unilateral versus bilateral thyroarytenoid Botulinum toxin injections in adductor spasmodic dysphonia: a prospective study

    PubMed Central

    Upile, Tahwinder; Elmiyeh, Behrad; Jerjes, Waseem; Prasad, Vyas; Kafas, Panagiotis; Abiola, Jesuloba; Youl, Bryan; Epstein, Ruth; Hopper, Colin; Sudhoff, Holger; Rubin, John

    2009-01-01

    Objectives In this preliminary prospective study, we compared unilateral and bilateral thyroarytenoid muscle injections of Botulinum toxin (Dysport) in 31 patients with adductor spasmodic dysphonia, who had undergone more than 5 consecutive Dysport injections (either unilateral or bilateral) and had completed 5 concomitant self-rated efficacy and complication scores questionnaires related to the previous injections. We also developed a Neurophysiological Scoring (NPS) system which has utility in the treatment administration. Method and materials Data were gathered prospectively on voice improvement (self-rated 6 point scale), length of response and duration of complications (breathiness, cough, dysphagia and total voice loss). Injections were performed under electromyography (EMG) guidance. NPS scale was used to describe the EMG response. Dose and unilateral/bilateral injections were determined by clinical judgment based on previous response. Time intervals between injections were patient driven. Results Low dose unilateral Dysport injection was associated with no significant difference in the patient's outcome in terms of duration of action, voice score (VS) and complication rate when compared to bilateral injections. Unilateral injections were not associated with any post treatment total voice loss unlike the bilateral injections. Conclusion Unilateral low dose Dysport injections are recommended in the treatment of adductor spasmodic dysphonia. PMID:19852852

  7. Clinical arthrography

    SciTech Connect

    Arndt, R.; Horns, J.W.; Gold, R.H.; Blaschke, D.D.

    1985-01-01

    This book deals with the method and interpretation of arthrography of the shoulder, knee, ankle, elbow, hip, wrist, and metacarpophalangeal, interphalangeal, and temporomandibular joints. The emphasis is on orthopaedic disorders, usually of traumatic origin, which is in keeping with the application of arthrography in clinical practice. Other conditions, such as inflammatory and degenerative diseases, congenital disorders and, in the case of the hip, arthrography of reconstructive joint surgery, are included. Each chapter is devoted to one joint and provides a comprehensive discussion on the method of arthrography, including single and double contrast techniques where applicable, normal radiographic anatomy, and finally, the interpretation of the normal and the abnormal arthrogram.

  8. Clinical neuroimaging

    SciTech Connect

    Gilman, S.; Mazziotta, J.C.

    1989-01-01

    Designed for practicing neurologists and neurosurgeons, this reference focuses on the newest techniques in computed assisted tomography. Text material covers basic principles of computed tomography, as well as the clinical advantages and disadvantages of each modality. The anatomical and/or physiological processes measured by XCT, PET, SPECT and MRI are first discussed in terms of the normal patient, and then applied to the diagnosis and treatment of patients with neurological disease (primarily of the brain). Emphasis is placed on areas of difficult diagnosis, such as differentiating recurrent tumor from radiation necrosis, early diagnosis of dementia, selection of patients for extracranial-intracranial bypass procedures, and localization of epileptic foci.

  9. Clinical Trial Basics

    MedlinePlus

    ... of clinical research make a difference? What are clinical trials and why do people participate? Clinical trials are ... them ineligible to continue the study. Types of clinical trials There are different types of clinical trials. Natural ...

  10. Learn about Clinical Studies

    MedlinePlus

    ... Studies Glossary of Common Site Terms Learn About Clinical Studies Contents What Is a Clinical Study? Clinical ... for Participation Questions to Ask What Is a Clinical Study? A clinical study involves research using human ...

  11. clinical practice

    PubMed Central

    Bauer, Douglas C.

    2014-01-01

    This Journal feature begins with a case vignette highlighting a common clinical problem. Evidence supporting various strategies is then presented, followed by a review of formal guidelines, when they exist. The article ends with the authors clinical recommendations. A 62-year-old healthy woman presents for routine care. She has no history of fracture, but she is worried about osteoporosis because her mother had a hip fracture at 72 years of age. She exercises regularly and has taken over-the-counter calcium carbonate at a dose of 1000 mg three times a day since her menopause at 54 years of age. This regimen provides 1200 mg of elemental calcium per day. She eats a healthy diet with multiple servings of fruits and vegetables and consumes one 8-oz serving of low-fat yogurt and one glass of low-fat milk almost every day. She recently heard that calcium supplements could increase her risk of cardiovascular disease and wants your opinion about whether or not she should receive them. What would you advise? PMID:24131178

  12. Clinical guidelines.

    PubMed

    Uppal, Elaine

    2016-01-01

    This article is part of the Advancing practice series which is aimed at exploring practice issues in more depth, considering topics that are frequently encountered and facilitating the development of new insights. Elaine Uppal focuses on the importance of all midwives developing guideline writing skills to ensure that local, national and international midwifery/maternity guidelines are up to date, relevant and reflect midwifery knowledge alongside 'gold' standard evidence. The article aims to consider the development, use and critical appraisal of clinical guidelines. It will define and explain guidelines; discuss their development and dissemination; and consider issues relating to their use in practice. Techniques to critique and develop guidelines using the AGREE tool will be outlined in the form of practice challenges to be undertaken by the individual or in a group. PMID:26975126

  13. Treatment of chronic plantar fasciitis with Botulinum toxin A: preliminary clinical results.

    PubMed

    Placzek, Richard; Deuretzbacher, Georg; Meiss, A Ludwig

    2006-02-01

    Based on recent results in chronic lateral epicondylitis we decided to investigate the efficacy of Botulinum toxin A (BTX-A) for treatment of chronic therapy resistant plantar fasciitis. Nine patients with an average duration of symptoms of 14 months and at least two prior conservative treatments received a one injection of 200 units of BTX-A (Dysport) subfascially into the painful area. The patients documented pain at rest and during weight-bearing after 2, 6, 10 and 14 weeks by a visual analogue scale. A significant reduction of pain during weight-bearing to about 50% was seen 6 weeks after injection. The effect was still present at the latest follow-up of 14 weeks. Similarly, the pain at rest was reduced to less than half of the initial value at any follow-up. All patients were satisfied and did not require further treatment. PMID:16428954

  14. Writing clinical scenarios for clinical science questions.

    PubMed

    Smith, Phil Em; Mucklow, John C

    2016-04-01

    Written knowledge assessments for physicians in training typically involve multiple-choice questions that use a clinical scenario in a single-best-answer format. The Royal College of Physicians Part 1 MRCP(UK) examination includes basic sciences themes that are challenging to assess through a clinical scenario. A realistic clinical setting based on everyday clinical practice and integral to the question is the clearest demonstration that the knowledge being assessed is clinically relevant. However, without special attention to detail, the scenario in a clinical science question can appear redundant or artificial. Reading unnecessary material frustrates candidates and threatens the reputation of the assessment. In this paper we discuss why a clinical scenario is important for basic science questions and offer advice on setting realistic and plausible clinical scenarios for such questions. PMID:27037383

  15. Hypothyroidism in Clinical Practice

    PubMed Central

    Qari, Faiza

    2014-01-01

    Background: Hypothyroidism is the most common endocrine disease that was seen in the clinical practice especially for family physicians. Methods: This review article covered the important practical clinical issues for managing overt hypothyroidism, subclinical hypothyroidism and hypothyroidism during pregnancy. Conclusions: The clinical issues were addressed by clinical scenario followed by questions and stressed on the important clinical points. PMID:25161963

  16. Clinical Research Operations

    Cancer.gov

    Resources Resources are organized alphabetically by topic: Cancer Therapy Evaluation Program (CTEP) Center for Cancer Research (CCR) Clinical Center Clinical Trials - Eligibility and Enrollment Clinical Trials - Research Resources Data Reporting and Monit

  17. Clinical Trials in Vision Research

    MedlinePlus

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

  18. Clinical Research Operations

    Cancer.gov

    Clinical Trial Design Clinical research is research conducted on human beings with the goal of generating useful knowledge about human health and illness. A clinical trial is one type of clinical research that seeks to answer a scientific or medical quest

  19. Being a Clinical Educator

    ERIC Educational Resources Information Center

    Higgs, Joy; Mcallister, Lindy

    2007-01-01

    What is it like to be a clinical educator? How do clinical educators experience and describe their continuing journey of becoming a clinical educator? Within the model developed in this research, dimensions of being a clinical educator were identified. These dimensions include (a) having a sense of self (and the impact of bringing self into the

  20. Managing clinical grant costs.

    PubMed

    Glass, Harold E; Hollander, Karen

    2009-05-01

    The rapidly increasing cost of pharmaceutical R&D presents a major challenge for the industry. This paper examines one aspect of that spending, clinical grants, and presents ways that pharmaceutical companies can best manage those expenditures. The first part of the paper examines the role of clinical grant payments as a motivation for clinical trial participation. The second part outlines a number of current management practices for controlling clinical grant costs. Financial compensation is an important matter for many physicians conducting clinical trials, especially those in office-based practices and those conducting phase 4 clinical trials. Since financial considerations are important to most types of investigators, and there is no compelling evidence that paying at high rates insures timely performance or quality data, companies engaging clinical investigators must manage their clinical grant funds as effectively as possible. Sound financial management requires that clinical development professionals appreciate the complex relationship between the pharmaceutical company and the physicians who serve as clinical investigators on that company's clinical trials. Sensible financial management of clinical grants also demands that sponsor companies get the most value for their clinical grant spending. Ultimately, good clinical grant management requires an attitude that combines good business sense with an understanding that pharmaceutical R&D strives to bring to market new drugs that can help patient populations around the world. Investigators are medical contractors in clinical trials, and while they are engaged in their vital research, they are a part of the research process that must be carefully budgeted and managed. Society, pharmaceutical companies, clinical investigators, and patients will reap the benefits of adequately budgeted, and well managed clinical grants. PMID:19470309

  1. Clinical Research Operations

    Cancer.gov

    Clinical Trial Seminar series 2015-2016 Schedule Monday, September 21, 2015: Sponsor and Investigator Responsibilities in FDA-regulated Medical Device Trialsannouncement Archieved Clinical Trials Seminar Series

  2. Clinical Research Operations

    Cancer.gov

    CCR Standard Operating Procedures This page contains links to the following categories of SOPs: Administrative - Clinical Research (ADCR) Administrative - Human Resources (ADHR) Clinical Data Management System (CDMS) Multi-Institutional Studies (MI) Proto

  3. Clinical Research Operations

    Cancer.gov

    Biostatistics and Data Management Section The Biostatistics and Data Management Section (BDMS), Office of the Clinical Director, provides statistical leadership and data management consultation for CCR's clinical activities and is involved in the design,

  4. Research Areas: Clinical Trials

    Cancer.gov

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

  5. Clinical Research Operations

    Cancer.gov

    Clinical Data Management  The content of this module is the Data Management in Clinical Research course developed by Vanderbilt University. The course teaches important concepts related to data planning, standards, collection, storage and dissemination. T

  6. Who's in Clinical Trials?

    MedlinePlus

    ... Consumers Home For Consumers Consumer Updates Who's in Clinical Trials? Share Tweet Linkedin Pin it More sharing ... it very helpful. back to top Designing Better Clinical Studies Beyond transparency, FDA hopes this initiative will ...

  7. Clinical nuclear medicine. [Handbook

    SciTech Connect

    Matin, P.

    1981-01-01

    ''Clinical Nuclear Medicine'' is an update to the author's ''Handbook of Clinical Nuclear Medicine.'' Sections on placental imaging, bone marrow imaging, biliary tract imaging and scintigraphy are included in the volume. (JMT)

  8. Types of Treatment: Clinical Trials

    MedlinePlus

    ... Disease Information Treatment Types of Treatment Clinical Trials Clinical Trials Clinical Trials SHARE: Print Glossary Taking part in a ... are based on previous clinical trials. Find personalized clinical trial searches or for more information, contact an ...

  9. Clinical ethics revisited

    PubMed Central

    Singer, Peter A; Pellegrino, Edmund D; Siegler, Mark

    2001-01-01

    A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems. PMID:11346456

  10. Good clinical practice in clinical interventional studies

    PubMed Central

    Pieterse, Herman; Diamant, Zuzana

    2014-01-01

    Good clinical practice (GCP) guidelines should always be implemented and obeyed in clinical interventional studies. In this mini-review, we will address several burning questions relating to GCP in a concise ‘frequently asked questions’ format. While compliance to current rules and regulations is our mission, we also wish to play devil's advocate attempting to translate the rules into sizeable chunks using a high dose of common sense. PMID:26557234

  11. Clinical Research Operations

    Cancer.gov

    Investigator Responsibilities The Clinical Center Medical Staff By-laws delineate who may serve as a principal investigator (PI) on a clinical research protocol. There may be only one PI on a clinical research protocol. The PI must be a health professiona

  12. Wheelchair clinics work.

    PubMed

    Brant, J A

    1988-01-01

    The positioning problems and needs of severely disabled adults greatly influence their ability to function independently. This paper will describe an interdisciplinary approach in a wheelchair clinic, the functions of a wheelchair clinic, and the role of a Certified Occupational Therapy Assistant as part of the wheelchair clinic team. PMID:23944882

  13. UCLA mobile clinic project.

    PubMed

    Hastings, Joseph; Zulman, Donna; Wali, Soma

    2007-11-01

    We report on a man seeking care at the UCLA mobile clinic, illustrating and then discussing the challenges of caring for people who are homeless (especially mental illness and potential distrust of providers). Student-run free clinics can be beneficial but further research must examine how well such clinics meet homeless patients' needs. PMID:17982203

  14. University cardiology clinic.

    PubMed

    Borozanov, V

    2013-01-01

    In distant 1972, within framework of the Internal Clinic, a cardiologic department was organized which was soon, on 29.XII.1974, transformed into the Cardiology Clinic, later the Institute for Heart Diseases, and in 2008 was renamed the University Cardiology Clinic. The greater part of its foundation was possible owing to Prof. Dimitar Arsov and Prof. Radovan Percinkovski, who was the clinic's first director in the period from 1974 to 1984. In 1985, the Clinic moved into its own new building, and in that way was physically detached from the Internal Clinics. Until its move to the new building, the Clinic functioned in the Internal Clinics building, organized as an outpatient polyclinic and inpatient infirmary department with clinical beds, a coronary intensive care unit and a haemodynamics laboratory equipped with the most modern equipment of that time. Today the Clinic functions through two integral divisions: an inpatient infirmary department which comprises an intensive coronary care unit and fourteen wards which altogether have 139 clinical beds, and the diagnostic centre which comprises an emergency clinic and day hospital, a communal and consultative outpatients' clinic functioning on a daily basis, through which some 300-350 patients pass every day, and diagnostic laboratories with a capacity of nearly 100 non-invasive and 20-30 invasive diagnostic procedures daily. The Clinic is a teaching base, and its doctors are educators of students at the Medical, Dental and Pharmacy Faculties, and also of students at the High School for Nurses and X-ray technicians, but also for those in Internal Medicine and especially Cardiology. The Clinic is also a base for scientific Masters' and post-doctoral studies, and such higher degrees are achieved not only by doctors who work here, but also by doctors from Medical Centres both in the country and abroad. Doctors working in this institution publish widely, not only a great number of books and monographs, but also original scientific papers published in indexed medical journals. PMID:23921478

  15. Assessing clinical pragmatism.

    PubMed

    Jansen, Lynn A

    1998-03-01

    "Clinical pragmatism" is an important new method of moral problem-solving in clinical practice. This method draws on the pragmatic philosophy of John Dewey and recommends an experimental approach to solving moral problems in clinical practice. Although the method may shed some light on how clinicians and their patients ought to interact when moral problems are at hand, it nonetheless is deficient in a number of respects. Clinical pragmatism fails to explain adequately how moral poblems can be solved experimentally, it underestimates the relevance and importance of judgment in clinical ethics, and it presents a questionable account of the role that moral principles should play in moral problem solving. PMID:11656751

  16. [The clinical research unit].

    PubMed

    Johnsen, Hans E; Korup, June; Lundby, Lene; Dybkaer, Karen; Bukh, Anne

    2010-05-01

    The organization and infrastructure of clinical research in Denmark is currently in focus due to an ongoing review of Clinical Science performed by the National Ministry of Health. This review describes the background and philosophy for the integration of clinical research into practice and vice versa. This process is catalyzed by activities within the clinical research unit and the foundation is the clinical databases and biobanks. Understanding these mechanisms is fundamental for the quality of care in the Danish health care system and needs a national supportive strategy. PMID:20444410

  17. [Randomized clinical trials and real clinical practice].

    PubMed

    Heerlein, Andrés

    2009-01-01

    One of the emerging problems in modern medicine is that part of its highly efficacious treatments do not show significant effectiveness in real world systems of care. Efficacy studies address the appropriate dosages, short term response and feasibility of treatments in carefully selected populations, but they do not necessarily provide information for decisions in clinical practice. This review aims to present strengths and limitations of different methodological types of trials and to offer an overview of how knowledge from clinical trials can be used for clinical practice. The important effect of funding source on the outcome of randomized controlled trials is discussed. Some key questions in the treatment assessment of depression, schizophrenia and different medical conditions are discussed, with a focus on the possibilities and restrictions of translating clinical trial results into real-world settings. Empirical evidence shows that although randomized controlled trials are the gold standard for proving efficacy of a therapeutic procedure they often suffer from funding source bias and from lack of generalizability. Effectiveness studies evaluate effects of treatments under conditions approximating usual care. Another key area that can be addressed by effectiveness studies is the impact on important health policy measures such as disability days, days of work or medical costs, etc. Conclusions show that the future assessment of treatment regimes for clinical utility requires less biased efficacy studies and more effectiveness studies addressing major issues from all relevant perspectives. PMID:19543562

  18. On evoking clinical meaning.

    PubMed

    Zaner, Richard M

    2006-12-01

    It was in the course of one particular clinical encounter that I came to realize the power of narrative, especially for expressing clinically presented ethical matters. In Husserlian terms, the mode of evidence proper to the unique and the singular is the very indirection that is the genius of story-telling. Moreover, the clinical consultant is unavoidably changed by his or her clinical involvement. The individuals whose situation is at issue have their own stories that need telling. Clinical ethics is in this sense a way of helping patients, families, and, yes, health providers to discover and give voice to those stories. In this way, clinical ethics is an evoking of meaning. Kierkegaard understood this well: Indirect communication is the language for the unique and the otherwise inexpressible. PMID:17162733

  19. Clinical Research Operations

    Cancer.gov

    Professional Associations ACRP (Association of Clinical Research Professionals) AHIMA (American Health Information Management Association) AMIA (American Medical Informatics Association) ASBH (American Society for Bioethics and Humanities) ASCO (American

  20. Development of clinical sites.

    PubMed

    O'Brien, Mary

    2015-02-01

    Clinical experiences are vital to all types of healthcare educational programs. Supervised clinical experiences provide the opportunity for the learner to apply didactic knowledge and theory to real world situations and hone skills necessary for entry into practice. Nurse anesthesia programs utilize a wide variety of clinical sites to expose student registered nurse anesthetists to experiences that will prepare them clinically, academically and professionally to enter practice as a Certified Registered Nurse Anesthetist. This article describes the process of developing a clinical site. A thorough evaluation will determine the types of experiences meant to be offered at the site, the resources available to house and educate the students, and how to evaluate the effectiveness of the clinical site. Open communication between the clinical coordinator and the program director or designee is essential to ensure success of the clinical site. The Council on Accreditation of Nurse Anesthesia Educational Programs has resources available to guide those interested in becoming a clinical site, as well as for program administrators who seek to add new experiences to their programs. PMID:25842629

  1. Clinical Trials for Wet AMD

    MedlinePlus

    ... Browse: Home / Research / Clinical Trials For Wet AMD Clinical Trials For Wet AMD Listen Clinical trials are the final research phase before a ... is testing in humans through a succession of clinical trials. Research on treatments starts in the laboratory ...

  2. Clinical Trials for Dry AMD

    MedlinePlus

    ... Degeneration? / Dry AMD / Clinical Trials For Dry AMD Clinical Trials For Dry AMD Listen Clinical trials are the final research phase before a ... is testing in humans through a succession of clinical trials. Research on treatments starts in the laboratory ...

  3. How Do Clinical Trials Work?

    MedlinePlus

    ... Studies NHLBI Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a ... protect patients and help produce reliable study results. Clinical Trial Protocol Each clinical trial has a master ...

  4. Clinical Application of Electrocardiography.

    ERIC Educational Resources Information Center

    Brammell, H. L.; Orr, William

    The scalar electrocardiogram (ECG) is one of the most important and commonly used clinical tools in medicine. A detailed description of the recordings of cardiac electrical activity made by the ECG is presented, and the vast numbers of uses made with the data provided by this diagnostic tool are cited. Clinical applications of the ECG are listed.…

  5. Clinical Research Operations

    Cancer.gov

    NIH and Clinical Center Orientation Requirements Below is a summary of the NIH and Clinical Center required orientation courses. All certificates of completion are to be sent to Liz Ness (Room 10/3-2571, Fax: 301.496.9020). All Web-based programs are to b

  6. Educating towards clinical governance.

    PubMed

    Heard, S

    1998-09-01

    Clinical governance represents a culture change in the NHS, making managers of health care institutions responsible for clinical standards as well as the financial bottom line. Doctors and managers will need to be educated to play their full part in this new culture. PMID:9829083

  7. [Clinical pharmacology of hepatoprotectors].

    PubMed

    Chekman, I S

    2001-01-01

    Data from published literature are summarized together with findings secured in the author's investigations on clinical pharmacology of hepatoprotectors. Classification of hepatoprotectors is submitted, their effects on the functional condition and metabolism in hepatocytes are discussed. Details are given of clinical and pharmacological properties of hepabene, legalon, essentiale, sirepara, wobenzime, phebichol, antral, thiotriazone. PMID:15311683

  8. Clinical Judgments of Depression.

    ERIC Educational Resources Information Center

    Jackson, Douglas N.; And Others

    1986-01-01

    Investigated degree to which judges could simulate Basic Personality Inventory (BPI) responses of a clinically depressed patient group. Judgmental profiles of depressed patients indicated very high reliabilities across information conditions, a high association with actual profiles of clinically depressed patients, and differentiation from other…

  9. The NASA Clinic System

    NASA Technical Reports Server (NTRS)

    Scarpa, Philip J.; Williams, Richard

    2009-01-01

    NASA maintains on site occupational health clinics at all Centers and major facilities NASA maintains an on-site clinic that offers comprehensive health care to astronauts at the Johnson Space Center NASA deploys limited health care capability to space and extreme environments Focus is always on preventive health care

  10. Clinical Research Operations

    Cancer.gov

    The learning modules below will provide clinical research teams with general information about clinical trials. Each module will have a list of objectives, required content (e.g., series of audio slides, links to YouTube videos), recommend content (i.e.,

  11. Clinical management of hypophosphatasia

    PubMed Central

    Bishop, Nick

    2015-01-01

    Summary HPP is a rare disease that manifests in different ways across the life course. Accurate diagnosis depends upon the use of appropriate age-related normative data. A new therapy is undergoing clinical trials; the preliminary published data is encouraging, but the scope of clinical application remains to be determined. PMID:26604944

  12. CLINICAL TRIALS.GOV

    EPA Science Inventory

    ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...

  13. The new clinical leader.

    PubMed

    Oates, Kim

    2012-06-01

    The complexity and cost of health care, along with a greater need for accountability calls for a new style of clinical leadership. The new clinical leader will lead reform by putting the needs of the patient first and foremost, looking at current and planned services from the patient's point of view as well as the clinician's. Excellent clinical skills will remain essential but will be supplemented by a focus on team work and mentoring, patient safety, clear communication and reduction in waste and inefficiency, leading to better financial outcomes. The new clinical leaders will understand the importance of consulting widely and engaging colleagues in creating change to improve patient care. They will develop trusting and mutually respectful relationships with health service management and be able to negotiate the delicate balance between clinical judgement, resource constraints and personal loyalties by keeping the best outcome for the patient at the forefront of their thinking. PMID:22690934

  14. [Arthritis and clinical history].

    PubMed

    Silva, Lígia; Sampaio, Luzia; Pinto, José; Ventura, Francisco S

    2011-01-01

    In front of a patient with arthritis, clinical good-sense tells that the most probable diagnosis are the most prevalent ones. Nevertheless, we have to exclude a multiplicity of other aetiologies, less frequent, but with highest implications in the therapeutic conduct. Infections by Brucella and by Borrelia are rare causes of chronic arthritis, yet are diagnosis to consider, even when the clinical manifestations aren't the most typical, as there still exist endemic areas in Portugal. Here we report two clinical cases about patients with arthritis for more than one year, subject to ineffective exams ant treatments. Only the clinical history could put on evidence clinical-epidemiological data, suggestive of Brucellosis and Lyme Disease, namely the professional contact with infected animals, and the history of probable erythema migrans, that pointed toward the correct diagnosis. So, with directed therapeutic, there was complete resolution of the inflammatory symptoms. PMID:22521022

  15. Clinical implementation of pharmacogenetics.

    PubMed

    García-González, Xandra; Cabaleiro, Teresa; Herrero, María José; McLeod, Howard; López-Fernández, Luis A

    2016-03-01

    In the last decade, pharmacogenetic research has been performed in different fields. However, the application of pharmacogenetic findings to clinical practice has not been as fast as desirable. The current situation of clinical implementation of pharmacogenetics is discussed. This review focuses on the advances of pharmacogenomics to individualize cancer treatments, the relationship between pharmacogenetics and pharmacodynamics in the clinical course of transplant patients receiving a combination of immunosuppressive therapy, the needs and barriers facing pharmacogenetic clinical application, and the situation of pharmacogenetic testing in Spain. It is based on lectures presented by speakers of the Clinical Implementation of Pharmacogenetics Symposium at the VII Conference of the Spanish Pharmacogenetics and Pharmacogenomics Society, held in April 20, 2015. PMID:26751902

  16. [Bioethics in clinical practice].

    PubMed

    Sánchez-Gonzaléz, Miguel; Herreros, Benjamín

    2015-01-01

    Bioethics has grown exponentially in recent decades. Its most important schools include principlism, casuistry, virtue ethics and the ethics of care. These schools are not exclusive. Within bioethics, clinical ethics addresses the inherent clinical practice ethical problems, problems which are many and very varied. Bioethics training is essential for clinicians to address these bioethics' problems. But even the professionals are trained, there are problems that cannot be solved individually and require advisory groups in clinical ethics: clinical ethics committees. These committees are also responsible for education in bioethics in health institutions. Clinical bioethics is a practical discipline, oriented to address specific problems, so its development is necessary to improve the decision making in such complex problems, inevitable problems in healthcare. PMID:25680645

  17. Clinical Pathway for Thyroidectomy.

    PubMed

    Villar del Moral, Jesús María; Soria Aledo, Víctor; Colina Alonso, Alberto; Flores Pastor, Benito; Gutiérrez Rodríguez, María Teresa; Ortega Serrano, Joaquín; Parra Hidalgo, Pedro; Ros López, Susana

    2015-05-01

    Clinical pathways are care plans applicable to patient care procedures that present variations in practice and a predictable clinical course. They are designed not as a substitute for clinical judgment, but rather as a means to improve the effectiveness and efficiency of the procedures. This clinical pathway is the result of a collaborative work of the Sections of Endocrine Surgery and Quality Management of the Spanish Association of Surgeons. It attempts to provide a framework for standardizing the performance of thyroidectomy, the most frequently performed operation in endocrine surgery. Along with the usual documents of clinical pathways (temporary matrix, variance tracking and information sheets, assessment indicators and a satisfaction questionnaire) it includes a review of the scientific evidence around different aspects of pre, intra and postoperative management. Among others, antibiotic and antithrombotic prophylaxis, preoperative preparation in hyperthyroidism, intraoperative neuromonitoring and systems for obtaining hemostasis are included, along with management of postoperative hypocalcemia. PMID:25732107

  18. Clinical Microbiology Informatics

    PubMed Central

    Sintchenko, Vitali; Rauch, Carol A.; Pantanowitz, Liron

    2014-01-01

    SUMMARY The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. PMID:25278581

  19. Learning for clinical leadership.

    PubMed

    Cook, Michael J; Leathard, Helen L

    2004-11-01

    Clinical leadership has been acclaimed widely as a major factor influencing the quality of patient care but research has revealed a paucity of preparation for this significant role. Leadership literature has rarely addressed clinical leadership specifically or referred to the difficulties in characterizing effective clinical leaders. The research informing this paper focused on clinical leadership and identified five attributes of effective clinical leaders: creativity, highlighting, influencing, respecting, and supporting. Effective clinical leaders adopted a transformational leadership style and improved care, through others, by including transformational (soft) knowledge as an integral part of their effective practice repertoire. Phronesis is introduced as practical wisdom that is gained through immersion in relevant experience, and as an essential element of preparation for clinical nursing leadership practice. It is argued, that learning to transform care requires opportunities to work within an environment that engenders and supports aspiring leaders. The paper describes the research process, elucidates the attributes through illustrative examples from the research data, and discusses an emergent educational strategy for the development of these attributes by clinicians in their practice environments. The paper also describes the application of this research through an interdisciplinary programme for staff leading teams in both health and social services sectors. PMID:15509273

  20. Design of clinical trials.

    PubMed

    Rollo, David; Machado, Sanjay; Ceschin, Mauro

    2010-09-01

    Clinical trial design for nuclear medicine diagnostic imaging radiopharmaceuticals must include a design for preclinical safety studies. These studies should establish that the investigational product (IP) does not have a toxic effect. As a further requirement, radiopharmaceutical clinical trials include a human study (phase 1) that provides biodistribution, pharmacokinetics, and radiation dosimetry information. These studies demonstrate to the Food and Drug Administration that the IP either meets or exceeds the toxicology and radiation exposure safety limits. Satisfying this requirement can result in the Food and Drug Administration approving the performance of late-phase (phase 2/3) clinical trials that are designed to validate the clinical efficacy of the diagnostic imaging agent in patients who have a confirmed diagnosis for the intended application. Emphasis is placed on the most typical trial design for diagnostic imaging agents that use a comparator to demonstrate that the new IP is similar in efficacy to an established standard comparator. Such trials are called equivalence, or noninferiority, trials that attempt to show that the new IP is not less effective than the comparator by more than a statistically defined amount. Importantly, the trial design must not inappropriately favor one diagnostic imaging agent over the other. Bias is avoided by the use of a core laboratory with expert physicians who are not involved in the trial for interpreting and objectively scoring the image sets obtained at the clinical trial sites. Clinical trial design must also follow Good Clinical Practice (GCP) guidelines. GCP stipulates the clinical trial process, including protocol and Case Report Form design, analyses planning, as well as analyzing and preparing interim and final clinical trial/study reports. PMID:20674592

  1. Automation in Clinical Microbiology

    PubMed Central

    Ledeboer, Nathan A.

    2013-01-01

    Historically, the trend toward automation in clinical pathology laboratories has largely bypassed the clinical microbiology laboratory. In this article, we review the historical impediments to automation in the microbiology laboratory and offer insight into the reasons why we believe that we are on the cusp of a dramatic change that will sweep a wave of automation into clinical microbiology laboratories. We review the currently available specimen-processing instruments as well as the total laboratory automation solutions. Lastly, we outline the types of studies that will need to be performed to fully assess the benefits of automation in microbiology laboratories. PMID:23515547

  2. Good clinical practice.

    PubMed

    Regnier, B

    1990-07-01

    Good Clinical Practice (GCP) is a quality assurance system dealing with all stages of clinical trials which is progressively being adopted by European countries. European GCP guidelines are in preparation and will be issued soon. However, implementation of the guidelines poses major and costly problems. The training of investigators, the proper functioning of research ethics committees, the practice of obtaining written informed consent, source data verification, and quality control with internal audit and official inspections are among the most difficult issues. The obvious benefits of GCP are the improved quality of clinical trials and of data generated by such trials, as well as mutual recognition of studies conducted abroad. PMID:2226484

  3. Clinical Decision Making.

    PubMed

    2016-01-30

    Critically Appraised Topics (CATs) are a standardised, succinct summary of research evidence organised around a clinical question, using a form of evidence synthesis based on the principles of evidence-based medicine (EBM) and evidence-based veterinary medicine (EBVM). Access to CATs enables clinicians to incorporate evidence from the scientific literature into clinical practice and they have been used to teach EBVM at the University of Bristol's School of Veterinary Sciences since 2011. Similar to BestBETs for vets (VR, April 4, 2015, vol 176, p360), CATs will also be regularly published in the Clinical Decision Making section of Veterinary Record. PMID:26823311

  4. The Perfect Clinical Trial.

    PubMed

    Bril, V

    2016-01-01

    Multiple phase III clinical trials have failed to show disease-modifying benefits for diabetic sensorimotor polyneuropathy (DSP) and this may be due to the design of the clinical trials. The perfect clinical trial in DSP would enroll sufficiently large numbers of patients having early or minimal disease, as demonstrated by nerve conduction studies (NCS). These patients would be treated with an intervention given at an effective and well-tolerated dose for a sufficient duration of time to show change in the end points selected. For objective or surrogate measures such as NCS and for some small fiber measures, the duration needed to show positive change may be as brief as 6-12 months, but subsequently, trials lasting 5-8 years will be required to demonstrate clinical benefits. PMID:27133143

  5. Clinical Research Operations

    Cancer.gov

    Online Self Learning Modules These online modules will provide a basic overview of clinical research. All modules and the associated evaluations are designed to be completed during the first 3 weeks of employment. At the conclusion of a module, participan

  6. CCR Clinical Informatics

    Cancer.gov

    DCTD (Division of Cancer Treatment and Diagnosis) sponsored studies with monitoring done via CTMS (Clinical Trials Monitoring Service), electronically report data to Theradex every two weeks according to the following calendar: CTMS 2011 Submission Calend

  7. [Carbohydrates in clinical nutrition].

    PubMed

    Lysikov, Iu A

    2013-01-01

    The article presents data on role of carbohydrate in clinical nutrition. The review described carbohydrate metabolism, hormonal regulation of carbohydrate, carbohydrate energy source role, carbohydrate requirements in critical study. PMID:23947170

  8. Clinical Research Operations

    Cancer.gov

    Education and Training Continuing Education Brown Bag Lunch Clinical Trials Seminar Series In-service Sessions Journal Club M2P2: Monday Morning Practice Pearls Nursing Grand Rounds Professional Development: Education Series & Resources  Orientation Cente

  9. CCR Clinical Informatics

    Cancer.gov

    Contents Purpose Record details of prior surgery related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study. Prior Surgery Supplement eCRF Field Name Description / Instructions

  10. CCR Clinical Informatics

    Cancer.gov

    Contents Purpose Record details of prior radiation therapy related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study. Prior Radiation Supplement eCRF Field Name Description /

  11. Clinical Trials - Participants

    MedlinePlus

    ... Training Labs at NIMH Labs at NIMH Home Principal Investigators Research Areas Collaborations & Partnerships Intramural Offices Join A ... gathered A clinical study is led by a principal investigator (PI), who is often a doctor. Members of ...

  12. Understanding Clinical Alarm Safety.

    PubMed

    Lukasewicz, Carol L; Mattox, Elizabeth Andersson

    2015-08-01

    Patient safety organizations and health care accreditation agencies recognize the significance of clinical alarm hazards. The Association for the Advancement of Medical Instrumentation, a nonprofit organization focused on development and use of safe and effective medical equipment, identifies alarm management as a major issue for health care organizations. ECRI Institute, a nonprofit organization that researches approaches for improving patient safety and quality of care, identifies alarm hazards as the most significant of the "Top Ten Health Technology Hazards" for 2014. A new Joint Commission National Patient Safety Goal focusing on clinical alarm safety contains new requirements for accredited hospitals to be fully implemented by 2016. Through a fictional unfolding case study, this article reviews selected contributing factors to clinical alarm hazards present in inpatient, high-acuity settings. Understanding these factors improves contributions by nurses to clinical alarm safety practice. PMID:26232801

  13. Hepatitis C: Clinical Trials

    MedlinePlus

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  14. [PR of clinical testing].

    PubMed

    Banno, Kohtaro

    2005-02-01

    Regardless of its vital role of providing quality of patients care and optimizing overall healthcare costs, a clinical testing in Japan bears too strong cost containment pressures, which lead to too economically driven cost reduction initiatives. As a result, there is a risk of hampering infrastructure of appropriate medical services in Japan, including accuracy of tests, speed of tests, adoptation of new IVD technology, quality of information, adding value information, risk management, etc. In order to maintain a proper clinical testing in Japan, people/organizations associated with IVD and clinical testing should take more proactive PR actions to appeal the importance and value addition of clinical testing to patients, media, governments, hospital management, and other medical professionals. PMID:15796048

  15. Participating in Clinical Trials

    MedlinePlus Videos and Cool Tools

    ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  16. Clinically based implant selection.

    PubMed

    Fugazzotto, P A

    1999-01-01

    A hierarchy of implant selection is presented, based on overcoming specific clinical challenges in a variety of situations, including maximization of the esthetic, comfort, and functional potentials of therapy. PMID:10709488

  17. Find a Free Clinic

    MedlinePlus

    ... Dental, Medical, Rx's www.amissionofmercy.org A Storehouse Free. Medical Ministries 675 E Lexington Rd Mocksville , NC ... E-mail: Info@nafcclinics.org National Association of Free & Charitable Clinics © 2016

  18. Cancer Clinical Trials

    MedlinePlus

    ... ve provided basic information about clinical trials to help you understand what’s involved in taking part. This includes information about the benefits and risks, who is responsible for which research ...

  19. Clinical specular microscopy

    SciTech Connect

    Hirst, L.W.; Laing, R.A.

    1987-01-01

    This book provides the general ophthalmologist with a guide to the clinical applications of specular microscopy. Important material is included on laser injury, cataract surgery, corneal transplants, glaucoma, uveitis, and trauma.

  20. Clinical Trial Basics

    MedlinePlus

    ... Stem Cell Information OppNet NIDB NIH Blueprint for Neuroscience Research Institutes at NIH List of Institutes, Centers & ... Informed consent Informed consent is the process of learning the key facts about a clinical trial before ...

  1. Clinical careers film.

    PubMed

    2015-09-01

    Those interested in developing clinical academic careers might be interested in a short animated film by Health Education England (HEE) and the National Institute for Health Research. The three-minute film, a frame from which is shown below, describes the sort of opportunities that are on offer to all professionals as part of the HEE's clinical academic careers framework. You can view the film on YouTube at tinyurl.com/pelb95c. PMID:26309005

  2. Listeriosis: clinical presentation.

    PubMed

    Doganay, Mehmet

    2003-04-01

    Listeria monocytogenes is an uncommon cause of illness in the general population. However, this bacterium is an important cause of severe infections in neonates, pregnant women, the elderly, transplant recipients and other patients with impaired cell-mediated immunity. Various clinical syndromes due to L. monocytogenes have been described such as sepsis, central nervous system infections, endocarditis, gastroenteritis and localized infections. A review of the clinical presentation of listeriosis is given in this paper. PMID:12648833

  3. Zonisamide in clinical practice.

    PubMed

    Dupont, S; Stefan, H

    2012-01-01

    Zonisamide is currently licensed in Europe and the USA for the adjunctive treatment of partial seizures (with or without secondary generalization) in adults, based on the results of four pivotal, randomized, double-blind, placebo-controlled trials. It is also licensed in Europe as monotherapy for adults with newly diagnosed partial epilepsy, based on the results of a randomized, double-blind, non-inferiority trial. Because clinical trials are conducted under tightly controlled conditions, using rigid dosing schedules and employing strict exclusion/exclusion criteria, there is a need for 'real-world' evidence of an antiepileptic drug's effectiveness and tolerability in clinical practice, where patients are much more diverse in terms of clinical characteristics and treatment is tailored to the individual's specific needs. Several studies have demonstrated that adjunctive treatment with zonisamide is effective when administered under everyday clinical practice conditions, with a favourable safety/tolerability profile similar to that observed in clinical trials. In the Zonisamid im Alltag Der Epilepsiepatienten (ZADE) study, almost 80% of patients showed a reduction in seizure frequency of ?50% over a median follow-up of 18weeks, and over one-third of patients became seizure free. Data from these clinical practice studies also indicate that zonisamide is effective and generally well tolerated when administered as a first-line adjunctive treatment and is associated with high retention rates and improvements in quality of life. Evidence from these clinical practice studies therefore complements data from zonisamide's clinical trial programme, providing pragmatic information on the likely benefits and risks of treatment under real-life conditions. PMID:23106523

  4. [Outlook for clinical hemorheology].

    PubMed

    Stoltz, J F

    1996-01-01

    Harvey may be considered to be the precursor of modern hemorheology, but it was not until the pioneering work of Loewenhoeck, Poiseuille, Fahraeus and Copley that the essential role of the hemorheological properties of blood and its cellular components was recognized. Before the advent of modern hemorheology in the 70s, studies were mainly focussed on microcirculation and validation of global hemorheological equations applied to blood circulation. Parallel studies on the microrheological properties (erythrocyte deformability and aggregation) explained analytically the non-Newtonian behavior of blood, and the essential contribution of these parameters to the understanding hyperviscosity syndromes. The development of clinical hemorheology in fact started at the international conferences held in Reykjavik (1966) and Heidelberg (1969), and with the initiation of the periodical European Microcirculation (since Nancy in 1960) and Clinical Hemorheology (since Nancy in 1979) Conferences. The current main avenues of research involve flow modelling, studies of cell-cell interaction mechanisms (aggregation and adhesion), in relation to the associated pathophysiological phenomena, such as cellular activation (platelets and leukocytes in particular), gene expression linked to blood flow (e.g. endothelial cells)... Clinically and therapeutically, it is crucial that pathophysiological studies be undertaken on the relationship existing between rheological parameters and objective clinical data (local flow rates, ischemic markers, hemostatic parameters, tissue oxygen, clinical symptoms,...). The main clinical application fields are cardiovascular diseases, thrombosis, diabetes, hypercholesterolemia... Also, studies on new therapeutics or on biomaterials should also be given priority. PMID:8656093

  5. Gene electrotransfer clinical trials.

    PubMed

    Heller, Richard; Heller, Loree C

    2015-01-01

    Plasmid or non-viral gene therapy offers an alternative to classic viral gene delivery that negates the need for a biological vector. In this case, delivery is enhanced by a variety of approaches including lipid or polymer conjugation, particle-mediated delivery, hydrodynamic delivery, ultrasound or electroporation. Electroporation was originally used as a laboratory tool to deliver DNA to bacterial and mammalian cells in culture. Electrode development allowed this technique to be modified for in vivo use. After preclinical therapeutic studies, clinical delivery of cell impermeant chemotherapeutic agents progressed to clinical delivery of plasmid DNA. One huge benefit of this delivery technique is its malleability. The pulse protocol used for plasmid delivery can be fine-tuned to control the levels and duration of subsequent transgene expression. This fine-tuning allows transgene expression to be tailored to each therapeutic application. Effective and appropriate expression induces the desired clinical response that is a critical component for any gene therapy. This chapter focuses on clinical trials using in vivo electroporation or electrotransfer as a plasmid delivery method. The first clinical trial was initiated in 2004, and now more than fifty trials use electric fields for gene delivery. Safety and tolerability has been demonstrated by several groups, and early clinical efficacy results are promising in both cancer therapeutic and infectious disease vaccine applications. PMID:25620013

  6. Clinical toxinology specialty training.

    PubMed

    White, Julian

    2013-07-01

    Clinical toxinology is the medical discipline dealing with the diagnosis, treatment and prevention of toxin diseases caused by exposure to venomous animals and poisonous animals, plants and mushrooms. Currently there is no national or international organisation accrediting or training doctors in this discipline, but the role of the IST in this area is the subject of a recently approved revised Constitution. A few courses covering some aspects of clinical toxinology exist, either with limited curricula, or with only a minor clinical focus, or with a very regional, non-global focus. The only comprehensive clinical toxinology course is the one provided in Adelaide, Australia, running regularly since 1997. This course may form the nucleus from which IST can develop a global accredited training scheme in clinical toxinology. Such a scheme will require input from diverse global regions and will be far more comprehensive and over a much longer time than the current Short Course, though may incorporate the Short Course in some way, or a derivative of it. Accreditation of medical expertise in clinical toxinology will be required at the national level and this might be accomplished by the IST working with existing national medical specialty organisations and governments, with the IST supervising the training and accreditation requirements and the national organisations providing the framework for registration of medical expertise at the local level. PMID:23524067

  7. Clinical Usefulness of Arbekacin.

    PubMed

    Lee, Jae Hoon; Lee, Chang-Seop

    2016-03-01

    Arbekacin is a broad-spectrum aminoglycoside used to treat methicillin-resistant Staphylococcus aureus (MRSA). Arbekacin has antibacterial activities against high-level gentamicin-resistant Enterococci, multidrug-resistant Pseudomonas aeruginosa, and Acinetobacter baumannii et al. Here, we reviewed in vitro data on arbekacin in Staphylococci and Gram-negative microorganisms. We also reviewed clinical studies for clinical efficacy and microbiologic efficacy data in patients with identified MRSA and suspected MRSA infections. The overall clinical efficacy ranged from 66.7% to 89.7%. The microbiologic efficacy rate ranged from 46.2% to 83%. In comparative studies between arbekacin and glycopeptides, arbekacin was similar to other glycopeptides with respect to clinical and microbiological efficacy rates. Combination trials with other antibiotics suggest that arbekacin will be a promising strategy to control Enterococcus spp. multi-drug resistant P. aeruginosa. The major adverse reaction was nephrotoxicity/hepatotoxicity, but patients recovered from most adverse reactions without any severe complications. Based on these results, arbekacin could be a good alternative to vancomycin/teicoplanin in MRSA treatment. Finally, therapeutic drug monitoring is recommended to maximize clinical efficacy and decrease nephrotoxicity. PMID:27104010

  8. Clinical Usefulness of Arbekacin

    PubMed Central

    2016-01-01

    Arbekacin is a broad-spectrum aminoglycoside used to treat methicillin-resistant Staphylococcus aureus (MRSA). Arbekacin has antibacterial activities against high-level gentamicin-resistant Enterococci, multidrug-resistant Pseudomonas aeruginosa, and Acinetobacter baumannii et al. Here, we reviewed in vitro data on arbekacin in Staphylococci and Gram-negative microorganisms. We also reviewed clinical studies for clinical efficacy and microbiologic efficacy data in patients with identified MRSA and suspected MRSA infections. The overall clinical efficacy ranged from 66.7% to 89.7%. The microbiologic efficacy rate ranged from 46.2% to 83%. In comparative studies between arbekacin and glycopeptides, arbekacin was similar to other glycopeptides with respect to clinical and microbiological efficacy rates. Combination trials with other antibiotics suggest that arbekacin will be a promising strategy to control Enterococcus spp. multi-drug resistant P. aeruginosa. The major adverse reaction was nephrotoxicity/hepatotoxicity, but patients recovered from most adverse reactions without any severe complications. Based on these results, arbekacin could be a good alternative to vancomycin/teicoplanin in MRSA treatment. Finally, therapeutic drug monitoring is recommended to maximize clinical efficacy and decrease nephrotoxicity. PMID:27104010

  9. Clinical Pharmacogenetics Implementation

    PubMed Central

    WEITZEL, KRISTIN W.; ELSEY, AMANDA R.; LANGAEE, TAIMOUR Y.; BURKLEY, BENJAMIN; NESSL, DAVID R.; OBENG, ANIWAA OWUSU; STALEY, BENJAMIN J.; DONG, HUI-JIA; ALLAN, ROBERT W.; LIU, J. FELIX; COOPER-DEHOFF, RHONDA M.; ANDERSON, R. DAVID; CONLON, MICHAEL; CLARE-SALZLER, MICHAEL J.; NELSON, DAVID R.; JOHNSON, JULIE A.

    2014-01-01

    Current challenges exist to widespread clinical implementation of genomic medicine and pharmacogenetics. The University of Florida (UF) Health Personalized Medicine Program (PMP) is a pharmacist-led, multidisciplinary initiative created in 2011 within the UF Clinical Translational Science Institute. Initial efforts focused on pharmacogenetics, with long-term goals to include expansion to disease-risk prediction and disease stratification. Herein we describe the processes for development of the program, the challenges that were encountered and the clinical acceptance by clinicians of the genomic medicine implementation. The initial clinical implementation of the UF PMP began in June 2012 and targeted clopidogrel use and the CYP2C19 genotype in patients undergoing left heart catheterization and percutaneous-coronary intervention (PCI). After 1 year, 1,097 patients undergoing left heart catheterization were genotyped preemptively, and 291 of those underwent subsequent PCI. Genotype results were reported to the medical record for 100% of genotyped patients. Eighty patients who underwent PCI had an actionable genotype, with drug therapy changes implemented in 56 individuals. Average turnaround time from blood draw to genotype result entry in the medical record was 3.5 business days. Seven different third party payors, including Medicare, reimbursed for the test during the first month of billing, with an 85% reimbursement rate for outpatient claims that were submitted in the first month. These data highlight multiple levels of success in clinical implementation of genomic medicine. PMID:24616371

  10. Neonatal clinical pharmacology.

    PubMed

    Allegaert, Karel; van de Velde, Marc; van den Anker, John

    2014-01-01

    Effective and safe drug administration in neonates should be based on integrated knowledge on the evolving physiological characteristics of the infant who will receive the drug and the pharmacokinetics (PK) and pharmacodynamics (PD) of a given drug. Consequently, clinical pharmacology in neonates is as dynamic and diverse as the neonates we admit to our units while covariates explaining the variability are at least as relevant as median estimates. The unique setting of neonatal clinical pharmacology will be highlighted based on the hazards of simple extrapolation of maturational drug clearance when only based on 'adult' metabolism (propofol, paracetamol). Second, maturational trends are not at the same pace for all maturational processes. This will be illustrated based on the differences between hepatic and renal maturation (tramadol, morphine, midazolam). Finally, pharmacogenetics should be tailored to neonates, not just mirror adult concepts. Because of this diversity, clinical research in the field of neonatal clinical pharmacology is urgently needed and facilitated through PK/PD modeling. In addition, irrespective of already available data to guide pharmacotherapy, pharmacovigilance is needed to recognize specific side effects. Consequently, pediatric anesthesiologists should consider to contribute to improved pharmacotherapy through clinical trial design and collaboration, as well as reporting on adverse effects of specific drugs. PMID:23617305

  11. Research in clinical practice.

    PubMed

    Schmitt, Colleen M

    2006-10-01

    Clinical research in the practice setting can be a rewarding experience. The atmosphere of research is changing, however, with tighter budgets, more oversight, increasing litigation risks, financial pressures, and increased competition. Sites must be increasingly careful to negotiate appropriate study budgets and contract language that is not overly burdensome or risky for the site. The focus on investigator training and use of qualifies personnel is paramount to preserve and improve the quality of clinical research in the United STates. The future may find certification examinations necessary for all research staff, including investigators. Eventually, the number of clinical research sites in the community will decrease, and academic sites, along with international sites, will once again fill the void. PMID:17098621

  12. Pediatric Anthrax Clinical Management

    PubMed Central

    Bradley, John S.; Peacock, Georgina; Krug, Steven E.; Bower, William A.; Cohn, Amanda C.; Meaney-Delman, Dana; Pavia, Andrew T.

    2015-01-01

    Anthrax is a zoonotic disease caused by Bacillus anthracis, which has multiple routes of infection in humans, manifesting in different initial presentations of disease. Because B anthracis has the potential to be used as a biological weapon and can rapidly progress to systemic anthrax with high mortality in those who are exposed and untreated, clinical guidance that can be quickly implemented must be in place before any intentional release of the agent. This document provides clinical guidance for the prophylaxis and treatment of neonates, infants, children, adolescents, and young adults up to the age of 21 (referred to as “children”) in the event of a deliberate B anthracis release and offers guidance in areas where the unique characteristics of children dictate a different clinical recommendation from adults. PMID:24777226

  13. [Terminology in clinical bioethics].

    PubMed

    Herreros, Benjamín; Moreno-Milán, Beatriz; Pacho-Jiménez, Eloy; Real de Asua, Diego; Roa-Castellanos, Ricardo Andrés; Valentia, Emanuele

    2015-01-01

    In this article some of the most relevant terms in clinical bioethics are defined. The terms were chosen based on three criteria: impact on the most important problems in clinical bioethics, difficulty in understanding, and need to clarify their meaning. For a better understanding, the terms were grouped into 5 areas: general concepts (conflict of values, deliberation, conflict of interest, conscientious objection); justice (justice, distributive justice, models of justice, triage); clinical matters (information, competency, capability, informed consent, mature minor, coercion, secrecy, privacy, confidentiality, professional secrecy); end of life (prior instructions, limitation of therapeutic efforts, professional obstinacy, futility, palliative care, palliative sedation, principle of double effect, euthanasia, assisted suicide, persistent vegetative state, minimally conscious state, locked-in syndrome, brain death), and beginning of life (assisted reproduction, genetic counseling, preimplantation genetic diagnosis). PMID:26506495

  14. Clinical judgments of depression.

    PubMed

    Jackson, D N; MacLennan, R N; Erdle, S W; Holden, R R; Lalonde, R N; Thompson, G R

    1986-01-01

    In an effort to reevaluate Gough's (1954) classic study of common misconceptions about neuroticism, an investigation was undertaken of the degree to which judges could simulate the Basic Personality Inventory (BPI) responses of a clinically depressed patient group. Judgments were recorded of the probability of responding to each of 240 BPI items by a total of 56 university student judges. Judges were assigned randomly to one of two information conditions, one that had only the label "clinical depression" and another that had, in addition, a more extensive definition. Judgmental profiles of depressed patients indicated very high reliabilities (.99) across information conditions, a high association with actual profiles of clinically depressed patients, and differentiation from other psychiatric patients and normal controls. Results were interpreted as supporting the accuracy of judgments of psychopathology, particularly when certain preconditions are met, namely, the use of a meaningful construct of psychopathology and the prediction of behavior relevant to that construct. PMID:3949999

  15. Hypomagnesemia: a clinical perspective

    PubMed Central

    Pham, Phuong-Chi T; Pham, Phuong-Anh T; Pham, Son V; Pham, Phuong-Truc T; Pham, Phuong-Mai T; Pham, Phuong-Thu T

    2014-01-01

    Although magnesium is involved in a wide spectrum of vital functions in normal human physiology, the significance of hypomagnesemia and necessity for its treatment are under-recognized and underappreciated in clinical practice. In the current review, we first present an overview of the clinical significance of hypomagnesemia and normal magnesium metabolism, with a focus on renal magnesium handling. Subsequently, we review the literature for both congenital and acquired hypomagnesemic conditions that affect the various steps in normal magnesium metabolism. Finally, we present an approach to the routine evaluation and suggested management of hypomagnesemia. PMID:24966690

  16. Memory clinics in context

    PubMed Central

    Jolley, David; Moniz-Cook, Esme

    2009-01-01

    The growing number of older people in all parts of the world raises the question of how best to respond to their health needs, including those associated with memory impairment. Specialist Memory Clinics have a role to play, complementing community services which reach out to older people with mental health problems and encompassing younger people who become forgetful. Dementia is the most common syndrome seen, but there are other important treatable conditions which present with subjective or objective dysmnesia. Memory Clinics provide a high quality, devoted focus for early intervention, treatment, support and research. PMID:21416022

  17. Clinical dimensions of masochism.

    PubMed

    Kernberg, O F

    1988-01-01

    In this paper, I propose a general classification of masochistic psychopathology and describe relations between this clinical domain and other types of psychopathology. My main objective is to provide an outline relevant for diagnostic, prognostic, and treatment considerations of masochistic pathology. This includes descriptions of and relations among a wide variety of masochistic phenomena from the depressive-masochistic personality to extreme forms of self-destructiveness. Ego organization, object relations, superego development, narcissistic organization, and polymorphous perverse infantile sexuality are considered as codeterminants of the levels and clinical features of masochistic pathology. Finally, the relations between masochistic pathology and negative therapeutic reactions are reexamined. PMID:3235758

  18. Pharmacogenomics in the clinic

    PubMed Central

    Relling, Mary V.; Evans, William E.

    2015-01-01

    Preface After decades of discovery, inherited variation in approximately 20 genes affecting about 80 medications has been identified as actionable in the clinic. Additional somatically acquired genomic variants direct the choice of “targeted” anticancer drugs for individual patients. Current efforts that focus on the processes required to appropriately act on pharmacogenomic variability in the clinic are systematically moving pharmacogenomics from discovery to implementation as an evidenced-based strategy for improving the use of medications, thereby providing an important cornerstone for precision medicine. PMID:26469045

  19. Genetic Tests:Clinical Validity and Clinical Utility

    PubMed Central

    Burke, Wylie

    2014-01-01

    When evaluating the appropriate use of new genetic tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient’s clinical status (clinical validity) and the risks and benefits resulting from test use (clinical utility). Genetic tests in current use vary in accuracy and potential to improve health outcomes, and these test properties may be influenced by testing technology and the clinical setting in which the test is used. This unit defines clinical validity and clinical utility, provides examples, and considers the implications of these test properties for clinical practice. PMID:24763995

  20. Marking out the clinical expert/clinical leader/clinical scholar: perspectives from nurses in the clinical arena

    PubMed Central

    2013-01-01

    Background Clinical scholarship has been conceptualised and theorised in the nursing literature for over 30 years but no research has captured nurses’ clinicians’ views on how it differs or is the same as clinical expertise and clinical leadership. The aim of this study was to determine clinical nurses’ understanding of the differences and similarities between the clinical expert, clinical leader and clinical scholar. Methods A descriptive interpretative qualitative approach using semi-structured interviews with 18 practising nurses from Australia, Canada and England. The audio-taped interviews were transcribed and the text coded for emerging themes. The themes were sorted into categories of clinical expert, clinical leader and clinical scholarship as described by the participants. These themes were then compared and contrasted and the essential elements that characterise the nursing roles of the clinical expert, clinical leader and clinical scholar were identified. Results Clinical experts were seen as linking knowledge to practice with some displaying clinical leadership and scholarship. Clinical leadership is seen as a positional construct with a management emphasis. For the clinical scholar they linked theory and practice and encouraged research and dissemination of knowledge. Conclusion There are distinct markers for the roles of clinical expert, clinical leader and clinical scholar. Nurses working in one or more of these roles need to work together to improve patient care. An ‘ideal nurse’ may be a blending of all three constructs. As nursing is a practice discipline its scholarship should be predominantly based on clinical scholarship. Nurses need to be encouraged to go beyond their roles as clinical leaders and experts to use their position to challenge and change through the propagation of knowledge to their community. PMID:23587282

  1. Clinical Research Operations

    Cancer.gov

    Brown Bag Lunch (BBL) The Brown Bag Lunch is a series of educational presentations developed to provide an open forum to discuss clinically focused topics in an informal, relaxed atmosphere. It is open to all oncology nurses at the NIH. The goal of the BB

  2. Clinical Research Operations

    Cancer.gov

    Fellowship Cinical Trial Education Series for 2013-2014 Series Syllabus Clinical Trial Design (6 slides per page) U.S. Drug Development and the Role of the Sponsor (6 slides per page) Protocol Development, Review and Approval Process (6 slides per page) S

  3. CCR Clinical Informatics

    Cancer.gov

    Contents Purpose Record details of prior therapies related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study as indicated on the Prior Treatment Summary case report form. Prio

  4. Clinical Research Operations

    Cancer.gov

    Clinical Informatics Protocol Development and Management iRIS (Integrated Research Information System (iRIS) helps create, manage and process CCR research protocols. iRIS can be accessed from any computer that has a connection to the NIH internal network.

  5. Clinical Research Operations

    Cancer.gov

    2012 Protocol Submission Deadlines and Meeting Dates National Cancer Institute Institutional Review Board (IRB) Time:  1:00 p.m. - 5:30 p.m. Location:  Clinical Research Center (CRC), Room 3-1608 IRB Deadline IRB Meeting Date IRB Deadline IRB Meeting Date

  6. Clinical Research Operations

    Cancer.gov

    2013 Protocol Submission Deadlines and Meeting Dates National Cancer Institute Institutional Review Board (IRB) Time:  1:00 p.m. - 5:30 p.m. Location:  Clinical Research Center (CRC), Room 3-1608 IRB Deadline IRB Meeting Date IRB Deadline IRB Meeting Date

  7. Clinical Research Operations

    Cancer.gov

    ICH and OHRP Guidance ICH (International Conference on Harminization of Technical Requirements for Registration of Pharmaceuticals for Human Use) E6_ICH Good Clinical Practice E15 FDA Guidance Document AAHRPP Tip Sheet 11: Following the Guideline of the I

  8. CCR Clinical Informatics

    Cancer.gov

    Contents Purpose Record the patient's lab results. Patients on NCI/CCR's intramural studies who have their labs drawn at the Clinical Center will use the Lab Load Interface (LLI) tool to select which labs results to electronically transfer into C3D. The s

  9. Clinical Research Operations

    Cancer.gov

    NIH/CC/CCR Orientation Requirements All new hires to the CCR, both government and contractor, are required to participate in orientation. This orientation program has been developed and coordinated by the CCR Office of the Clinical Director to be complian

  10. Clinical Intuition at Play

    ERIC Educational Resources Information Center

    Marks-Tarlow, Terry

    2014-01-01

    A clinical psychologist and consulting psychotherapist discusses how elements of play, inherent in the intuition required in analysis, can provide a cornerstone for serious therapeutic work. She argues that many aspects of play--its key roles in human development, individual growth, and personal creativity, among others--can help therapists and…

  11. Validating clinical competence.

    PubMed

    Chappell, Kathy; Koithan, Mary

    2012-07-01

    Professional registered nurses must be competent to provide care in today's fast-paced, highly technical clinical environment. Competency programs designed to teach and evaluate essential knowledge, skills, and abilities of registered nurses are one method organizations may use to demonstrate nursing proficiency. PMID:22731495

  12. Clinical Nuclear Pharmacy Clerkship

    ERIC Educational Resources Information Center

    Dunson, George L.; Christopherson, William J., Jr.

    1977-01-01

    The School of Pharmacy, University of the Pacific, and the Pharmacy Service, Letterman Army Medical Center, initiated a 15-week clinical nuclear pharmacy clerkship in 1975. It includes basic nuclear medical science, technical competency, professional competency, and special interest emphasis. (LBH)

  13. The Unstructured Clinical Interview

    ERIC Educational Resources Information Center

    Jones, Karyn Dayle

    2010-01-01

    In mental health, family, and community counseling settings, master's-level counselors engage in unstructured clinical interviewing to develop diagnoses based on the "Diagnostic and Statistical Manual of Mental Disorders" (4th ed., text rev.; "DSM-IV-TR"; American Psychiatric Association, 2000). Although counselors receive education about…

  14. Shuffling Adaptive Clinical Trials.

    PubMed

    Gokhale, Sanjay G; Gokhale, Sankalp

    2016-01-01

    Clinical trials are interventional studies on human beings, designed to test the hypothesis for diagnostic techniques, treatments, and disease preventions. Any novel medical technology should be evaluated for its efficacy and safety by clinical trials. The costs associated with developing drugs have increased dramatically over the past decade, and fewer drugs are obtaining regulatory approval. Because of this, the pharmaceutical industry is continually exploring new ways of improving drug developments, and one area of focus is adaptive clinical trial designs. Adaptive designs, which allow for some types of prospectively planned mid-study changes, can improve the efficiency of a trial and maximize the chance of success without undermining validity and integrity of the trial. However it is felt that in adaptive trials; perhaps by using accrued data the actual patient population after the adaptations could deviate from the originally target patient population and so to overcome this drawback; special methods like Bayesian Statistics, predicted probability are used to deduce data-analysis. Here, in this study, mathematical model of a new adaptive design (shuffling adaptive trial) is suggested which uses real-time data, and because there is no gap between expected and observed data, statistical modifications are not needed. Results are obviously clinically relevant. PMID:23751329

  15. The Clinical Supervision Process.

    ERIC Educational Resources Information Center

    Ramsey, MaryLou

    This document defines clinical supervision as an intensive, interpersonally-focused, one-to-one relationship in which one person is designated to facilitate the development of therapeutic competence in the other person. Ways in which supervision is similar to, and different from, therapy are explained. The following stages in the clinical…

  16. Clinical Mastery of Hypnosis.

    ERIC Educational Resources Information Center

    Horevitz, Richard P.

    Hypnosis is an increasingly popular clinical intervention. The number of training courses in hypnosis is growing each year. Research on hypnosis training appears to show that limited exposure to training, as is typical in the common 3 to 5 day format of mass training, produces limited results. Only when training is extended over time do the

  17. [Clinical application of calcimimetics].

    PubMed

    Nishi, Hiroshi; Fukagawa, Masafumi

    2004-05-01

    Calcimimetic agents modulate the activity of calcium-sensing receptor on the surface of parathyroid cell and suppress the secretion of parathyroid hormone. Several clinical trials demonstrated that the second-generation calcimimetics cinacalcet HCl reduced PTH level, as well as Ca x P product in secondary hyperparathyroidism, while the agents reduced PTH and calcium level in primary hyperparathyroidism. PMID:15577038

  18. Clinical Trials: CSDRG Overview

    ERIC Educational Resources Information Center

    Logemann, Jeri A.

    2004-01-01

    Recent importance placed upon efficacy research has spawned the development of the Communication Sciences and Disorders Clinical Trials Research Group (CSDRG). This group, funded by the National Institutes of Health (NIH), was organized by the American Speech Language and Hearing Association to address the need for more treatment efficacy research…

  19. Designing Clinical Remediation Programs.

    ERIC Educational Resources Information Center

    Oleszewski, Susan C.

    1989-01-01

    Elements and considerations in the provision of effective remediation for optometry students not achieving in clinical competence are discussed. Remediation of technical, cognitive, and noncognitive skills are included. A course in professional communication offered by the Pennsylvania College of Optometry is described. (MSE)

  20. Clinical Mastery of Hypnosis.

    ERIC Educational Resources Information Center

    Horevitz, Richard P.

    Hypnosis is an increasingly popular clinical intervention. The number of training courses in hypnosis is growing each year. Research on hypnosis training appears to show that limited exposure to training, as is typical in the common 3 to 5 day format of mass training, produces limited results. Only when training is extended over time do the…

  1. Computerized Clinical Simulations.

    ERIC Educational Resources Information Center

    Reinecker, Lynn

    1985-01-01

    Describes technique involved in designing a clinical simulation problem for the allied health field of respiratory therapy; discusses the structure, content, and scoring categories of the simulation; and provides a sample program which illustrates a programming technique in BASIC, including a program listing and a sample flowchart. (MBR)

  2. [Management in clinical nutrition].

    PubMed

    Alvarez, J; Monereo, S; Ortiz, P; Salido, C

    2004-01-01

    Terms such as management, costs, efficacy, efficiency, etc. that are so common in the discourse of managers are now beginning to appear in the vocabulary of clinicians. Management in Clinical Nutrition is an innovative aspect of interest among health-care professionals dealing with the needs of undernourished patients or those at risk of malnutrition. The basic goal of this paper is to show that the tools for clinical management of hospitals are applicable to such a multidisciplinary and complex speciality as clinical nutrition and also to propose the measures needed to improve our information systems and optimize management in this field. The very concept of hospitals has changed, as has their activity, over the years. Hospitals are nowadays no longer just a charitable institution but has become a service company, a public utility for the promotion of good health and they have to be managed in accordance with criteria of efficacy, efficiency, equity and quality. The concepts of Evidence-Based Medicine (EBM) and Cost-Effective Medicine (CEM) are of evident importance in the different ways of managing health-care services. Good clinical practice is the combination of EBM and CEM. This review defines the various cost studies of fundamental importance when taking decisions in hospital management and analyzes such clinical management tools as analytical accounting, Minimum Hospital Database Set (MHDS) and encoding systems, among others, thus facilitating an analysis of the usefulness of data in clinical nutrition management systems. Finally, after reviewing some specific examples, measures are proposed to optimize current information systems. The medical staff and those of us responsible for Nutrition Units operate in hospitals as part of a centralized service transferring information to the various departments where the patient is physically located (Surgery, Internal Medicine, Digestive, ICU, etc.). One of the priority goals in micro-management and middle management is to observe the quality improvement in the discharge reports for the patients admitted, including the nutritional diagnosis within the section for the main diagnosis, and also the administration of artificial nutrition (enteral or parenteral) in the section on procedures. With all of these measures we will improve the quality of the hospitals' information systems and contribute directly to ensuring that our activities in clinical nutrition have an impact on the overall results of the hospital when measured in terms of effectiveness, efficacy or quality. PMID:15211719

  3. Mayo Clinic's Flower of Hope™.

    PubMed

    Wentz, Margaret R

    2016-02-01

    Recognizing the contribution art has had in the Mayo Clinic environment since the original Mayo Clinic Building was finished in 1914; Mayo Clinic Proceedings features some of the numerous works of art displayed throughout the buildings and grounds on Mayo Clinic campuses. PMID:26848010

  4. Clinical pharmacy administration.

    PubMed

    Einarson, T R

    1988-11-01

    Clinical pharmacy administration has emerged as a separate discipline, but this new field has not been functionally defined. This article defines clinical pharmacy administration from an academic point of view and provides a framework within which it may be understood. It is an applied field of study that deals with the research, evaluation, and management of the patient, the drug, and the health care practitioner as they all relate to patient care. These entities and relationships are studied at the micro, macro, and global levels from financial, economic, managerial, legal, ethical, social, behavioral, educational, and historical perspectives. It is intended that this paper generate debate and discussion in order to refine and develop the field. PMID:3069428

  5. Clinical trials in children

    PubMed Central

    Joseph, Pathma D; Craig, Jonathan C; Caldwell, Patrina HY

    2015-01-01

    Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects of medicines and to prevent the delayed or non-use of beneficial therapies. Clinical trials provide reliable evidence of treatment effects by rigorous controlled testing of interventions on human subjects. Paediatric trials are more challenging to conduct than trials in adults because of the paucity of funding, uniqueness of children and particular ethical concerns. Although current regulations and initiatives are improving the scope, quantity and quality of trials in children, there are still deficiencies that need to be addressed to accelerate radically equitable access to evidence-based therapies in children. PMID:24325152

  6. Simulation of clinical trials.

    PubMed

    Holford, N H; Kimko, H C; Monteleone, J P; Peck, C C

    2000-01-01

    Computer simulation of clinical trials has evolved over the past two decades from a simple instructive game to "full" simulation models yielding pharmacologically sound, realistic trial outcomes. The need to make drug development more efficient and informative and the awareness that many industries make extensive use of simulation in product development have advanced considerably the use of simulation of clinical trials in pharmaceutical product development over the past decade. The structural and stochastic components of trial simulation models are explained as a prelude to a listing of representative simulation projects, reflecting investigative applications of statistical methods, trial design comparisons, and full simulation of new drugs being developed. Lessons learned from these projects are reviewed in the context of their current impact and potential for influencing the future of drug development. PMID:10836134

  7. Clinical vaccine development

    PubMed Central

    2015-01-01

    Vaccination is regarded as one of the biggest triumphs in the history of medicine. We are living in the most successful period of vaccine development. The accumulation of multidisciplinary knowledge and the investment of massive funding have enabled the development of vaccines against many infectious diseases as well as other diseases including malignant tumors. The paradigm of clinical vaccine evaluation and licensure has also been modernized based on scientific improvements and historical experience. However, there remain a number of hurdles to overcome. Continuous efforts are focused on increasing the efficacy and reducing the risks related to vaccine use. Cutting-edge knowledge about immunology and microbiology is being rapidly translated to vaccine development. Thus, physicians and others involved in the clinical development of vaccines should have sufficient understanding of the recent developmental trends in vaccination and the diseases of interest. PMID:25648742

  8. Managing digital clinical photographs.

    PubMed

    Nayler, J; Geddes, N; Gomez-Castro, C

    2001-12-01

    Digital cameras have been used for clinical photography in the Medical Illustration Department at Great Ormond Street Hospital NHS Trust for eight years. In that time methods have evolved to take advantage of both technological advances and experiences gained in operating a routine digital photographic service. The management of a large number of digital images requires assiduous attention to all stages of production. Current techniques are described for: controlling quality and exposure in the acquisition of images with a digital camera; temporary and permanent storage, backing up and archiving procedures; and cataloguing of clinical images. Planning for network delivery, the Electronic Patient Record and the management of images in teaching collections are discussed. PMID:11802704

  9. Clinical relevance of adipokines.

    PubMed

    Blüher, Matthias

    2012-10-01

    The incidence of obesity has increased dramatically during recent decades. Obesity increases the risk for metabolic and cardiovascular diseases and may therefore contribute to premature death. With increasing fat mass, secretion of adipose tissue derived bioactive molecules (adipokines) changes towards a pro-inflammatory, diabetogenic and atherogenic pattern. Adipokines are involved in the regulation of appetite and satiety, energy expenditure, activity, endothelial function, hemostasis, blood pressure, insulin sensitivity, energy metabolism in insulin sensitive tissues, adipogenesis, fat distribution and insulin secretion in pancreatic β-cells. Therefore, adipokines are clinically relevant as biomarkers for fat distribution, adipose tissue function, liver fat content, insulin sensitivity, chronic inflammation and have the potential for future pharmacological treatment strategies for obesity and its related diseases. This review focuses on the clinical relevance of selected adipokines as markers or predictors of obesity related diseases and as potential therapeutic tools or targets in metabolic and cardiovascular diseases. PMID:23130315

  10. Pharmacovigilance using Clinical Text.

    PubMed

    Lependu, Paea; Iyer, Srinivasan V; Bauer-Mehren, Anna; Harpaz, Rave; Ghebremariam, Yohannes T; Cooke, John P; Shah, Nigam H

    2013-01-01

    The current state of the art in post-marketing drug surveillance utilizes voluntarily submitted reports of suspected adverse drug reactions. We present data mining methods that transform unstructured patient notes taken by doctors, nurses and other clinicians into a de-identified, temporally ordered, patient-feature matrix using standardized medical terminologies. We demonstrate how to use the resulting high-throughput data to monitor for adverse drug events based on the clinical notes in the EHR. PMID:24303315

  11. Clinical multiphoton FLIM tomography

    NASA Astrophysics Data System (ADS)

    König, Karsten

    2012-03-01

    This paper gives an overview on current clinical high resolution multiphoton fluorescence lifetime imaging in volunteers and patients. Fluorescence lifetime imaging (FLIM) in Life Sciences was introduced in Jena/Germany in 1988/89 based on a ZEISS confocal picosecond dye laser scanning microscope equipped with a single photon counting unit. The porphyrin distribution in living cells and living tumor-bearing mice was studied with high spatial, temporal, and spectral resolution. Ten years later, time-gated cameras were employed to detect dental caries in volunteers based on one-photon excitation of autofluorescent bacteria with long fluorescence lifetimes. Nowadays, one-photon FLIM based on picosecond VIS laser diodes are used to study ocular diseases in humans. Already one decade ago, first clinical twophoton FLIM images in humans were taken with the certified clinical multiphoton femtosecond laser tomograph DermaInspectTM. Multiphoton tomographs with FLIM modules are now operating in hospitals at Brisbane, Tokyo, Berlin, Paris, London, Modena and other European cities. Multiple FLIM detectors allow spectral FLIM with a temporal resolution down to 20 ps (MCP) / 250 ps (PMT) and a spectral resolution of 10 nm. Major FLIM applications include the detection of intradermal sunscreen and tattoo nanoparticles, the detection of different melanin types, the early diagnosis of dermatitis and malignant melanoma, as well as the measurement of therapeutic effects in pateints suffering from dermatitis. So far, more than 1,000 patients and volunteers have been investigated with the clinical multiphoton FLIM tomographs DermaInspectTM and MPTflexTM.

  12. Applied clinical engineering

    SciTech Connect

    Feinberg, B.

    1986-01-01

    This book demonstrates how clinical engineering has applied engineering principles to the development and use of complex medical devices for the diagnosis and treatment of the sick and injured. It discusses the proper utilization of medical devices and equipment in the health-care industry and provides understanding of complex engineering systems, and their uses in the modern hospital or other health-care facility.

  13. [Guidelines for clinical practice].

    PubMed

    Vleugels, A M

    1997-01-01

    Clinical practice guidelines are systematically developed statements that are intended to support medical decision making in well-defined clinical situations. Essentially, their object is to reduce the variability in medical practice, to improve quality, and to make appropriated control of the financial resources possible. Internationally, ever more organisations, associations, and institutions are concerned with the development of guidelines in many different areas of care. Making implicit knowledge explicit is one of the associated advantages of guidelines: they have a potential utility in training, in process evaluation, and in the reevaluation of outcome studies. In liability issues, their existence has a double effect: they can be used to justify medical behaviour, and they constitute a generally accepted reference point. A derivative problem is the legal liability of the compilers of the guidelines. The principle of the guideline approach can be challenged academically: science cannot give a definition of optimal care with absolute certainty. What is called objectivity often rests on methodologically disputable analyses; also the opinion of opinion leaders is not always a guarantee for scientific soundness. Moreover, patients are not all identical: biological variability, situational factors, patient expectations, and other elements play a role in this differentiation. Clinicians are often hesitant with respect to clinical guidelines: they are afraid of cookbook medicine and curtailment of their professional autonomy. Patients fear reduction of individualization of care and the use of guidelines as a rationing instrument. The effects of the introduction of clinical practice guidelines on medical practice, on the results and on the cost of care vary but are generally considered to be favourable. The choice of appropriate strategies in development, dissemination, and implementation turns out to be of critical importance. The article ends with concrete suggestions for the various steps in the development of guidelines and their actual compilation. PMID:9490917

  14. Innovative Clinical Trial Designs

    PubMed Central

    Lavori, Philip W.

    2015-01-01

    Whereas the 20th-century health care system sometimes seemed to be inhospitable to and unmoved by experimental research, its inefficiency and unaffordability have led to reforms that foreshadow a new health care system. We point out certain opportunities and transformational needs for innovations in study design offered by the 21st-century health care system, and describe some innovative clinical trial designs and novel design methods to address these needs and challenges. PMID:26140056

  15. Sedation in clinical oncology.

    PubMed

    González Barón, Manuel; Gómez Raposo, César; Pinto Marín, Alvaro

    2005-08-01

    The clinical status of terminal cancer patients is very complex and is affected by several severe symptoms, of extended duration, changing with time and of multifactorial origin. When there are no reasonable cancer treatments specifically able to modify the natural history of the disease, symptom control acquires priority and favours the possible better adaptation to the general inexorable deterioration related to the neoplasic progression. Despite the important advances in Palliative Medicine, symptoms are frequently observed that are intolerable for the patient and which do not respond to usual palliative measures. This situation, characterised by rapid deterioration of the patient, very often heralds, implicitly or explicitly, approaching death. The intolerable nature and being refractory to treatment indicates to the health-care team, on many occasions, the need for sedation of the patient. The requirement for sedation of the cancer patient is a situation that does not allow for an attitude of doubt regarding maintenance of the patient in unnecessary suffering for more than a reasonable time. Given the undoubted clinical difficulty in its indication, it is important to have explored at an earlier stage all usual treatments possible and the grade of response, commensurate with the patient's values and desires. Sedation consists of the deliberate administration of drugs in minimum doses and combinations required not only to reduce the consciousness of the patients but also to achieve adequate alleviation of one or more refractory symptoms, and with the prior consent given by the patient explicitly, or implicitly or delegated. Sedation is accepted as ethically warranted when considering the imperative of palliation and its administration and, whenever contemplated, the arguments that justify them are clear recorded in the clinical history. It is not an easy decision for the physician since, traditionally, the training has been "for the fight to save life". Nevertheless, it seems necessary to make some preparations regarding these problems that have a central affect on the clinical oncologist in his daily function. PMID:16185591

  16. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2004-05-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 166Ho-DOTMP 5A8; A-179578, abetimus sodium, adefovir dipivoxil, AGI-1067, AIDSVAX gp120 B/B, AK-602, alefacept alemtuzumab, aliskiren fumarate, ALVAC vCP1433, ALVAC vCP1452, anecortave acetate, arzoxifene hydrochloride, atazanavir sulfate, atlizumab, avasimibe; Binodenoson, BMS-488043; Choriogonadotropin alfa, ciclesonide, COL-1621, CVT-3146, CVT-E002, Cypher; Daptomycin, darbepoetin alfa, darunavir, D-D4FC, deferasirox, desloratadine, desmoteplase, duloxetine hydrochloride, DX-9065a; E-5564, efalizumab, emfilermin, emivirine, emtricitabine, enfuvirtide, estradiol acetate, ezetimibe; Frovatriptan; Gallium maltolate, gefitinib; HIV-1 Immunogen, human insulin; Iguratimod, IL-4/IL-13 Trap, imatinib mesylate, inhaled insulin, insulin glargine, irofulven, ISS-1018, ivabradine hydrochloride; Lutropin alfa; Melatonin; Nesiritide; O6-Benzylguanine, omapatrilat, oritavancin, ospemifene; Parecoxib sodium, peginterferon alfa-2a, pexelizumab, pimecrolimus, pirfenidone, pramlintide acetate, prasterone sulfate PT-141; Rasburicase, razaxaban hydrochloride, recombinant malaria vaccine, rhBMP-2/ACS, roflumilast, rosiglitazone maleate/metformin hydrochloride, rotavirus vaccine; SCH-D, sitaxsentan sodium, solifenacin succinate; Targinine hydrochloride, taxus, TER-199, tramadol hydrochloride/acetaminophen; Valdecoxib, valganciclovir hydrochloride, vatalanib succinate, VEG Trap(R1R2); Ximelagatran; Yttrium Y90 Epratuzumab. PMID:15319808

  17. Basic and clinical immunology

    NASA Technical Reports Server (NTRS)

    Chinen, Javier; Shearer, William T.

    2003-01-01

    Progress in immunology continues to grow exponentially every year. New applications of this knowledge are being developed for a broad range of clinical conditions. Conversely, the study of primary and secondary immunodeficiencies is helping to elucidate the intricate mechanisms of the immune system. We have selected a few of the most significant contributions to the fields of basic and clinical immunology published between October 2001 and October 2002. Our choice of topics in basic immunology included the description of T-bet as a determinant factor for T(H)1 differentiation, the role of the activation-induced cytosine deaminase gene in B-cell development, the characterization of CD4(+)CD25(+) regulatory T cells, and the use of dynamic imaging to study MHC class II transport and T-cell and dendritic cell membrane interactions. Articles related to clinical immunology that were selected for review include the description of immunodeficiency caused by caspase 8 deficiency; a case series report on X-linked agammaglobulinemia; the mechanism of action, efficacy, and complications of intravenous immunoglobulin; mechanisms of autoimmunity diseases; and advances in HIV pathogenesis and vaccine development. We also reviewed two articles that explore the possible alterations of the immune system caused by spaceflights, a new field with increasing importance as human space expeditions become a reality in the 21st century.

  18. Automating clinical dietetics documentation.

    PubMed

    Grace-Farfaglia, P; Rosow, P

    1995-06-01

    A review of commonly used charting formats discussed in the dietetics literature revealed that the subjective, objective assessment and planning (SOAP) approach is most frequently used by dietitians. Formats reported in the nursing literature were charting by exception (CBE); problem, intervention, evaluation (PIE); and focus/data, action, response (Focus/DAR). The strengths and weaknesses of the charting styles as they apply to the needs of clinical dietetic specialists were reviewed. We then decided to test in house the Focus/DAR format by assessing chart entries for adherence to style, brevity, and physician response. Dietitians pilot tested all the methods, but found them time consuming to use. The consensus was that SOAP could be adapted to the documentation needs of the individual situation and required little additional staff training. Often because of time limitations, a narrative summary was most appropriate. Chart entry length was reduced as much as 200% when staff were given brief clinical communication as a goal, and a further reduction when line limits were imposed. The physician response was positive, with recommendations followed in 50% of charts, compared with 34% in a previous audit. A nutrition documentation system was developed by the researchers by reviewing medical chart structure, documentation standards, methods of risk identification, and terminology for clinical documentation style. The resulting system affected the decision making of physicians, who could now scan notes more quickly and implement nutrition recommendations in a more timely fashion. PMID:7759746

  19. Reuse of Clinical Data

    PubMed Central

    2014-01-01

    Summary Objectives To provide an overview of the benefits of clinical data collected as a by-product of the care process, the potential problems with large aggregations of these data, the policy frameworks that have been formulated, and the major challenges in the coming years. Methods This report summarizes some of the major observations from AMIA and IMIA conferences held on this admittedly broad topic from 2006 through 2013. This report also includes many unsupported opinions of the author. Results The benefits of aggregating larger and larger sets of routinely collected clinical data are well documented and of great societal benefit. These large data sets will probably never answer all possible clinical questions for methodological reasons. Non-traditional sources of health data that are patient-sources will pose new data science challenges. Conclusions If we ever hope to have tools that can rapidly provide evidence for daily practice of medicine we need a science of health data perhaps modeled after the science of astronomy. PMID:25123722

  20. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2003-12-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abetimus sodium, adalimumab, alefacept, alemtuzumab, almotriptan, AMGN-0007, anakinra, anti-CTLA-4 Mab, L-arginine hydrochloride, arzoxifene hydrochloride, astemizole, atazanavir sulfate, atlizumab; Belimumab, BG-9928, binodenoson, bosentan, botulinum toxin type B, bovine lactoferrin, BufferGel; Caspofungin acetate, ciclesonide,cilomilast, ciluprevir, clofarabine, CVT-3146; Darbepoetin alfa, desloratadine, diflomotecan, doripenem, dronedarone hydrochloride, drotrecogin alfa (activated), DT388-GM-CSF, duloxetine hydrochloride, E-5564, efalizumab, enfuvirtide, esomeprazole magnesium, estradiol acetate, ETC-642, exenatide, exisulind, ezetimib; Febuxostat; Gallium maltolate, ganirelix acetate, garenoxacin mesilate, gefitinib; H11, HuMax; IL-15, IDD-1, IGIV-C, imatinib mesylate, ISIS-14803, ITF-1697, ivabradine hydrochloride; KRN-5500; L-365260, levetiracetam, levosimendan, licofelone, linezolid, LJP-1082, lopinavir lumiracoxib; MCC-478, melatonin, morphine hydrochloride, morphine-6-glucuronide, moxidectin; N-Acetylcarnosine, natalizumab, NM-702, NNC-05-1869, NSC-703940; Ocinaplon OM-89, omalizumab, omeprazole/ sodium bicarbonate, OPC-28326, ospemifene; PEG-filgrastim peginterferon alfa-2a, pegsunercept, pirfenidone, pralmorelin, pregabalin; Recombinant glucagon-like peptide-1 (7-36) amide, repifermin, RSD-1235; S-8184, selodenoson, sodium dichloroacetate, suberanilohydroxamic acid; TAS-102, terfenadine, teriparatide, tipranavir troxacitabine; Ximelagatran; YM-337. PMID:14735233

  1. Ciliocytophthoria in clinical virology.

    PubMed

    Hadziyannis, E; Yen-Lieberman, B; Hall, G; Procop, G W

    2000-08-01

    Direct immunofluorescence assays (DFAs) are used in the clinical virology laboratory for the rapid detection of viruses. An assessment of the cellularity of specimens submitted for DFA is necessary for the most effective use of this assay. This assessment ensures that an adequate number of the appropriate cells are present for examination. During this assessment, clinical virologists may encounter unfamiliar cellular elements or cellular fragments. One of these elements, ciliocytophthoria, has been misinterpreted as a parasite in specimens submitted for cytologic testing. We describe a similar case in which a technologist thought that ciliocytophthoria possibly represented a ciliated parasite in a nasopharyngeal specimen sent for respiratory syncytial virus DFA. After a thorough morphologic examination, the staff dismissed the possibility of a ciliated parasite. We confirmed this entity as ciliocytophthoria using morphologic criteria and the Diff-Quik stain. This near misidentification of ciliocytophthoria as a ciliated parasite affords us the opportunity to raise the awareness of clinical virologists about ciliocytophthoria. Additionally, we briefly review useful features for differentiating ciliocytophthoria from the only ciliate parasitic for humans, Balantidium coli. Finally, we present the utility of a commonly used cytologic stain, the Diff-Quik stain, for the confirmation of ciliocytophthoria. PMID:10923088

  2. Clinical Assay Development Support - Office of Cancer Clinical Proteomics Research

    Cancer.gov

    The NCI’s Division of Cancer Treatment and Diagnosis and the Cancer Diagnosis Program announce a request for applications for the Clinical Assay Development Program (CADP) for investigators seeking clinical assay development and validation resources.

  3. Development and Clinical Outcomes of a Dialectical Behavior Therapy Clinic

    ERIC Educational Resources Information Center

    Lajoie, Travis; Sonkiss, Joshua; Rich, Anne

    2011-01-01

    Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…

  4. Assuring Quality Control of Clinical Education in Multiple Clinical Affiliates.

    ERIC Educational Resources Information Center

    Davis, Judith A.

    A plan was developed to assure equivalency of clinical education among the medical laboratory technician (MLT) programs affiliated with Sandhills Community College. The plan was designed by faculty to monitor the quality of clinical courses offered by the clinical affiliates. The major strategies were to develop competencies, slide/tape modules, a…

  5. Development and Clinical Outcomes of a Dialectical Behavior Therapy Clinic

    ERIC Educational Resources Information Center

    Lajoie, Travis; Sonkiss, Joshua; Rich, Anne

    2011-01-01

    Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a

  6. Terminal Behavioral Objectives for Teaching Clinical Toxicology to Clinical Pharmacists

    ERIC Educational Resources Information Center

    Veltri, Joseph C.; And Others

    1976-01-01

    As a first step in the development of a competency-based clinical toxicology clerkship, a set of terminal behavioral objectives were developed that reflect the anticipated role that clinical pharmacists should play as part of the clinical toxicology team. The evaluation approaches used at the University of Utah are presented. (LBH)

  7. "Clinical Reasoning Theater": A New Approach to Clinical Reasoning Education.

    ERIC Educational Resources Information Center

    Borleffs, Jan C. C.; Custers, Eugene J. F. M.; van Gijn, Jan; ten Gate, Olle Th. J.

    2003-01-01

    Describes a new approach to clinical reasoning education called clinical reasoning theater (CRT). With students as the audience, the doctor's clinical reasoning skills are modeled in CRT when he or she thinks aloud during conversations with the patient. Preliminary results of students' evaluations of the relevance of CRT reveal that they…

  8. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2005-10-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (Z)-4-hydroxytamoxifen; Ad.muIFN-beta AD-237, adalimumab, adefovir dipivoxil, agalsidase alfa, alemtuzumab, almotriptan, ALVAC vCP1452, alvimopan hydrate, ambrisentan, anakinra, anti-IFN-gamma MAb; Bimatoprost, BMS-188797, BMS-214662, bortezomib, bosentan, bovine lactoferrin; Caffeine, canertinib dihydrochloride, canfosfamide hydrochloride, cannabidiol, caspofungin acetate, cetuximab, cH36, ChimeriVax-JE, ciclesonide, cilansetron, cinacalcet hydrochloride, clopidogrel, CpG-7909, Cypher; Daptomycin, darbepoetin alfa, darifenacin hydrobromide, decitabine, denufosol tetrasodium, Dexamet, diindolemethane, drotrecogin alfa (activated), duloxetine hydrochloride, DX-9065a; E-7010, edaravone, efalizumab, eicosapentaenoic acid/docosahexaenoic acid, elacridar, eletriptan, emtricitabine, epratuzumab, erlotinib hydrochloride, ertapenem sodium, eszopiclone, everolimus, ezetimibe; Fludarabine, fondaparinux sodium; gamma-Hydroxybutyrate sodium, gavestinel sodium, gefitinib, granisetron-Biochronomer; Human Albumin, human insulin; Imatinib mesylate, indiplon, interleukin-2 XL, isatoribine, ISS-1018, i.v. gamma-globulin, ivabradine hydrochloride, ixabepilone; Lanthanum carbonate, L-arginine hydrochloride, liposomal doxorubicin, LY-450139; Magnesium sulfate, melatonin, motexafin gadolinium, mycophenolic acid sodium salt; Natalizumab, nesiritide, niacin/lovastatin; OGX-011, olmesartan medoxomil, omalizumab, ospemifene; PACAP38, panitumumab, parathyroid hormone (human recombinant), parecoxib sodium, patupilone, pegfilgrastim, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, pirfenidone, posaconazole, prasterone, pregabalin; R-112, ramelteon, ranolazine, rasagiline mesilate, rebimastat, roflumilast, rosuvastatin calcium, rotigotine hydrochloride, rupatadine fumarate; S-3013, S-3304, semustine, sitaxsentan sodium, St. John's Wort extract; Tadalafil, tamoxifen, Taxus, Tc-99m-EDDA-HYNIC-TOC, TH-9507, tiotropium bromide, tipifarnib, tocilizumab, tolvaptan, torcetrapib, TR-14035, tramadol hydrochloride/acetaminophen, treprostinil diethanolamine, troglitazone, troxacitabine; Valdecoxib, valganciclovir hydrochloride, vandetanib, vardenafil hydrochloride hydrate, VAS-991, veglin, vinflunine, voriconazole; White sweet potato extract; Ximelagatran. PMID:16273137

  9. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2004-01-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abetimus sodium, Ad5-FGF4, adeno-Interferon gamma, AE-941, AERx, alemtuzumab, alicaforsen sodium, almotriptan, alpharadin, anakinra, anatumomab mafenatox, ANG-453, anti-CTLA-4 Mab, AP-12009, aprepitant, aripiprazole, arsenic trioxide, astemizole, atlizumab, atomoxetine hydrochloride; Bevacizumab, BG-9928, BMS-188667, botulinum toxin type B, BufferGel; Caffeine, CDP-870, cetuximab, cilomilast, ciluprevir, clofarabine, continuous erythropoiesis receptor activator, CP-461; Darbepoetin alfa, deferasirox, desloratadine, desoxyepothilone B, diflomotecan, dolasetron, drotrecogin alfa (activated), duloxetine hydrochloride; ED-71, efalizumab, efaproxiral sodium, EKB-569, eletriptan, EMD-72000, enfuvirtide, erlotinib hydrochloride, escitalopram oxalate, etoricoxib; Fampridine, ferumoxytol, fondaparinux sodium; Gadofosveset sodium, gastrazole, gefitinib, gemtuzumab ozogamicin, gepirone hydrochloride glutamine; hLM609, HSPPC-96, human insulin; IDD-1, imatinib mesylate, indisulam, inhaled insulin, ixabepilone; Keratinocyte growth factor; Lapatinib, laquinimod, LDP-02, LE-SN38, levetiracetam, levosimendan, licofelone, liposomal doxorubicin, liposomal NDDP, lopinavir, lumiracoxib, LY-156735; Morphine hydrochloride, morphine-6-glucuronide, motexafin gadolinium, MS-27-275, MVA-5T4, MVA-Muc1-IL-2; Nemifitide ditriflutate, neridronic acid nitronaproxen, NSC-683864, NSC-703940, NVP-LAF-237; Oblimersen sodium, ocinaplon, oncomyc-NG, OPC-28326, ortataxel, ospemifene; Palonosetron hydrochloride, PEG-filgrastim peginterferon alfa-2(a), peginterferon alfa-2b, pegsunercept, pemetrexed disodium, pregabalin, prilocaine, pyridoxamine; RDP-58, recombinant glucagon-like peptide-1 (7-36) amide, recombinant human ApoA-I milano/phospholipid complex; SB-715992, soblidotin, sodium dichloroacetate, St. John's Wort extract; TAS-102, terfenadine, TG-1024, TG-5001, 4'-Thio-ara-C, tipranavir, topixantrone hydrochloride, trabectedin, transdermal selegiline, trimethoprim, troxacitabine, TT-232; Vatalanib succinate, vinflunine; Ximelagatran; Ziprasidone hydrochloride, Zoledronic acid monohydrate. PMID:14988742

  10. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2003-09-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abetimus sodium, adefovir dipivoxil, AGI-1067, alefacept, alemtuzumab, ALVAC-p53, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, Anti-CTLA-4 Mab, AOD-9604, apafant, aprinocarsen sodium, arsenic trioxide; Balaglitazone, BIM-23190, bimatoprost, bortezomib, bosentan, BR-1; Canertinib dihydrochloride, CDP-850, cevimeline hydrochloride, cinacalcet hydrochloride, clenoliximab, clevudine, CN-787; D-003, darusentan, deferasirox, desloratadine dexanabinol, duloxetine hydrochloride; E-5564, edaravone, efaproxiral sodium, elvucitabine emfilermin, EN-101, enfuvirtide, entecavir, epithalon, eplerenone, erlotinib hydrochloride, escitalopram oxalate, esomeprazole magnesium, eszopiclone, etilefrine pivalate hydrochloride etoricoxib, everolimus, exenatide; Fidarestat, fondaparinux sodium; Ganstigmine hydrochloride; Homoharringtonine, HuMax-IL-15, hyperimmune IVIG; Imatinib mesylate, IMC-1C11, Inhaled insulin, irofulven, iseganan hydrochloride, ISIS-14803, ISIS-5132, ivabradine hydrochloride; Keratinocyte growth factor; Lafutidine, lanthanum carbonate, LAS-34475, levocetirizine, liraglutide, LY-307161 SR; Magnesium sulfate, maribavir, melatonin, mycobacterium cell wall complex; NN-414, NO-aspirin, nociceptin, nolomirole hydrochloride; Olmesartan medoxomil oral insulin, ospemifene; PDX, perillyl alcohol, pimecrolimus, pitavastatin calcium, pramlintide acetate, prasterone, pregabalin, PRO-542, PV-701, pyrazoloacridine; R-744, ranelic acid distrontium salt, rasburicase, rDNA insulin, resiniferatoxin, reslizumab, ridogrel, riplizumab ropivacaine, rosuvastatin calcium, roxifiban acetate, ruboxistaurin mesilate hydrate; Satraplatin, Sch-58500, semaxanib, sitaxsentan sodium, SMP-114, SU-6668; Teriparatide, tetrathiomolybdate, tipifarnib, tolvaptan, travoprost, treprostinil sodium; Valdecoxib, valganciclovir hydrochloride, vardenafil hydrochloride hydrate, vatalanib succinate; Ximelagatran; Z-335, ziprasidone hydrochloride, zoledronic acid monohydrate, ZYC-00101. PMID:14571286

  11. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2006-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 5-Methyltetrahydrofolate, 9-aminocamptothecin; AdPEDF.11, AE-37, albumin interferon alfa, alicaforsen sodium, alvocidib hydrochloride, AMG-706, arginine butyrate, avanafil, axitinib, azimilide hydrochloride; BAY-579352, belagenpumatucel-L, beta-lapachone, BHT-3009, BIBW-2992, bremelanotide, BX-471; Casopitant mesylate, cediranib, certolizumab pegol, CH-1504, ChimeriVax-West Nile, clofazimine, CpG-7909, curcumin, Cypher; Dapoxetine hydrochloride, darusentan, diflomotecan, D-methionine, dnaJP1, D-serine, DTPw-HB Hib-MenAC, DTPw-HepB-Hib; E-7010, ecogramostim, edodekin alfa, EGFRvlll peptide vaccine, elcometrine, elcometrine/ethinylestradiol, elsilimomab, enrasentan, ertumaxomab, etalocib sodium, exisulind; Fenretinide, fesoterodine, fingolimod hydrochloride, fontolizumab; Gefitinib, gemtuzumab ozogamicin, ghrelin (human), GV-1001; HTU-PA, human papillomavirus vaccine; Indacaterol, indiplon, interleukin-21, intranasal insulin, irinotecan hydrochloride/floxuridine, ISIS-301012, ispinesib mesylate, ixabepilone; K562/GM-CSF; Lapatinib, L-BLP-25, linezolid, liposome encapsulated paclitaxel, LY-2124275; MC-1, MC-1/lisinopril, MDX-066, melanoma vaccine, MMR-V, multivalent (ACYW) meningitis vaccine; Nilotinib, nobori, nociceptin; Oblimersen sodium, orbofiban acetate, ospemifene; Paliperidone, panitumumab, PEG-filgrastim, PEGylated interferon alfacon-1, perflubutane, pertuzumab, phenserine tartrate, phVEGF-A165, pleconaril, prasugrel, prednisolone sodium metasulfobenzoate; R-411, recombinant malaria vaccine, rhGM-CSF, roflumilast, romidepsin, ruboxistaurin mesilate hydrate; Sirolimus-eluting stent, SR-4554, St. John's Wort extract; Talabostat, Taxus, TGN-255, tifacogin, tiotropium bromide, tolevamer sodium, trabectedin, tretinoin LF; Vatalanib succinate; Yellow fever vaccine, YM-155. PMID:17235418

  12. Clinical management of SIADH

    PubMed Central

    2012-01-01

    Hyponatremia is the most frequent electrolyte disorder and the syndrome of inappropriate antidiuretic hormone secretion (SIADH) accounts for approximately one-third of all cases. In the diagnosis of SIADH it is important to ascertain the euvolemic state of extracellular fluid volume, both clinically and by laboratory measurements. SIADH should be treated to cure symptoms. While this is undisputed in the presence of grave or advanced symptoms, the clinical role and the indications for treatment in the presence of mild to moderate symptoms are currently unclear. Therapeutic modalities include nonspecific measures and means (fluid restriction, hypertonic saline, urea, demeclocycline), with fluid restriction and hypertonic saline commonly used. Recently vasopressin receptor antagonists, called vaptans, have been introduced as specific and direct therapy of SIADH. Although clinical experience with vaptans is limited at this time, they appear advantageous to patients because there is no need for fluid restriction and the correction of hyponatremia can be achieved comfortably and within a short time. Vaptans also appear to be beneficial for physicians and staff because of their efficiency and reliability. The side effects are thirst, polydipsia and frequency of urination. In any therapy of chronic SIADH it is important to limit the daily increase of serum sodium to less than 8–10 mmol/liter because higher correction rates have been associated with osmotic demyelination. In the case of vaptan treatment, the first 24 h are critical for prevention of an overly rapid correction of hyponatremia and the serum sodium should be measured after 0, 6, 24 and 48 h of treatment. Discontinuation of any vaptan therapy for longer than 5 or 6 days should be monitored to prevent hyponatremic relapse. It may be necessary to taper the vaptan dose or restrict fluid intake or both. PMID:23148195

  13. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2004-03-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Activated protein C concentrate, Ad-CD154, Adeno-Interferon gamma, alemtuzumab, APC-8024, 9-aminocamptothecin, aprepitant, l-arginine hydrochloride, aripiprazole, arsenic trioxide, asimadoline; O6-Benzylguanine, bevacizumab, Bi-20, binodenoson, biphasic insulin aspart, bivatuzumab, 186Re-bivatuzumab, BMS-181176, bosentan, botulinum toxin type B, BQ-123, bryostatin 1; Carboxy- amidotriazole, caspofungin acetate, CB-1954, CC-4047, CDP-860, cerivastatin sodium, clevidipine, CTL-102; 3,4-DAP, darbepoetin alfa, decitabine, desloratadine, DHA-paclitaxel, duloxetine hydrochloride; Efalizumab, EGF vaccine, eletriptan, eniluracil, ENMD-0997, eplerenone, eplivanserin, erlosamide, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, eszopiclone, everolimus, exatecan mesilate, exenatide, ezetimibe; Fondaparinux sodium, FR-901228, FTY-720; Gefitinib, gemtuzumab ozogamicin, gepirone hydrochloride; Hexyl insulin M2, human insulin; Imatinib mesylate, insulin detemir, insulin glargine, iodine (I131) tositumomab, ISV-205, ivabradine hydrochloride, ixabepilone; Levetiracetam, levocetirizine, linezolid, liposomal NDDP, lonafarnib, lopinavir, LY-156735; Mafosfamide cyclohexylamine salt, magnesium sulfate, maxacalcitol, meclinertant, melagatran, melatonin, MENT, mepolizumab, micafungin sodium, midostaurin, motexafin gadolinium; Nesiritide, NS-1209, NSC-601316, NSC-683864; Osanetant; Palonosetron hydrochloride, parecoxib sodium, pegaptanib sodium, peginterferon alfa-2a, peginterferon alfa-2b, pegylated OB protein, pemetrexed disodium, perillyl alcohol, picoplatin, pimecrolimus, pixantrone maleate, plevitrexed, polyglutamate paclitaxel, posurdex, pramlintide acetate, prasterone, pregabalin; Rasburicase, rimonabant hydrochloride, rostaporfin, rosuvastatin calcium; SDZ-SID-791, sibrotuzumab, sorafenib, SU-11248; Tadalafil, targinine, tegaserod maleate, telithromycin, TheraCIM, tigecycline, tiotropium bromide, tipifarnib, tirapazamine, treprostinil sodium; Valdecoxib, Valganciclovir hydrochloride, Vardenafil hydrochloride hydrate; Ximelagatran; Zofenopril calcium, Zoledronic acid monohydrate. PMID:15071612

  14. Philosophy of clinical psychopharmacology.

    PubMed

    Aragona, Massimiliano

    2013-03-01

    The renewal of the philosophical debate in psychiatry is one exciting news of recent years. However, its use in psychopharmacology may be problematic, ranging from self-confinement into the realm of values (which leaves the evidence-based domain unchallenged) to complete rejection of scientific evidence. In this paper philosophy is conceived as a conceptual audit of clinical psychopharmacology. Its function is to criticise the epistemological and methodological problems of current neopositivist, ingenuously realist and evidence-servant psychiatry from within the scientific stance and with the aim of aiding psychopharmacologists in practicing a more self-aware, critical and possibly useful clinical practice. Three examples are discussed to suggest that psychopharmacological practice needs conceptual clarification. At the diagnostic level it is shown that the crisis of the current diagnostic system and the problem of comorbidity strongly influence psychopharmacological results, new conceptualizations more respondent to the psychopharmacological requirements being needed. Heterogeneity of research samples, lack of specificity of psychotropic drugs, difficult generalizability of results, need of a phenomenological study of drug-induced psychopathological changes are discussed herein. At the methodological level the merits and limits of evidence-based practice are considered, arguing that clinicians should know the best available evidence but that guidelines should not be constrictive (due to several methodological biases and rhetorical tricks of which the clinician should be aware, sometimes respondent to extra-scientific, economical requests). At the epistemological level it is shown that the clinical stance is shaped by implicit philosophical beliefs about the mind/body problem (reductionism, dualism, interactionism, pragmatism), and that philosophy can aid physicians to be more aware of their beliefs in order to choose the most useful view and to practice coherently. In conclusion, psychopharmacologists already use methodological audit (e.g. statistical audit); similarly, conceptual clarification is needed in both research planning/evaluation and everyday psychopharmacological practice. PMID:23470600

  15. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2004-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABI-007, adalimumab, adefovir dipivoxil, alefacept, alemtuzumab, 3-AP, AP-12009, APC-8015, L-Arginine hydrochloride, aripiprazole, arundic acid, avasimibe; Bevacizumab, bivatuzumab, BMS-181176, BMS-184476, BMS-188797, bortezomib, bosentan, botulinum toxin type B, BQ-123, BRL-55730, bryostatin 1; CEP-1347, cetuximab, cinacalcet hydrochloride, CP-461, CpG-7909; D-003, dabuzalgron hydrochloride, darbepoetin alfa, desloratadine, desoxyepothilone B, dexmethylphenidate hydrochloride, DHA-paclitaxel, diflomotecan, DN-101, DP-b99, drotrecogin alfa (activated), duloxetine hydrochloride, duramycin; Eculizumab, Efalizumab, EKB-569, elcometrine, enfuvirtide, eplerenone, erlotinib hydrochloride, ertapenem sodium, eszopiclone, everolimus, exatecan mesilate, ezetimibe; Fenretinide, fosamprenavir calcium, frovatriptan; GD2L-KLH conjugate vaccine, gefitinib, glufosfamide, GTI-2040; Hexyl insulin M2, human insulin, hydroquinone, gamma-Hydroxybutyrate sodium; IL-4(38-37)-PE38KDEL, imatinib mesylate, indisulam, inhaled insulin, ixabepilone; KRN-5500; LY-544344; MDX-210, melatonin, mepolizumab, motexafin gadolinium; Natalizumab, NSC-330507, NSC-683864; 1-Octanol, omalizumab, ortataxel; Pagoclone, peginterferon alfa-2a, peginterferon alfa-2b, pemetrexed disodium, phenoxodiol, pimecrolimus, plevitrexed, polyphenon E, pramlintide acetate, prasterone, pregabalin, PX-12; QS-21; Ragaglitazar, ranelic acid distrontium salt, RDP-58, recombinant glucagon-like peptide-1 (7-36) amide, repinotan hydrochloride, rhEndostatin, rh-Lactoferrin, (R)-roscovitine; S-8184, semaxanib, sitafloxacin hydrate, sitaxsentan sodium, sorafenib, synthadotin; Tadalafil, tesmilifene hydrochloride, theratope, tipifarnib, tirapazamine, topixantrone hydrochloride, trabectedin, traxoprodil, Tri-Luma; Valdecoxib, valganciclovir hydrochloride, vinflunine; Ximelagatran; Ziconotide. PMID:15148527

  16. Shared clinical decision making

    PubMed Central

    AlHaqwi, Ali I.; AlDrees, Turki M.; AlRumayyan, Ahmad; AlFarhan, Ali I.; Alotaibi, Sultan S.; AlKhashan, Hesham I.; Badri, Motasim

    2015-01-01

    Objectives: To determine preferences of patients regarding their involvement in the clinical decision making process and the related factors in Saudi Arabia. Methods: This cross-sectional study was conducted in a major family practice center in King Abdulaziz Medical City, Riyadh, Saudi Arabia, between March and May 2012. Multivariate multinomial regression models were fitted to identify factors associated with patients preferences. Results: The study included 236 participants. The most preferred decision-making style was shared decision-making (57%), followed by paternalistic (28%), and informed consumerism (14%). The preference for shared clinical decision making was significantly higher among male patients and those with higher level of education, whereas paternalism was significantly higher among older patients and those with chronic health conditions, and consumerism was significantly higher in younger age groups. In multivariate multinomial regression analysis, compared with the shared group, the consumerism group were more likely to be female [adjusted odds ratio (AOR) =2.87, 95% confidence interval [CI] 1.31-6.27, p=0.008] and non-dyslipidemic (AOR=2.90, 95% CI: 1.03-8.09, p=0.04), and the paternalism group were more likely to be older (AOR=1.03, 95% CI: 1.01-1.05, p=0.04), and female (AOR=2.47, 95% CI: 1.32-4.06, p=0.008). Conclusion: Preferences of patients for involvement in the clinical decision-making varied considerably. In our setting, underlying factors that influence these preferences identified in this study should be considered and tailored individually to achieve optimal treatment outcomes. PMID:26620990

  17. Gateways to clinical trials.

    PubMed

    Bayes, M; Rabasseda, X; Prous, J R

    2004-01-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Know- ledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABI-007, Ad.Egr.TNF.11D, adefovir dipivoxil, AdPEDF.11, AES-14, albumex, alefacept, alemtuzumab, aliskiren fumarate, alvimopan hydrate, aAminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anti-IL-12 MAb, aprepitant, atazanavir sulfate, atrasentan, avanafil; Banoxantrone, BG-12, bimatoprost, bortezomib, bosentan; Calcipotriol/betamethasone dipropionate, caspofungin acetate, CBT-1, ciclesonide, clofarabine, conivaptan hydrochloride, CpG-7909, C-Vax, Cypher; DA-8159, DAC:GLP-1, darbepoetin alfa, darifenacin, duloxetine hydrochloride; Eculizumab, efalizumab, efaproxiral sodium, EGF vaccine, eletriptan, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, ETC-642, etoricoxib, everolimus, exenatide; Gefitinib, IV gamma-globulin; Human insulin, gamma-hydroxybutyrate sodium; IDN-6556, iguratimod, imatinib mesylate, indiplon, ixabepilone; Laquinimod, LB-80380, lidocaine/prilocaineliraglutide, lopinavir, lopinavir/ritonavir, lucinactant; MAb-14.18, melatonin, MLN-591-DM1; NC-531, neridronic acid, nesiritide, neutrophil-inhibitory factor, niacin/lovastatin; Oblimersen sodium, olcegepant, oral Insulin, ORV-105; Palonosetron hydrochloride, PAmAb, pegaptanib sodium, peginterferon alfa-2a, pegvisomant, perifosine, pexelizumab, phenoxodiol, phenserine tartrate, pimecrolimus, pramlintide acetate, pregabalin, PRO-542, prostate cancer vaccine, PT-141; Ramelteon, rasagiline mesilate, rDNA insulin, reslizumab, rh-Lactoferrin, ribamidine hydrochloride, rosuvastatin calcium; S-8184l, SC-1, sorafenib, St. John's Wort extract, SU-11248; Taxus, telbivudine, tenofovir disoproxil fumarate, teriparatide, testosterone gel, tezosentan disodium, tipifarnib, tolvaptan, trabectedin, travoprost, travoprost/timolol, treprostinil sodium; Vardenafil hydrochloride hydrate; Xcellerated T cells, XR-5944; Yttrium 90 (90Y) ibritumomab tiuxetan; Ziconotide. PMID:15349141

  18. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2007-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide, Uracil, Ustekinumab; V-260, Vandetanib, Vatalanib succinate, Vernakalant hydrochloride, Vorinostat; YM-155; Zileuton, Zoledronic acid monohydrate. PMID:18200333

  19. Gateways to clinical trials.

    PubMed

    Tomillero, A; Moral, M A

    2009-09-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV1/SERCA2a, Abacavir sulfate/lamivudine, Adalimumab, Aliskiren fumarate, Ambrisentan, Aripiprazole, AT-7519, Atazanavir sulfate, Atomoxetine hydrochloride, Azacitidine, Azelnidipine; Besifloxacin hydrochloride, Bevacizumab, Bioabsorbable everolimus-eluting coronary stent, Bortezomib, Bosentan, Budesonide/formoterol fumarate; CAIV-T, Carisbamate, Casopitant mesylate, Certolizumab pegol, Cetuximab, Ciclesonide, Ciprofloxacin/dexamethasone, CTCE-9908; Dalcetrapib, Darunavir, Deferasirox, Desloratadine, Disitertide, Drotrecogin alfa (activated), DTA-H19, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Efalizumab, Emtricitabine, Eribulin mesilate, Escitalopram oxalate, Eszopiclone, EUR-1008, Everolimus-eluting coronary stent, Exenatide; Fampridine, Fluticasone furoate, Formoterol fumarate/fluticasone propionate, Fosamprenavir calcium, Fulvestrant; Gabapentin enacarbil, GS-7904L; HPV-6/11/16/18, Human Secretin, Hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, Imexon, Inalimarev/Falimarev, Indacaterol, Indacaterol maleate, Inhalable human insulin, Insulin detemir, Insulin glargine, Ixabepilone; L-Alanosine, Lapatinib ditosylate, Lenalidomide, Levocetirizine dihydrochloride, Liraglutide, Lisdexamfetamine mesilate, Lopinavir, Loratadine/montelukast sodium, Lutropin alfa; MeNZB, Mepolizumab, Micafungin sodium, Morphine hydrochloride; Nabiximols, Nikkomycin Z; Olmesartan medoxomil, Omalizumab; Paclitaxel-eluting stent, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Perifosine, PF-489791, Plitidepsin, Posaconazole, Pregabalin; QAX-576; Raltegravir potassium, Ramelteon, Rasagiline mesilate, Recombinant human relaxin H2, rhGAD65, Rivaroxaban, Rosuvastatin calcium, Rotigotine; Saxagliptin, SCH-530348, Sirolimus-eluting stent, SLIT-amikacin, Sorafenib, Sotrastaurin, SR-16234, Sulforaphane; Tadalafil, Tanespimycin, Tapentadol hydrochloride, Teriparatide, Tesofensine, Tiotropium bromide, Tipifarnib, Tirapazamine, TMC-207, Tocilizumab, Tolvaptan, Tosedostat, Treprostinil sodium; Ustekinumab; Varespladib methyl, Vicriviroc, Vildagliptin, Vildagliptin/metformin hydrochloride, Volociximab, Voriconazole; Ziconotide, Ziprasidone hydrochloride. PMID:19907722

  20. Gateways to clinical trials.

    PubMed

    Bayés, M; Rabasseda, X; Prous, J R

    2004-10-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abiraterone acetate, Ad5CMV-p53, adefovir dipivoxil, AE-941, ambrisentan, aripiprazole, atomoxetine hydrochloride, atrasentan; BCH-10618, bimatoprost, BMS-184476, BMS-275183, BMS-387032, botulinum toxin type B, BR-1, BR96-Doxorubicin; Capravirine, caspofungin acetate, cinacalcet hydrochloride; Darbepoetin alfa, desloratadine, dextrin sulfate, DJ-927, duloxetine hydrochloride; Elacridar, emtricitabine, eplerenone, ertapenem sodium, escitalopram oxalate, ESP-24217, etoricoxib, exenatide, ezetimibe; Ferumoxtran-10, fondaparinux sodium, fosamprenavir calcium; GS-7904L, GW-5634; HMN-214, human insulin; IC-14, imatinib mesylate, indiplon, insulin glargine, insulinotropin, iseganan hydrochloride; Lanthanum carbonate, L-Arginine hydrochloride, LEA29Y, lenalidomide, LE-SN38, lestaurtinib, L-MDAM, lometrexol, lopinavir, lopinavir/ritonavir; Magnesium sulfate, maraviroc, mepolizumab, metreleptin, milataxel, MNA-715, morphine hydrochloride; Nesiritide, neutrophil-inhibitory factor, NK-911; Olanzapine/fluoxetine hydrochloride, olmesartan medoxomil, omalizumab, ortataxel, oxycodone hydrochloride/ibuprofen; Panitumumab, patupilone, PC-515, PD-MAGE-3 Vaccine, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ ribavirin, pemetrexed disodium, pimecrolimus, prasugrel, pregabalin, PRO-2000; Rosuvastatin calcium, RPR-113090; sabarubicin hydrochloride, safinamide mesilate, SB-715992, sitaxsentan sodium, soblidotin, synthadotin; Tadalafil, taltobulin, temsirolimus, tenofovir disoproxil fumarate, tenofovir disoproxil fumarate/emtricitabine, testosterone gel, tigecycline, tipranavir, tirapazamine, trabectedin, travoprost; UCN-01; Vardenafil hydrochloride hydrate; XB-947; Yttrium 90 (90Y) ibritumomab tiuxetan. PMID:15605126

  1. Gateways to clinical trials.

    PubMed

    Tomillero, A; Moral, M A

    2010-11-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil fumarate, Tocilizumab, Tositumomab/iodine (I131) tositumomab, Trabectedin, TransVax™ hepatitis C vaccine; Ustekinumab; V-260, Valspodar, Varenicline tartrate, VCL-IPT1, Vildagliptin, VRC-HIVADV014-00-VP, VRC-HIVDNA009-00-VP, VRC-HIVDNA016-00-VP; Yttrium 90 (90Y) ibritumomab tiuxetan, Yttrium Y90 Epratuzumab; Zibotentan, Zotarolimus-eluting stent. PMID:21225019

  2. Clinical Neurogenetics: Stroke

    PubMed Central

    Rost, Natalia S.

    2013-01-01

    Understanding the genetic architecture of cerebrovascular disease holds promise of novel stroke prevention strategies and therapeutics that are both safe and effective. Apart from a few single-gene disorders associated with cerebral ischemia or intracerebral hemorrhage, stroke is a complex genetic phenotype, which requires careful ascertainment and robust association testing for discovery and validation analyses. Recently uncovered shared genetic contribution between clinically manifest stroke syndromes and closely-related intermediate cerebrovascular phenotypes offers effective and efficient approaches to complex trait analysis. PMID:24176416

  3. Clinical pharmacokinetics of nefazodone.

    PubMed

    Greene, D S; Barbhaiya, R H

    1997-10-01

    Nefazodone is a new antidepressant drug, chemically unrelated to the tricyclic, tetracyclic or selective serotonin uptake inhibitors. Nefazodone blocks the serotonin 5-HT2 receptors and reversibly inhibits serotonin reuptake in vivo. Nefazodone is completely and rapidly absorbed after oral administration with a peak plasma concentration observed within 2 hours of administration. Nefazodone undergoes significant first-pass metabolism resulting in an oral bioavailability of approximately 20%. Although there is an 18% increase in nefazodone bioavailability with food, this increase is not clinically significant and nefazodone can be administered without regard to meals. Three pharmacologically active nefazodone metabolites have been identified: hydroxy-nefazodone, triazoledione and m-chlorophenylpiperazine (mCPP). The pharmacokinetics of nefazodone are nonlinear. The increase in plasma concentrations of nefazodone are greater than would be expected if they were proportional to increases in dose. Steady-state plasma concentrations of nefazodone are attained within 4 days of the commencement of administration. The pharmacokinetics of nefazodone are not appreciably altered in patients with renal or mild-to-moderate hepatic impairment. However, nefazodone plasma concentrations are increased in severe hepatic impairment and in the elderly, especially in elderly females. Lower doses of nefazodone may be necessary in these groups. Nefazodone is a weak inhibitor of cytochrome P450 (CYP) 2D6 and does not inhibit CYP1A2. It is not anticipated that nefazodone will interact with drugs cleared by these isozymes. Indeed, nefazodone did not affect the pharmacokinetics of theophylline, a compound cleared by CYP1A2. Nefazodone is metabolised by and inhibits CYP3A4. Clinically significant interactions have been observed between nefazodone and the benzodiazepines triazolam and alprazolam, cyclosporin and carbamazepine. The potential for a clinically significant interaction between nefazodone and other drugs cleared by CYP3A4 (e.g. terfenadine) should be considered before the coadministration of these compounds. There was an increase in haloperidol plasma concentrations when coadministered with nefazodone; nefazodone pharmacokinetics were not affected after coadministration. No clinically significant interaction was observed when nefazodone was administered with lorazepam, lithium, alcohol, cimetidine, warfarin, theophylline or propranolol. PMID:9342502

  4. [Clinical use of chlorhexidine].

    PubMed

    Figueroa, M; López-Valenzuela, C; Rivera, S

    1990-11-01

    There is a wide variety of literature regarding chlorhexidine, so we have tried to put together the most recent studies in order to apply them to our clinical reality. Chlorhexidine is an excellent alternative which should be considered as the best chemical collaborator available in the market. In order to obtain the best therapeutic effects, chlorhexidine should always be used within a plaque control program administered by a professional. It's the best way to get the best advantages offered by this medicine. PMID:2075271

  5. Managing clinical improvement projects.

    PubMed

    Phillips, Joanna; Simmonds, Lorraine

    This paper, the second of a three-part series looking at change management tools, provides a practical guide on how to use common project management principles in practice. Much of the literature on project management focuses on the business arena, with little reference to clinical settings. Identifying this literature and understanding its relevance to managing projects in healthcare can be difficult. This article provides a practical guide to identifying the key principles of good project management and applying these in health settings. PMID:23697006

  6. [Dyslexia: clinical characteristics].

    PubMed

    Billard, C; Delteil-Pinton, F

    2010-12-01

    Dyslexia is characterized by a severe, persistent reading disorder occurring in an intelligent child. In the large field of learning disabilities, dyslexia is related to a cerebral dysfunction well described with Imagery and genetic studies. Nevertheless the diagnosis of dyslexia cannot be done by another way than clinical symptoms. Optimizing the management of children with dyslexia is a critical issue and is now possible, thanks to the improvement of neurosciences data and the mobilization of the key stakeholders. The knowledge of the precise symptoms is essential in order to lead the child's doctor able to improve coordination and harmonization of teaching and care and guidance of parents. PMID:21074390

  7. [Pulmonary embolectomy. Clinical experience].

    PubMed

    Jaumin, P; Moriau, M; el Gariani, A; Rubay, J; Baele, P; Dautrebande, J; Goenen, M; Servaye-Kestens, Y; Ponlot, R

    1986-01-01

    Between 1969 and 1984, twenty-three patients underwent an emergency pulmonary embolectomy under extracorporeal circulation in the Catholic University of Louvain (UCL), Department of Cardiovascular and Thoracic Surgery. The aim of this paper is to delineate the indications of this procedure. Patients were 23 to 70 years old. Diagnosis of Pulmonary Embolism was made according to clinical signs, ECG and Chest X Ray with Swan-Ganz catheter insertion into the pulmonary artery and the help of pulmonary angiogram if time permitted. The surgical technique is briefly described. Four patients died during the immediate postoperative period and three died later. The sixteen survivors all enjoy a normal life. PMID:3716721

  8. Clinical applications of angiocardiography

    NASA Technical Reports Server (NTRS)

    Dodge, H. T.; Sandler, H.

    1974-01-01

    Several tables are presented giving left ventricular (LV) data for normal patients and patients with heart disease of varied etiologies, pointing out the salient features. Graphs showing LV pressure-volume relationships (compliance) are presented and discussed. The method developed by Rackley et al. (1964) for determining left ventricular mass in man is described, and limitations to the method are discussed. Some clinical methods for determining LV oxygen consumption are briefly described, and the relation of various abnormalities of ventricular performance to coronary artery disease and ischemic heart disease is characterized.

  9. Clinical Issues-March 2016.

    PubMed

    Burlingame, Byron L; Chambers, Kerrie

    2016-03-01

    Increasing ambient room temperature Key words: OR temperature, core temperature, unplanned hypothermia, ambient room temperature, thermoregulation. Clinical alarm management Key words: alarm fatigue, clinical alarms, alert alarms. PMID:26924373

  10. Retail clinics: threat or opportunity?

    PubMed

    Stempniak, Marty

    2013-10-01

    The explosion of retail clinics worries some traditional health care providers. But clinic leaders say far from competing with hospitals and physicians, they're helping to build a care continuum. PMID:24303633

  11. Glossary of Clinical Trials Terms

    MedlinePlus

    ... the Sponsor of a clinical study and the Principal Investigator (PI) that does not allow the PI to ... in a clinical study. Related terms include Site Principal Investigator, Site Sub-Investigator, Study Chair, Study Director, and ...

  12. American Association for Clinical Chemistry

    MedlinePlus

    ... a series of videos about the clinical laboratory tests critical to oncology care. (Image credit: ... showcases the cutting edge science and technology shaping the future of clinical testing and patient ...

  13. Rare Diseases Clinical Research Network

    MedlinePlus

    ... is the RDCRN? Aims of the Rare Diseases Clinical Research Network Contact Us RDCRN Members Login Accessibility Disclaimer The Rare Diseases Clinical Research Network is an initiative of the Office ...

  14. Are Clinical Studies for You?

    MedlinePlus

    ... Contact Us | Site Map | Search The "About the Clinical Center" navigation menu has been enchanced by javascript. ... reach the non-javascript version . The "Participate in Clinical Studies" navigation menu has been enchanced by javascript. ...

  15. Constructing clinical science.

    PubMed

    Gaspare de Santo, Natale; Bisaccia, Carmela; Cirillo, Massimo; Salvatore de Santo, Luca; Richet, Gabriel

    2005-01-01

    Clinical practice became clinical science in the years 1720-1820. There were many reasons for this transformation. The discoveries by Santorio Santorio, William Harvey, Marcello Malpighi, Giovanni Alfonso Borelli, Lorenzo Bellini, Thomas Sydenham, Giovanni Maria Lancisi, were perceived by students who asked for changes in the medical curriculum. In 1761 Morgagni centered the study of diseases on morbid anatomy, a way to control at autopsy the validity of diagnosis. J.P. Frank who worked on public health and John Locke who supported a method of scientific reasoning based on asking questions were also instrumental for changes. Hospitals, formerly hospices for the poor, became places for curing and healing. Military hospitals represented models to be followed. In Vienna Marie Therese inaugurated the Allegemein Krankenhaus in 1785. In revolutionary France Fourcroy with the law Frimaire An III, 1794 gave a new rationale. Medicine and surgery were unified in the curriculum. Basic sciences were introduced. Dissection became compulsory, practical teaching became the rule. But it was with John Hunter, Domenico Cotugno and P. Joseph Desault that the great advancement was achieved. They were anatomists and therefore they made the knowledge of human body the core of medical curriculum. However experimentation on animals, as well as practical bedside teaching at the hospital also became important. Through their work hospitals and universities were associated in a common goal. PMID:16285082

  16. Clinically isolated laryngeal sarcoidosis.

    PubMed

    Plaschke, Christina Caroline; Owen, Hanne Hoejris; Rasmussen, Niels

    2011-04-01

    Laryngeal sarcoidosis is rare (0.5% of patients with sarcoidosis), the pathogenesis is unknown and the optimal treatment remains a matter of debate. We undertook this study to elucidate possible pathogenic factors in clinically isolated laryngeal sarcoidosis and to describe results of supraglottoplastic surgery. From 1995 to 2009, we identified six patients with histologically proven sarcoidosis of the larynx treated at Rigshospitalet. All patients were subjected to a panel of blood tests and MR scan of the head and neck. All patients had dyspnoea at admission, and five were subjected to a combination of CO(2)-laser excision of supraglottic tissue and closure of the incision with sutures. All serological tests were negative or normal, including angiotensin 1 converting enzyme. The clinical expression was uniform with pale, smooth swellings of the supraglottic structures. Surgery proved successful to maintain normal breathing. None of the many parameters examined--some previously having been found to be abnormal in sarcoidosis--were abnormal in the present cohort. We are therefore unable to elucidate the pathogenesis. The combined surgical approach re-established normal airway function for all five patients and complete remission without further swellings was seen in two patients. PMID:21132317

  17. Ethics and clinical trials.

    PubMed

    Chassany, O; Duracinsk, M

    1999-01-01

    The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not. PMID:10456284

  18. Thiamin in Clinical Practice.

    PubMed

    Frank, Laura L

    2015-07-01

    Thiamin is a water-soluble vitamin also known as vitamin B1. Its biologically active form, thiamin pyrophosphate (TPP), is a cofactor in macronutrient metabolism. In addition to its coenzyme roles, TPP plays a role in nerve structure and function as well as brain metabolism. Signs and symptoms of thiamin deficiency (TD) include lactic acidosis, peripheral neuropathy, ataxia, and ocular changes (eg, nystagmus). More advanced symptoms include confabulation and memory loss and/or psychosis, resulting in Wernicke's encephalopathy and/or Wernicke's Korsakoff syndrome, respectively. The nutrition support clinician should be aware of patients who may be at risk for TD. Risk factors include those patients with malnutrition due to 1 or more nutrition-related etiologies: decreased nutrient intake, increased nutrient losses, or impaired nutrient absorption. Clinical scenarios such as unexplained heart failure or lactic acidosis, renal failure with dialysis, alcoholism, starvation, hyperemesis gravidarum, or bariatric surgery may increase the risk for TD. Patients who are critically ill and require nutrition support may also be at risk for TD, especially those who are given intravenous dextrose void of thiamin repletion. Furthermore, understanding thiamin's role as a potential therapeutic agent for diabetes, some inborn errors of metabolism, and neurodegenerative diseases warrants further research. This tutorial describes the absorption, digestion, and metabolism of thiamin. Issues pertaining to thiamin in clinical practice will be described, and evidence-based practice suggestions for the prevention and treatment of TD will be discussed. PMID:25564426

  19. Naltrexone: its clinical utility.

    PubMed

    Ginzburg, H M

    Naltrexone is a long-acting orally-administered opioid antagonist that has demonstrated clinical utility as an adjunct in the outpatient treatment of opioid abuse. Naltrexone can be administered on a daily, twice a week or three times a week regimen, based on the clinical needs of the patient, and the therapeutic goals of the patient and therapist. Because naltrexone is unscheduled under the Controlled Substances Act, any licensed physician can prescribe this drug. This decentralized therapeutic approach for the highly motivated patient permits a ready separation between the patient's drug using friends and his or her current activities. The patients most likely to benefit from naltrexone therapy are employed, married, stabilized on low-dose methadone prior to detoxification, or detoxified from their opioid dependency 7 or more days previously, and are highly motivated to be maintained on a nonopioid chemotherapeutic agent. Naltrexone does not cure dependency. It does assist clinicians in dealing with the medical, psychological and economic problems associated with primary opioid abuse. Naltrexone will work well only when it is part of a larger therapeutic regimen which is tailored to the individual needs of the patient. PMID:3832903

  20. Clinical application of magnetocardiography.

    PubMed

    Fenici, Riccardo; Brisinda, Donatella; Meloni, Anna Maria

    2005-05-01

    Magnetocardiography is a noninvasive contactless method to measure the magnetic field generated by the same ionic currents that create the electrocardiogram. The time course of magnetocardiographic and electrocardiographic signals are similar. However, compared with surface potential recordings, multichannel magnetocardiographic mapping (MMCG) is a faster and contactless method for 3D imaging and localization of cardiac electrophysiologic phenomena with higher spatial and temporal resolution. For more than a decade, MMCG has been mostly confined to magnetically shielded rooms and considered to be at most an interesting matter for research activity. Nevertheless, an increasing number of papers have documented that magnetocardiography can also be useful to improve diagnostic accuracy. Most recently, the development of standardized instrumentations for unshielded MMCG, and its ease of use and reliability even in emergency rooms has triggered a new interest from clinicians for magnetocardiography, leading to several new installations of unshielded systems worldwide. In this review, clinical applications of magnetocardiography are summarized, focusing on major milestones, recent results of multicenter clinical trials and indicators of future developments. PMID:15934809

  1. Biomedical Knowledge and Clinical Expertise.

    ERIC Educational Resources Information Center

    Boshuizen, Henny P. A.; Schmidt, Henk G.

    A study examined the application and availability of clinical and biomedical knowledge in the clinical reasoning of physicians as well as possible mechanisms responsible for changes in the organization of clinical and biomedical knowledge in the development from novice to expert. Subjects were 28 students (10 second year, 8 fourth year, and 10…

  2. Gateways to clinical trials.

    PubMed

    Tomillero, A; Moral, M A

    2008-09-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com.This issue focuses on the following selection of drugs: ABT-263, AC-2307, Aclidinium bromide, Adefovir dipivoxil, ADH-1, Agatolimod sodium, Alefacept, Aliskiren fumarate, Aminolevulinic acid methyl ester, Anakinra, Apaziquone, Aprepitant, Aripiprazole, ASM-8, Atiprimod hydrochloride, AVE-0277, AVE-1642, AVE-8062, Axitinib, Azacitidine, AZD-0530; Bazedoxifene acetate, Bevacizumab, Bexarotene, BI-2536, Biphasic insulin aspart, BMS-387032, BMS-663513, Bortezomib, BQ-123, Brivanib alaninate, BSI-201; Caspofungin acetate, CDX-110, Cetuximab, Ciclesonide, CR-011, Cypher; Daptomycin, Darbepoetin alfa, Dasatinib, Decitabine, Deferasirox, Denosumab, Dexlansoprazole, Dexmethylphenidate hydrochloride, DNA-Hsp65 vaccine, Dovitinib, Drotrecogin alfa (activated), DTaP-HBV-IPV/Hibvaccine, DTaP-IPV-HB-PRP-T, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Elacytarabine, Emtricitabine, Endothelin, Entecavir, Eplivanserin fumarate, Escitalopram oxalate, Everolimus, Ezetimibe, Ezetimibe/simvastatin; Farletuzumab, Fesoterodine fumarate, Fibrin sealant (human), Fulvestrant; Gefitinib, Gemtuzumab ozogamicin, Glufosfamide, GSK-1562902A; Hib-TT; Imatinib mesylate, IMC-11F8, Imidazoacridinone, IMP-321, INCB-18424, Indiplon, Indisulam, INNO-406, Irinotecan hydrochloride/Floxuridine, ITF-2357, Ixabepilone; KRN-951; Lasofoxifene tartrate; Lenalidomide, LGD-4665, Lonafarnib, Lubiprostone, Lumiliximab; MDX-1100, Melan-A/MART-1/gp100/IFN-alfa, Methyl-CDDO, Metreleptin, MLN-2704, Mycophenolic acid sodium salt; Na-ASP-2, Naproxcinod, Nilotinib hydrochloride monohydrate, NPI-2358; Oblimersen sodium, Odanacatib; Paclitaxel nanoparticles, PAN-811, Panobinostat, PBI-1402, PC-515, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Perillyl alcohol, Perphenazine 4-aminobutyrate, PeviPRO/breast cancer, PF-03814735, PHA-739358, Pimecrolimus, Plitidepsin, Posaconazole, Prasterone, Prasugrel, Pregabalin, Prucalopride, PRX-08066; rAAV2-TNFR:Fc, Ranelic acid distrontium salt, Ranibizumab, rCD154-CLL, Retapamulin, RTS,S/SBAS2, rV-PSA-TRICOM/rF-PSA-TRICOM; SG-2000, Sinecatechins, Sirolimus-eluting stent, Sorafenib, SP-1640, Strontium malonate, Succinobucol, Sunitinib malate; Taxus, Teduglutide, Telavancin hydrochloride, Telbivudine, Telmisartan/hydrochlorothiazide, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate/emtricitabine, Tocilizumab; Ustekinumab; V-5 Immunitor, Voriconazole, Vorinostat; Xience V, XL-184, XL-647, XL-765; Y-39983, Zibotentan. PMID:18985183

  3. Clinical pharmacokinetics of oxcarbazepine.

    PubMed

    May, Theodor W; Korn-Merker, Elisabeth; Rambeck, Bernhard

    2003-01-01

    Oxcarbazepine is an antiepileptic drug with a chemical structure similar to carbamazepine, but with different metabolism. Oxcarbazepine is rapidly reduced to 10,11-dihydro-10-hydroxy-carbazepine (monohydroxy derivative, MHD), the clinically relevant metabolite of oxcarbazepine. MHD has (S)-(+)- and the (R)-(-)-enantiomer, but the pharmacokinetics of the racemate are usually reported. The bioavailability of the oral formulation of oxcarbazepine is high (>95%). It is rapidly absorbed after oral administration, reaching peak concentrations within about 1-3 hours after a single dose, whereas the peak of MHD occurs within 4-12 hours. At steady state, the peak of MHD occurs about 2-4 hours after drug intake. The plasma protein binding of MHD is about 40%. Cerebrospinal fluid concentrations of MHD are in the same range as unbound plasma concentrations of MHD. Oxcarbazepine can be transferred significantly through the placenta in humans. Oxcarbazepine and MHD exhibit linear pharmaco-kinetics and no autoinduction occurs. Elimination half-lives in healthy volunteers are 1-5 hours for oxcarbazepine and 7-20 hours for MHD. Longer and shorter elimination half-lives have been reported in elderly volunteers and children, respectively. Mild to moderate hepatic impairment does not appear to affect MHD pharmacokinetics. Renal impairment affects the pharmacokinetics of oxcarbazepine and MHD. The interaction potential of oxcarbazepine is relatively low. However, enzyme-inducing antiepileptic drugs such as phenytoin, phenobarbital or carbamazepine can reduce slightly the concentrations of MHD. Verapamil may moderately decrease MHD concentrations, but this effect is probably without clinical relevance. The influence of oxcarbazepine on other antiepileptic drugs is not clinically relevant in most cases. However, oxcarbazepine appears to increase concentrations of phenytoin and to decrease trough concentrations of lamotrigine and topiramate. Oxcarbazepine lowers concentrations of ethinylestra-diol and levonorgestrel, and women treated with oxcarbazepine should consider additional contraceptive measures. Due to the absent or lower enzyme-inducing effect of oxcarbazepine, switching from carbamazepine to oxcarbazepine can result in increased serum concentrations of comedication, sometimes associated with adverse effects. The effect of oxcarbazepine appears to be related to dose and to serum concentrations of MHD. In general, daily fluctuations of MHD concentration are relatively slight, smaller than would be expected from the elimination half-life of MHD. However, relatively high fluctuations can be observed in individual patients. Therapeutic monitoring may help to decide whether adverse effects are dependent on MHD concentrations. A mean therapeutic range of 15-35 mg/L for MHD seems to be appropriate. However, more systematic studies exploring the concentration-effect relationship are required. PMID:12959634

  4. Contextual and temporal clinical guidelines.

    PubMed Central

    Guarnero, A.; Marzuoli, M.; Molino, G.; Terenziani, P.; Torchio, M.; Vanni, K.

    1998-01-01

    In this paper, we propose an approach for managing clinical guidelines. We sketch a modular architecture, allowing us to separate conceptually distinct aspects in the management and use of clinical guidelines. In particular, we describe the clinical guidelines knowledge representation module and we sketch the acquisition module. The main focus of the paper is the definition of an expressive formalism for representing clinical guidelines, which allows one to deal with the context dependent character of clinical guidelines and takes into account different temporal aspects. PMID:9929306

  5. Neurogenic neuroprotection: clinical perspectives

    PubMed Central

    Mandel, Mauricio; Fonoff, Erich Talamoni; Bor-Seng-Shu, Edson; Teixeira, Manoel Jacobsen; Chadi, Gerson

    2012-01-01

    Summary Neurogenic neuroprotection is a promising approach for treating patients with ischemic brain lesions. In rats, stimulation of the deep brain nuclei has been shown to reduce the volume of focal infarction. In this context, protection of neural tissue can be a rapid intervention that has a relatively long-lasting effect, making fastigial nucleus stimulation (FNS) a potentially valuable method for clinical application. Although the mechanisms of neuroprotection induced by FNS remain partially unclear, important data have been presented in the last two decades. A 1-h electrical FNS reduced, by 59%, infarctions triggered by permanent occlusion of the middle cerebral artery in Fisher rats. The acute effect of electrical FNS is likely mediated by a prolonged opening of potassium channels, and the sustained effect appears to be linked to inhibition of the apoptotic cascade. A better understanding of the neuronal circuitry underlying neurogenic neuroprotection may contribute to improving neurological outcomes in ischemic brain insults. PMID:23597434

  6. Clinical radiation nephropathy

    SciTech Connect

    Cassady, J.R.

    1995-03-30

    An analysis of the normal tissue effects of irradiation of the kidney is presented. Various clinical syndromes resulting from treatment are described as well as the potential cellular basis for these findings. Effects of concurrent and/or sequential treatment with irradiation and various chemotherapeutic agents are discussed and the impact of these agents on toxicity presented. Adverse consequences of renal treatment in the child is described and possible radiation effects on so-called compensatory hypertrophy following nephrectomy presented. Renal consequences described to date of bone marrow transplantation programs utilizing irradiation are also presented. The necessity of a dose-volume histogram analysis approach to analyzing renal toxic effects in patients followed for long (>10 year) periods is essential in developing accurate guidelines of renal tolerance. 53 refs., 6 figs., 5 tabs.

  7. Clinical techniques of invertebrates.

    PubMed

    Braun, Matthew E; Heatley, J Jill; Chitty, John

    2006-05-01

    This article highlights techniques and equipment needed to successfully restrain, diagnose, and treat gastropods (including snails and slugs) and arthropods (including spiders, scorpions, honey-bees, cockroaches, silkworms, phasmids, centipedes, and millipedes). A review of current clinical techniques for invertebrates kept as pets and those kept for agricultural use is provided. The specific techniques of restraint, assessment of hydration, fluid therapy, diagnostic sampling, imaging, exoskeleton repair, ectoparasite control and removal, euthanasia, and postmortem examination are reviewed for use in the invertebrate patient. The authors intend this article to stimulate further research and reporting on appropriate and humane techniques for use in these species and to increase the ability of the veterinary practitioner to successfully attend to these animals. PMID:16759944

  8. Comfrey: A Clinical Overview

    PubMed Central

    Staiger, Christiane

    2012-01-01

    Comfrey has a centuries-old tradition as a medicinal plant. Today, multiple randomized controlled trials have demonstrated the efficacy and safety of comfrey preparations for the topical treatment of pain, inflammation and swelling of muscles and joints in degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 or 4 and over. This paper provides information on clinical trials and non-interventional studies published on comfrey to date and further literature, substantiating the fact that topical comfrey preparations are a valuable therapy option for the treatment of painful muscle and joint complaints. Copyright © 2012 John Wiley & Sons, Ltd. PMID:22359388

  9. Clinical risk modification.

    PubMed

    Wilson, J

    Claims for compensation in cases of clinical negligence have risen dramatically in recent years. The implementation of the NHS reforms, with greater clarity of roles and responsibilities and the emphasis on devolving decision-making as close to the patient as possible, is meant to affect the entire performance of healthcare delivery. For most senior managers and clinicians, the environment in which they operate has grown increasingly turbulent and complex. Both purchasers and providers of health care want the best and most effective and efficient care. The cost and quality of care are components in determining the value of health care delivered, and both are elements of healthcare risk. To begin to manage these elements of risk, the process of healthcare risk modification can be applied. Healthcare risk modification provides the best service for patients through obtaining a synergy between risk management, quality and the law. PMID:9370571

  10. Updating clinical endpoint definitions

    PubMed Central

    Hassoun, Paul M.; Nikkho, Sylvia; Rosenzweig, Erika B.; Moreschi, Gail; Lawrence, John; Teeter, John; Meier, Christian; Ghofrani, Ardeshir H.; Minai, Omar; Rinaldi, Paula; Michelakis, Evangelos; Oudiz, Ronald J

    2013-01-01

    The 6-Minute Walk Distance (6-MWD) has been the most utilized endpoint for judging the efficacy of pulmonary arterial hypertension (PAH) therapy in clinical trials conducted over the past two decades. Despite its simplicity, widespread use in recent trials and overall prognostic value, the 6-MWD has often been criticized over the past several years and pleas from several PAH experts have emerged from the literature to find alternative endpoints that would be more reliable in reflecting the pulmonary vascular resistance as well as cardiac status in PAH and their response to therapy. A meeting of PAH experts and representatives from regulatory agencies and pharmaceutical companies was convened in early 2012 to discuss the validity of current as well as emerging valuable endpoints. The current work represents the proceedings of the conference. PMID:23662199

  11. [Nomegestrol acetate: clinical pharmacology].

    PubMed

    Lello, S

    2009-10-01

    Progestogens are used in clinical practice in some conditions. Their effects depend on their chemical structure, pharmacokinetics, pharmacodynamics, with important differences among various progestogens. Generally, progestins are classified according to their parent molecule, of which often they keep some features. Derivatives of 19-nor-progesterone are characterized by high selectivity of action on progestin receptor. In particular, nomegestrol acetate (NomAc) shows an important progestational potency, neutral gluco-lipid profile, and antigonadotropic activity. It is used for treating menstrual cycle disorders and for hormone replacement therapy in menopause in association with an estrogen. In future, thanks to its antigonadotropic activity, NomAc will be used in estroprogestin combinations in fertile women, thus taking advantage of its tolerability profile and obtaining numerous non-contraceptive benefits as well. PMID:19749678

  12. [Anamnesis and clinical examination].

    PubMed

    Grüne, Stefan

    2016-01-01

    Anamnesis and clinical examination are the key functions of medical doctors to reveal the health problems of their patients. The correct assessment and handoff of these informations are the preconditions for a specific and cost saving diagnostic and therapy. The handoff can be made orally, in written form analogue or digital. The examination and documentation should be conducted in the order specified for every patient to avoid mistakes. New digital programs help to reach this aim but absorb the time of the medical doctor and depart him from the patients. Nurses and medical doctors should perform the rounds together for a mutually acquisition of information. This conduces towards a single-minded and cost-effectively diagnostic and therapy. PMID:26710199

  13. Venomous animals: clinical toxinology.

    PubMed

    White, Julian

    2010-01-01

    Venomous animals occur in numerous phyla and present a great diversity of taxa, toxins, targets, clinical effects and outcomes. Venomous snakes are the most medically significant group globally and may injure >1.25 million humans annually, with up to 100 000 deaths and many more cases with long-term disability. Scorpion sting is the next most important cause of envenoming, but significant morbidity and even deaths occur following envenoming with a wide range of other venomous animals, including spiders, ticks, jellyfish, marine snails, octopuses and fish. Clinical effects vary with species and venom type, including local effects (pain, swelling, sweating, blistering, bleeding, necrosis), general effects (headache, vomiting, abdominal pain, hypertension, hypotension, cardiac arrhythmias and arrest, convulsions, collapse, shock) and specific systemic effects (paralytic neurotoxicity, neuroexcitatory neurotoxicity, myotoxicity, interference with coagulation, haemorrhagic activity, renal toxicity, cardiac toxicity). First aid varies with organism and envenoming type, but few effective first aid methods are recommended, while many inappropriate or frankly dangerous methods are in widespread use. For snakebite, immobilisation of the bitten limb, then the whole patient is the universal method, although pressure immobilisation bandaging is recommended for bites by non-necrotic or haemorrhagic species. Hot water immersion is the most universal method for painful marine stings. Medical treatment includes both general and specific measures, with antivenom being the principal tool in the latter category. However, antivenom is available only for a limited range of species, not for all dangerous species, is in short supply in some areas of highest need, and in many cases, is supported by historical precedent rather than modern controlled trials. PMID:20358686

  14. Evidence and Clinical Trials.

    NASA Astrophysics Data System (ADS)

    Goodman, Steven N.

    1989-11-01

    This dissertation explores the use of a mathematical measure of statistical evidence, the log likelihood ratio, in clinical trials. The methods and thinking behind the use of an evidential measure are contrasted with traditional methods of analyzing data, which depend primarily on a p-value as an estimate of the statistical strength of an observed data pattern. It is contended that neither the behavioral dictates of Neyman-Pearson hypothesis testing methods, nor the coherency dictates of Bayesian methods are realistic models on which to base inference. The use of the likelihood alone is applied to four aspects of trial design or conduct: the calculation of sample size, the monitoring of data, testing for the equivalence of two treatments, and meta-analysis--the combining of results from different trials. Finally, a more general model of statistical inference, using belief functions, is used to see if it is possible to separate the assessment of evidence from our background knowledge. It is shown that traditional and Bayesian methods can be modeled as two ends of a continuum of structured background knowledge, methods which summarize evidence at the point of maximum likelihood assuming no structure, and Bayesian methods assuming complete knowledge. Both schools are seen to be missing a concept of ignorance- -uncommitted belief. This concept provides the key to understanding the problem of sampling to a foregone conclusion and the role of frequency properties in statistical inference. The conclusion is that statistical evidence cannot be defined independently of background knowledge, and that frequency properties of an estimator are an indirect measure of uncommitted belief. Several likelihood summaries need to be used in clinical trials, with the quantitative disparity between summaries being an indirect measure of our ignorance. This conclusion is linked with parallel ideas in the philosophy of science and cognitive psychology.

  15. Gateways to clinical trials.

    PubMed

    Tomillero, A; Moral, M A

    2008-10-01

    Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar, Taurine, Tecovirimat, Telatinib, Telavancin hydrochloride, Telcagepant, Terameprocol, Tesofensine, Tetrodotoxin, Tezampanel, Tipifarnib, TPI-287, Tremelimumab; Valspodar, Vatalanib succinate, VCL-CB01, vCP1452, Vorinostat; XL-228; Ziprasidone hydrochloride. PMID:19088949

  16. Clinical decision support systems.

    PubMed

    Beeler, Patrick Emanuel; Bates, David Westfall; Hug, Balthasar Luzius

    2014-01-01

    Clinical decision support (CDS) systems link patient data with an electronic knowledge base in order to improve decision-making and computerised physician order entry (CPOE) is a requirement to set up electronic CDS. The medical informatics literature suggests categorising CDS tools into medication dosing support, order facilitators, point-of-care alerts and reminders, relevant information display, expert systems and workflow support. To date, CDS has particularly been recognised for improving processes. CDS successfully fostered prevention of deep-vein thrombosis, improved adherence to guidelines, increased the use of vaccinations, and decreased the rate of serious medication errors. However, CDS may introduce errors, and therefore the term "e-iatrogenesis" has been proposed to address unintended consequences. At least two studies reported severe treatment delays due to CPOE and CDS. In addition, the phenomenon of "alert fatigue" - arising from a high number of CDS alerts of low clinical significance - may facilitate overriding of potentially critical notifications. The implementation of CDS needs to be carefully planned, CDS interventions should be thoroughly examined in pilot wards only, and then stepwise introduced. A crucial feature of CPOE in combination with CDS is speed, since time consumption has been found to be a major factor determining failure. In the near future, the specificity of alerts will be improved, notifications will be prioritised and offer detailed advice, customisation of CDS will play an increasing role, and finally, CDS is heading for patient-centred decision support. The most important research question remains whether CDS is able to improve patient outcomes beyond processes. PMID:25668157

  17. Clinical Reasoning Terms Included in Clinical Problem Solving Exercises?

    PubMed

    Musgrove, John L; Morris, Jason; Estrada, Carlos A; Kraemer, Ryan R

    2016-05-01

    Background Published clinical problem solving exercises have emerged as a common tool to illustrate aspects of the clinical reasoning process. The specific clinical reasoning terms mentioned in such exercises is unknown. Objective We identified which clinical reasoning terms are mentioned in published clinical problem solving exercises and compared them to clinical reasoning terms given high priority by clinician educators. Methods A convenience sample of clinician educators prioritized a list of clinical reasoning terms (whether to include, weight percentage of top 20 terms). The authors then electronically searched the terms in the text of published reports of 4 internal medicine journals between January 2010 and May 2013. Results The top 5 clinical reasoning terms ranked by educators were dual-process thinking (weight percentage = 24%), problem representation (12%), illness scripts (9%), hypothesis generation (7%), and problem categorization (7%). The top clinical reasoning terms mentioned in the text of 79 published reports were context specificity (n = 20, 25%), bias (n = 13, 17%), dual-process thinking (n = 11, 14%), illness scripts (n = 11, 14%), and problem representation (n = 10, 13%). Context specificity and bias were not ranked highly by educators. Conclusions Some core concepts of modern clinical reasoning theory ranked highly by educators are mentioned explicitly in published clinical problem solving exercises. However, some highly ranked terms were not used, and some terms used were not ranked by the clinician educators. Effort to teach clinical reasoning to trainees may benefit from a common nomenclature of clinical reasoning terms. PMID:27168884

  18. Guidelines for School-Based Clinics.

    ERIC Educational Resources Information Center

    Center for Population Options, Washington, DC.

    The school-based clinic is a primary health care facility located within or on the campus of a public school. The suggested requirements for a school-based clinic are enumerated in five sections dealing with: (1) clinic organization; (2) clinic staff; (3) clinic services; (4) clinic recordkeeping and evaluation; and (5) clinic facilities and…

  19. Clinical significance of translocation.

    PubMed Central

    Van Leeuwen, P A; Boermeester, M A; Houdijk, A P; Ferwerda, C C; Cuesta, M A; Meyer, S; Wesdorp, R I

    1994-01-01

    The gastrointestinal tract, besides being the organ responsible for nutrient absorption, is also a metabolic and immunological system, functioning as an effective barrier against endotoxin and bacteria in the intestinal lumen. The passage of viable bacteria from the gastrointestinal tract through the epithelial mucosa is called bacterial translocation. Equally important may be the passage of bacterial endotoxin through the mucosal barrier. This article reviews the evidence that translocation of both endotoxin and bacteria is of clinical significance. It summarises recent published works indicating that translocation of endotoxin in minute amounts is a physiological important phenomenon to boost the reticuloendothelial system (RES), especially the Kupffer cells, in the liver. Breakdown of both the mucosal barrier and the RES capacity results in systemic endotoxaemia. Systemic endotoxaemia results in organ dysfunction, impairs the mucosal barrier, the clotting system, the immune system, and depresses Kupffer cell function. If natural defence mechanisms such as lipopolysaccharide binding protein, high density lipoprotein, in combination with the RES, do not respond properly, dysfunction of the gut barrier results in bacterial translocation. Extensive work on bacterial translocation has been performed in animal models and occurs notably in haemorrhagic shock, thermal injury, protein malnutrition, endotoxaemia, trauma, and intestinal obstruction. It is difficult to extrapolate these results to humans and its clinical significance is not clear. The available data show that the resultant infection remains important in the development of sepsis, especially in the critically ill patient. Uncontrolled infection is, however, neither necessary nor sufficient to account for the development of multiple organ failure. A more plausible sequelae is that bacterial translocation is a later phenomenon of multiple organ failure, and not its initiator. It is hypothesized that multiple organ failure is more probably triggered by the combination of tissue damage and systemic endotoxaemia. Endotoxaemia, as seen in trauma patients especially during the first 24 hours, in combination with tissue elicits a systemic inflammation, called Schwartzmann reaction. Interferon gamma, a T cell produced cytokine, is thought to play a pivotal part in the pathogenesis of this reaction. This reaction might occur only if the endotoxin induced cytokines like tumour necrosis factor and interleukin 1, act on target cells prepared by interferon gamma. After exposure to interferon gamma target cells become more sensitive to stimuli like endotoxin, thus boosting the inflammatory cycle. Clearly, following this line of reasoning, minor tissue damage or retroperitoneal haematoma combined with systemic endotoxaemia could elicit this reaction. The clinically observed failure of multiple organ systems might thus be explained by the interaction of tissue necrosis and high concentrations of endotoxin because of translocation. Future therapeutic strategies could therefore focus more on binding endotoxin in the gut before the triggering event, for example before major surgery. Such a strategy could be combined with the start of early enteral feeding, which has been shown in animal studies to have a beneficial effect on intestinal mucosal barrier function and in traumatized patients to reduce the incidence of septic complications. PMID:8125386

  20. An Opportunity to Bridge the Gap Between Clinical Research and Clinical Practice: Implications for Clinical Training

    PubMed Central

    Hershenberg, Rachel; Drabick, Deborah A. G.; Vivian, Dina

    2013-01-01

    Clinical researchers and clinical practitioners share a goal of increasing the integration of research and clinical practice, which is reflected in an evidence-based practice (EBP) approach to psychology. The EBP framework involves the integration of research findings with clinical expertise and client characteristics, values, and preferences, and consequently provides an important foundation for conducting clinically relevant research, as well as empirically based and clinically sensitive practice. Given the critical role that early training can play in the integration of science and practice and in promoting the future of the field, the present article addresses predoctoral training programs as a context for adopting an EBP approach to clinical work. We address training in the three components of EBP and provide suggestions for curriculum development and practicum training that we hope will contribute to bridging the gap between research and practice. PMID:22642520

  1. Clinical Practice. Postmenopausal Osteoporosis.

    PubMed

    Black, Dennis M; Rosen, Clifford J

    2016-01-21

    Key Clinical Points Postmenopausal Osteoporosis Fractures and osteoporosis are common, particularly among older women, and hip fractures can be devastating. Treatment is generally recommended in postmenopausal women who have a bone mineral density T score of -2.5 or less, a history of spine or hip fracture, or a Fracture Risk Assessment Tool (FRAX) score indicating increased fracture risk. Bisphosphonates (generic) and denosumab reduce the risk of hip, nonvertebral, and vertebral fractures; bisphosphonates are commonly used as first-line treatment in women who do not have contraindications. Teriparatide reduces the risk of nonvertebral and vertebral fractures. Osteonecrosis of the jaw and atypical femur fractures have been reported with treatment but are rare. The benefit-to-risk ratio for osteoporosis treatment is strongly positive for most women with osteoporosis. Because benefits are retained after discontinuation of alendronate or zoledronic acid, drug holidays after 5 years of alendronate therapy or 3 years of zoledronic acid therapy may be considered for patients at lower risk for fracture. PMID:26789873

  2. Clinical pharmacokinetics of moricizine.

    PubMed

    Siddoway, L A; Schwartz, S L; Barbey, J T; Woosley, R L

    1990-02-20

    Moricizine is well absorbed after oral administration and undergoes extensive first-pass metabolism. The drug has a large apparent volume of distribution (approximately 4 liters/kg), exhibits extensive plasma protein binding (approximately 95%) and produces at least 30 metabolites. Indirect evidence indicates that some of those metabolites may be pharmacologically active. The elimination half-life of moricizine is 2 to 6 hours, but its duration of antiarrhythmic action is much longer suggesting active metabolites. Moricizine induces its own metabolism with no change in pharmacologic effect. It also induces the metabolism of theophylline and specific pathways of antipyrine. Cimetidine reduces metabolism of moricizine but does not alter its pharmacologic effects. This observation provides further support for the hypothesis that the metabolites of moricizine contribute to the pharmacologic actions during therapy and indicate that plasma level monitoring is not likely to be of value. There are no known clinically significant pharmacokinetic interactions between moricizine and digoxin, warfarin or propranolol. Excessive prolongation of the PR interval has been seen in some patients receiving both digoxin and moricizine, probably due to additive electrophysiologic effects of the 2 drugs. PMID:2407090

  3. Overview of Clinical Cytogenetics.

    PubMed

    Gonzales, Patrick R; Carroll, Andrew J; Korf, Bruce R

    2016-01-01

    Chromosome analysis is one of the first approaches to genetic testing and remains a key component of genetic analysis of constitutional and somatic genetic disorders. Numerical or unbalanced structural chromosome abnormalities usually lead to multiple congenital anomalies. Sometimes these are compatible with live birth, usually resulting in severe cognitive and physical handicaps; other times they result in miscarriage or stillbirth. Chromosome rearrangements also occur as somatic changes in malignancies. Identification of constitutional chromosomal anomalies (anomalies present in most or all cells of the body and/or the germline) can provide important information for genetic counseling. In this unit, we introduce chromosomal microarray analysis (CMA), which is a relatively recent addition to cytogenetic technologies, and has become the recommended first-tier testing method for patients with developmental delay, intellectual disability, autism, and/or multiple congenital anomalies. We also discuss non-invasive prenatal testing/screening (NIPTS), which uses circulating cell-free fetal DNA (cfDNA) from maternal plasma to rapidly screen for autosomal and sex-chromosome aneuploidies. Cytogenetic analysis of tumors is helpful in diagnosis and in monitoring the effects of treatment. The protocols in this chapter cover the clinical study of chromosomes in nonmalignant tissues. © 2016 by John Wiley & Sons, Inc. PMID:27037488

  4. Clinical definition of sarcopenia

    PubMed Central

    Santilli, Valter; Bernetti, Andrea; Mangone, Massimiliano; Paoloni, Marco

    2014-01-01

    Summary Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Although it is primarily a disease of the elderly, its development may be associated with conditions that are not exclusively seen in older persons. Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength and it is strictly correlated with physical disability, poor quality of life and death. Risk factors for sarcopenia include age, gender and level of physical activity. In conditions such as malignancy, rheumatoid arthritis and aging, lean body mass is lost while fat mass may be preserved or even increased. The loss in muscle mass may be associated with increased body fat so that despite normal weight there is marked weakness, this is a condition called sarcopenic obesity. There is an important correlation between inactivity and losses of muscle mass and strength, this suggests that physical activity should be a protective factor for the prevention but also the management of sarcopenia. Furthermore one of the first step to be taken for a person with sarcopenia or clinical frailty is to ensure that the sarcopenic patient is receiving correct and sufficient nutrition. Sarcopenia has a greater effect on survival. It should be important to prevent or postpone as much as possible the onset of this condition, to enhance survival and to reduce the demand for long-term care. Interventions for sarcopenia need to be developed with most attention on exercise and nutritional interventions. PMID:25568649

  5. Pediatric DXA: clinical applications

    PubMed Central

    Sparke, Paul; Henwood, Maria J.

    2007-01-01

    Normal bone mineral accrual requires adequate dietary intake of calcium, vitamin D and other nutrients; hepatic and renal activation of vitamin D; normal hormone levels (thyroid, parathyroid, reproductive and growth hormones); and neuromuscular functioning with sufficient stress upon the skeleton to induce bone deposition. The presence of genetic or acquired diseases and the therapies that are used to treat them can also impact bone health. Since the introduction of clinical DXA in pediatrics in the early 1990s, there has been considerable investigation into the causes of low bone mineral density (BMD) in children. Pediatricians have also become aware of the role adequate bone mass accrual in childhood has in preventing osteoporotic fractures in late adulthood. Additionally, the availability of medications to improve BMD has increased with the development of bisphosphonates. These factors have led to the increased utilization of DXA in pediatrics. This review summarizes much of the previous research regarding BMD in children and is meant to assist radiologists and clinicians with DXA utilization and interpretation. PMID:17431606

  6. Clinical management of pruritus.

    PubMed

    Ständer, Sonja; Zeidler, Claudia; Magnolo, Nina; Raap, Ulrike; Mettang, Thomas; Kremer, Andreas E; Weisshaar, Elke; Augustin, Matthias

    2015-02-01

    The care of patients with chronic pruritus as a symptom of a wide variety of underlying diseases continues to confront dermatologists with diagnostic and therapeutic challenges. However, a structured history and a physical examination may already substantially help in narrowing down the number of potential differential diagnoses. Apart form reducing the intensity of pruritus, identification and appropriate treatment of the underlying disease are important needs of patients. If these goals doesn't lead to improvement of itch, current guidelines provide a number of topical and systemic therapies for symptomatic treatment. Various skin lesions (for example, xerosis caused by irritant substances, secondary scratch lesions) prompt patients to consult a dermatologist, but most cases require an interdisciplinary therapeutic approach to identify potential internal medicine, neurologic, or psychosomatic aspects. Although great strides have been made in basic research, specific therapies are still rare, and a precise knowledge of the legal framework for the implementation of guidelines (for example, off-label use) is essential. This CME article gives an overview of the causes of and treatment options for chronic pruritus and discusses both advances in basic research as well as progress in clinical knowledge. PMID:25631127

  7. Clinical biochemistry of aluminum

    SciTech Connect

    King, S.W.; Savory, J.; Wills, M.R.

    1981-05-01

    Aluminum toxicity has been implicated in the pathogenesis of a number of clinical disorders in patients with chronic renal failure on long-term intermittent hemodialysis treatment. The predominant disorders have been those involving either bone (osteomalacic dialysis osteodystrophy) or brain (dialysis encephalopathy). In nonuremic patients, an increased brain aluminum concentration has been implicated as a neurotoxic agent in the pathogenesis of Alzheimer's disease and was associated with experimental neurofibrillary degeneration in animals. The brain aluminum concentrations of patients dying with the syndrome of dialysis encephalopathy (dialysis dementia) are significantly higher than in dialyzed patients without the syndrome and in nondialyzed patients. Two potential sources for the increased tissue content of aluminum in patients on hemodialysis have been proposed: (1) intestinal absorption from aluminum containing phosphate-binding gels, and (2) transfer across the dialysis membrane from aluminum in the water used to prepare the dialysate. These findings, coupled with our everyday exposure to the ubiquitous occurrence of aluminum in nature, have created concerns over the potential toxicity of this metal.

  8. CLINICAL POTASSIUM PROBLEMS

    PubMed Central

    Martin, Helen Eastman; Wertman, Maxine; Westover, Leola; Simonsen, D. G.; Mehl, John W.

    1950-01-01

    Alterations in serum potassium are common in many diseases. In a series of 390 determinations of serum potassium, the levels found were low in 24 per cent and high in 2.6 per cent. The major causes of low serum potassium are (1) decreased potassium intake due to intravenous feedings which do not contain potassium; (2) increased loss of potassium in the urine due to accelerated tissue breakdown, or renal lesions; (3) loss from the gastrointestinal tract due to diarrhea, or fistulae, and (4) shift between serum and cells, due to metabolic causes, drugs or changes in pH. The major cause of high serum potassium is uremia with renal retention. Clinical symptoms and signs of low body potassium include muscle weakness and paralysis, which may lead to death in respiratory failure if not corrected, tachycardia, gallop rhythm, dilatation of the heart. The electrocardiogram shows inverted, low amplitude, or isoelectric T waves and a prolonged QT interval. Potassium chloride orally, subcutaneously or intravenously is recommended for use in the treatment of potassium deficits. It should not be used in the presence of oliguria or anuria or dehydration. The amounts of potassium necessary to correct deficits vary widely and cannot be predicted from the serum level. Special reference is made to the prevention and therapy of potassium deficits in diabetic acidosis. High serum potassium levels are difficult to correct. Suggested measures are administration of glucose, insulin or calcium, gastric or peritoneal lavage or use of the artificial kidney. PMID:15405024

  9. Clinical pharmacokinetics of sertraline.

    PubMed

    DeVane, C Lindsay; Liston, Heidi L; Markowitz, John S

    2002-01-01

    Sertraline is a naphthalenamine derivative with the predominant pharmacological action of inhibiting presynaptic reuptake of serotonin from the synaptic cleft. It was initially marketed for the treatment of major depressive disorder and is now approved for the management of panic disorder, obsessive-compulsive disorder and post-traumatic stress disorder. Sertraline is slowly absorbed following oral administration and undergoes extensive first-pass oxidation to form N-desmethyl-sertraline, a weakly active metabolite that accumulates to a greater concentration in plasma than the parent drug at steady state. Sertraline is eliminated from the body by other metabolic pathways to form a ketone and an alcohol, which are largely excreted renally as conjugates. The elimination half-life of sertraline ranges from 22-36 hours, and once-daily administration is therapeutically effective. Steady-state plasma concentrations vary widely, up to 15-fold, in patients receiving usual antidepressant dosages between 50 and 150 mg/day. However, only sparse data have been published that support useful correlations between sertraline plasma concentrations and therapeutic or adverse effects to justify therapeutic drug monitoring. Sertraline has minimal inhibitory effects on the major cytochrome P450 enzymes, and few drug-drug interactions of clinical significance have been documented. Like other selective serotonin reuptake inhibitors, sertraline is well tolerated in therapeutic dosages and relatively safe in overdosage. PMID:12452737

  10. The Dynamo Clinical Trial

    NASA Astrophysics Data System (ADS)

    Ayres, Thomas R.

    2016-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  11. Clinical profile of trichotillomania.

    PubMed

    Bhatia, M S; Singhal, P K; Rastogi, V; Dhar, N K; Nigam, V R; Taneja, S B

    1991-05-01

    Twenty-four cases of trichotillomania attending psychiatry outpatient department and child guidance clinic at Kalawati Saran Children's and Smt Sucheta Kriplani Hospitals over a period of 2 years from July, 1985 to November 1987 were studied. Females (66.7%) outnumbered the males (33.3%). Majority of cases belonged to age group 6-10 years (54.2%) and nuclear family (68.5%). Nail-biting (25.0%) was the commonest associated neurotic trait, followed by enuresis (20.9%), temper-tantrum (12.5%), etc. A past history of hysterical fits and neurotic depression was found in 3 cases (12.5%) and 2 cases (8.3%) respectively. Family history of neurosis was seen in mothers and fathers of 20.9% and 12.5% cases respectively. Trichobezoars and trichophytobezoars were found in 6 cases (25.0%) and 3 cases (12.5%) respectively. Majority of patients of trichobezoars presented with vague complaints like heaviness in the stomach (55.6%), inability to gain weight (44.4%), etc, while 22.2% cases were asymptomatic and detected only on screening. PMID:1748781

  12. [The geriatric university clinic].

    PubMed

    Stähelin, H B

    1995-01-01

    The very old are the fastest growing population group. Medical progress allows more autonomy and better quality of life for the elderly. Traditional medical concepts are, however, only partly suited for dealing with age-associated problems. Medical education responds to these new requirements in a limited way. Interdisciplinary teamwork is a prerequisite in treating the multimorbid, acutely ill elderly patient. The task of the university is not only the development and implementation of high-tech medicine, but first of all a comprehensive training in medicine, including geriatrics. The Geriatric University Clinic therefore offers pre- and postgraduate training in geriatrics, but also in related disciplines by promoting teaching and research. In order to attain these goals, the geriatric acute ward was created for acutely ill, very old, multimorbid, frail elderly patients. A geriatric ward for rehabilitation complements this ward. A consultation service offers geriatric know-how to all other services. A special task is the early diagnosis and treatment of dementia in an outpatient service. The aim is to prevent chronification by early intervention and to reestablish satisfactory function and autonomy. PMID:7780809

  13. The Dynamo Clinical Trial

    NASA Astrophysics Data System (ADS)

    Ayres, Thomas R.

    2015-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  14. Cherubism: best clinical practice

    PubMed Central

    2012-01-01

    Cherubism is a skeletal dysplasia characterized by bilateral and symmetric fibro-osseous lesions limited to the mandible and maxilla. In most patients, cherubism is due to dominant mutations in the SH3BP2 gene on chromosome 4p16.3. Affected children appear normal at birth. Swelling of the jaws usually appears between 2 and 7 years of age, after which, lesions proliferate and increase in size until puberty. The lesions subsequently begin to regress, fill with bone and remodel until age 30, when they are frequently not detectable. Fibro-osseous lesions, including those in cherubism have been classified as quiescent, non-aggressive and aggressive on the basis of clinical behavior and radiographic findings. Quiescent cherubic lesions are usually seen in older patients and do not demonstrate progressive growth. Non-aggressive lesions are most frequently present in teenagers. Lesions in the aggressive form of cherubism occur in young children and are large, rapidly growing and may cause tooth displacement, root resorption, thinning and perforation of cortical bone. Because cherubism is usually self-limiting, operative treatment may not be necessary. Longitudinal observation and follow-up is the initial management in most cases. Surgical intervention with curettage, contouring or resection may be indicated for functional or aesthetic reasons. Surgical procedures are usually performed when the disease becomes quiescent. Aggressive lesions that cause severe functional problems such as airway obstruction justify early surgical intervention. PMID:22640403

  15. Clinically Relevant Biometry

    PubMed Central

    Sahin, Afsun; Hamrah, Pedram

    2012-01-01

    Purpose of review Obtaining precise post-operative target refraction is of utmost importance in today’s modern cataract and refractive surgery. Given the growing number of patients undergoing premium intraocular lens implantations, patient expectation continues to rise. In order to meet heightened patient expectations, it is crucial to pay utmost attention to patient selection, accurate keratometry and biometry readings, as well as to the application of correct intraocular lens power formula with optimized lens constants. This article reviews recent advances in the field of clinical biometry and intraocular lens power calculations. Recent findings Recently developed low-coherence reflectometry optical biometry is comparable to older ultrasonic biometric and keratometric techniques. In addition, the new IOL Master software upgrade has improved reproducibility and enhanced signal acquisition. Further, the modern lens power formulas currently determine the effective lens position and the shape of the intraocular lens power prediction curve more accurately. Summary In order to reach target refraction, precise biometric measurements are imperative. Understanding the strengths and limitations of the currently available biometry devices, allows prevention of high variability and inaccuracy, ultimately determining the refractive outcomes. PMID:22081032

  16. Endocrowns: a clinical report.

    PubMed

    Lander, Erika; Dietschi, Didier

    2008-02-01

    The endocrown is a restorative option for endodontically treated teeth. It consists of a circular butt-joint margin and a central retention cavity inside the pulp chamber and lacks intraradicular anchorage. This article describes the rationale and clinical guidelines for the placement of endocrowns. In the case presented, 2 old amalgam restorations on mandibular molars were replaced with endocrowns made of pressed ceramics (Empress 2, Ivoclar) following endodontic and periodontal therapy. A composite resin base was also used to fill undercuts and ensure a correct design of the preparations, contributing to significant tissue preservation. The postoperative situation shows the potential of this restorative approach to provide adequate function and esthetics, as well as biomechanical integrity of structurally compromised posterior nonvital teeth. It also prevents interferences with periodontal tissues, thanks to a supragingival position of the restoration margins. The foundation of this technique is to use the surface available in the pulpal chamber to assume the stability and retention of the restoration through adhesive procedures. Guidelines for the preparation, as well as the decision for omitting a post, are dictated by the amount of remaining coronal substance. This technique represents a promising and conservative alternative to full crowns for the treatment of posterior nonvital teeth that require long-term protection and stability. PMID:18560648

  17. Nontraditional applications in clinical pathology.

    PubMed

    Jordan, Holly L; Register, Thomas C; Tripathi, Niraj K; Bolliger, Anne Provencher; Everds, Nancy; Zelmanovic, David; Poitout, Florence; Bounous, Denise I; Wescott, Debra; Ramaiah, Shashi K

    2014-10-01

    Most published reviews of preclinical toxicological clinical pathology focus on the fundamental aspects of hematology, clinical chemistry, coagulation, and urinalysis in routine toxicology animal species, for example, rats, mice, dogs, and nonhuman primates. The objective of this continuing education course was to present and discuss contemporary examples of nonroutine applications of clinical pathology endpoints used in the drug development setting. Area experts discussed bone turnover markers of laboratory animal species, clinical pathology of pregnant and growing laboratory animals, clinical pathology of nonroutine laboratory animal species, and unique applications of the Siemens Advia() hematology analyzer. This article is a summary based on a presentation given at the 31st Annual Symposium of the Society of Toxicologic Pathology, during the Continuing Education Course titled "Nontraditional Applications of Clinical Pathology in Drug Discovery and Preclinical Toxicology." PMID:24705882

  18. Modern Management of Clinical Chorioamnionitis

    PubMed Central

    Knuppel, Robert A.

    1995-01-01

    Clinical chorioamnionitis continues to contribute to fetal and maternal morbidity and mortality. Significant advances have been made in the last 20 years in understanding the pathophysiologic processes leading to chorioamnionitis. This review addresses the history, incidence, pathophysiology, host defenses, risk factors, diagnosis, and maternal and neonatal management of clinically evident chorioamnionitis. After a detailed review of the physiologic processes leading to clinical chorioamnionitis and sepsis, we present a modern management scheme designed to optimize perinatal outcome for both mother and fetus. PMID:18476034

  19. Executing clinical guidelines: temporal issues.

    PubMed Central

    Terenziani, P.; Mastromonaco, F.; Molino, G.; Torchio, M.

    2000-01-01

    In our previous work, we proposed a domain-independent language to describe clinical guidelines and a graphical tool to acquire them. In this paper, we describe an approach to execute clinical guidelines. We propose a flexible execution engine that can be used in clinical decision support applications, and also for medical education, or for integrating guidelines into the clinical workflow. We also focus our attention on temporal issues in the execution of guidelines, including the treatment of composite, concurrent and/or cyclic actions. PMID:11080004

  20. [Critical reading of clinical trials].

    PubMed

    Aptel, F; Cucherat, M; Blumen-Ohana, E; Denis, P

    2011-12-01

    Clinical trials are playing an increasingly crucial role in modern evidence based medicine, allowing for rigorous scientific evaluation of treatment strategies and validation of patient care. The results of clinical trials often form the rational basis from which physicians draw information used to adapt their therapeutic practices. Critical reading and analysis of trials involves the assessment of whether the available data provide enough credible evidence that the treatment will result in a clinically significant and relevant improvement. Evaluating the quality of a clinical trial is a process that draws upon sometimes complex methodological and statistical concepts, with which the reader should nonetheless be familiar in order to come to impartial conclusions regarding the raw data presented in the clinical trials. The goal of the current article is to review the methodological and statistical concepts required for the design and interpretation of clinical trials, so as to allow for a critical analysis of publications or presentations of clinical trials. The first section describes the major methodological principles of clinical trial design required for a rigorous evaluation of the treatment benefit, as well as the various pitfalls or biases that could lead to erroneous conclusions. The second section briefly describes the main statistical tests used in clinical trials, as well as certain situations that may increase the risk of false positive findings (type 1 error), such as multiple, subgroup, intermediate and non-inferiority analysis. PMID:21992992

  1. Integrating Academic and Clinical Learning Using a Clinical Swallowing Assessment

    ERIC Educational Resources Information Center

    Phillips, Daniel E.

    2013-01-01

    This article describes an experiential learning activity designed to integrate classroom knowledge and a clinical swallowing assessment. Twenty master's-level graduate students in a dysphagia course conducted a clinical swallowing assessment with a resident of an independent retirement community. The exercise was designed to allow students an…

  2. Integrating Academic and Clinical Learning Using a Clinical Swallowing Assessment

    ERIC Educational Resources Information Center

    Phillips, Daniel E.

    2013-01-01

    This article describes an experiential learning activity designed to integrate classroom knowledge and a clinical swallowing assessment. Twenty master's-level graduate students in a dysphagia course conducted a clinical swallowing assessment with a resident of an independent retirement community. The exercise was designed to allow students an

  3. Clinical pharmacokinetics of metformin.

    PubMed

    Graham, Garry G; Punt, Jeroen; Arora, Manit; Day, Richard O; Doogue, Matthew P; Duong, Janna K; Furlong, Timothy J; Greenfield, Jerry R; Greenup, Louise C; Kirkpatrick, Carl M; Ray, John E; Timmins, Peter; Williams, Kenneth M

    2011-02-01

    Metformin is widely used for the treatment of type 2 diabetes mellitus. It is a biguanide developed from galegine, a guanidine derivative found in Galega officinalis (French lilac). Chemically, it is a hydrophilic base which exists at physiological pH as the cationic species (>99.9%). Consequently, its passive diffusion through cell membranes should be very limited. The mean ± SD fractional oral bioavailability (F) of metformin is 55 ± 16%. It is absorbed predominately from the small intestine. Metformin is excreted unchanged in urine. The elimination half-life (t(½)) of metformin during multiple dosages in patients with good renal function is approximately 5 hours. From published data on the pharmacokinetics of metformin, the population mean of its clearances were calculated. The population mean renal clearance (CL(R)) and apparent total clearance after oral administration (CL/F) of metformin were estimated to be 510 ± 130 mL/min and 1140 ± 330 mL/min, respectively, in healthy subjects and diabetic patients with good renal function. Over a range of renal function, the population mean values of CL(R) and CL/F of metformin are 4.3 ± 1.5 and 10.7 ± 3.5 times as great, respectively, as the clearance of creatinine (CL(CR)). As the CL(R) and CL/F decrease approximately in proportion to CL(CR), the dosage of metformin should be reduced in patients with renal impairment in proportion to the reduced CL(CR). The oral absorption, hepatic uptake and renal excretion of metformin are mediated very largely by organic cation transporters (OCTs). An intron variant of OCT1 (single nucleotide polymorphism [SNP] rs622342) has been associated with a decreased effect on blood glucose in heterozygotes and a lack of effect of metformin on plasma glucose in homozygotes. An intron variant of multidrug and toxin extrusion transporter [MATE1] (G>A, SNP rs2289669) has also been associated with a small increase in antihyperglycaemic effect of metformin. Overall, the effect of structural variants of OCTs and other cation transporters on the pharmacokinetics of metformin appears small and the subsequent effects on clinical response are also limited. However, intersubject differences in the levels of expression of OCT1 and OCT3 in the liver are very large and may contribute more to the variations in the hepatic uptake and clinical effect of metformin. Lactic acidosis is the feared adverse effect of the biguanide drugs but its incidence is very low in patients treated with metformin. We suggest that the mean plasma concentrations of metformin over a dosage interval be maintained below 2.5 mg/L in order to minimize the development of this adverse effect. PMID:21241070

  4. Lasers in clinical ophthalmology

    NASA Astrophysics Data System (ADS)

    Ribeiro, Paulo A.

    1992-03-01

    The clinical application of lasers in ophthalmology is schematized, showing for each anatomic eye structure, pathologies that may be treated through this procedure. In the cornea, the unusual laser practice for suture removals and the promising possibility of the excimer laser in refractive surgery are discussed. In the iris, the camerular angle, and the ciliary body, the laser application is essentially used to treat the glaucoma and other situations that are not so frequent. The capsulotomy with YAG LASER is used in the treatment of structures related with crystalline and, at least, the treatment of the retina and choroid pathology is expanded. A. A. explained the primordial interest and important of laser in the diabetic retinopathy treatment and some results in patients with more than 5 years of evolution are: 55 of the patients with proliferative diabetic retinopathy (RDP) treated for more than 5 years noticed their vision improved or stabilized; 5 years after treating patients with PDR, 49.3 had their vision stabilized or even improved, provided the diabetics had declared itself more than 20 years ago, versus 61.7 provided the diabetics had declared itself less than 20 years before; finally, 53.8 of the patients under 40-years-old when the diabetics was diagnosed, had their vision improved or at least stabilized 5 years after the beginning of the treatment. On the other side, when patients were over 40 years old when the diabetics was diagnosed percentage increased to 55.9. This study was established in the follow-up of 149 cases over 10 years.

  5. Clinical review: severe asthma.

    PubMed

    Papiris, Spyros; Kotanidou, Anastasia; Malagari, Katerina; Roussos, Charis

    2002-02-01

    Severe asthma, although difficult to define, includes all cases of difficult/therapy-resistant disease of all age groups and bears the largest part of morbidity and mortality from asthma. Acute, severe asthma, status asthmaticus, is the more or less rapid but severe asthmatic exacerbation that may not respond to the usual medical treatment. The narrowing of airways causes ventilation perfusion imbalance, lung hyperinflation, and increased work of breathing that may lead to ventilatory muscle fatigue and life-threatening respiratory failure. Treatment for acute, severe asthma includes the administration of oxygen, beta2-agonists (by continuous or repetitive nebulisation), and systemic corticosteroids. Subcutaneous administration of epinephrine or terbutaline should be considered in patients not responding adequately to continuous nebulisation, in those unable to cooperate, and in intubated patients not responding to inhaled therapy. The exact time to intubate a patient in status asthmaticus is based mainly on clinical judgment, but intubation should not be delayed once it is deemed necessary. Mechanical ventilation in status asthmaticus supports gas-exchange and unloads ventilatory muscles until aggressive medical treatment improves the functional status of the patient. Patients intubated and mechanically ventilated should be appropriately sedated, but paralytic agents should be avoided. Permissive hypercapnia, increase in expiratory time, and promotion of patient-ventilator synchronism are the mainstay in mechanical ventilation of status asthmaticus. Close monitoring of the patient's condition is necessary to obviate complications and to identify the appropriate time for weaning. Finally, after successful treatment and prior to discharge, a careful strategy for prevention of subsequent asthma attacks is imperative. PMID:11940264

  6. Clinical aspects of telemedicine

    NASA Technical Reports Server (NTRS)

    Merrell, Ronald C.

    1991-01-01

    Communication among physicians is an essential in order to combine our experiences for the elucidation and application of new knowledge and for the accurate and uniform application of established medical practice. This communication requires an adequate understanding of the culture of the patient and the social context of disease and indeed the culture of the physician. Malnutrition in Bangladesh means caloric insufficiency, and a program to lower cholesterol would be impertinent, while a program to enhance the nutrition of patients in Texas by an international effort to import more grain would be ludicrous. In the same vein a public health effort to combat alcoholic cirrhosis in Mecca would be as silly as a program to increase fiber in the diet of the Bantu. Clinical communication must acknowledge the culture of the issue at hand and the differences in the experiential base of the physicians. Not only do geography and culture affect the potential differences in the experiential bases, but the world utilizes very different traditions of education and science in training physicians. We are influenced by the diseases we treat, and learn to look for the expected at least as much as we are attentive to the unexpected. A physician in Siberia would be much more likely to recognize frostbite than one from Buenos Aires, and the Argentine doctor would much more likely consider Chaga's Disease to explain abdominal pain than a colleague in Zurich. Beyond these obvious issues in communication among physicians we must deal with the many languages and idioms used in the world. An overview of using Telemedicine SpaceBridge after the earthquake in the Republic of Armenia in 1988 is presented.

  7. The National Institutes of Health Clinical Center

    MedlinePlus

    ... Issue Past Issues The National Institutes of Health Clinical Center Past Issues / Spring 2007 Table of Contents ... Communications, NIH Clinical Center Welcome to the nation's clinical research hospital. The NIH Clinical Center: For more ...

  8. Clinical mastitis in ewes; bacteriology, epidemiology and clinical features

    PubMed Central

    Mørk, Tormod; Waage, Steinar; Tollersrud, Tore; Kvitle, Bjørg; Sviland, Ståle

    2007-01-01

    Background Clinical mastitis is an important disease in sheep. The objective of this work was to identify causal bacteria and study certain epidemiological and clinical features of clinical mastitis in ewes kept for meat and wool production. Methods The study included 509 ewes with clinical mastitis from 353 flocks located in 14 of the 19 counties in Norway. Clinical examination and collection of udder secretions were carried out by veterinarians. Pulsed-field gel electrophoresis (PFGE) was performed on 92 Staphylococcus aureus isolates from 64 ewes. Results and conclusion S. aureus was recovered from 65.3% of 547 clinically affected mammary glands, coagulase-negative staphylococci from 2.9%, enterobacteria, mainly Escherichia coli, from 7.3%, Streptococcus spp. from 4.6%, Mannheimia haemolytica from 1.8% and various other bacteria from 4.9%, while no bacteria were cultured from 13.2% of the samples. Forty percent of the ewes with unilateral clinical S. aureus mastitis also had a subclinical S. aureus infection in the other mammary gland. Twenty-four of 28 (86%) pairs of S. aureus isolates obtained from clinically and subclinically affected mammary glands of the same ewe were indistinguishable by PFGE. The number of identical pairs was significantly greater than expected, based on the distribution of different S. aureus types within the flocks. One-third of the cases occurred during the first week after lambing, while a second peak was observed in the third week of lactation. Gangrene was present in 8.8% of the clinically affected glands; S. aureus was recovered from 72.9%, Clostridium perfringens from 6.3% and E. coli from 6.3% of the secretions from such glands. This study shows that S. aureus predominates as a cause of clinical ovine mastitis in Norway, also in very severe cases. Results also indicate that S. aureus is frequently spread between udder halves of infected ewes. PMID:17892567

  9. Genetic and Mechanistic Evaluation for the Mixed-Field Agglutination in B3 Blood Type with IVS3+5G>A ABO Gene Mutation

    PubMed Central

    Wang, Wei-Ting; Sun, Chien-Feng

    2012-01-01

    Background The ABO blood type B3 is the most common B subtype in the Chinese population with a frequency of 1/900. Although IVS3+5G>A (rs55852701) mutation of B gene has been shown to associate with the development of B3 blood type, genetic and mechanistic evaluation for the unique mixed-field agglutination phenotype has not yet been completely addressed. Methodology/Principal Findings In this study, we analyzed 16 cases of confirmed B3 individuals and found that IVS3+5G>A attributes to all cases of B3. RT-PCR analyses revealed the presence of at least 7 types of aberrant B3 splicing transcripts with most of the transcripts causing early termination and producing non-functional protein during translation. The splicing transcript without exon 3 that was predicted to generate functional B3 glycosyltransferase lacking 19 amino acids at the N-terminal segment constituted only 0.9% of the splicing transcripts. Expression of the B3 cDNA with exon 3 deletion in the K562 erythroleukemia cells revealed that the B3 glycosyltransferase had only 40% of B1 activity in converting H antigen to B antigen. Notably, the typical mixed-field agglutination of B3-RBCs can be mimicked by adding anti-B antibody to the K562-B3 cells. Conclusions/Significance This study thereby demonstrates that both aberrant splicing of B transcripts and the reduced B3 glycosyltransferase activity contribute to weak B expression and the mixed-field agglutination of B3, adding to the complexity for the regulatory mechanisms of ABO gene expression. PMID:22624005

  10. Clinical pharmacokinetics of dapsone.

    PubMed

    Zuidema, J; Hilbers-Modderman, E S; Merkus, F W

    1986-01-01

    Dapsone (DDS) has for about 4 decades been the most important antileprosy drug. Concentrations of dapsone and its monoacetyl metabolite, MADDS, can be determined in biological media by high-performance liquid chromatography. After oral administration, the drug is slowly absorbed, the maximum concentration in plasma being reached at about 4 hours, with an absorption half-life of about 1.1 hours. However, the extent of absorption has not been adequately determined. The elimination half-life of dapsone is about 30 hours. The drug shows linear pharmacokinetics within the therapeutic range and the time-course after oral administration fits a 2-compartment model. The concentration-time profile of dapsone after parenteral administration is reviewed. Of clinical importance is the development of a new long acting injection, which permits monthly supervised administration as recommended by the World Health Organization. Following dapsone injection in gluteal subcutaneous adipose tissue, a sufficiently sustained absorption for this purpose has been reported. Dapsone is about 70 to 90% protein bound and its monoacetylated metabolite (MADDS) is almost completely protein bound. The volume of distribution of dapsone is estimated to be 1.5 L/kg. It is distributed in most tissues, but M. leprae living in the Schwann cells of the nerves might be unaffected. Dapsone crosses the placenta and is excreted in breast milk and saliva. Dapsone is extensively metabolised. Dapsone, some MADDS and their hydroxylated metabolites are found in urine, partly conjugated as N-glucuronides and N-sulphates. The acetylation ratio (MADDS:dapsone) shows a genetically determined bimodal distribution and allows the definition of 'slow' and 'rapid' acetylators. As enterohepatic circulation occurs, the elimination half-life of dapsone is markedly decreased after oral administration of activated charcoal. This permits successful treatment in cases of intoxication. The daily dose of dapsone in leprosy is 50 to 100mg, but varies from 50 to 400mg in the treatment of other dermatological disorders. In malaria prophylaxis, a weekly dose of 100mg is used in combination with pyrimethamine. Side effects are mostly not serious below a daily dose of 100mg and are mainly haematological effects. The dapsone therapeutic serum concentration range can be defined as 0.5 to 5 mg/L. Alcoholic liver disease decreases the protein binding of dapsone; coeliac disease and dermatitis herpetiformis may delay its oral absorption and severe leprosy has been reported to affect the extent of absorption.(ABSTRACT TRUNCATED AT 400 WORDS) PMID:3530584

  11. Evaluating Clinical Teaching in Medicine.

    ERIC Educational Resources Information Center

    Irby, David; Rakestraw, Philip

    1981-01-01

    Medical students have been rating clinical teaching in an obstetrics and gynecology clerkship at the University of Washington using an assessment form designed to reflect six factors of clinical teaching effectiveness. High interrater reliability and the utility of the data for faculty development and advancement are discussed. (Author/JMD)

  12. In the clinic. Plantar fasciitis.

    PubMed

    Young, Craig

    2012-01-01

    This issue provides a clinical overview of plantar fasciitis focusing on prevention, diagnosis, treatment, practice improvement, and patient information. Readers can complete the accompanying CME quiz for 1.5 credits. Only ACP members and individual subscribers can access the electronic features of In the Clinic. Non-subscribers who wish to access this issue of In the Clinic can elect "Pay for View." Subscribers can receive 1.5 category 1 CME credits by completing the CME quiz that accompanies this issue of In the Clinic. The content of In the Clinic is drawn from the clinical information and education resources of the American College of Physicians (ACP), including PIER (Physicians' Information and Education Resource) and MKSAP (Medical Knowledge and Self Assessment Program). Annals of Internal Medicine editors develop In the Clinic from these primary sources in collaboration with the ACP's Medical Education and Publishing division and with assistance of science writers and physician writers. Editorial consultants from PIER and MKSAP provide expert review of the content. Readers who are interested in these primary resources for more detail can consult www.acponline.org, http://pier.acponline.org, and other resources referenced within each issue of In the Clinic. PMID:22213510

  13. [Clinical pharmacy and surgery: Review].

    PubMed

    Jarfaut, A; Nivoix, Y; Vigouroux, D; Kehrli, P; Gaudias, J; Kempf, J-F; Levêque, D; Gourieux, B

    2014-05-01

    Clinical pharmacy has been developed and evaluated in various medical hospital activities. Reviews conducted in this area reported a higher value of this discipline. In surgical services, evenly adverse drug events may occur, so clinical pharmacy activities must also help to optimize the management of drug's patient. The objectives of this literature review is to determine the profile of clinical pharmacy activities developed in surgical services and identify indicators. The research was conducted on Pubmed(®) database with the following keywords (2000-2013), "surgery", "pharmacy", "pharmacist", "pharmaceutical care", "impact" and limited to French or English papers. Studies dealing on simultaneously medical and surgical areas were excluded. Twenty-one papers were selected. The most frequently developed clinical pharmacy activities were history and therapeutic drug monitoring (antibiotics or anticoagulants). Two types of indicators were identified: activity indicators with the number of pharmaceutical interventions, their description and clinical signification, the acceptance rate and workload. Impact indicators were mostly clinical and economic impacts. The development of clinical pharmacy related to surgical patients is documented and appears to have, as for medical patients, a clinical and economical value. PMID:24780831

  14. PROFESSIONAL INTEGRATION AND CLINICAL RESEARCH.

    ERIC Educational Resources Information Center

    WARD, TED W.

    THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…

  15. Mindfulness Meditation in Clinical Practice

    ERIC Educational Resources Information Center

    Salmon, Paul; Sephton, Sandra; Weissbecker, Inka; Hoover, Katherine; Ulmer, Christi; Studts, Jamie L.

    2004-01-01

    The practice of mindfulness is increasingly being integrated into contemporary clinical psychology. Based in Buddhist philosophy and subsequently integrated into Western health care in the contexts of psychotherapy and stress management, mindfulness meditation is evolving as a systematic clinical intervention. This article describes…

  16. Clinical Disorders of Phosphorus Metabolism

    PubMed Central

    Yu, George C.; Lee, David B. N.

    1987-01-01

    Deranged phosphorus metabolism is commonly encountered in clinical medicine. Disturbances in phosphate intake, excretion and transcellular shift account for the abnormal serum levels. As a result of the essential role played by phosphate in intracellular metabolism, the clinical manifestations of hypophosphatemia and hyperphosphatemia are extensive. An understanding of the pathophysiology of various phosphate disorders is helpful in guiding therapeutic decisions. Images PMID:3321712

  17. Clinical Guidelines. Dental Hygiene Program.

    ERIC Educational Resources Information Center

    Branson, Bonnie

    This manual contains information concerning the policies and procedures of the Southern Illinois University-Carbondale Dental Hygiene Clinic. The manual is presented in a question/answer format for the information and convenience of dental hygiene students in the program, and is intended to answer their questions concerning clinical policies and…

  18. Clinical Teaching: Some Experimental Observations.

    ERIC Educational Resources Information Center

    Scott, Ralph

    A study attempted to measure some effects of a 2-week postbaccalaureate workshop on clinical teaching (teaching which provides children with individualized materials and procedures) and to assess administrative encouragement and appreciation of clinical experimentation and innovation. An experimental group of 20 experienced elementary teachers who…

  19. Clinical application of radiolabelled platelets

    SciTech Connect

    Kessler, C. )

    1990-01-01

    This book presents papers on the clinical applications of radiolabelled platelets. The papers are grouped into six sections on platelet labelling techniques, radiolabelled platelets in cardiology, monitoring of antiplatelet therapy, platelet scintigraphy in stroke patients, platelet scintigraphy in angiology, and platelet scintigraphy in hematology and other clinical applications, including renal transplant rejection.

  20. Clinical Teacher Preparation: A Retrospective

    ERIC Educational Resources Information Center

    Whitford, Betty Lou; Villaume, Susan Kidd

    2014-01-01

    In this article, we explore how teacher preparation programs have developed from the mid-1800s to present day, emphasizing changes in the clinical component. Drawing from the history of teacher education from the normal schools of the 19th century to present-day interest in clinically based preparation, we first review the migration of teacher…

  1. Clinical Applications of Otoacoustic Emissions.

    ERIC Educational Resources Information Center

    Lonsbury-Martin, Brenda L.; And Others

    1991-01-01

    This tutorial paper examines the potential of otoacoustic emissions (OAEs) in diagnostic audiology. It discusses classification of OAEs, basic properties of various types of OAEs, and clinical applications. It concludes that both transiently evoked and distortion product OAEs have beneficial clinical application resulting from their objectivity,…

  2. Dream Busters...Clinic Income.

    ERIC Educational Resources Information Center

    Hasler, John F.

    1995-01-01

    Several approaches that could allow dental schools to conduct clinical care programs more profitably in a difficult economic and health-care climate are offered. Focus is on organizing delivery systems around patient-centered care, achieving optimal care quality, enhancing clinic revenue, minimizing operating costs, and becoming better positioned…

  3. Enhancing adherence in clinical research.

    PubMed

    Robiner, William N

    2005-02-01

    This article presents overviews of adherence or compliance in clinical care and research, focusing on the need to enhance research adherence. The scope of the clinical research enterprise and costs of conducting clinical research are summarized. Costs associated with suboptimal adherence in clinical care and research also are addressed, along with their implications for enhancing adherence. Methodological problems and statistical challenges (including intent-to-treat) associated with poor adherence are reviewed. Addressing social factors, regimen characteristics, behavioral patterns, and systems issues can affect adherence. Strategies for enhancing adherence in clinical research subjects, including pre-randomization screening, behavioral and educational interventions, monitoring, and enhancing subjects' status and contingencies for adhering are discussed. Integrating adherence-enhancing strategies throughout research phases, from pre-randomization screening during recruitment to endpoint, has the potential to improve the quality and outcome of research while limiting costs. PMID:15837453

  4. Clinical intervention research in nursing.

    PubMed

    Forbes, Angus

    2009-04-01

    As a healthcare profession nursing has a duty to develop practices that contribute to the health and well being of patients. The aim of this paper is to discuss current issues in clinical research within nursing. The paper defines clinical interventions research as a theoretically based, integrated and sequential approach to clinical knowledge generation. The paper provides specific criteria for defining a clinical intervention together with an overview of the stages involved in clinical research from problem identification to implementing knowledge in practice. The paper also explored the extent to which nursing research was focussed on clinical issues, through a snapshot review of all the original research papers in Europe's three leading nursing research journals. In total of 517 different papers were included and classified in the review. Of these 88% (n=455) were classified as non-clinical intervention and 12% (n=62) as clinical intervention studies. The paper examined the intervention studies in detail examining: the underpinning theory; linkage to previous (pre-clinical) work; evidence of granularity; protocol clarity (generalisable and parsimonious); the phase of knowledge development; and evidence of safety (adverse event reporting). The paper discusses some of the shortcomings of interventions research in nursing and suggests a number of ideas to help address these problems, including: a consensus statement on interventions research in nursing; a register of nursing intervention studies; the need for nursing to develop clinical research areas in which to develop potential interventions (nursing laboratories); and a call for nursing researchers to publish more research in nursing specific journals. PMID:18930228

  5. Implications of Look AHEAD for Clinical Trials and Clinical Practice

    PubMed Central

    Wing, Rena R.

    2014-01-01

    Look AHEAD was a randomized clinical trial designed to examine the long-term health effects of weight loss in overweight and obese individuals with type 2 diabetes. The primary result was that the incidence of cardiovascular events over a median follow up of 9.6 years was not reduced in the intensive lifestyle group relative to the control group. This finding is discussed, with emphasis on its implications for design of clinical trials and clinical treatment of obese people with type 2 diabetes. PMID:24853636

  6. Contextualizing clinical research: the epistemological role of clinical equipoise.

    PubMed

    Anderson, James A

    2009-01-01

    Since its introduction in 1987, Benjamin Freedman's principle of clinical equipoise has enjoyed widespread uptake in bioethics discourse. Recent years, however, have witnessed a growing consensus that the principle is fundamentally flawed. One of the most vocal critics has undoubtedly been Franklin Miller. In a 2008 paper, Steven Joffe and Miller build on this critical work, offering a new conception of clinical research ethics based on science, taking what they call a "scientific orientation" toward the ethics of clinical research. Though there is much to recommend Joffe and Miller's scientifically oriented conception of clinical research ethics, I believe that both the critical and constructive projects suffer from the same basic mistake: inattention to context. The internal norms of science cannot be fully specified, let alone satisfied, independently of contextual (external) factors that only come into view when we are attentive to the particular context of that form of inquiry. PMID:19404770

  7. Children and Clinical Studies: Why Clinical Studies Are Important

    MedlinePlus Videos and Cool Tools

    ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural ...

  8. Clinical review 55: Advances in clinical in vitro fertilization.

    PubMed

    Penzias, A S; DeCherney, A H

    1994-03-01

    The advances in human in vitro fertilization are excellent examples of the partnership between basic science and clinical medicine. It is reasonable to assume that future breakthroughs will result from this continued collaboration. PMID:8126119

  9. Social media in clinical trials.

    PubMed

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape. PMID:24857086

  10. What is a clinical fact?

    PubMed

    O'Shaughnessy, E

    1994-12-01

    As a preliminary to the question, 'What is a clinical fact?', the author asks the wider question, 'What is a fact?', answering that facts are double in aspect: they both say how the world is, and they also depend on our species, our language, theory, etc. A claim of fact in any empirical discipline--in the natural sciences or in human studies with their different methods--is a truth claim which is not infallible or unique to the fact, and also a claim that must offer itself for verification. Using the clinical record of three sessions, she then tries to answer the question, 'What is a clinical fact?', offering the starting formulation that clinical facts, under the unusual conditions of an analytic hour which give an analyst access to a patient's inner world, manifests themselves in the form of immediate psychological realities between patient and analyst. On the way, the author discusses the analyst's anxieties about making a claim of clinical fact; further striking features emerge about clinical facts in the three sessions, and some unsolved problems, i.e. the variety of analytic theories, subjectivity and objectivity, are noted. Even while they bear the perplexities of their problems, clinical facts are of great significance to the study of the mind. They extend the domain of psychology to the area of the mind's interiority, with its human experiences of subjective meaning, conscious, and especially unconscious. PMID:7713671

  11. Endpoints in cancer clinical trials.

    PubMed

    Fiteni, F; Westeel, V; Pivot, X; Borg, C; Vernerey, D; Bonnetain, F

    2014-02-01

    Endpoints are measurable clinical and biological findings that are used for the development and assessment of treatment options. In the treatment of cancer, endpoints can be classified into two categories: "patient-centered clinical endpoints" including overall survival (OS) and health-related quality of life (QoL), and "tumor-centered clinical endpoints" such as progression-free survival. Surrogate endpoints are tumor-centered clinical endpoints that can be used as substitutes for patient-centered clinical endpoints, particularly OS. The choice of endpoints in oncology trials is a major problem. The published Consolidated Standards of Reporting Trials (CONSORT) best-practice guidelines encourage the reporting of clearly defined primary and secondary outcome measures. OS is the gold standard of endpoints but as increasing numbers of effective salvage treatments become available for many types of cancer, much larger numbers of patients are included; this requires a longer follow-up period and increases the cost of clinical trials. Thus, tumor-centered clinical endpoints that can be assessed earlier and used as surrogates for overall survival are increasingly studied, but most of them currently lack standardized definitions to enable cross comparison of results among different clinical trials and they have not been validated as surrogate endpoints. In addition, the variability of their definition can strongly impact the trial's conclusions by affecting both statistical power and estimation. In this context, QoL constitutes an available and useful surrogate endpoint for trials to ensure treatment benefit from both the patient and public health points of view. Methodological research should be pursued to develop standard outcome definitions for use in cancer clinical trials and to define a standardized longitudinal analysis of QoL data. PMID:24440056

  12. Clinical Genetic Testing in Gastroenterology

    PubMed Central

    Goodman, Russell P; Chung, Daniel C

    2016-01-01

    Rapid advances in genetics have led to an increased understanding of the genetic determinants of human disease, including many gastrointestinal (GI) disorders. Coupled with a proliferation of genetic testing services, this has resulted in a clinical landscape where commercially available genetic tests for GI disorders are now widely available. In this review, we discuss the current status of clinical genetic testing for GI illnesses, review the available testing options, and briefly discuss indications for and practical aspects of such testing. Our goal is to familiarize the practicing gastroenterologist with this rapidly changing and important aspect of clinical care. PMID:27124700

  13. Critical appraisal of clinical guidelines.

    PubMed

    Netsch, Debra S; Kluesner, Jean A

    2010-01-01

    Utilization of clinical guidelines is gaining in popularity due to their significant impact on clinical practice. While a plethora of guidelines exist, many are lacking in quality, based on current critical appraisal standards. It then becomes necessary for the end users of the guidelines to adopt or develop those that are deemed adequate for implementation. This often requires that users possess critical appraisal skills as they become proficient in discerning between guidelines of varying quality. This article provides direction and tools to support the critical appraisal process in the adoption of clinical guidelines. PMID:20838314

  14. Data fraud in clinical trials

    PubMed Central

    George, Stephen L; Buyse, Marc

    2015-01-01

    Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality. PMID:25729561

  15. CMA Infobase: clinical practice guidelines.

    PubMed

    Fitzpatrick, Roberta Bronson

    2008-01-01

    The CMA Infobase is a free Web-based resource that contains evidence-based clinical practice guidelines. The database is maintained by the Canadian Medical Association (CMA) and is available on its Web site. The CMA Infobase currently contains 1,200-plus clinical practice guidelines either developed or endorsed by an authoritative health care organization located in Canada. It is an alternative source of free clinical practice guidelines to the National Guideline Clearinghouse. This column will cover the basics of CMA Infobase, including searching, special features, and available resources which complement the database. PMID:19042721

  16. AIDS Clinical Trials Group Network

    MedlinePlus

    ... Newsletter serves to keep those in the HIV/AIDS community up-to-date on the latest research ... 2017 Annual ACTG Network Meeting 2016 Upcoming HIV/AIDS Conferences Quick Links ACTG Repository Access AIDSInfo ClinicalTrials. ...

  17. BMPs and their clinical potentials

    PubMed Central

    Kim, Meejung; Choe, Senyon

    2012-01-01

    Bone morphogenetic protein (BMP) signaling in diseases is the subject of an overwhelming array of studies. BMPs are excellent targets for treatment of various clinical disorders. Several BMPs have already been shown to be clinically beneficial in the treatment of a variety of conditions, including BMP-2 and BMP-7 that have been approved for clinical application in nonunion bone fractures and spinal fusions. With the use of BMPs increasingly accepted in spinal fusion surgeries, other therapeutic approaches targeting BMP signaling are emerging beyond applications to skeletal disorders. These approaches can further utilize next-generation therapeutic tools such as engineered BMPs and ex vivo-conditioned cell therapies. In this review, we focused to provide insights into such clinical potentials of BMPs in metabolic and vascular diseases, and in cancer. PMID:22026995

  18. [Internet use in clinical trials].

    PubMed

    Refolo, P; Sacchini, D; Minacori, R; Spagnolo, A G

    2014-01-01

    Recruiting patients is a critical point of today's clinical research and, along the years, several solutions have been proposed, even if their efficacy seems to be doubtful. On the other hand, nowadays, Internet represents a great opportunity for improving clinical trial recruitments. Nevertheless, on-line recruitment services (e-recruitment) could ensure some advantages (such as facilitating interaction between supply and demand of clinical research, time and money savings/optimizations, data entry errors reduction), but also raise some issues (such as those related to sampling, information, consent, real identity of participants and risks for data breaches). The article debates on the difficulties to recruit patients for clinical research, in general, and e-recruitment particularly, discussing some ethical issues raised by internet enrolment. PMID:24589968

  19. CLINICAL ASPECTS OF VETERINARY LISTERIOSIS

    Technology Transfer Automated Retrieval System (TEKTRAN)

    This invited presentation updates the clinical aspects of Listeria monocytogenes in food animals. It summarizes the epidemiology and diagnostic methods. Virtually all domesticated animal species are susceptible to listeric infection, with a large proportion of healthy asymptomatic animals shedding...

  20. The virtual clinical evaluation tool.

    PubMed

    Sander, Rebecca; Trible, Karen A

    2008-01-01

    Two years ago, faculty and students at this rural university setting collaborated to implement a virtual clinical evaluation tool. In recognition of the frustrations involved in coordinating instructor and student input to a hard copy tool, a virtual clinical evaluation tool was created in the form of an Excel spreadsheet. Excel documents have the advantage of immediate retrieval and use by instructors or students, ease of narration by word processing, automatic mathematical computation of formative and summative scores, and data storage through computer archives. Using the online Blackboard course, students and instructors are able to collaboratively input a Likert score for each posted evaluation outcome and word process-related comments about students' clinical performance. An overview of the 2-year implementation of this virtual clinical evaluation tool, as well as the evaluation process, is discussed. PMID:18232613

  1. Clinical Trials and Older People

    MedlinePlus

    ... Division of Geriatrics and Clinical Gerontology Division of Neuroscience FAQs Funding Opportunities Intramural Research Program Office of ... perfect. Based on many years of experience and learning, Congress has passed laws to protect study participants. ...

  2. American Society for Clinical Pathology

    MedlinePlus

    ... With the National Cancer Institute for Inaugural Global Pathology Conference March 2016 OneLab Memo ASCP Action Alert - ... 2016 Copyright © 2016 by American Society for Clinical Pathology. All Rights Reserved. Terms of Use About ASCP ...

  3. Clinical aspects of crew health

    NASA Technical Reports Server (NTRS)

    Hawkins, W. R.; Zieglschmid, J. F.

    1975-01-01

    Medical procedures and findings for Apollo astronauts in the preflight, inflight, and postflight phases of the Apollo missions are described in detail. Preflight medical examinations, inflight monitoring and medications, crew illnesses, and clinical findings are summarized.

  4. Checklist for clinical readiness published

    Cancer.gov

    Scientists from NCI, together with collaborators from outside academic centers, have developed a checklist of criteria to evaluate the readiness of complex molecular tests that will guide decisions made during clinical trials. The checklist focuses on tes

  5. Cleveland Clinic Next Generation Neuroimaging

    SciTech Connect

    Lowe, Mark

    2009-09-30

    This was an award to purchase equipment for state-of-the-art MRI radiofrequency coils. There was no personnel effort or construction as a part of this project. This report details the final status of the approved budget items for this project. All approved budget items were successfully delivered and installed. The equipment provided to Cleveland Clinic under this project will allow Cleveland Clinic researchers to build imaging equipment with improved capability to investigate brain disorders.

  6. The Clinical Approach to Encephalitis.

    PubMed

    Piquet, Amanda L; Cho, Tracey A

    2016-05-01

    Encephalitis has various etiologies, but viral infections and autoimmune disorders are the most commonly identified. Clinical signs, geographical clues, and diagnostic testing-including cerebrospinal fluid abnormalities and magnetic resonance imaging abnormalities-can be helpful in identifying the cause. Certain forms of encephalitis have specific treatments; hence, establishing a diagnosis rapidly and accurately is crucial. Here, we describe the clinical approach to diagnosing several common etiologies of encephalitis as well as treatment strategies. PMID:27021774

  7. Detailed Clinical Models: A Review

    PubMed Central

    Goossen-Baremans, Anneke; van der Zel, Michael

    2010-01-01

    Objectives Due to the increasing use of electronic patient records and other health care information technology, we see an increase in requests to utilize these data. A highly level of standardization is required during the gathering of these data in the clinical context in order to use it for analyses. Detailed Clinical Models (DCM) have been created toward this purpose and several initiatives have been implemented in various parts of the world to create standardized models. This paper presents a review of DCM. Methods Two types of analyses are presented; one comparing DCM against health care information architectures and a second bottom up approach from concept analysis to representation. In addition core parts of the draft ISO standard 13972 on DCM are used such as clinician involvement, data element specification, modeling, meta information, and repository and governance. Results Six initiatives were selected: Intermountain Healthcare, 13606/OpenEHR Archetypes, Clinical Templates, Clinical Contents Models, Health Level 7 templates, and Dutch Detailed Clinical Models. Each model selected was reviewed for their overall development, involvement of clinicians, use of data types, code bindings, expressing semantics, modeling, meta information, use of repository and governance. Conclusions Using both a top down and bottom up approach to comparison reveals many commonalties and differences between initiatives. Important differences include the use of or lack of a reference model and expressiveness of models. Applying clinical data element standards facilitates the use of conceptual DCM models in different technical representations. PMID:21818440

  8. Birth Control in Clinical Trials

    PubMed Central

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  9. Ubiquitous Multicriteria Clinic Recommendation System.

    PubMed

    Chen, Toly

    2016-05-01

    Advancements in information, communication, and sensor technologies have led to new opportunities in medical care and education. Patients in general prefer visiting the nearest clinic, attempt to avoid waiting for treatment, and have unequal preferences for different clinics and doctors. Therefore, to enable patients to compare multiple clinics, this study proposes a ubiquitous multicriteria clinic recommendation system. In this system, patients can send requests through their cell phones to the system server to obtain a clinic recommendation. Once the patient sends this information to the system, the system server first estimates the patient's speed according to the detection results of a global positioning system. It then applies a fuzzy integer nonlinear programming-ordered weighted average approach to assess four criteria and finally recommends a clinic with maximal utility to the patient. The proposed methodology was tested in a field experiment, and the experimental results showed that it is advantageous over two existing methods in elevating the utilities of recommendations. In addition, such an advantage was shown to be statistically significant. PMID:26984357

  10. Quality Assurance for Clinical Trials

    PubMed Central

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  11. Clinical engagement: improving healthcare together.

    PubMed

    Riches, E; Robson, B

    2014-02-01

    Clinical engagement can achieve lasting change in the delivery of healthcare. In October 2011, Healthcare Improvement Scotland formulated a clinical engagement strategy to ensure that a progressive and sustainable approach to engaging healthcare professionals is firmly embedded in its health improvement and public assurance activities. The strategy was developed using a 90-day process, combining an evidence base of best practice and feedback from semi-structured interviews and focus groups. The strategy aims to create a culture where clinicians view working with Healthcare Improvement Scotland as a worthwhile venture, which offers a number of positive benefits such as training, career development and research opportunities. The strategy works towards developing a respectful partnership between Healthcare Improvement Scotland, the clinical community and key stakeholders whereby clinicians' contributions are recognised in a non-financial reward system. To do this, the organisation needs a sustainable infrastructure and an efficient, cost-effective approach to clinical engagement. There are a number of obstacles to achieving successful clinical engagement and these must be addressed as key drivers in its implementation. The implementation of the strategy is supported by an action and resource plan, and its impact will be monitored by a measurement plan to ensure the organisation reviews its approaches towards clinical engagement. PMID:24434856

  12. What makes clinical research ethical?

    PubMed

    Emanuel, E J; Wendler, D; Grady, C

    Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711. PMID:10819955

  13. On the Merits of Clinical Judgment: Comment

    ERIC Educational Resources Information Center

    Garb, Howard N.; Grove, William M.

    2005-01-01

    This paper presents comments on the article by D. Westen and J. Weinberger , which criticized academic clinical psychologists for being cynical about clinical judgment and clinical practice. In the authors' view, it seems unlikely that more than a few academic clinical psychologists believe that they have little to learn from clinical practice or…

  14. 75 FR 57472 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... HUMAN SERVICES Food and Drug Administration Clinical Investigator Training Course AGENCY: Food and Drug... Programs, in cosponsorship with the Clinical Trials Transformation Initiative (CTTI), is announcing a 3-day... clinical trials (clinical investigators). This course is intended to assist clinical investigators...

  15. Clinical Leadership: A Call to Action.

    PubMed

    Grindel, Cecelia Gatson

    2016-01-01

    Clinical nurses are expected to assume leadership roles to enhance patient care and assure efficient work processes. Dimensions of clinical leadership and the essential knowledge and skills of the clinical leader are described. PMID:27044123

  16. National Institutes of Health, Clinical Center

    MedlinePlus

    ... safety and continuous improvement. Find us on social media: NIH Clinical Center NIH Blood Bank @NIHClinicalCntr @CCMedEd Clinical Center TV Privacy Statement | Accessibility | Plain Language | FOIA | Disclaimer Clinical ...

  17. Bayesian Clinical Trials in Action

    PubMed Central

    Lee, J. Jack; Chu, Caleb T.

    2012-01-01

    Although the frequentist paradigm has been the predominant approach to clinical trial design since the 1940s, it has several notable limitations. The alternative Bayesian paradigm has been greatly enhanced by advancements in computational algorithms and computer hardware. Compared to its frequentist counterpart, the Bayesian framework has several unique advantages, and its incorporation into clinical trial design is occurring more frequently. Using an extensive literature review to assess how Bayesian methods are used in clinical trials, we find them most commonly used for dose finding, efficacy monitoring, toxicity monitoring, diagnosis/decision making, and for studying pharmacokinetics/pharmacodynamics. The additional infrastructure required for implementing Bayesian methods in clinical trials may include specialized software programs to run the study design, simulation, and analysis, and Web-based applications, which are particularly useful for timely data entry and analysis. Trial success requires not only the development of proper tools but also timely and accurate execution of data entry, quality control, adaptive randomization, and Bayesian computation. The relative merit of the Bayesian and frequentist approaches continues to be the subject of debate in statistics. However, more evidence can be found showing the convergence of the two camps, at least at the practical level. Ultimately, better clinical trial methods lead to more efficient designs, lower sample sizes, more accurate conclusions, and better outcomes for patients enrolled in the trials. Bayesian methods offer attractive alternatives for better trials. More such trials should be designed and conducted to refine the approach and demonstrate its real benefit in action. PMID:22711340

  18. Clinical Utility of Quantitative Imaging

    PubMed Central

    Rosenkrantz, Andrew B; Mendiratta-Lala, Mishal; Bartholmai, Brian J.; Ganeshan, Dhakshinamoorthy; Abramson, Richard G.; Burton, Kirsteen R.; Yu, John-Paul J.; Scalzetti, Ernest M.; Yankeelov, Thomas E.; Subramaniam, Rathan M.; Lenchik, Leon

    2014-01-01

    Quantitative imaging (QI) is increasingly applied in modern radiology practice, assisting in the clinical assessment of many patients and providing a source of biomarkers for a spectrum of diseases. QI is commonly used to inform patient diagnosis or prognosis, determine the choice of therapy, or monitor therapy response. Because most radiologists will likely implement some QI tools to meet the patient care needs of their referring clinicians, it is important for all radiologists to become familiar with the strengths and limitations of QI. The Association of University Radiologists Radiology Research Alliance Quantitative Imaging Task Force has explored the clinical application of QI and summarizes its work in this review. We provide an overview of the clinical use of QI by discussing QI tools that are currently employed in clinical practice, clinical applications of these tools, approaches to reporting of QI, and challenges to implementing QI. It is hoped that these insights will help radiologists recognize the tangible benefits of QI to their patients, their referring clinicians, and their own radiology practice. PMID:25442800

  19. Malaria Diagnostics in Clinical Trials

    PubMed Central

    Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann

    2013-01-01

    Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wide array of available malaria diagnostic tests for their suitability for screening trial participants and/or obtaining study endpoints for malaria clinical trials, including studies of HIV/malaria co-infection and other malaria natural history studies. The MLN provides recommendations on microscopy, rapid diagnostic tests, serologic tests, and molecular assays to guide selection of the most appropriate test(s) for specific research objectives. In addition, this report provides recommendations regarding quality management to ensure reproducibility across sites in clinical trials. Performance evaluation, quality control, and external quality assessment are critical processes that must be implemented in all clinical trials using malaria tests. PMID:24062484

  20. The web of clinical data.

    PubMed

    Gori, M; Campiani, G; Rossi, A; Setacci, C

    2014-07-17

    Eric J. Topol, in his popular book, "The creative destruction of medicine: How the Digital Revolution Will Create Better Health Care", claims that medicine will inevitably be Schumpetered in the coming years. Interestingly, while we can afford to digitize the genome, to record any single heartbeat, and provide real--time measures of myriads of medical data, we are still missing a crucial catalyzer for strongly accelerating the Schumpetering: The "Web of Clinical Data". In this paper, we hypothesized its birth as the outcome of a viral collection of anonymized personal health records, that are made publicly available to scientists and professionals in medicine. Such a universal collection would not represent only a truly paradigm shift on the access to clinical data, but it would open the doors to the new grand challenge of building decision support systems that operate on a universal repository on the basis of the content of the health records and on clinical similarities. PMID:25030048

  1. Clinical applications of bacterial glycoproteins.

    PubMed

    Fulton, Kelly M; Smith, Jeffrey C; Twine, Susan M

    2016-04-01

    There is an ongoing race between bacterial evolution and medical advances. Pathogens have the advantages of short generation times and horizontal gene transfer that enable rapid adaptation to new host environments and therapeutics that currently outpaces clinical research. Antibiotic resistance, the growing impact of nosocomial infections, cancer-causing bacteria, the risk of zoonosis, and the possibility of biowarfare all emphasize the increasingly urgent need for medical research focussed on bacterial pathogens. Bacterial glycoproteins are promising targets for alternative therapeutic intervention since they are often surface exposed, involved in host-pathogen interactions, required for virulence, and contain distinctive glycan structures. The potential exists to exploit these unique structures to improve clinical prevention, diagnosis, and treatment strategies. Translation of the potential in this field to actual clinical impact is an exciting prospect for fighting infectious diseases. PMID:26971465

  2. Clinical utility of curcumin extract.

    PubMed

    Asher, Gary N; Spelman, Kevin

    2013-01-01

    Turmeric root has been used medicinally in China and India for thousands of years. The active components are thought to be the curcuminoids, primarily curcumin, which is commonly available worldwide as a standardized extract. This article reviews the pharmacology of curcuminoids, their use and efficacy, potential adverse effects, and dosage and standardization. Preclinical studies point to mechanisms of action that are predominantly anti-inflammatory and antineoplastic, while early human clinical trials suggest beneficial effects for dyspepsia, peptic ulcer, inflammatory bowel disease, rheumatoid arthritis, osteoarthritis, uveitis, orbital pseudotumor, and pancreatic cancer. Curcumin is well-tolerated; the most common side effects are nausea and diarrhea. Theoretical interactions exist due to purported effects on metabolic enzymes and transport proteins, but clinical reports do not support any meaningful interactions. Nonetheless, caution, especially with chemotherapy agents, is advised. Late-phase clinical trials are still needed to confirm most beneficial effects. PMID:23594449

  3. [Clinical examinations in Usher's syndrome].

    PubMed

    Lubiński, W; Palacz, O; Zajaczek, S

    1996-01-01

    In this paper we are showing the results of clinical examinations in the family in which three siblings had the following symptoms: congenital deafness and nyctalopia. Clinical examinations including genetic counseling, audiometry, caloric test, Flash ERG, perimetry, computer tomography revealed total deafness, no vestibular function, and an advanced stage of retinitis pigmentosa. On the basis of clinical results, we determined the correct diagnosis: autosomal recessive Usher's syndrome-type 1. Diagnosis of the syndrome enables qualification of prognosis, complications, possibility of treatment and the risk of having the disease in the next generations. Early identification of the presence of Usher's syndrome can help in the formulation of an appropriate educational and training program. It seems purposeful that all patients with hearing loss should be examined by ophthalmologists. PMID:9019578

  4. Who attends family planning clinics?

    PubMed

    Chick, P; Nixon, J

    1984-08-01

    Data were obtained from 1,810 consecutive women who attended a central metropolitan (Brisbane) Family Planning Clinic during a 5 week period in 1982. Young women in particular formed the major client group with 32% being under 20 years of age. The client population was skewed towards women of upper socioeconomic status (SES). There was no SES disproportion in the use of oral contraceptives or IUD's. However, diaphragm use occurred disproportionately in women of upper SES groups; postcoital contraception was sought by and limited to, women of SES classes A and B only. The clinic satisfied a need for women with a history of failed or absent contraception and 15% had already had a termination of pregnancy by the time they first presented at the clinic. PMID:6596088

  5. Clinical imaging of the pancreas

    SciTech Connect

    May, G.; Gardiner, R.

    1987-01-01

    Featuring more than 300 high-quality radiographs and scan images, clinical imaging of the pancreas systematically reviews all appropriate imaging modalities for diagnosing and evaluating a variety of commonly encountered pancreatic disorders. After presenting a succinct overview of pancreatic embryology, anatomy, and physiology, the authors establish the clinical indications-including postoperative patient evaluation-for radiologic examination of the pancreas. The diagnostic capabilities and limitations of currently available imaging techniques for the pancreas are thoroughly assessed, with carefully selected illustrations depicting the types of images and data obtained using these different techniques. The review of acute and chronic pancreatitis considers the clinical features and possible complications of their variant forms and offers guidance in selecting appropriate imaging studies.

  6. Advances in clinical forensic medicine.

    PubMed

    Santucci, Karen A; Hsiao, Allen L

    2003-06-01

    Clinical forensic medicine is the branch of medicine that deals specifically with cases involving both legal and medical aspects of patient care. A forensic evaluation refers to the detection, collection, and preservation of evidence. Pattern injury recognition, interpretation of injuries, documentation of testimonial and injuries (including photography), reporting requirements, and regulations are all vital components of a forensic evaluation, but are rarely the topic of discussion in training hospitals. Medical professionals working in prehospital care and acute care settings are likely to encounter perplexing forensic issues related to child abuse, sexual assault, or unexpected childhood death in their practice. This article focuses on the most recent insights related to sexual assault and forensic evidence as it relates to successful prosecution, shaken baby syndrome, and pediatric nonaccidental thermal injury. Also reviewed are the most current publications related to clinical forensic medicine for the year 2002, incorporating practical clinical tips from the most informative articles from the past decade. PMID:12806262

  7. Clinical microbiology of coryneform bacteria.

    PubMed Central

    Funke, G; von Graevenitz, A; Clarridge, J E; Bernard, K A

    1997-01-01

    Coryneform bacteria are aerobically growing, asporogenous, non-partially-acid-fast, gram-positive rods of irregular morphology. Within the last few years, there has been a massive increase in the number of publications related to all aspects of their clinical microbiology. Clinical microbiologists are often confronted with making identifications within this heterogeneous group as well as with considerations of the clinical significance of such isolates. This review provides comprehensive information on the identification of coryneform bacteria and outlines recent changes in taxonomy. The following genera are covered: Corynebacterium, Turicella, Arthrobacter, Brevibacterium, Dermabacter. Propionibacterium, Rothia, Exiguobacterium, Oerskovia, Cellulomonas, Sanguibacter, Microbacterium, Aureobacterium, "Corynebacterium aquaticum," Arcanobacterium, and Actinomyces. Case reports claiming disease associations of coryneform bacteria are critically reviewed. Minimal microbiological requirements for publications on disease associations of coryneform bacteria are proposed. PMID:8993861

  8. Developmental thermography [4]: clinical evaluation

    NASA Astrophysics Data System (ADS)

    Nagasawa, Akinori; Katoh, Kazuichi

    1993-06-01

    This paper presents the data examples for clinical application of the authors' original thermographic techniques named developmental thermography (DT); (1) triple aspect thermography (TAT), (2) multiple aspect thermography (MAT) and (3) panoramic thermography (PT). Appropriate examples for the advantageous application for each technique of DT are selected and the specific advantages are discussed. The greatest advantage in the clinical application of DT is the capability of simultaneous display of the thermogram over even the entire aspect of a subject, and so DT has a lot of advantages in clinical application. Error free and wide coverage in DT are especially useful for the diagnosis of cancer. DT is expected to contribute to future advance of medical thermology.

  9. Clinical development of Ebola vaccines

    PubMed Central

    Sridhar, Saranya

    2015-01-01

    The ongoing outbreak of Ebola virus disease in West Africa highlighted the lack of a licensed drug or vaccine to combat the disease and has renewed the urgency to develop a pipeline of Ebola vaccines. A number of different vaccine platforms are being developed by assessing preclinical efficacy in animal models and expediting clinical development. Over 15 different vaccines are in preclinical development and 8 vaccines are now in different stages of clinical evaluation. These vaccines include DNA vaccines, virus-like particles and viral vectors such as live replicating vesicular stomatitis virus (rVSV), human and chimpanzee adenovirus, and vaccinia virus. Recently, in preliminary results reported from the first phase III trial of an Ebola vaccine, the rVSV-vectored vaccine showed promising efficacy. This review charts this rapidly advancing area of research focusing on vaccines in clinical development and discusses the future opportunities and challenges faced in the licensure and deployment of Ebola vaccines. PMID:26668751

  10. [Lipedema: clinical and diagnostic criteria].

    PubMed

    Bilancini, S; Lucchi, M; Tucci, S

    1990-01-01

    Lipedema is a common disease in the usual clinical practice. None organic description about the clinical symptoms and signs associated to this condition has been published. Fifty women with lipedema have been examined by the authors, and incidence rates of symptoms and signs have been emphasized. The following signs and symptoms were constantly reported: "Egyptian column", elastic edema, negative Stemmer's sign, alterated plantar support, cutaneous hypothermia. Some others were frequently found: ecchymosis, spontaneous pain, liposclerosis on the thigh, hypodermic hyperalgesia and pain on the internal face of the knee. Moreover, the two most relevant differential diagnosis as well as their two variant's clinical features (mixed lipedema and "thin women" lipedema) have been described. PMID:2248420

  11. Clinical Scientists Improving Clinical Practices: In Thoughts and Actions

    ERIC Educational Resources Information Center

    Apel, Kenn

    2014-01-01

    Purpose: In this article, the author comments on aspects of Kamhi's (2014) article, which caused the author to think more deeply about definitions of language, theories of learning, and how these two core components of intervention prepare clinical scientists as they search the literature for new knowledge. Interprofessional collaborative…

  12. Physicians Reentering Clinical Practice: Characteristics and Clinical Abilities

    ERIC Educational Resources Information Center

    Grace, Elizabeth S.; Korinek, Elizabeth J.; Weitzel, Lindsay B.; Wentz, Dennis K.

    2011-01-01

    Introduction: Limited information exists to describe physicians who return to practice after absences from patient care. The Center for Personalized Education for Physicians (CPEP) is an independent, not-for-profit organization that provides clinical competency assessment and educational programs for physicians, including those reentering…

  13. Death Anxiety in Clinical and Non-Clinical Groups

    ERIC Educational Resources Information Center

    Abdel-Khalek, Ahmed M.

    2005-01-01

    The Arabic Scale of Death Anxiety (ASDA) was administered, individually, to 7 groups (N=765) of Egyptian normal participants (non-clinical), anxiety disorder patients, and patients suffering from schizophrenia (males and females), and addicts (males only). They were generally matched as groups according to age, occupation, and education. The…

  14. Counterpoint: clinical neuroscience is not ready for clinical use.

    PubMed

    Rego, Mark D

    2016-04-01

    Radical proposals are being made to change the practice, teaching and research basis of psychiatry to that of clinical neuroscience. Such changes would affect practice via what is studied, published, recommended as standard treatment and what is decided in medico-legal forums. These proposed changes are very premature and misguided. Here, I refute these proposals. PMID:27036693

  15. Gatekeepers for pragmatic clinical trials.

    PubMed

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding the use of limited and valuable resources. PMID:26374683

  16. Independent clinical trials: a commentary.

    PubMed

    Cocconi, Giorgio

    2002-01-01

    The so-called norms of good clinical practice have been incorporated into the Italian regulatory legislation governing clinical trials sponsored by pharmaceutical companies, but there are no legislative provisions governing independent clinical trials: ie those not sponsored by the industry. The pharmaceutical industry has recently increased considerably its commitment to sponsored trials by establishing a series of economic relationships with individual researchers and hospital or university institutions. It has also set up and strengthened a series of bodies and service companies with the aim of making the clinical trials "machine" more efficient. Such developments have aroused alarm in the medical literature because of the risk that they may have negative effects on the freedom of research and research results. At the same time, there is also the risk that independent clinical trials will be greatly penalized by having to compete with sponsored trials in terms of patient enrollment, and because they are currently having to face a series of difficulties connected with the lack or scarcity of economic resources provided by the State or non-profit organizations, with problems relating to patient insurance and to the availability of the necessary drugs. However, the objective of independent trials is to improve the medical art by answering specific diagnostic and therapeutic questions, whereas that of industry-sponsored trials is to generate money, directly or indirectly, by means of the registration of new drugs. It is therefore now necessary to ensure better surveillance of the influence of pharmaceutical companies over the trials they sponsor (as a minimum by ensuring the transparency of a series of potential conflicts of interest between them and clinical researchers) and, simultaneously, protect independent trials from coming to an inglorious end by means of specific support initiatives such as those proposed in this article. PMID:12088263

  17. New developments in clinical CARS

    NASA Astrophysics Data System (ADS)

    Weinigel, Martin; Breunig, Hans Georg; Kellner-Höfer, Marcel; Bückle, Rainer; Darvin, Maxim; Lademann, Juergen; König, Karsten

    2013-02-01

    We combined two-photon fluorescence and coherent anti-Stokes Raman scattering (CARS) imaging in a clinical hybrid multiphoton tomograph for in vivo imaging of human skin. The clinically approved TPEF/CARS system provides simultaneous imaging of endogenous fluorophores and non-fluorescent lipids. The Stokes laser for the two-beam configuration of CARS is based on spectral broadening of femtosecond laser pulses in a photonic crystal fiber (PCF). We report on the highly flexible medical TPEF/CARS tomograph MPTflex®-CARS with an articulated arm and first in vivo measurements on human skin.

  18. Oral cysticercosis: a clinical dilemma.

    PubMed

    Wanjari, Sangeeta Panjab; Patidar, Kalpana A; Parwani, Rajkumar N; Tekade, Satyajitraje A

    2013-01-01

    Cysticercosis is a potentially fatal parasitic disease caused by cysticercus cellulosae, the larval stage of Taenia solium. Oral cysticercosis is a rare entity and represents difficulty in clinical diagnosis. This article reports two cases of oral cysticercosis involving buccal and labial mucosa. Both the cases presented with solitary, nodular swelling that had been clinically diagnosed as a mucocele. Histopathology of excisional biopsy revealed it to be cysticercosis. Single, cystic nodular swelling of oral cavity may be the only evidence of cysticercosis and may present first to dentist. These cases emphasise the role of dentist and thorough histopathological examination in the early diagnosis of disease that can prevent potential systemic complication. PMID:23580668

  19. Clinical myths of forensic neuropsychology.

    PubMed

    Greiffenstein, Manfred F

    2009-02-01

    Clinical myths and lore are unfounded beliefs that still influence practice decisions. I examine the validity of six beliefs commonly encountered in forensic neuropsychology practice: the admissibility of test batteries; avoidance of practice effects; forewarning insures good effort; average deficits in bright persons; 15% chronic impairment in mild brain injury; and examiner bias causing malingering. I show these beliefs are invalid because of material misunderstandings of case law and literature, falsification by empirical findings, and lack of authoritative sources. The benefits, costs, and persistence of clinical myths are discussed. PMID:18609338

  20. Practitioner involvement in clinical evaluation.

    PubMed

    Penka, C E; Kirk, S A

    1991-11-01

    Contrary to popular belief, social workers are evaluating their practice, but what they do falls short of the use of quantitative procedures that researchers have promoted. Data obtained from a survey of social workers drawn from the National Association of Social Workers national membership list suggest that the gap between practitioners and clinical researchers may stem in part from different mindsets as well as from actual differences in the commitment to the importance of clinical evaluation. Moreover, in the minds of practitioners there appears to be a sharp distinction between formal single-subject design studies and the general evaluative tasks in which they routinely engage. PMID:1754928

  1. [Clinical studies in prostatic carcinoma].

    PubMed

    Kumanov, Kh; Tsvetkov, M

    1993-01-01

    Carcinoma of the prostate is a widespread disease posing serious problems, especially when patient in stage T3-T4 are concerned. Proceeding from clinical observations on 269 patients presenting the aforementioned condition, and on the basis of thorough clinical, laboratory and histologic studies, a combined therapeutic approach using cyproterone acetate is adopted, supplemented by orchiectomy in some patients, and transurethral resection in others. After 3-month treatment course, changes in the level of microelements, copper, zinc and iron in particular, are recorded. In some cases the level of prostate specific antigen is lowered. Control of the underlying disease is successfully attained in 72 per cent of the patients. PMID:7983831

  2. Handbook of clinical nursing practice

    SciTech Connect

    Asheervath, J.; Blevins, D.R.

    1986-01-01

    Written in outline format, this reference will help nurses further their understanding of advanced nursing procedures. Information is provided on the physiological, psychological, environmental, and safety considerations of nursing activities associated with diagnostic and therapeutic procedures. Special consideration is given to the areas of pediatric nursing, nursing assessment, and selected radiologic and nuclear medicine procedures for each system. Contents: Clinical Introduction. Clinical Nursing Practice: Focus on Basics. Focus on Cardiovascular Function. Focus on Respiratory Function. Focus on Gastrointestinal Function. Focus on Renal and Genito-Urological Function. Focus on Neuro-Skeletal and Muscular Function. Appendices.

  3. Electrochemical Sensors for Clinic Analysis

    PubMed Central

    Wang, You; Xu, Hui; Zhang, Jianming; Li, Guang

    2008-01-01

    Demanded by modern medical diagnosis, advances in microfabrication technology have led to the development of fast, sensitive and selective electrochemical sensors for clinic analysis. This review addresses the principles behind electrochemical sensor design and fabrication, and introduces recent progress in the application of electrochemical sensors to analysis of clinical chemicals such as blood gases, electrolytes, metabolites, DNA and antibodies, including basic and applied research. Miniaturized commercial electrochemical biosensors will form the basis of inexpensive and easy to use devices for acquiring chemical information to bring sophisticated analytical capabilities to the non-specialist and general public alike in the future.

  4. Oral cysticercosis: a clinical dilemma

    PubMed Central

    Wanjari, Sangeeta Panjab; Patidar, Kalpana A; Parwani, Rajkumar N; Tekade, Satyajitraje A

    2013-01-01

    Cysticercosis is a potentially fatal parasitic disease caused by cysticercus cellulosae, the larval stage of Taenia solium. Oral cysticercosis is a rare entity and represents difficulty in clinical diagnosis. This article reports two cases of oral cysticercosis involving buccal and labial mucosa. Both the cases presented with solitary, nodular swelling that had been clinically diagnosed as a mucocele. Histopathology of excisional biopsy revealed it to be cysticercosis. Single, cystic nodular swelling of oral cavity may be the only evidence of cysticercosis and may present first to dentist. These cases emphasise the role of dentist and thorough histopathological examination in the early diagnosis of disease that can prevent potential systemic complication. PMID:23580668

  5. Clinical Subtypes of Frontotemporal Dementia.

    PubMed

    Ghosh, Sayantani; Lippa, Carol F

    2015-11-01

    Frontotemporal dementia (FTD) was one of the lesser known dementias until the recent advancements revealing its genetic and pathological foundation. This common neurodegenerative disorder has three clinical subtypes- behavioral, semantic and progressive non fluent aphasia. The behavioral variant mostly exhibits personality changes, while the other two encompass various language deficits. This review discusses the basic pathology, genetics, clinical and histological presentation and the diagnosis of the 3 subtypes. It also deliberates the different therapeutic modalities currently available for frontotemporal dementia and the challenges faced by the caregivers. Lastly it explores the scope of further research into the diagnosis and management of FTD. PMID:23813692

  6. [Women, forgotten by clinical research].

    PubMed

    Potterat, M M; Monnin, Y; Pechère, A; Guessous, I

    2015-09-23

    For years, women were underrepresented in clinical studies. But the effect of many drugs differ among women and men, due to pharmacokinetic and pharmacodynamic differences. As a result, there is a lack of information on therapeutic or adverse effets of drugs and, more generally, a lack of knowledge on diseases, leading more frequently to sub-optimal medical care in women. This underrepresentation is due to various factors, including the social role of women or ethical issues about pregnancy. The need for adequate representation of women in clinical studies is a social as well as medical concern, that implies political and legal changes. PMID:26591785

  7. Clinical management of pulmonary sarcoidosis.

    PubMed

    Zhou, Ying; Lower, Elyse E; Li, Huiping; Baughman, Robert P

    2016-05-01

    Sarcoidosis is a multisystem disease for which diagnosis relies on the integration of clinical, radiologic, laboratory, and pathologic information. Assessment of clinical features is an important part of the disease evaluation. Computer Tomography provides information not available on routine chest roentgenogram which can assist diagnosing and establishing extent of disease. Monitoring for pulmonary and extra-pulmonary disease facilitates disease management. Patients with quality of life affecting symptoms or threatened end organ damage require systemic treatment which can be recommended in a stepwise fashion. Here, we provide guidance for the initial assessment, disease monitoring, and treatment recommendations for pulmonary and extra pulmonary disease. PMID:26959110

  8. Peptide radioimmunoassays in clinical medicine

    SciTech Connect

    Geokas, M.C.; Yalow, R.S.; Straus, E.W.; Gold, E.M.

    1982-09-01

    The radioimmunoassay technique, first developed for the determination of hormones, has been applied to many substances of biologic interest by clinical and research laboratories around the world. It has had an enormous effect in medicine and biology as a diagnostic tool, a guide to therapy, and a probe for the fine structure of biologic systems. For instance, the assays of insulin, gastrin, secretin, prolactin, and certain tissue-specific enzymes have been invaluable in patient care. Further refinements of current methods, as well as the emergence of new immunoassay techniques, are expected to enhance precision, specificity, reliability, and convenience of the radioimmunoassay in both clinical and research laboratories.

  9. Clinical significance of neonatal menstruation.

    PubMed

    Brosens, Ivo; Benagiano, Giuseppe

    2016-01-01

    Past studies have clearly shown the existence of a spectrum of endometrial progesterone responses in neonatal endometrium, varying from proliferation to full decidualization with menstrual-like shedding. The bleedings represent, similar to what occurs in adult menstruation, a progesterone withdrawal bleeding. Today, the bleeding is completely neglected and considered an uneventful episode of no clinical significance. Yet clinical studies have linked the risk of bleeding to a series of events indicating fetal distress. The potential link between the progesterone response and major adolescent disorders requires to be investigated by prospective studies. PMID:26685798

  10. 42 CFR 405.2450 - Clinical psychologist and clinical social worker services.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 2 2014-10-01 2014-10-01 false Clinical psychologist and clinical social worker... 405.2450 Clinical psychologist and clinical social worker services. (a) For clinical psychologist or clinical social worker professional services to be payable under this subpart, the services must be...

  11. 42 CFR 405.2450 - Clinical psychologist and clinical social worker services.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 2 2012-10-01 2012-10-01 false Clinical psychologist and clinical social worker... 405.2450 Clinical psychologist and clinical social worker services. (a) For clinical psychologist or clinical social worker professional services to be payable under this subpart, the services must be...

  12. 42 CFR 405.2450 - Clinical psychologist and clinical social worker services.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 2 2013-10-01 2013-10-01 false Clinical psychologist and clinical social worker... 405.2450 Clinical psychologist and clinical social worker services. (a) For clinical psychologist or clinical social worker professional services to be payable under this subpart, the services must be...

  13. How clinical decisions are made

    PubMed Central

    Bate, Louise; Hutchinson, Andrew; Underhill, Jonathan; Maskrey, Neal

    2012-01-01

    There is much variation in the implementation of the best available evidence into clinical practice. These gaps between evidence and practice are often a result of multiple individual decisions. When making a decision, there is so much potentially relevant information available, it is impossible to know or process it all (so called ‘bounded rationality’). Usually, a limited amount of information is selected to reach a sufficiently satisfactory decision, a process known as satisficing. There are two key processes used in decision making: System 1 and System 2. System 1 involves fast, intuitive decisions; System 2 is a deliberate analytical approach, used to locate information which is not instantly recalled. Human beings unconsciously use System 1 processing whenever possible because it is quicker and requires less effort than System 2. In clinical practice, gaps between evidence and practice can occur when a clinician develops a pattern of knowledge, which is then relied on for decisions using System 1 processing, without the activation of a System 2 check against the best available evidence from high quality research. The processing of information and decision making may be influenced by a number of cognitive biases, of which the decision maker may be unaware. Interventions to encourage appropriate use of System 1 and System 2 processing have been shown to improve clinical decision making. Increased understanding of decision making processes and common sources of error should help clinical decision makers to minimize avoidable mistakes and increase the proportion of decisions that are better. PMID:22738381

  14. [Clinical pathway "Acute Coronary Syndrome"].

    PubMed

    Grimm, W; Maisch, B

    2006-07-01

    The clinical pathway "acute coronary syndrome" of the university hospital Marburg describes the guideline-conform and consented management of patients with ST-segment elevation infarct (STEMI), non-ST-segment elevation infarct (NSTEMI) and Troponin negative unstable angina. A 12-lead ECG recording is made and read in all patients within 10 minutes. All patients with STEMI undergo immediate revascularisation using primary percutanuous catheter intervention (PCI) after administration of basic medical therapy. Primary PCI is also used in all patients with NSTEMI, persistent chest pain, rhythm or hemodynamic instability. Patients with unstable angina, who became free of symptoms after application of basic medication, but who have additional risk factors undergo cardiac catheterisation within 48 hours. Acute myocardial infarction can be ruled out in patients with twofold negative cardiac troponin levels during 6-12 hours. In the absence of further symptoms, these patiens undergo differential diagnostic evaluation of cardiac and extracardiac causes of chest pain. The introduction of this clinical pathway 2 years ago, which was consented before by the hospital board and the clinical directors, has lead to a remarkable improvement in the clinical decision-making at the emergency room of the hospital and reduced the door to intervention time considerably. PMID:16763796

  15. The Future of Clinical Dentistry.

    ERIC Educational Resources Information Center

    Slavkin, Harold C.

    1998-01-01

    Discussion of the future of clinical dentistry looks at a variety of influences, including historical development factors; demographic trends; the role of the Human Genome Project in the development of scientific knowledge; a paradigm shift in approaches to oral infection and systemic disease; advancing technology; and reforms resulting from these

  16. Instructional Development for Clinical Settings.

    ERIC Educational Resources Information Center

    Cranton, P. A.

    Clinical teaching involves instruction in a natural health-related environment which allows students to observe and participate in the actual practice of the profession. The use of objectives, the sequence of instruction, the instructional methods and materials, and the evaluation of student performance constitute the components studied in

  17. Clinical Bioinformatics: challenges and opportunities

    PubMed Central

    2012-01-01

    Background Network Tools and Applications in Biology (NETTAB) Workshops are a series of meetings focused on the most promising and innovative ICT tools and to their usefulness in Bioinformatics. The NETTAB 2011 workshop, held in Pavia, Italy, in October 2011 was aimed at presenting some of the most relevant methods, tools and infrastructures that are nowadays available for Clinical Bioinformatics (CBI), the research field that deals with clinical applications of bioinformatics. Methods In this editorial, the viewpoints and opinions of three world CBI leaders, who have been invited to participate in a panel discussion of the NETTAB workshop on the next challenges and future opportunities of this field, are reported. These include the development of data warehouses and ICT infrastructures for data sharing, the definition of standards for sharing phenotypic data and the implementation of novel tools to implement efficient search computing solutions. Results Some of the most important design features of a CBI-ICT infrastructure are presented, including data warehousing, modularity and flexibility, open-source development, semantic interoperability, integrated search and retrieval of -omics information. Conclusions Clinical Bioinformatics goals are ambitious. Many factors, including the availability of high-throughput "-omics" technologies and equipment, the widespread availability of clinical data warehouses and the noteworthy increase in data storage and computational power of the most recent ICT systems, justify research and efforts in this domain, which promises to be a crucial leveraging factor for biomedical research. PMID:23095472

  18. Stimulability: A Useful Clinical Tool.

    ERIC Educational Resources Information Center

    Powell, Thomas W.; Miccio, Adele W.

    1996-01-01

    This article for clinicians treating children with phonological disorders reviews changing trends in the definition of stimulability, standardized and nonstandardized approaches to its measurement, and clinical implications of stimulability for prognosis and treatment plan development as they have evolved over a 40-year period. Clinical…

  19. Ongoing clinical trials in AKI.

    PubMed

    Faubel, Sarah; Chawla, Lakhmir S; Chertow, Glenn M; Goldstein, Stuart L; Jaber, Bertrand L; Liu, Kathleen D

    2012-05-01

    AKI is an important public health issue. AKI is a common hospital complication associated with increased in-hospital and long-term mortality, extensive morbidity (including prolonged hospital length of stay), and an estimated annual cost of at least $10 billion in the United States. At present, no specific therapy has been developed to prevent AKI, hasten recovery of kidney function, or abrogate the deleterious systemic effects of AKI. However, recent progress includes establishing a consensus definition of AKI and discovery of novel biomarkers that may allow early detection of AKI. Furthermore, significant insights into the pathophysiology of AKI and its deleterious systemic effects have been gleaned from animal studies. Urgently needed are large, definitive randomized clinical trials testing interventions to prevent and/or treat AKI. This review summarizes and analyzes current ongoing clinical trials registered with clinicaltrials.gov that address prevention or management of AKI. The purpose of this review is to provide a resource for people interested in potential prophylactic and therapeutic approaches to patient care and investigators hoping to plan and execute the next round of randomized clinical trials. Finally, this review discusses research needs that are not addressed by the current clinical trials portfolio and suggests key areas for future research in AKI. PMID:22442183

  20. Effect Size in Clinical Phonology

    ERIC Educational Resources Information Center

    Gierut, Judith A.; Morrisette, Michele L.

    2011-01-01

    The purpose of this article is to motivate the use of effect size (ES) for single-subject research in clinical phonology, with an eye towards meta-analyses of treatment effects for children with phonological disorders. Standard mean difference (SMD) is introduced and illustrated as one ES well suited to the multiple baseline (MBL) design and

  1. Supervisees' Perception of Clinical Supervision

    ERIC Educational Resources Information Center

    Willis, Lisa

    2010-01-01

    Supervisors must become aware of the possible conflicts that could arise during clinical supervision. It is important that supervisors communicate their roles and expectations effectively with their supervisees. This paper supports the notion that supervision is a mutual agreement between the supervisee and the supervisor and the roles of…

  2. Assessment of Clinical Supervisor Competencies.

    ERIC Educational Resources Information Center

    Getz, Hildy

    1999-01-01

    Presents a focus and process to assist those training clinical supervisors to assess competencies of the supervisor. States that process creates a practical framework that can be adapted for supervision competencies in other fields. Concludes that assessment methodology gives meaning to the support and structure vital at all levels of training…

  3. Therapeutic Communication and Clinical Instruction.

    ERIC Educational Resources Information Center

    Karns, Phyllis J.; Schwab, Therese A.

    1982-01-01

    The use of interpersonal skills can greatly enhance the learning process, not only by reducing stress, but also by significantly increasing cognitive growth in students. The authors review these findings and discuss their application to teaching in the clinical area. (CT)

  4. Current clinical approach to achalasia

    PubMed Central

    Eckardt, Alexander J; Eckardt, Volker F

    2009-01-01

    Idiopathic achalasia is a rare primary motility disorder of the esophagus. The classical features are incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and a lack of peristalsis in the tubular esophagus. These motor abnormalities lead to dysphagia, stasis, regurgitation, weight loss, or secondary respiratory complications. Although major strides have been made in understanding the pathogenesis of this rare disorder, including a probable autoimmune mediated destruction of inhibitory neurons in response to an unknown insult in genetically susceptible individuals, a definite trigger has not been identified. The diagnosis of achalasia is suggested by clinical features and confirmed by further diagnostic tests, such as esophagogastroduodenoscopy (EGD), manometry or barium swallow. These studies are not only used to exclude pseudoachalasia, but also might help to categorize the disease by severity or clinical subtype. Recent advances in diagnostic methods, including high resolution manometry (HRM), might allow prediction of treatment responses. The primary treatments for achieving long-term symptom relief are surgery and endoscopic methods. Although limited high-quality data exist, it appears that laparoscopic Heller myotomy with partial fundoplication is superior to endoscopic methods in achieving long-term relief of symptoms in the majority of patients. However, the current clinical approach to achalasia will depend not only on patients’ characteristics and clinical subtypes of the disease, but also on local expertise and patient preferences. PMID:19705490

  5. A clinical perspective on dying

    PubMed Central

    Janes, Robert G.

    1972-01-01

    There is continuing need for dissemination of already available, clinically useful knowledge concerning the psychological needs of the seriously ill and dying. Against the changing social context of dying, some of our erroneous assumptions about these patients are explored and the genuine fears and personal needs are discussed. The implications of this knowledge for medical education are recognized. PMID:5074753

  6. Autism: Clinical and Research Issues.

    ERIC Educational Resources Information Center

    Accardo, Pasquale J., Ed.; Magnusen, Christy, Ed.; Capute, Arnold J., Ed.

    This text examines the characteristics that define autism: impairments in communication; abnormal social development; and clinically significant odd behaviors. Specific chapters include: (1) Neural Mechanisms in Autism (Andrew W. Zimmerman and Barry Gordon); (2) Epidemiology of Autism and Other Pervasive Developmental Disorders: Current…

  7. Improving transparency of clinical trials.

    PubMed

    Dal-R, Rafael

    2015-06-01

    Recent data reveal that subtle selective publication affects critical aspects of trial reporting, in some cases altering the interpretation of results. Timely prospective registration could help deter selective reporting and clinical trial stakeholders from government authorities to journal editors should work together to foster prospective registration of trials. PMID:25596802

  8. Clinical Judgment in Science: Reply

    ERIC Educational Resources Information Center

    Westen, Drew; Weinberger, Joel

    2005-01-01

    This paper presents replies to comments published by M. S. Schulz and R. J. Waldinger, J. M. Wood and M. T. Nezworski, and H. N. Garb and W. M. Grove on the original article by D. Westen and J. Weinberger. Schulz and Waldinger (2005) make the important point that just as researchers can capitalize on the knowledge of experienced clinical observers…

  9. Pericardial disease: a clinical review.

    PubMed

    Yusuf, Syed Wamique; Hassan, Saamir A; Mouhayar, Elie; Negi, Smita I; Banchs, Jose; O'Gara, Patrick T

    2016-04-01

    Pericardial disease is infrequently encountered in cardiovascular practice, but can lead to significant morbidity and mortality. Clinical data and practice guidelines are relatively sparse. Early recognition and prompt treatment of pericardial diseases are critical to optimize patient outcomes. In this review we provide a concise summary of acute pericarditis, constrictive pericarditis and pericardial effusion/tamponade. PMID:26691443

  10. Clinical Judgment in Science: Reply

    ERIC Educational Resources Information Center

    Westen, Drew; Weinberger, Joel

    2005-01-01

    This paper presents replies to comments published by M. S. Schulz and R. J. Waldinger, J. M. Wood and M. T. Nezworski, and H. N. Garb and W. M. Grove on the original article by D. Westen and J. Weinberger. Schulz and Waldinger (2005) make the important point that just as researchers can capitalize on the knowledge of experienced clinical observers

  11. Clinical Guidelines Contextualization in GLARE

    PubMed Central

    Bottrighi, Alessio; Terenziani, Paolo; Montani, Stefania; Torchio, Mauro; Molino, Gianpaolo

    2006-01-01

    The adaptation of clinical guidelines to specific contexts is a fundamental task to promote guideline dissemination and use. Several aspects of contextualization need to be faced, including the adaptation of guidelines to local resource availability and (for computer-based guideline approaches) to local software environment. We show how a computer-based approach can help in such a challenging task. PMID:17238480

  12. Effect Size in Clinical Phonology

    ERIC Educational Resources Information Center

    Gierut, Judith A.; Morrisette, Michele L.

    2011-01-01

    The purpose of this article is to motivate the use of effect size (ES) for single-subject research in clinical phonology, with an eye towards meta-analyses of treatment effects for children with phonological disorders. Standard mean difference (SMD) is introduced and illustrated as one ES well suited to the multiple baseline (MBL) design and…

  13. Transforming Staff through Clinical Supervision

    ERIC Educational Resources Information Center

    Pfeifer, Douglas

    2011-01-01

    In order to continue to do great work with challenging youth, teachers should know that learning helps them be better professionals. Clinical supervision is one of the vehicles used. In a Re-ED program, those who work directly with youth (called teacher-counselors) are the primary agents of change. This makes it necessary to equip them with the…

  14. The Future of Clinical Dentistry.

    ERIC Educational Resources Information Center

    Slavkin, Harold C.

    1998-01-01

    Discussion of the future of clinical dentistry looks at a variety of influences, including historical development factors; demographic trends; the role of the Human Genome Project in the development of scientific knowledge; a paradigm shift in approaches to oral infection and systemic disease; advancing technology; and reforms resulting from these…

  15. Clinical Approach to Teacher Education.

    ERIC Educational Resources Information Center

    Boise State Univ., ID.

    The Clinical Approach to Teacher Education at Boise State Colleges places its students into two concurrent classes which run for two consecutive semesters and which emphasize the integration of theory and practice. Its ultimate goal is the development of a culminating year-long internship for the study of child behavior, curriculum, and…

  16. Teaching Techniques in Clinical Chemistry.

    ERIC Educational Resources Information Center

    Wilson, Diane

    This master's thesis presents several instructional methods and techniques developed for each of eleven topics or subject areas in clinical chemistry: carbohydrate metabolism, lipid metabolism, diagnostic enzymology, endocrinology, toxicology, quality control, electrolytes, acid base balance, hepatic function, nonprotein nitrogenous compounds, and…

  17. Temporomandibular joint multidisciplinary team clinic.

    PubMed

    Ahmed, Nabeela; Poate, Tim; Nacher-Garcia, Cristina; Pugh, Nicola; Cowgill, Helen; Page, Lisa; Matthews, N Shaun

    2014-11-01

    Patients with dysfunction of the temporomandibular joint (TMJ) commonly present to oral and maxillofacial departments and are increasingly being managed by a subspecialist group of surgeons. We review the outcomes of patients attending a specialist TMJ multidisciplinary team (MDT) clinic. All patients are simultaneously reviewed by a consultant oral and maxillofacial surgeon, consultant in oral medicine, specialist physiotherapist, and maxillofacial prosthetist, and they can also see a consultant liaison psychiatrist. They are referred from primary, secondary, and tertiary care when medical and surgical treatment in the routine TMJ clinic has failed, and are triaged by the attending maxillofacial surgeon. On discharge they are returned to the care of the referring practitioner. We review the outcomes of patients attending this clinic over a 2-year period and show improvements in pain scores and maximal incisal opening, as well as quality of life outcome measures. All units in the UK with an interest in the management of diseases of the TMJ should consider establishing this type of clinic and should use available resources and expertise to maximise outcomes. PMID:25179688

  18. Gentamicin in the Clinical Setting

    ERIC Educational Resources Information Center

    Pillers, De-Ann M.; Schleiss, Mark R.

    2005-01-01

    Gentamicin is an aminoglycoside antibiotic that has been a mainstay in pediatric care for decades. Although new antibiotics are constantly under development, gentamicin continues to play an important role in clinical medicine. Although this may be surprising in the context of evidence of an association with hearing loss, both on a toxicity and a…

  19. Immunosensors in Clinical Laboratory Diagnostics.

    PubMed

    Justino, Celine I L; Duarte, Armando C; Rocha-Santos, Teresa A P

    2016-01-01

    The application of simple, cost-effective, rapid, and accurate diagnostic technologies for detection and identification of cardiac and cancer biomarkers has been a central point in the clinical area. Biosensors have been recognized as efficient alternatives for the diagnostics of various diseases due to their specificity and potential for application on real samples. The role of nanotechnology in the construction of immunological biosensors, that is, immunosensors, has contributed to the improvement of sensitivity, since they are based in the affinity between antibody and antigen. Other analytes than biomarkers such as hormones, pathogenic bacteria, and virus have also been detected by immunosensors for clinical point-of-care applications. In this chapter, we first introduced the various types of immunosensors and discussed their applications in clinical diagnostics over the recent 6 years, mainly as point-of-care technologies for the determination of cardiac and cancer biomarkers, hormones, pathogenic bacteria, and virus. The future perspectives of these devices in the field of clinical diagnostics are also evaluated. PMID:26975970

  20. Clinical Teacher Education. Monograph Exerpt.

    ERIC Educational Resources Information Center

    Griffin, Gary A.

    1987-01-01

    Suggests a framework for clinical teacher education (to be used in programs for prospective, beginning, and career teachers) that proposes context as a defining property and outlines seven critical features. Programs should be purposeful, participatory, knowledge-based, ongoing, developmental, analytical, and reflective. Includes 55 notes. (MLH)

  1. Clinical Experiences in Athletic Training.

    ERIC Educational Resources Information Center

    Knight, Kenneth L.

    This book offers a systematic approach to teaching athletic training. Modules are separated into 10 content areas: direct clinical experience; policies and procedures; emergency procedures; modality operation; advanced modality operation; taping, wrapping, bracing, and padding; management of specific injuries; examination; supervision; and…

  2. Purposive Sampling in Clinical Research.

    ERIC Educational Resources Information Center

    Royeen, Charlotte Brasic; Fortune, Jim Carlton

    This paper identifies typical sampling problems, including improper application of the Central Limit Theorem, that are associated with the probability-based sampling procedures currently used in clinical psychology research. It then presents two alternative research designs, the theory validation model and the extended case study model, which…

  3. Clinical Approach to Teacher Evaluation.

    ERIC Educational Resources Information Center

    Tipton, William

    This manual, prepared for the state of Washington, provides tools and strategies aimed at assisting building administrators in clinical approaches to teacher evaluation. The first section provides preliminary thoughts on the evaluation process and discusses the two major problems: acceptance and time. The second section discusses the sources and…

  4. Adaptive designs in clinical trials.

    PubMed

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities. PMID:21584178

  5. Clamping down on clinic violence.

    PubMed

    1993-11-16

    The editorial remarked that anti abortion groups using violence must be stopped through legislation currently under consideration by the House and Senate of the US Congress. An important distinction is made between expressing freedom of speech on a deeply held belief and intimidation and violence that directly impacts on the rights of others. Women's health clinics where abortions are performed have repeatedly been the setting for intimidation and violence. There have been over 1000 reports of violence against these facilities and the people working at abortion centers since 1977. The most extreme act was the March 1993 murder of Dr. David Gunn outside a Pensacola, Florida, clinic and the wounding in August 1993 of a doctor in Wichita, Kansas. Unfortunately, the clinic violence not only interfere with abortion seekers, but also interferes with normal routine procedures such as Pap smears, prenatal care, well baby visits, and contraceptive counseling. Politically motivated violence antagonizes many women who rely on these clinics as the only source of care. The House and Senate bills would make it a federal criminal act to use force or physical obstruction to prevent a woman from getting an abortion or to damage a medical facility that provides abortion-related services. The Senate voted November 16, 1993 and the House vote will follow within the week. Anti abortion activists have cited the change to a pro-choice president as one of the reasons for the increase in violence against clinics, which amounted to a tripling of acts between 1990 and 1992. It is quixotic that movement to protect life would use extreme acts such as murder to protect life. Persuasion and appeals to hearts and minds would serve the abortion foes better as a viable strategy in the exercise of their right of free speech. PMID:12345222

  6. The "clinics without walls" controversy.

    PubMed

    1993-08-01

    We began this article with the report from the Washington-based Health Care Advisory Board that "clinics without walls" are a "recipe for failure". But the analysis we've done indicates that the so-called "clinics without walls" may become the single most frequent format for new medical groups throughout the country. In some markets, hospitals and physicians simply don't have a viable alternative. The "clinic without walls" concept may just be a half-way house for fully integrated groups. If it is, then failures among "clinics without walls" should be viewed as simply failures of groups to gel. They shouldn't be viewed as the failure of a model for integration. In fact, any attempts by physicians to organize in our highly volatile industry should be viewed as a positive. The organizing physicians at least have a shot at survival and are not waiting to become casualties of managed care or healthcare reform. The variations in the three models we analyzed all seem to boil down to the extent the individual physician trades independent decision-making for the benefits of the larger group structure. In the adjacent table, we've attempted to highlight key issues and the decision-making authority in each of the three models. We've also suggested objectives that can be achieved when decision making authority is delegated by the physicians to a central board and management. Very clearly, it's important to address all of the issues in the table early in forming a "clinic without walls".(ABSTRACT TRUNCATED AT 250 WORDS) PMID:10128312

  7. Clinical manifestation of mitochondrial diseases.

    PubMed

    Magner, Martin; Kolářová, Hana; Honzik, Tomáš; Švandová, Ivana; Zeman, Jiří

    2015-01-01

    Mitochondrial disorders (MD) represent a clinically, biochemically and genetically heterogeneous group of diseases associated with dysfunction of the oxidative phosphorylation system and pyruvate dehydrogenase complex. Our aim was to illustrate the most common clinical presentation of MD on the example of selected diseases and syndromes. The minimal prevalence of MD is estimated as 1 to 5,000. MD may manifest at any age since birth until late-adulthood with acute manifestation or as a chronic progressive disease. Virtually any organ may be impaired, but the organs with the highest energetic demands are most frequently involved, including brain, muscle, heart and liver. Some MD may manifest as a characteristic cluster of clinical features (e.g. MELAS syndrome, Kearns-Sayre syndrome). Diagnostics includes detailed history, the comprehensive clinical examination, results of specialized examinations (especially cardiology, visual fundus examination, brain imaging, EMG), laboratory testing of body fluids (lactate, aminoacids, organic acids), and analysis of bioptic samples of muscle, skin, and liver, eventually. Normal lactate level in blood does not exclude the possibility of MD. Although the aimed molecular genetic analyses may be indicated in some of mitochondrial diseases, the methods of next generation sequencing come into focus. Examples of treatment are arginine supplementation in MELAS syndrome, ketogenic diet in pyruvate oxidation disorders or quinone analogs in patients with LHON. Conclusion: The clinical suspicion of a mitochondrial disorder is often delayed, or the disease remains undiagnosed. The correct diagnosis and adequate treatment can improve prognosis of the patient. Access to genetic counseling is also of great importance. PMID:26982751

  8. [Quality control in clinical trials].

    PubMed

    Fukushima, M

    1996-01-01

    Quality control (QC) in clinical trials means the procedures which insure protection of human subjects from research risk, reliability of the data, and thereby assures internal consistency. This has been developed since 1970s in the US, by establishing various regulations which are now called GCP. From the viewpoint of total QC, it should be emphasized that rigorous review of protocol by the Institutional Review Board and obtaining Informed Consent are prerequisites for insuring the quality of the given trial at high scientific level. When pursuing a clinical trial, first of all, facilities of the institutions and the ability of investigators must be of high quality. For this reason, at each institution previous data related to trials should be thoroughly reviewed and analyzed prior to developing a protocol. Educational courses in QC in clinical practice are invaluable. QC of diagnosis means, for example, central pathology review and standardization of diagnostic procedures and process. Secondly, at each institution, data managers collect the data and submit them to the central office at the indicated time. In order to evolve clinical trial, continuous education for data managers and expansion of their job are encouraged. Thirdly, at the statistical center independent from the research group office, subject-specific data managers, the biostatistical staff, must check submitted forms for completeness, consistency and accuracy. Finally, at the data analysis, quality evaluation of the research should also be carried out. Throughout the trial, monitoring and audit are particularly important to assure quality. The sponsor has the responsibility of monitoring the trial and make rigorous onsite visits, and the individual study group also have a monitoring program, while the FDA and the NCI audit by themselves. The purpose of audit is not only to assure data reliability but also to check out patient compliance to drug, education as to regulations and rules of clinical trials and the analysis of violations so as to provide suggestions to improve medical care. PMID:8611045

  9. Clinical multiphoton tomography and clinical two-photon microendoscopy

    NASA Astrophysics Data System (ADS)

    Knig, Karsten; Bckle, Rainer; Weinigel, Martin; Elsner, Peter; Kaatz, Martin

    2009-02-01

    We report on applications of high-resolution clinical multiphoton tomography based on the femtosecond laser system DermaInspectTM with its flexible mirror arm in Australia, Asia, and Europe. Applications include early detection of melanoma, in situ tracing of pharmacological and cosmetical compounds including ZnO nanoparticles in the epidermis and upper dermis, the determination of the skin aging index SAAID as well as the study of the effects of anti-aging products. In addition, first clinical studies with novel rigid high-NA two-photon 1.6 mm GRIN microendoscopes have been conducted to study the effect of wound healing in chronic wounds (ulcus ulcera) as well as to perform intrabody imaging with subcellular resolution in small animals.

  10. Clinical Evaluation of Cervicogenic Headache: A Clinical Perspective

    PubMed Central

    Hall, Toby; Briffa, Kathy; Hopper, Diana

    2008-01-01

    Headache is a common complaint that affects the majority of the population at some point in their lives. The underlying pathological bases for headache symptoms are many, diverse, and often difficult to distinguish. Classification of headache is principally based on the evaluation of headache symptoms as well as clinical testing. Although manual therapy has been advocated to treat a variety of different forms of headache, the current evidence only supports treatment for cervicogenic headache (CGH). This form of headache can be identified from migraine and other headache forms by a comprehensive musculoskeletal examination. Examination and subsequent diagnosis is essential not only to identify patients with headache where manual therapy is appropriate but also to form a basis for selection of the most appropriate treatment for the identified condition. The purpose of this paper is to outline, in clinical terms, the classification of headache, so that the clinician can readily identify those patients with headache suited to manual therapy. PMID:19119390

  11. HIV/AIDS Clinical Trials Fact Sheet

    MedlinePlus

    HIV Prevention HIV/AIDS Clinical Trials (Last updated 9/15/2015; last reviewed 9/15/2015) Key Points HIV/AIDS clinical trials are ... and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help researchers ...

  12. Situational Supervision for Athletic Training Clinical Education

    ERIC Educational Resources Information Center

    Levy, Linda S.; Gardner, Greg; Barnum, Mary G.; Willeford, K. Sean; Sexton, Patrick; Guyer, M. Susan; Fincher, A. Louise

    2009-01-01

    Introduction: The medical education model provides the basis for athletic training students to learn theoretical and practical skills. Clinical rotations are completed where they apply what they have learned under the direct supervision of a clinical instructor (CI) or approved clinical instructor (ACI). Approved clinical instructors are taught

  13. 42 CFR 440.90 - Clinic services.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Clinic services. 440.90 Section 440.90 Public...) MEDICAL ASSISTANCE PROGRAMS SERVICES: GENERAL PROVISIONS Definitions § 440.90 Clinic services. Clinic... furnished at the clinic by or under the direction of a physician or dentist. (b) Services furnished...

  14. 42 CFR 440.90 - Clinic services.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 4 2011-10-01 2011-10-01 false Clinic services. 440.90 Section 440.90 Public...) MEDICAL ASSISTANCE PROGRAMS SERVICES: GENERAL PROVISIONS Definitions § 440.90 Clinic services. Clinic... furnished at the clinic by or under the direction of a physician or dentist. (b) Services furnished...

  15. 21 CFR 862.2860 - Mass spectrometer for clinical use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury,...

  16. 21 CFR 862.2860 - Mass spectrometer for clinical use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury,...

  17. 21 CFR 862.2860 - Mass spectrometer for clinical use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury,...

  18. 21 CFR 862.2860 - Mass spectrometer for clinical use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury,...

  19. 21 CFR 862.2860 - Mass spectrometer for clinical use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury,...

  20. [Clinical research=design*measurements*statistical analyses].

    PubMed

    Furukawa, Toshiaki

    2012-06-01

    A clinical study must address true endpoints that matter for the patients and the doctors. A good clinical study starts with a good clinical question. Formulating a clinical question in the form of PECO can sharpen one's original question. In order to perform a good clinical study one must have a knowledge of study design, measurements and statistical analyses: The first is taught by epidemiology, the second by psychometrics and the third by biostatistics. PMID:22834102

  1. Summary of ceftaroline fosamil clinical trial studies and clinical safety.

    PubMed

    File, Thomas M; Wilcox, Mark H; Stein, Gary E

    2012-09-01

    In October 2010, the new cephalosporin, ceftaroline fosamil, was approved by the US Food and Drug Administration for therapy of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs). The active metabolite, ceftaroline, demonstrates in vitro activity against typical bacterial pathogens most often associated with CABP or ABSSSIs, including resistant Gram-positive pathogens such as multidrug-resistant Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus. The efficacy and safety of ceftaroline fosamil was assessed in 2 large phase 3 programs of randomized, double-blind, clinical trials for CABP and ABSSSIs. For both indications, therapy with ceftaroline fosamil was observed to be noninferior to the comparator agents (ceftriaxone for CABP and vancomycin plus aztreonam for ABSSSIs) at both a standard test of cure assessment time (8-15 days after discontinuation of study drug) and an early assessment time point (day 3 or 4 of study). In the integrated analysis of the trials for CABP (FOCUS 1 and 2), clinical cure rates for the ceftaroline group were numerically higher than those for the ceftriaxone group (for the clinically evaluable population 84.3% vs 77.7%; difference: 6.6%; 95% confidence interval, 1.6%-11.8%). Among patients with CABP caused by S. pneumoniae, clinical cure rates were markedly higher in the ceftaroline treatment group than in the ceftriaxone treatment group (59 of 69 [85.5%] vs 48 of 70 [68.6%], respectively). For the ABSSSI studies (CANVAS 1 and 2), microbiologically evaluable (ME) success rates were similar between the treatment groups. Notably, the clinical cure rates in ME patients with methicillin-resistant S. aureus ABSSSIs were 142 of 152 (93.4%) and 115 of 122 (94.3%), for ceftaroline and vancomycin plus aztreonam, respectively, and did not differ from those achieved in infections due to methicillin-susceptible S. aureus (93.0%-94.5%). Ceftaroline fosamil was well tolerated, with a safety profile similar to the comparator agents used in these phase 3 trials. PMID:22903949

  2. [Hybrid imaging: clinical evidence, opportunities].

    PubMed

    Trencsényi, György; Barna, Sándor Kristóf; Garai, Ildikó

    2015-12-27

    Nowadays the hybrid imaging technologies which combine the modern equipments of radiology and nuclear medicine play an important role in both the translational research process and clinical diagnostics. Among the routine diagnostic imaging procedures positron emission tomography and single photon emission computed tomography combined with computed tomography or magnetic resonance imaging currently belong to the most advanced techniques allowing that functional and morphological images can be superimposed on each other in the same position. The hybrid imaging equipments provide useful information about the pathological processes in the body due to their high sensibility and resolution. Furthermore, with the help of these imaging modalities we can get acquainted with the biochemical and pathobiochemical processes that are essential for understanding and treating diseases, or getting acquainted with the behaviour of a new drug candidate. With the help of the clinical and preclinical non-invasive in vivo molecular imaging systems the drug developing process can be shortened and its costs can be reduced. PMID:26686747

  3. Clinical review: neuromonitoring - an update.

    PubMed

    Stocchetti, Nino; Le Roux, Peter; Vespa, Paul; Oddo, Mauro; Citerio, Giuseppe; Andrews, Peter J; Stevens, Robert D; Sharshar, Tarek; Taccone, Fabio S; Vincent, Jean-Louis

    2013-01-01

    Critically ill patients are frequently at risk of neurological dysfunction as a result of primary neurological conditions or secondary insults. Determining which aspects of brain function are affected and how best to manage the neurological dysfunction can often be difficult and is complicated by the limited information that can be gained from clinical examination in such patients and the effects of therapies, notably sedation, on neurological function. Methods to measure and monitor brain function have evolved considerably in recent years and now play an important role in the evaluation and management of patients with brain injury. Importantly, no single technique is ideal for all patients and different variables will need to be monitored in different patients; in many patients, a combination of monitoring techniques will be needed. Although clinical studies support the physiologic feasibility and biologic plausibility of management based on information from various monitors, data supporting this concept from randomized trials are still required. PMID:23320763

  4. Reflections in the clinical practice.

    PubMed

    Borrell-Carrió, F; Hernández-Clemente, J C

    2014-03-01

    The purpose of this article is to analyze some models of expert decision and their impact on the clinical practice. We have analyzed decision-making considering the cognitive aspects (explanatory models, perceptual skills, analysis of the variability of a phenomenon, creating habits and inertia of reasoning and declarative models based on criteria). We have added the importance of emotions in decision making within highly complex situations, such as those occurring within the clinical practice. The quality of the reflective act depends, among other factors, on the ability of metacognition (thinking about what we think). Finally, we propose an educational strategy based on having a task supervisor and rectification scenarios to improve the quality of medical decision making. PMID:24468001

  5. Introduction to clinical radiation oncology

    SciTech Connect

    Coia, L.R. . Dept. of Radiation Oncology); Moylan, D.J. III . Dept. of Medicine)

    1991-01-01

    This book discusses the management of cancer by radiation therapy both for cure and palliation. A wide range of clinical topics are introduced. In the introductory chapters on radiation physics and radiobiology, important terms and concepts used in clinical radiation oncology are covered. The subsequent chapters, which form the core of the book, group tumors predominantly according to major physiologic systems or anatomic site. Acute and chronic complications of treatment are listed along with pertinent information regarding their pathogenesis and management. There are also chapters dealing with radiation oncology emergencies, palliative treatment, combined-modality therapy and quality assurance. The radiation safety chapter presents guidelines for radiation protection. Current areas of promising investigation are presented in the final chapter. Individual chapters have been processed separately for inclusion in the appropriate data bases.

  6. Dendritic cell immunotherapy: clinical outcomes

    PubMed Central

    Apostolopoulos, Vasso; Pietersz, Geoffrey A; Tsibanis, Anastasios; Tsikkinis, Annivas; Stojanovska, Lily; McKenzie, Ian FC; Vassilaros, Stamatis

    2014-01-01

    The use of tumour-associated antigens for cancer immunotherapy studies is exacerbated by tolerance to these self-antigens. Tolerance may be broken by using ex vivo monocyte-derived dendritic cells (DCs) pulsed with self-antigens. Targeting tumour-associated antigens directly to DCs in vivo is an alternative and simpler strategy. The identification of cell surface receptors on DCs, and targeting antigens to DC receptors, has become a popular approach for inducing effective immune responses against cancer antigens. Many years ago, we demonstrated that targeting the mannose receptor on macrophages using the carbohydrate mannan to DCs led to appropriate immune responses and tumour protection in animal models. We conducted Phase I, I/II and II, clinical trials demonstrating the effectiveness of oxidised mannan-MUC1 in patients with adenocarcinomas. Here we summarise DC targeting approaches and their efficacy in human clinical trials. PMID:25505969

  7. Clinical Genetics of Alzheimer's Disease

    PubMed Central

    Zou, Zhangyu; Liu, Changyun; Che, Chunhui; Huang, Huapin

    2014-01-01

    Alzheimer's disease (AD) is the most common progressive neurodegenerative disease and the most common form of dementia in the elderly. It is a complex disorder with environmental and genetic components. There are two major types of AD, early onset and the more common late onset. The genetics of early-onset AD are largely understood with mutations in three different genes leading to the disease. In contrast, while susceptibility loci and alleles associated with late-onset AD have been identified using genetic association studies, the genetics of late-onset Alzheimer's disease are not fully understood. Here we review the known genetics of early- and late-onset AD, the clinical features of EOAD according to genotypes, and the clinical implications of the genetics of AD. PMID:24955352

  8. [Thoracic nocardiosis - a clinical report].

    PubMed

    Vale, Artur; Guerra, Miguel; Martins, Daniel; Lameiras, Angelina; Miranda, José; Vouga, Luís

    2014-01-01

    Nocardia genus microorganisms are ubiquitous, Gram positive aerobic bacterias, responsible for disease mainly in immunocompromised hosts, with cellular immune response commitment. Inhalation is the main form of transmition and pulmonary disease is the most frequent presentation. Dissemination may occur by contiguity and also via hematogenous. The clinical and imaging presentation is not specific, and diagnosis is obtained after identification of Nocardia bacteria in biological samples. Since there are no reliable studies that indicate the best therapeutic option, treatment should be individualized and based on antimicrobial susceptibility testing. Surgical drainage should also be considered in all patients. The authors present a clinical case of a patient with thoracic nocardiosis, and make a short literature review on the theme. PMID:25596394

  9. Positive interventions in clinical practice.

    PubMed

    Rashid, Tayyab

    2009-05-01

    Mainstream psychotherapy has made huge strides in treating symptoms and disorders, but it has largely overlooked happiness as a therapeutic goal despite frequently hearing from clients, "Doctor, I want to be happy." This issue of Journal of Clinical Psychology: In Session describes a number of positive interventions for specific clinical problems, such as depression, anxiety, schizophrenia, loss, grief, and relationship distress. Although the name may suggest it, positive interventions do not imply that rest of psychotherapies are negative. Neither are negatives denied nor minimized. Distinct from self-help recipes proffering instant changes, positive psychology interventions refer to systematic approaches to overcome challenges by using clients' strengths and assets. A hybrid psychotherapy-coaching model and strength-based assessment can ask a client "What is right with you?" All articles are supplemented with rich case illustrations. PMID:19294745

  10. [Clinical stratification of cardiogenic shock].

    PubMed

    Martínez Sánchez, Carlos Rodolfo; Martínez-Reding, Jesús Octavio; Lupi Herrera, Eulo

    2006-01-01

    Cardiogenic shock (CHC) associated to acute myocardial infarct has high mortality and their manifestations are heterogenous. In our institution historical mortality, was 98%, but with different methods of reperfusion, its reduced to 53%. In other hand, with opportune clinical stratification is useful to improve the treatment strategy. This stratification on basis in clinical signs: age, infarction location, cardiac frequency and systemic arterial pressure, and hemodynamical valuation with the use of right catheterism with quantification miocardial work parameters like "Cardiac power" that is the product of flow and arterial pressure and that is of utility to know the "Miocardial reserve". In our experience after reperfusion procedure patients with CHC and cardiac power less than 1.0 had highly mortality. PMID:17017114

  11. Clinical review: Neuromonitoring - an update

    PubMed Central

    2013-01-01

    Critically ill patients are frequently at risk of neurological dysfunction as a result of primary neurological conditions or secondary insults. Determining which aspects of brain function are affected and how best to manage the neurological dysfunction can often be difficult and is complicated by the limited information that can be gained from clinical examination in such patients and the effects of therapies, notably sedation, on neurological function. Methods to measure and monitor brain function have evolved considerably in recent years and now play an important role in the evaluation and management of patients with brain injury. Importantly, no single technique is ideal for all patients and different variables will need to be monitored in different patients; in many patients, a combination of monitoring techniques will be needed. Although clinical studies support the physiologic feasibility and biologic plausibility of management based on information from various monitors, data supporting this concept from randomized trials are still required. PMID:23320763

  12. Tuberculosis vaccines in clinical trials

    PubMed Central

    Rowland, Rosalind; McShane, Helen

    2011-01-01

    Effective prophylactic and/or therapeutic vaccination is a key strategy for controlling the global TB epidemic. The partial effectiveness of the existing TB vaccine, bacille Calmette–Guérin (BCG), suggests effective vaccination is possible and highlights the need for an improved vaccination strategy. Clinical trials are evaluating both modifications to the existing BCG immunization methods and also novel TB vaccines, designed to replace or boost BCG. Candidate vaccines in clinical development include live mycobacterial vaccines designed to replace BCG, subunit vaccines designed to boost BCG and therapeutic vaccines designed as an adjunct to chemotherapy. There is a great need for validated animal models, identification of immunological biomarkers of protection and field sites with the capacity for large-scale efficacy testing in order to develop and license a novel TB vaccine or regimen. PMID:21604985

  13. Career opportunities in clinical engineering.

    PubMed

    Morse, W A

    1992-01-01

    The varied career opportunities open to clinical engineers are described in this paper. Many of these opportunities are within the medical device industry in research, development, manufacturing design, regulatory activities, production, operations, sales, marketing, service, and management. Additional opportunities are available in hospitals, with the Veterans Administration, or working as an entrepreneur or a consultant. Each of these careers requires specific training and skills, and they all require a fundamental scientific knowledge of physical principles and mathematics. Research and management, however, require different educational preparation. The research emphasis should be on theoretical principles and creativity; the management emphasis should be on financial and labor problems. In all clinical engineering careers, the individual is a problem solver. PMID:10120058

  14. Clinical Factors Associated with PANDAS

    PubMed Central

    Murphy, Tanya K.; Storch, Eric A.; Lewin, Adam B.; Edge, Paula J.; Goodman, Wayne K.

    2011-01-01

    Objective To explore associated clinical factors in children with pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS). Study design Children with tics and/or OCD (n = 109) were examined by personal and family history, diagnostic interview, physical examination, medical record review, and measurement of baseline levels of streptococcal antibodies. Results Significant group differences were found on several variables, such that those diagnosed with PANDAS (versus without PANDAS) were more likely to have had dramatic onset; definite remissions; remission of neuropsychiatric symptoms during antibiotic therapy; a history of tonsillectomies/adenoidectomies; evidence of GAS infection, and clumsiness. Conclusion The identification of clinical features associated with PANDAS should assist in delineating risks for this subtype of OCD/tics. PMID:21868033

  15. Clinical manifestations of celiac disease.

    PubMed

    Green, Peter H R; Krishnareddy, Suneeta; Lebwohl, Benjamin

    2015-01-01

    Celiac disease (CD) is an immune-based condition affecting multiple organ systems. Clinical manifestations are manifold in form and number due to the multisystem nature of CD. There has been a progressive change in the clinical manifestations over the recent decades with fewer patients, both adults and children, presenting with a diarrheal, classical form. This, in children, is seen in only the youngest, while growth issues, screening at-risk groups and recurrent abdominal pain are the most common modes of presentation among children. Among adults, diarrhea is the most common presentation followed by anemia. Screening at-risk groups, metabolic bone disease and incidental recognition at endoscopy performed for reflux are the other main modes of presentation. The bulk of those with CD remain undiagnosed. The symptoms are often common, and increased medical education should lead to greater awareness in the medical community and an increased rate of diagnosis. PMID:25925914

  16. The ethics of clinical trials.

    PubMed

    Nardini, Cecilia

    2014-01-01

    Over the past decades, randomised controlled trials (RCTs) have prevailed over clinical judgement, case reports, and observational studies and became the gold evidential standard in medicine. Furthermore, during the same time frame, RCTs became a crucial part of the regulatory process whereby a new therapeutic can gain access to the drug market. Today, clinical trials are large and tightly regulated enterprises that have to comply with ethical requirements while maintaining high epistemic standards, a balance that becomes increasingly difficult as the research questions become more sophisticated. In this review, the author will discuss some of the most important ethical issues surrounding RCTs, with an eye to the most recent debates and the context of oncological research in particular. PMID:24482672

  17. The ethics of clinical trials

    PubMed Central

    Nardini, Cecilia

    2014-01-01

    Over the past decades, randomised controlled trials (RCTs) have prevailed over clinical judgement, case reports, and observational studies and became the gold evidential standard in medicine. Furthermore, during the same time frame, RCTs became a crucial part of the regulatory process whereby a new therapeutic can gain access to the drug market. Today, clinical trials are large and tightly regulated enterprises that have to comply with ethical requirements while maintaining high epistemic standards, a balance that becomes increasingly difficult as the research questions become more sophisticated. In this review, the author will discuss some of the most important ethical issues surrounding RCTs, with an eye to the most recent debates and the context of oncological research in particular. PMID:24482672

  18. Clinical applications of wearable technology.

    PubMed

    Bonato, Paolo

    2009-01-01

    An important factor contributing to the process involved in choosing a rehabilitation intervention is the assessment of its impact on the real life of patients. Therapists and physicians have to infer the effectiveness of rehabilitation approaches from observations performed in the clinical setting and from patients' feedback. Recent advances in wearable technology have provided means to supplement the information gathered using tools based on patient's direct observation as well as interviews and questionnaires. A new generation of wearable sensors and systems has recently become available thus providing clinical personnel with a "window of observation" in the home and community settings. These tools allow one to capture patients' activity level and exercise compliance, facilitate titration of medications in chronic patients, and provide means to assess the ability of patients to perform specific motor activities. In this paper, we review recent advances in the field of wearable technology and provide examples of application of this technology in rehabilitation. PMID:19964699

  19. Clinical biomarkers of angiogenesis inhibition

    PubMed Central

    Brown, Aaron P.; Citrin, Deborah E.; Camphausen, Kevin A.

    2009-01-01

    Introduction An expanding understanding of the importance of angiogenesis in oncology and the development of numerous angiogenesis inhibitors are driving the search for biomarkers of angiogenesis. We review currently available candidate biomarkers and surrogate markers of anti-angiogenic agent effect. Discussion A number of invasive, minimally invasive, and non-invasive tools are described with their potential benefits and limitations. Diverse markers can evaluate tumor tissue or biological fluids, or specialized imaging modalities. Conclusions The inclusion of these markers into clinical trials may provide insight into appropriate dosing for desired biological effects, appropriate timing of additional therapy, prediction of individual response to an agent, insight into the interaction of chemotherapy and radiation following exposure to these agents, and perhaps most importantly, a better understanding of the complex nature of angiogenesis in human tumors. While many markers have potential for clinical use, it is not yet clear which marker or combination of markers will prove most useful. PMID:18414993

  20. Tularaemia: clinical aspects in Europe.

    PubMed

    Maurin, Max; Gyuranecz, Miklós

    2016-01-01

    Tularaemia is a zoonotic disease caused by Francisella tularensis, a Gram-negative, facultative intracellular bacterium. Typically, human and animal infections are caused by F tularensis subspecies tularensis (type A) strains mainly in Canada and USA, and F tularensis subspecies holarctica (type B) strains throughout the northern hemisphere, including Europe. In the past, the epidemiological, clinical, therapeutic, and prognostic aspects of tularaemia reported in the English medical literature were mainly those that had been reported in the USA, where the disease was first described. Tularaemia has markedly changed in the past decade, and a large number of studies have provided novel data for the disease characteristics in Europe. In this Review we aim to emphasise the specific and variable aspects of tularaemia in different European countries. In particular, two natural lifecycles of F tularensis have been described in this continent, although not fully characterised, which are associated with different modes of transmission, clinical features, and public health burdens of tularaemia. PMID:26738841

  1. [Cluster headache. A clinical study].

    PubMed

    Molins, A; Lafuente, A; Malagelada, A; Codina, A; Titus, F

    1991-03-01

    The personal experience with cluster headache in 108 patients is reported. Significant clinical findings included a clear male predominance, with a male/female prevalence ratio of 4.7/1, the persistent homolateral character of pain during the attacks, seen in 100% of cases, and the tendency to repeat the attacks on the same side (96%). The cluster headache predominated during spring and the painful crisis, in our experience, had a clear nocturnal predominance. Regarding the signs and symptoms accompanying pain, our series was similar to those in the international literature, except for a smaller prevalence of Horner's sign in our cases. The association with tenderness of the carotid territory ipsilateral to pain is reported here for the first time. The importance of a correct anamnesis of all parameters associated with pain is emphasized in the present study, as in many patients only a detailed investigation permits an adequate clinical definition. PMID:2054206

  2. Can clinical psychoanalysis be scientific?

    PubMed

    Paniagua, C

    1987-01-01

    Criticism of psychoanalysis as a scientific discipline has increased recently. Even though psychoanalytic theory deserves ample criticism by the scientific community for its ambiguous definitions, deficient construct validity and precarious operationalization of its procedures, as long as there are clinical observables susceptible of recording, psychoanalysis remains in the realm of science. The scientific merit is reviewed of some psychoanalytic concepts such as repression, the unconscious, psychic structures, and intrapsychic conflict. The possibility of objectivity, prediction, and confirmation of hypotheses is discussed. PMID:3578601

  3. Clinical Genetic Testing in Epilepsy

    PubMed Central

    2015-01-01

    New technologies for mutation detection in the human genome have greatly increased our understanding of epilepsy genetics. Application of genomic technologies in the clinical setting allows for more efficient genetic diagnosis in some patients; therefore, it is important to understand the types of tests available and the types of mutations that can be detected. Making a genetic diagnosis improves overall patient care by enhancing prognosis and recurrence risk counseling and informing treatment decisions. PMID:26316867

  4. [Clinical activity in nursing education].

    PubMed

    Brignon, Béatrice

    2009-12-01

    The purpose of this research is to enlight the actual nursing act of the student in order to search for what makes sense in his (her) self nursing becoming and to reinterpret what is said regarding what is done. Up till, researchs were focused on declarative intentions; instead here, we go beyond using an innovative approach based on the clinical activity research method applied to the nursing education field. PMID:20180339

  5. Clinical manifestations of food allergy.

    PubMed

    Perry, Tamara T; Pesek, Robbie D

    2013-06-01

    Adverse reactions to foods are a diverse group of clinical syndromes resulting from immunologic and non-immunologic responses to food ingestion. Symptoms can range from mild, self-limiting reactions to severe, life-threatening reactions depending on the mechanism. This review primarily focuses on the clinical manifestations of immunologically derived adverse food reactions or food allergies.The true prevalence of food allergy is unknown. Up to 25% of the general population believes that they may be allergic to some food; however, the actual prevalence of food allergy diagnosed by a provider appears to be 1.5% to 2% of the adult population and approximately 6% to 8% of children. This discrepancy makes it imperative that clinicians are aware of the different food allergy syndromes. With a clear understanding of the clinical manifestations of food allergies, an accurate diagnosis and treatment plan can be formulated. Failing to do so may result in unnecessary dietary restrictions that may adversely affect nutritional status, growth, and quality of life.Most food allergic reactions are secondary to a limited number of foods, and the most common foods causing allergic reactions in children include milk, egg, peanuts, tree nuts, and fish. In adolescents and adults, allergies to peanuts, tree nuts, fish, and shellfish are most prevalent. Food allergies can result from immunoglobulin E (IgE)-mediated, non-IGE-mediated, or mixed IgE/non-IgE mechanisms. The purpose of this review is to discuss the clinical manifestations of each of these types of food allergy. PMID:23718237

  6. Human clinical trials in antiepileptogenesis

    PubMed Central

    Mani, Ram; Pollard, John; Dichter, Marc A.

    2011-01-01

    Blocking the development of epilepsy (epileptogenesis) is a fundamental research area with the potential to provide large benefits to patients by avoiding the medical and social consequences that occur with epilepsy and lifelong therapy. Human clinical trials attempting to prevent epilepsy (antiepileptogenesis) have been few and universally unsuccessful to date. In this article, we review data about possible pathophysiological mechanisms underlying epileptogenesis, discuss potential interventions, and summarize prior antiepileptogenesis trials. Elements of ideal trials designs for successful antiepileptogenic intervention are suggested. PMID:21439351

  7. Educational innovations in clinical pharmacogenomics.

    PubMed

    Perry, C G; Maloney, K A; Beitelshees, A L; Jeng, Ljb; Ambulos, N P; Shuldiner, A R; Blitzer, M G

    2016-06-01

    Genetic and genomic discovery is revolutionizing medicine at an extraordinary pace, leading to a better understanding of disease and improved treatments for patients. This advanced pace of discovery presents an urgency to expand medical school curricula to include genetic and genomic testing (including pharmacogenomics), and integration of genomic medicine into clinical practice. Consequently, organizations and healthcare authorities have charged medical schools with training future physicians to be competent in their knowledge of genomic implementation. PMID:26875057

  8. Harnessing neuroplasticity for clinical applications

    PubMed Central

    Sur, Mriganka; Dobkin, Bruce H.; O'Brien, Charles; Sanger, Terence D.; Trojanowski, John Q.; Rumsey, Judith M.; Hicks, Ramona; Cameron, Judy; Chen, Daofen; Chen, Wen G.; Cohen, Leonardo G.; deCharms, Christopher; Duffy, Charles J.; Eden, Guinevere F.; Fetz, Eberhard E.; Filart, Rosemarie; Freund, Michelle; Grant, Steven J.; Haber, Suzanne; Kalivas, Peter W.; Kolb, Bryan; Kramer, Arthur F.; Lynch, Minda; Mayberg, Helen S.; McQuillen, Patrick S.; Nitkin, Ralph; Pascual-Leone, Alvaro; Reuter-Lorenz, Patricia; Schiff, Nicholas; Sharma, Anu; Shekim, Lana; Stryker, Michael; Sullivan, Edith V.; Vinogradov, Sophia

    2011-01-01

    Neuroplasticity can be defined as the ability of the nervous system to respond to intrinsic or extrinsic stimuli by reorganizing its structure, function and connections. Major advances in the understanding of neuroplasticity have to date yielded few established interventions. To advance the translation of neuroplasticity research towards clinical applications, the National Institutes of Health Blueprint for Neuroscience Research sponsored a workshop in 2009. Basic and clinical researchers in disciplines from central nervous system injury/stroke, mental/addictive disorders, paediatric/developmental disorders and neurodegeneration/ageing identified cardinal examples of neuroplasticity, underlying mechanisms, therapeutic implications and common denominators. Promising therapies that may enhance training-induced cognitive and motor learning, such as brain stimulation and neuropharmacological interventions, were identified, along with questions of how best to use this body of information to reduce human disability. Improved understanding of adaptive mechanisms at every level, from molecules to synapses, to networks, to behaviour, can be gained from iterative collaborations between basic and clinical researchers. Lessons can be gleaned from studying fields related to plasticity, such as development, critical periods, learning and response to disease. Improved means of assessing neuroplasticity in humans, including biomarkers for predicting and monitoring treatment response, are needed. Neuroplasticity occurs with many variations, in many forms, and in many contexts. However, common themes in plasticity that emerge across diverse central nervous system conditions include experience dependence, time sensitivity and the importance of motivation and attention. Integration of information across disciplines should enhance opportunities for the translation of neuroplasticity and circuit retraining research into effective clinical therapies. PMID:21482550

  9. Managing clinical research permissions electronically

    PubMed Central

    Sanderson, Iain C; Obeid, Jihad S; Madathil, Kapil Chalil; Gerken, Katherine; Fryar, Katrina; Rugg, Daniel; Alstad, Colin E; Alexander, Randall; Brady, Kathleen T; Gramopadhye, Anand K; Moskowitz, Jay

    2014-01-01

    Background One mechanism to increase participation in research is to solicit potential research participants general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. Purpose The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants interest in current and future research involvement and to provide a foundation for facilitating the research workflow. Methods The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users. Results An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions. Limitations There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials. Conclusions We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents. PMID:23785065

  10. Can research influence clinical practice?

    PubMed

    Jimnez, Juan Pablo

    2007-06-01

    After briefly reviewing the unfavourable reception accorded empirical research by parts of the psychoanalytic community, as well as some of the benefits to clinical practice of analysts being involved in research activities, the author examines whether the findings of process and outcome research in psychotherapy and psychoanalysis can help identify the most appropriate forms of intervention for producing therapeutic change, given the specific condition of the patient and the relationship that the individual establishes with the analyst. He argues that research findings can influence clinical practice on various levels and in different areas, and goes on to examine a number of related issues: the specificity of therapeutic interventions versus the relevance of common curative factors; the dyadic conception of technique and ways of understanding the therapeutic action of the treatment alliance; and the strategic or heuristic conception in psychoanalytic therapy. Finally, the author presents clinical material with the aim of illustrating how the knowledge acquired through research can be applied to psychoanalytic treatment. PMID:17537698

  11. Painful diabetic neuropathy: clinical aspects.

    PubMed

    Didangelos, Triantafyllos; Doupis, John; Veves, Aristidis

    2014-01-01

    Painful diabetic neuropathy (PDN) is one of several clinical syndromes in patients with diabetic peripheral neuropathy (DPN) and presents a major challenge for optimal management. The epidemiology of PDN has not been extensively studied. On the basis of available data, the prevalence of pain ranges from 10% to 20% in patients with diabetes and from 40% to 50% in those with diabetic neuropathy. Neuropathic pain can be disabling and devastating, with a significant impact on the patient's quality of life and associated healthcare cost. Pathophysiologic mechanisms underlying PDN are similar to other neuropathic pain disorders and broadly invoke peripheral and central sensitization. The natural course of PDN is variable, with the majority of patients experiencing spontaneous improvement and resolution of pain. Quantifying neuropathic pain is difficult, especially in clinical practice, but has improved recently in clinical trials with the development of neuropathic pain-specific tools, such as the Neuropathic Pain Questionnaire and the Neuropathic Pain Symptom Inventory. Hyperglycemia-induced pathways result in nerve dysfunction and damage, which lead to hyperexcitable peripheral and central pathways of pain. Glycemic control may prevent or partially reverse DPN and modulate PDN. PMID:25410214

  12. Post-mortem clinical pharmacology

    PubMed Central

    Ferner, R E

    2008-01-01

    Clinical pharmacology assumes that deductions can be made about the concentrations of drugs from a knowledge of the pharmacokinetic parameters in an individual; and that the effects are related to the measured concentration. Post-mortem changes render the assumptions of clinical pharmacology largely invalid, and make the interpretation of concentrations measured in post-mortem samples difficult or impossible. Qualitative tests can show the presence of substances that were not present in life, and can fail to detect substances that led to death. Quantitative analysis is subject to error in itself, and because post-mortem concentrations vary in largely unpredictable ways with the site and time of sampling, as a result of the phenomenon of post-mortem redistribution. Consequently, compilations of ‘lethal concentrations’ are misleading. There is a lack of adequate studies of the true relationship between fatal events and the concentrations that can be measured subsequently, but without such studies, clinical pharmacologists and others should be wary of interpreting post-mortem measurements. PMID:18637886

  13. Cough: an unmet clinical need.

    PubMed

    Dicpinigaitis, Peter V

    2011-05-01

    Cough is among the most common complaints for which patients worldwide seek medical attention. Thus, the evaluation and treatment of cough result in tremendous financial expenditure and consumption of health care resources. Yet, despite the clinical significance of cough, research efforts aimed at improving diagnostic capabilities and developing more effective therapeutic agents have been, to date, disappointing in their limited scope and outcomes. Acute cough due to the common cold represents the most common type of cough. Currently, available medications for the symptomatic management of acute cough are inadequate due to lack of proven efficacy and/or their association with undesirable or intolerable side effects at anti-tussive doses. Subacute cough, often representing a prolonged post-viral response, is typically refractory to standard anti-tussive therapy. Few clinical trials have evaluated therapeutic options for subacute cough. Diagnostic challenges facing the clinician in the management of chronic cough include the determination of whether symptoms of upper airway cough syndrome (formerly, postnasal drip syndrome) or gastro-oesophageal reflux disease are indeed the underlying cause of cough. Chronic, refractory unexplained (formerly, idiopathic) cough must be distinguished from cough that has not been fully evaluated and treated according to current guideline recommendations. Eagerly awaited are new safe and effective anti-tussive agents for use when cough suppression is desired, regardless of underlying aetiology of cough, as well as practical, validated ambulatory cough counters to aid clinical assessment and future research in the field of cough. PMID:21198555

  14. [Clinical cytology: why and how?].

    PubMed

    Znidarcić, Zeljka

    2013-12-01

    Clinical cytology is a morphological diagnostic profession, which has not been properly utilized in current medicine, primarily due to inadequate awareness among physicians of its diagnostic possibilities and advantages. The purpose of this historical review of clinical cytology and its diagnostic role is to contribute to higher awareness of the current possibilities offered by cytologic diagnosis and its future development in the era of technological progress and medical striking into profitability, with its negative connotations. The main features of cytologic diagnosis, i.e. non-aggressiveness, simplicity, promptness and accuracy, should be maintained while following new technological possibilities. Standard cytomorphology provides a basis for deciding on using additional technologies (cytochemistry, immunocytochemistry, flow cytometry, molecular analysis and cytogenetics) after thorough microscopic analysis, on cytologic samples or/and cytologic smears. The conditio sine qua non for that purpose is appropriate education of cytologists and cytotechnologists as well as appropriate organization of cytology in the healthcare system. As in the historical development of clinical cytology, enthusiasts are necessary to maintain and even improve all its possibilities to the benefit of our patients. PMID:24979879

  15. Clinical Trials in Head Injury

    PubMed Central

    NARAYAN, RAJ K.; MICHEL, MARY ELLEN; Ansell, Beth; Baethmann, Alex; Biegon, Anat; Bracken, Michael B.; Bullock, M. Ross; Choi, Sung C.; Clifton, Guy L.; Contant, Charles F.; Coplin, William M.; Dietrich, W. Dalton; Ghajar, Jamshid; Grady, Sean M.; Grossman, Robert G.; Hall, Edward D.; Heetderks, William; Hovda, David A.; Jallo, Jack; Katz, Russell L.; Knoller, Nachshon; Kochanek, Patrick M.; Maas, Andrew I.; Majde, Jeannine; Marion, Donald W.; Marmarou, Anthony; Marshall, Lawrence F.; McIntosh, Tracy K.; Miller, Emmy; Mohberg, Noel; Muizelaar, J. Paul; Pitts, Lawrence H.; Quinn, Peter; Riesenfeld, Gad; Robertson, Claudia S.; Strauss, Kenneth I.; Teasdale, Graham; Temkin, Nancy; Tuma, Ronald; Wade, Charles; Walker, Michael D.; Weinrich, Michael; Whyte, John; Wilberger, Jack; Young, A. Byron; Yurkewicz, Lorraine

    2006-01-01

    Traumatic brain injury (TBI) remains a major public health problem globally. In the United States the incidence of closed head injuries admitted to hospitals is conservatively estimated to be 200 per 100,000 population, and the incidence of penetrating head injury is estimated to be 12 per 100,000, the highest of any developed country in the world. This yields an approximate number of 500,000 new cases each year, a sizeable proportion of which demonstrate signficant long-term disabilities. Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform. Despite promising pre-clinical data, most of the trials that have been performed in recent years have failed to demonstrate any significant improvement in outcomes. The reasons for these failures have not always been apparent and any insights gained were not always shared. It was therefore feared that we were running the risk of repeating our mistakes. Recognizing the importance of TBI, the National Institute of Neurological Disorders and Stroke (NINDS) sponsored a workshop that brought together experts from clinical, research, and pharmaceutical backgrounds. This workshop proved to be very informative and yielded many insights into previous and future TBI trials. This paper is an attempt to summarize the key points made at the workshop. It is hoped that these lessons will enhance the planning and design of future efforts in this important field of research. PMID:12042091

  16. Planning an Academic Clinical Trial.

    PubMed

    Champion, Kim M; Jones, Gemma R

    2015-01-01

    Clinical trials are performed to discover or verify the efficacy and safety of one or more investigational medicinal product (IMP). Biological medicinal products, including gene therapies, offer groundbreaking new opportunities for the treatment of disease and injury, but they are also highly regulated and trials with these products can be logistically challenging to set up and execute. To ensure a compliant and successful trial, it is important to know and understand the regulatory framework, and to be aware of available guidance documents published to advise the different stakeholders on how to develop, manufacture, handle, administer, or destroy these products safely and legally. This chapter summarizes the standard requirements and considerations applicable for clinical trials with IMPs and also describes additional requirements for trials with gene therapies or genetically modified microorganisms (GMM).This chapter has been written from the perspective of a UK noncommercial (academic) sponsor. As such, the discussion and guidance has its basis in gene therapy research as governed by UK law. Nevertheless, European legislation and guidance documents are also referenced; most of the following recommendations will be applicable to clinical trials with a gene therapy medicinal product in any European Member State, and the overriding principles would be applicable to any trial. PMID:26072413

  17. Clinical grade expansion of MSCs.

    PubMed

    Capelli, C; Pedrini, O; Valgardsdottir, R; Da Roit, F; Golay, J; Introna, M

    2015-12-01

    Producing advanced therapy medicinal products (ATMP) according to Good Manufacturing Practice (GMP) guidelines represents a global challenge for the expansion of cells intended for human use. Mesenchymal stromal cells (MSCs) from different sources are one of the most actively developed cell type for a variety of clinical applications in cellular therapy. Complying with GMP means defining accurately both the production process and the release criteria required for a final safe product. We have here reported our manufacturing experience on 103 consecutive clinical-grade in vitro expansions of both bone marrow-derived and umbilical cord-derived mesenchymal stromal cells together with description of methods and reagents utilized in our Cell Factory. The same animal- and serum-free medium, additioned with human platelet lysate, has been used for all the expansions performed. This is the largest experience published so far with this alternative and clinical-grade reagent (compared to the traditional fetal bovine serum) and shows the feasibility and the reproducibility of the method. Indeed, we have been able to produce a sufficient number of MSCs to treat 57 patients so far, enrolled in 7 different experimental phase I/II protocols. PMID:26092523

  18. Standardisation of neonatal clinical practice.

    PubMed

    Bhutta, Z A; Giuliani, F; Haroon, A; Knight, H E; Albernaz, E; Batra, M; Bhat, B; Bertino, E; McCormick, K; Ochieng, R; Rajan, V; Ruyan, P; Cheikh Ismail, L; Paul, V

    2013-09-01

    The International Fetal and Newborn Growth Consortium for the 21(st) Century (INTERGROWTH-21(st) ) is a large-scale, population-based, multicentre project involving health institutions from eight geographically diverse countries, which aims to assess fetal, newborn and preterm growth under optimal conditions. Given the multicentre nature of the project and the expected number of preterm births, it is vital that all centres follow the same standardised clinical care protocols to assess and manage preterm infants, so as to ensure maximum validity of the resulting standards as indicators of growth and nutrition with minimal confounding. Moreover, it is well known that evidence-based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. The INTERGROWTH-21(st) Neonatal Group produced an operations manual, which reflects the consensus reached by members of the group regarding standardised definitions of neonatal morbidities and the minimum standards of care to be provided by all centres taking part in the project. The operational definitions and summary management protocols were developed by consensus through a Delphi process based on systematic reviews of relevant guidelines and management protocols by authoritative bodies. This paper describes the process of developing the Basic Neonatal Care Manual, as well as the morbidity definitions and standardised neonatal care protocols applied across all the INTERGROWTH-21(st) participating centres. Finally, thoughts about implementation strategies are presented. PMID:23841879

  19. Ultrasound enhanced thrombolysis: Clinical evidence

    NASA Astrophysics Data System (ADS)

    Alexandrov, Andrei V.

    2005-04-01

    Phase II CLOTBUST randomized clinical trial (Houston, Barcelona, Edmonton, Calgary) evaluated patients with acute ischemic stroke due to intracranial occlusion and treated with intravenous tissue plasminogen activator (TPA) within 3 h of symptom onset. Randomization: monitoring with pulsed wave 2 MHz transcranial Doppler (TCD) (Target) or placebo monitoring (Control). Safety: symptomatic bleeding to the brain (sICH). Primary end-point: complete recanalization on TCD or dramatic clinical recovery by the total NIHSS score <3, or improvement by >10 NIHSS points within 2 hours after TPA bolus. All projected 126 patients were randomized 1:1 to target (median NIHSS 16) or control (NIHSS 17). sICH: 4.8% Target, 4.8% Controls. Primary end-point was achieved by 31 (49%, Target) versus 19 (30%, Control), p<0.03. At 3 months, 22 (42% Target) and 14 (29% Control) patients achieved favorable outcomes. Continuous TCD monitoring of intracranial occlusion safely augments TPA-induced arterial recanalization, and 2 MHz diagnostic ultrasound has a positive biological activity that aids systemic thrombolytic therapy. For the first time in clinical medicine, the CLOTBUST trial provides the evidence that ultrasound enhances thrombolytic activity of a drug in humans thereby confirming intense multi-disciplinary experimental research conducted worldwide for the past 30 years.

  20. Clinical overview of the synucleinopathies.

    PubMed

    Martí, Maria J; Tolosa, Eduardo; Campdelacreu, Jaume

    2003-09-01

    The term synucleinopathies is used to name a group of neurodegenerative disorders characterized by fibrillary aggregates of alpha-synuclein protein in the cytoplasm of selective populations of neurons and glia. These disorders include Parkinson's disease (PD), dementia with Lewy bodies (DLB), pure autonomic failure (PAF), and multiple system atrophy (MSA). Clinically, they are characterized by a chronic and progressive decline in motor, cognitive, behavioural, and autonomic functions, depending on the distribution of the lesions. Because of clinical overlap, differential diagnosis is sometimes very difficult. Parkinsonism is the predominant symptom of PD, but it can be indistinguishable from the parkinsonism of DLB and MSA. Autonomic dysfunction, which is an isolated finding in PAF, may be present in PD and DLB, but is usually more prominent and appears earlier in MSA. DLB could be the same disease as PD but with widespread cortical pathological states, leading to dementia, fluctuating cognition, and the characteristic visual hallucinations. The deposition of aggregates of synuclein in neurons and glia suggests that a common pathogenic mechanism may exist for these disorders. Even though synuclein may play an important role in disease development in these disorders, in light of the different symptom complex and prognosis and management issues that characterize each disorder, we think that the term synucleinopathy has little practical value as a diagnostic term for the clinician. Clinicians should attempt to reach standard clinical diagnosis on patients, such as PD, PAF, or MSA. PMID:14502652

  1. Clinical features of gastroenteropancreatic tumours

    PubMed Central

    Czarnywojtek, Agata; Bączyk, Maciej; Ziemnicka, Katarzyna; Fischbach, Jakub; Wrotkowska, Elżbieta; Ruchała, Marek

    2015-01-01

    Gastroenteropancreatic (GEP) endocrine tumours (carcinoids and pancreatic islet cell tumours) are composed of multipotent neuroendocrine cells that exhibit a unique ability to produce, store, and secrete biologically active substances and cause distinct clinical syndromes. The classification of GEP tumours as functioning or non-functioning is based on the presence of symptoms that accompany these syndromes secondary to the secretion of hormones, neuropeptides and/or neurotransmitters (functioning tumours). Non-functioning tumours are considered to be neoplasms of neuroendocrine differentiation that are not associated with obvious symptoms attributed to the hypersecretion of metabolically active substances. However, a number of these tumours are either capable of producing low levels of such substances, which can be detected by immunohistochemistry but are insufficient to cause symptoms related to a clinical syndrome, or alternatively, they may secrete substances that are either metabolically inactive or inappropriately processed. In some cases, GEP tumours are not associated with the production of any hormone or neurotransmitter. Both functioning and non-functioning tumours can also produce symptoms due to mass effects compressing vital surrounding structures. Gastroenteropancreatic tumours are usually classified further according to the anatomic site of origin: foregut (including respiratory tract, thymus, stomach, duodenum, and pancreas), midgut (including small intestine, appendix, and right colon), and hindgut (including transverse colon, sigmoid, and rectum). Within these subgroups the biological and clinical characteristics of the tumours vary considerably, but this classification is still in use because a significant number of previous studies, mainly observational, have used it extensively. PMID:26516377

  2. Silver staining in clinical cytogenetics.

    PubMed

    Martin, A O

    1985-09-01

    Silver staining of human chromosomes at prometaphase or metaphase identifies variants in the stalk (nucleolar organizing) regions of acrocentric chromosomes (Nos. 13, 14, 15, 21, 22). Variants are defined by size, number, and morphology of silver staining areas. They are heritable polymorphisms and have not been associated with clinical abnormalities. However, these variants are useful in clinical cytogenetics, specifically in studies attempting to determine whether genetic material has been gained or lost in chromosomal rearrangements, the origin of chromosomal aberrations, the origin of cells in tissue culture, the chromosomal location of single genes, clonal origin of tumors, the zygosity of twins, and paternity. Some chromosomal aberrations require silver staining for their definition. Because loss of the stalk regions per se is apparently not deleterious, demonstration that chromosomal breaks occurred within this region without concomitant loss or gain of genetic material essential for normal human development provides basis for a good prognosis for the individual with the chromosomal rearrangement resulting from such breakage. The principle underlying most of the other applications is to determine whether variants being compared are identical or dissimilar, and to make inferences from these results (e.g., variants in monozygotic twins should all be identical, whereas in dizygotic twins they are as similar as in any pair of sibs). Silver staining is a valuable technique for special questions in clinical analysis. PMID:2412316

  3. The renaissance of clinical leadership.

    PubMed

    Cook, M J

    2001-03-01

    The purpose of this work was to explore clinical nursing leadership. The research was based on a critical examination of the leadership themes derived from the nursing literature of the United Kingdom, the United States of America and Australia, between 1992 and 1997. The work was also influenced by the findings from semistructured interviews undertaken with five clinical leaders in nursing from the United Kingdom, and study tours to both the United States of America and Australia. The findings support a proposed leadership model as a basis for further exploration and as a framework for contemplating clinical leadership and leadership preparation. A model is presented that identifies factors which influence leadership styles, such as external environment, internal environment, experience and understanding. Four leadership styles are outlined: transactional, transformational, connective and renaissance. These leadership styles are linked to nursing care approaches. A second model provides a basis for considering power and its impact in the workplace. Based on these findings, the contents of a leadership preparation course are outlined. PMID:11316275

  4. Clinical Applications of Gallium-68

    PubMed Central

    Banerjee, Sangeeta Ray; Pomper, Martin G.

    2013-01-01

    Gallium-68 is a positron-emitting radioisotope that is produced from a 68Ge/68Ga generator. As such it is conveniently used, decoupling radiopharmacies from the need for a cyclotron on site. Gallium-68-labeled peptides have been recognized as a new class of radiopharmaceuticals showing fast target localization and blood clearance. 68Ga-DOTATOC, 8Ga-DOTATATE, 68Ga-DOTANOC, are the most prominent radiopharmaceuticals currently in use for imaging and differentiating lesions of various somatostatin receptor subtypes, overexpressed in many neuroendocrine tumors. There has been a tremendous increase in the number of clinical studies with 68Ga over the past few years around the world, including within the United States. An estimated ~10,000 scans are being performed yearly in Europe at about 100 centers utilizing 68Ga-labeled somatostatin analogs within clinical trials. Two academic sites within the US have also begun to undertake human studies. This review will focus on the clinical experience of selected, well-established and recently applied 68Ga-labeled imaging agents used in nuclear medicine. PMID:23522791

  5. Clinical experience with cinacalcet HCl.

    PubMed

    Ureña Torres, Pablo

    2004-08-01

    Secondary hyperparathyroidism (SHPT) is associated with parathyroid gland hyperplasia, increased parathyroid hormone (PTH) production and secretion, disturbed bone and mineral metabolism, soft tissue calcification and an increased risk of death. The condition is an almost universal complication of end-stage renal disease (ESRD) and currently is managed by treatment with phosphate binders and vitamin D compounds, both of which are associated with significant side effects, including hypercalcaemia and hyperphosphataemia. Therapy with calcimimetics is a new approach to the treatment of SHPT. These agents act at the calcium-sensing receptor (CaR), where they increase the sensitivity of the receptor to ionized serum calcium. Activation of the CaR results in a rapid reduction in PTH secretion. The calcimimetic drug cinacalcet HCl currently is undergoing clinical trials in dialysis patients who have uncontrolled SHPT, despite treatment with vitamin D compounds and/or phosphate binders. Clinical trials have confirmed that the drug rapidly reduces plasma PTH, phosphorus and calcium-phosphorus product (Ca x P) levels, and that levels of PTH, phosphorus and Ca x P remain suppressed for up to 3 years. In clinical trials, cinacalcet HCl was a well-tolerated drug; only nausea and vomiting occurred more frequently in patients who took cinacalcet HCl than in those who took placebo, and the occurrence of transient hypocalcaemia was limited to the initial phase of the treatment. Cinacalcet HCl is therefore a potentially highly effective and well-tolerated treatment for SHPT in patients with ESRD. PMID:15284357

  6. Clinical applications of immunoglobulin: update

    PubMed Central

    Novaretti, Marcia Cristina Zago; Dinardo, Carla Luana

    2011-01-01

    Human immunoglobulin is the most used blood product in the clinical practice. Immunoglobulin applications have increased quickly since the elucidation of its immunomodulatory and antiinflammatory properties which turned this blood product into a precious tool in the treatment of numerous diseases that present with humoral immune deficiency or that cause immune system dysfunction. Currently, the approved indications for Ig are: primary immunodeficiencies, secondary immunodeficiencies (multiple myeloma or chronic lymphoid leukemia), Kawasaki syndrome, immune thrombocytopenic purpura, Guillain Barré syndrome, graft-versus-host disease following bone marrow transplantation and repeat infections in HIV children. On the other hand, there are numerous "off-label" indications of immunoglobulin, which represent 20-60% of all clinical applications of this drug. It is important to study all these indications and, above all, the scientific evidence for its use, in order to provide patients with a new therapeutic option without burdening the health system. This review results from a wide selection of papers identified in the Pubmed and Lilacs scientific electronic databases. A group of descriptors were used from human immunoglobulin to the names of each disease that immunoglobulin is clinically applied. Our main objective is to list the numerous indications of immunoglobulin, both authorized and "off-label" and to analyze these indications in the light of the most recent scientific evidence. PMID:23049300

  7. 42 CFR 405.2450 - Clinical psychologist and clinical social worker services.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... social worker or clinical psychologist who is legally authorized to perform such services under State law... requirements of State law are satisfied. (c) The services of clinical psychologists or clinical social workers... 42 Public Health 2 2011-10-01 2011-10-01 false Clinical psychologist and clinical social...

  8. 42 CFR 405.2450 - Clinical psychologist and clinical social worker services.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... social worker or clinical psychologist who is legally authorized to perform such services under State law... requirements of State law are satisfied. (c) The services of clinical psychologists or clinical social workers... 42 Public Health 2 2010-10-01 2010-10-01 false Clinical psychologist and clinical social...

  9. Variability in Clinical Integration Achieved by Athletic Training Students across Different Clinical Sport Assignments

    ERIC Educational Resources Information Center

    Dodge, Thomas M.; Mazerolle, Stephanie M.; Bowman, Thomas G.

    2015-01-01

    Context: Clinical integration impacts athletic training students' (ATSs) motivation and persistence. Research has yet to elucidate the manner in which different clinical placements can influence clinical integration. Objective: To examine differences in the levels of clinical integration achieved by ATSs across various clinical sport assignments.…

  10. Variability in Clinical Integration Achieved by Athletic Training Students across Different Clinical Sport Assignments

    ERIC Educational Resources Information Center

    Dodge, Thomas M.; Mazerolle, Stephanie M.; Bowman, Thomas G.

    2015-01-01

    Context: Clinical integration impacts athletic training students' (ATSs) motivation and persistence. Research has yet to elucidate the manner in which different clinical placements can influence clinical integration. Objective: To examine differences in the levels of clinical integration achieved by ATSs across various clinical sport assignments.

  11. Clinical Preceptors' Perspectives on Clinical Education in Post-Professional Athletic Training Education Programs

    ERIC Educational Resources Information Center

    Phan, Kelvin; McCarty, Cailee W.; Mutchler, Jessica M.; Van Lunen, Bonnie

    2012-01-01

    Context: Clinical education is the interaction between a clinical preceptor and student within the clinical setting to help the student progress as a clinician. Post-professional athletic training clinical education is especially important to improve these students' clinical knowledge and skills. However, little research has been conducted to…

  12. Placebo Effects: Biological, Clinical and Ethical Advances

    PubMed Central

    Kaptchuk, Ted J; Miller, Franklin; Benedetti, Fabrizio

    2010-01-01

    For many years, placebos have been conceptualised by their inert content and their use as controls in clinical trials and treatments in clinical practice. Recent research demonstrates that placebo effects are genuine psychobiological phenomenon attributable to the overall therapeutic context, and that placebo effects can be robust in both laboratory and clinical settings. Evidence has also emerged that placebo effects can exist in clinical practice, even if no placebo is given. Further promotion and integration of laboratory and clinical research will allow advances in the ethical harnessing of placebo mechanisms that are inherent in routine clinical care and the potential use of treatments to primarily promote placebo effects. PMID:20171404

  13. Perspectives on Clinical Informatics: Integrating Large-Scale Clinical, Genomic, and Health Information for Clinical Care

    PubMed Central

    Choi, In Young; Kim, Tae-Min; Kim, Myung Shin; Mun, Seong K.

    2013-01-01

    The advances in electronic medical records (EMRs) and bioinformatics (BI) represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO) aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population. PMID:24465229

  14. Where are clinical trials going? Society and clinical trials.

    PubMed

    Sleight, P

    2004-02-01

    Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor. PMID:14746553

  15. What is a clinical fact? Clinical psychoanalysis as inductive method.

    PubMed

    Ahumada, J L

    1994-12-01

    This paper is an inquiry into the nature of clinical facts in psychoanalysis. The attainment of representability of psychic reality being requisite for insight, the author examines inductive processes on the part of both analyst and analysand, which are to be considered proper aspects of the study of clinical facts. It is argued that the analyst chooses his interpretations guided in good measure by nonverbal material, based on how he intuits that he is 'used' by the analysand and the ways the analysand feels 'used' by him; such nonverbal clues on the nature of the unconscious relational 'frames' operating in sessions guide him to select relevant associations from the universe of the analysand's verbal utterances. He thus comes to voice his interpretations, purveying a 'mapping' of psychic reality that typically makes use of a new viewpoint for description. Insight is achieved when the analysand attains ostensive refutation or redefinition of his unconscious 'theories' about the relationship, and this happens only in concrete individual situations, when the effects of his relational unconscious 'theories' come to be contrasted observationally in diverse 'screens', perceptual and mnemic, against the background of the analyst's neutrality: in such a way unconscious 'theories' attain the Pcs.-Cs. domain of the 'no'. PMID:7713672

  16. Clinical markers and clinical consequences of stunned myocardium.

    PubMed

    Lowenstein, E

    1993-03-01

    Clinical markers must be identified to distinguish between stunned and acutely ischemic myocardial tissue, as well as to assess the viability of myocardium. Evaluation of electrocardiographic ST segment abnormalities can distinguish transmural oxygen deprivation from subendocardial oxygen declines, but stunned myocardium may have normal ST segments. Myocardial contrast echocardiography can estimate regional myocardial blood flow but ultrasound measurement of blood flow is not always able to discern stunned from nonviable myocardium. Change in extracellular pH has been used to study ischemia, but has not yet been shown to reflect differences between stunned and ischemic myocardium. A combination of clinical markers of flow, delivery, and oxygen consumption may be necessary in order to differentiate between stunned and ischemic regions. This distinction can have important therapeutic consequences because patients with acutely ischemic but viable myocardium may be ultimately harmed by inotropic drugs that increase myocardial oxygen demand. In contrast, inotropes may be indicated for stunned myocardial tissue. The determination of the reversibility of myocardial dysfunction can also impact on decisions to use mechanical cardiocirculatory support. Differentiation of stunned and ischemic myocardium might also streamline ICU assignments and lead to more effective use of high technology resources. PMID:8461509

  17. [International clinical trials: perspectives of clinical research coordinators].

    PubMed

    Aotani, Eriko

    2007-02-01

    There are several different task roles among the co-medicals who are involved in international clinical trials (ICTs). In this review article, several issues related with ICTs from the view point of clinical research coordinators (CRCs) will be discussed. The discussions include interview results from eight CRCs of four institutions who have been involved in ICTs, current status of education for co-medicals in the field of ICTs, and future perspectives of ICTs from the CRC's view point. The following topics are especially focused in the discussion. 1) It is necessary to establish the infra-structure for free discussion among the ICT team so that opinions of co-medicals as the operation managers of the participating institutions can be openly shared and importantly taken into account. 2) It is also important for co-medicals to conduct research studies to clarify the problems in the current ICT support systems. 3) Lastly, the significance of early involvement of CRCs into the ICT protocol development must be emphasized, because the quality of protocols will be better improved by the practical insight of CRCs, and consequently, the accomplishment of the ICT, such as the speed and the data quality, may be accelerated. PMID:17301551

  18. Rewards and advancements for clinical pharmacists.

    PubMed

    Goodwin, S Diane; Kane-Gill, Sandra L; Ng, Tien M H; Melroy, Joel T; Hess, Mary M; Tallian, Kimberly; Trujillo, Toby C; Vermeulen, Lee C

    2010-01-01

    The American College of Clinical Pharmacy charged the Clinical Practice Affairs Committee to review and update the College's 1995 White Paper, "Rewards and Advancements for Clinical Pharmacy Practitioners." Because of the limited data on the present state of rewards and advancements for clinical pharmacists, an online survey of "front-line" clinical pharmacists and pharmacy managers was conducted (1126 total respondents, 14% response rate). The resulting White Paper discusses motivators and existing systems of rewards and advancements for clinical pharmacists, as well as perceived barriers to implementation of these systems. Clinical pharmacists reported work-life balance, a challenging position, and opportunities for professional advancement as the most important factors for career success. At the time of the survey, financial rewards appeared not to be a major motivator for clinical pharmacists. Managers underestimated the importance that clinical pharmacists place on work-life balance and favorable work schedules. Although almost two thirds of the clinical pharmacists surveyed had not developed a professional development plan, 84% indicated an interest in career planning. Both clinical pharmacists and managers rated the lack of a clear reward and advancement structure as the most important barrier to effective systems of rewards and advancements. Pharmacy managers and administrators are encouraged to develop effective systems of rewards and advancements for clinical pharmacists that positively impact patient care and the institution's mission; these systems will benefit the clinical pharmacist, the health care institution, and the patient. PMID:20030483

  19. Clinical nutrition and drug interactions

    PubMed Central

    Ekincioğlu, Aygin Bayraktar; Demirkan, Kutay

    2013-01-01

    A drug’s plasma level, pharmacological effects or side effects, elimination, physicochemical properties or stability could be changed by interactions of drug-drug or drug-nutrition products in patients who receive enteral or parenteral nutritional support. As a result, patients might experience ineffective outcomes or unexpected effects of therapy (such as drug toxicity, embolism). Stability or incompatibility problems between parenteral nutrition admixtures and drugs might lead to alterations in expected therapeutic responses from drug and/or parenteral nutrition, occlusion in venous catheter or symptoms or mortality due to infusion of composed particles. Compatibilities between parenteral nutrition and drugs are not always guaranteed in clinical practice. Although the list of compatibility or incompatibilities of drugs are published for the use of clinicians in their practices, factors such as composition of parenteral nutrition admixture, drug concentration, contact time in catheter, temperature of the environment and exposure to light could change the status of compatibilities between drugs and nutrition admixtures. There could be substantial clinical changes occurring in the patient’s nutritional status and pharmacological effects of drugs due to interactions between enteral nutrition and drugs. Drug toxicity and ineffective nutritional support might occur as a result of those predictable interactions. Although administration of drugs via feeding tube is a complex and problematic route for drug usage, it is possible to minimise the risk of tube occlusion, decreased effects of drug and drug toxicity by using an appropriate technique. Therefore, it is important to consider pharmacological dosage forms of drugs while administering drugs via a feeding tube. In conclusion, since the pharmacists are well-experienced and more knowledgeable professionals in drugs and drug usage compared to other healthcare providers, it is suggested that provision of information and drug counselling by pharmacists in terms of detection and prevention of problems (such as interactions, stability, incompatibility) related with enteral/parenteral nutrition and drugs are invaluable in clinical practice. PMID:25931873

  20. Clinical Correlations in Cerebral Palsy

    PubMed Central

    MINCIU, Ioana

    2012-01-01

    ABSTRACT Background: Cerebral palsy (CP) is a group of persistent (but not necessarily unchanged), movement, posture, muscle tone and motor skills disorders non-progressive, with early onset, due to non-progressive impairments, occurring on an immature brain or a brain under development (prenatal, perinatal, postnatal during the first 3-4 years of life). It is associated to a variable extent with: cognitive disorders, epilepsy, sensory deficits, behaviour disorders. Aim: The study of the correlations between the clinical forms/subtypes of CP, comorbidities, and severity of functional impairment. Material and method: It is a retrospective trial aimed only at patients with the diagnosis of cerebral palsy admitted at Paediatric Neurology Clinic of the "Alexandru Obregia" Clinical Hospital in 2010. Results, discussions and conclusions: Patients with cerebral palsy corresponding with the criteria for inclusion: 379. The spastic CP type has prevailed. Comorbidities like mental retardation, epilepsy, and ophthalmic disorders were found with greater frequency than in the studies in the literature. The unilateral spastic form was statistically correlated with slight functional impairment (GMFCS I), with the absence of comorbidities or mild mental retardation, or with focal epilepsy when there is epilepsy. The bilateral spastic, tetraparetic and dyskinetic forms were correlated significantly with severe functional impairment (GMFCS IV, V), with profound or severe retardation, microcephaly, swallowing disorders, statural, ponderal hypotrophy, blindness and epilepsy. The bilateral spastic paraparetic form, which in the literature is mentioned as having fewer associated disorders (for example strabismus, slight retardation), when there is severe functional impairment, it may have the same comorbidities as the tetraparetic form (similar to the cases studied in the hospital). Comorbidities are the main admission cause and it correlates with the severity and prognosis. PMID:23483832

  1. Clinical Guideline: Management of Gastroparesis

    PubMed Central

    Camilleri, Michael; Parkman, Henry P.; Shafi, Mehnaz A.; Abell, Thomas L.; Gerson, Lauren

    2013-01-01

    This guideline presents recommendations for the evaluation and management of patients with gastroparesis. Gastroparesis is identified in clinical practice through the recognition of the clinical symptoms and documentation of delayed gastric emptying. Symptoms from gastroparesis include nausea, vomiting, early satiety, postprandial fullness, bloating, and upper abdominal pain. Management of gastroparesis should include assessment and correction of nutritional state, relief of symptoms, improvement of gastric emptying and, in diabetics, glycemic control. Patient nutritional state should be managed by oral dietary modifications. If oral intake is not adequate, then enteral nutrition via jejunostomy tube needs to be considered. Parenteral nutrition is rarely required when hydration and nutritional state cannot be maintained. Medical treatment entails use of prokinetic and antiemetic therapies. Current approved treatment options, including metoclopramide and gastric electrical stimulation (GES, approved on a humanitarian device exemption), do not adequately address clinical need. Antiemetics have not been specifically tested in gastroparesis, but they may relieve nausea and vomiting. Other medications aimed at symptom relief include unapproved medications or off-label indications, and include domperidone, erythromycin (primarily over a short term), and centrally acting antidepressants used as symptom modulators. GES may relieve symptoms, including weekly vomiting frequency, and the need for nutritional supplementation, based on open-label studies. Second-line approaches include venting gastrostomy or feeding jejunostomy; intrapyloric botulinum toxin injection was not effective in randomized controlled trials. Most of these treatments are based on open-label treatment trials and small numbers. Partial gastrectomy and pyloroplasty should be used rarely, only in carefully selected patients. Attention should be given to the development of new effective therapies for symptomatic control. PMID:23147521

  2. Cough: an unmet clinical need

    PubMed Central

    Dicpinigaitis, Peter V

    2011-01-01

    Cough is among the most common complaints for which patients worldwide seek medical attention. Thus, the evaluation and treatment of cough result in tremendous financial expenditure and consumption of health care resources. Yet, despite the clinical significance of cough, research efforts aimed at improving diagnostic capabilities and developing more effective therapeutic agents have been, to date, disappointing in their limited scope and outcomes. Acute cough due to the common cold represents the most common type of cough. Currently, available medications for the symptomatic management of acute cough are inadequate due to lack of proven efficacy and/or their association with undesirable or intolerable side effects at anti-tussive doses. Subacute cough, often representing a prolonged post-viral response, is typically refractory to standard anti-tussive therapy. Few clinical trials have evaluated therapeutic options for subacute cough. Diagnostic challenges facing the clinician in the management of chronic cough include the determination of whether symptoms of upper airway cough syndrome (formerly, postnasal drip syndrome) or gastro-oesophageal reflux disease are indeed the underlying cause of cough. Chronic, refractory unexplained (formerly, idiopathic) cough must be distinguished from cough that has not been fully evaluated and treated according to current guideline recommendations. Eagerly awaited are new safe and effective anti-tussive agents for use when cough suppression is desired, regardless of underlying aetiology of cough, as well as practical, validated ambulatory cough counters to aid clinical assessment and future research in the field of cough. LINKED ARTICLES This article is part of a themed issue on Respiratory Pharmacology. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2011.163.issue-1 PMID:21198555

  3. Clinical quality standards for radiotherapy

    PubMed Central

    2012-01-01

    Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:23788854

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

    PubMed

    Berry, Donald A

    2015-05-01

    Clinical trials are the final links in the chains of knowledge and for determining the roles of therapeutic advances. Unfortunately, in an important sense they are the weakest links. This article describes two designs that are being explored today: platform trials and basket trials. Both are attempting to merge clinical research and clinical practice. PMID:25888066

  5. [Psychiatry at the maternal clinic].

    PubMed

    Ammälä, Antti-Jussi

    2015-01-01

    Various mental disorders are encountered at the maternal clinic. Pregnancy predisposes to some mental disorders, most commonly depressive and anxiety disorders. The recognition of substance use disorders during pregnancy is very important, but difficult owing to the associated disgrace. An eating disorder with an onset preceding the pregnancy may cause problems for growth and development of the fetus and should thus be identified early enough. The rare but severe postpartum psychosis may often break out only after discharge from the maternity hospital. Drug therapy during pregnancy requires careful consideration and clear-cut reasoning. PMID:26237899

  6. New clinical pathways for keratoconus

    PubMed Central

    Gore, D M; Shortt, A J; Allan, B D

    2013-01-01

    Pre-2000, the clinical management of keratoconus centred on rigid contact lens fitting when spectacle corrected acuity was no longer adequate, and transplantation where contact lens wear failed. Over the last decade, outcome data have accumulated for new interventions including corneal collagen crosslinking, intracorneal ring implantation, topographic phototherapeutic keratectomy, and phakic intraocular lens implantation. We review the current evidence base for these interventions and their place in new management pathways for keratoconus under two key headings: corneal shape stabilisation and visual rehabilitation. PMID:23258309

  7. Clinical review: Percutaneous dilatational tracheostomy

    PubMed Central

    Al-Ansari, Mariam A; Hijazi, Mohammed H

    2006-01-01

    As the number of critically ill patients requiring tracheotomy for prolonged ventilation has increased, the demand for a procedural alternative to the surgical tracheostomy (ST) has also emerged. Since its introduction, percutaneous dilatational tracheostomies (PDT) have gained increasing popularity. The most commonly cited advantages are the ease of the familiar technique and the ability to perform the procedure at the bedside. It is now considered a viable alternative to (ST) in the intensive care unit. Evaluation of PDT procedural modifications will require evaluation in randomized clinical trials. Regardless of the PDT technique, meticulous preoperative and postoperative management are necessary to maintain the excellent safety record of PDT. PMID:16356203

  8. Trimethoprim: laboratory and clinical studies

    PubMed Central

    Darrell, J. H.; Garrod, L. P.; Waterworth, Pamela M.

    1968-01-01

    Trimethoprim is a synthetic compound which arrests the step in bacterial purine synthesis immediately succeeding that interfered with by sulphonamides. Acting alone it inhibits the growth of a wide range of bacteria in generally much lower concentrations than sulphonamides. Its action with a sulphonamide is strongly synergic and bactericidal. Studies are described of suitable cultural conditions, methods of testing sensitivity, and acquired resistance. Some clinical results of its use are reported in respiratory tract infections, Gram-negative septicaemia, and urinary tract infections, and further therapeutic possibilities are discussed. Images PMID:5697054

  9. Clinical uses of radiolabeled platelets

    SciTech Connect

    Datz, F.L.; Christian, P.E.; Baker, W.J.

    1985-12-01

    Platelets were first successfully radiolabeled in 1953. At that time, investigators were primarily interested in developing a technique to accurately measure platelet life span in both normal and thrombocytopenic patients. Studies using platelets labeled with /sup 51/Cr have shown shortened platelet survival times in a number of diseases including idiopathic thrombocytopenic purpura, coronary artery disease, and diabetes mellitus. More recently, labels such as /sup 111/In have been developed that allow in vivo imaging of platelets. Indium-111 platelets are being used to better understand the pathophysiology of atherosclerosis, thrombophlebitis, pulmonary embolism and clotting disorders, and to improve the clinical diagnosis of these diseases.

  10. Introduction to veterinary clinical oncology

    SciTech Connect

    Weller, R.E.

    1991-10-01

    Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.

  11. Phenotypic mapping and clinical ideology

    SciTech Connect

    Lurie, I.W.; Opitz, J.M.

    1995-07-17

    Scientists have been trying to determine whether the main clinical findings in the 4p deletion syndrome are due to a deletion of one small critical segment, or whether deletions of some particular segments of 4p are responsible for different phenotypic manifestations. This is the basic issue for the whole group of autosomal deletion syndromes, as well as for our understanding of mechanisms of the origin of the abnormal phenotype. All circumstances need to be taken into consideration when trying to apply molecular methods for the mapping of phenotypic findings in the 4p deletion or in any other autosomal deletion syndrome. 8 refs.

  12. Update on clinically isolated syndrome.

    PubMed

    Thouvenot, Éric

    2015-04-01

    Optic neuritis, myelitis and brainstem syndrome accompanied by a symptomatic MRI T2 or FLAIR hyperintensity and T1 hypointensity are highly suggestive of multiple sclerosis (MS) in young adults. They are called "clinically isolated syndrome" (CIS) and correspond to the typical first multiple sclerosis (MS) episode, especially when associated with other asymptomatic demyelinating lesions, without clinical, radiological and immunological sign of differential diagnosis. After a CIS, the delay of apparition of a relapse, which corresponds to the conversion to clinically definite MS (CDMS), varies from several months to more than 10 years (10-15% of cases, generally called benign RRMS). This delay is generally associated with the number and location of demyelinating lesions of the brain and spinal cord and the results of CSF analysis. Several studies comparing different MRI criteria for dissemination in space and dissemination in time of demyelinating lesions, two hallmarks of MS, provided enough substantial data to update diagnostic criteria for MS after a CIS. In the last revision of the McDonald's criteria in 2010, diagnostic criteria were simplified and now the diagnosis can be made by a single initial scan that proves the presence of active asymptomatic lesions (with gadolinium enhancement) and of unenhanced lesions. However, time to conversion remains highly unpredictable for a given patient and CIS can remain isolated, especially for idiopathic unilateral optic neuritis or myelitis. Univariate analyses of clinical, radiological, biological or electrophysiological characteristics of CIS patients in small series identified numerous risk factors of rapid conversion to MS. However, large series of CIS patients analyzing several characteristics of CIS patients and the influence of disease modifying therapies brought important information about the risk of CDMS or RRMS over up to 20 years of follow-up. They confirmed the importance of the initial MRI pattern of demyelinating lesions and of CSF oligoclonal bands. Available treatments of MS (immunomodulators or immunosuppressants) have also shown unequivocal efficacy to slow the conversion to RRMS after a CIS, but they could be unnecessary for patients with benign RRMS. Beyond diagnostic criteria, knowledge of established and potential risk factors of conversion to MS and of disability progression is essential for CIS patients' follow-up and initiation of disease modifying therapies. PMID:25813099

  13. Design Methods for Clinical Systems

    PubMed Central

    Blum, B.I.

    1986-01-01

    This paper presents a brief introduction to the techniques, methods and tools used to implement clinical systems. It begins with a taxonomy of software systems, describes the classic approach to development, provides some guidelines for the planning and management of software projects, and finishes with a guide to further reading. The conclusions are that there is no single right way to develop software, that most decisions are based upon judgment built from experience, and that there are tools that can automate some of the better understood tasks.

  14. Hypothermia as a clinical neuroprotectant.

    PubMed

    Sherman, Andrew L; Wang, Michael Y

    2014-08-01

    Applying therapeutic hypothermia (TH) for the purposes of neuroprotection, originally termed "hibernation," started nearly 100 years ago. Because TH cooling systems have improved to the point where it is practical and safe for general application, interest in providing such treatment in conditions such as spinal cord injury, traumatic brain injury, stroke, and cardiac arrest has increased. This article reviews the mechanisms by which TH mitigates secondary neurologic injury, the clinical scenarios where TH is being applied, and reviews selected published studies using TH for central nervous system neuroprotection. PMID:25064786

  15. Meningitis, clinical presentation of tetanus.

    PubMed

    Moniuszko, Anna; Zajkowska, Agata; Tumiel, Ewa; Rutkowski, Krzysztof; Czupryna, Piotr; Pancewicz, Sławomir; Rutkowski, Ryszard; Zdrodowska, Agnieszka; Zajkowska, Joanna

    2015-01-01

    Background. Tetanus is an acute disease caused by a neurotoxin produced by Clostridium tetani. Tetanus immunization has been available since the late 1930s but sporadic cases still occur, usually in incompletely vaccinated or unvaccinated individuals. Case Report. An elderly previously vaccinated female contracted tetanus following foot injury. Clinically she presented with meningitis causing diagnostic and therapeutic delays. Why Should Physician Be Aware of This? Even in developed countries the differential diagnosis of meningitis, especially in the elderly, should include tetanus. Treatment in intensive care unit is required. General population might benefit from vaccine boosters and education on this potentially fatal disease. PMID:25789186

  16. Capital planning for clinical integration.

    PubMed

    Grauman, Daniel M; Neff, Gerald; Johnson, Molly Martha

    2011-04-01

    When assessing the financial implications of a physician alignment and clinical integration initiative, a hospital should measure the initiative's potential ROI, perhaps best using a combination of net present value and payback period. The hospital should compare its own historical and projected performance with rating agency median benchmarks for key financial indicators of profitability, debt service, capital and cash flow, and liquidity. The hospital should also consider potential indirect benefits, such as retained outpatient/ancillary revenue, increased inpatient revenue, improved cost control, and improved quality and reporting transparency. PMID:21548429

  17. Informatics and the Clinical Laboratory

    PubMed Central

    Jones, Richard G; Johnson, Owen A; Batstone, Gifford

    2014-01-01

    The nature of pathology services is changing under the combined pressures of increasing workloads, cost constraints and technological advancement. In the face of this, laboratory systems need to meet new demands for data exchange with clinical electronic record systems for test requesting and results reporting. As these needs develop, new challenges are emerging especially with respect to the format and content of the datasets which are being exchanged. If the potential for the inclusion of intelligent systems in both these areas is to be realised, the continued dialogue between clinicians and laboratory information specialists is of paramount importance. Requirements of information technology (IT) in pathology, now extend well beyond the provision of purely analytical data. With the aim of achieving seamless integration of laboratory data into the total clinical pathway, ‘Informatics’ – the art and science of turning data into useful information – is becoming increasingly important in laboratory medicine. Informatics is a powerful tool in pathology – whether in implementing processes for pathology modernisation, introducing new diagnostic modalities (e.g. proteomics, genomics), providing timely and evidence-based disease management, or enabling best use of limited and often costly resources. Providing appropriate information to empowered and interested patients – which requires critical assessment of the ever-increasing volume of information available – can also benefit greatly from appropriate use of informatics in enhancing self-management of long term conditions. The increasing demands placed on pathology information systems in the context of wider developmental change in healthcare delivery are explored in this review. General trends in medical informatics are reflected in current priorities for laboratory medicine, including the need for unified electronic records, computerised order entry, data security and recovery, and audit. We conclude that there is a need to rethink the architecture of pathology systems and in particular to address the changed environment in which electronic patient record systems are maturing rapidly. The opportunity for laboratory-based informaticians to work collaboratively with clinical systems developers to embed clinically intelligent decision support systems should not be missed. PMID:25336763

  18. Clinical management of pressure ulcers.

    PubMed

    Thomas, David R

    2013-05-01

    Pressure ulcers are chronic and difficult to heal. Pressure-reducing devices are clearly superior to a standard hospital mattress in preventing pressure ulcers, but only limited evidence and clinical intuition supports pressure-reducing devices in improving the healing rate of pressure ulcers. Local wound treatment should aim at maintaining a moist wound environment. The choice of a particular dressing depends on wound characteristics, such as the amount of exudate, dead space, or wound location. Nutritional status should be addressed as a process of good care. Debridement may improve time to a clean wound bed, but no clearly superior approach has been demonstrated. PMID:23571035

  19. Clinics in diagnostic imaging (167)

    PubMed Central

    Tan, Tien Jin; Aljefri, Ahmad Mohammad; Elliott, Marc Bruce; Nicolaou, Savvas

    2016-01-01

    A 59-year-old woman who had previously undergone an anatomic left total shoulder arthroplasty presented with increasing left shoulder pain and significant reduction in motion of the left shoulder joint. No evidence of prosthetic loosening or periprosthetic fracture was detected on the radiographs or fluoroscopic arthrogram images. Dual-energy computed tomography (DECT) images revealed evidence of loosening of the glenoid component and secondary rotator cuff failure. This case illustrates how a combination of detailed clinical history, careful physical examination and DECT arthrogram evaluation may be used to identify complications of an anatomic total shoulder arthroplasty. PMID:27075207

  20. Clinical applications of skin substitutes.

    PubMed

    Nyame, Theodore T; Chiang, H Abraham; Orgill, Dennis P

    2014-08-01

    A unique understanding of the components of mammalian skin has led to the development of numerous skin substitutes. These skin substitutes attempt to compensate for functional and physiologic deficits present in damaged tissue. Skin substitutes, when appropriately applied in optimized settings, offer a promising solution to difficult wound management. The body of literature on skin substitutes increases as the understanding of tissue engineering and molecular biology expands. Given the high cost of these products, future randomized large prospective studies are needed to guide the clinical applications of skin substitutes. PMID:25085091

  1. Informatics and the clinical laboratory.

    PubMed

    Jones, Richard G; Johnson, Owen A; Batstone, Gifford

    2014-08-01

    The nature of pathology services is changing under the combined pressures of increasing workloads, cost constraints and technological advancement. In the face of this, laboratory systems need to meet new demands for data exchange with clinical electronic record systems for test requesting and results reporting. As these needs develop, new challenges are emerging especially with respect to the format and content of the datasets which are being exchanged. If the potential for the inclusion of intelligent systems in both these areas is to be realised, the continued dialogue between clinicians and laboratory information specialists is of paramount importance. Requirements of information technology (IT) in pathology, now extend well beyond the provision of purely analytical data. With the aim of achieving seamless integration of laboratory data into the total clinical pathway, 'Informatics' - the art and science of turning data into useful information - is becoming increasingly important in laboratory medicine. Informatics is a powerful tool in pathology - whether in implementing processes for pathology modernisation, introducing new diagnostic modalities (e.g. proteomics, genomics), providing timely and evidence-based disease management, or enabling best use of limited and often costly resources. Providing appropriate information to empowered and interested patients - which requires critical assessment of the ever-increasing volume of information available - can also benefit greatly from appropriate use of informatics in enhancing self-management of long term conditions. The increasing demands placed on pathology information systems in the context of wider developmental change in healthcare delivery are explored in this review. General trends in medical informatics are reflected in current priorities for laboratory medicine, including the need for unified electronic records, computerised order entry, data security and recovery, and audit. We conclude that there is a need to rethink the architecture of pathology systems and in particular to address the changed environment in which electronic patient record systems are maturing rapidly. The opportunity for laboratory-based informaticians to work collaboratively with clinical systems developers to embed clinically intelligent decision support systems should not be missed. PMID:25336763

  2. Nocardiosis: updates and clinical overview.

    PubMed

    Wilson, John W

    2012-04-01

    Nocardia, a gram-positive bacillus with the microscopic appearance of branching hyphae, can produce considerable disease in the appropriate host. The taxonomy of Nocardia continues to evolve; more than 50 species have been described. Early recognition and effective therapy are imperative to achieve successful outcomes. Although nocardiosis typically occurs in patients with cell-mediated immunosuppressive conditions, infection may occasionally develop in immunocompetent patients as well. This review addresses the microbiology of Nocardia, risk factors for infection, clinical presentations, and management strategies. PMID:22469352

  3. Clinical application of bio ceramics

    NASA Astrophysics Data System (ADS)

    Anu, Sharma; Gayatri, Sharma

    2016-05-01

    Ceramics are the inorganic crystalline material. These are used in various field such as biomedical, electrical, electronics, aerospace, automotive and optical etc. Bio ceramics are the one of the most active areas of research. Bio ceramics are the ceramics which are biocompatible. The unique properties of bio ceramics make them an attractive option for medical applications and offer some potential advantages over other materials. During the past three decades, a number of major advances have been made in the field of bio ceramics. This review focuses on the use of these materials in variety of clinical scenarios.

  4. Extracorporeal Membrane Oxygenation Clinical Dilemmas

    PubMed Central

    Sidebotham, David

    2012-01-01

    Abstract: Three scenarios are presented, based on real patients, illustrating various clinical dilemmas involving critical illness and extracorporeal membrane oxygenation (ECMO). The scenarios are outlined in the form of questions and answers. In most cases there is no single correct answer to the dilemmas presented. The pros and cons of particular interventions are discussed along with the actual treatment provided. In all cases, the ECMO circuit consisted of a polymethylpentene oxygenator (Quadrox PLS; MAQUET Cardiovascular, Hirlingen, Germany) and a centrifugal pump (Rotaflow; MAQUET Cardiovascular). Case 2 has been previously published as a letter to the editor (1). PMID:23441569

  5. [Cellulitis: clinical manifestations and management].

    PubMed

    Blum, C-L; Menzinger, S; Genné, D

    2013-10-01

    Cellulitis is an acute bacterial non-necrotizing dermal-hypodermal infection predominantly affecting the lower limbs. It is characterised by a circumscribed erythema with a raised border and fever. The predisposing factors are skin wounds, edema from any cause and systemic factors (diabetes, immunosuppression). The diagnosis is clinical and the most common complication is recurrence. Other complications include local abscess, fasciitis and bacteremia. The germ is rarely identified. The majority of infections (85%) is due to group A beta-hemolytic streptococcus. The treatment of cellulitis consists of an association of an antibiotic with rest of the concerned area. PMID:24191414

  6. Clinical approach to marrow failure.

    PubMed

    Shimamura, Akiko

    2009-01-01

    The treatment and medical management of aplastic anemia fundamentally differ between patients with inherited versus acquired marrow failure; however, the diagnosis of an inherited bone marrow failure syndrome is frequently obscure. Recent exciting advances in our understanding of the molecular pathophysiology of the inherited bone marrow failure syndromes have resulted in a profusion of new tests to aid in diagnosis. This in turn has raised questions regarding the appropriate choice of testing for the patient presenting with aplastic anemia. Important clues to the diagnosis of an inherited marrow failure syndrome may be gleaned from careful attention to the clinical history, physical exam, and laboratory workup. PMID:20008218

  7. Mast cell sarcoma: clinical management.

    PubMed

    Weiler, Catherine R; Butterfield, Joseph

    2014-05-01

    Mast cell sarcoma is a disorder that results in abnormal mast cells as identified by morphology, special stains, and in some publications, c-kit mutation analysis. It affects animal species such as canines more commonly than humans. In humans it is a very rare condition, with variable clinical presentation. There is no standard therapy for the disorder. It can affect any age group. It is occasionally associated with systemic mastocytosis and/or urticaria pigmentosa. The prognosis of mast cell sarcoma in published literature is very poor in humans. PMID:24745684

  8. C.M.L. * * Clinical Medical Librarian.

    ERIC Educational Resources Information Center

    Lawrence, Gerri G.

    1979-01-01

    Describes the responsibilities of the clinical medical librarian, an occupation in which the medical librarian operates in a clinical setting, identifying information needs of medical personnel through direct patient-physician-librarian contact. (CWM)

  9. Developing good practice for clinical research nurses.

    PubMed

    McDermott, Shona; Hathaway, Kornelia; Saunders, Caroline

    This article outlines the role of clinical research in the UK government's strategy for economic growth and the role of clinical research nurses in that research. The diverse skills and knowledge required by clinical research nurses to support a range of research studies in a number of research environments are described. The development and aim of the UK Clinical Research Facility Network is discussed, with particular focus on the role of the UK Clinical Research Facility Network Education Group in supporting clinical research nurses and research teams to acquire and maintain relevant research skills. The outcomes delivered by the UK Clinical Research Facility Network Education Group are outlined along with ongoing and future work. Recommendations to ensure that the workforce will be skilled appropriately to support future clinical research are provided. PMID:24568424

  10. Clinical Trials | Division of Cancer Prevention

    Cancer.gov

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  11. Legal issues in clinical nursing education.

    PubMed

    Patton, Carla Wheeler; Lewallen, Lynne Porter

    2015-01-01

    Nurse educators are concerned about legal implications of teaching students in clinical settings. Although literature is available about legal issues in working with students in the classroom, there is little recent information on clinical nursing faculty's legal liability when working with students and ways to reduce the risk of becoming involved in a lawsuit. This article discusses the major issues in clinical settings that contribute to lawsuits against faculty and offers suggestions to reduce legal liability with students in clinical settings. PMID:25501655

  12. Tremelimumab: research and clinical development

    PubMed Central

    Comin-Anduix, Begoña; Escuin-Ordinas, Helena; Ibarrondo, Francisco Javier

    2016-01-01

    The immune checkpoint therapy is a relatively recent strategy that aims to tweak the immune system to effectively attack cancer cells. The understanding of the immune responses and their regulation at the intracellular level and the development of fully humanized monoclonal antibodies are the pillars of an approach that could elicit durable clinical responses and even remission in some patients with cancer. Most of the immune checkpoints that regulate the T-cell responses (activation and inhibition) operate through proteins present on the cytoplasmic membrane of the immune cells. Therefore, specific antibodies capable of blocking the inhibitory signals should lead to unrestrained immune responses that supersede the inhibitory mechanisms, which are naturally present in the tumor microenviroment. The best-known and most successful targets for immune checkpoint therapy are the cytotoxic T-lymphocyte antigen-4 and programmed cell death-1 coreceptors. Tremelimumab (CP-675,206) is a fully humanized monoclonal antibody specific for cytotoxic T-lymphocyte antigen-4, which has been successfully used to treat patients with metastatic melanoma and some other cancers. Although still a work in progress, the use of tremelimumab as an immune checkpoint therapeutic agent is a promising approach alone or in combination with other anticancer drugs. Here, we review the use of this antibody in a number of clinical trials against solid tumors. PMID:27042127

  13. Tremelimumab: research and clinical development.

    PubMed

    Comin-Anduix, Begoña; Escuin-Ordinas, Helena; Ibarrondo, Francisco Javier

    2016-01-01

    The immune checkpoint therapy is a relatively recent strategy that aims to tweak the immune system to effectively attack cancer cells. The understanding of the immune responses and their regulation at the intracellular level and the development of fully humanized monoclonal antibodies are the pillars of an approach that could elicit durable clinical responses and even remission in some patients with cancer. Most of the immune checkpoints that regulate the T-cell responses (activation and inhibition) operate through proteins present on the cytoplasmic membrane of the immune cells. Therefore, specific antibodies capable of blocking the inhibitory signals should lead to unrestrained immune responses that supersede the inhibitory mechanisms, which are naturally present in the tumor microenviroment. The best-known and most successful targets for immune checkpoint therapy are the cytotoxic T-lymphocyte antigen-4 and programmed cell death-1 coreceptors. Tremelimumab (CP-675,206) is a fully humanized monoclonal antibody specific for cytotoxic T-lymphocyte antigen-4, which has been successfully used to treat patients with metastatic melanoma and some other cancers. Although still a work in progress, the use of tremelimumab as an immune checkpoint therapeutic agent is a promising approach alone or in combination with other anticancer drugs. Here, we review the use of this antibody in a number of clinical trials against solid tumors. PMID:27042127

  14. Clinical experience with intravenous fenoldopam.

    PubMed

    Holcslaw, T L; Beck, T R

    1990-06-01

    Fenoldopam (Corlopam), a new dopaminergic agent in clinical development by SmithKline Beecham Pharmaceuticals, is a dopamine-1 (DA1) agonist at post-synaptic dopamine receptors. Preclinical and clinical studies have demonstrated that it is a potent renal vasodilator as well as a peripheral vasodilator. In both normal volunteers and hypertensive patients intravenous fenoldopam causes dose-related decreases in blood pressure and important increases in renal hemodynamics and function including increased renal blood flow, diuresis and natriuresis. Fenoldopam does not alter glomerular filtration. Intravenous fenoldopam has been demonstrated to be efficacious in severe hypertensive patients in several multicenter, multinational trials. In severe hypertension efficacy trials fenoldopam was judged to be as effective as sodium nitroprusside and to produce less serious side effects. In patients with moderate to severe heart failure, fenoldopam has been demonstrated to produce dose-related acute increases in cardiac output, stroke volume and work index, decreased systemic vascular resistance but no important changes in pulmonary wedge pressure or right atrial pressure. In CHF patients fenoldopam has been demonstrated to be as efficacious as sodium nitroprusside. Fenoldopam, as a specific (DA1) agonist resulting in decreased peripheral and renal vascular resistance, diuresis, natriuresis and increases in cardiac hemodynamics on intravenous administration, appears to be an efficacious agent which offers a reasonable alternative in the treatment of severe hypertension and acute congestive heart failure. PMID:1974440

  15. Clinical correlates with diaper dermatitis.

    PubMed

    Benjamin, L

    1987-01-01

    Three types of clinical studies were carried out to better understand diaper dermatitis in a general infant population. In 'snapshot' clinical studies, skin condition under the diaper was evaluated at a given point in time across a large base of infants. Correlations were sought between diaper dermatitis incidence and severity and a number of factors, including sex, diet, maturity, type of diaper, history of allergy, contact with fecal matter, presence of Candida albicans, and diaper change frequency. Severe diaper rash correlated strongly with the presence of C. albicans, and the frequency of rash correlated with duration of contact with feces and inversely with diaper change frequency. Diaper rash peaked at ages 9-12 months and was lower for breast-fed than for formula-fed infants. Exclusive use of disposable diapers correlated with lower rash levels than when some or all cloth diapers were used. In a longitudinal study, infants were observed daily for 50 days in order to determine the frequency and duration of rash episodes. In this study, the tendency for some infants to be rash-prone was clearly indicated. In a third type of study, over 10,000 infant visits to physicians' offices were used to record skin condition. Results showed a three-to fourfold increase in diaper rash if the child had diarrhea during the previous 48 h. PMID:3299331

  16. Clinical pharmacokinetics during continuous haemofiltration.

    PubMed

    Bressolle, F; Kinowski, J M; de la Coussaye, J E; Wynn, N; Eledjam, J J; Galtier, M

    1994-06-01

    Continuous haemofiltration is an extracorporeal technique that is increasingly used to remove fluid, electrolytes, and other waste products from the blood supply of critically ill patients with acute renal failure. Continuous arteriovenous haemofiltration (CAVH), where the blood exits the body from an artery and re-enters through a vein, is widely used. Continuous venovenous haemofiltration (CVVH), where blood both exits and enters through a vein by way of a mechanical pump, avoids problems that result from the variable ultrafiltration rate found during CAVH. Continuous arteriovenous or venovenous haemodiafiltration (CAVHD or CVVHD) combine continuous haemofiltration and haemodialysis. All methods involve ultrafiltration of the patient's blood through a filter that is highly permeable to water and small molecules. Drug elimination by haemofiltration depends mainly on the rate of ultrafiltration, the drug protein binding and the sieving coefficient of the membrane. Because patients undergoing continuous haemofiltration have impaired renal function, dosage reduction is often recommended so that adverse drug reactions are avoided. In contrast, if drug removal by haemofiltration is significant, dosage supplementation may be required to ensure therapeutic efficacy of the drug. Therefore, knowledge of the impact of continuous haemofiltration on drug elimination and the pharmacokinetic profile of drugs is essential to good clinical management. The currently available information on the clinical pharmacokinetic aspects of drug therapy during continuous haemofiltration are summarised. Drugs commonly associated with haemofiltration therapy are tabulated with updated pharmacokinetics and drug-monitoring information. PMID:8070219

  17. Sixty years of clinical electroencephalography.

    PubMed

    Karbowski, K

    1990-01-01

    As a result of painstaking studies carried out over a period of almost 30 years, the German neurologist and psychiatrist Hans Berger, of Jena, published the first paper on the human electroencephalogram (Uber das Elektrenkephalogramm des Menschen') in 1929. Clinical electroencephalography, which reached a zenith in the 1950s and 1960s, increased the range of diagnostic techniques available for a series of brain diseases and revolutionized the study of epilepsy. Today, conventional electroencephalography no longer yields startling scientific discoveries. Nor can it complete with computer tomography and magnetic resonance imaging, in the diagnosis of structural disorders of the brain. In spite of this, the scope of its uses continues to increase and it remains an indispensable instrument of neurophysiological diagnosis, especially in its capacity as a 'seismograph' of the brain. The trend that is apparent throughout the world to cut back clinical electroencephalographic units in favor of other neurophysiological investigative techniques is both unjustified and dangerous. If it continues, it will inevitably lead to a decline in epileptology, which is an essential part of the work of many different medical specialists both in practice and in hospitals. PMID:2192889

  18. Clinical Manifestations of Aural Fullness

    PubMed Central

    Park, Moon Suh; Lee, Ho Yun; Kang, Ho Min; Ryu, Eun Woong; Lee, Sun Kyu

    2012-01-01

    Purpose Even though aural fullness is ubiquitous among patients presenting to otolaryngology clinics, the association between aural fullness and disease development has not yet been clearly determined. Materials and Methods Our study was performed on outpatients from June 2006 to February 2010 whose major complaint was "ear fullness", "aural fullness", or "ear pressure". We assessed their demographic and clinical characteristics, including sex, associated diseases, symptoms, otoscopic findings, audiology test results, and final diagnoses. Results Among 432 patients, 165 (38.2%) were males and 267 (61.8%) were females, with mean ages of 4219 years and 4717 years, respectively. Tinnitus, hearing disturbance, autophony (p<0.01) as well as nasal obstruction and sore throat (p<0.05) showed a statistically significant correlation with aural fullness. Among patients who complained of hearing fullness, tests and measures such as impedance audiometry, speech reception threshold, and pure tone audiometry generated statistically significant results (p<0.05). Ear fullness was most frequently diagnosed as Eustachian tube dysfunction (28.9%), followed by otitis media with effusion (13.4%) and chronic otitis media (7.2%). However, 13.4% of patients could not be definitively diagnosed. Conclusion Among patients complaining of ear fullness, Eustachian tube dysfunction, otitis media with effusion, chronic otitis media were most commonly observed. Performance of otoscopy, nasal endoscopy, the Valsalva maneuver, and additional audiological tests is necessary to exclude other diseases. PMID:22869482

  19. Clinical status of benzoporphyrin derivative

    NASA Astrophysics Data System (ADS)

    Levy, Julia G.; Chan, Agnes H.; Strong, H. Andrew

    1996-01-01

    Benzoporphyrin derivative monoacid ring A (BPD) is currently in Phase II clinical trials for the treatment of cutaneous malignancies (basal cell carcinoma and cutaneous metastases) and psoriasis. Results to date suggest that this photosensitizer has potential in both of these areas. Recently, a clinical trial with BPD was initiated for the treatment of age related macular degeneration, a neovascular condition in the eye which leads to blindness. BPD is a lipophilic photosensitizer which is rapidly taken up by activated cells and the vascular endothelium of neovasculature. The PDT effects seen with BPD appear to be a combination of vascular occlusion and direct killing of target cells. Since many diseases involve either activated cells and/or neovasculature, PDT with photosensitizer with characteristics like those of BPD, has applications far wider than oncology. A new area of interest involving photosensitizers is that of immune modulation. A number of photosensitizers have been shown to effect immune modulation in animal models of immune dysfunction including autoimmunity (rheumatoid arthritis, lupus), cutaneous hypersensitivity and allografts. BPD and PHOTOFRINR have both been shown to be effective in ameliorating arthritic symptoms in a number of animal models. The mechanisms by which immune modulation is affected in these studies still remains to be resolved.

  20. Clinical pharmacokinetics of ibuprofen arginine.

    PubMed

    Cattaneo, Dario; Clementi, Emilio

    2010-11-01

    Currently, several ibuprofen compounds are available on the market, mainly differing in terms of pharmaceutical composition that influence the pharmacokinetic profile and eventually the onset of drug action. This review will mainly deal with the clinical pharmacokinetics of ibuprofen arginine, an alternative formulation specifically designed to improve the absorption of ibuprofen. Indeed, available data from studies in healthy volunteers have consistently shown that the formulation of ibuprofen arginine is characterized by prompt absorption of ibuprofen as compared to the conventional formulation at all tested doses with higher peak plasma concentration and lower Tmax values. This trend has been confirmed also in studies dealing with chiral ibuprofen pharmacokinetics. Most importantly, the shortening in the absorption time observed either with racemic mixture or with the S(+)-enantiomer of ibuprofen arginine did not imply a faster drug elimination eventually leading to inadequate daily drug exposure, as documented by T1/2 and AUC values being comparable to those measured with the free acid form. Taken together, the pharmacokinetic/dynamic characteristics of ibuprofen arginine can be considered particularly favorable for several clinical conditions, such as moderate/severe pain, in which a rapid pharmacologic effect is required. PMID:20925647

  1. [Sarcopenia: prevalence, detection, clinical significance].

    PubMed

    Bezdenezhnykh, A V; Sumin, A N

    2012-01-01

    Population aging is a most important demographic process in the recent decades. The elderly subjects constitute an increasingly greater fraction of the patients staying at multifield hospitals. They are characterized not only by having multiple pathologies but also by age-related changes in peripheral tissues. These physiological changes may considerably aggravate the clinical conditions of the patients. One of the processes accompanying aging is sarcopenia or the loss of muscular mass leading to deterioration of the quality of life and physical independence, disablement and a poor life prognosis. Sarcopenia has been extensively studied in recent decades with reference to it social and economic consequences. At the same time the efficacy of measures designed to control sarcopenia is impaired by concomitant diseases and age-related changes in the muscular tissue. The problem of sarcopenia is insufficiently dealt with in the Russian-language literature despite its clinical significance. This review is intended for a wide circle of clinicians dealing with aged patients in their practical work. PMID:23285756

  2. Respiratory microbiota: addressing clinical questions, informing clinical practice

    PubMed Central

    Rogers, Geraint B; Shaw, Dominick; Marsh, Robyn L; Carroll, Mary P; Serisier, David J; Bruce, Kenneth D

    2015-01-01

    Over the last decade, technological advances have revolutionised efforts to understand the role played by microbes in airways disease. With the application of ever more sophisticated techniques, the literature has become increasingly inaccessible to the non-specialist reader, potentially hampering the translation of these gains into improvements in patient care. In this article, we set out the key principles underpinning microbiota research in respiratory contexts and provide practical guidance on how best such studies can be designed, executed and interpreted. We examine how an understanding of the respiratory microbiota both challenges fundamental assumptions and provides novel clinical insights into lung disease, and we set out a number of important targets for ongoing research. PMID:25035125

  3. Republished: Respiratory microbiota: addressing clinical questions, informing clinical practice

    PubMed Central

    Rogers, Geraint B; Shaw, Dominick; Marsh, Robyn L; Carroll, Mary P; Serisier, David J; Bruce, Kenneth D

    2015-01-01

    Over the last decade, technological advances have revolutionised efforts to understand the role played by microbes in airways disease. With the application of ever more sophisticated techniques, the literature has become increasingly inaccessible to the non-specialist reader, potentially hampering the translation of these gains into improvements in patient care. In this article, we set out the key principles underpinning microbiota research in respiratory contexts and provide practical guidance on how best such studies can be designed, executed and interpreted. We examine how an understanding of the respiratory microbiota both challenges fundamental assumptions and provides novel clinical insights into lung disease, and we set out a number of important targets for ongoing research. PMID:26304986

  4. [Clinical management. A always current tool].

    PubMed

    Désaulniers, Pierre; Letendre, Jean F

    2006-03-01

    Clinical reasoning is the fundamental tool every clinician must master. This paper gives a definition of clinical reasoning process using real cases and presents some of the cognitive models underlying it (especially the script concept). We discuss the caveats of clinical reasoning process and its impact on interdisciplinary work, the use of technologies and medical teaching. PMID:16711074

  5. Measuring Clinical Significance in Rehabilitation Research

    ERIC Educational Resources Information Center

    Johnson, Erica K.; Dow, Christian; Lynch, Ruth T.; Hermann, Bruce P.

    2006-01-01

    Measurement of clinically significant change is critical for rehabilitation research because it can enhance the credibility of rehabilitation efforts and guide evidence-based practices. The practical appeal of clinically significant change is that it can bridge research and clinical practice by focusing on individual rather than group differences.…

  6. Clinical Trials Management | Division of Cancer Prevention

    Cancer.gov

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  7. Serving Inland Rural Communities through University Clinics

    ERIC Educational Resources Information Center

    Allan, Julaine; Pope, Rod; O'Meara, Peter; Higgs, Joy; Kent, Jenny

    2011-01-01

    Aim: To effectively provide clinical placements for students and increase healthcare options for rural communities, an investigation of university clinics was conducted. Method: This project adopted a consultative inquiry strategy and involved two processes: (1) a review of literature; and (2) interviews with existing health sciences clinic staff.…

  8. Curriculum Revolution: Reconceptualizing Clinical Nursing Education.

    ERIC Educational Resources Information Center

    Lindeman, Carol A.

    1989-01-01

    While the clinical competence of the nurse is taking on greater importance, the clinical laboratory settings are changing in ways that detract from their suitability for use in entry-level programs. Initial consideration of the health care setting reveals several paradoxes that must be resolved if clinical education is to be affected. (JOW)

  9. Clinical Facts, Turning Points and Complexity Theory

    ERIC Educational Resources Information Center

    Lush, Margaret

    2011-01-01

    In this paper, I explore how we might link ideas about clinical facts to current issues in child psychotherapy research. I consider what our understanding of clinical facts might contribute to our research methods and how our research methods might better represent the clinical facts. The paper introduces a selection of psychoanalytic writers'…

  10. Clinical Psychology: A Research and Development Model.

    ERIC Educational Resources Information Center

    Broskowski, Anthony

    The purpose of this paper is to present a clinical research and development (R and D) model along with the rationale for its implementation and a sample training program for clinical psychologists. Although it may be possible to correct some problems by a clearer restatement of the scientist-professional model, a new model of clinical R and D has…

  11. 42 CFR 440.90 - Clinic services.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false Clinic services. 440.90 Section 440.90 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: GENERAL PROVISIONS Definitions § 440.90 Clinic services. Clinic services means preventive, diagnostic,...

  12. 42 CFR 440.90 - Clinic services.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 4 2012-10-01 2012-10-01 false Clinic services. 440.90 Section 440.90 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: GENERAL PROVISIONS Definitions § 440.90 Clinic services. Clinic services means preventive, diagnostic,...

  13. 42 CFR 440.90 - Clinic services.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 4 2014-10-01 2014-10-01 false Clinic services. 440.90 Section 440.90 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: GENERAL PROVISIONS Definitions § 440.90 Clinic services. Clinic services means preventive, diagnostic,...

  14. Effective Mentoring in the Clinical Setting.

    PubMed

    Shellenbarger, Teresa; Robb, Meigan

    2016-04-01

    This article is one in a series on the roles of adjunct clinical faculty and preceptors, who teach nursing students and new graduates to apply knowledge in clinical settings. This article describes mentoring strategies clinical instructors and preceptors can use to help ease novice nurses' transition to practice. PMID:27011145

  15. 42 CFR 70.9 - Vaccination clinics.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...

  16. 42 CFR 70.9 - Vaccination clinics.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...

  17. 42 CFR 70.9 - Vaccination clinics.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...

  18. 42 CFR 70.9 - Vaccination clinics.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...

  19. 42 CFR 70.9 - Vaccination clinics.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...

  20. Clinical Computer Applications in Mental Health

    PubMed Central

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

    1982-01-01

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