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Sample records for subjects underwent clinical

  1. LARYNGEAL CANCER: SOCIODEMOGRAPHIC, LIFE STYLE AND CLINICAL RISK FACTORS AMONG PATIENTS UNDERWENT TOTAL LARYNGECTOMY

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    E. A. EL-MOSELHY, Y. M. SALEH, M. M. EL-SAWY

    2010-01-01

    Introduction: Laryngeal cancer (LC) is an important health problem. It is one of the most common respiratory cancers. The prevalence of this cancer is increasing all over the world. Objectives: The aim of the present study is to determine the clinical features of the laryngeal cancer patients underwent total laryngectomty (TL); to define the characteristic features of surgery in these patients; and to define the life style, health behavioral, sociodemographic and clinical risk factors of the ...

  2. Undergrading and understaging in patients with clinically insignificant prostate cancer who underwent radical prostatectomy

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    Irai S. Oliveira

    2010-06-01

    Full Text Available PURPOSE: The aim of our study is to evaluate the undergrading and understaging rates in patients with clinically localized insignificant prostate cancer who underwent radical prostatectomy. MATERIALS AND METHODS: Between July 2005 and July 2008, 406 patients underwent radical prostatectomy for clinical localized prostate cancer in our hospital. Based on preoperative data, 93 of these patients fulfilled our criteria of non-significance: Gleason score < 7, stage T1c, PSA < 10 ng/mL and percentage of affected fragments less than 25%. The pathologic stage and Gleason score were compared to preoperative data to evaluate the rate of understaging and undergrading. The biochemical recurrence free survival of these operated insignificant cancers were also evaluated. RESULTS: On surgical specimen analysis 74.7% of patients had Gleason score of 6 or less and 25.3% had Gleason 7 or greater. Furthermore 8.3% of cases showed extracapsular extension. After 36 months of follow-up 3.4% had biochemical recurrence, defined by a PSA above 0.4 ng/mL. CONCLUSIONS: Despite the limited number of cases, we have found considerable rates of undergrading and understaging in patients with prostate cancer whose current definitions classified them as candidates for active surveillance. According to our results the current definition seems inadequate as up to a third of patients had higher grade or cancer outside the prostate.

  3. Clinical profiles of 710 premenopausal women with adenomyosis who underwent hysterectomy.

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    Li, Xuelian; Liu, Xishi; Guo, Sun-Wei

    2014-02-01

    The aim of this study was to determine the frequency of various symptoms and their associated characteristics in women with adenomyosis who underwent hysterectomy, and to determine which symptoms are likely to go with which others in these patients. In 2007, 1697 consecutive patients underwent hysterectomy in our hospital. Among them, 734 (43.3%) were histologically confirmed to have adenomyosis, and 710 of them were premenopausal. The medical charts of all 734 patients were retrieved, and their demographic, clinical information and postoperative findings were recorded. We used the Verbal Descriptor Scale to measure the preoperative severity of dysmenorrhea. The Apriori Algorithm was used for mining the association of different symptoms. Among the 710 premenopausal patients, only 4.5% of them had no symptoms. Dysmenorrhea was the most common complaint, occurring in 81.7% of patients. Dysmenorrhea co-occurred most frequently with menorrhagia. The presence of adhesion, presence of endometriosis, complaint of menorrhagia, longer duration of disease, gravidity, palpable pain during pelvic examination, and diffuse adenomyosis were positively associated with the severity of dysmenorrhea. Age, severity of dysmenorrhea, and complaint of metrorrhagia were positively associated with the risk of menorrhagia. Dysmenorrhea is the most common complaint in women with adenomyosis, which often goes with that of menorrhagia. Adenomyosis often co-occurs with endometriosis and leiomyomas. Various factors are associated with the risk of having different symptoms. © 2013 The Authors. Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology.

  4. Norms of the Mini-Mental state Examination for Japanese subjects that underwent comprehensive brain examinations: the Kashima Scan Study.

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    Yakushiji, Yusuke; Horikawa, Etsuo; Eriguchi, Makoto; Nanri, Yusuke; Nishihara, Masashi; Hirotsu, Tatsumi; Hara, Hideo

    2014-01-01

    The distribution of the Mini-Mental State Examination (MMSE) scores by age and educational level was investigated in subjects that underwent comprehensive brain examinations. This cross-sectional study included 1,414 adults without neurological disorders who underwent health-screening tests of the brain, referred to as the "Brain Dock," in our center. The MMSE scores were compared between age groups (40-44, 45-49, 50-54, 55-59, 60-64, 65-69, or ≥70 years) and educational levels [the low education level group (6-12 years) and the high education level group (≥13 years)]. The median age was 59 years, and 763 (54%) were women. There was no significant difference in the MMSE total score between women and men. The stepwise method of the multiple linear regression analysis confirmed that a higher age [β value, -0.129; standard error (S.E.), 0.020; p<0.001], low education level (6-12 years) (β value, -0.226; S.E., 0.075; p=0.003), and women (β values, 0.148; S.E., 0.066; p=0.024) was significantly associated with decreased MMSE score. In general, both the percentile scores and mean scores decreased with aging and were lower in the low education level group than in the high education level group. The degree of decrement in scores with age was stronger in the low education level group than in the high education level group. The provided data for age- and education-specific reference norms will be useful for both clinicians and investigators who perform comprehensive brain examinations to assess the cognitive function of subjects.

  5. CLINICAL PECULIARITIES OF EPSTEIN BARR VIRAL INFECTION AMONG CHILDREN, WHO UNDERWENT GLANDULAR FEVER

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    Ye.V. Potarskaya

    2006-01-01

    Full Text Available The work deals with the findings of the 5byear observation after children, who have undergone glandular fever. The researchers have found out that among the majority of them there are clinical and hematological abnormalities of various degree of manifestation. The application of _b2b interferon contributes to the reduction of the acute period of glandular fever, although it doesn't always warn about the appearance of closest and distant manifestations. Key words: children, glandular fever, 2B interferon.

  6. Clinical trials. A pending subject.

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    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2017-07-31

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  7. Reestablishing Clinical Psychology's Subjective Core

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    Hunsberger, Peter Hume

    2007-01-01

    Comments on the report by the APA Presidential Task Force on Evidence-Based Practice (see record 2006-05893-001) entitled Evidence-based practice in psychology. The Task Force is to be commended for their report valuing evidence from "clinical expertise" on a par with "research data" (p. 272) in guiding psychological practices. The current author…

  8. Clinical management of transsexual subjects.

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    Costa, Elaine Maria Frade; Mendonca, Berenice Bilharinho

    2014-03-01

    Transsexual subjects are individuals who have a desire to live and be accepted as a member of the opposite sex, usually accompanied by a sense of discomfort with, or inappropriateness of, one's anatomic sex, and a wish to have surgery and hormonal treatment to make one's body as congruent as possible with one's preferred sex. They seek to develop the physical characteristics of the desired gender, and should undergo an effective and safe treatment regimen. The goal of treatment is to rehabilitate the individual as a member of society in the gender he or she identifies with. Sex reassignment procedures necessary for the treatment of transsexual patients are allowed in our country, at Medical Services that have a multidisciplinary team composed of a psychologist, a social worker, a psychiatrist, an endocrinologist and surgeons (gynecologists, plastic surgeons, and urologists). Patients must be between 21 to 75 years old and in psychological and hormonal treatment for at least 2 years. Testosterone is the principal agent used to induce male characteristics in female transsexual patients, and the estrogen is the chosen hormone used to induce the female sexual characteristics in male transsexual patients. Based on our 15 years of experience, we can conclude that testosterone and estradiol treatment in physiological doses are effective and safe in female and male transsexual patients, respectively.

  9. [Assessment of the correlation between histological degeneration and radiological and clinical parameters in a series of patients who underwent lumbar disc herniation surgery].

    Science.gov (United States)

    Munarriz, Pablo M; Paredes, Igor; Alén, José F; Castaño-Leon, Ana M; Cepeda, Santiago; Hernandez-Lain, Aurelio; Lagares, Alfonso

    2017-09-26

    The use of histological degeneration scores in surgically-treated herniated lumbar discs is not common in clinical practice and its use has been primarily restricted to research. The objective of this study is to evaluate if there is an association between a higher grade of histological degeneration when compared with clinical or radiological parameters. Retrospective consecutive analysis of 122 patients who underwent single-segment lumbar disc herniation surgery. Clinical information was available on all patients, while the histological study and preoperative magnetic resonance imaging were also retrieved for 75 patients. Clinical variables included age, duration of symptoms, neurological deficits, or affected deep tendon reflex. The preoperative magnetic resonance imaging was evaluated using Modic and Pfirrmann scores for the affected segment by 2 independent observers. Histological degeneration was evaluated using Weiler's score; the presence of inflammatory infiltrates and neovascularization, not included in the score, were also studied. Correlation and chi-square tests were used to assess the association between histological variables and clinical or radiological variables. Interobserver agreement was also evaluated for the MRI variables using weighted kappa. No statistically significant correlation was found between histological variables (histological degeneration score, inflammatory infiltrates or neovascularization) and clinical or radiological variables. Interobserver agreement for radiological scores resulted in a kappa of 0.79 for the Pfirrmann scale and 0.65 for the Modic scale, both statistically significant. In our series of patients, we could not demonstrate any correlation between the degree of histological degeneration or the presence of inflammatory infiltrates when compared with radiological degeneration scales or clinical variables such as the patient's age or duration of symptoms. Copyright © 2017 Sociedad Española de Neurocirug

  10. Clinical impacts of inhibition of renin-angiotensin system in patients with acute ST-segment elevation myocardial infarction who underwent successful late percutaneous coronary intervention.

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    Park, Hyukjin; Kim, Hyun Kuk; Jeong, Myung Ho; Cho, Jae Yeong; Lee, Ki Hong; Sim, Doo Sun; Yoon, Nam Sik; Yoon, Hyun Ju; Hong, Young Joon; Kim, Kye Hun; Park, Hyung Wook; Kim, Ju Han; Ahn, Youngkeun; Cho, Jeong Gwan; Park, Jong Chun; Kim, Young Jo; Cho, Myeong Chan; Kim, Chong Jim

    2017-01-01

    Successful percutaneous coronary intervention (PCI) of the occluded infarct-related artery (IRA) in latecomers may improve long-term survival mainly by reducing left ventricular remodeling. It is not clear whether inhibition of renin-angiotensin system (RAS) brings additional better clinical outcomes in this specific population subset. Between January 2008 and June 2013, 669 latecomer patients with acute ST-segment elevation myocardial infarction (STEMI) (66.2±12.1 years, 71.0% males) in Korea Acute Myocardial Infarction Registry (KAMIR) who underwent a successful PCI were enrolled. The study population underwent a successful PCI for a totally occluded IRA. They were divided into two groups according to whether they were prescribed RAS inhibitors at the time of discharge: group I (RAS inhibition, n=556), and group II (no RAS inhibition, n=113). During the one-year follow-up, major adverse cardiac events (MACE), which consist of cardiac death and myocardial infarction, occurred in 71 patients (10.6%). There were significantly reduced incidences of MACE in the group I (hazard ratio=0.34, 95% confidence interval 0.199-0.588, p=0.001). In subgroup analyses, RAS inhibition was beneficial in patients with male gender, history of hypertension or diabetes mellitus, and even in patients with left ventricular ejection fraction (LVEF) ≥40%. In the baseline and follow-up echocardiographic data, benefit in changes of LVEF and left ventricular end-systolic volume was noted in group I. In latecomers with STEMI, RAS inhibition improved long-term clinical outcomes after a successful PCI, even in patients with low risk who had relatively preserved LVEF. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  11. Prospective clinical trial of patients who underwent ankle arthroscopy with articular diseases to match clinical and radiological scores with intra-articular cytokines.

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    Henkelmann, Ralf; Schmal, Hagen; Pilz, Ingo H; Salzmann, Gian M; Dovi-Akue, David; Südkamp, Norbert P

    2015-08-01

    There is still a lack of reliable data on cytokine concentrations in the ankle and their value for prognosis. In a prospective clinical trial, lavage fluids were collected from 49 patients with an arthroscopy of the ankle. The fluids were investigated by ELISA for cytokine levels. Clinical scores (FFI, AOFAS) were evaluated both pre-operatively and then again 12 months after surgery (n = 43, 88%). Radiological changes were noted with the Kellgren-Lawrence-Score (KLS) and the Ankle Osteoarthritis Scoring System (AOSS). Based on the difference between the pre- and postoperative clinical scores, two groups were defined according to whether they had benefited from the surgical therapy (Δ score ≥ 10) or not (Δ score < 10). The average clinical scores had improved to a statistically significant extent in the one-year follow-up (p < 0.01). BMP-2 (p = 0.02), IGF-1 (p = 0.04), BMP-7 (p = 0.01) and aggrecan (p = 0.04) showed significant correlations with pre-operative clinical and radiological scores (p = 0.02, p = 0.01, p = 0.01, p = 0.01). Furthermore, BMP-2 (p = 0.01), IGF-1/TPC (p = 0.03) and aggrecan (p = 0.01) correlated with scores after one year (p = 0.02, p = 0.01). High aggrecan concentrations were associated with a low clinical and a high radiological score at both time points, both indicating progress of cartilage degeneration in contrast to BMP-2 or IGF-1. Furthermore, MMP-13 concentrations were significantly higher in the non-benefit group (p = 0.02). BMP-2, IGF-1, aggrecan and MMP-13 seem to be involved in the degenerative process of cartilage in the ankle joint. Additionally, high synovial MMP-13 concentrations indicate a worse clinical outcome.

  12. Clinical Signs and Subjective Symptoms of Temporomandibular Disorders in Instrumentalists.

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    Jang, Jae Young; Kwon, Jeong Seung; Lee, Debora H; Bae, Jung Hee; Kim, Seong Taek

    2016-11-01

    Most of the reports on instrumentalists' experiences of temporomandibular disorders (TMD) have been reported not by clinical examinations but by subjective questionnaires. The aim of this study was to investigate the clinical signs and subjective symptoms of TMD in a large number of instrumentalists objectively. A total of 739 musicians from a diverse range of instrument groups completed a TMD questionnaire. Among those who reported at least one symptom of TMD, 71 volunteers underwent clinical examinations and radiography for diag-nosis. Overall, 453 participants (61.3%) reported having one or more symptoms of TMD. The most frequently reported symptom was a clicking or popping sound, followed by temporomandibular joint (TMJ) pain, muscle pain, crepitus, and mouth opening limitations. Compared with lower-string instrumentalists, a clicking or popping sound was about 1.8 and 2 times more frequent in woodwind and brass instrumentalists, respectively. TMJ pain was about 3.2, 2.8, and 3.2 times more frequent in upper-string, woodwind, and brass instrumentalists, respectively. Muscle pain was about 1.5 times more frequent in instrumentalists with an elevated arm position than in those with a neutral arm position. The most frequent diagnosis was myalgia or myofascial pain (MFP), followed by disc displacement with reduction. Myalgia or MFP was 4.6 times more frequent in those practicing for no less than 3.5 hours daily than in those practicing for less than 3.5 hours. The results indicate that playing instruments can play a contributory role in the development of TMD.

  13. Clinical Perspective An adolescent's subjective experiences of ...

    African Journals Online (AJOL)

    An adolescent's subjective experiences of mindfulness were explored in a single case study of a 17-yearold female. Data were created by means of 'mindfulness sessions', unstructured interviews, creative expression, journals and field notes. The data were analysed and interpreted using a combination of typological and ...

  14. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...

  15. Assessment of clinical residents' needs for ten educational subjects

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    Mansour Razavi

    2002-04-01

    Full Text Available Background Fulfilling the learners' "real needs" will improve medical education. There are subjects that are necessary for any clinical residents not considering their field of specialty. Among the subjects ten seems to be the most important: research methodology and data analysis, computer-based programs, medical recording, cardiopulmonary and cerebral resuscitation, clinical teaching programs, communication skills, clinical ethics, laboratory examinations, reporting special diseases and death certification, and prescription. Purpose This cross-sectional study assessed educational needs of clinical residents for ten educational subjects. Methods A questionnaire prepared by board faculty members consisted of 10 close-ended questions, and one open­ ended question was distributed among 1307 residents from 22 clinical disciplines, who registered for preboard or promotion exam in June 2000. Results Among the subjects three were the most needed: computer-based programs 149 (60%, data collecting system 606 (49%, and clinical ethics 643 (46%. The prescription standard was the least required 177(13%. Conclusion Complementary training courses on these subjects can be an answer to the clinical residents needs. Keywords : research methodology, computer in medicine, cpr, clinical teaching methods, communication in medicine, medical ethics, laboratory ordering, disease coding system, death certificate, prescription writing

  16. Adult Treatment Panel III 2001 but not International Diabetes Federation 2005 criteria of the metabolic syndrome predict clinical cardiovascular events in subjects who underwent coronary angiography.

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    Saely, Christoph H; Koch, Lorena; Schmid, Fabian; Marte, Thomas; Aczel, Stefan; Langer, Peter; Hoefle, Guenter; Drexel, Heinz

    2006-04-01

    The International Diabetes Federation (IDF) has recently established a worldwide consensus definition of the metabolic syndrome. No prospective data are available on the cardiovascular risk associated with this new metabolic syndrome definition. In a prospective study of 750 coronary patients, we recorded vascular events over 4 years. From our patients, 37.3% (n = 280) had the metabolic syndrome according to the Adult Treatment Panel III (ATPIII) definition and 45.5% (n = 341) according to the IDF definition. The metabolic syndrome as defined by the ATPIII criteria significantly predicted vascular events (adjusted hazard ratio 1.745 [95% CI 1.255-2.427]; P = 0.001), but the metabolic syndrome as defined by IDF criteria did not (1.189 [0.859-1.646]; P = 0.297). Accordingly, event-free survival was significantly lower among patients who fulfilled the ATPIII but not the IDF criteria than among those who met the IDF but not the ATPIII criteria (P = 0.012). The metabolic syndrome as defined by ATPIII criteria remained significantly predictive of vascular events after adjustment for type 2 diabetes but not after additional adjustment for the metabolic syndrome components high triglycerides and low HDL cholesterol. These lipid traits in turn proved significantly predictive of vascular events even after adjustment for the metabolic syndrome. The ATPIII definition of the metabolic syndrome confers a significantly higher risk of vascular events than the IDF definition. However, among angiographied coronary patients, even the ATPIII definition of the metabolic syndrome does not provide prognostic information beyond its dyslipidemic features.

  17. Beyond human subjects: risk, ethics, and clinical development of nanomedicines.

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    Kimmelman, Jonathan

    2012-01-01

    Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena. © 2012 American Society of Law, Medicine & Ethics, Inc.

  18. Subjective cognitive decline: The first clinical manifestation of Alzheimer's disease?

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    Adalberto Studart Neto

    Full Text Available ABSTRACT Background: Mild cognitive impairment is considered as the first clinical manifestation of Alzheimer's disease (AD, when the individual exhibits below performance on standardized neuropsychological tests. However, some subjects before having a lower performance on cognitive assessments already have a subjective memory complaint. Objective: A review about subjective cognitive decline, the association with AD biomarkers and risk of conversion to dementia. Methods: We performed a comprehensive non-systematic review on PubMed. The keywords used in the search were terms related to subjective cognitive decline. Results: Subjective cognitive decline is characterized by self-experience of deterioration in cognitive performance not detected objectively through formal neuropsychological testing. However, various terms and definitions have been used in the literature and the lack of a widely accepted concept hampers comparison of studies. Epidemiological data have shown that individuals with subjective cognitive decline are at increased risk of progression to AD dementia. In addition, there is evidence that this group has a higher prevalence of positive biomarkers for amyloidosis and neurodegeneration. However, Alzheimer's disease is not the only cause of subjective cognitive decline and various other conditions can be associated with subjective memory complaints, such as psychiatric disorders or normal aging. The features suggestive of a neurodegenerative disorder are: onset of decline within the last five years, age at onset above 60 years, associated concerns about decline and confirmation by an informant. Conclusion: These findings support the idea that subjective cognitive complaints may be an early clinical marker that precedes mild cognitive impairment due to Alzheimer's disease.

  19. Constructing diagnostic likelihood: clinical decisions using subjective versus statistical probability.

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    Kinnear, John; Jackson, Ruth

    2017-07-01

    Although physicians are highly trained in the application of evidence-based medicine, and are assumed to make rational decisions, there is evidence that their decision making is prone to biases. One of the biases that has been shown to affect accuracy of judgements is that of representativeness and base-rate neglect, where the saliency of a person's features leads to overestimation of their likelihood of belonging to a group. This results in the substitution of 'subjective' probability for statistical probability. This study examines clinicians' propensity to make estimations of subjective probability when presented with clinical information that is considered typical of a medical condition. The strength of the representativeness bias is tested by presenting choices in textual and graphic form. Understanding of statistical probability is also tested by omitting all clinical information. For the questions that included clinical information, 46.7% and 45.5% of clinicians made judgements of statistical probability, respectively. Where the question omitted clinical information, 79.9% of clinicians made a judgement consistent with statistical probability. There was a statistically significant difference in responses to the questions with and without representativeness information (χ2 (1, n=254)=54.45, pprobability. One of the causes for this representativeness bias may be the way clinical medicine is taught where stereotypic presentations are emphasised in diagnostic decision making. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  20. Terminal ileum of patients who underwent colonoscopy: endoscopic, histologic and clinical aspects Íleo terminal de pacientes submetidos a colonoscopia: aspectos endoscópicos, histológicos e clínicos

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    Marcelo Maia Caixeta de Melo

    2009-06-01

    Full Text Available CONTEXT: For the diagnosis of the diseases which affect the terminal ileum, the colonoscopy allows macroscopic evaluation and the performing of biopsies. Studies with criteria for the endoscopic and histological characterization of this segment are scarce and there are still some doubts about the need of biopsies in patients with normal ileoscopy. OBJECTIVE: Study the terminal ileum of patients who underwent colonoscopy considering: endoscopic and histological correlation; agreement between results of the initial histological evaluation and slides review, and the chance of subjects with normal ileoscopy with abdominal pain and/or chronic diarrhea to show histological alterations. METHODS: In a prospective study, 111 patients who presented smooth mucosa without enanthema in the endoscopic exam of the terminal ileum were selected. Biopsies of the ileal mucosa of such patients were performed, being the slides routinely examined and reviewed afterwards. RESULTS: The correlation between patients with normal ileoscopy and ileum with preserved histological architecture was of 99.1%. The agreement between initial histological evaluation and slides review calculated by the Kappa test was 0.21. In patients with abdominal pain and/or chronic diarrhea, the chance of showing histological alterations was 2.5 times higher than the others. CONCLUSIONS: The correlation between endoscopic and histological findings was high. The agreement between the initial histologic evaluation and slides review was not satisfactory. The chance of subjects with normal ileoscopy with abdominal pain and/or chronic diarrhea, showing histological alterations was higher in relation to the asymptomatic ones or with other symptoms, although the clinical importance of this datum was not evaluated.CONTEXTO: Para o diagnóstico de doenças que afetam o íleo terminal, a colonoscopia permite avaliação macroscópica e realização de biopsias. Estudos com critérios para caracteriza

  1. Clinical and Pulmonary Function Markers of Respiratory Exacerbation Risk in Subjects With Quadriplegic Cerebral Palsy.

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    Vianello, Andrea; Carraro, Elena; Pipitone, Emanuela; Marchese-Ragona, Rosario; Arcaro, Giovanna; Ferraro, Marco; Paladini, Luciana; Martinuzzi, Andrea

    2015-10-01

    Although respiratory exacerbations are common in patients with quadriplegic cerebral palsy (CP), little is known about the factors that are related to increased exacerbation risk. This study aimed to identify the clinical and pulmonary function variables signaling risk of exacerbation in this type of patient. Thirty-one children and young adults with quadriplegic CP underwent a comprehensive history, physical examination, and pulmonary function test, including arterial blood gas analysis, airway resistance using the interrupter technique, and home overnight SpO2 monitoring. Subjects were divided into 2 groups depending on the number of respiratory exacerbations reported during the year before study entry: frequent exacerbators (ie, ≥ 2 exacerbations) and infrequent exacerbators (ie, < 2 exacerbations). The frequent exacerbators were more likely to require hospitalization due to respiratory disorders compared with the infrequent exacerbators (13/14 vs 9/17, P = .02). Respiratory exacerbation was found to be associated with diagnosis of gastroesophageal reflux (adjusted odds ratio of 23.95 for subjects with confirmed diagnosis, P = .02) and higher PaCO2 levels (adjusted odds ratio of 12.60 for every 5-mm Hg increase in PaCO2 , P = .05). Subjects with PaCO2 ≥ 35 mm Hg showed an exacerbation odds ratio of 15.2 (95% CI 1.5-152.5, P = .01). Gastroesophageal reflux and increased PaCO2 can be considered simple, clinically useful markers of increased exacerbation risk in young subjects with quadriplegic CP. Copyright © 2015 by Daedalus Enterprises.

  2. Subjectivity

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    Jesús Vega Encabo

    2015-11-01

    Full Text Available In this paper, I claim that subjectivity is a way of being that is constituted through a set of practices in which the self is subject to the dangers of fictionalizing and plotting her life and self-image. I examine some ways of becoming subject through narratives and through theatrical performance before others. Through these practices, a real and active subjectivity is revealed, capable of self-knowledge and self-transformation. 

  3. Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important?

    Science.gov (United States)

    2012-01-01

    Background Development of new tinnitus treatments requires prospective placebo-controlled randomized trials to prove their efficacy. The Tinnitus Questionnaire (TQ) is a validated and commonly used instrument for assessment of tinnitus severity and has been used in many clinical studies. Defining the Minimal Clinically Important Difference (MCID) for TQ changes is an important step to a better interpretation of the clinical relevance of changes observed in clinical trials. In this study we aimed to estimate the minimum change of the TQ score that could be considered clinically relevant. Methods 757 patients with chronic tinnitus were pooled from the TRI database and the RESET study. An anchor-based approach using the Clinical Global Impression (CGI) scale and distributional approaches were used to estimate MCID. Receiver Operating Characteristic (ROC) curves were calculated to define optimal TQ change cutoffs discriminating between minimally changed and unchanged subjects. Results The relationship between TQ change scores and CGI ratings of change was good (r = 0.52, p MCID for improvement was −5 points and for deterioration +1 points. Conclusion Distribution and anchor-based methods yielded comparable results in identifying MCIDs. ΔTQ scores of −5 and +1 points were identified as the minimal clinically relevant change for improvement and worsening respectively. The asymmetry of the MCIDs for improvement and worsening may be related to expectation effects. PMID:22781703

  4. Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important?

    Directory of Open Access Journals (Sweden)

    Adamchic Ilya

    2012-07-01

    Full Text Available Abstract Background Development of new tinnitus treatments requires prospective placebo-controlled randomized trials to prove their efficacy. The Tinnitus Questionnaire (TQ is a validated and commonly used instrument for assessment of tinnitus severity and has been used in many clinical studies. Defining the Minimal Clinically Important Difference (MCID for TQ changes is an important step to a better interpretation of the clinical relevance of changes observed in clinical trials. In this study we aimed to estimate the minimum change of the TQ score that could be considered clinically relevant. Methods 757 patients with chronic tinnitus were pooled from the TRI database and the RESET study. An anchor-based approach using the Clinical Global Impression (CGI scale and distributional approaches were used to estimate MCID. Receiver Operating Characteristic (ROC curves were calculated to define optimal TQ change cutoffs discriminating between minimally changed and unchanged subjects. Results The relationship between TQ change scores and CGI ratings of change was good (r = 0.52, p  Conclusion Distribution and anchor-based methods yielded comparable results in identifying MCIDs. ΔTQ scores of −5 and +1 points were identified as the minimal clinically relevant change for improvement and worsening respectively. The asymmetry of the MCIDs for improvement and worsening may be related to expectation effects.

  5. Physical and social characteristics and support needs of adult female childhood cancer survivors who underwent hormone replacement therapy.

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    Tomioka, Akiko; Maru, Mitsue; Kashimada, Kenichi; Sakakibara, Hideya

    2017-08-01

    Female childhood cancer survivors who develop gonadal dysfunction require female hormone replacement therapy (HRT) from puberty until menopause. However, the support provided in such cases has not been studied. We investigated the physical and social characteristics and support needs of adult female childhood cancer survivors who underwent HRT. Forty-nine adult female childhood cancer survivors completed self-administered questionnaires. We compared the clinical characteristics, health status, and social conditions between a group that underwent HRT and a group that did not, and we surveyed support needs of the group that underwent HRT. The median age of the subjects was 25.0 years (range 20-41). Twenty subjects (40.8%) underwent HRT. A significantly high number of those who underwent HRT also underwent radiation therapy (p social characteristics between the groups. Those who experienced anxiety regarding fertility required information about HRT, a platform to share their concerns, and psychological support and cooperation among healthcare providers. Although the subjects of this survey exhibited good social adjustment regardless of whether or not they underwent HRT, they were anxious about fertility. It is important to understand the concerns and anxieties unique to female childhood cancer survivors and to enhance psychological support in addition to providing educational support so that HRT can be administered.

  6. Clinical observation of the adverse drug reactions caused by non-ionic iodinated contrast media: results from 109,255 cases who underwent enhanced CT examination in Chongqing, China.

    Science.gov (United States)

    Li, X; Chen, J; Zhang, L; Liu, H; Wang, S; Chen, X; Fang, J; Wang, S; Zhang, W

    2015-03-01

    To analyse the pattern and factors that influence the incidence of adverse drug reactions (ADRs) induced by non-ionic iodinated contrast media and to evaluate their safety profiles. Data from 109,255 cases who underwent enhanced CT examination from 1 January 2008 to 31 August 2013 were analysed. ADRs were classified according to the criteria issued by the American College of Radiology and the Chinese Society of Radiology. A total of 375 (0.34%) patients had ADRs, including 281 mild (0.26%); 80 moderate (0.07%); and 14 severe (0.01%) ADRs; no death was found. 302 (80.53%) of the ADRs occurred within 15 min after examination. Patients aged 40-49 years (204 cases, 0.43%; p contrast media are mainly mild ones, while moderate or severe ADRs are relatively rare, suggesting that enhanced CT examination with non-ionic iodinated contrast media is highly safe, and severe adverse events will seldom occur under appropriate care. The study included 109,255 patients enrolled in various types of enhanced CT examinations, which could reflect ADR conditions and regulations in Chinese population accurately and reliably.

  7. NUTRITION SUPPORT COMPLICATIONS IN PATIENT WHO UNDERWENT CARDIAC SURGERY

    OpenAIRE

    Krdžalić, Alisa; Kovčić, Jasmina; Krdžalić, Goran; Jahić, Elmir

    2016-01-01

    Background: The nutrition support complications after cardiac surgery should be detected and treated on time. Aim: To show the incidence and type of nutritional support complication in patients after cardiac surgery. Methods: The prospective study included 415 patients who underwent cardiac surgery between 2010 and 2013 in Clinic for Cardiovascular Disease of University Clinical Center Tuzla. Complications of the delivery system for nutrition support (NS) and nutrition itself were analy...

  8. Clinical and microbiological effects of a combined mechanic-antibiotic therapy in subjects with Actinobacillus actinomycetemcomitans-associated periodontitis.

    Science.gov (United States)

    Dannewitz, Bettina; Pohl, Sabine; Eickholz, Peter; Kim, Ti-Sun

    2007-06-01

    To evaluate the clinical and microbiological effects of a combined mechanic-antibiotic periodontal therapy in subjects that were tested positive for subgingival Actinobacillus actinomycetemcomitans (A.a.). The postoperative follow-up ranged from 12-115 months (average 39.2 months). This follow-up study analyzed the data of 53 subjects (37 females) aged from 16-59 years, who underwent systemic periodontal therapy with adjunctive systemic antibiotics between 1992-2001 and had their last re-examination including microbiological analysis done in 2003. The antibiotic regime was either amoxicillin/metronidazole or ciprofloxacine/metronidazole. During this study, A.a. was detected with two gene probe tests (IAI PadoTest 4.5 and DMDx/PathoTek) and cultivation on TSBV agar plates. The clinical situation was characterized with the help of pocket probing depths and subsequent categorization into three different groups ( or = 7 mm). After therapy, A.a. was detected with IAI PadoTest 4.5 in a magnitude between 3.0 x 10(3) up to 2.06 x 10(5) counts per specimen in 9 out of 53 subjects. Only two subjects tested positive for A.a. with the DMDx/PathoTek-assays and the agar cultivation. The clinical situation improved significantly in all subjects after systemic periodontal therapy. The treatment results remained stable during the course of the postoperative follow-up. Concerning the clinical data, no differences were found between the subjects that were tested positive and negative for A.a in the postoperative period.

  9. Clinical Outcomes in Diabetic Patients Who Underwent Percutaneous Coronary Intervention during the Plain Old Balloon Angioplasty (POBA)-, Bare Metal Stents (BMS)- and Drug-eluting Stents (DES)-eras from 1984 to 2010

    Science.gov (United States)

    Naito, Ryo; Miyauchi, Katsumi; Konishi, Hirokazu; Tsuboi, Shuta; Ogita, Manabu; Dohi, Tomotaka; Kasai, Takatoshi; Tamura, Hiroshi; Okazaki, Shinya; Isoda, Kikuo; Daida, Hiroyuki

    2017-01-01

    Objective Diabetes is a negative predictor in coronary artery disease patients. Since the introduction of percutaneous coronary intervention (PCI), PCI has evolved through technological advances in devices, improvements in operators' techniques and the establishment of effective therapeutic protocols. The aim of this study is to examine the changes in the clinical outcomes following PCI in patients with diabetes. Methods We compared the clinical outcomes in patients with diabetes following PCI from 1984 to 2010 at Juntendo University over three eras (plain old balloon angioplasty (POBA)-, bare metal stents (BMS)- and drug-eluting stents (DES)-eras). The primary endpoint was a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and repeat revascularization within 3 years after the index PCI. Results A total of 1,584 patients were examined. The baseline characteristics became unfavorable over time with regard to age, prevalence of hypertension, presentation with acute coronary syndrome and a reduced left ventricular ejection fraction. The administration of aspirin, statins and β-blockers increased over time. The event-free survival rate for the 3-year cardiovascular events was lower in the DES-era. The adjusted relative risk reduction for 3-year cardiovascular events was 46 % in the DES-era compared with the POBA-era. Conclusion The incidence of 3-year cardiovascular events decreased from 1984 to 2010 in patients with diabetes following PCI, despite the higher risk profiles in the DES-era. PMID:28049984

  10. Clinical reactivity to ingestion challenge with mixed mold extract may be enhanced in subjects sensitized to molds.

    Science.gov (United States)

    Luccioli, Stefano; Malka-Rais, Jonathan; Nsouli, Talal M; Bellanti, Joseph A

    2009-01-01

    Manifestations of mold allergy are classically associated with inhalation of mold spores leading to symptoms of asthma and other respiratory illnesses. It is largely unknown, however, whether ingestion of aeroallergenic molds, mold spores, or other fungi found in food can also elicit hypersensitivity reactions in mold-sensitive individuals. The aim of this study was to evaluate the association between exposure to molds by oral challenge and elicitation of symptoms in mold- versus nonmold-sensitive individuals. Thirty-four adult atopic subjects were randomized into mold-sensitive groups based on skin test reactivity by skin percutaneous testing (SPT) and/or intradermal (ID) testing to a mixed mold (MM) extract preparation. All subjects underwent a single-blinded, placebo-controlled food challenge to the MM preparation. A modified scoring system was used to grade the clinical severity of symptoms elicited by challenge. All subjects tolerated challenges to the maximal oral mold dose concentration. However, higher symptom scores after challenge were found in mold-sensitive subjects compared with nonmold-sensitive subjects (p = 0.01). When mold-sensitive subjects were compared based on SPT and/or ID reactivity, higher symptom scores and lower symptom-eliciting concentrations of mold were associated with the SPT reactive subgroup compared with the subgroup with ID reactivity alone. In summary, based on our challenge results and scoring model, mold-sensitive subjects compared with nonmold-sensitive subjects experienced cumulatively higher symptom scores after oral challenge to an MM extract preparation. Future studies are warranted to confirm whether ingestion of aeroallergenic molds in food may be another contributor to symptoms in mold-sensitive individuals.

  11. Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clinical results of a multicentric study of 221 consecutive diabetic subjects.

    Science.gov (United States)

    Faglia, E; Mantero, M; Caminiti, M; Caravaggi, C; De Giglio, R; Pritelli, C; Clerici, G; Fratino, P; De Cata, P; Dalla Paola, L; Mariani, G; Poli, M; Settembrini, P G; Sciangula, L; Morabito, A; Graziani, L

    2002-09-01

    To evaluate the feasibility, technical effectiveness and limb salvage potential of percutaneous transluminal angioplasty (PTA), particularly infrapopliteal, in diabetic subjects with ischaemic foot ulcer. Intervention study with PTA in consecutive series. Six Diabetology Foot Centres and one Cardiovascular Catheterization Laboratory in Italy. Two hundred and twenty-one consecutive diabetic subjects hospitalized for ischaemic foot ulcer. Peripheral arterial occlusive disease (PAOD) was investigated by means of foot pulses assessment, ankle-brachial-index (ABI), transcutaneous oxygen tension (TcPO2) and duplex scanning. If non-invasive parameters suggested PAOD, angiography was performed and a PTA was carried out during the same session. PTA feasibility, improvement of ABI and TcPO2, limb salvage rate, clinical recurrence. On angiography, two patients had stenoses which were 50%, even when longer than 10 cm and/or multiple/calcified. In 11 patients (5.8%) PTA was performed in the proximal axis exclusively, in 81 (42.4%) patients in the infrapopliteal axis exclusively and in 99 (51.8%) in both the femoropopliteal and infrapopliteal axis. Both ABI and TcPO2 improved significantly after PTA (P < 0.0001). Clinical recurrence occurred in 14 subjects: 10 of whom underwent a second successful PTA. Of the 191 patients who underwent PTA, 10 (5.2%) underwent an above-the-ankle amputation. PTA, including infrapopliteal, is feasible in most diabetic subjects with ischaemic foot ulcer and is effective for foot revascularization. Clinical recurrence was infrequent and the procedure could successfully be repeated in most cases. In subjects treated successfully with PTA the above-the-ankle amputation rate was low. PTA should be considered as the revascularization treatment of first choice in all diabetic subjects with foot ulcer and PAOD.

  12. Elevated urinary albumin excretion is associated with impaired arterial dilatory capacity in clinically healthy subjects

    DEFF Research Database (Denmark)

    Clausen, P; Jensen, J S; Jensen, G

    2001-01-01

    BACKGROUND: Elevated urinary albumin excretion (UAE) predicts atherosclerotic cardiovascular disease. It is hypothesized that elevated UAE is associated with a generalized vascular dysfunction. This study tested this hypothesis for conduit arteries. METHODS AND RESULTS: Clinically healthy subject...

  13. Additive prognostic value of subjective assessment with respect to clinical cardiological data in patients with chronic heart failure.

    Science.gov (United States)

    Majani, Giuseppina; Pierobon, Antonia; Pinna, Gian Domenico; Giardini, Anna; Maestri, Roberto; La Rovere, Maria Teresa

    2011-12-01

    Health-related quality of life tools that better reflect the unique subjective perception of heart failure (HF) are needed for patients with this disorder. The aim of this study was to explore whether subjective satisfaction of HF patients about daily life may provide additional prognostic information with respect to clinical cardiological data. One hundred and seventy-eight patients (age 51 ± 9 years) with moderate to severe HF [New York Heart Association (NYHA) class 2.0 ± 0.7; left ventricular ejection fraction (LVEF) 29 ± 8%] in stable clinical condition underwent a standard clinical evaluation and compiled the Satisfaction Profile (SAT-P) questionnaire focusing on subjective satisfaction with daily life. Cox regression analysis was used to assess whether SAT-P factors (psychological functioning, physical functioning, work, sleep/eating/leisure, social functioning) had any prognostic value. Forty-six cardiac deaths occurred during a median of 30 months. Patients who died had higher NYHA class, more depressed left ventricular function, reduced systolic blood pressure (SBP), increased heart rate (HR), and worse biochemistry (all p patients who died (p = 0.003). Using the best subset selection procedure, resistance to physical fatigue (RPF) was selected from among the items of the PF factor. RPF showed independent predictive value when entered into a prognostic model including NYHA class, LVEF, SBP, and HR with an adjusted hazard ratio of 0.86 per 10 units increase (95% CI 0.75-0.98, p = 0.02). Patients' dissatisfaction with physical functioning is associated with reduced long-term survival, after adjustment for known risk factors in HF. Given its user-friendly structure, simplicity, and significant prognostic value, the RPF score may represent a useful instrument in clinical practice.

  14. Strategies to exclude subjects who conceal and fabricate information when enrolling in clinical trials

    Directory of Open Access Journals (Sweden)

    Eric G. Devine

    2017-03-01

    Full Text Available Clinical trials within the US face an increasing challenge with the recruitment of quality candidates. One readily available group of subjects that have high rates of participation in clinical research are subjects who enroll in multiple trials for the purpose of generating income through study payments. Aside from issues of safety and generalizability, evidence suggests that these subjects employ methods of deception to qualify for the strict entrance criteria of some studies, including concealing information and fabricating information. Including these subjects in research poses a significant risk to the integrity of data quality and study designs. Strategies to limit enrollment of subjects whose motivation is generating income have not been systematically addressed in the literature. The present paper is intended to provide investigators with a range of strategies for developing and implementing a study protocol with protections to minimize the enrollment of subjects whose primary motivation for enrolling is to generate income. This multifaceted approach includes recommendations for advertising strategies, payment strategies, telephone screening strategies, and baseline screening strategies. The approach also includes recommendations for attending to inconsistent study data and subject motivation. Implementing these strategies may be more or less important depending upon the vulnerability of the study design to subject deception. Although these strategies may help researchers exclude subjects with a higher rate of deceptive practices, widespread adoption of subject registries would go a long way to decrease the chances of subjects enrolling in multiple studies or more than once in the same study.

  15. The Strauss and Carpenter Prognostic Scale in subjects clinically at high risk of psychosis

    NARCIS (Netherlands)

    Nieman, D. H.; Velthorst, E.; Becker, H. E.; de Haan, L.; Dingemans, P. M.; Linszen, D. H.; Birchwood, M.; Patterson, P.; Salokangas, R. K. R.; Heinimaa, M.; Heinz, A.; Juckel, G.; von Reventlow, H. G.; Morrison, A.; Schultze-Lutter, F.; Klosterkötter, J.; Ruhrmann, S.; McGorry, Patrick D.; McGlashan, Thomas H.; Knapp, Martin; van de Fliert, Reinaud; Klaassen, Rianne; Picker, Heinz; Neumann, Meike; Brockhaus-Dumke, Anke; Pukrop, Ralf; Svirskis, Tanja; Huttunen, Jukka; Laine, Tiina; Ilonen, Tuula; Ristkari, Terja; Hietala, Jarmo; Skeate, Amanda; Gudlowski, Yehonala; Ozgürdal, Seza; French, Paul; Stevens, Helen

    2013-01-01

    To investigate the predictive value of the Strauss and Carpenter Prognostic Scale (SCPS) for transition to a first psychotic episode in subjects clinically at high risk (CHR) of psychosis. Two hundred and forty-four CHR subjects participating in the European Prediction of Psychosis Study were

  16. Ambulatory blood pressure and urinary albumin excretion in clinically healthy subjects

    DEFF Research Database (Denmark)

    Clausen, Peter Vilhelm; Jensen, J S; Borch-Johnsen, K

    1998-01-01

    UAER. Because 24-hour ambulatory blood pressure is a superior predictor of hypertensive target organ involvement, we aimed to investigate blood pressure profile in clinically healthy subjects with elevated UAER. Ambulatory blood pressure monitoring was performed with a portable recorder in 27 subjects...... with an elevated UAER (>6.6 microg/min, overnight urine collection) and 46 normoalbuminuric control subjects. Mean+/-SD systolic and diastolic ambulatory blood pressures (24-hour) were significantly higher in subjects with elevated UAER than in normoalbuminuric controls (134+/-12 versus 128+/-11 mm Hg and 78...

  17. Clinical encounter and the logic of relationality: Reconfiguring bodies and subjectivities in clinical relations.

    Science.gov (United States)

    Kazimierczak, Karolina A

    2017-01-01

    This article critically examines the significance of relational approaches for sociological understandings of clinical interactions, relations and practices, by exploring the ways in which relational theories and concepts have been employed in the recent sociological accounts of clinical encounters to trouble the classical dyadic models of clinical interaction and the related atomistic conceptions of agency and accountability. Reading this work through the theoretical contributions from feminist science studies scholarship, and particularly the work of Donna Haraway and Karen Barad, the article proposes an alternative understanding of clinical interactions, relations and practices, where relations are conceived as constitutive of individuals (objects/bodies and their attributes/identities), rather than being constituted by encounters between individuals. Key for this understanding is the reconceptualisation of clinical encounter as an apparatus of bodily production through which different agents (patients, clinicians, diseases and healthcare services) are materialised and enacted.

  18. Profiles of Urine Drug Test in Clinical Pain Patients vs Pain Research Study Subjects.

    Science.gov (United States)

    Lee, Cheng-ting; Vo, Trang T; Cohen, Abigail S; Ahmed, Shihab; Zhang, Yi; Mao, Jianren; Chen, Lucy

    2016-04-01

    To examine similarities and differences in urine drug test (UDT) results in clinical pain patients and pain subjects participating in pain research studies. An observational study with retrospective chart review and data analysis. We analyzed 1,874 UDT results obtained from 1) clinical pain patients (Clinical Group; n = 1,529) and 2) pain subjects consented to participate in pain research studies (Research Group; n = 345). Since several medications such as opioids used in pain management are drugs of abuse (DOA) and can result in a positive UDT, we specifically identified those cases of positive UDT due to nonprescribed DOA and designated these cases as positive UDT with DOA (PUD). We found that 1) there was a higher rate of PUD in clinical pain patients (41.3%) than in pain research study subjects (14.8%); 2) although subjects in the Research Group were informed ahead of time that UDT will be conducted as a screening test, a substantial number (14.8%) of pain research study subjects still showed PUD; 3) there were different types of DOA between clinical pain patients (cannabinoids as the top DOA) and research study subjects (cocaine as the top DOA); and 4) a common factor associated with PUD was opioid therapy in both Clinical Group and Research Group. These results support previous findings that PUD is a common finding in clinical pain patients, particularly in those prescribed opioid therapy, and we suggest that UDT be used as routine screening testing in pain research studies. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  19. Atherosclerotic risk factors are increased in clinically healthy subjects with microalbuminuria

    DEFF Research Database (Denmark)

    Jensen, J S; Borch-Johnsen, K; Jensen, G

    1995-01-01

    in clinically healthy subjects. All healthy 40-65 year-old participants with microalbuminuria, examined within the first 21 months of The Copenhagen City Heart Study, were invited, and 28 were studied. An age- and sex-matched group of 60 randomly chosen subjects with normoalbuminuria served as control......Increased morbidity and mortality from atherosclerotic vascular disease were observed in subjects with slightly elevated urinary albumin excretion rate (UAER), known as microalbuminuria. Therefore, the association between microalbuminuria and established atherogenic risk factors was studied...... and fasting serum insulin concentration were slightly elevated in the microalbuminuric group but not statistically significant. It is concluded that microalbuminuria in clinically healthy subjects is associated with increased levels of atherogenic risk factors. This may contribute to the increased vascular...

  20. Assessment of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans in Down's syndrome subjects and systemically healthy subjects: A comparative clinical trial

    OpenAIRE

    Ahmed, Nizar; Parthasarathy, Harinath; Arshad, Mohamed; Victor, Dhayanand John; Mathew, Danny; Sankari, Siva

    2014-01-01

    Objectives: To compare and quantify the presence of periodontal pathogens Aggregatibacter actinomycetemcomitans (Aac) and Porphyromonas gingivalis (Pg) in Down's syndrome (DS) and systemically healthy subjects with periodontitis and gingivitis. Materials and Methods: Fifty-nine age-matched subjects were categorized into four groups; Group I: DS subjects with gingivitis, Group II: DS subjects with periodontitis, Group III: Systemically healthy subjects with gingivitis and Group IV: Systemicall...

  1. Differences in quantitative methods for measuring subjective cognitive decline - results from a prospective memory clinic study

    DEFF Research Database (Denmark)

    Vogel, Asmus; Salem, Lise Cronberg; Andersen, Birgitte Bo

    2016-01-01

    decline. Depression scores were significantly correlated to both scales measuring subjective decline. Linear regression models showed that age did not have a significant contribution to the variance in subjective memory beyond that of depressive symptoms. CONCLUSIONS: Measures for subjective cognitive......BACKGROUND: Cognitive complaints occur frequently in elderly people and may be a risk factor for dementia and cognitive decline. Results from studies on subjective cognitive decline are difficult to compare due to variability in assessment methods, and little is known about how different methods...... influence reports of cognitive decline. METHODS: The Subjective Memory Complaints Scale (SMC) and The Memory Complaint Questionnaire (MAC-Q) were applied in 121 mixed memory clinic patients with mild cognitive symptoms (mean MMSE = 26.8, SD 2.7). The scales were applied independently and raters were blinded...

  2. Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials.

    Science.gov (United States)

    Breithaupt-Groegler, Kerstin; Coch, Christoph; Coenen, Martin; Donath, Frank; Erb-Zohar, Katharina; Francke, Klaus; Goehler, Karin; Iovino, Mario; Kammerer, Klaus Peter; Mikus, Gerd; Rengelshausen, Jens; Sourgens, Hildegard; Schinzel, Reinhard; Sudhop, Thomas; Wensing, Georg

    2017-04-01

    A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolling stakeholders from the pharmaceutical industry, contract research organisations, academia, ethics committees and competent authority. Pivotal eligibility criteria were defined for trials with new investigational medicinal products (IMPs) or with clinically established IMPs. In general, a pulse rate ranging between 50 and 90 beats/min is recommended for first-in-human (FIH) trials, while wider ranges seem acceptable for trials with clinically established IMPs, provided there are no indications of thyroid dysfunction. Hepatic laboratory parameters not to exceed the upper limit of normal (ULN) comprise ALT (alanine aminotransferase) and AST (aspartate aminotransferase) in FIH trials, whereas slight elevations (10% above ULN) seem acceptable in trials with clinically established IMPs without known hepatotoxicity. A normal renal function is required for any clinical trial in healthy subjects. A risk-adapted approach for stopping rules was adopted. Stopping rules for an individual subject are one adverse event of severe intensity or one serious adverse event. In case of a severe adverse event, some stakeholders demand a causal relationship with the IMP (i.e. an adverse reaction). Stopping rules for a cohort are one serious adverse reaction or ≥50% of subjects experiencing any adverse reaction of moderate or severe intensity. The application of this consensus resulted in a reduction in protocol deficiencies issued by the competent authority.

  3. Stress-Induced Dopamine Response in Subjects at Clinical High Risk for Schizophrenia with and without Concurrent Cannabis Use

    Science.gov (United States)

    Mizrahi, Romina; Kenk, Miran; Suridjan, Ivonne; Boileau, Isabelle; George, Tony P; McKenzie, Kwame; Wilson, Alan A; Houle, Sylvain; Rusjan, Pablo

    2014-01-01

    Research on the environmental risk factors for schizophrenia has focused on either psychosocial stress or drug exposure, with limited investigation of their interaction. A heightened dopaminergic stress response in patients with schizophrenia and individuals at clinical high risk (CHR) supports the dopaminergic sensitization hypothesis. Cannabis is believed to contribute to the development of schizophrenia, possibly through a cross-sensitization with stress. Twelve CHR and 12 cannabis-using CHR (CHR-CU, 11 dependent) subjects underwent [11C]-(+)-PHNO positron emission tomography scans, while performing a Sensorimotor Control Task (SMCT) and a stress condition (Montreal Imaging Stress task). The simplified reference tissue model was used to obtain binding potential relative to non-displaceable binding (BPND) in the whole striatum, its functional subdivisions (limbic striatum (LST), associative striatum (AST), and sensorimotor striatum (SMST)), globus pallidus (GP), and substantia nigra (SN). Changes in BPND, reflecting alterations in synaptic dopamine (DA) levels, were tested with analysis of variance. SMCT BPND was not significantly different between groups in any brain region (p>0.21). Although stress elicited a significant reduction in BPND in the CHR group, CHR-CU group exhibited an increase in BPND. Stress-induced changes in regional BPND between CHR-CU and CHR were significantly different in AST (p<0.001), LST (p=0.007), SMST (p=0.002), SN (p=0.021), and whole striatum (p=0.001), with trend level in the GP (p=0.099). All subjects experienced an increase in positive (attenuated) psychotic symptoms (p=0.001) following the stress task. Our results suggest altered DA stress reactivity in CHR subjects who concurrently use cannabis, as compared with CHR subjects. Our finding does not support the cross-sensitization hypothesis, which posits greater dopaminergic reactivity to stress in CHR cannabis users, but adds to the growing body of literature showing reduced DA

  4. Subjectivity in clinical practice: on the origins of psychiatric semiology in early French alienism.

    Science.gov (United States)

    Huertas, Rafael

    2014-12-01

    The aim of this article is to contribute to the analysis of the origins of psychiatric semiology, which by emphasizing subjectivity in clinical practice, gave birth to psychopathology as the scientific and intellectual enterprise of alienism. In other words, beyond simple anatomical and clinical observation, there was an effort to 'listen to' and 'read' the patient's delirium. In essence, the basic thesis which this short paper seeks to defend is that, despite a growing anatomical and clinical mind-set and a clear interest in physically locating mental illness within the body, during the Romantic period, psychiatry was able to construct a semiology largely based on the experience of the ego, on the inner world of the individual. This makes it possible to establish, from a clinical perspective, that the birth of alienism - of psychiatry - must be situated within the framework of a modernity in which the culture of subjectivity was one of its most characteristic features. © The Author(s) 2014.

  5. Comparison between refraction measured by Spot Vision ScreeningTM and subjective clinical refractometry

    OpenAIRE

    Daniela Lima de Jesus; Flávio Fernandes Villela; Luis Fernando Orlandin; Fernando Naves Eiji; Daniel Oliveira Dantas; Milton Ruiz Alves

    2016-01-01

    OBJECTIVE: The purpose of this study was to evaluate the accuracy of Spot Vision ScreeningTM as an autorefractor by comparing refraction measurements to subjective clinical refractometry results in children and adult patients. METHODS: One-hundred and thirty-four eyes of 134 patients were submitted to refractometry by Spot and clinical refractometry under cycloplegia. Patients, students, physicians, staff and children of staff from the Hospital das Clínicas (School of Medicine, University of...

  6. Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

    Science.gov (United States)

    Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

    2015-11-01

    The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

  7. Pigmented Villonodular Synovitis in a Patient who Underwent Hip Arthroplasty

    Directory of Open Access Journals (Sweden)

    Nevzat Dabak

    2014-09-01

    Full Text Available Pigmented villonodular synovitis (PVNS is a rare, benign, but a locally aggressive tumor. It is characterized by the proliferation of synovial membrane, but it can also be seen in tendon sheaths and bursae. Clinical presentation of solitary lesions include compression and locking of the joint suggesting loose bodies in the joint and a subsequent findings of an effusion, whereas diffuse lesions manifest with pain and chronic swelling. In this article, we presented a curious case of PVNS in a female patient who have been followed up due to an acetabular cystic lesion. She underwent total hip arthroplasty for severe osteoarthritis of the hip joint and associated pain. The diagnosis of PVNS was established intraoperatively. (The Me­di­cal Bul­le­tin of Ha­se­ki 2014; 52: 235-7

  8. Clinical evaluation of dynamic visual acuity in subjects with unilateral vestibular hypofunction.

    Science.gov (United States)

    Dannenbaum, Elizabeth; Paquet, Nicole; Chilingaryan, Gevorg; Fung, Joyce

    2009-04-01

    The objectives of this study are threefold: 1) to examine the effect of frequency of head motion on the clinical dynamic visual acuity (DVA) score in subjects with unilateral vestibular hypofunction (UVH); 2) to compare DVA scores between subjects with UVH and subjects with a complete unilateral vestibular deficit; and 3) to establish whether a relationship exists between the extent of the vestibular deficit and the DVA score. Experimental study. Vestibular outpatient rehabilitation program. A convenience sample of 10 subjects with UVH. Dynamic visual acuity scores were recorded using 2 standard acuity charts: Snellen and E-chart. The DVA scores were obtained at slow (0.5 Hz), moderate (1 and 1.5 Hz), and fast (2.0 Hz) frequencies of head motion in the horizontal and the vertical planes. Percentage of caloric weakness was compared with DVA scores in each subject to test whether a relationship exists between the two. As the frequency of head motion increased, the number of UVH subjects with an abnormal DVA score increased. Subjects with an abnormal DVA score at 1 Hz had the same or higher score as the frequency of the head motion was increased. Spearman correlation analyses revealed low-correlation coefficients between percentage of vestibular paresis at the caloric test and DVA scores (horizontal direction: r = 0.31, p = 0.38 for Snellen chart and r = -0.33, p = 0.35 for the E-chart; vertical: r = 0.05, p = 0.91 for the Snellen chart and r = -0.28, p = 0.50 for the E-chart). Subjects with UVH manifest impaired DVA. The frequency of head motion has an impact on clinical DVA scores in UVH subjects.

  9. Subjective measures of hearing aid benefit in the NIDCD/VA Clinical Trial.

    Science.gov (United States)

    Haskell, George B; Noffsinger, Douglas; Larson, Vernon D; Williams, David W; Dobie, Robert A; Rogers, Janette L

    2002-08-01

    Subjective measures of performance were assessed on three different hearing aid circuits as part of a large clinical trial. These measurements included the Profile of Hearing Aid Performance and a subjective ranking of individual preference. A multi-center, double-masked clinical trial of hearing aids was conducted at eight VA Medical Centers. Three hearing aid circuits, a linear peak-clipper, a linear compression limiter and a wide dynamic range compressor, were investigated. The experimental design was a three-period, three-treatment crossover design. Subjects (N = 360) were stratified by site and randomized to one of six sequences for the hearing aid circuits. All fittings were binaural and involved a 3-mo trial with each of the three circuits. All subjective measures were administered for unaided and aided conditions at the end of each trial period. While all of the circuits resulted in improved scores on the aided versus the unaided PHAP, there were few conditions in which one circuit outperformed the others. An exception was the aversiveness of sound subscale where the peak clipper frequently scored worse than either the compression limiter or the wide dynamic range compressor. In the subjective ranking scale the compression limiter received more first place rankings than the other two circuits, especially for one subgroup of patients with moderate flat hearing loss. All circuits were perceived as beneficial by these subjects in most situations. The peak clipper scored worse on aversiveness of sound than did the other two circuits for most subjects, while the compression limiter seemed to have a slight advantage in subjective rankings. Most subjects perceived considerable aided benefit in situations involving background noise and reverberation, situations where hearing aid benefit is often questioned.

  10. Clinical and functional aspects of body balance in elderly subjects with benign paroxysmal positional vertigo.

    Science.gov (United States)

    Vaz, Daniela Patricia; Gazzola, Juliana Maria; Lança, Solange Martiliano; Dorigueto, Ricardo Schaffeln; Kasse, Cristiane Akemi

    2013-01-01

    Benign paroxysmal positional vertigo (BPPV) may compromise the balance of elderly subjects. To observe the effects of the Epley maneuver in elderly subjects with BPPV and assess clinical and functional aspects of body balance. This is a prospective clinical study. Patients diagnosed with BPPV (Dix-Hallpike test) were submitted to the Timed Up & Go (TUG) test, the Clinical Test of Sensory Interaction and Balance (CTSIB), and lower limb testing before and after they were repositioned using the modified Epley maneuver. Most subjects were females, and the group's mean age was 70.10 years (SD = 7.00). All patients had canalithiasis of the posterior canal. The following symptoms improved after the maneuver: postural instability (p = 0.006), nausea and vomiting (p = 0.021), and tinnitus (p = 0.003). Subjects improved their times significantly in the TUG and lower limb tests after the Epley maneuver (p < 0.001). Patients performed better on the CTSIB after the Epley maneuver on condition 2 (p < 0.003), condition 3 (p < 0.001), condition 4 (p < 0.001), condition 5 (p < 0.001), and condition 6 (p < 0.001). Clinical and functional aspects of body balance in elderly with BPPV improved after treatment with the modified Epley maneuver.

  11. Assessing subject privacy and data confidentiality in an emerging region for clinical trials: United Arab Emirates.

    Science.gov (United States)

    Nair, Satish Chandrasekhar; Ibrahim, Halah

    2015-01-01

    Pharmaceutical sponsored clinical trials, formerly conducted predominantly in the United States and Europe, have expanded to emerging regions, including the Middle East. Our study explores factors influencing clinical trial privacy and confidentiality in the United Arab Emirates. Factors including concept familiarity, informed consent compliance, data access, and preservation, were analyzed to assess current practices in the Arab world. As the UAE is an emerging region for clinical trials, there is a growing need for regulations related to data confidentiality and subject privacy. Informational and decisional privacy should be viewed within the realms of Arab culture and religious background.

  12. Clinical Utility of Additional Measurement of Total Lung Capacity in Diagnosing Obstructive Lung Disease in Subjects With Restrictive Pattern of Spirometry.

    Science.gov (United States)

    Lee, Hyun; Chang, Boksoon; Kim, Kyunga; Song, Won Jun; Chon, Hae Ri; Kang, Hyung Koo; Kim, Jung Soo; Jeong, Byeong-Ho; Oh, Yeon-Mok; Koh, Won-Jung; Park, Hye Yun

    2016-04-01

    Total lung capacity (TLC), forced expiratory flow between 25 and 75% (FEF25-75%), peak expiratory flow (PEF), or post-bronchodilator volume response is recommended to detect obstructive abnormalities in the lung. The present study was performed to evaluate the usefulness of these pulmonary function test (PFT) parameters to diagnose obstructive lung disease in subjects with a restrictive pattern of spirometry. A retrospective study was conducted in 64 subjects with a restrictive pattern of spirometry (normal FEV1/FVC and low FVC) out of 3,030 patients who underwent all pre- and post-bronchodilator spirometry and lung volume measurement between April 2008 and December 2010. After subjects were clinically classified into those with obstructive lung disease, restrictive lung disease, and mixed lung disease, the agreements between the clinical diagnosis and PFT classification according to TLC, FEF(25-75%), PEF, and post-bronchodilator response criteria were compared. Of 64 subjects, 18 (28.1%) were classified with obstructive lung disease, 39 (60.9%) had restrictive lung disease, 1 (1.6%) had mixed lung disease, and 6 (9.4%) had no clinical lung disease. Among the 58 subjects with clinical lung disease, 22 (37.9%), 37 (63.8%), 33 (56.9%), and 3 (5.2%) were classified as having obstructive pattern based on TLC, FEF25-75%, PEF, and post-bronchodilator response criteria, respectively. The kappa coefficients for the agreement between the clinical classification and PFT classification using TLC, FEF25-75%, PEF, and post-bronchodilator response criteria in 58 subjects were 0.59, 0.18, 0.17, and spirometry, when obstructive lung disease is clinically suspected. Copyright © 2016 by Daedalus Enterprises.

  13. [The request for consent in clinical research: a randomized study in healthy subjects].

    Science.gov (United States)

    Perrone, F; De Placido, S; Giusti, C; Gallo, C

    1995-09-01

    To compare two strategies of consent requirement (classical informed consent and randomised consent according to Zelen), the Clinical Data Elaboration Centre of South Italy, within the special project Clinical Application of Oncological Research of the National Research Council of Italy (CNR-ACRO) invited healthy people visiting the 7th edition of the scientific exhibition "Futuro Remoto" to simulate of being ill and receiving the offer of entering a clinical trial. Within informed consent strategy patients are asked to agree to the randomisation process, while, in the randomised consent, randomised treatment assignment is performed before consent requirement and patients should agree directly to the assigned therapy. Major aims of the study were (a) to compare the strategies in terms of refusal rate to a hypothetical clinical trial, and (b) to estimate whether severity of prognosis affected subjects' decision. 3,217 visiting people participated to the simulation; they were prevalently young, males and with a high level of school education. The study was performed in two different scenarios. In the first one, with one choice option, subject refusing consent could receive standard therapy only; refusal rate was 16% after informed consent and 13.4% after randomised consent (for experimental therapy). In the other scenario, with two choice options, subjects refusing consent could choose the preferred therapy; refusal rate was 20.6% after informed consent, 48.1% after randomised consent (for standard therapy) and 13.4% after randomised consent (for experimental therapy).(ABSTRACT TRUNCATED AT 250 WORDS)

  14. Biomedical subjectivities and reproductive assumptions in the CAMELIA clinical trial in Cambodia.

    Science.gov (United States)

    Petitet, Pascale Hancart

    2014-01-01

    The inclusion of women in clinical trials has raised a variety of ethical and practical issues in their implementation. In the recent CAMELIA clinical trial in Cambodia, the inclusion criteria included a negative pregnancy test and signature of the consent form confirming commitment to double contraceptive use as patients were given drugs contra-indicated in case of pregnancy. But despite precautions and the requirement stated in the informed consent form, 19 out of 236 enrolled women became pregnant during the trial. The current paper describes the frictions and subjectivities that emerge as new medical technologies travel to resource-poor settings--and more specifically, how trial researchers, health workers, and research subjects involved in the CAMELIA trial negotiate the injunction to avoid pregnancy while using a teratogenic drug.

  15. Effect of recruitment strategy on types of subjects entered into a primary prevention clinical trial.

    Science.gov (United States)

    King, A C; Harris, R B; Haskell, W L

    1994-07-01

    Clinical trials typically recruit subjects through referrals or media promotion, with generalizability of the results often uncertain. As part of a primary prevention trial to evaluate strategies for increasing physical activity in sedentary men and women, two recruitment sources, a random-digit-dial telephone survey and a community media campaign, were used to identify subjects. Baseline characteristics of 357 randomized men and women aged 50 to 65 years were compared by recruitment source. Whereas there were few differences between recruitment sources for demographic variables, telephone survey recruitment was particularly successful in recruiting smokers and persons with other cardiovascular risk factors into the trial. Counter to expectations, subsequent exercise adherence rates did not differ by recruitment source. The results suggest that the survey method, while more expensive, may be particularly useful for locating higher-risk subjects who could especially benefit from increases in physical activity but who rarely are recruited through more traditional approaches.

  16. A comparative study on the clinical and polysomnographic pattern of obstructive sleep apnea among obese and non-obese subjects

    Directory of Open Access Journals (Sweden)

    Rajiv Garg

    2012-01-01

    Full Text Available Objective: This study was designed to compare the pattern of obstructive sleep apnea (OSA among obese and nonobese subjects regarding clinical and polysomnographic data obtained for a polysomnographic study. Methods: A cross-sectional retrospective descriptive study was conducted by analyzing polysomnographic data in 112 consecutive patients underwent a sleep study at our sleep laboratory from January 2009 to July 2010. Out of them, 81 were diagnosed to have OSA (apnea-hypopnoea Index ≥5. These patients were classified in two groups with body mass index (BMI 0.001. The minimal oxygen saturation was lower in the obese than the nonobese group (68.5 ± 13.00 vs. 80.3 ± 7.40, P0.001 and was well below 90% in both groups. Overall, the OSA in nonobese patients was mild-to-moderate as compared to that of the obese and no significant differences were observed between them as regard to age, gender, mean neck circumference, excessive daytime sleepiness, adenoid or tonsillar enlargement, smoking, and remaining polysomnographic parameters. Conclusion: Obstructive sleep apnea can occur in nonobese persons though with less severity as compared to obese leading to a concept that OSA is not restricted to obese persons only and there is a high demand of its awareness regarding evaluation, diagnosis, and management in such individuals.

  17. Single-subject voxel-based relaxometry for clinical assessment of temporal lobe epilepsy.

    Science.gov (United States)

    Kosior, Robert K; Lauzon, M Louis; Frayne, Richard; Federico, Paolo

    2009-09-01

    T2 relaxometry, quantitative assessment of T2 relaxation time in magnetic resonance (MR) data, typically uses manually drawn regions of interest (ROIs). This approach is limited by its subjectivity and its restricted scope of investigation. A recently developed approach called voxel-based relaxometry (VBR) provides an unbiased statistical analysis of the whole brain. Our objective was to assess the clinical utility of single-subject VBR for patients with temporal lobe epilepsy (TLE). Forty-five patients with TLE confirmed by history, EEG, and structural MRI and 25 control subjects were scanned at 3T using a modified Carr-Purcell-Meiboom-Gill MR sequence. ROIs were drawn for each patient and control subject, and measurements were made on unregistered T2 maps. VBR was performed on a single-subject basis at a significance level of alpha=0.05. Patients were grouped according to seizure focus (left mesial, right mesial, other), and whether structural MR imaging was normal or abnormal. Up to 85% of patients in the temporal lobe groups demonstrated T2 abnormalities. VBR detected abnormalities either in equal numbers or in more patients (up to 23% more) than ROI analysis for each group. The number of detected abnormalities per patient was higher using VBR (3.38 versus 2.04, p<0.05). VBR also identified abnormalities that were missed by ROI analysis. The rate of VBR detection of abnormalities was higher for patients than controls (76% versus 36%). VBR can be performed on single subjects with TLE and it detects considerably more abnormalities than ROI analysis. VBR may be a clinically useful tool for the detection of T2 abnormalities at the seizure focus and sites remote from it.

  18. Comorbid personality disorders in subjects with panic disorder: which personality disorders increase clinical severity?

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    Mustafa Ozkan

    2003-03-01

    Full Text Available Personality disorders are common in subjects with panic disorder. Personality disorders have shown to affect the course of panic disorder. The purpose of this study was to examine which personality disorders effect clinical severity in subjects with panic disorder. This study included 122 adults (71 female, 41 male, who met DSM-IV criteria for panic disorder (with or without agoraphobia. Clinical assessment was conducted by using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I, the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II and the Panic and Agoraphobia Scale (PAS, Global Assessment Functioning Scale (GAF, Beck Depression Inventory (BDI, and State-Trait Anxiety Inventory (STAI. Patients who had a history of sexual abuse were assessed with Sexual Abuse Severity Scale. Logistic regressions were used to identify predictors of suicide attempts, suicidal ideation, agoraphobia, different panic attack symptoms, sexual abuse, and early onset of disorders. The rates of comorbid Axis I and Axis II psychiatric disorders were 80.3% and 33.9%, consecutively, in patients with panic disorder. Panic disorder patients with comorbid personality disorders had more severe anxiety, depression and agoraphobia symptoms, and had earlier ages of onset, and lower levels of functioning. The rates of suicidal ideation and suicide attempts were 34.8% and 9.8%, consecutively, in subjects with panic disorder. The rate of patients with panic disorder had a history of childhood sexual abuse was 12.5%. The predictor of sexual abuse was more than one comorbid Axis II diagnosis. The predictors of suicide attempt were comorbid paranoid and borderline personality disorders, and the predictor of suicidal ideation was major depressive disorder in subjects with panic disorder. In conclusion, this study documents that comorbid personality disorders increase the clinical severity of panic disorder. Patients with more than one

  19. Comparison between refraction measured by Spot Vision ScreeningTM and subjective clinical refractometry

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    Daniela Lima de Jesus

    2016-02-01

    Full Text Available OBJECTIVE: The purpose of this study was to evaluate the accuracy of Spot Vision ScreeningTM as an autorefractor by comparing refraction measurements to subjective clinical refractometry results in children and adult patients. METHODS: One-hundred and thirty-four eyes of 134 patients were submitted to refractometry by Spot and clinical refractometry under cycloplegia. Patients, students, physicians, staff and children of staff from the Hospital das Clínicas (School of Medicine, University of São Paulo aged 7-50 years without signs of ocular disease were examined. Only right-eye refraction data were analyzed. The findings were converted in magnitude vectors for analysis. RESULTS: The difference between Spot Vision ScreeningTM and subjective clinical refractometry expressed in spherical equivalents was +0.66±0.56 diopters (D, +0.16±0.27 D for the vector projected on the 90 axis and +0.02±0.15 D for the oblique vector. CONCLUSIONS: Despite the statistical significance of the difference between the two methods, we consider the difference non-relevant in a clinical setting, supporting the use of Spot Vision ScreeningTM as an ancillary method for estimating refraction.

  20. Comparison between refraction measured by Spot Vision Screening™ and subjective clinical refractometry.

    Science.gov (United States)

    de Jesus, Daniela Lima; Villela, Flávio Fernandes; Orlandin, Luis Fernando; Eiji, Fernando Naves; Dantas, Daniel Oliveira; Alves, Milton Ruiz

    2016-02-01

    The purpose of this study was to evaluate the accuracy of Spot Vision Screening™ as an autorefractor by comparing refraction measurements to subjective clinical refractometry results in children and adult patients. One-hundred and thirty-four eyes of 134 patients were submitted to refractometry by Spot and clinical refractometry under cycloplegia. Patients, students, physicians, staff and children of staff from the Hospital das Clínicas (School of Medicine, University of São Paulo) aged 7-50 years without signs of ocular disease were examined. Only right-eye refraction data were analyzed. The findings were converted in magnitude vectors for analysis. The difference between Spot Vision Screening™ and subjective clinical refractometry expressed in spherical equivalents was +0.66±0.56 diopters (D), +0.16±0.27 D for the vector projected on the 90 axis and +0.02±0.15 D for the oblique vector. Despite the statistical significance of the difference between the two methods, we consider the difference non-relevant in a clinical setting, supporting the use of Spot Vision Screening™ as an ancillary method for estimating refraction.

  1. Comparison between refraction measured by Spot Vision ScreeningTM and subjective clinical refractometry

    Science.gov (United States)

    de Jesus, Daniela Lima; Villela, Flávio Fernandes; Orlandin, Luis Fernando; Eiji, Fernando Naves; Dantas, Daniel Oliveira; Alves, Milton Ruiz

    2016-01-01

    OBJECTIVE: The purpose of this study was to evaluate the accuracy of Spot Vision ScreeningTM as an autorefractor by comparing refraction measurements to subjective clinical refractometry results in children and adult patients. METHODS: One-hundred and thirty-four eyes of 134 patients were submitted to refractometry by Spot and clinical refractometry under cycloplegia. Patients, students, physicians, staff and children of staff from the Hospital das Clínicas (School of Medicine, University of São Paulo) aged 7-50 years without signs of ocular disease were examined. Only right-eye refraction data were analyzed. The findings were converted in magnitude vectors for analysis. RESULTS: The difference between Spot Vision ScreeningTM and subjective clinical refractometry expressed in spherical equivalents was +0.66±0.56 diopters (D), +0.16±0.27 D for the vector projected on the 90 axis and +0.02±0.15 D for the oblique vector. CONCLUSIONS: Despite the statistical significance of the difference between the two methods, we consider the difference non-relevant in a clinical setting, supporting the use of Spot Vision ScreeningTM as an ancillary method for estimating refraction. PMID:26934234

  2. Comparative Clinical, Physiological, and Inflammatory Characteristics of Elderly Subjects With or Without Asthma and Young Subjects With Asthma.

    Science.gov (United States)

    Boulet, Louis-Philippe; Robitaille, Catherine; Deschesnes, Francine; Villeneuve, Hélène; Boulay, Marie-Ève

    2017-12-01

    Asthma seems to present in the elderly as a specific phenotype that remains to be further described. In this prospective observational study, we aimed to assess the multidimensional aspects of asthma in the elderly. In young (18 to 35 years old) subjects with mild to moderate asthma and elderly subjects (aged ≥60 years) either with or without mild to moderate asthma, we compared asthma control, health care and medication use, lung function, markers of airway and systemic inflammation, and adherence to therapy. Fifty subjects were recruited in each group. Elderly people with asthma showed more marked airway obstruction compared with young people with asthma and elderly people without asthma. They also had poorer asthma control, mainly associated with a lower FEV1, compared with young people with asthma, although airway responsiveness, health care use, prescribed doses of inhaled corticosteroids, and adherence to treatment were similar in both groups. Elderly subjects had an increase in some markers of systemic inflammation and bronchial epithelial dysfunction compared with young people with asthma. Blood eosinophils were higher in both asthma groups, particularly in elderly people with asthma. Sputum neutrophils were increased in both groups of elderly subjects and sputum eosinophils were increased in elderly people with asthma compared with the other two groups. Asthma in the elderly presents as a specific phenotype associated with increased airway obstruction and mixed airway inflammation in addition to signs of systemic inflammation. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  3. Liver enzymes in diabetic and non diabetic subjects with clinically diagnosed hepatitis

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    Bidhan Chandra Sarkar

    2011-07-01

    Full Text Available The occurrence of liver disease and raised liver enzymes is common in diabetic patients and the increasing level of enzymes indicates the severity of hepatic injury. Very few studies have addressed this issue in Bangladesh though Bangladeshi population is very much susceptible to diabetes. This study investigated a total of 1400 diabetic patients and 100 non diabetic individuals to compare the level of liver enzymes between diabetic and non-diabetic subjects. The comparisons were made among subjects who were referred to the department of Gastro-hepato-pancreatic diseases (GHPD of BIRDEM with the clinical diagnosis of chronic hepatitis and other gastro-intestinal disorders. The investigations included alanine aminotransferase (ALT, aspartate aminotransferase (AST, alkaline phosphatase (ALP and bilirubin levels. The subjects were categorized with and without hepatitis based on these investigations. The biochemical markers (ALT, AST, ALP, bilirubin did not differ significantly between non-diabetic male and female subjects. Neither the differences were significant between diabetic males and females though the diabetic patients had higher level of markers. In contrast, when compared between diabetic and non-diabetic subjects there were striking differences in either sex. Compared with the non-diabetic the diabetic subjects had significantly higher level of ALT (48.3 vs. 277.0, AST (42.0 vs. 213.0 and ALP (148 vs. 302 in males (p<0.005 for all. Similarly, these values were found significantly higher in diabetic females than their non-diabetic counterparts (p<0.01. For bilirubin, it was also found significant in males (p<0.001. The study revealed that the liver enzymes were found elevated in both diabetic and non-diabetic subjects who were referred with clinically diagnosed hepatitis. The enzymes were found markedly elevated among the diabetic than non diabetic patients, which indicate hepatic injury was more marked among the diabetic patients. Further

  4. Body Experience and Mirror Behaviour in Female Eating Disorders Patients and non Clinical Subjects

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    Michel Probst

    2008-12-01

    Full Text Available Recently the attention for mirror exercises in therapies targeted specifically to body experience concerns has increased. This retrospective study will explore the mirror behaviour of anorexia nervosa (AN, bulimia nervosa (BN and non-clinical female subjects (CG and investigate whether mirror avoidance or checking are related to negative body experiences.The group of eating disorders consisted of 560 AN and 314 BN patients. The control group consisted of 1151 female subjects. The Body Attitude Test and the Eating Disorder Inventory subscales drive for thinness and body dissatisfaction were used. To explore the mirror behaviour, one item of the Body Attitude Test ‘I am observing my appearance in the mirror’ was used. Nonparametric analyses (Spearman rho correlations, Kruskal-Wallis and Mann Whitney test were used because of the categorical data.BN patients observed their body more often in the mirror than AN patients and the control subjects do. Age and BMI showed no significant main effect of mirror frequency. The relation between the frequency of mirror behaviour and body experience were significant but low (under .40. AN patients and control subjects with a mirror checking behaviour had a more negative body experience than those with mirror avoidance behaviour. In the BN group, no differences were found.There is support to integrate mirror exercises in a treatment of eating disorder patients. From a clinical point, mirror exercises are preferably combined with a body oriented therapy within a multidimensional cognitive behavioural approach. Recommendations for mirror exercises based on the clinical experience are given.

  5. The Semantic Variant of Primary Progressive Aphasia: Clinical and Neuroimaging Evidence in Single Subjects

    Science.gov (United States)

    Iaccarino, Leonardo; Crespi, Chiara; Della Rosa, Pasquale Anthony; Catricalà, Eleonora; Guidi, Lucia; Marcone, Alessandra; Tagliavini, Fabrizio; Magnani, Giuseppe; Cappa, Stefano F.; Perani, Daniela

    2015-01-01

    Background/Aim We present a clinical-neuroimaging study in a series of patients with a clinical diagnosis of semantic variant of primary progressive aphasia (svPPA), with the aim to provide clinical-functional correlations of the cognitive and behavioral manifestations at the single-subject level. Methods We performed neuropsychological investigations, 18F-FDG-PET single-subject and group analysis, with an optimized SPM voxel-based approach, and correlation analyses. A measurement of white matter integrity by means of diffusion tensor imaging (DTI) was also available for a subgroup of patients. Results Cognitive assessment confirmed the presence of typical semantic memory deficits in all patients, with a relative sparing of executive, attentional, visuo-constructional, and episodic memory domains. 18F-FDG-PET showed a consistent pattern of cerebral hypometabolism across all patients, which correlated with performance in semantic memory tasks. In addition, a majority of patients also presented with behavioral disturbances associated with metabolic dysfunction in limbic structures. In a subgroup of cases the DTI analysis showed FA abnormalities in the inferior longitudinal and uncinate fasciculi. Discussion Each svPPA individual had functional derangement involving an extended, connected system within the left temporal lobe, a crucial part of the verbal semantic network, as well as an involvement of limbic structures. The latter was associated with behavioral manifestations and extended beyond the area of atrophy shown by CT scan. Conclusion Single-subject 18F-FDG-PET analysis can account for both cognitive and behavioral alterations in svPPA. This provides useful support to the clinical diagnosis. PMID:25756991

  6. Reduced FDG-PET brain metabolism and executive function predict clinical progression in elderly healthy subjects

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    Michael Ewers

    2014-01-01

    Full Text Available Brain changes reminiscent of Alzheimer disease (AD have been previously reported in a substantial portion of elderly cognitive healthy (HC subjects. The major aim was to evaluate the accuracy of MRI assessed regional gray matter (GM volume, 18F-fluorodeoxyglucose positron emission tomography (FDG-PET, and neuropsychological test scores to identify those HC subjects who subsequently convert to mild cognitive impairment (MCI or AD dementia. We obtained in 54 healthy control (HC subjects a priori defined region of interest (ROI values of medial temporal and parietal FDG-PET and medial temporal GM volume. In logistic regression analyses, these ROI values were tested together with neuropsychological test scores (free recall, trail making test B (TMT-B as predictors of HC conversion during a clinical follow-up between 3 and 4 years. In voxel-based analyses, FDG-PET and MRI GM maps were compared between HC converters and HC non-converters. Out of the 54 HC subjects, 11 subjects converted to MCI or AD dementia. Lower FDG-PET ROI values were associated with higher likelihood of conversion (p = 0.004, with the area under the curve (AUC yielding 82.0% (95% CI = (95.5%, 68.5%. The GM volume ROI was not a significant predictor (p = 0.07. TMT-B but not the free recall tests were a significant predictor (AUC = 71% (95% CI = 50.4%, 91.7%. For the combination of FDG-PET and TMT-B, the AUC was 93.4% (sensitivity = 82%, specificity = 93%. Voxel-based group comparison showed reduced FDG-PET metabolism within the temporo-parietal and prefrontal cortex in HC converters. In conclusion, medial temporal and-parietal FDG-PET and executive function show a clinically acceptable accuracy for predicting clinical progression in elderly HC subjects.

  7. Clinical performance of a dermal filler containing natural glycolic Acid and a polylactic Acid polymer: results of a clinical trial in human immunodeficiency virus subjects with facial lipoatrophy.

    Science.gov (United States)

    Tagle, Jorge M; Macchetto, Pedro Cervantes; Durán Páramo, Rosa Margarita

    2010-02-01

    : seven in two sessions, eight in three sessions, 14 in four sessions, and one in five sessions. Each treatment session was separated by approximately 20 days as per the manufacturer's instructions. The follow-up phase consisted of four observation periods over two years from the last injection. The primary efficacy endpoint was measurement of correction of human immunodeficiency virus highly active antiretroviral therapy induced facial lipoatrophy. Using a multipoint scale of facial divergence, correction was measured as a percentage of correction (diversion correction percentage) from baseline. A secondary endpoint was safety based upon the incidence and type of adverse events experienced. All 30 patients completed the active treatment phase with 100 percent (N=30) undergoing at least two treatments at Days 1 and 20 after entry into study. Seventy-four percent (n=23) underwent a third treatment at Day 60, and 50 percent (n=15) received a fourth treatment at Day 80. A single subject received a fifth treatment at Day 100. There were no serious adverse events and no adverse events noted during the study period. Histology through skin biopsy (2mm punch) was performed on 10 subjects, and all subjects had dermal skin thickness measured with ultrasound. Histology demonstrated a foreign body reaction with multinucleated giant cells with phagocytized lactate crystals. New collagen formation was demonstrated. United States measurements of dermal skin thickness increase ranged from 0.22cm to 0.37cm. All subjects were rated for expected injection events to include erythema, edema, ecchymosis, and hematoma. This dermal collagen stimulator containing glycolic acid and polylactic acid represents a tangible alternative in therapeutic and aesthetic medicine. More than four years of clinical trials have demonstrated that this dermal collagen stimulator helps to improve the exterior quality of the skin while restoring lost facial volumes. Patient satisfaction was high due to its

  8. Predictive Clinical Parameters and Glycemic Efficacy of Vildagliptin Treatment in Korean Subjects with Type 2 Diabetes

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    Jin-Sun Chang

    2013-02-01

    Full Text Available BackgroundThe aims of this study are to investigate the glycemic efficacy and predictive parameters of vildagliptin therapy in Korean subjects with type 2 diabetes.MethodsIn this retrospective study, we retrieved data for subjects who were on twice-daily 50 mg vildagliptin for at least 6 months, and classified the subjects into five treatment groups. In three of the groups, we added vildagliptin to their existing medication regimen; in the other two groups, we replaced one of their existing medications with vildagliptin. We then analyzed the changes in glucose parameters and clinical characteristics.ResultsUltimately, 327 subjects were analyzed in this study. Vildagliptin significantly improved hemoglobin A1c (HbA1c levels over 6 months. The changes in HbA1c levels (ΔHbA1c at month 6 were -2.24% (P=0.000, -0.77% (P=0.000, -0.80% (P=0.001, -0.61% (P=0.000, and -0.34% (P=0.025 for groups 1, 2, 3, 4, and 5, respectively, with significance. We also found significant decrements in fasting plasma glucose levels in groups 1, 2, 3, and 4 (P<0.05. Of the variables, initial HbA1c levels (P=0.032 and history of sulfonylurea use (P=0.026 were independently associated with responsiveness to vildagliptin treatment.ConclusionVildagliptin was effective when it was used in subjects with poor glycemic control. It controlled fasting plasma glucose levels as well as sulfonylurea treatment in Korean type 2 diabetic subjects.

  9. Cultural-psychological and clinical perspectives of research on phenomena of subjective uncertainty and ambiguity

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    Sokolova, Elena T.

    2013-06-01

    Full Text Available The article analyzes certain socio-cultural and personal predispositions, which determine the modern diversity of subjective uncertainty and ambiguity manifestations. It stresses that for the creation of ‘realistic’ clinical psychology (in terms of A.R. Luria one needs to retrace the relations between the resourceful and the psychopathological aspects of the ambiguity phenomenon and the cultural environment with its destructive ideals and mythologems, manipulative media-technologies and all-pervading idea of ‘deconstruction’. Methods for modeling the experiences of ambiguity in experimental settings, in pathopsychological examination and in projective psychological diagnostics are put in comparison. The arguments are adduced for the interpretation of deficient manifestations of subjective uncertainty as a criterion for diagnostics of the severity of personality disorder.

  10. The Adequacy of the Q Methodology for Clinical Validation of Nursing Diagnoses Related to Subjective Foci.

    Science.gov (United States)

    Miguel, Susana; Caldeira, Sílvia; Vieira, Margarida

    2016-11-17

    This article describes the adequacy of the Q methodology as a new option for the validation of nursing diagnoses related to subjective foci. Discussion paper about the characteristics of the Q methodology. This method has been used in nursing research particularly related to subjective concepts and includes both a quantitative and qualitative dimension. The Q methodology seems to be an adequate and innovative method for the clinical validation of nursing diagnoses. The validation of nursing diagnoses related to subjective foci using the Q methodology could improve the level of evidence and provide nurses with clinical indicators for clinical reasoning and for the planning of effective interventions. Descrever a adequação da metodologia Q como uma nova opção para a validação clínica de diagnósticos de enfermagem relacionados com focos subjetivos. MÉTODOS: Artigo de discussão sobre as características da metodologia Q. Este método tem sido utilizado na pesquisa em enfermagem relacionada com conceitos subjetivos e inclui em simultâneo uma vertente qualitativa e quantitativa. CONCLUSÕES: A metodologia Q parece ser uma opção metodológica adequada para a validação clínica de diagnósticos de enfermagem. IMPLICAÇÕES PARA A PRÁTICA: A utilização da metodologia Q na validação clínica de diagnósticos de enfermagem relacionados com focos subjetivos pode melhorar o nível e evidência e facilitar o raciocínio clínico dos enfermeiros, ao providenciar indicadores clínicos também necessários ao desenvolvimento de intervenções efetivas. © 2016 NANDA International, Inc.

  11. The wide genetic landscape of clinical frontotemporal dementia: systematic combined sequencing of 121 consecutive subjects.

    Science.gov (United States)

    Blauwendraat, Cornelis; Wilke, Carlo; Simón-Sánchez, Javier; Jansen, Iris E; Reifschneider, Anika; Capell, Anja; Haass, Christian; Castillo-Lizardo, Melissa; Biskup, Saskia; Maetzler, Walter; Rizzu, Patrizia; Heutink, Peter; Synofzik, Matthis

    2017-07-27

    PurposeTo define the genetic spectrum and relative gene frequencies underlying clinical frontotemporal dementia (FTD).MethodsWe investigated the frequencies and mutations in neurodegenerative disease genes in 121 consecutive FTD subjects using an unbiased, combined sequencing approach, complemented by cerebrospinal fluid Aβ1-42 and serum progranulin measurements. Subjects were screened for C9orf72 repeat expansions, GRN and MAPT mutations, and, if negative, mutations in other neurodegenerative disease genes, by whole-exome sequencing (WES) (n = 108), including WES-based copy-number variant (CNV) analysis.ResultsPathogenic and likely pathogenic mutations were identified in 19% of the subjects, including mutations in C9orf72 (n = 8), GRN (n = 7, one 11-exon macro-deletion) and, more rarely, CHCHD10, TARDBP, SQSTM1 and UBQLN2 (each n = 1), but not in MAPT or TBK1. WES also unraveled pathogenic mutations in genes not commonly linked to FTD, including mutations in Alzheimer (PSEN1, PSEN2), lysosomal (CTSF, 7-exon macro-deletion) and cholesterol homeostasis pathways (CYP27A1).ConclusionOur unbiased approach reveals a wide genetic spectrum underlying clinical FTD, including 11% of seemingly sporadic FTD. It unravels several mutations and CNVs in genes and pathways hitherto not linked to FTD. This suggests that clinical FTD might be the converging downstream result of a delicate susceptibility of frontotemporal brain networks to insults in various pathways.Genetics in Medicine advance online publication, 27 July 2017; doi:10.1038/gim.2017.102.

  12. The clinical spectrum of non-dementia cognitive impairment: Subjective mild-to-moderate disorders

    Directory of Open Access Journals (Sweden)

    V. V. Zakharov

    2015-01-01

    Full Text Available The important task of nevrology is to improve the diagnosis of chronic progressive degenerative and vascular brain diseases – to detect them at the earliest stages. The paper presents current views on the non-dementia stages of brain diseases: moderate, mild, and subjective cognitive impairments. It sets forth data on their prevalence and clinical features and types, as well as international diagnostic criteria. There is evidence for the expediency of the earliest neuroprotective therapy to prevent dementia. A methodology for neuroprotective therapy is discussed; the available data on the long-term effect of intermittent treatment cycles with the vasotropic and neurometabolic drug tanakan are given.

  13. The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.

    Science.gov (United States)

    Kelleher, Finnuala

    2004-01-01

    Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions.

  14. Skin prick test results of atopic asthmatic subjects in a chest disease clinic in Sanliurfa

    Directory of Open Access Journals (Sweden)

    İbrahim Koç

    2015-06-01

    Full Text Available Objective: Skin prick test (SPT is used widely to determine the allergens in atopic patients. In this study, we aimed to determine the spectrum of aeroallergen sensitivity of atopic asthmatic subjects in Şanlıurfa district. Methods: We evaluated clinical, demographic findings and SPT results of 95 male and 162 female in a total 257 patients who had asthma and allergic symptoms. Results: Most common allergens causing a sensitivity reaction detected in our clinic were as follows; cockroach (56.8%, wheat pollen (53.3%, corn pollen (47.4%, grass pollen (36.5%, poplar tree pollen (26%, house dust mite (19.4%, pepper (16.7% and cat dander (15.1%. Conclusion: High levels of sensitivity to wheat and corn pollens and relatively low sensitivity levels of cat dander results meet our expectations in the area of agricultural land and where pet ownership is not common.

  15. The Mayo Clinic quadratic equation improves the prediction of glomerular filtration rate in diabetic subjects.

    Science.gov (United States)

    Rigalleau, Vincent; Lasseur, Catherine; Raffaitin, Christelle; Perlemoine, Caroline; Barthe, Nicole; Chauveau, Philippe; Combe, Christian; Gin, Henri

    2007-03-01

    Although recommended, both the Cockcroft and Gault formula (CG) and the modification of diet in renal disease (MDRD) equation are not ideally predictive of glomerular filtration rate (GFR) in diabetic subjects; we tested whether the new Mayo Clinic Quadratic (MCQ) equation performed better. In 200 diabetic subjects with a wide range of renal function, GFR was measured by 51Cr-EDTA clearance, and compared with the results of the three predictive equations by regression analysis and Bland and Altman procedures. The correlations with body mass index, age and albumin excretion rates were tested. The precisions (absolute difference as percentage), diagnostic accuracies [receiver operating characteristic (ROC) curves for the diagnosis of moderate and severe chronic kidney disease (CKD)], and the results of stratification according to the KDOQ classification were compared. The CG and MCQ overestimated mean GFR, whereas the MDRD underestimated it. Correlation coefficients and areas under the ROC curves were better for the MDRD and the MCQ as compared with the CG, which was biased by body weight (+30% overestimation in obese diabetic subjects). The absolute differences with true GFR were slightly lower for the MDRD than the MCQ, and both better than the CG. Both the MDRD and MCQ correctly stratified 65% of the subjects (CG: 55%, P<0.05). In contrast with the MDRD, the MCQ did not underestimate normal GFR, and its performance for stratification was uniformly good over a wide GFR range. In diabetic subjects, the MCQ has a similar diagnostic performance to the MDRD, but it does not underestimate normal GFR, which is an important advantage.

  16. Clinical predictors of obesity hypoventilation syndrome in obese subjects with obstructive sleep apnea.

    Science.gov (United States)

    Bingol, Zuleyha; Pıhtılı, Aylin; Cagatay, Penbe; Okumus, Gulfer; Kıyan, Esen

    2015-05-01

    Arterial blood gas (ABG) analysis is not a routine test in sleep laboratories due to its invasive nature. Therefore, the diagnosis of obesity hypoventilation syndrome (OHS) is underestimated. We aimed to evaluate the differences in subjects with OHS and pure obstructive sleep apnea (OSA) and to determine clinical predictors of OHS in obese subjects. Demographics, body mass index (BMI), Epworth Sleepiness Scale score, polysomnographic data, ABG, spirometric measurements, and serum bicarbonate levels were recorded. Of 152 obese subjects with OSA (79 females/73 males, mean age of 50.3 ± 10.6 y, BMI of 40.1 ± 5.6 kg/m(2), 51.9% with severe OSA), 42.1% (n = 64) had OHS. Subjects with OHS had higher BMI (P = .02), neck circumference (P sleep time with S(pO2) sleep efficiency (P = .032), mean S(pO2) (P < .001), and nadir S(pO2) (P < .001). Serum bicarbonate levels and nadir S(pO2) were the only independent predictive factors for OHS. A serum bicarbonate level of ≥ 27 mmol/L as the cutoff gives a satisfactory discrimination for the diagnosis of OHS (sensitivity of 76.6%, specificity of 74.6%, positive predictive value of 54.5%, negative predictive value of 88.9%). A nadir S(pO2) of < 80% as the cutoff gives a satisfactory discrimination for the diagnosis of OHS (sensitivity of 82.8%, specificity of 54.5%, positive predictive value of 56.9%, negative predictive value of 81.4%). When we used a serum bicarbonate level of ≥ 27 mmol/L and/or a nadir S(pO2) of < 80% as a screening measure, only 3 of 64 subjects with OHS were missed. Serum bicarbonate level and nadir saturation were independent predictive factors for the diagnosis of OHS. Copyright © 2015 by Daedalus Enterprises.

  17. Subjective versus objective assessment in early clinical outcome of modified Lapidus procedure for hallux valgus deformity.

    Science.gov (United States)

    Chopra, S; Moerenhout, K; Crevoisier, X

    2016-02-01

    Studies have assessed the outcome of hallux valgus surgeries based on subjective questionnaires, usually the American Orthopaedic Foot and Ankle Society Score, and radiographic results reporting good to excellent outcome at 6-12 months postoperatively. However, contrasting results were reported by gait studies at 12-24 months postoperatively. In a previous study, we found nine gait parameters which can describe the altered gait in hallux valgus deformity. This study aimed, to assess the outcome of modified Lapidus at 6 months postoperatively, using gait assessment method, to determine if the nine specified gait parameters effectively relates with the clinical scores and the radiological results or add information missed by these commonly used clinical assessments. We assessed 21 participants including 11 controls and 10 patients with moderate to severe hallux valgus deformity. The patient group was followed 6 months postoperatively. The ambulatory gait assessment was performed utilizing pressure insoles and inertial sensors. Clinical assessment includes foot and ankle questionnaires along with radiographic results. Comparison was made using non parametric tests, Phallux valgus surgeries. The existing clinical assessment overestimates the functional outcome at the early postoperative phase. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Outcomes are not different for patient-matched vs. non-matched treatment in subjects with chronic, recurrent low back pain: a randomized clinical trial

    Science.gov (United States)

    Henry, Sharon M.; Van Dillen, Linda; Ouellette-Morton, Rebecca H.; Hitt, Juvena R.; Lomond, Karen V.; DeSarno, Michael J.; Bunn, Janice Y.

    2014-01-01

    Background Classification schemas for low back pain (LBP), such as the Treatment Based Classification and the Movement System Impairment schemas, use common clinical features to subgroup patients with LBP and are purported to improve treatment outcomes. Purpose To assess if providing matched treatments based on patient specific clinical features led to superior treatment outcomes compared to an unmatched treatment for subjects with chronic, recurrent LBP. Study Design A randomized controlled trial. Patient Sample Subjects (n=124) with LBP (≥ 12 months) with or without recurrences underwent a standardized clinical exam to group them into one of 2 strata: (1) ineligible or (2) eligible for stabilization exercises based on the Treatment Based Classification schema. Subjects underwent additional clinical tests to assign them to one of the 5 possible Movement System Impairment categories. Outcome Measures Questionnaires were collected electronically at: Week 0, prior to treatment; Week 7 (following the 6 weekly, one hour treatment sessions); and 12 months. Using the Oswestry Disability Index (0-100) and the Numeric Pain Rating Scale (0-10), the primary analysis was performed using the intention-to-treat principle. Secondary outcomes included fear-avoidance beliefs as well as psychosocial, work related and general health status. Methods After subjects were categorized based on their particular clinical features using both the Treatment Based Classification and Movement System Impairment schemas, they were randomized into one of two treatments using a 3:1 ratio for matched or unmatched treatments. The treatments were (1) trunk stabilization exercise, or (2) Movement System Impairment-directed exercises. The study was funded by National Institutes of Health (NCMRR/R01HD040909; $1,485,000). There are no study specific conflicts of interest to report. Results Of the patients allocated to treatment for this study, 76 received a matched treatment and 25 received an unmatched

  19. Informed consent for inclusion into clinical trials: a serious subject to note in the developing world.

    Science.gov (United States)

    Izadi, Morteza; Fazel, Mozhgan; Nasiri-Vanashi, Taha; Saadat, Seyed Hasan; Taheri, Saeed

    2012-05-01

    Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"

  20. No Clinically Significant Difference Between Adult and Pediatric IKDC Subjective Knee Evaluation Scores in Adults.

    Science.gov (United States)

    Stegmeier, Nicole; Oak, Sameer R; O'Rourke, Colin; Strnad, Greg; Spindler, Kurt P; Jones, Morgan; Farrow, Lutul D; Andrish, Jack; Saluan, Paul

    Two versions of the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form currently exist: the original version (1999) and a recently modified pediatric-specific version (2011). Comparison of the pediatric IKDC with the adult version in the adult population may reveal that either version could be used longitudinally. We hypothesize that the scores for the adult IKDC and pediatric IKDC will not be clinically different among adult patients aged 18 to 50 years. Randomized crossover study design. Level 2. The study consisted of 100 participants, aged 18 to 50 years, who presented to orthopaedic outpatient clinics with knee problems. All participants completed both adult and pediatric versions of the IKDC in random order with a 10-minute break in between. We used a paired t test to test for a difference between the scores and a Welch's 2-sample t test to test for equivalence. A least-squares regression model was used to model adult scores as a function of pediatric scores, and vice versa. A paired t test revealed a statistically significant 1.6-point difference between the mean adult and pediatric scores. However, the 95% confidence interval (0.54-2.66) for this difference did not exceed our a priori threshold of 5 points, indicating that this difference was not clinically important. Equivalence testing with an equivalence region of 5 points further supported this finding. The adult and pediatric scores had a linear relationship and were highly correlated with an R2 of 92.6%. There is no clinically relevant difference between the scores of the adult and pediatric IKDC forms in adults, aged 18 to 50 years, with knee conditions. Either form, adult or pediatric, of the IKDC can be used in this population for longitudinal studies. If the pediatric version is administered in adolescence, it can be used for follow-up into adulthood.

  1. Baroreflex Sensitivity in Relation to Clinical Characteristics in Subject Aged 40 to 80 Years

    DEFF Research Database (Denmark)

    Brinth, Louise Schouborg; Pors, Kirsten; Latif, Tabassam

    2014-01-01

    women) with a mean age of 59 ± 11 years (range 41-79 years) were included. Baroreceptor activity was quantified through the Valsalva manoeuvre (VM) and as a spontaneous function. BRS was tested against age, gender, smoking status, body size and predicted risk of coronary heart disease based......Baroreflex function measured as baroreflex sensitivity (BRS) mirrors an integrated capacity of the autonomic nervous system. We aimed to assess the relationship between measures of BRS and age and relevant clinical characteristics. 80 subjects participating in the Copenhagen City Heart study (43...... breathing and VM. We could not demonstrate any correlation between BRS, smoking status, and body size when adjusting for age and gender, whereas spontaneous BRS was reduced with increasing Framingham risk score. Principal component analysis revealed three component explaining 69% of the total variance...

  2. Effects of orthopedic maxillary expansion on nasal cavity size in growing subjects: a low dose computer tomography clinical trial.

    Science.gov (United States)

    Cordasco, Giancarlo; Nucera, Riccardo; Fastuca, Rosamaria; Matarese, Giovanni; Lindauer, Steven J; Leone, Pietro; Manzo, Paolo; Martina, Roberto

    2012-11-01

    The aim of this retrospective clinical trial was to evaluate the effects of rapid maxillary expansion on skeletal nasal cavity size in growing subjects by use of low dose computer tomography. Eight Caucasian children (three male; five female) with a mean age of 9.7 years (SD±1.41) were the final sample of this research that underwent palatal expansion as a first phase of orthodontic treatment. The maxillary expander was banded to the upper first molars and was activated according a rapid maxillary expansion protocol. Low-dose computer tomography examinations of maxilla and of the low portion of nasal cavity were performed before inserting the maxillary expander (T0) and at the end of retention (T1), 7 months later. A low-dose computer tomography protocol was applied during the exams. Image processing was achieved in 3 steps: reslicing; dental and skeletal measurements; skeletal nasal volume computing. A set of reproducible skeletal and dental landmarks were located in the coronal passing through the first upper right molar furcation. Using the landmarks, a set of transverse linear measurements were identified to estimate maximum nasal width and nasal floor width. To compute the nasal volume the lower portion of the nasal cavity was set as region of interest. Nasal volume was calculated using a set of coronal slices. In each coronal slice, the cortical bone of the nasal cavity was identified and selected with a segmentation technique. Dependent t-tests were used to evaluate changes due to expansion. For all tests, a significance level of Pmaxillary expansion produced significant increases of linear transverse skeletal measurements, these increments were bigger in the lower portion of the nasal cavities: nasal floor width (+3.15 mm; SD ± 0.99), maximum nasal width (+2.47 mm; SD ± 0.99). Rapid maxillary expansion produced significant increment of the total nasal volume (+1.27 cm(3) ± SD 0.65). The anterior volume increase was 0.58 cm(3) while the posterior one was

  3. [Clinical and psychosocial characteristics of subjects with fibromyalgia. Impact of the diagnosis on patients' activities].

    Science.gov (United States)

    Ubago Linares, Maria del Carmen; Ruiz Pérez, Isabel; Bermejo Pérez, Maria José; Olry de Labry Lima, Antonio; Plazaola Castaño, Juncal

    2005-01-01

    Little is known today about the characteristics of individuals diagnosed with fibromyalgia, their degree of disability and the health system response system response to this condition. The objectives of this work include: to establish the sociodemographic, clinical and psychosocial profile of male and female patients with fibromyalgia. To describe the response they receive from the health service, and to study the repercussions of this syndrome on the daily activities of subjects who suffer it, including its effects on their work environment. Descriptive cross-sectional study. The information was received from telephone interviews of individuals diagnosed with fibromyalgia in the Hospital Universitario Virgen de las Nieves in Granada during 2003. 92.1% of those interviewed were women. Fibromyalgia caused work absenteeism in 31.4% of cases; and 64% regarded their health as poor or very poor. Fibromyalgia was associated with other diseases in 52.3% of cases. The family doctor is the specialist consulted before diagnosis in 92.1% of cases. A total of 50.5% had a history of psychiatric disorders, these were still present at the time of interview in 36.4%. Around 71% of the sample received family support, and 70.1% of cases considered the disease to seriously affect their environment. Fibromyalgia was mainly diagnosed in women. Subjects with this syndrome have a poor perception of their own health and work situation, and it negatively affects their family environment.

  4. Facing death, gazing inward: end-of-life and the transformation of clinical subjectivity in Thailand.

    Science.gov (United States)

    Stonington, Scott

    2011-06-01

    In this article, I describe a new form of clinical subjectivity in Thailand, emerging out of public debate over medical care at the end of life. Following the controversial high-tech death of the famous Buddhist monk Buddhadasa, many began to denounce modern death as falling prey to social ills in Thai society, such as consumerism, technology-worship, and the desire to escape the realities of existence. As a result, governmental and non-governmental organizations have begun to focus on the end-of-life as a locus for transforming Thai society. Moving beyond the classic outward focus of the medical gaze, they have begun teaching clinicians and patients to gaze inward instead, to use the suffering inherent in medicine and illness to face the nature of existence and attain inner wisdom. In this article, I describe the emergence of this new gaze and its major conceptual components, including a novel idea of what it means to be 'human,' as well as a series of technologies used to craft this humanity: confession, "facing suffering," and untying "knots" in the heart. I also describe how this new subjectivity has begun to change the long-stable Buddhist concept of death as taking place at a moment in time, giving way for a new concept of "end-of-life," an elongated interval to be experienced, studied, and used for inner wisdom.

  5. Liver Afferents Contribute to Water Drinking-Induced Sympathetic Activation in Human Subjects: A Clinical Trial

    Science.gov (United States)

    May, Marcus; Gueler, Faikah; Barg-Hock, Hannelore; Heiringhoff, Karl-Heinz; Engeli, Stefan; Heusser, Karsten; Diedrich, André; Brandt, André; Strassburg, Christian P.; Tank, Jens; Sweep, Fred C. G. J.; Jordan, Jens

    2011-01-01

    Water drinking acutely increases sympathetic activity in human subjects. In animals, the response appears to be mediated through transient receptor potential channel TRPV4 activation on osmosensitive hepatic spinal afferents, described as osmopressor response. We hypothesized that hepatic denervation attenuates water drinking-induced sympathetic activation. We studied 20 liver transplant recipients (44±2.6 years, 1.2±0.1 years post transplant) as model of hepatic denervation and 20 kidney transplant recipients (43±2.6 years, 0.8±0.1 years post transplant) as immunosuppressive drug matched control group. Before and after 500 ml water ingestion, we obtained venous blood samples for catecholamine analysis. We also monitored brachial and finger blood pressure, ECG, and thoracic bioimpedance. Plasma norepinephrine concentration had changed by 0.01±0.07 nmol/l in liver and by 0.21±0.07 nmol/l in kidney transplant recipients (pwater drinking. While blood pressure and systemic vascular resistance increased in both groups, the responses tended to be attenuated in liver transplant recipients. Our findings support the idea that osmosensitive hepatic afferents are involved in water drinking-induced sympathetic activation in human subjects. Trial Registration ClinicalTrials.gov NCT01237431 PMID:22016786

  6. Liver afferents contribute to water drinking-induced sympathetic activation in human subjects: a clinical trial.

    Directory of Open Access Journals (Sweden)

    Marcus May

    Full Text Available Water drinking acutely increases sympathetic activity in human subjects. In animals, the response appears to be mediated through transient receptor potential channel TRPV4 activation on osmosensitive hepatic spinal afferents, described as osmopressor response. We hypothesized that hepatic denervation attenuates water drinking-induced sympathetic activation. We studied 20 liver transplant recipients (44±2.6 years, 1.2±0.1 years post transplant as model of hepatic denervation and 20 kidney transplant recipients (43±2.6 years, 0.8±0.1 years post transplant as immunosuppressive drug matched control group. Before and after 500 ml water ingestion, we obtained venous blood samples for catecholamine analysis. We also monitored brachial and finger blood pressure, ECG, and thoracic bioimpedance. Plasma norepinephrine concentration had changed by 0.01±0.07 nmol/l in liver and by 0.21±0.07 nmol/l in kidney transplant recipients (p<0.05 between groups after 30-40 minutes of water drinking. While blood pressure and systemic vascular resistance increased in both groups, the responses tended to be attenuated in liver transplant recipients. Our findings support the idea that osmosensitive hepatic afferents are involved in water drinking-induced sympathetic activation in human subjects.ClinicalTrials.gov NCT01237431.

  7. A case that underwent bilateral video-assisted thoracoscopic ...

    African Journals Online (AJOL)

    A case that underwent bilateral video-assisted thoracoscopic surgical (VATS) biopsy combined with pneumonectomy is presented. The patient developed hypoxia during the contralateral VATS biopsy. His hypoxia was treated with positive expiratory pressure (PEEP) to the dependent lung and apneic oxygen insufflation to ...

  8. Single-subject designs as a tool for evidence-based clinical practice: Are they unrecognised and undervalued?

    Science.gov (United States)

    Perdices, Michael; Tate, Robyn L

    2009-12-01

    One could be forgiven for thinking that the only road to evidence-based clinical practice is the application of results from randomised controlled trials (or systematic reviews of such). By contrast, single-subject designs in the context of evidence-based clinical practice are believed by many to be strange bedfellows. In this paper, we argue that single-subject designs play an important role in evidence-based clinical practice. We survey the contents of Neuropsychological Rehabilitation in relation to single-subject designs and tackle the main criticisms that have been levelled against them. We offer practical guidance for rating the methodological quality of single-subject designs and applying statistical techniques to measure treatment efficacy. These guides are equally applicable to research studies and everyday clinical practice with individual patients.

  9. Do Subjective Measures Improve the Ability to Identify Limited Health Literacy in a Clinical Setting?

    Science.gov (United States)

    Goodman, Melody S; Griffey, Richard T; Carpenter, Christopher R; Blanchard, Melvin; Kaphingst, Kimberly A

    2015-01-01

    Existing health literacy assessments developed for research purposes have constraints that limit their utility for clinical practice, including time requirements and administration protocols. The Brief Health Literacy Screen (BHLS) consists of 3 self-administered Single-Item Literacy Screener (SILS) questions and obviates these clinical barriers. We assessed whether the addition of SILS items or the BHLS to patient demographics readily available in ambulatory clinical settings reaching underserved patients improves the ability to identify limited health literacy. We analyzed data from 2 cross-sectional convenience samples of patients from an urban academic emergency department (n = 425) and a primary care clinic (n = 486) in St. Louis, Missouri. Across samples, health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R), Newest Vital Sign (NVS), and the BHLS. Our analytic sample consisted of 911 adult patients, who were primarily female (62%), black (66%), and had at least a high school education (82%); 456 were randomly assigned to the estimation sample and 455 to the validation sample. The analysis showed that the best REALM-R estimation model contained age, sex, education, race, and 1 SILS item (difficulty understanding written information). In validation analysis this model had a sensitivity of 62%, specificity of 81%, a positive likelihood ratio (LR(+)) of 3.26, and a negative likelihood ratio (LR(-)) of 0.47; there was a 28% misclassification rate. The best NVS estimation model contained the BHLS, age, sex, education and race; this model had a sensitivity of 77%, specificity of 72%, LR(+) of 2.75, LR(-) of 0.32, and a misclassification rate of 25%. Findings suggest that the BHLS and SILS items improve the ability to identify patients with limited health literacy compared with demographic predictors alone. However, despite being easier to administer in clinical settings, subjective estimates of health literacy have

  10. USE OF BACTERIAL LYSATES IN SUBJECTIVE IMPROVEMENT OF CLINICAL RESPONSE IN ALLERGIC RHINITIS PATIENTS

    Directory of Open Access Journals (Sweden)

    Vineel Muppidi

    2017-06-01

    Full Text Available BACKGROUND Allergic rhinitis is known to be one of the most common chronic diseases in the world. In this study, we provide an overview of allergic rhinitis responding to immunostimulating agents. According to the concept that allergic rhinitis patients generally suffer from an immune deficit in order to stimulate their immune system specifically or nonspecifically, immunomodulating agents from various sources such as synthetic compounds, tissue extracts or a mixture of bacterial extracts have been used. MATERIALS AND METHODS The aim of the present trial is to evaluate the efficacy of the treatment with an immunostimulating agent consisting of a freeze dried bacterial lysates (Ismigen and analyse the improvement in clinical response in allergic rhinitis patients. 50 allergic rhinitis patients were enrolled. For all patients, after 3 months of PMBL (polyvalent mechanical bacterial lysates treatment clinical response was analysed. RESULTS A clinical improvement in subjective symptoms was observed in 43 of the 50 patients treated with bacterial lysates (85.6%. The results are as follows- 45 patients (91.8%, we noticed a decrease in symptoms of nasal blockage and 38 patients (90.4% were relieved from rhinorrhea; purulent nasal discharge was reduced in 13 cases (81.5%, 30 patients (90.9% had a large improvement in nasal/palate itching and 15 patients (75% with headache were relieved. CONCLUSION From this study, bacterial lysates have shown to have a protective effect, which induces a significant reduction of the symptoms and duration related to allergic rhinitis. No negative side effects or worsening of the symptoms have been observed with this medication.

  11. Clinical Yield of Familial Screening After Sudden Death in Young Subjects: The French Experience.

    Science.gov (United States)

    Quenin, Pauline; Kyndt, Florence; Mabo, Philippe; Mansourati, Jacques; Babuty, Dominique; Thollet, Aurélie; Guyomarch, Béatrice; Redon, Richard; Barc, Julien; Schott, Jean-Jacques; Sacher, Frederic; Probst, Vincent; Gourraud, Jean Baptiste

    2017-09-01

    After sudden cardiac death with negative autopsy, clinical screening of relatives identifies a high proportion of inherited arrhythmia syndrome. However, the efficacy of this screening in families not selected by autopsy has never been assessed. We aim to investigate the value of clinical screening in relatives of all subjects who died suddenly before 45 years of age. One hundred and three consecutive families who experienced unexplained sudden cardiac death before 45 years of age were included from May 2009 to December 2014 in a prospective multicenter registry. Clinical screening was provided to all relatives and performed in 64 families (230 relatives, 80 unexplained sudden cardiac death). Diagnosis was established in 16 families (25%), including Brugada syndrome (7), long QT syndromes (5), dilated cardiomyopathy (2), and hypertrophic cardiomyopathy (2). The diagnostic yield was mainly dependent on the number of screened relatives (3.8±3.4 screened relatives in diagnosed families versus 2.0±1.5; P<0.005) rising to 47% with at least 3 relatives. It additionally increased from 3 of 32 (9%) to 9 of 22 (41%) when both parents were screened (P=0.01). Diagnostic performance was also dependent on the exhaustiveness of screening (70% of complete screening in the diagnosed families versus 25%; P<0.0001) with 17 Brugada syndromes and 15 long QT syndromes diagnosed based on pharmacological tests. Even without autopsy, familial screening after sudden death in young patients is effective. Broad screening of relatives and systematic tests, including pharmacological challenges, greatly increases the likelihood of diagnosis in families. © 2017 American Heart Association, Inc.

  12. Increasing subject compliance in pivotal phase III clinical trials of dolutegravir (DTG, S/GSK1349572 in HIV-infected, ART-naïve subjects

    Directory of Open Access Journals (Sweden)

    J Harris

    2012-11-01

    Full Text Available To maximise the application of results of large-scale clinical trials, recruitment and retention of a diverse subject population is key. With commonly used algorithms (Snapshot, TLOVR, missing = failure, all withdrawals in HIV studies, regardless of reason, are classed as failures in efficacy analyses. Good subject compliance therefore improves statistical power and the quality of trial results. In four recent GSK/ViiV-sponsored phase IIIB/IV HIV ART-naïve studies (HEAT, KLEAN, APV109141 and ARIES, 24% of subjects withdrew and approximately 2/3 of these withdrawals (16% potentially were avoidable (i.e. not treatment related [1]. To increase subject compliance in the phase III, treatment-naïve studies of DTG (ING113086 “SPRING-2” and ING114467 “SINGLE”, a more robust subject compliance program focussing on understanding subject needs and building sponsor-site and site-subject relationships was implemented. The compliance program included opt-in study visit reminders, late study visit tracking, subject compliance support materials, subject transportation support, on-going site training, relationship management and presentations on prior withdrawal rates and associated risk factors for attrition at investigator meetings. Week 48 withdrawals, both overall and for potentially avoidable reasons, were considerably lower in SPRING-2 and SINGLE than historical HIV trials. Comparison of withdrawal rates prior to, and after implementation of robust patient compliance program. Addressing individual study subject needs with a customized approach in SPRING-2 and SINGLE contributed to considerably lower percentages of withdrawals than in historical HIV studies. Identifying the specific impact of a single subject compliance initiative is difficult as study compliance can be influenced by overall study design, investigational product tolerability profile, current standard of care and treatment access for the disease under study. However, consistently

  13. SPARED RECOGNITION CAPACITY IN ELDERLY AND CLOSED-HEAD-INJURY SUBJECTS WITH CLINICAL MEMORY DEFICITS

    NARCIS (Netherlands)

    Spikman, J.M.; Berg, I.J.; Deelman, B.G.

    This study describes the performance of three groups of subjects on a pictorial forced-recognition task, the Hundred Pictures Test. The aim was to determine whether subjects with memory deficits (elderly and closed-head-injured subjects) would perform as well as healthy young subjects, both on

  14. A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis.

    Science.gov (United States)

    Adam, P; Stiffman, M; Blake, R L

    1998-01-01

    To determine whether hypertonic saline nasal spray relieves nasal symptoms and shortens illness duration in patients with the common cold or acute rhinosinusitis. Randomized trial with 2 control groups. Two family practice clinics. One hundred forty-three adult patients with a cold or sinus infection. Patients with allergic rhinitis, symptoms for more than 3 weeks, or other respiratory diagnoses were excluded, as were those who had used topical decongestants. Hypertonic saline or normal saline spray 3 times a day or observation. Subjects completed a 7-day symptom checklist that included a well-being question ("Do you feel back to normal?"). Nasal symptom score (sum of scores for nasal congestion, rhinorrhea, and headache) on day 3 and day of well-being (day of symptom resolution). Data were collected for 119 subjects. No difference was found in either primary outcome when hypertonic saline was compared with either normal saline or observation. Mean day of well-being was 8.3 (95% confidence interval [CI], 6.9-9.7), 9.2 (95% CI, 6.9-11.43), and 8.0 (95% CI, 6.7-9.3) days in the hypertonic saline, normal saline, and observation groups, respectively. Day 3 mean nasal symptom score was 3.8 (95% CI, 3.0-4.5) for hypertonic saline, 3.7 (95% CI, 2.9-4.5) for normal saline, and 4.1 (95% CI, 3.5-4.7) for observation. Only 44% of the patients would use the hypertonic saline spray again. Thirty-two percent noted burning, compared with 13% of the normal saline group (P = .05). Hypertonic saline does not improve nasal symptoms or illness duration in patients with the common cold or rhinosinusitis.

  15. Frequency and spectrum of mitochondrial 12S rRNA variants in 440 Han Chinese hearing impaired pediatric subjects from two otology clinics

    Directory of Open Access Journals (Sweden)

    Zhou Jianjin

    2011-01-01

    Full Text Available Abstract Background Aminoglycoside ototoxicity is one of the common health problems. Mitochondrial 12S rRNA mutations are one of the important causes of aminoglycoside ototoxicity. However, the incidences of 12S rRNA mutations associated with aminoglycoside ototoxicity are less known. Methods A total of 440 Chinese pediatric hearing-impaired subjects were recruited from two otology clinics in the Ningbo and Wenzhou cities of Zhejiang Province, China. These subjects underwent clinical, genetic evaluation and molecular analysis of mitochondrial 12S rRNA. Resultant mtDNA variants were evaluated by structural and phylogenetic analysis. Results The study samples consisted of 227 males and 213 females. The age of all participants ranged from 1 years old to 18 years, with the median age of 9 years. Ninety-eight subjects (58 males and 40 females had a history of exposure to aminoglycosides, accounting for 22.3% cases of hearing loss in this cohort. Molecular analysis of 12S rRNA gene identified 41 (39 known and 2 novel variants. The incidences of the known deafness-associated 1555A > G, 1494C > T and 1095T > C mutations were 7.5%, 0.45% and 0.91% in this entire hearing-impaired subjects, respectively, and 21.4%, 2% and 2% among 98 subjects with aminoglycoside ototoxicity, respectively. The structural and phylogenetic evaluations showed that a novel 747A > G variant and known 839A > G, 1027A > G, 1310C > T and 1413T > C variants conferred increased sensitivity to aminoglycosides or nonsyndromic deafness as they were absent in 449 Chinese controls and localized at highly conserved nucleotides of this rRNA. However, other variants were polymorphisms. Of 44 subjects carrying one of definite or putative deafness-related 12S rRNA variants, only one subject carrying the 1413T > C variant harbored the 235DelC/299DelAT mutations in the GJB2 gene, while none of mutations in GJB2 gene was detected in other 43 subjects. Conclusions Mutations in mitochondrial 12S r

  16. [The effect of acupuncture in the treatment of insomnia. Clinical study of subjective and objective evaluation].

    Science.gov (United States)

    Montakab, H; Langel, G

    1994-01-01

    The sleep-wake cycle is the most important circadian rhythm in man and thus constitutes an excellent indicator of internal equilibrium and of health. Sleep disorders, and particularly insomnia, affect a great percentage of the population. In daily practice, an inappropriate treatment may transform a bad sleeper into an insomniac dependent on pharmaceuticals for life. It is therefore necessary to give priority to non-chemical treatments in the management of insomnia. Acupuncture, which offers a personalized treatment, is particularly indicated for reharmonizing a disturbed sleep-wake cycle. Furthermore, there is an interesting similarity between the 5000-year-old theoretical basis of Chinese medicine and the recent scientific discoveries about man's internal rhythms. Clinical and statistical studies of the effects of acupuncture on insomnia are rare and evaluate only the subjective appreciation of sleep. Objective analysis of sleep by polysomnography permits evaluation of sleep architecture and visualizes the site and depth of action of the therapeutic method. Such studies have only been conducted in relation to pharmaceutical treatments. No such study has been carried out for acupuncture. A scientific and objective evaluation of the effects of acupuncture on insomnia by polysomnography could be not only of academic but mainly of great practical interest. If the efficiency of acupuncture is thus verified, this method could be integrated and proposed along with other classical therapeutic technics.

  17. Temperature measurement and control system for transtibial prostheses: Single subject clinical evaluation.

    Science.gov (United States)

    Ghoseiri, Kamiar; Zheng, Yong Ping; Leung, Aaron K L; Rahgozar, Mehdi; Aminian, Gholamreza; Masoumi, Mehdi; Safari, Mohammad Reza

    2017-01-05

    The snug fit of a prosthetic socket over the residual limb can disturb thermal balance and put skin integrity in jeopardy by providing an unpleasant and infectious environment. The prototype of a temperature measurement and control (TM&C) system was previously introduced to resolve thermal problems related to prostheses. This study evaluates its clinical application in a setting with reversal, single subject design. The TM&C system was installed on a fabricated prosthetic socket of a man with unilateral transtibial amputation. Skin temperature of the residual limb without prosthesis at baseline and with prosthesis during rest and walking was evaluated. The thermal sense and thermal comfort of the participant were also evaluated. The results showed different skin temperature around the residual limb with a temperature decrease tendency from proximal to distal. The TM&C system decreased skin temperature rise after prosthesis wearing. The same situation occurred during walking, but the thermal power of the TM&C system was insufficient to overcome heat build-up in some regions of the residual limb. The participant reported no significant change of thermal sense and thermal comfort. Further investigations are warranted to examine thermography pattern of the residual limb, thermal sense, and thermal comfort in people with amputation.

  18. Clinical Validation of a Sound Processor Upgrade in Direct Acoustic Cochlear Implant Subjects.

    Science.gov (United States)

    Kludt, Eugen; D'hondt, Christiane; Lenarz, Thomas; Maier, Hannes

    2017-06-01

    The objectives of the investigation were to evaluate the effect of a sound processor upgrade on the speech reception threshold in noise and to collect long-term safety and efficacy data after 2½ to 5 years of device use of direct acoustic cochlear implant (DACI) recipients. The study was designed as a mono-centric, prospective clinical trial. Tertiary referral center. Fifteen patients implanted with a direct acoustic cochlear implant. Upgrade with a newer generation of sound processor. Speech recognition test in quiet and in noise, pure tone thresholds, subject-reported outcome measures. The speech recognition in quiet and in noise is superior after the sound processor upgrade and stable after long-term use of the direct acoustic cochlear implant. The bone conduction thresholds did not decrease significantly after long-term high level stimulation. The new sound processor for the DACI system provides significant benefits for DACI users for speech recognition in both quiet and noise. Especially the noise program with the use of directional microphones (Zoom) allows DACI patients to have much less difficulty when having conversations in noisy environments. Furthermore, the study confirms that the benefits of the sound processor upgrade are available to the DACI recipients even after several years of experience with a legacy sound processor. Finally, our study demonstrates that the DACI system is a safe and effective long-term therapy.

  19. Neural representation and clinically relevant moderators of individualised self-criticism in healthy subjects

    Science.gov (United States)

    Schlumpf, Yolanda; Spinelli, Simona; Späti, Jakub; Brakowski, Janis; Quednow, Boris B.; Seifritz, Erich; Grosse Holtforth, Martin

    2014-01-01

    Many people routinely criticise themselves. While self-criticism is largely unproblematic for most individuals, depressed patients exhibit excessive self-critical thinking, which leads to strong negative affects. We used functional magnetic resonance imaging in healthy subjects (N = 20) to investigate neural correlates and possible psychological moderators of self-critical processing. Stimuli consisted of individually selected adjectives of personally negative content and were contrasted with neutral and negative non-self-referential adjectives. We found that confrontation with self-critical material yielded neural activity in regions involved in emotions (anterior insula/hippocampus–amygdala formation) and in anterior and posterior cortical midline structures, which are associated with self-referential and autobiographical memory processing. Furthermore, contrasts revealed an extended network of bilateral frontal brain areas. We suggest that the co-activation of superior and inferior lateral frontal brain regions reflects the recruitment of a frontal top–down pathway, representing cognitive reappraisal strategies for dealing with evoked negative affects. In addition, activation of right superior frontal areas was positively associated with neuroticism and negatively associated with cognitive reappraisal. Although these findings may not be specific to negative stimuli, they support a role for clinically relevant personality traits in successful regulation of emotion during confrontation with self-critical material. PMID:23887820

  20. [Clinical approach to work-related subjective processes: The perspective of psychodinamic of work].

    Science.gov (United States)

    Wlosko, Miriam

    2015-01-01

    Under what conditions the work activity may be structuring health and in which ones can become a source of disease and suffering? How explain the current situation of deterioration and increased mental pathology in relation to work? The job must be conceived as a trigger among others, or could play a specific role in the etiology of various psychological and psychosomatic pictures? This article addresses these questions from the perspective of Psychodynamic of work. Based on the theory of living labor developed by C. Dejours, the article analyzes the dynamic pleasure-suffering in relation to work and the role of defensive mechanisms in those dynamics. In turn, it characterized the current epidemiological situation, describing the prevalent pathologies related to mental health and work. Finally, the article exposes the thesis of Psychodynamic of work regarding the increase and aggravation of these pathologies. The article aims to present the main axes of Psychodynamics of Work, which is a theory and clinical practice whose object is the psychodynamic analysis of subjective and intersubjective processes mobilized by work situations.

  1. The perceptual preferences in learning among dental students in clinical subjects.

    Science.gov (United States)

    Shenoy, Nandita; Shenoy K, Ashok; U P, Ratnakar

    2013-08-01

    the subjects had a higher preference for multimodal learning. With our preliminary data, we conclude that the students in our clinical set up preferred a multimodal and a more of kinesthetic method of learning. To meet their needs, variations in the teaching, learning and the examination must be implemented. If not, the students with a high kinesthetic preference for perception and learning may be at the losing end.

  2. Subjective experience and dopamine D2 receptor occupancy in patients treated with antipsychotics: clinical implications

    NARCIS (Netherlands)

    de Haan, Lieuwe; Lavalaye, Jules; van Bruggen, Marion; van Nimwegen, Lonneke; Booij, Jan; van Amelsvoort, Therese; Linszen, Don

    2004-01-01

    OBJECTIVES: This paper gives an overview of studies on the association between dopaminergic neurotransmission and the subjective experience of patients with schizophrenia. METHODS: We undertook a review of the literature. RESULTS: Dopaminergic neurotransmission may be relevant for subjective

  3. Across-subject calibration of an instrumented glove to measure hand movement for clinical purposes.

    Science.gov (United States)

    Gracia-Ibáñez, Verónica; Vergara, Margarita; Buffi, James H; Murray, Wendy M; Sancho-Bru, Joaquín L

    2017-05-01

    Motion capture of all degrees of freedom of the hand collected during performance of daily living activities remains challenging. Instrumented gloves are an attractive option because of their higher ease of use. However, subject-specific calibration of gloves is lengthy and has limitations for individuals with disabilities. Here, a calibration procedure is presented, consisting in the recording of just a simple hand position so as to allow capture of the kinematics of 16 hand joints during daily life activities even in case of severe injured hands. 'across-subject gains' were obtained by averaging the gains obtained from a detailed subject-specific calibration involving 44 registrations that was repeated three times on multiple days to 6 subjects. In additional 4 subjects, joint angles that resulted from applying the 'across-subject calibration' or the subject-specific calibration were compared. Global errors associated with the 'across-subject calibration' relative to the detailed, subject-specific protocol were small (bias: 0.49°; precision: 4.45°) and comparable to those that resulted from repeating the detailed protocol with the same subject on multiple days (0.36°; 3.50°). Furthermore, in one subject, performance of the 'across-subject calibration' was directly compared to another fast calibration method, expressed relative to a videogrammetric protocol as a gold-standard, yielding better results.

  4. Effects of High-Dose Capsaicin on TMD Subjects: A Randomized Clinical Study.

    Science.gov (United States)

    Campbell, B K; Fillingim, R B; Lee, S; Brao, R; Price, D D; Neubert, J K

    2017-01-01

    Temporomandibular joint disorder (TMD) is a complex musculoskeletal disorder that presents with pain, limited jaw opening, and abnormal noises in the temporomandibular joint. Despite the significant impact that TMD has in terms of suffering and financial burden, relatively few new treatments have emerged; therefore, development of novel treatments to treat TMD pain remains a high priority. The rationale of this study was to use a double-blind, vehicle-controlled clinical trial to evaluate the effects of a high-concentration (8%) capsaicin cream on TMD. This is based on the hypothesis that targeting TRP vanilloid subfamily member 1 (TRPV1) for pain control may provide a novel method for pain relief in TMD patients. TRPV1 is primarily expressed on a population of nociceptive-specific neurons and provides a candidate target for the development of pain treatments. Capsaicin is the primary agonist for TRPV1 and has been used previously in relatively low doses (0.025% to 0.075%) as a therapeutic for a variety of pain disorders, including postherpetic neuralgia and osteoarthritis; however, analgesic efficacy remains equivocal. TMD and healthy control subjects were assigned to either an active capsaicin or vehicle control group. The treatments were applied for 2 h and then removed. Quantitative sensory testing (QST) was completed prior to drug application (baseline), 2 h after drug application, and 1 wk later. Perceived pain intensity was measured using a visual analog scale (VAS) following capsaicin or vehicle cream application. Significantly lower pain was reported in the week after application in the capsaicin-treated TMD subjects. For QST measures, there was a decreased thermal pain threshold 2 h after capsaicin application for both the control and TMD groups, but this resolved within a week. Capsaicin had no effect on pressure pain threshold or mechanical sensitivity in both TMD and healthy individuals. This study demonstrates that 8% topical capsaicin therapy is a

  5. Stress response of a clinical Enterococcus faecalis isolate subjected to a novel antimicrobial surface coating.

    Science.gov (United States)

    Clauss-Lendzian, Emanuel; Vaishampayan, Ankita; de Jong, Anne; Landau, Uwe; Meyer, Carsten; Kok, Jan; Grohmann, Elisabeth

    2018-03-01

    Emerging antibiotic resistance among pathogenic bacteria, paired with their ability to form biofilms on medical and technical devices, represents a serious problem for effective and long-term decontamination in health-care environments and gives rise to an urgent need for new antimicrobial materials. Here we present the impact of AGXX ® , a novel broad-spectrum antimicrobial surface coating consisting of micro-galvanic elements formed by silver and ruthenium, on the transcriptome of Enterococcus faecalis. A clinical E. faecalis isolate was subjected to metal stress by growing it for different periods in presence of the antimicrobial coating or silver-coated steel meshes. Subsequently, total RNA was isolated and next-generation RNA sequencing was performed to analyze variations in gene expression in presence of the antimicrobial materials with focus on known stress genes. Exposure to the antimicrobial coating had a large impact on the transcriptome of E. faecalis. After 24min almost 1/5 of the E. faecalis genome displayed differential expression. At each time-point the cop operon was strongly up-regulated, providing indirect evidence for the presence of free Ag + -ions. Moreover, exposure to the antimicrobial coating induced a broad general stress response in E. faecalis. Genes coding for the chaperones GroEL and GroES and the Clp proteases, ClpE and ClpB, were among the top up-regulated heat shock genes. Differential expression of thioredoxin, superoxide dismutase and glutathione synthetase genes indicates a high level of oxidative stress. We postulate a mechanism of action where the combination of Ag + -ions and reactive oxygen species generated by AGXX ® results in a synergistic antimicrobial effect, superior to that of conventional silver coatings. Copyright © 2017 Elsevier GmbH. All rights reserved.

  6. The low-dose dexamethasone suppression test in patients with adrenal incidentalomas: comparisons with clinically euadrenal subjects and patients with Cushing's syndrome.

    Science.gov (United States)

    Tsagarakis, S; Kokkoris, P; Roboti, C; Malagari, C; Kaskarelis, J; Vlassopoulou, V; Alevizaki, C; Thalassinos, N

    1998-05-01

    Increasing evidence favours subtle glucocorticoid excess in many patients with adrenal incidentalomas. However, existing evidence is based mainly on the overnight dexamethasone suppression test, a test that is commonly abnormal even among clinically euadrenal subjects. The aim of the present study was to evaluate patients with adrenal incidentalomas for subtle glucocorticoid excess by the more specific low-dose dexamethasone test (LDDST). Moreover, since the criteria of what constitutes an abnormal cortisol response following this test have been largely anecdotal, we report our results in comparison with those obtained in clinically euadrenal subjects, and patients with Cushing's syndrome. A prospective study of 57 patients with adrenal incidentalomas with CT characteristics highly suggestive of benign adrenocortical adenomas and 85 clinically euadrenal subjects consisting of 54 obese women with BMI > 30 kg/m2 (range 30-54.7), 13 women with BMI < 30 kg/m2 (range 20.3-29.6) and 18 healthy volunteers (10 women and eight men) over 40 years of age (mean age 51.7 +/- 9.9, range 40-74; mean BMI 30 +/- 6.6, range 20.3-47.5 kg/m2). A retrospective analysis was performed on 60 patients with a confirmed diagnosis of Cushing's syndrome. All subjects were admitted to the endocrine ward and underwent a standard LDDST, as follows: after a 48-h stabilization period, a 24-h urine collection for basal urinary free cortisol was performed. Basal serum cortisol and plasma ACTH were measured at 0800 h the following day, and subjects were started on dexamethasone 0.5 mg 6-hourly for 2 days. Post-dexamethasone cortisol and ACTH levels were measured at 0800 h, 6 h after the last dose of dexamethasone. Following dexamethasone suppression serum cortisol concentrations became undetectable (< 28 nmol/l) in all clinically euadrenal subjects. In patients with incidentally discovered adrenal masses, post-LDDST cortisol concentrations were undetectable in 12 (21%), between 28-140 nmol/l in 38 (67

  7. Hepatic iron in African Americans who underwent liver biopsy.

    Science.gov (United States)

    Barton, James C; Bertoli, Luigi F; Alford, Thomas J; Barton, J Clayborn; Edwards, Corwin Q

    2015-01-01

    Primary iron overload in African Americans has been reported predominantly from autopsy studies. We characterized hepatic iron phenotypes in 83 African Americans who underwent liver biopsy during the interval 1990 to 1995. We tabulated pathology report form data, iron grades in hepatocytes (0-4) and Kupffer cells (0-3) and abnormal liver histology. Increased iron was defined as hepatocyte or Kupffer iron grades ≥ 2, respectively. Heavy iron was defined as hepatocyte iron grade 3 or 4. Primary iron overload was defined as the presence of grade 3 or 4 hepatocellular iron in the absence of evidence of chronic alcohol effect, viral hepatitis, steatosis, unexplained inflammation, chronic erythrocyte transfusion or chronic ingestion of iron supplements. There were 37 men and 46 women (mean age: 53 ± 15 [SD] years). We observed heavy ethanol consumption, 12.0%; viral hepatitis, 26.5%; steatosis without heavy ethanol consumption, 43.4%; inflammation, 45.6%; fibrosis, 26.2% and bridging fibrosis/cirrhosis, 29.4%. Logistic regression on bridging fibrosis/cirrhosis revealed positive associations with heavy ethanol consumption (P = 0.0410) and viral hepatitis (P = 0.0044). The 22 patients (26.5%) with increased iron had greater mean age, proportion of men and heavy ethanol consumption. Five patients had heavy iron staining, among whom were 3 women (mean age: 54 years) with primary iron overload. Two of the 3 women had cirrhosis and diabetes mellitus. Among 83 adult African Americans who underwent liver biopsy, 3.6% had hepatic iron phenotypes consistent with primary iron overload.

  8. ALGORITHM FOR MANAGEMENT OF HYPERTENSIVE PATIENTS UNDERWENT UROLOGY INTERVENTIONS

    Directory of Open Access Journals (Sweden)

    S. S. Davydova

    2015-09-01

    Full Text Available Aim. To study the efficacy of cardiovascular non-invasive complex assessment and pre-operative preparation in hypertensive patients needed in surgical treatment of urology dis- eases.Material and methods. Males (n=883, aged 40 to 80 years were included into the study. The main group consisted of patients that underwent laparotomic nephrectomy (LTN group; n=96 and patients who underwent laparoscopic nephrectomy (LSN group; n=53. Dynamics of ambulatory blood pressure monitoring (ABPM data was analyzed in these groups in the immediate postoperative period. The efficacy of a package of non-invasive methods for cardiovascular system assessment was studied. ABPM was performed after nephrectomy (2-nd and 10-th days after surgery in patients with complaints of vertigo episodes or intense general weakness to correct treatment.Results. In LTN group hypotension episodes or blood pressure (BP elevations were observed in 20 (20.8% and 22 (22.9% patients, respectively, on the 2-nd day after the operation. These complications required antihypertensive treatment correction. Patients with hypotension episodes were significantly older than patients with BP elevation and had significantly lower levels of 24-hour systolic BP, night diastolic BP and minimal night systolic BP. Re-adjustment of antihypertensive treatment on the 10-th postoperative day was required to 2 (10% patients with hypotension episodes and to 1 (4.5% patient with BP elevation. Correction of antihypertensive therapy was required to all patients in LSN group on the day 2, and to 32 (60.4% patients on the 10-th day after the operation. Reduction in the incidence of complications (from 1.2% in 2009 to 0.3% in 2011, p<0.001 was observed during the application of cardiovascular non-invasive complex assessment and preoperative preparation in hypertensive patients.Conclusion. The elaborated management algorithm for patients with concomitant hypertension is recommended to reduce the cardiovascular

  9. Analysis of 42 patients who underwent tracheal resection

    Directory of Open Access Journals (Sweden)

    Gönül Sağıroğlu

    2010-12-01

    Full Text Available Objectives: We aimed to analyze the etiology, diagnostic and surgical methods, complications and mortality of the patients who underwent tracheal resection for tracheal stenosis.Materials and methods: Between January 2006 and January 2010, 42 patients who underwent tracheal resection and reconstruction was retrospectively analyzed in terms of age, sex, co-morbid disease, etiology of tracheal stenosis, symptoms, the location of stenosis, surgical approach, incision techniques, length of resected segment, types of different suture materials, length of anesthesia and surgery, the ratio of prolonged intubation, morbidities and mortality ratios were analyzed.Results: There were 26 men and 16 female with the mean age was 48 (9-79 years. The etiology was tracheal stenos in 30 patients, tracheal tumor in 10 patients, trauma and congenital tracheal stenos in one each. Symptoms were dispnea, cough, stridor and hemoptysis. Surgical technique was performed through cervical incision (n=36 and cervical incision plus partial sternotomy (n=4 in patients with high tracheal stenosis where the stenosis is lower then complete sternotomy was performed. The mean tracheal segmental resection was 4.1 cm (2-5.2 cm. The morbidities were respiratory insufficiency, secretion retention and atelectasis, pneumonia, sepsis and tracheal re-stenosis. The postoperative mortality was seen in 4 (%9.5 patients.Conclusion: The most important issue leading to complication during tracheal surgery is the ventilation and aspiration towards bronchus. The intense collaboration between surgeon, anesthesiologist and intensive care physician is a necessity in order to reduce complication rates and mortality.

  10. Factors predicting quality of life in a group of Polish subjects with multiple sclerosis: accounting for functional state, socio-demographic and clinical factors.

    Science.gov (United States)

    Papuć, Ewa; Stelmasiak, Zbigniew

    2012-05-01

    Quality of life (QoL) has presently a firmly established position as an important endpoint in medical care. Multiple sclerosis (MS) is a chronic neurological disease with considerable effect on patients' QoL. QoL of MS patients from many European countries has already been assessed but little is known on health-related QoL of Polish subjects with MS. Few studies have taken into consideration multiple predictors of QoL. The aim of this study was to elicit the most relevant factors that determine QoL of Polish group of MS patients. Socio-demographic and clinical factors as well as the influence of disability level were analyzed in this study. 173 MS patients and 86 healthy controls underwent assessment using the Mini Mental Status Examination, WHOQOL-100, Beck Depression Inventory and Fatigue Severity Scale. Data were analyzed by a stepwise linear regression analysis. MS patients had significantly worse global QoL and worse QoL in physical and psychological health domains, lower level of independence, worse social relations and were less satisfied with the surrounding environment they lived in compared with healthy controls (p<0.05). MS subjects had also higher level of depression and fatigue compared to healthy controls (p<0.05). The study determined that the strongest predictors of global QoL of Polish MS patients were depression, disability level and fatigue. Copyright © 2011 Elsevier B.V. All rights reserved.

  11. Effect of respiratory pattern on automated clinical blood pressure measurement: an observational study with normotensive subjects.

    Science.gov (United States)

    Herakova, Natalia; Nwobodo, Nnenna Harmony Nzeribe; Wang, Ying; Chen, Fei; Zheng, Dingchang

    2017-01-01

    It has been reported that deep breathing could reduce blood pressures (BP) in general. It is also known that BP is decreased during inhalation and increased during exhalation. Therefore, the measured BPs could be potentially different during deep breathing with different lengths of inhalation and exhalation. This study aimed to quantitatively investigate the effect of different respiratory patterns on BPs. Forty healthy subjects (20 males and 20 females, aged from 18 to 60 years) were recruited. Systolic and diastolic BPs (SBP and DBP) were measured using a clinically validated automated BP device. There were two repeated measurement sessions for each subject. Within each session, eight BP measurements were performed, including 4 measurements during deep breathing with different respiratory patterns (Pattern 1: 4.5 s vs 4.5 s; Patter 2: 6 s vs 2 s; Pattern 3: 2 s vs 6 s; and Pattern 4: 1.5 s vs 1.5 s, respectively for the durations of inhalation and exhalation) and additional 4 measurements from 1 min after the four different respiratory patterns. At the beginning and end of the two repeated measurement sessions, there were two baseline BP measurements under resting condition. The key experimental results showed that overall automated SBP significantly decreased by 3.7 ± 5.7 mmHg, 3.9 ± 5.2 mmHg, 1.7 ± 5.9 mmHg and 3.3 ± 5.3 mmHg during deep breathing, respectively for Patterns 1, 2, 3 and 4 (all p Pattern 3). Similarly, the automated DBPs during deep breathing in pattern 1, 2 and 4 decreased by 3.7 ± 5.0 mmHg, 3.7 ± 4.9 mmHg and 4.6 ± 3.9 mmHg respectively (all p Pattern 3 with a decrease of 1.0 ± 4.3 mmHg, p = 0.14). Correspondingly, after deep breathing, automated BPs recovered back to normal with no significant difference in comparison with baseline BP (all p > 0.05, except for SBP in Pattern 4). In summary, this study has quantitatively demonstrated that the measured automated BPs decreased

  12. Cerebrospinal fluid A beta 42 is the best predictor of clinical progression in patients with subjective complaints

    NARCIS (Netherlands)

    van Harten, A.C.; Visser, P.J.; Pijnenburg, Y.A.L.; Teunissen, C.E.; Blankenstein, M.A.; Scheltens, P.; van der Flier, W.M.

    2013-01-01

    Background: The need to recognize Alzheimer's disease (AD) as early as possible led us to evaluate the predictive value of amyloid β(1-42) (Aβ42), total tau (tau), and phosphorylated tau (ptau) in cerebrospinal fluid (CSF) for clinical progression in patients with subjective complaints. Methods: We

  13. Liver afferents contribute to water drinking-induced sympathetic activation in human subjects: a clinical trial

    NARCIS (Netherlands)

    May, M.; Gueler, F.; Barg-Hock, H.; Heiringhoff, K.H.; Engeli, S.; Heusser, K.; Diedrich, A.; Brandt, A.; Strassburg, C.P.; Tank, J.; Sweep, F.C.; Jordan, J.

    2011-01-01

    Water drinking acutely increases sympathetic activity in human subjects. In animals, the response appears to be mediated through transient receptor potential channel TRPV4 activation on osmosensitive hepatic spinal afferents, described as osmopressor response. We hypothesized that hepatic

  14. Frequency of Helicobacter pylori in patients underwent endoscopy

    Directory of Open Access Journals (Sweden)

    Ahmet Tay

    2012-06-01

    Full Text Available Objectives: The aim of this study was to investigate thefrequency of Helicobacter pylori in patients underwent endoscopyeastern Anatolia.Materials and methods: The patients whose endoscopicantral biopsies were taken for any reason in our endoscopyunit in February-June 2010 period were includedand retrospectively investigated. The frequency of Helicobacterpylori was determined as separating the patientsaccording to general, sex and the age groups. Antral biopsieswere stained with hematoxylin-eosin and modified giemsamethod and examined under light microscope andreported as (+ mild, (++ moderate, (+++ severe positiveaccording to their intensities.Results: Biopsy specimens of 1298 patients were includedinto the study. The mean age was 47.5 ± 17.5 years(range 14-88 and 607 of these patients (47% were male.Histopathological evaluation revealed that, 918 of the patientswere (71% positive and 379 (29% were negativefor Helicobacter pylori. Approximately 60% of our patientshad mild, 29% had moderate and 11% had severe positivityfor Helicobacter pylori. No significant difference wasfound in the frequency of Helicobacter pylori betweenwomen and men. The frequencies of Helicobacter pyloriwere 73.2%, 71.5%, 68.6% and 70.4%, respectively, inthe age groups of 14-30 years, 31-45 years, 46-60 yearsand 61-88 years.Conclusion: The frequency of Helicobacter pylori was71% in Eastern Anatolia Region. No statistically significantdifference was found between genders and agegroups in term of the frequency of Helicobacter pylori.

  15. Subjective cognitive complaints included in diagnostic evaluation of dementia helps accurate diagnosis in a mixed memory clinic cohort

    DEFF Research Database (Denmark)

    Salem, L C; Vogel, Asmus Mejling; Ebstrup, J

    2015-01-01

    functions were assessed with the Mini-mental state examination (MMSE) and Addenbrooke's cognitive examination (ACE), and symptoms of depression were rated with Major Depression Inventory (MDI). All interviews and the diagnostic conclusion were blinded to the SMC score. RESULTS: We found that young patients......OBJECTIVE: Our objective was to examine the quantity and profile of subjective cognitive complaints in young patients as compared with elderly patients referred to a memory clinic. METHODS: Patients were consecutively recruited from the Copenhagen University Hospital Memory Clinic at Rigshospitalet....... In total, 307 patients and 149 age-matched healthy controls were included. Patients were classified in 4 diagnostic groups: dementia, mild cognitive impairment, affective disorders and no cognitive impairment. Subjective memory was assessed with subjective memory complaints (SMC) scale. Global cognitive...

  16. [Clinical analysis of normal subjects and dizzy patients with postural sway test].

    Science.gov (United States)

    Wen, Yan-hua; Jiang, Zi-Dong; Zhang, Yan; Zhang, Lian-Shan; Gao, Zhi-Qiang

    2008-12-01

    To study the characteristics of the normal subjects with postural sway test and discuss the value of postural sway test in the diagnosis of dizzy patients. Totally 112 normal subjects, 72 patients with peripheral vertigo, and 30 patients with central vertigo were examined using a stabilometer (EAB-100, Anima Co., Japan). Items include patterns, length of locus, envelope area, deflection average center displacement, and romberg rate were recorded and compared. The postural sway was classified into the following five patterns: centripetal, forward and backward, right and left, diffuse, and multicentric. Centripetal pattern was the most prominent figure pattern in the normal subjects, while diffuse pattern was the most prominent figure pattern in the patients with central vertigo. When the normal subjects closed their eyes, age was linearly correlated with the length of locus, envelope area, rectangel area, and unit area path length (P < 0.05). Sex was not correlated to all of these parameters. The length of locus and envelope area in the patient groups were significantly increased when compared with the normal subjects (P < 0.0167). Romberg rate was not significantly different between the patients and the normal subjects. The pattern of postural sway is useful for the diagnosis of vertigo. Age is an important factor that affects the balance function. Sex seems has no influence. Visual input plays an important role in maintaining postural balance. Stabilometer is a useful tool for evaluating balance function, and postural sway test may be a valuable assistant examination.

  17. Dynamic transcriptional signatures and network responses for clinical symptoms in influenza-infected human subjects using systems biology approaches.

    Science.gov (United States)

    Linel, Patrice; Wu, Shuang; Deng, Nan; Wu, Hulin

    2014-10-01

    Recent studies demonstrate that human blood transcriptional signatures may be used to support diagnosis and clinical decisions for acute respiratory viral infections such as influenza. In this article, we propose to use a newly developed systems biology approach for time course gene expression data to identify significant dynamically response genes and dynamic gene network responses to viral infection. We illustrate the methodological pipeline by reanalyzing the time course gene expression data from a study with healthy human subjects challenged by live influenza virus. We observed clear differences in the number of significant dynamic response genes (DRGs) between the symptomatic and asymptomatic subjects and also identified DRG signatures for symptomatic subjects with influenza infection. The 505 common DRGs shared by the symptomatic subjects have high consistency with the signature genes for predicting viral infection identified in previous works. The temporal response patterns and network response features were carefully analyzed and investigated.

  18. Clinical features and psychiatric comorbidity of subjects with pathological gambling behavior.

    Science.gov (United States)

    Black, D W; Moyer, T

    1998-11-01

    Sociodemographic features, phenomenology, and psychiatric comorbidity of 30 subjects reporting pathological gambling behavior were examined. Twenty-three men and seven women were recruited by advertisement and word-of-mouth. They all scored higher than 5 points on the South Oaks Gambling Screen, indicating problematic gambling behaviors. They completed structured and semistructured assessments, including the Diagnostic Interview Schedule for DSM-III-R disorders (DIS), the Personality Diagnostic Questionnaire, Fourth Revision (PDQ-IV), and the Minnesota Impulsive Disorders Interview. The typical subject was a 44-year-old white married man with a mean income of $34,250 who visited a casino once or more weekly. All 30 subjects reported gambling more money than they intended to. Twenty subjects (67 percent) reported gambling as a current problem, and nine (30 percent) reported it as a past problem. Twenty-one subjects (70 percent) wanted to stop gambling but did not feel they could. According to DIS results, 18 subjects (60 percent) had a lifetime mood disorder, 19 (64 percent) a lifetime substance use disorder, and 12 (40 percent) a lifetime anxiety disorder. Based on the PDQ-IV, 26 subjects (87 percent) had a personality disorder, the most common being obsessive-compulsive, avoidant, schizotypal, and paranoid personality disorders. The sample also had a relatively high rate of antisocial personality disorder. Impulse control disorders were common, especially compulsive buying and compulsive sexual behavior. The results confirm that individuals with pathological gambling suffer substantial psychiatric comorbidity. They support continued inclusion of pathological gambling in the diagnostic category of impulse control disorders.

  19. Dysphagia among Adult Patients who Underwent Surgery for Esophageal Atresia at Birth

    Directory of Open Access Journals (Sweden)

    Valérie Huynh-Trudeau

    2015-01-01

    Full Text Available BACKGROUND: Clinical experiences of adults who underwent surgery for esophageal atresia at birth is limited. There is some evidence that suggests considerable long-term morbidity, partly because of dysphagia, which has been reported in up to 85% of adult patients who undergo surgery for esophageal atresia. The authors hypothesized that dysphagia in this population is caused by dysmotility and/or anatomical anomalies.

  20. The Deaconess Informed Consent Comprehension Test: an assessment tool for clinical research subjects.

    Science.gov (United States)

    Miller, C K; O'Donnell, D C; Searight, H R; Barbarash, R A

    1996-01-01

    We developed an instrument to assess comprehension of informed consent information among 275 adults entering one of four ambulatory trials. At the conclusion of trial enrollment, subjects rated their understanding of the information presented and completed the Deaconess Informed Consent Comprehension Test (DICCT). Subjects completed the vocabulary subtest of the revised Weschler Adult Intelligence Scale (WAIS-R) and the reading subtest of the revised Wide Range Achievement Test (WRAT-R). The DICCT for 50 subjects was scored by 2 blinded investigators. Interrater agreement was 0.84 (df = 49, p < 0.001). To investigate the DICCT's potential validity, its scores were correlated with WAIS-R vocabulary scores (r = 0.44, df = 199, p < 0.01) and WRAT-R reading scores (r = 0.39, df = 268, p < 0.01). Understanding of consent information was rated as thorough by 70% of subjects. The mean +/- SD DICCT score was 20.4 +/- 3.9. The DICCT is a reliable instrument to assess comprehension of informed consent information. There is preliminary evidence for the scale's validity. The subjects believed that they had greater understanding of study information than was shown by the DICCT.

  1. Reexamining the validity and reliability of the clinical version of the Iowa gambling task: Evidence from a normal subject group

    Directory of Open Access Journals (Sweden)

    Ching-Hung eLin

    2013-05-01

    Full Text Available Over past decade, the Iowa gambling task (IGT has been utilized to test various decision deficits induced by neurological damage or psychiatric disorders. The IGT has recently been standardized for identifying 13 different neuropsychological disorders. Neuropsychological patients choose bad decks frequently, and normal subjects prefer good EV decks. However, the IGT has several validity and reliability problems. Some research groups have pointed out that the validity of IGT is influenced by the personality and emotional state of subjects. Additionally, several other studies have proposed that the prominent deck B phenomenon (PDB phenomenon – that is, normal subjects preferring bad deck B – may be the most serious problem confronting IGT validity. Specifically, deck B offers a high frequency of gains but negative EV. In the standard IGT administration, choice behavior can be understood with reference to gain-loss frequency (GLF rather than inferred future consequences (EV, the basic assumption of IGT. Furthermore, using two different criteria (basic assumption vs. professional norm results in significantly different classification results. Therefore, we recruited 72 normal subjects to test the validity and reliability of IGT. Each subject performed three runs of the computer-based clinical IGT version. The PDB phenomenon has been observed to a significant degree in the first and second stages of the clinical IGT version. Obviously, validity, reliability and the practice effect were unstable between two given stages. The present form of the clinical IGT version has only one stage, so its use should be reconsidered for examining normal decision makers; results from patient groups must also be interpreted with great care. GLF could be the main factor to be considered in establishing the constructional validity and reliability of the clinical IGT version.

  2. Subjective well-being among Episcopal priests: predictors and comparisons to non-clinical norms.

    Science.gov (United States)

    Stewart-Sicking, Joseph A

    2012-01-01

    Few studies of the clergy have examined emotional well-being using normed measures. This study examined subjective well-being among 1,581 non-retired Episcopal priests. Subjective well-being was measured with the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988) and the Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985). Predictors of subjective well-being were measured with the Dispositional Hope Scale (Snyder et al., 1991) and scales of personal practices, social support, congregational dynamics, fit, and economic satisfaction. Participants reported more positive affect (Hedges's g = 1.19), more negative affect (Hedges's g = 0.61) and more satisfaction with life (Hedges's g = 0.73) than nonclinical norms. Hope agency was the strongest predictor for positive affect and satisfaction with life; stress was the strongest predictor for negative affect and partially mediated the effect of congregational dynamics and fit on this outcome. Results suggest that prevention programs must focus on all aspects of subjective well-being and consider the direct effects of different levels of the ecosystem to be effective.

  3. HIV-1 resistance rarely observed in subjects using darunavir once-daily regimens across clinical studies.

    Science.gov (United States)

    Lathouwers, Erkki; Wong, Eric Y; Luo, Donghan; Seyedkazemi, Sareh; De Meyer, Sandra; Brown, Kimberley

    2017-11-16

    Darunavir 800 mg once daily (QD) is indicated for HIV-1-infected treatment-naïve and treatment-experienced (without darunavir resistance-associated mutations [RAMs]) individuals, and has been evaluated in phase 2/3 studies with durations between 48 and 192 weeks. To summarize the development (or identification) of post-baseline resistance (RAMs and antiretroviral phenotypic susceptibility) among subjects receiving darunavir QD dosing. Seven phase 2/3 studies with available genotypes/phenotypes for subjects treated with ritonavir- or cobicistat-boosted darunavir 800 mg QD regimens were assessed: ARTEMIS (NCT00258557; n = 343), GS-US-299-0102 (NCT01565850; n = 153), GS-US-216-0130 (NCT01440569; n = 313), ODIN (NCT00524368; n = 294), INROADS (NCT01199939; n = 54), MONET (NCT00458302; n = 256), and PROTEA (NCT01448707; n = 273). Genotypic analyses were conducted at baseline (except switch studies enrolling virologically suppressed subjects [MONET, PROTEA]). Criteria for post-baseline resistance testing and evaluation of the development (or identification [switch studies]) of RAMs (respective IAS-USA mutations) varied slightly across studies. Among 1686 subjects treated with darunavir 800 mg QD regimens, 184 had protocol-defined virologic failure; 182 had post-baseline genotypes analyzed. Overall, 4/1686 (0.2%) developed (or had identified [switch studies]) primary protease inhibitor and/or darunavir RAMs (ARTEMIS, n = 1; GS-US-216-0130, n = 1; ODIN, n = 1; MONET, n = 1). Only 1/1686 (1%) subject lost darunavir phenotypic susceptibility (ODIN; possibly related to prior ritonavir-boosted lopinavir virologic failure). Among 1103 subjects using a nucleos(t)ide reverse transcriptase inhibitor (N[t]RTI) backbone, 10 (0.9%) developed ≥ 1 N(t)RTI RAM (8 had the emtricitabine RAM M184I/V). Darunavir has a high genetic barrier to resistance. Across a diverse population of HIV-1-infected subjects treated with darunavir 800 mg QD regimens, the

  4. Plasma concentrations of endothelial vasoactive substances in clinically healthy subjects. associations with urinary albumin excretion and ambulatory blood pressure

    DEFF Research Database (Denmark)

    Clausen, P; Jensen, J S; Jensent, G

    2000-01-01

    Elevated urinary albumin excretion (UAE) is a predictor of cardiovascular disease, and one possible explanation is that elevated UAE reflects a generalized vascular dysfunction. The present study tests whether the plasma concentrations of the two main endothelial vasoactive substances (nitric oxide...... and endothelin-1 [ET-1]) are changed in clinically healthy subjects with elevated UAE (>6.6 microg/ min-the 90th percentile in the background population) and to test associations between these concentrations and systemic blood pressure. Twenty-seven subjects with elevated UAE were compared with 46 matched...

  5. (Pre)analytical imprecision, between-subject variability, and daily variations in serum and urine hepcidin: implications for clinical studies.

    Science.gov (United States)

    Kroot, Joyce J C; Hendriks, Jan C M; Laarakkers, Coby M M; Klaver, Siem M; Kemna, Erwin H J M; Tjalsma, Harold; Swinkels, Dorine W

    2009-06-15

    The utility of urine and serum hepcidin measurements in the clinic depends on their reproducibility. We sought to expand our previous work on the within-subject variability and between-subject variability of this novel iron parameter in the serum and urine of 24 healthy controls by time-of-flight mass spectrometry at four different time points during the day. A linear mixed model for repeated data was used to distinguish three components of the total variability in the measurements: within-day/within-subject variability, between-subject variability, and additional residual or (pre)analytical variability. Differences in diurnal hepcidin patterns were observed between urine and serum. Urine levels remained similar during the course of the morning and increased significantly during the afternoon, whereas serum levels increased significantly throughout both the morning and afternoon. Furthermore, in serum the (pre)analytical variability (28.6%) was smaller than the between-subject (48.1%) and within-day/within-subject variability (30.3%) compared with urine variability (97.2% vs. 67.7 and 77.3%, respectively). High serum ferritin levels were associated with higher serum hepcidin levels but not with urine levels. Transferrin saturation did not correlate with hepcidin levels. To minimize variability, we recommend (i) standardizing for sampling time and (ii) measuring serum hepcidin levels.

  6. Identification of subtypes in subjects with mild-to-moderate airflow limitation and its clinical and socioeconomic implications

    Science.gov (United States)

    Lee, Jin Hwa; Rhee, Chin Kook; Kim, Kyungjoo; Kim, Jee-Ae; Kim, Sang Hyun; Yoo, Kwang Ha; Kim, Woo Jin; Park, Yong Bum; Park, Hye Yun; Jung, Ki-Suck

    2017-01-01

    Purpose The purpose of this study was to identify subtypes in patients with mild-to-moderate airflow limitation and to appreciate their clinical and socioeconomic implications. Methods Subjects who were aged ≥20 years and had forced expiratory volume in 1 second (FEV1) ≥60% predicted and FEV1/forced vital capacity ratio of total medical expense to household income, the mean ratio was highest in the COPD group. Conclusion Clinical and epidemiological heterogeneities of subjects with mild-to-moderate airflow limitation and a different level of health care utilization by each subtype are shown. Identification of a subtype with high health care demand could be a priority for effective utilization of limited resources. PMID:28442900

  7. Adult attention-deficit/hyperactivity disorder in major depressed and bipolar subjects: role of personality traits and clinical implications.

    Science.gov (United States)

    Di Nicola, Marco; Sala, Loretta; Romo, Lucia; Catalano, Valeria; Even, Christian; Dubertret, Caroline; Martinotti, Giovanni; Camardese, Giovanni; Mazza, Marianna; Tedeschi, Daniela; Callea, Antonino; De Risio, Luisa; Guelfi, Julien Daniel; Rouillon, Frederic; Janiri, Luigi; Gorwood, Philip

    2014-08-01

    A significant comorbidity between attention-deficit/hyperactivity disorder (ADHD) and affective disorders has been consistently reported in adults. Less data regarding the role of personality traits and the influence of ADHD co-occurrence on clinical characteristics and outcome of mood disorders are currently available. One hundred and six remitted major depressed, 102 euthymic bipolar subjects, and 120 healthy controls, homogeneous with respect to demographic characteristics, were included in the study. ADHD diagnosis was based on DSM-IV-TR criteria. Childhood and adult ADHD features were measured with the Wender Utah Rating Scale, the Adult ADHD Self-rating Scale, and the Brown Attention-Deficit Disorder Scale. The Revised NEO Personality Inventory was also administered to the clinical groups, in order to investigate personality dimensions. The occurrence of adult ADHD in subjects with bipolar disorders (BD) or major depressive disorder (MDD) was 15.7 and 7.5 %, respectively, compared to 3.3 % in healthy controls (HC). Significant associations (p < .001) between personality traits (neuroticism, conscientiousness, and extraversion) and ADHD features were observed. Logistic regression analysis of all clinical subjects (n = 208) showed that those with lower levels of neuroticism (OR = 1.031; p = .025) had a lower frequency of ADHD comorbidity. The present study emphasizes the close relationship between affective disorders, especially BD, and ADHD in adults. Our findings support the need to assess subjects with mood disorders in the clinical setting for possible coexisting ADHD and to further investigate personality traits to better understand the etiology of affective disorders and ADHD co-occurrence.

  8. 78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

    Science.gov (United States)

    2013-02-25

    ... regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that... Medical Devices B. Reasons for Proposing To Revise the Regulations II. Description of the Proposed Rule A... regulations for PMA of medical devices in part 814 (21 CFR part 814) permit the acceptance of data from...

  9. Evolution of elderly patients who underwent cardiac surgery with cardiopulmonary bypass

    Directory of Open Access Journals (Sweden)

    Alain Moré Duarte

    2016-01-01

    Full Text Available Introduction: There is a steady increase in the number of elderly patients with severe cardiovascular diseases who require a surgical procedure to recover some quality of life that allows them a socially meaningful existence, despite the risks.Objectives: To analyze the behavior of elderly patients who underwent cardiac surgery with cardiopulmonary bypass.Method: A descriptive, retrospective, cross-sectional study was conducted with patients over 65 years of age who underwent surgery at the Cardiocentro Ernesto Che Guevara, in Santa Clara, from January 2013 to March 2014.Results: In the study, 73.1% of patients were men; and there was a predominance of subjects between 65 and 70 years of age, accounting for 67.3%. Coronary artery bypass graft was the most prevalent type of surgery and had the longest cardiopulmonary bypass times. Hypertension was present in 98.1% of patients. The most frequent postoperative complications were renal dysfunction and severe low cardiac output, with 44.2% and 34.6% respectively.Conclusions: There was a predominance of men, the age group of 65 to 70 years, hypertension, and patients who underwent coronary artery bypass graft with prolonged cardiopulmonary bypass. Renal dysfunction was the most frequent complication.

  10. Reactivity in pain-free subjects and a clinical pain population: evaluation of the Kohn Reactivity Scale-dutch Version.

    Science.gov (United States)

    Veldhuijzen, Dieuwke S; Noordermeer, Siri D S; van Wijck, Albert J M; Snijders, Tom J; Geenen, Rinie

    2013-07-01

    Patients with pain are more reactive to various types of sensations, not limited to pain alone. A potential useful instrument to assess reactivity is the Kohn Reactivity Scale (KRS). This study examines the psychometric characteristics of the KRS-Dutch version and its ability to differentiate between subjects with and without pain. Internal consistency, convergent validity, and test-retest reliability of the Dutch translation of the KRS were assessed in 321 pain-free control subjects and different subgroups of this sample. Subsequently, reactivity scores were compared between the pain-free subjects and 291 pain patients who were referred to a pain clinic for treatment. Reliability analyses indicated good internal consistency (α ≥ 0.77) and high test-retest reliability (intraclass correlation = 0.95) of the KRS in the control subjects. Validity analyses yielded positive correlations of the KRS with related constructs like pain vigilance and awareness (r = 0.37), symptom severity (r = 0.29), and the personality characteristic neuroticism (r = 0.20). Pain patients had overall significantly higher KRS scores than the pain-free subjects indicating increased reactivity, particularly for the patients with medically unexplained pain. These findings indicate that the KRS is a useful instrument to screen for reactivity in pain patients, which may be of particular relevance for those suffering from medically unexplained pain. © 2012 The Authors Pain Practice © 2012 World Institute of Pain.

  11. CLINICAL PRACTICE GUIDELINE: MANAGEMENT OF SINUSITIS (SUBJECT REVIEW OF AMERICAN ACADEMY OF PEDIATRICS

    Directory of Open Access Journals (Sweden)

    article editorial

    2006-01-01

    Full Text Available This clinical practice guideline formulates recommendations for health care providers regarding the diagnosis, evaluation, and treatment of children, ages 1 to 21 years, with uncomplicated acute, subacute, and recurrent acute bacterial sinusitis. Three specific issues were considered: 1 evidence for the efficacy of various antibiotics in children; 2 evidence for the efficacy of various ancillary, nonantibiotic regimens; and 3 the diagnostic accuracy and concordance of clinical symptoms, radiography (and other imaging methods, and sinus aspiration.It is recommended that the diagnosis of acute bacterial sinusitis be based on clinical criteria in children ≤6 years of age who present with upper respiratory symptoms that are either persistent or severe. Although controversial, imaging studies may be necessary to confirm a diagnosis of acute bacterial sinusitis in children >6 years of age. Computed tomography scans of the paranasal sinuses should be reserved for children who present with complications of acute bacterial sinusitis or who have very persistent or recurrent infections and are not responsive to medical management.There were only 5 controlled randomized trials and 8 case series on antimicrobial therapy for acute bacterial sinusitis in children. However, these data, plus data derived from the study of adults with acute bacterial sinusitis, support the recommendation that acute bacterial sinusitis be treated with antimicrobial therapy to achieve a more rapid clinical cure. Children with complications or suspected complications of acute bacterial sinusitis should be treated promptly and aggressively with antibiotics and, when appropriate, drainage. Based on controversial and limited data, no recommendations are made about the use of prophylactic antimicrobials, ancillary therapies, or complementary/alternative medicine for prevention and treatment of acute bacterial sinusitis.Key words: sinusitis, treatment, management, children.

  12. Estudo clínico e cardiorrespiratório em cadelas gestantes com parto normal ou submetidas à cesariana sob anestesia inalatória com sevofluorano Clinical and cardiorespiratory study in bitches under normal parturition or underwent to cesarean section using inalatory anesthesia with sevoflurane

    Directory of Open Access Journals (Sweden)

    D.T. Gabas

    2006-08-01

    temperature and invasive arterial blood pressure throughout the anaesthetic period, besides the anaesthetic recovery quality. The bitches, submitted to the caesarean sections showed lower values of cardiac frequency, arterial pressure, respiratory frequency, time of capilar reperfusion and arterial blood pH when compared to the bitches which underwent natural birth, showing the cardiorespiratoy depression induced by the anaesthetic procedure. In spite of the anaesthetic depression, the anaesthetic protocol employed had no effect on the viability and health of the bitches and the puppies, and can be safely recommend for caesarean sections.

  13. Validity of subjective assessment as screening tool for dry eye disease and its association with clinical tests

    Directory of Open Access Journals (Sweden)

    Kavita R Bhatnagar

    2015-02-01

    Full Text Available AIM: To determine the role of subjective assessment using McMonnies dry eye questionnaire in diagnosing dry eye disease and its association with clinical tests. METHODS: There were 500 patients screened for dry eye using McMonnies dry eye questionnaire between May to October 2013 at the outpatient Department of Ophthalmology of a medical college hospital. All 500 patients were subjected to clinical tests. Dry eye was defined as having one or more symptoms often or all the time. Positive signs were if one or both eyes revealed tear film breakup time (TBUT of ≤10s, a Schirmer test score of ≤10 mm, a Rose Bengal staining score of ≥1, a Lissamine green staining score of ≥1 or existence of meibomian gland disease (≥grade 1. Statistical analysis was performed to describe the distribution of symptoms and signs, to assess the correlations between McMonnies score (MS and variable clinical signs of dry eye, and to explore the association between dry eye symptoms and variable clinical signs. Analysis was performed using software package Epi info. A Probability (P value using Chi-square test of RESULTS: Dry eye prevalence with symptoms (questionnaire, Schirmer test, TBUT, Rose Bengal staining and Lissamine green staining was 25.6%, 15.20%, 20.80%, 23.60%, and 22.60% respectively. Among those with severe symptoms (MS>20, 75.86% had a low TBUT (CONCLUSION: Subjective assessment plays an important role in diagnosing dry eye disease. There is strong correlation between MS and Schirmer test, TBUT, Rose Bengal staining and Lissamine green staining in normal as well as marginal and pathological dry eye.

  14. A better alternative to stratified permuted block design for subject randomization in clinical trials.

    Science.gov (United States)

    Zhao, Wenle

    2014-12-30

    Stratified permuted block randomization has been the dominant covariate-adaptive randomization procedure in clinical trials for several decades. Its high probability of deterministic assignment and low capacity of covariate balancing have been well recognized. The popularity of this sub-optimal method is largely due to its simplicity in implementation and the lack of better alternatives. Proposed in this paper is a two-stage covariate-adaptive randomization procedure that uses the block urn design or the big stick design in stage one to restrict the treatment imbalance within each covariate stratum, and uses the biased-coin minimization method in stage two to control imbalances in the distribution of additional covariates that are not included in the stratification algorithm. Analytical and simulation results show that the new randomization procedure significantly reduces the probability of deterministic assignments, and improve the covariate balancing capacity when compared to the traditional stratified permuted block randomization. Copyright © 2014 John Wiley & Sons, Ltd.

  15. Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database.

    Science.gov (United States)

    Watkins, Paul B; Lewis, James H; Kaplowitz, Neil; Alpers, David H; Blais, Jaime D; Smotzer, Dan M; Krasa, Holly; Ouyang, John; Torres, Vicente E; Czerwiec, Frank S; Zimmer, Christopher A

    2015-11-01

    Subjects with autosomal dominant polycystic kidney disease (ADPKD) who were taking tolvaptan experienced aminotransferase elevations more frequently than those on placebo in the TEMPO 3:4 (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) clinical trial. An independent, blinded, expert Hepatic Adjudication Committee re-examined data from TEMPO 3:4 and its open-label extension TEMPO 4:4, as well as from long-term (>14 months) non-ADPKD tolvaptan trials, using the 5-point Drug-Induced Liver Injury Network classification. In TEMPO 3:4, 1445 subjects were randomized 2:1 (tolvaptan vs. placebo) and 1441 had post-baseline assessments of hepatic injury. Sixteen patients on tolvaptan and one on placebo had significant aminotransferase elevations judged to be at least probably related to study drug. No association with dose or systemic exposure was found. Two of 957 subjects taking tolvaptan (0.2 %) and zero of 484 taking placebo met the definition of a Hy's Law case. One additional Hy's Law case was identified in a TEMPO 4:4 subject who had received placebo in the lead study. The onset of a hepatocellular injury occurred between 3 and 18 months after starting tolvaptan, with gradual resolution over the subsequent 1-4 months. None of the events were associated with liver failure or chronic liver injury/dysfunction. No imbalance in hepatic events was observed between tolvaptan and placebo in lower-dose clinical trials of patients with hyponatremia, heart failure, or cirrhosis. Although hepatocellular injury following long-term tolvaptan treatment in ADPKD subjects was infrequent and reversible, the potential for serious irreversible injury exists. Regular monitoring of transaminase levels is warranted in this patient population.

  16. [Serum myeloperoxidase activity and serum paraoxonase-1 activity in patients with silicosis and observation subjects and their clinical significance].

    Science.gov (United States)

    Zou, Wei-hua; Qiu, Sheng-qiang; Hong, Xiao-ping; Wu, Quan

    2013-01-01

    To investigate the serum myeloperoxidase (MPO) activity and serum paraoxonase-1 (PON-1) activity in patients with silicosis and observation subjects and their clinical significance. Seventy-two patients with silicosis (stage I: 30 cases, stage II: 22 cases, stage III: 20 cases) and 37 observation subjects were selected as a case group, and 110 healthy men were selected as a control group. Serum MPO activity was measured by double-antibody sandwich enzyme-linked immunosorbent assay, and serum PON-1 activity was measured by chemical spectrophotometry. Serum MPO activity was significantly higher in the case group than in the control group [(102.1 ± 15.7) U/L vs. (62.4 ± 11.4) U/L, P silicosis than in the observation subjects [(91.3 ± 13.5) U/L, (85.7 ± 14.4) U/L, and (88.6 ± 14.5) U/L vs. (128.4 ± 16.4) U/L, P silicosis increased; serum PON-1 activity was significantly lower in the patients with stages II and III silicosis than in the observation subjects and the patients with stage I silicosis [(70.4 ± 11.4) U/ml and (67.6 ± 13.7) U/ml vs. (101.5 ± 14.0) U/ml and (89.1 ± 10.1) U/ml, P silicosis and evaluation of patient's condition.

  17. TOPS: an internet-based system to prevent healthy subjects from over-volunteering for clinical trials.

    Science.gov (United States)

    Boyce, M; Walther, M; Nentwich, H; Kirk, J; Smith, S; Warrington, S

    2012-07-01

    Our aim was to set up a system to help UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or from starting a second trial too soon after the first. TOPS (The Over-volunteering Prevention System) is internet-based, simple and quick to use, free to users and a charity run by a Board of Trustees. Users enter only two or three pieces of information: (1) 'National Insurance number' (NINO) of UK citizens, or 'passport number' and country of origin of non-UK citizens, as their identifier, (2) 'date of last dose' of trial medicine or (3) 'never dosed'. Subjects must consent, but TOPS collects only non-personal data, so it does not require Ethics Committee approval and is not covered by the Data Protection Act. A total of 55 research units (29 clinical research organisations, 5 pharmaceutical companies, 13 universities and 8 hospitals) throughout the UK have registered to use TOPS, and have entered 124,906 volunteers since we launched it. All commercial and many non-commercial units now use TOPS. In our unit, no subject has to the best of our knowledge participated in two trials simultaneously. TOPS has reduced to research units to comply with UK clinical trial regulations.

  18. Effect of using pump on postoperative pleural effusion in the patients that underwent CABG

    Directory of Open Access Journals (Sweden)

    Mehmet Özülkü

    2015-08-01

    Full Text Available Abstract Objective: The present study investigated effect of using pump on postoperative pleural effusion in patients who underwent coronary artery bypass grafting. Methods: A total of 256 patients who underwent isolated coronary artery bypass grafting surgery in the Cardiovascular Surgery clinic were enrolled in the study. Jostra-Cobe (Model 043213 105, VLC 865, Sweden heart-lung machine was used in on-pump coronary artery bypass grafting. Off-pump coronary artery bypass grafting was performed using Octopus and Starfish. Proximal anastomoses to the aorta in both on-pump and off-pump techniques were performed by side clamps. The patients were discharged from the hospital between postoperative day 6 and day 11. Results: The incidence of postoperative right pleural effusion and bilateral pleural effusion was found to be higher as a count in Group 1 (on-pump as compared to Group 2 (off-pump. But the difference was not statistically significant [P>0.05 for right pleural effusion (P=0.893, P>0.05 for bilateral pleural effusion (P=0.780]. Left pleural effusion was encountered to be lower in Group 2 (off-pump. The difference was found to be statistically significant (P<0.05, P=0.006. Conclusion: Under the light of these results, it can be said that left pleural effusion is less prevalent in the patients that underwent off-pump coronary artery bypass grafting when compared to the patients that underwent on-pump coronary artery bypass grafting.

  19. Clinical characteristics of self-mutilating behavior in Turkish male subjects with antisocial personality disorder: relationship to psychopathy.

    Science.gov (United States)

    Alpay Ates, M; Algul, Ayhan; Semiz, Umit B; Gecici, Omer; Basoglu, Cengiz; Ebrinc, Servet; Cetin, Mesut

    2011-05-01

    The aims of this study were to determine the characteristics of self-mutilation (SM) and examine the relationship between SM and psychopathy in male subjects with antisocial personality disorder (APD). APD diagnosis was established by the Structured Clinical Interview for DSM-III-R Axis II Disorders. Subjects (N = 116) were assessed using the Psychopathy Checklist-Revised and a semi-structured self-mutilation questionnaire form. In males with APD, the percentages of psychopathy and SM were 48.3% (N =56) and 96.6% (N = 112), respectively. There were positive correlations between severity of psychopathy and severity, number, and frequency of SM. Considerably high rates of SM and psychopathy were found in Turkish males with APD. The features of SM were associated with comorbidity of psychopathy. These results showed the importance of exploring the self-injurious behavior and psychopathy when diagnosed with APD.

  20. Hypofibrinolytic State in Subjects with Type 2 Diabetes Mellitus Aggravated by the Metabolic Syndrome before Clinical Manifestations of Atherothrombotic Disease.

    Science.gov (United States)

    Aburto-Mejía, Elsa; Santiago-Germán, David; Martínez-Marino, Manuel; María Eugenia Galván-Plata; Almeida-Gutiérrez, Eduardo; López-Alarcón, Mardia; Hernández-Juárez, Jesús; Alvarado-Moreno, Antonio; Leaños-Miranda, Alfredo; Majluf-Cruz, Abraham; Isordia-Salas, Irma

    2017-01-01

    Background. Metabolic and genetic factors induce plasminogen activator inhibitor type-1 (PAI-1) overexpression; higher PAI-1 levels decrease fibrinolysis and promote atherothrombosis. Aim. To assess PAI-1 antigen levels among subjects with type 2 diabetes mellitus (T2DM) plus Metabolic Syndrome (MetS) before clinical manifestations of atherothrombosis and the contribution of metabolic factors and 4G/5G polymorphism of PAI-1 gene on the variability of PAI-1. Methods. We conducted an observational, cross-sectional assay in a hospital in Mexico City from May 2010 to September 2011. MetS was defined by the International Diabetes Federation criteria. PAI-1 levels and 4G/5G polymorphism were determined by ELISA and PCR-RFLP analysis. Results. We enrolled 215 subjects with T2DM plus MetS and 307 controls. Subjects with T2DM plus MetS had higher PAI-1 levels than the reference group (58.4 ± 21 versus 49.9 ± 16 ng/mL, p = 0.026). A model with components of MetS explained only 12% of variability on PAI-1 levels (R(2) = 0.12; p = 0.001), with β = 0.18 (p = 0.03) for hypertension, β = -0.16 (p = 0.05) for NL HDL-c, and β = 0.15 (p = 0.05) for NL triglycerides. Conclusion. Subjects with T2DM plus MetS have elevated PAI-1 levels before clinical manifestations of atherothrombotic disease. Metabolic factors have a more important contribution than 4G/5G polymorphism on PAI-1 plasma variability.

  1. Hypofibrinolytic State in Subjects with Type 2 Diabetes Mellitus Aggravated by the Metabolic Syndrome before Clinical Manifestations of Atherothrombotic Disease

    Directory of Open Access Journals (Sweden)

    Elsa Aburto-Mejía

    2017-01-01

    Full Text Available Background. Metabolic and genetic factors induce plasminogen activator inhibitor type-1 (PAI-1 overexpression; higher PAI-1 levels decrease fibrinolysis and promote atherothrombosis. Aim. To assess PAI-1 antigen levels among subjects with type 2 diabetes mellitus (T2DM plus Metabolic Syndrome (MetS before clinical manifestations of atherothrombosis and the contribution of metabolic factors and 4G/5G polymorphism of PAI-1 gene on the variability of PAI-1. Methods. We conducted an observational, cross-sectional assay in a hospital in Mexico City from May 2010 to September 2011. MetS was defined by the International Diabetes Federation criteria. PAI-1 levels and 4G/5G polymorphism were determined by ELISA and PCR-RFLP analysis. Results. We enrolled 215 subjects with T2DM plus MetS and 307 controls. Subjects with T2DM plus MetS had higher PAI-1 levels than the reference group (58.4 ± 21 versus 49.9 ± 16 ng/mL, p=0.026. A model with components of MetS explained only 12% of variability on PAI-1 levels (R2 = 0.12; p=0.001, with β=0.18 (p=0.03 for hypertension, β=-0.16 (p=0.05 for NL HDL-c, and β=0.15 (p=0.05 for NL triglycerides. Conclusion. Subjects with T2DM plus MetS have elevated PAI-1 levels before clinical manifestations of atherothrombotic disease. Metabolic factors have a more important contribution than 4G/5G polymorphism on PAI-1 plasma variability.

  2. Hypofibrinolytic State in Subjects with Type 2 Diabetes Mellitus Aggravated by the Metabolic Syndrome before Clinical Manifestations of Atherothrombotic Disease

    Science.gov (United States)

    Aburto-Mejía, Elsa; Santiago-Germán, David; Martínez-Marino, Manuel; María Eugenia Galván-Plata; Almeida-Gutiérrez, Eduardo; Hernández-Juárez, Jesús; Alvarado-Moreno, Antonio; Leaños-Miranda, Alfredo

    2017-01-01

    Background. Metabolic and genetic factors induce plasminogen activator inhibitor type-1 (PAI-1) overexpression; higher PAI-1 levels decrease fibrinolysis and promote atherothrombosis. Aim. To assess PAI-1 antigen levels among subjects with type 2 diabetes mellitus (T2DM) plus Metabolic Syndrome (MetS) before clinical manifestations of atherothrombosis and the contribution of metabolic factors and 4G/5G polymorphism of PAI-1 gene on the variability of PAI-1. Methods. We conducted an observational, cross-sectional assay in a hospital in Mexico City from May 2010 to September 2011. MetS was defined by the International Diabetes Federation criteria. PAI-1 levels and 4G/5G polymorphism were determined by ELISA and PCR-RFLP analysis. Results. We enrolled 215 subjects with T2DM plus MetS and 307 controls. Subjects with T2DM plus MetS had higher PAI-1 levels than the reference group (58.4 ± 21 versus 49.9 ± 16 ng/mL, p = 0.026). A model with components of MetS explained only 12% of variability on PAI-1 levels (R2 = 0.12; p = 0.001), with β = 0.18 (p = 0.03) for hypertension, β = −0.16 (p = 0.05) for NL HDL-c, and β = 0.15 (p = 0.05) for NL triglycerides. Conclusion. Subjects with T2DM plus MetS have elevated PAI-1 levels before clinical manifestations of atherothrombotic disease. Metabolic factors have a more important contribution than 4G/5G polymorphism on PAI-1 plasma variability. PMID:28271069

  3. Evaluation of undergraduate clinical learning experiences in the subject of pediatric dentistry using critical incident technique.

    Science.gov (United States)

    Vyawahare, S; Banda, N R; Choubey, S; Parvekar, P; Barodiya, A; Dutta, S

    2013-01-01

    In pediatric dentistry, the experiences of dental students may help dental educators better prepare graduates to treat the children. Research suggests that student's perceptions should be considered in any discussion of their education, but there has been no systematic examination of India's undergraduate dental students learning experiences. This qualitative investigation aimed to gather and analyze information about experiences in pediatric dentistry from the students' viewpoint using critical incident technique (CIT). The sample group for this investigation came from all 240 3rd and 4th year dental students from all the four dental colleges in Indore. Using CIT, participants were asked to describe at least one positive and one negative experience in detail. They described 308 positive and 359 negative experiences related to the pediatric dentistry clinic. Analysis of the data resulted in the identification of four key factors related to their experiences: 1) The instructor; 2) the patient; 3) the learning process; and 4) the learning environment. The CIT is a useful data collection and analysis technique that provides rich, useful data and has many potential uses in dental education.

  4. Artificial gait in complete spinal cord injured subjects: how to assess clinical performance

    Directory of Open Access Journals (Sweden)

    Karla Rocha Pithon

    2015-02-01

    Full Text Available Objective Adapt the 6 minutes walking test (6MWT to artificial gait in complete spinal cord injured (SCI patients aided by neuromuscular electrical stimulation. Method Nine male individuals with paraplegia (AIS A participated in this study. Lesion levels varied between T4 and T12 and time post injured from 4 to 13 years. Patients performed 6MWT 1 and 6MWT 2. They used neuromuscular electrical stimulation, and were aided by a walker. The differences between two 6MWT were assessed by using a paired t test. Multiple r-squared was also calculated. Results The 6MWT 1 and 6MWT 2 were not statistically different for heart rate, distance, mean speed and blood pressure. Multiple r-squared (r2 = 0.96 explained 96% of the variation in the distance walked. Conclusion The use of 6MWT in artificial gait towards assessing exercise walking capacity is reproducible and easy to apply. It can be used to assess SCI artificial gait clinical performance.

  5. Familial history of diabetes and clinical characteristics in Greek subjects with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Apostolou Ourania

    2009-04-01

    Full Text Available Abstract Background A lot of studies have showed an excess maternal transmission of type 2 diabetes (T2D. The aim, therefore, of the present study was to estimate the prevalence of familial history of T2D in Greek patients, and to evaluate its potential effect on the patient's metabolic control and the presence of diabetic complications. Methods A total of 1,473 T2D patients were recruited. Those with diabetic mothers, diabetic fathers, diabetic relatives other than parents and no known diabetic relatives, were considered separately. Results The prevalence of diabetes in the mother, the father and relatives other than parents, was 27.7, 11.0 and 10.7%, respectively. Patients with paternal diabetes had a higher prevalence of hypertension (64.8 vs. 57.1%, P = 0.05 and lower LDL-cholesterol levels (115.12 ± 39.76 vs. 127.13 ± 46.53 mg/dl, P = 0.006 than patients with diabetes in the mother. Patients with familial diabetes were significantly younger (P 2, P = 0.08, higher prevalence of dyslipidemia (49.8 vs. 44.6%, P = 0.06 and retinopathy (17.9 vs. 14.5%, P = 0.08 compared with patients with no diabetic relatives. No difference in the degree of metabolic control and the prevalence of chronic complications were observed. Conclusion The present study showed an excess maternal transmission of T2D in a sample of Greek diabetic patients. However, no different influence was found between maternal and paternal diabetes on the clinical characteristics of diabetic patients except for LDL-cholesterol levels and presence of hypertension. The presence of a family history of diabetes resulted to an early onset of the disease to the offspring.

  6. Can active music-making ameliorate neglect? An assessor-blind, within-subject, controlled clinical trial

    DEFF Research Database (Denmark)

    Bodak, Rebeka; Mazhari-Jensen, Daniel; Evald, Lars

    functional gains. Drawing on recent successful case study pilot work, the aim of the present study is to investigate the impact of an active music-making intervention compared with a control. Stroke survivors with a diagnosis of neglect will be invited to participate in an assessor-blind, within......-subject, home program study that lasts 12 weeks and comprises four 3-week phases: baseline, control, intervention, and follow-up. The intervention and control each comprise six 30-minute sessions plus daily homework. The intervention involves playing scales and familiar melodies on a horizontally...... and on an assessment of their activities-of-daily-living. By validating and extending published case study work, the knowledge gained from this study has the capacity to pave the way for future clinical interventions and deepen our understanding of the use of music as a clinical tool in neurorehabilitation settings....

  7. Recapitulation of Clinical Individual Susceptibility to Drug-Induced QT Prolongation in Healthy Subjects Using iPSC-Derived Cardiomyocytes

    Directory of Open Access Journals (Sweden)

    Tadahiro Shinozawa

    2017-02-01

    Full Text Available To predict drug-induced serious adverse events (SAE in clinical trials, a model using a panel of cells derived from human induced pluripotent stem cells (hiPSCs of individuals with different susceptibilities could facilitate major advancements in translational research in terms of safety and pharmaco-economics. However, it is unclear whether hiPSC-derived cells can recapitulate interindividual differences in drug-induced SAE susceptibility in populations not having genetic disorders such as healthy subjects. Here, we evaluated individual differences in SAE susceptibility based on an in vitro model using hiPSC-derived cardiomyocytes (hiPSC-CMs as a pilot study. hiPSCs were generated from blood samples of ten healthy volunteers with different susceptibilities to moxifloxacin (Mox-induced QT prolongation. Different Mox-induced field potential duration (FPD prolongation values were observed in the hiPSC-CMs from each individual. Interestingly, the QT interval was significantly positively correlated with FPD at clinically relevant concentrations (r > 0.66 in multiple analyses including concentration-QT analysis. Genomic analysis showed no interindividual significant differences in known target-binding sites for Mox and other drugs such as the hERG channel subunit, and baseline QT ranges were normal. The results suggest that hiPSC-CMs from healthy subjects recapitulate susceptibility to Mox-induced QT prolongation and provide proof of concept for in vitro preclinical trials.

  8. Cancer fear and fatalism: how African American participants construct the role of research subject in relation to clinical cancer research.

    Science.gov (United States)

    Somayaji, Darryl; Cloyes, Kristin Gates

    2015-01-01

    Lack of African American participation in cancer clinical trials has been identified as a critical problem. Historical interactions related to race, identity, and power may contribute to continued inequity in healthcare and research participation. The aim of this study was to explore the perceptions of African Americans regarding cancer and research and how these perceptions shape their beliefs about participating as cancer research subjects. Three African American focus groups were conducted including people who had never participated in cancer research, those who had, and those who were asked but refused (n = 16). Discussion focused on their perceptions of cancer research and actual or potential participation as research subjects. Data were coded using both structured and inductive coding methods. Fear and fatalism emerged in relation to research, race, power, and identity and were related to larger historical and social issues rather than only individual thoughts or feelings. Participants described fears of the unknown, death, mistrust, conspiracy, and discrimination together with positive/negative tensions between self, family, and community responsibilities. Complex identities linked perceptions of cancer and cancer research with broader historical and cultural issues. Fear, fatalism, and current and historical relationships influence how people perceive themselves as research subjects and may influence their decisions to participate in cancer research. Acknowledging how complex factors including race and racism contribute to health disparities may give nurses and other healthcare providers a better appreciation of how historical, social, and cultural dynamics at individual, community, and organizational levels influence access to and participation in cancer research.

  9. Plasma concentrations of endothelial vasoactive substances in clinically healthy subjects. associations with urinary albumin excretion and ambulatory blood pressure

    DEFF Research Database (Denmark)

    Clausen, P; Jensen, J S; Jensent, G

    2000-01-01

    and endothelin-1 [ET-1]) are changed in clinically healthy subjects with elevated UAE (>6.6 microg/ min-the 90th percentile in the background population) and to test associations between these concentrations and systemic blood pressure. Twenty-seven subjects with elevated UAE were compared with 46 matched...... controls with normoalbuminuria. Plasma concentration of ET-1 was measured using an ELISA method and plasma concentration of nitrate/nitrite using a photometric method. Twenty-four-hour blood pressure was measured using a portable recorder (TM-2421). No significant differences in the concentrations...... of nitrate/nitrite and ET-1 were found between the groups, e.g. 21 (10-105) vs. 18 (11 -152) (p=0.33) and 0.98 (0.58 1.95) vs. 1.10 (0.54 -1.50) (p = 0.27), respectively. However, plasma nitrate/nitrite was significantly positively correlated to systolic and diastolic blood pressure in subjects...

  10. Exercise capacity and mortality - a follow-up study of 3033 subjects referred to clinical exercise testing.

    Science.gov (United States)

    Korpelainen, Raija; Lämsä, Jenni; Kaikkonen, Kaisu M; Korpelainen, Juha; Laukkanen, Jari; Palatsi, Ilkka; Takala, Timo E; Ikäheimo, Tiina M; Hautala, Arto J

    2016-08-01

    Exercise stress testing is used as a diagnostic and prognostic tool. We determined the prognostic significance of exercise test findings for cardiovascular (CVD) and all-cause mortality in men and women. 3033 subjects underwent a symptom-limited bicycle exercise test. Exercise capacity was defined as the mean of last four minutes of exercise workload. During an average follow-up of 19 years, 186 (11.6%) CVD and 370 (20.6%) all-cause deaths in men and 57 (5.0%) CVD and 155 (12.5%) all-cause deaths in women occurred. Among exercise test variables (workload, ECG, BP, HR), exercise capacity was the strongest predictor of mortality. Low exercise capacity (1st quartile) was associated with a hazard ratio of 4.2 (95% CI: 1.7, 10.8) for CVD and 4.0 (95% CI: 2.5, 6.4) for all-cause mortality compared with high exercise capacity (4th quartile) among men and in women with a 5.4-fold (95% CI: 1.2, 24.0) risk for CVD and 2.3-fold (95% CI: 1.2, 4.3) risk for all-cause mortality, respectively. The relationship between other exercise test variables and mortality was much weaker. Among exercise test variables exercise capacity was the strongest predictor of CVD and all-cause mortality in both genders, and especially CVD deaths in women. Key Messages Exercise capacity was the most powerful predictor of CVD and all-cause mortality in both men and women. Low exercise capacity is a strong predictor of CVD death, especially among women.

  11. Sarcopenia: a new predictor of postoperative complications for elderly gastric cancer patients who underwent radical gastrectomy.

    Science.gov (United States)

    Zhou, Chong-Jun; Zhang, Feng-Min; Zhang, Fei-Yu; Yu, Zhen; Chen, Xiao-Lei; Shen, Xian; Zhuang, Cheng-Le; Chen, Xiao-Xi

    2017-05-01

    A geriatric assessment is needed to identify high-risk elderly patients with gastric cancer. However, the current geriatric assessment has been considered to be either time-consuming or subjective. The present study aimed to investigate the predictive effect of sarcopenia on the postoperative complications for elderly patients who underwent radical gastrectomy. We conducted a prospective study of patients who underwent radical gastrectomy from August 2014 to December 2015. Computed tomography-assessed lumbar skeletal muscle, handgrip strength, and gait speed were measured to define sarcopenia. Sarcopenia was present in 69 of 240 patients (28.8%) and was associated with lower body mass index, lower serum albumin, lower hemoglobin, and higher nutritional risk screening 2002 scores. Postoperative complications significantly increased in the sarcopenic patients (49.3% versus 24.6%, P sarcopenia (odds ratio: 2.959, 95% CI: 1.629-5.373, P Sarcopenia, presented as a new geriatric assessment factor, was a strong and independent risk factor for postoperative complications of elderly patients with gastric cancer. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Subjective and clinical assessment criteria suggestive for five clinical patterns discernible in nonspecific neck pain patients. A Delphi-survey of clinical experts.

    Science.gov (United States)

    Dewitte, Vincent; Peersman, Wim; Danneels, Lieven; Bouche, Katie; Roets, Arne; Cagnie, Barbara

    2016-12-01

    Nonspecific neck pain patients form a heterogeneous group with different musculoskeletal impairments. Classifying nonspecific neck pain patients into subgroups based on clinical characteristics might lead to more comprehensive diagnoses and can guide effective management. To establish consensus among a group of experts regarding the clinical criteria suggestive of a clinical dominance of 'articular', 'myofascial', 'neural', 'central' and 'sensorimotor control' dysfunction patterns distinguishable in patients with nonspecific neck pain. Delphi study. A focus group with 10 academic experts was organized to elaborate on the different dysfunction patterns discernible in neck pain patients. Consecutively, a 3-round online Delphi-survey was designed to obtain consensual symptoms and physical examination findings for the 5 distinct dysfunction patterns resulting from the focus group. A total of 21 musculoskeletal physical therapists from Belgium and the Netherlands experienced in assessing and treating neck pain patients completed the 3-round Delphi-survey. Respectively, 33 (response rate, 100.0%), 27 (81.8%) and 21 (63.6%) respondents replied to rounds 1, 2 and 3. Eighteen 'articular', 16 'myofascial', 20 'neural', 18 'central' and 10 'sensorimotor control' clinical indicators reached a predefined ≥80% consensus level. These indicators suggestive of a clinical dominance of 'articular', 'myofascial', 'neural', 'central', and 'sensorimotor control' dysfunction patterns may help clinicians to assess and diagnose patients with nonspecific neck pain. Future validity testing is needed to determine how these criteria may help to improve the outcome of physical therapy interventions in nonspecific neck pain patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

    Directory of Open Access Journals (Sweden)

    Gitanjali B

    2003-01-01

    Full Text Available CONTEXT: Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. AIMS: To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. SETTINGS AND DESIGN: A simulated clinical trial in two tertiary health care facilities on in-patients. METHODS AND MATERIAL: An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. RESULTS: The percentages of those consenting after full disclosure 29/102 (30% and after partial disclosure 15/50 (30% were the same. There was a significant (p=0.043 gender difference with a lesser percentage of females (30% consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. CONCLUSIONS: The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

  14. Functional magnetic resonance imaging study of external source memory and its relation to cognitive insight in non-clinical subjects.

    Science.gov (United States)

    Buchy, Lisa; Hawco, Colin; Bodnar, Michael; Izadi, Sarah; Dell'Elce, Jennifer; Messina, Katrina; Lepage, Martin

    2014-09-01

    Previous research has linked cognitive insight (a measure of self-reflectiveness and self-certainty) in psychosis with neurocognitive and neuroanatomical disturbances in the fronto-hippocampal neural network. The authors' goal was to use functional magnetic resonance imaging (fMRI) to investigate the neural correlates of cognitive insight during an external source memory paradigm in non-clinical subjects. At encoding, 24 non-clinical subjects travelled through a virtual city where they came across 20 separate people, each paired with a unique object in a distinct location. fMRI data were then acquired while participants viewed images of the city, and completed source recognition memory judgments of where and with whom objects were seen, which is known to involve prefrontal cortex. Cognitive insight was assessed with the Beck Cognitive Insight Scale. External source memory was associated with neural activity in a widespread network consisting of frontal cortex, including ventrolateral prefrontal cortex (VLPFC), temporal and occipital cortices. Activation in VLPFC correlated with higher self-reflectiveness and activation in midbrain correlated with lower self-certainty during source memory attributions. Neither self-reflectiveness nor self-certainty significantly correlated with source memory accuracy. By means of virtual reality and in the context of an external source memory paradigm, the study identified a preliminary functional neural basis for cognitive insight in the VLPFC in healthy people that accords with our fronto-hippocampal theoretical model as well as recent neuroimaging data in people with psychosis. The results may facilitate the understanding of the role of neural mechanisms in psychotic disorders associated with cognitive insight distortions. © 2014 The Authors. Psychiatry and Clinical Neurosciences © 2014 Japanese Society of Psychiatry and Neurology.

  15. An investigation of factors that impact patients' subjective experience of nurse-led clinics: a qualitative systematic review.

    Science.gov (United States)

    Jakimowicz, Samantha; Stirling, Christine; Duddle, Maree

    2015-01-01

    To systematically review the qualitative evidence on factors that affect the experience of patients attending nurse-led clinics and compare with key elements of person-centred care. As the number of nurse-led clinics increases in response to health system needs, evaluation has focused on clinical outcomes and cost. Patient experiences are less researched and yet, they are an important influence on clinical outcomes and an indicator of person-centred care. A detailed review of existing research in this area is needed. A systematic review of primary, qualitative literature was conducted using the Joanna Briggs Institute methodology of meta-aggregation. Published research from 1990-2012 was located using CINAHL, PubMed, Medline and PsycINFO. Reference lists were searched and analysed. Two reviewers assessed the papers for methodological quality using instruments from the Joanna Briggs Institute to critically appraise, extract data and meta-aggregate findings. Eleven studies met all inclusion criteria. Three meta-synthesis statements were derived from 46 findings aggregated to nine categories. The key themes relating to establishment of a therapeutic relationship, effective communication, and clinical skills and collaboration mapped closely to the person-centred care framework. Concepts central to person-centred care proved to be factors impacting patients' subjective experience. Further research is warranted to meet the challenge to transform the key concepts of the person-centred care model into everyday nursing practice. Knowledge of patients' feelings and the importance of person-centred, individualised care may contribute to development of future training and re-training programs in basic nursing skills. This is significant in that it contributes to future positive patient experience. © 2014 John Wiley & Sons Ltd.

  16. The value of structured data elements from electronic health records for identifying subjects for primary care clinical trials.

    Science.gov (United States)

    Ateya, Mohammad B; Delaney, Brendan C; Speedie, Stuart M

    2016-01-11

    An increasing number of clinical trials are conducted in primary care settings. Making better use of existing data in the electronic health records to identify eligible subjects can improve efficiency of such studies. Our study aims to quantify the proportion of eligibility criteria that can be addressed with data in electronic health records and to compare the content of eligibility criteria in primary care with previous work. Eligibility criteria were extracted from primary care studies downloaded from the UK Clinical Research Network Study Portfolio. Criteria were broken into elemental statements. Two expert independent raters classified each statement based on whether or not structured data items in the electronic health record can be used to determine if the statement was true for a specific patient. Disagreements in classification were discussed until 100 % agreement was reached. Statements were also classified based on content and the percentages of each category were compared to two similar studies reported in the literature. Eligibility criteria were retrieved from 228 studies and decomposed into 2619 criteria elemental statements. 74 % of the criteria elemental statements were considered likely associated with structured data in an electronic health record. 79 % of the studies had at least 60 % of their criteria statements addressable with structured data likely to be present in an electronic health record. Based on clinical content, most frequent categories were: "disease, symptom, and sign", "therapy or surgery", and "medication" (36 %, 13 %, and 10 % of total criteria statements respectively). We also identified new criteria categories related to provider and caregiver attributes (2.6 % and 1 % of total criteria statements respectively). Electronic health records readily contain much of the data needed to assess patients' eligibility for clinical trials enrollment. Eligibility criteria content categories identified by our study can be

  17. Identification of clinically significant psychological distress and psychiatric morbidity by examining quality of life in subjects with occupational asthma

    Directory of Open Access Journals (Sweden)

    Ghezzo Heberto

    2011-09-01

    Full Text Available Abstract Background The Juniper Asthma Specific Quality of Life Questionnaire (AQLQ(S is a questionnaire that allows measurement of disease specific quality of life. We wanted to examine correlations between the (AQLQ(S general and different subscale scores and both psychiatric morbidity and levels of psychological distress in individuals with occupational asthma (OA and to determine if results in the emotional function subscale allow identification of individuals with clinically significant psychological distress or current psychiatric disorders. Methods This was a cross-sectional study of individuals with OA who were assessed during a re-evaluation for permanent disability, after they were no longer exposed to the sensitizing agent. Patients underwent a general sociodemographic and medical history evaluation, a brief psychiatric interview (Primary Care Evaluation of Mental Disorders, PRIME-MD and completed a battery of questionnaires including the AQLQ(S, the St-Georges Respiratory Questionnaire (SGRQ, and the Psychiatric Symptom Index (PSI. Results There was good internal consistency (Cronbach alpha = 0.936 for the AQLQ(S total score and construct validity for the AQLQ(S (Spearman rho = -0.693 for the SGRQ symptom score and rho = -0.650 for the asthma severity score. There were medium to large correlations between the total score of the AQLQ(S and the SGRQ symptom score (r = -.693, and PSI total (r = -.619 and subscale scores (including depression, r = -.419; anxiety, r = -.664; anger, r = -.367; cognitive disturbances, r = -.419. A cut-off of 5.1 on the AQLQ(S emotional function subscale (where 0 = high impairment and 7 = no impairment had the best discriminative value to distinguish individuals with or without clinically significant psychiatric distress according to the PSI, and a cut-off of 4.7 best distinguished individuals with or without a current psychiatric disorder according to the PRIME-MD. Conclusions Impaired quality of life is

  18. HLA-G regulatory haplotypes and implantation outcome in couples who underwent assisted reproduction treatment.

    Science.gov (United States)

    Costa, Cynthia Hernandes; Gelmini, Georgia Fernanda; Wowk, Pryscilla Fanini; Mattar, Sibelle Botogosque; Vargas, Rafael Gustavo; Roxo, Valéria Maria Munhoz Sperandio; Schuffner, Alessandro; Bicalho, Maria da Graça

    2012-09-01

    The role of HLA-G in several clinical conditions related to reproduction has been investigated. Important polymorphisms have been found within the 5'URR and 3'UTR regions of the HLA-G promoter. The aim of the present study was to investigate 16 SNPs in the 5'URR and 14-bp insertion/deletion (ins/del) polymorphism located in the 3'UTR region of the HLA-G gene and its possible association with the implantation outcome in couples who underwent assisted reproduction treatments (ART). The case group was composed of 25 ART couples. Ninety-four couples with two or more term pregnancies composed the control group. Polymorphism haplotype frequencies of the HLA-G were determined for both groups. The Haplotype 5, Haplotype 8 and Haplotype 11 were absolute absence in ART couples. The HLA-G*01:01:02a, HLA-G*01:01:02b alleles and the 14-bp ins polymorphism, Haplotype 2, showed an increased frequency in case women and similar distribution between case and control men. However, this susceptibility haplotype is significantly presented in case women and in couple with failure implantation after treatment, which led us to suggest a maternal effect, associated with this haplotype, once their presence in women is related to a higher number of couples who underwent ART. Copyright © 2012. Published by Elsevier Inc.

  19. Percentage of subjects with no heavy drinking days: evaluation as an efficacy endpoint for alcohol clinical trials.

    Science.gov (United States)

    Falk, Daniel; Wang, Xin Qun; Liu, Lei; Fertig, Joanne; Mattson, Margaret; Ryan, Megan; Johnson, Bankole; Stout, Robert; Litten, Raye Z

    2010-12-01

    Percent subjects with no heavy drinking days (PSNHDDs), an efficacy end point recommended by the Food and Drug Administration, considers abstinent individuals or those engaging in low-risk drinking behavior as successful responders to treatment. As PSNHDD has been used infrequently in previous alcohol clinical trials, we evaluated the utility and validity of the PSNHDD outcome measure in 2 large alcohol clinical trials. Data sets from 2 alcohol trials, COMBINE and a multisite topiramate trial, were used to analyze PSNHDDs and other traditional end points for the topiramate, naltrexone, acamprosate, and placebo groups. Effect sizes of PSNHDDs were determined for each month of active treatment and by varying grace periods-early periods in the trial where outcome is not considered in the analysis-and were compared with that of other traditional outcome measures. Long-term outcomes were compared for groups that had no heavy drinking days versus those that had heavy drinking days during active treatment. PSNHDD effect sizes were significant for both topiramate (0.34 and 0.25 at months 2 and 3, respectively) and naltrexone (0.24 and 0.26 at months 3 and 4, respectively). Given a 2-month grace period for naltrexone, the effect size of PSNHDDs was comparable to the effect sizes using traditional outcome measures. With a 1-month grace period for topiramate, it was greater than the majority of traditional outcome measures. Little is gained by allowing up to 1, 2, or 3 heavy drinking days as an end point. Subjects with no HDDs during treatment fared better than those with some HDDs on drinking outcomes and alcohol-related consequences during a 1-year follow-up. PSNHDD appears to be a clinically informative end point measure, especially when used with a grace period, and is as sensitive as most traditional outcome measures in detecting differences between the medication and placebo groups. Nonetheless, these findings should be replicated in other clinical data sets

  20. Hepatitis E virus (HEV): seroprevalence and HEV RNA detection in subjects attending a sexually transmitted infection clinic in Brussels, Belgium.

    Science.gov (United States)

    Dauby, N; Suin, V; Jacques, M; Abady, M; VAN DEN Wijngaert, S; Delforge, M; DE Wit, S; Libois, A

    2017-12-01

    Men who have sex with men (MSM) have an increased incidence of pathogens transmitted by the oro-fecal route. Hepatitis E virus (HEV) is an emerging cause of acute hepatitis and fecal shedding is observed during primary infection. We investigated whether MSM are at increased risk of HEV infection. Subjects who attended a sexually transmitted infection clinic in Brussels and had an HIV test performed between 1 June 2014 and 15 January 2016 were identified. A total of 576 samples were retrospectively screened for both total HEV IgG and HEV RNA. Samples positive for IgG were tested for IgM. MSM proportion was 31·1% (179/576). Overall HEV IgG prevalence was 9·03% (52/576) and was identical in MSM and heterosexual subjects. Among the IgG positive samples, 2/52 (3·84%) samples (both women) were positive for anti-HEV IgM. No sample was positive for HEV RNA. Age over 35 was the only risk factor significantly associated with HEV seropositivity (OR 2·07; 95% CI 1·16-3·67). In conclusion, MSM were not found to have an increased prevalence of HEV as previously reported in other European countries suggesting distinct dynamics of HEV infection in this group across Europe and increased age was associated with a higher risk of seropositivity.

  1. Rapid Targeted Next-Generation Sequencing Platform for Molecular Screening and Clinical Genotyping in Subjects with Hemoglobinopathies

    Directory of Open Access Journals (Sweden)

    Xuan Shang

    2017-09-01

    Full Text Available Hemoglobinopathies are among the most common autosomal-recessive disorders worldwide. A comprehensive next-generation sequencing (NGS test would greatly facilitate screening and diagnosis of these disorders. An NGS panel targeting the coding regions of hemoglobin genes and four modifier genes was designed. We validated the assay by using 2522 subjects affected with hemoglobinopathies and applied it to carrier testing in a cohort of 10,111 couples who were also screened through traditional methods. In the clinical genotyping analysis of 1182 β-thalassemia subjects, we identified a group of additional variants that can be used for accurate diagnosis. In the molecular screening analysis of the 10,111 couples, we detected 4180 individuals in total who carried 4840 mutant alleles, and identified 186 couples at risk of having affected offspring. 12.1% of the pathogenic or likely pathogenic variants identified by our NGS assay, which were undetectable by traditional methods. Compared with the traditional methods, our assay identified an additional at-risk 35 couples. We describe a comprehensive NGS-based test that offers advantages over the traditional screening/molecular testing methods. To our knowledge, this is among the first large-scale population study to systematically evaluate the application of an NGS technique in carrier screening and molecular diagnosis of hemoglobinopathies.

  2. A phase 2a randomized controlled study to evaluate the pharmacokinetic, safety, tolerability and clinical effect of topically applied Umeclidinium in subjects with primary axillary hyperhidrosis.

    Science.gov (United States)

    Nasir, A; Bissonnette, R; Maari, C; DuBois, J; Pene Dumitrescu, T; Haddad, J; Yamaguchi, Y; Dalessandro, M

    2018-01-01

    Hyperhidrosis is a common medical condition which can have a significant impact on quality of life. Umeclidinium (UMEC) is a long-acting muscarinic antagonist (LAMA) developed as a dermal formulation. This 2-week, double-blind, randomized, vehicle-controlled study evaluated systemic exposure, safety and tolerability of topically administered UMEC in subjects with primary axillary hyperhidrosis. Clinical effect was a secondary objective, measured by gravimetry and the hyperhidrosis disease severity scale (HDSS). Vehicle was included to evaluate safety. Twenty-three subjects were randomized to either 1.85% UMEC (N = 18) or vehicle (N = 5) once daily. Measurable plasma concentrations were observed in 78% of subjects after the treatment. Nine subjects (50%) on UMEC and two subjects (40%) on vehicle reported AEs, most commonly application site reactions. At Day 15, seven subjects (41%) in UMEC and two subjects (40%) in vehicle had at least a 50% reduction in sweat production. Eight subjects (47%) in UMEC and one subject (20%) in vehicle had at least a two-point reduction in HDSS. No comparisons of treatment arms were planned prospectively. The measurable exposure, acceptable safety and preliminary clinical activity observed in this proof-of-concept study suggest the potential clinical utility of topical UMEC in subjects with axillary hyperhidrosis. © 2017 European Academy of Dermatology and Venereology.

  3. The Biological Activity of Propolis-Containing Toothpaste on Oral Health Environment in Patients Who Underwent Implant-Supported Prosthodontic Rehabilitation

    National Research Council Canada - National Science Library

    Morawiec, Tadeusz; Dziedzic, Arkadiusz; Niedzielska, Iwona; Mertas, Anna; Tanasiewicz, Marta; Skaba, Dariusz; Kasperski, Jacek; Machorowska-Pieniążek, Agnieszka; Kucharzewski, Marek; Szaniawska, Karolina; Więckiewicz, Włodzimierz; Więckiewicz, Mieszko

    2013-01-01

    .... Sixteen subjects who underwent an oral rehabilitation with dental implants were selected and randomly assigned into two groups, which received a newly formulated propolis-containing toothpaste (3% (CA...

  4. Identification of subtypes in subjects with mild-to-moderate airflow limitation and its clinical and socioeconomic implications

    Directory of Open Access Journals (Sweden)

    Lee JH

    2017-04-01

    Full Text Available Jin Hwa Lee,1 Chin Kook Rhee,2 Kyungjoo Kim,2 Jee-Ae Kim,3 Sang Hyun Kim,4 Kwang Ha Yoo,5 Woo Jin Kim,6 Yong Bum Park,7 Hye Yun Park,8 Ki-Suck Jung9 1Division of Pulmonary and Critical Care Medicine, Department of Medicine, School of Medicine, EwhaWomans University, 2Department of Internal Medicine, Seoul St Mary’s Hospital, The Catholic University of Korea, Seoul, 3Pharmaceutical Policy Evaluation Research Team, Research Institution, Health Insurance Review and Assessment Service, 4Big Data Division, Health Insurance Review and Assessment Service, Wonju, 5Department of Internal Medicine, Konkuk University College of Medicine, Seoul, 6Department of Internal Medicine and Environmental Health Center, Kangwon National University Hospital, Chuncheon, 7Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, 8Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 9Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea Purpose: The purpose of this study was to identify subtypes in patients with mild-to-moderate airflow limitation and to appreciate their clinical and socioeconomic implications.Methods: Subjects who were aged ≥20 years and had forced expiratory volume in 1 second (FEV1 ≥60% predicted and FEV1/forced vital capacity <0.7 were selected from the fourth Korea National Health and Nutrition Examination Survey (KNHANES in 2007–2012. The data were merged to the National Health Insurance reimbursement database during the same period. k-Means clustering was performed to explore subtypes. For clustering analysis, six key input variables – age, body mass index (BMI, FEV1% predicted, the presence or absence of self-reported wheezing

  5. Accuracy of bone SPECT/CT for identifying hardware loosening in patients who underwent lumbar fusion with pedicle screws

    Energy Technology Data Exchange (ETDEWEB)

    Hudyana, Hendrah; Maes, Alex [AZ Groeninge, Department of Nuclear Medicine, Kortrijk (Belgium); University Hospital Leuven, Department of Morphology and Medical Imaging, Leuven (Belgium); Vandenberghe, Thierry; Fidlers, Luc [AZ Groeninge, Department of Neurosurgery, Kortrijk (Belgium); Sathekge, Mike [University of Pretoria, Department of Nuclear Medicine, Pretoria (South Africa); Nicolai, Daniel [AZ Groeninge, Department of Nuclear Medicine, Kortrijk (Belgium); Wiele, Christophe van de [AZ Groeninge, Department of Nuclear Medicine, Kortrijk (Belgium); University Ghent, Department of Radiology and Nuclear Medicine, Ghent (Belgium)

    2016-02-15

    The aim of this retrospective study was to evaluate the accuracy of bone SPECT (single photon emission computed tomography)/CT (computed tomography) in diagnosing loosening of fixation material in patients with recurrent or persistent back pain that underwent lumbar arthrodesis with pedicle screws using surgery and clinical follow-up as gold standard A total of 48 patients (median age 49 years, range 21-81 years; 17 men) who had undergone lumbar spinal arthrodesis were included in this retrospective analysis. SPECT/CT results were compared to the gold standard of surgical evaluation or clinical follow-up. Positive SPECT/CT results were considered true positives if findings were confirmed by surgery or if clinical and other examinations were completely consistent with the positive SPECT/CT finding. They were considered false positives if surgical evaluation did not find any loose pedicle screws or if symptoms subsided with non-surgical therapy. Negative SPECT/CT scans were considered true negatives if symptoms either improved without surgical intervention or remained stable over a minimum follow-up period of 6 months. Negative SPECT/CT scans were determined to be false negatives if surgery was still required and loosening of material was found. The median length of time from primary surgery to bone SPECT/CT referral was 29.5 months (range 12-192 months). Median follow-up was 18 months (range 6-57) for subjects who did not undergo surgery. Thirteen of the 48 patients were found to be positive for loosening on bone SPECT/CT. Surgical evaluation (8 patients) and clinical follow-up (5 patients) showed that bone SPECT/CT correctly predicted loosening in 9 of 13 patients, while it falsely diagnosed loosening in 4 patients. Of 35 negative bone SPECT/CT scans, 12 were surgically confirmed. In 18 patients, bone SPECT/CT revealed lesions that could provide an alternative explanation for the symptoms of pain (active facet degeneration in 14 patients, and disc and sacroiliac

  6. Acoustic CR neuromodulation therapy for subjective tonal tinnitus: a review of clinical outcomes in an independent audiology practice setting

    Directory of Open Access Journals (Sweden)

    Mark eWilliams

    2015-03-01

    Full Text Available OBJECTIVE: To describe the quantitative treatment outcomes of patients undergoing acoustic coordinated reset (CR neuromodulation at a single independent audiology practice over a 22 – 26 week period as part of an open label, non-randomized, non-controlled observational study.Methods: Sixty six patients with subjective tonal tinnitus were treated with acoustic CR Neuromodulation with a retrospective review of patient records being performed in order to identify changes of visual analogue scale (VAS, n=66 and in the score of the Tinnitus Handicap Questionnaire (THQ, n =51. Patients had their tinnitus severity recorded prior to the initiation of therapy using the Tinnitus Handicap Inventory (THI in order to categorize patients into slight up to catastrophic impact categories. THQ and VAS for tinnitus loudness / annoyance were obtained at the patient’s initial visit, at 10-14 weeks and 22-26 weeks. RESULTS: VAS scores were significantly improved, demonstrating a 25.8% mean reduction in tinnitus loudness and a 32% mean reduction in tinnitus annoyance with a clinically significant reduction in percept loudness and annoyance being recorded in 59.1% and 72.7% of the patient group. THQ scores were significantly improved by 19.4% after 22-26 weeks of therapy compared to baseline. CONCLUSION: Acoustic CR neuromodulation therapy appears to be a practical and promising treatment for subjective tonal tinnitus. However, due to the lack of a control group it is difficult to reach an absolute conclusion regarding to what extent the observed effects are related directly to the acoustic CR neuromodulation therapy. Also as the observed patient group was made up of paying clients it is unknown as to whether this could have caused any additional placebo like effects to influence the final results.

  7. Study of the seroma volume changes in the patients who underwent Accelerated Partial Breast Irradiation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Dae Ho; Son, Sang Jun; Mun, Jun Ki; Seo, Seok Jin; Lee, Je Hee [Dept. of Radiation Oncology, Seoul National University Hospital, Seoul (Korea, Republic of)

    2016-06-15

    By analyzing seroma volume changes in the patients who underwent Partial breast radiation therapy after breast conserving surgery, we try to contribute to the improvement of radiotherapy effect. Enrolled 20 patients who underwent partial breast radiation therapy by ViewRay MRIdian System were subject. After seeking for the size of the removed sample in the patients during surgery and obtained seroma volume changes on a weekly basis. On the Basis of acquired volume, it was compared with age, term from start of the first treatment after surgery, BMI (body mass index) and the extracted sample size during surgery. And using the ViewRay MRIdian RTP System, the figure was analyzed by PTV(=seroma volume + margin) to obtain a specific volume of the Partial breast radiation therapy. The changes of seroma volume from MR simulation to the first treatment (a week) is 0~5% in 8, 5~10% in 3, 10 to 15% in 2, and 20% or more in 5 people. Two patients(A, B patient) among subjects showed the biggest change. The A patient's 100% of the prescribed dose volume is 213.08 cc, PTV is 181.93 cc, seroma volume is 15.3 cc in initial plan. However, while seroma volume decreased 65.36% to 5.3 cc, 100% of the prescribed dose volume was reduced to 3.4% to 102.43 cc and PTV also did 43.6% to 102.54 cc. In the case of the B patient, seroma volume decreased 42.57% from 20.2 cc to 11.6 cc. Because of that, 100% of the prescribed dose volume decreased 8.1% and PTV also did to 40%. As the period between the first therapy and surgery is shorter, the patient is elder and the size of sample is smaller than 100 cc, the change grow bigger. It is desirable to establish an adaptive plan according to each patient's changes of seroma volume through continuous observation. Because partial breast patients is more sensitive than WBRT patients about dose conformity in accordance with the volume change.

  8. Clinicopathological Features of Cervical Esophageal Cancer: Retrospective Analysis of 63 Consecutive Patients Who Underwent Surgical Resection.

    Science.gov (United States)

    Saeki, Hiroshi; Tsutsumi, Satoshi; Yukaya, Takafumi; Tajiri, Hirotada; Tsutsumi, Ryosuke; Nishimura, Sho; Nakaji, Yu; Kudou, Kensuke; Akiyama, Shingo; Kasagi, Yuta; Nakashima, Yuichiro; Sugiyama, Masahiko; Sonoda, Hideto; Ohgaki, Kippei; Oki, Eiji; Yasumatsu, Ryuji; Nakashima, Torahiko; Morita, Masaru; Maehara, Yoshihiko

    2017-01-01

    The objectives of this retrospective study were to elucidate the clinicopathological features and recent surgical results of cervical esophageal cancer. Cervical esophageal cancer has been reported to have a dismal prognosis. Accurate knowledge of the clinical characteristics of cervical esophageal cancer is warranted to establish appropriate therapeutic strategies. The clinicopathological features and treatment results of 63 consecutive patients with cervical esophageal cancer (Ce group) who underwent surgical resection from 1980 to 2013 were analyzed and compared with 977 patients with thoracic or abdominal esophageal cancer (T/A group) who underwent surgical resection during that time. Among the patients who received curative resection, the 5-year overall and disease-specific survival rates of the Ce patients were significantly better than those of the T/A patients (overall: 77.3% vs 46.5%, respectively, P = 0.0067; disease-specific: 81.9% vs 55.8%, respectively, P = 0.0135). Although total pharyngo-laryngo-esophagectomy procedures were less frequently performed in the recent period, the rate of curative surgical procedures was markedly higher in the recent period (2000-1013) than that in the early period (1980-1999) (44.4% vs 88.9%, P = 0.0001). The 5-year overall survival rate in the recent period (71.5%) was significantly better than that in the early period (40.7%, P = 0.0342). Curative resection for cervical esophageal cancer contributes to favorable outcomes compared with other esophageal cancers. Recent surgical results for cervical esophageal cancer have improved, and include an increased rate of curative resection and decreased rate of extensive surgery.

  9. Gender-specific differences in serum immunoglobulin E levels and prevalence of fungus in sinonasal tissue noted in patients with chronic rhinosinusitis who underwent endoscopic sinus surgery.

    Science.gov (United States)

    Azar, Antoine; Rank, Matthew A; Zarka, Matthew A; Chang, Yu-Hui; Lal, Devyani

    2017-11-01

    We previously presented that women with chronic rhinosinusitis (CRS) who elected endoscopic sinus surgery (ESS) have a higher symptom burden than men. Causes of these gender-based differences warranted further study. To study gender differences in another cohort of adult patients with CRS who underwent ESS and to compare key histopathologic and serologic features Methods: Patients with CRS who underwent ESS (from 2011 to 2014) with structured histopathology reports on surgical samples were studied. The 13-item structured histopathology report detailed key metrics of inflammation and the presence of fungal elements. Clinical, 22-item Sino-Nasal Outcome Test (SNOT-22) score, Lund-Mackay computed tomography (CT) score, serologic (immunoglobulin E [IgE] level, absolute eosinophil count) and histopathologic data were compared between male and female patients by using statistical software. We studied 130 eligible subjects (mean age, 54.7 years; 49.2% women). Compared with the men, the women had significantly higher preoperative SNOT-22 scores (women, 48.7; men 38.0 [p = 0.004]) but similar CT scores. Serum IgE levels were significantly higher among women versus men (peak, 433.3 versus 190.8 kU/L [p = 0.03]; closest to surgery, 435.0 versus 190.8 kU/L [p = 0.03]). Tissue fungal elements were significantly more prevalent in women versus men (19.0 versus 5.2%; p = 0.02). Up to this point, the analysis was agnostic of clinical details of the subjects. Further analysis was conducted regarding clinical features. Allergic fungal sinusitis (AFS) was found significantly more commonly in the female versus male patients (21.9 versus 9.1%; p = 0.04). Women versus men had a higher prevalence of migraine (19.4 versus 4.6%; p = 0.01) or any primary headache disorders (23.0 versus 6.2%; p = 0.007). Women who underwent ESS for CRS had higher SNOT-22 symptom burden. Worsened symptomatology may be secondary to a higher prevalence of primary headache disorders in women. However, surgeons

  10. High Prevalence of Stress and Low Prevalence of Alzheimer Disease CSF Biomarkers in a Clinical Sample with Subjective Cognitive Impairment.

    Science.gov (United States)

    Eckerström, Marie; Berg, Anne Ingeborg; Nordlund, Arto; Rolstad, Sindre; Sacuiu, Simona; Wallin, Anders

    2016-01-01

    Subjective cognitive impairment (SCI) is a trigger for seeking health care in a possible preclinical phase of Alzheimer's disease (AD), although the characteristics of SCI need clarification. We investigated the prevalence of psychosocial stress, depressive symptoms and CSF AD biomarkers in SCI and MCI (mild cognitive impairment). Memory clinic patients (SCI: n = 90; age: 59.8 ± 7.6 years; MCI: n = 160; age: 63.7 ± 7.0 years) included in the Gothenburg MCI study were examined at baseline. Variables were analyzed using logistic regression with SCI as dependent variable. Stress was more prevalent in SCI (51.1%) than MCI (23.1%); p patients had more previous depressive symptoms (p = 0.006), but showed no difference compared to MCI patients considering current depressive symptoms. A positive CSF AD profile was present in 14.4% of SCI patients and 35.0% of MCI patients (p = 0.001). Stress (p = 0.002), previous stress/depressive symptoms (p = 0.006) and a negative CSF AD profile (p = 0.036) predicted allocation to the SCI group. Psychosocial stress is more prevalent in SCI than previously acknowledged. The high prevalence and long-term occurrence of stress/depressive symptoms in SCI in combination with a low prevalence of altered CSF AD biomarkers strengthens the notion that AD is not the most likely etiology of SCI. © 2016 S. Karger AG, Basel.

  11. Correlates of subjective transportation deficiency among older adults attending outpatient clinics in a tertiary care hospital in Mexico City.

    Science.gov (United States)

    Navarrete-Reyes, Ana Patricia; Medina-Rimoldi, Carlos Tonatiuh; Avila-Funes, José Alberto

    2017-11-01

    Older adults frequently report problems of transportation. Little is known about the correlates of transportation deficiency in Latin America. Therefore, the aim of the present study was to determine the correlates of subjective transportation deficiency (STD) among community-dwelling older adults attending a tertiary care hospital in Mexico City. Cross-sectional study of 228 participants aged ≥70 years being followed in any of the outpatient clinics of a tertiary care hospital in Mexico City. Data were obtained through a structured questionnaire. Univariate and multivariate logistic regression analyses were carried out in order to identify the correlates of STD. The mean age of the participants was 79.8 years (SD 6.4) and 67.1% were women. STD was present in 46% of participants. The multivariate logistic regression model showed that female sex, illiteracy, mobility disability and the use of an assistive walking device had an independent and statistically significant association with STD. Female sex, illiteracy, mobility disability and the use of an assistive walking device were independent correlates of STD in the present study. Identifying the frequency and correlates of transportation deficiency in vulnerable populations will allow for the identification and implementation of useful public policies, as well as for the optimization of prevention and treatment strategies in an attempt to preserve mobility and autonomy, especially in low- and middle-income countries where previous work on transportation deficiency is lacking. Geriatr Gerontol Int 2017; 17: 1893-1898. © 2017 Japan Geriatrics Society.

  12. Clinical and treatment-related determinants of subjective quality of life in patients with first-episode psychosis.

    Science.gov (United States)

    Kwong, Vivian Wing Yan; Chang, Wing Chung; Chan, Gloria Hoi Kei; Jim, Olivia Tsz Ting; Lau, Emily Sin Kei; Hui, Christy Lai Ming; Chan, Sherry Kit Wa; Lee, Edwin Ho Ming; Chen, Eric Yu Hai

    2017-03-01

    Subjective quality of life (SQoL) has been increasingly studied in first-episode psychosis (FEP). Prior research primarily examined the impact of psychiatric symptoms on SQoL. Relationship between treatment-related factors and SQoL is under-studied. In this study, 159 Chinese patients who had completed 2-year treatment from early intervention service in Hong Kong were recruited. Assessments on premorbid adjustment, clinical profiles including social anxiety measure, functioning, antipsychotic-induced extrapyramidal side-effects and attitude toward medication treatment were conducted. SQoL was evaluated by Chinese version SF36 which generated mental and physical component summary (MCS and PCS) scores for analysis. Our results showed that more severe positive symptoms, higher level of depression, greater social anxiety, more negative attitude toward antipsychotic medications and greater degree of akathisia independently predicted lower MCS score. Higher social anxiety level and poorer functioning predicted lower PCS score. Our results indicate that affective and positive symptoms, functioning, and treatment-related variables are critical determinants of SQoL in FEP patients. These identified factors thus represent potentially malleable therapeutic targets for early detection and prompt intervention to promote enhancement of SQoL in the early stage of illness. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  13. Clearance of /sup 99m/-technetium-labelled DTPA in asbestos-exposed subjects without clinical or radiological evidence of interstitial lung disease

    Energy Technology Data Exchange (ETDEWEB)

    Gellert, A.R.; Langford, J.A.; Winter, R.J.; Lewis, C.A.; Tolfree, S.E.; Rudd, R.M.

    1985-01-01

    The half-time clearance of an inhaled aerosol of /sup 99m/-technetium-labelled diethylene triamine pentacetate from lung to blood (T1/2LB) was measured using a gamma camera in 20 non-smoking subjects (mean age 54, range 40-69 years) with previous occupational asbestos exposure, but no clinical or radiological evidence of asbestosis, and 20 non-smoking normal subjects (mean age 54, range 40-62). Mean T1/2LB was 44.7 minutes (range 12-102) in exposed subjects, significantly less than 57.2 minutes (range 30.5-109) in normal subjects (P less than 0.05). There was no correlation between age and T1/2LB in either group. In exposed subjects T1/2LB showed a weak rank correlation with the membrane component of DLco (Dm) (r = 0.40, P less than 0.05) but no significant correlation with FVC, TLC, DLco, Kco, resting Pao2 or change in Pao2 on exercise. In six exposed subjects T1/2LB was shorter than in any of the normal subjects. These six did not differ from the other 14 exposed subjects in any physiological variables. T1/2LB is abnormal in some asbestos-exposed subjects without clinical, radiological or physiological evidence of asbestosis. Follow-up will show whether it is an early indicator of development of interstitial lung disease.

  14. Clearance of 99m-technetium-labelled DTPA in asbestos-exposed subjects without clinical or radiological evidence of interstitial lung disease.

    Science.gov (United States)

    Gellert, A R; Langford, J A; Winter, R J; Lewis, C A; Tolfree, S E; Rudd, R M

    1985-01-01

    The half-time clearance of an inhaled aerosol of 99m-technetium-labelled diethylene triamine pentacetate from lung to blood (T1/2LB) was measured using a gamma camera in 20 non-smoking subjects (mean age 54, range 40-69 years) with previous occupational asbestos exposure, but no clinical or radiological evidence of asbestosis, and 20 non-smoking normal subjects (mean age 54, range 40-62). Mean T1/2LB was 44.7 minutes (range 12-102) in exposed subjects, significantly less than 57.2 minutes (range 30.5-109) in normal subjects (P less than 0.05). There was no correlation between age and T1/2LB in either group. In exposed subjects T1/2LB showed a weak rank correlation with the membrane component of DLco (Dm) (r = 0.40, P less than 0.05) but no significant correlation with FVC, TLC, DLco, Kco, resting Pao2 or change in Pao2 on exercise. In six exposed subjects T1/2LB was shorter than in any of the normal subjects. These six did not differ from the other 14 exposed subjects in any physiological variables. T1/2LB is abnormal in some asbestos-exposed subjects without clinical, radiological or physiological evidence of asbestosis. Follow-up will show whether it is an early indicator of development of interstitial lung disease.

  15. [Clinical, paraclinic and evolutive profile of HIV infected subject compared with that of non-HIV infected subject in pneumology hospitalization at Abidjan].

    Science.gov (United States)

    Horo, K; Koffi, M O; Dje Bi, H; Bemba, L P; Adanon, K D N; Brou-Gode, V C; Ahui, J M B; Kouassi, A B; N'Gom, A; Koffi, N; Aka-Danguy, E

    2016-04-01

    The HIV infection is a problem of public health in Côte d'Ivoire. Voluntary screening is encouraged for the premature management of HIV infected patients before the stage of serious opportunist affections. Antiretroviral therapy became free. The purpose of this study was to describe the characteristics of HIV infected subject infected in hospitalization of pneumology. Our retrospective and analytic study concerned the activity period from January 2001 to December 2012 of pneumology department of Cocody university hospital. On 1141 recorded files, the prevalence of HIV infection was 48.20%. The multi-varied analysis showed the following results. Male patients were less HIV infected (OR=0.490 [0.363-0.661]) as the old patients of more than 64 years (OR=0.150 [0.080-0.280]). In case of HIV infection, infectious pathology, severe anemia and renal insufficiency were dominating respectively with OR=1.763 (1.212-2.564), OR=3.167 (2.125-4.720) and OR=2.054 (1.335-3.161). A stronger mortality was associated with HIV infection (OR=1.920 [1.312-2.809]). HIV infection always remains frequented in pneumology hospitalization in Abidjan with late discovery, source of complications and abnormally high death rate. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  16. Comparative analysis of pain in patients who underwent total knee replacement regarding the tourniquet pressure

    Directory of Open Access Journals (Sweden)

    Marcos George de Souza Leão

    Full Text Available ABSTRACT OBJECTIVES: To evaluate through the visual analog scale (VAS the pain in patients undergoing total knee replacement (TKR with different pressures of the pneumatic tourniquet. METHODS: An observational, randomized, descriptive study on an analytical basis, with 60 patients who underwent TKR, divided into two groups, which were matched: a group where TKR was performed with tourniquet pressures of 350 mmHg (standard and the other with systolic blood pressure plus 100 mmHg (P + 100. These patients had their pain assessed by VAS at 48 h, and at the 5th and 15th days after procedure. Secondarily, the following were also measured: range of motion (ROM, complications, and blood drainage volume in each group; the data were subjected to statistical analysis. RESULTS: After data analysis, there was no statistical difference regarding the incidence of complications (p = 0.612, ROM (p = 0.202, bleeding after 24 and 48 h (p = 0.432 and p = 0.254 or in relation to VAS. No correlation was observed between time of ischemia compared to VAS and bleeding. CONCLUSIONS: The use of the pneumatic tourniquet pressure at 350 mmHg or systolic blood pressure plus 100 mmHg did not influence the pain, blood loss, ROM, and complications. Therefore the pressures at these levels are safe and do not change the surgery outcomes; the time of ischemia must be closely observed to avoid major complications.

  17. 2000 Volvo Award winner in clinical studies: Lumbar high-intensity zone and discography in subjects without low back problems.

    Science.gov (United States)

    Carragee, E J; Paragioudakis, S J; Khurana, S

    2000-12-01

    A prospective observational study of patients with low back pain and those without was performed. To investigate the prevalence and significance of a high-intensity zone in a group of patients asymptomatic for low back pain, but who had known risk factors for lumbar disc degeneration. This asymptomatic group was compared with a symptomatic group of patients with respect to the presence of anular high-intensity zone and the pain response with discography. Some authors have estimated the prevalence of a high-intensity zone in a group of symptomatic patients to be 86%. They have reported a strong correlation between a high-intensity zone and positive discography in patients with low back pain. Other investigators have reported evidence either supporting or discounting these findings. Patients with low back pain and those without underwent physical examination, psychometric testing, plain radiograph, magnetic resonance imaging, and discography. The presence of a high-intensity zone, anular disruption, and positive discographic pain then were compared between the two groups. There were strict inclusion criteria for both groups. A total of 109 discs in 42 patients were evaluated in the symptomatic group and compared with 143 discs in 54 patients in the asymptomatic group. The presence of a high-intensity zone was determined by a standardized criteria on T2-weighted magnetic resonance images. Psychometric testing also was administered to each patient before discography. Standard discography was performed on all the patients, and the pain response was recorded using a visual analog scale according to the Walsh et al criteria. The prevalence of a high-intensity zone in the patient populations was 59% in the symptomatic group and 24% in the asymptomatic group. In the symptomatic group, 33 (30.2%) of 109 discs were found to have a high-intensity zone. In the asymptomatic group, 13 of 143 discs were found to have a high-intensity zone. In the symptomatic group, 72.7% of the

  18. Impaired Fat-induced Thermogenesis in Obese Subjects: The NUGENOB Study

    NARCIS (Netherlands)

    Blaak, E.E.; Hul, G.; Verdich, C.; Stich, V.; Martinez, J.A.; Petersen, M.; Feskens, E.J.M.; Patel, K.; Oppert, J.M.; Barbe, P.; Tourbro, S.; Polak, J.; Anderson, I.; Astrup, A.; Macdonald, I.; Langin, D.; Sorensen, T.; Saris, W.H.M.

    2007-01-01

    Objectives: To study energy expenditure before and 3 hours after a high-fat load in a large cohort of obese subjects (n=701) and a lean reference group (n = 113). Research Methods and Procedures: Subjects from seven European countries underwent a 1-day clinical study with a liquid test meal

  19. Clinical, endocrinological and histopathological patterns of infertile Saudi men subjected to testicular biopsy: A retrospective study from a single center.

    Science.gov (United States)

    Madbouly, Khaled; Al-Hooti, Qais; Albkri, Abdullah; Ragheb, Samir; Alghamdi, Khaled; Al-Jasser, Abdullah

    2012-09-01

    To evaluate the outcome of testicular biopsies as well as the etiology of azoospermia and severe oligospermia in Saudi men referred for tertiary care. To correlate testicular histology with patients' clinical and hormonal profiles. Charts of men subjected to testicular biopsies in the last 10-year period were retrospectively reviewed. Relative history and physical examination findings were reported. Results of male fertility profile tests and semen analysis of at least two ejaculates were collected. Reported histopathology was obtained. Reports of 229 patients were included; 199 (86.9%) with azoospermia and 30 (13.1%) with severe oligospermia. The mean (SD) age was 30.6 (6.4) years. A small right or left testis was reported in 88 (38.4%) and 87 (38%) of the patients, respectively. The mean (SD) testosterone and follicle stimulating hormone (FSH) values were 17.2 (7.2) nmol/L and 13.1 (10.9) IU/L, respectively. Hypospermatogenesis was the most common histology encountered (36.5%), followed by Sertoli cell-only (SCO) histology (31.5%). Low testicular volume (P = 0.000), high FSH (P = 0.001) and high leutenizing hormone (LH) (P = 0.001) were found to be of significantly adverse effect on spermatogenesis. Despite having bilateral small testes, high serum FSH and LH, 24.3% of our patients showed active spermatogenesis. Hypospermatogenesis was the most common pattern of spermatogenic defect in our patients. SCO histology was the most common pattern in patients with small testes, primary testicular failure, primary infertility and azoospermia. Low testicular volume, high FSH and LH are significantly associated with impaired spermatogenesis. Even with severe male factor infertility disorders, infertile men can have some spermatogenesis.

  20. Common and rare genetic markers of lipid variation in subjects with type 2 diabetes from the ACCORD clinical trial

    Directory of Open Access Journals (Sweden)

    Skylar W. Marvel

    2017-05-01

    Full Text Available Background Individuals with type 2 diabetes are at an increased risk of cardiovascular disease. Alterations in circulating lipid levels, total cholesterol (TC, low-density lipoprotein (LDL, high-density lipoprotein (HDL, and triglycerides (TG are heritable risk factors for cardiovascular disease. Here we conduct a genome-wide association study (GWAS of common and rare variants to investigate associations with baseline lipid levels in 7,844 individuals with type 2 diabetes from the ACCORD clinical trial. Methods DNA extracted from stored blood samples from ACCORD participants were genotyped using the Affymetrix Axiom Biobank 1 Genotyping Array. After quality control and genotype imputation, association of common genetic variants (CV, defined as minor allele frequency (MAF ≥ 3%, with baseline levels of TC, LDL, HDL, and TG was tested using a linear model. Rare variant (RV associations (MAF < 3% were conducted using a suite of methods that collapse multiple RV within individual genes. Results Many statistically significant CV (p < 1 × 10−8 replicate findings in large meta-analyses in non-diabetic subjects. RV analyses also confirmed findings in other studies, whereas significant RV associations with CNOT2, HPN-AS1, and SIRPD appear to be novel (q < 0.1. Discussion Here we present findings for the largest GWAS of lipid levels in people with type 2 diabetes to date. We identified 17 statistically significant (p < 1 × 10−8 associations of CV with lipid levels in 11 genes or chromosomal regions, all of which were previously identified in meta-analyses of mostly non-diabetic cohorts. We also identified 13 associations in 11 genes based on RV, several of which represent novel findings.

  1. Common and rare genetic markers of lipid variation in subjects with type 2 diabetes from the ACCORD clinical trial.

    Science.gov (United States)

    Marvel, Skylar W; Rotroff, Daniel M; Wagner, Michael J; Buse, John B; Havener, Tammy M; McLeod, Howard L; Motsinger-Reif, Alison A

    2017-01-01

    Individuals with type 2 diabetes are at an increased risk of cardiovascular disease. Alterations in circulating lipid levels, total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides (TG) are heritable risk factors for cardiovascular disease. Here we conduct a genome-wide association study (GWAS) of common and rare variants to investigate associations with baseline lipid levels in 7,844 individuals with type 2 diabetes from the ACCORD clinical trial. DNA extracted from stored blood samples from ACCORD participants were genotyped using the Affymetrix Axiom Biobank 1 Genotyping Array. After quality control and genotype imputation, association of common genetic variants (CV), defined as minor allele frequency (MAF) ≥ 3%, with baseline levels of TC, LDL, HDL, and TG was tested using a linear model. Rare variant (RV) associations (MAF < 3%) were conducted using a suite of methods that collapse multiple RV within individual genes. Many statistically significant CV (p < 1 × 10-8) replicate findings in large meta-analyses in non-diabetic subjects. RV analyses also confirmed findings in other studies, whereas significant RV associations with CNOT2, HPN-AS1, and SIRPD appear to be novel (q < 0.1). Here we present findings for the largest GWAS of lipid levels in people with type 2 diabetes to date. We identified 17 statistically significant (p < 1 × 10-8) associations of CV with lipid levels in 11 genes or chromosomal regions, all of which were previously identified in meta-analyses of mostly non-diabetic cohorts. We also identified 13 associations in 11 genes based on RV, several of which represent novel findings.

  2. Rare genetic variants with large effect on triglycerides in subjects with a clinical diagnosis of familial vs nonfamilial hypertriglyceridemia.

    Science.gov (United States)

    De Castro-Orós, Isabel; Civeira, Fernando; Pueyo, María Jesús; Mateo-Gallego, Rocío; Bolado-Carrancio, Alfonso; Lamíquiz-Moneo, Itziar; Álvarez-Sala, Luis; Fabiani, Fernando; Cofán, Montserrat; Cenarro, Ana; Rodríguez-Rey, José Carlos; Ros, Emilio; Pocoví, Miguel

    2016-01-01

    Most primary severe hypertriglyceridemias (HTGs) are diagnosed in adults, but their molecular foundations have not been completely elucidated. We aimed to identify rare dysfunctional mutations in genes encoding regulators of lipoprotein lipase (LPL) function in patients with familial and non-familial primary HTG. We sequenced promoters, exons, and exon-intron boundaries of LPL, APOA5, LMF1, and GPIHBP1 in 118 patients with severe primary HTG (triglycerides >500 mg/dL) and 53 normolipidemic controls. Variant functionality was analyzed using predictive software and functional assays for mutations in regulatory regions. We identified 29 rare variants, 10 of which had not been previously described: c.(-16A>G), c.(1018+2G>A), and p.(His80Arg) in LPL; p.(Arg143Alafs*57) in APOA5; p.(Val140Ile), p.(Leu235Ile), p.(Lys520*), and p.(Leu552Arg) in LMF1; and c.(-83G>A) and c.(-192A>G) in GPIHBP1. The c.(1018+2G>A) variant led to deletion of exon 6 in LPL cDNA, whereas the c.(-16A>G) analysis showed differences in the affinity for nuclear proteins. Overall, 20 (17.0%) of the patients carried at least one allele with a rare pathogenic variant in LPL, APOA5, LMF1, or GPIHBP1. The presence of a rare pathogenic variant was not associated with lipid values, family history of HTG, clinical diagnosis, or previous pancreatitis. Less than one in five subjects with triglycerides >500 mg/dL and no major secondary cause for HTG may carry a rare pathogenic mutation in LPL, APOA5, LMF1, or GPIHBP1. The presence of a rare pathogenic variant is not associated with a differential phenotype. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  3. Safety and efficacy of sodium hyaluronate (IBD98E) in the induction of clinical and endoscopic remission in subjects with distal ulcerative colitis.

    Science.gov (United States)

    Fiorino, Gionata; Gilardi, Daniela; Naccarato, Patrizia; Sociale, Orsola R; Danese, Silvio

    2014-04-01

    Sodium hyaluronate can contribute to the hydration and maintenance of the integrity of the intestinal mucosa. Restoration of the protective layer with sodium hyaluronate may contribute to the induction of remission of active ulcerative colitis. We investigated the safety and efficacy of sodium hyaluronate enema (IBD98E) in distal active ulcerative colitis, in a prospective, uncontrolled, open-label pilot trial. Subjects with active distal ulcerative colitis (UCDAI ≥ 4 and sigmoidoscopy score ≥ 1) received IBD98E 60 mL enema once a day. Primary endpoints were safety and clinical response rate at Day 28. Secondary endpoints included clinical remission, endoscopic remission, and tolerability of IBD98E. Paired Student's t-test was performed to assess statistically significant differences in subjects between baseline and Day 28. Twenty-one subjects were enrolled. The overall safety profile was good; no serious adverse events were recorded. At Day 28, 9 subjects (42.9%) were clinical responders, and 10 subjects (47.6%) had an endoscopic response. Eight subjects (38.1%) achieved clinical remission, and 10 subjects (47.6%) achieved endoscopic remission. The mean average UCDAI score decreased from 6.10 to 3.81 at Day 28 (p=0.001), and average endoscopic score decreased from 1.57 to 1.10 (p=0.004). IBD98E seems to be safe and effective for the induction of clinical and endoscopic remission. Placebo-controlled studies are warranted. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  4. [Mycobacterium tuberculosis infection in a pediatric patient who underwent a hematopoietic stem cell transplant].

    Science.gov (United States)

    Palma, Julia; Catalán, Paula; Mardones, Patricia; Santolaya, M Elena

    2013-04-01

    We report the case of a 10 year old girl with a relapsed acute lymphoblastic leukemia, who underwent a haploidentical hematopoietic stem cell transplant (HSCT), with grade II skin and digestive graft versus host disease, treated with corticosteroids and cyclosporine. On day + 54, she presented fever, with no other remarkable clinical findings. Imaging study showed the presence of lung and liver nodules, liver biopsy was performed. The study included histology, staining and culture for bacteria and fungi, and the preservation of a piece of tissue at -20°C for future prospective studies. Ziehl Nielsen stain was positive, and study for Mycobacterium infection was performed. Microbiological smears of tracheal and gastric aspirate, and bronchial fluid obtained by bronchoalveolar lavage (BAL) were positive. The final report confirmed Mycobacterium tuberculosis in gastric content, sputum, BAL and liver tissue, susceptible to rifampin, isoniazid, streptomycin and ethambutol, with determination of mutations for genes rpoβ and kat G (-). Tuberculosis (TB) diagnosis was confirmed. The girl received daily therapy for two months and then she continued on three times per week therapy for 9 months. Controlled by the transplant, infectious diseases and respiratory teams, the patient remained in good general condition, with radiologic resolution of pulmonary and liver involvement and negative smears. We conclude that Mycobacterium tuberculosis infection should be part of differential diagnosis of febrile illness in patients undergoing HSCT, and biopsy should be a standard practice of early diagnosis in these patients.

  5. The Effect of Two Different Hand Exercises on Grip Strength, Forearm Circumference, and Vascular Maturation in Patients Who Underwent Arteriovenous Fistula Surgery

    OpenAIRE

    Kong, Sangwon; Lee, Kyung Soo; Kim, Junho; Jang, Seong Ho

    2014-01-01

    Objective To compare the effect of two different hand exercises on hand strength and vascular maturation in patients who underwent arteriovenous fistula surgery. Methods We recruited 18 patients who had chronic kidney disease and had undergone arteriovenous fistula surgery for hemodialysis. After the surgery, 10 subjects performed hand-squeezing exercise with GD Grip, and other 8 subjects used Soft Ball. The subjects continued the exercises for 4 weeks. The hand grip strength, pinch strength ...

  6. Clinical interpretation of a masticatory normative indicator analysis of masticatory function in subjects with different occlusal and prosthodontic status

    NARCIS (Netherlands)

    Witter, D.J.; Woda, A.; Bronkhorst, E.M.; Creugers, N.H.J.

    2013-01-01

    OBJECTIVES: To analyse the masticatory function of subjects characterised by different occlusal and prosthodontic status. Using Optosil((R)) as a test food, the masticatory normative indicator (MNIOPT) was used to differentiate between sufficient ('normal') and impaired masticatory function.

  7. A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study

    Directory of Open Access Journals (Sweden)

    Ward Loren S

    2008-03-01

    Full Text Available Abstract Background This study evaluated a specialized whey fraction (Prolibra™, high in leucine, bioactive peptides and milk calcium for use as a dietary supplement to enhance weight loss. Methods This was a randomized, double-blind, parallel-arm, 12-week study. Caloric intake was reduced 500 calories per day. Subjects consumed Prolibra or an isocaloric ready-to-mix beverage 20 minutes before breakfast and 20 minutes before dinner. Body fat and lean muscle tissue were measured by dual-energy x-ray absorptiometry (DEXA. Body weight and anthropometric measurements were recorded every 4 weeks. Blood samples were taken at the beginning and end of the study. Statistical analyses were performed on all subjects that completed (completer analysis and all subjects that lost at least 2.25 kg of body weight (responder analysis. Within group significance was determined at P Results Both groups lost a significant amount of weight and the Prolibra group tended to lose more weight than the control group; however the amount of weight loss was not significantly different between groups after 12 weeks. Prolibra subjects lost significantly more body fat compared to control subjects for both the completer (2.81 vs. 1.62 kg P = 0.03 and responder (3.63 vs. 2.11 kg, P = 0.01 groups. Prolibra subjects lost significantly less lean muscle mass in the responder group (1.07 vs. 2.41 kg, P = 0.02. The ratio of fat to lean loss (kg fat lost/kg lean lost was much larger for Prolibra subjects for both completer (3.75 vs. 1.05 and responder (3.39 vs. 0.88 groups. Conclusion Subjects in both the control and treatment group lost a significant amount of weight with a 500 calorie reduced diet. Subjects taking Prolibra lost significantly more body fat and showed a greater preservation of lean muscle compared to subjects consuming the control beverage. Because subjects taking Prolibra lost 6.1% of their body fat mass, and because a 5% reduction of body fat mass has been shown to

  8. From the ideal market to the ideal clinic: constructing a normative standard of fairness for human subjects research.

    Science.gov (United States)

    Phillips, Trisha

    2011-02-01

    Preventing exploitation in human subjects research requires a benchmark of fairness against which to judge the distribution of the benefits and burdens of a trial. This paper proposes the ideal market and its fair market price as a criterion of fairness. The ideal market approach is not new to discussions about exploitation, so this paper reviews Wertheimer's inchoate presentation of the ideal market as a principle of fairness, attempt of Emanuel and colleagues to apply the ideal market to human subjects research, and Ballantyne's criticisms of both the ideal market and the resulting benchmark of fairness. It argues that the criticism of this particular benchmark is on point, but the rejection of the ideal market is mistaken. After presenting a complete account of the ideal market, this paper proposes a new method for applying the ideal market to human subjects research and illustrates the proposal by considering a sample case.

  9. Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia.

    Science.gov (United States)

    Bain, Earle E; Shafner, Laura; Walling, David P; Othman, Ahmed A; Chuang-Stein, Christy; Hinkle, John; Hanina, Adam

    2017-02-21

    Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. Most clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. It is assumed that doses are taken, but the exact timing of these events is often incomplete and imprecise. The objective of this pilot study was to evaluate the use of a novel artificial intelligence (AI) platform (AiCure) on mobile devices for measuring medication adherence, compared with modified directly observed therapy (mDOT) in a substudy of a Phase 2 trial of the α7 nicotinic receptor agonist (ABT-126) in subjects with schizophrenia. AI platform generated adherence measures were compared with adherence inferred from drug concentration measurements. The mean cumulative pharmacokinetic adherence over 24 weeks was 89.7% (standard deviation [SD] 24.92) for subjects receiving ABT-126 who were monitored using the AI platform, compared with 71.9% (SD 39.81) for subjects receiving ABT-126 who were monitored by mDOT. The difference was 17.9% (95% CI -2 to 37.7; P=.08). Using drug levels, this substudy demonstrates the potential of AI platforms to increase adherence, rapidly detect nonadherence, and predict future nonadherence. Subjects monitored using the AI platform demonstrated a percentage change in adherence of 25% over the mDOT group. Subjects were able to use the technology successfully for up to 6 months in an ambulatory setting with early termination rates that are comparable to subjects outside of the substudy. ClinicalTrials.gov NCT01655680 https://clinicaltrials.gov/ct2/show/NCT01655680?term=NCT01655680.

  10. Elevated urinary albumin excretion is not linked to the angiotensin I-converting enzyme gene polymorphism in clinically healthy subjects

    DEFF Research Database (Denmark)

    Clausen, P; Jensen, J S; Borch-Johnsen, K

    2000-01-01

    An elevated urinary albumin excretion (UAE) in non-diabetic subjects without renal or cardiovascular disease has been shown to be predictive of ischaemic heart disease. An insertion (I)/deletion (D) polymorphism in the angiotensin I-converting enzyme (ACE) gene has been identified and the D allel...

  11. The Relevance of student seminars on clinically related subjects in a biochemistry course for medical and nutrition students

    National Research Council Canada - National Science Library

    Hermes‐Lima, Marcelo; Muniz, Karinne C; Coutinho, Iracema S

    2002-01-01

    The aim of this study was to determine the value of a system of seminars on clinically related biochemistry topics for undergraduate students in medicine and nutrition at the University of Brasília, Brazil...

  12. Decline of Pulmonary Function Is Associated With the Presence of Rheumatoid Factor in Korean Health Screening Subjects Without Clinically Apparent Lung Disease: A Cross-Sectional Study.

    Science.gov (United States)

    Hwang, Jiwon; Song, Jae-Uk; Ahn, Joong Kyong

    2016-05-01

    Although higher-than-normal levels of rheumatoid factor (RF) are often observed in subjects without specific medical problems, little is known about the influence of RF on pulmonary function in health screening subjects. This study aimed to determine the association between the presence of RF and decreased pulmonary function in Korean health screening subjects without any history of joint disease or clinically apparent lung disease.A total of 115,641 study subjects (age range, 18-88 years) participated in the health checkup program. We excluded subjects who did not have pulmonary function test, as well as those with abnormal chest radiographs. Subjects with medical history of arthritis including rheumatoid arthritis, and lung disease based on the self-reported questionnaire. Final analysis was performed on 94,438 Koreans (41,261 women).RF-positive subjects had a lower forced vital capacity (FVC) predicted value and forced expiratory volume in 1 s (FEV1) predicted value than RF-negative subjects (82.8 ± 11.5% vs 83.8 ± 11.4% for FVC% predicted and 83.5 ± 13.0% vs 85.1 ± 12.9% for FEV1% predicted, P smoking history (adjusted odds ratio [OR] = 1.289 [95% confidence interval [CI] 1.163-1.429], P < 0.001 for nonsmokers and adjusted OR = 1.138 [95% CI 1.004-1.289], P < 0.001 for smokers) while the decline of FVC% predicted only in nonsmokers (adjusted OR = 1.251 [95% CI 1.133-1.382], P < 0.001). Our results suggest that the presence of RF could impact pulmonary function in apparently healthy subjects. A follow-up study to investigate serial changes in pulmonary function may reveal the actual influence of raised RF titers.

  13. Assessment and comparison of anemia of chronic disease in healthy subjects and chronic periodontitis patients: A clinical and hematological study

    Directory of Open Access Journals (Sweden)

    Rajashri A Kolte

    2014-01-01

    Full Text Available Background: Bacteremia is associated with periodontal diseases whose extent is related to the severity of inflammation in periodontal tissues. The purpose of this study was to assess and compare the various blood parameters in healthy subjects and severe chronic periodontitis patients. Materials and Methods: 100 patients with severe chronic periodontitis (test group and 100 periodontally healthy subjects (control group in the age group 35-60 years participated in the study. Blood parameters were recorded with blood samples drawn from the antecubital fossa by venous puncture. Results: Periodontitis group showed lower erythrocyte count and mean corpuscular hemoglobin concentration (MCHC, and increased total leukocyte count (TLC and neutrophil, lymphocyte, and eosinophil count, compared to the healthy control group. Conclusions: To conclude, periodontitis may tend toward anemia and there is marked leukocytosis due to increased number of circulating neutrophils and lymphocytes.

  14. Dataset of mRNA levels for dopaminergic receptors, adrenoceptors and tyrosine hydroxylase in lymphocytes from subjects with clinically isolated syndromes

    Directory of Open Access Journals (Sweden)

    Marco Cosentino

    2016-12-01

    Full Text Available This data article presents a dataset of mRNA levels for dopaminergic receptors, adrenoceptors and for tyrosine hydoxylase, the rate-limiting enzyme in the synthesis of catecholamines, in peripheral blood mononuclear cells as well as in CD4+ T effector and regulatory cells from subjects with clinically isolated syndromes (CIS, which is a first episode of neurological disturbance(s suggestive of multiple sclerosis. CIS subjects are divided into two groups according to their eventual progression, after 12 months from CIS, to clinically established multiple sclerosis. The data reported are related to the article entitled "Dopaminergic receptors and adrenoceptors in circulating lymphocytes as putative biomarkers for the early onset and progression of multiple sclerosis" (M. Cosentino, M. Zaffaroni, M. Legnaro, R. Bombelli, L. Schembri, D. Baroncini, A. Bianchi, R. Clerici, M. Guidotti, P. Banfi, G. Bono, F. Marino, 2016 [1].

  15. Machine Learning classification of MRI features of Alzheimer's disease and mild cognitive impairment subjects to reduce the sample size in clinical trials.

    Science.gov (United States)

    Escudero, Javier; Zajicek, John P; Ifeachor, Emmanuel

    2011-01-01

    There is a need for objective tools to help clinicians to diagnose Alzheimer's Disease (AD) early and accurately and to conduct Clinical Trials (CTs) with fewer patients. Magnetic Resonance Imaging (MRI) is a promising AD biomarker but no single MRI feature is optimal for all disease stages. Machine Learning classification can address these challenges. In this study, we have investigated the classification of MRI features from AD, Mild Cognitive Impairment (MCI), and control subjects from ADNI with four techniques. The highest accuracy rates for the classification of controls against ADs and MCIs were 89.2% and 72.7%, respectively. Moreover, we used the classifiers to select AD and MCI subjects who are most likely to decline for inclusion in hypothetical CTs. Using the hippocampal volume as an outcome measure, we found that the required group sizes for the CTs were reduced from 197 to 117 AD patients and from 366 to 215 MCI subjects.

  16. Enthesitis in patients with psoriatic arthritis, axial spondyloarthritis and healthy subjects assessed by ‘head-to-toe’ whole-body MRI and clinical examination

    DEFF Research Database (Denmark)

    Poggenborg, René Panduro; Eshed, Iris; Østergaard, Mikkel

    2015-01-01

    OBJECTIVES: To investigate the ability of whole-body MRI (WBMRI) to detect axial and peripheral enthesitis in patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), and in healthy subjects (HS). Furthermore, to develop MRI enthesitis indices based on WBMRI and validate...... and patient global (ρ=0.29-0.31, pimaging modality for evaluation of enthesitis in patients with PsA and axSpA, but requires further investigation before clinical use....

  17. The rod orientation test in patients with right-hemisphere infarction : a clinical study of spatial perception in 154 subjects

    NARCIS (Netherlands)

    J.D. Meerwaldt (Johannes David (Jan))

    1982-01-01

    textabstractThis thesis describes a clinical study of disturbances of spatial perception. Chapter I gives a short review of hemispheric asymmetry. For a long time the right hemisphere was regarded as the minor hemisphere, of which substantial regions were thought to have no specific function.

  18. The Relevance of Student Seminars on Clinically Related Subjects in a Biochemistry Course for Medical and Nutrition Students

    Science.gov (United States)

    Hermes-Lima, Marcelo; Muniz, Karinne C.; Coutinho, Iracema S.

    2002-01-01

    The aim of this study was to determine the value of a system of seminars on clinically related biochemistry topics for undergraduate students in medicine and nutrition at the University of Brasilia, Brazil. During the second semester of 1998 (1998-2), the teaching staff decided to establish new and stricter rules for the seminar method and to…

  19. Determining the association of medical co-morbidity with subjective and objective cognitive performance in an inner city memory disorders clinic: a retrospective chart review

    Directory of Open Access Journals (Sweden)

    Jiang Depeng

    2010-12-01

    Full Text Available Abstract Background Medical co-morbidity may be associated with impaired cognitive function based on prior studies. However, no studies to date have determined to what extent this association is linked to medical illness or other factors that may be linked to medical illness (such as education, income levels, depression or subjective memory loss. The present study examined how medical co-morbidity, socioeconomic status (defined as residential SES, education and depression are associated with subjective and objective memory function in a sample of patients recruited from a university affiliated Memory Disorders Clinic located in a large Canadian inner city teaching hospital. Methods Data was collected from 85 consecutive referrals to an Inner City Memory Disorders Clinic including socio-demographic characteristics, cognitive status and medical co-morbidity. Descriptive and correlational analyses were conducted. Results Impaired objective cognitive function correlated significantly with increased medical co-morbidity and partially with education but not with residential SES or depression. Elevated memory complaints correlated significantly with depression, inversely with residential SES and not at all with medical co-morbidity or education. Conclusions Increased medical co-morbidity is significantly associated with impaired cognitive performance but not with subjective memory complaints in an Inner City Memory Clinic sample.

  20. A tale of three blind men on the proper subject matter of clinical science and practice: commentary on Plaud's behaviorism vs. Ilardi and Feldman's cognitive neuroscience.

    Science.gov (United States)

    Forsyth, J P; Kelly, M M

    2001-09-01

    Plaud (J Clin Psychol 57, 1089-1102, 1109-1111, 1119-1120) and Ilardi and Feldman (J Clin Psychol 57, 1067-1088, 1103-1107, 1113-1117, 1121-1124) argue for two very different approaches to clinical science and practice (i.e., behavior analysis and cognitive neuroscience, respectively). We comment on the assets and liabilities of both perspectives as presented and attempt to achieve some semblance of balance between the three protagonists embroiled in this current debate. The vision of clinical science we articulate is more ecumenical and evolutionary, rather than paradigmatic and revolutionary. As we see it, the problem clinical psychology faces is much larger than the authors let on; namely, how best to make clinical science meaningful and relevant to practitioners, consumers, the general public, and the behavioral health-care community. Clinical psychology's immediate internal problem is not pluralism with regard to subject matter, worldview, methodology, or school of thought, but pluralism in clinical psychologists' adherence to a scientific epistemology as the only legitimate form of clinical psychology. On this latter point, we still have a very long way to go. Copyright 2001 John Wiley & Sons, Inc.

  1. A comparison of biochemical pregnancy rates between women who underwent IVF and fertile controls who conceived spontaneously†.

    Science.gov (United States)

    Zeadna, Atif; Son, Weon Young; Moon, Jeong Hee; Dahan, Michael H

    2015-04-01

    Does IVF affect the biochemical pregnancy rate? The likelihood of an early pregnancy loss may be lower and is certainly not higher in IVF cycles when compared with published rates of biochemical pregnancy in fertile women ≤42 years old. The use of gonadotrophins to stimulate multi-folliculogenesis alters endometrial expression of genes and proteins, compared with unstimulated cycles. Exogenous estrogen and progesterone taken for endometrial preparation in frozen embryo transfer cycles, also cause changes in endometrial gene and protein expression .These endometrial alterations may compromise the ability of embryos to develop once implanted, possibly increasing the biochemical pregnancy rate. This is a retrospective study, involving 1636 fresh and 188 frozen, single embryo transfer (SET) IVF cycles performed between August 2008 and December 2012. The biochemical pregnancy rate of the 1824 combined IVF and frozen cycles were compared with fertile controls, derived from the three prospective studies in the medical literature that evaluate this rate. Subjects ≤42-years old, who underwent a SET, as part of a fresh or thawed IVF cycle were considered for inclusion. Each subject is represented only once. The biochemical pregnancy rates were compared with those of historical standard, fertile populations with spontaneous conceptions. The pregnancy rates per transfer for fresh and frozen IVF cycles were similar at 39 and 40%, respectively. There was also no significant difference in the likelihood of pregnancy outcomes (clinical, biochemical and ectopic pregnancy) between fresh IVF and frozen cycles (85.4 versus 85.6%, 13.8 versus 14.8%, 0.5 versus 0%, P = 0.82). However, pregnancy rates decreased in older patients when compared with younger ones P IVF cycles combined was 13.8% of all pregnancies. IVF and frozen cycles were combined as the IVF group treated with hormones for further comparison with the fertile control group. The biochemical pregnancy rate (14%) in the

  2. Safety evaluation of p-synephrine following 15 days of oral administration to healthy subjects: A clinical study.

    Science.gov (United States)

    Shara, Mohd; Stohs, Sidney J; Smadi, Mahmoud M

    2018-01-01

    Extracts of bitter orange (BOE, Citrus aurantium L.) and its primary protoalkaloid p-synephrine are extensively consumed as dietary supplements. p-Synephrine is also present in foods and juices prepared from various Citrus species. The safety of p-synephrine has been questioned as a result of structural similarities with ephedrine. This study assessed the cardiovascular (stimulant) and hemodynamic effects of BOE (49 mg p-synephrine) daily given to 16 healthy subjects for 15 days in a placebo-controlled, cross-over, double-blinded study. A physical evaluation by a cardiologist, as well as heart rates, blood pressures, and electrocardiograms were determined, and blood samples were drawn at baseline, and Days 5, 10, and 15. Serum levels for caffeine and p-synephrine were measured at 1 and 2 weeks. Subjects completed a 10-item health and metabolic questionnaire at baseline and on Day 15. No significant changes occurred in heart rate, electrocardiograms, systolic blood or diastolic pressures, blood cell counts, or blood chemistries in either the control or p-synephrine treated groups at any time point. No adverse effects were reported in response to the bitter orange (p-synephrine). Caffeine consumed by the participants varied markedly. Under these experimental conditions, BOE and p-synephrine were without stimulant (cardiovascular) and adverse effects. Copyright © 2017 John Wiley & Sons, Ltd.

  3. A search for new MRI criteria for dissemination in space in subjects with a clinically isolated syndrome

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    Korteweg, T.; Barkhof, F. [VU University Medical Centre, Department of Radiology, De Boelelaan 1118, HV, Amsterdam (Netherlands); Tintore, M.; Montalban, X. [Hospital Vall d' Hebron, Department of Neuroimmunology, Barcelona (Spain); Uitdehaag, B.M.J. [VU University Medical Centre, Department of Clinical Epidemiology and Biostatistics, Amsterdam (Netherlands); VU University Medical Centre, Department of Neurology, Amsterdam (Netherlands); Knol, D.L. [VU University Medical Centre, Department of Clinical Epidemiology and Biostatistics, Amsterdam (Netherlands); Vrenken, H. [VU University Medical Centre, Department of Physics and Medical Technology, Amsterdam (Netherlands); Rovira, A. [Magnetic Resonance Unit, Department of Radiology, Barcelona (Spain); Frederiksen, J. [University of Copenhagen, The MS Clinic, Department of Neurology, Copenhagen (Denmark); Miller, D.H.; Fernando, K. [University College London, MS NMR Research Unit, Department of Neuroinflammation, Institute of Neurology, London (United Kingdom); Filippi, M.; Agosta, F.; Rocca, M.A. [Scientific Institute and University Ospedale San Raffaele, Neuroimaging Research Unit, Department of Neurology, Milan (Italy); Fazekas, F.; Enzinger, C. [Medical University Graz, Department of Neurology, Graz (Austria); Parry, A. [University of Oxford, Department of Clinical Neurology, Oxford (United Kingdom); Polman, C.H. [VU University Medical Centre, Department of Neurology, Amsterdam (Netherlands)

    2009-09-15

    The International Panel on the Diagnosis of Multiple Sclerosis (MS) incorporated the Barkhof/Tintore (B/T) magnetic resonance criteria into their diagnostic scheme to provide evidence of dissemination in space of central nervous system lesions, a prerequisite for diagnosing MS in patients who present with clinically isolated syndromes (CIS). Although specific for MS, the B/T criteria were criticised for their low sensitivity and relative complexity in clinical use. We used lesion characteristics at onset from 349 CIS patients in logistic regression and recursive partitioning modelling in a search for simpler and more sensitive criteria, while maintaining current specificity. The resulting models, all based on the presence of periventricular and deep white matter lesions, performed roughly in agreement with the B/T criteria, but were unable to provide higher diagnostic accuracy based on information from a single scan. Apparently, findings from contrast-enhanced and follow-up magnetic resonance scans are needed to improve the diagnostic algorithm. (orig.)

  4. Prognostic Impact of the Geriatric Nutritional Risk Index on Long-Term Outcomes in Patients Who Underwent Percutaneous Coronary Intervention.

    Science.gov (United States)

    Wada, Hideki; Dohi, Tomotaka; Miyauchi, Katsumi; Doi, Shinichiro; Naito, Ryo; Konishi, Hirokazu; Tsuboi, Shuta; Ogita, Manabu; Kasai, Takatoshi; Hassan, Ahmed; Okazaki, Shinya; Isoda, Kikuo; Suwa, Satoru; Daida, Hiroyuki

    2017-06-01

    Malnutrition has been identified as an important predictor of poor clinical outcomes in patients with heart failure. The aim of this study is to examine the prognostic impact of nutritional status in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). The impact of nutrition, assessed using the geriatric nutritional risk index (GNRI) calculated by serum albumin and body mass index, was evaluated in 2,853 patients with CAD who underwent their first PCI between 2000 and 2011. Patients were assigned to tertiles based on their GNRI levels. The incidences of all-cause death and cardiac death were assessed. The median GNRI values were 101 (interquartile range 95 to 106). Lower GNRI levels were associated with older age and higher prevalence of acute coronary syndrome and chronic kidney disease. During the median follow-up period of 7.4 years, Kaplan-Meier curves showed ongoing divergence in rates of mortality among tertiles (GNRI nutritional status was associated with long-term clinical outcomes in CAD patients after PCI. Evaluation of GNRI carries important prognostic information and may guide the therapeutic approach to such patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Prevalence and clinical characteristics of insulin-treated, anti-GAD-positive, type 2 diabetic subjects in an outpatient clinical department of a Dutch teaching hospital.

    NARCIS (Netherlands)

    Romkens, T.E.H.; Kusters, G.C.M.; Netea, M.G.; Netten, P.M.

    2006-01-01

    BACKGROUND: In clinical practice, type 1 and type 2 diabetic patients are sometimes difficult to distinguish. Type 1 diabetes has an immune-mediated pathogenesis, resulting in a loss of insulin-secreting beta-cells. Type 2 diabetes mellitus is characterised by a relative insulin insufficiency,

  6. Practice-based randomized controlled-comparison clinical trial of chiropractic adjustments and brief massage treatment at sites of subluxation in subjects with essential hypertension: pilot study.

    Science.gov (United States)

    Plaugher, Gregory; Long, Cynthia R; Alcantara, Joel; Silveus, Alyssa D; Wood, Herbert; Lotun, Kapildeo; Menke, J Michael; Meeker, William C; Rowe, Stephen H

    2002-05-01

    To determine the feasibility of conducting a randomized clinical trial in the private practice setting examining short- and long-term effects of chiropractic adjustments for subjects with essential hypertension compared with a brief soft tissue massage, as well as a nontreatment control group. Randomized controlled-comparison trial with 3 parallel groups. Private practice outpatient chiropractic clinic. Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. Two months of full-spine chiropractic care (ie, Gonstead) consisting primarily of specific-contact, short-lever-arm adjustments delivered at motion segments exhibiting signs of subluxation. The massage group had a brief effleurage procedure delivered at localized regions of the spine believed to be exhibiting signs of subluxation. The nontreatment control group rested alone for a period of approximately 5 minutes in an adjustment room. Cost per enrolled subject, as well as systolic and diastolic blood pressure (BP) measured with a random-0 sphygmomanometer and patient reported health status (SF-36). Pilot study outcome measures also included an assessment of cooperation of subjects to randomization procedures and drop-out rates, recruitment effectiveness, analysis of temporal stability of BPs at the beginning of care, and the effects of inclusion/exclusion criteria on the subject pool. Thirty subjects enrolled, yielding a cost of $161 per enrolled subject. One subject was later determined to be ineligible, and 6 others dropped out. In both the chiropractic and massage therapy groups, all subjects were classified as either overweight or obese; in the control group there were only 2 classified as such. SF-36 profiles for the groups were similar to that of a normal population. The mean change in diastolic BP was -4 (95% confidence interval [CI]: -8.6, 0.5) in the chiropractic care group, 0.5 (95% CI: -3.5, 4.5) in the brief massage treatment group, and -4.9 (95% CI: -9.7, -0

  7. Measurement properties and feasibility of clinical tests to assess sit-to-stand/stand-to-sit tasks in subjects with neurological disease: a systematic review

    Directory of Open Access Journals (Sweden)

    Paula F. S. Silva

    2014-04-01

    Full Text Available BACKGROUND: Subjects with neurological disease (ND usually show impaired performance during sit-to-stand and stand-to-sit tasks, with a consequent reduction in their mobility levels. OBJECTIVE: To determine the measurement properties and feasibility previously investigated for clinical tests that evaluate sit-to-stand and stand-to-sit in subjects with ND. METHOD: A systematic literature review following the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses protocol was performed. Systematic literature searches of databases (MEDLINE/SCIELO/LILACS/PEDro were performed to identify relevant studies. In all studies, the following inclusion criteria were assessed: investigation of any measurement property or the feasibility of clinical tests that evaluate sit-to-stand and stand-to-sit tasks in subjects with ND published in any language through December 2012. The COSMIN checklist was used to evaluate the methodological quality of the included studies. RESULTS: Eleven studies were included. The measurement properties/feasibility were most commonly investigated for the five-repetition sit-to-stand test, which showed good test-retest reliability (Intraclass Correlation Coefficient:ICC=0.94-0.99 for subjects with stroke, cerebral palsy and dementia. The ICC values were higher for this test than for the number of repetitions in the 30-s test. The five-repetition sit-to-stand test also showed good inter/intra-rater reliabilities (ICC=0.97-0.99 for stroke and inter-rater reliability (ICC=0.99 for subjects with Parkinson disease and incomplete spinal cord injury. For this test, the criterion-related validity for subjects with stroke, cerebral palsy and incomplete spinal cord injury was, in general, moderate (correlation=0.40-0.77, and the feasibility and safety were good for subjects with Alzheimer's disease. CONCLUSIONS: The five-repetition sit-to-stand test was used more often in subjects with ND, and most of the measurement

  8. Clinical and neurophysiologic assessment of strength and spasticity during intrathecal baclofen titration in incomplete spinal cord injury: single-subject design.

    Science.gov (United States)

    Bowden, Mark; Stokic, Dobrivoje S

    2009-01-01

    Spasticity after spinal cord injury (SCI) is commonly managed with oral and intrathecal baclofen (ITB), with less attention to the effects on voluntary motor control. Studies combining clinical and neurophysiologic assessments during dose optimization are rare. Study aims (a) systematically evaluate effects of varied doses of oral and ITB on clinical and neurophysiologic measures of strength and spasticity and (b) relate clinical and neurophysiologic findings. A 41-year-old man with an incomplete T11-ASIA D SCI was studied during ITB titration. Spasticity and strength in the lower extremities were assessed clinically and neurophysiologically at 5 different daily dosages of baclofen: (a) 80 mg oral, (b) 80 mg oral/50 microg ITB, (c) 80 mg oral/125 microg ITB, (d) 30 mg oral/125 microg ITB, and (e) 125 microg ITB only. A dose-dependent change in the Ashworth score and lower limb motor score was observed during titration of oral and ITB. Whereas the Hoffman (H)-reflex was abolished after the introduction of ITB, the flexion withdrawal reflex approximated a dose-dependent pattern. Changes in the motor score and EMG during voluntary muscle activation were proportionally smaller than the corresponding changes in clinical and neurophysiologic measures of spasticity. Neurophysiologic assessment largely paralleled clinical findings. This single-subject study shows that the control of spasticity can be achieved without detrimental effects on strength in incomplete SCI and suggests the need for including strength testing in comprehensive clinical assessment of spasticity. The study shows convergent validity between clinical and neurophysiologic assessments during ITB dose titration. Adding neurophysiologic assessment to clinical assessment may provide objectivity and sensitivity and facilitate decision-making during ITB titration.

  9. Clinical and Laboratory Features of Acute Porphyria: A Study of 36 Subjects in a Chinese Tertiary Referral Center

    Science.gov (United States)

    Yang, Jing; Chen, Qianlong; Yang, Hang; Hua, Baolai; Zhu, Tienan; Zhao, Yongqiang; Yu, Xuezhong; Zhang, Li

    2016-01-01

    Porphyria is a group of eight metabolic disorders characterized by defects in heme biosynthesis. The presentation of porphyria is highly variable, and the symptoms are nonspecific, which accounts in part for delays in establishing a diagnosis. In this study, we report the characteristics of 36 Chinese acute porphyria patients. Most of them were female (33/36), and the median age was 25.3 years (range 18–45 years). The most frequent presenting symptom was abdominal pain (32/36). Hyponatremia was the most common electrolyte abnormality (29/36), and the serum sodium concentration was significantly negatively correlated with convulsion (p = 0.00). Genetic testing provided a precise diagnosis of the patients. Genetic analysis of the porphobilinogen deaminase (PBGD) gene was performed for 10 subjects. Of them, 9 were found to harbor a mutation in the PBGD gene, proving a diagnosis of acute intermittent porphyria, and, in 1 case, a novel Cys209Term mutation was found. PMID:28025645

  10. Clinical and Laboratory Features of Acute Porphyria: A Study of 36 Subjects in a Chinese Tertiary Referral Center.

    Science.gov (United States)

    Yang, Jing; Chen, Qianlong; Yang, Hang; Hua, Baolai; Zhu, Tienan; Zhao, Yongqiang; Zhu, Huadong; Yu, Xuezhong; Zhang, Li; Zhou, Zhou

    2016-01-01

    Porphyria is a group of eight metabolic disorders characterized by defects in heme biosynthesis. The presentation of porphyria is highly variable, and the symptoms are nonspecific, which accounts in part for delays in establishing a diagnosis. In this study, we report the characteristics of 36 Chinese acute porphyria patients. Most of them were female (33/36), and the median age was 25.3 years (range 18-45 years). The most frequent presenting symptom was abdominal pain (32/36). Hyponatremia was the most common electrolyte abnormality (29/36), and the serum sodium concentration was significantly negatively correlated with convulsion (p = 0.00). Genetic testing provided a precise diagnosis of the patients. Genetic analysis of the porphobilinogen deaminase (PBGD) gene was performed for 10 subjects. Of them, 9 were found to harbor a mutation in the PBGD gene, proving a diagnosis of acute intermittent porphyria, and, in 1 case, a novel Cys209Term mutation was found.

  11. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Bharmal Murtuza

    2011-04-01

    Full Text Available Abstract Background Because of the subjective nature of Restless Legs Syndrome (RLS symptoms and the impact of these symptoms on sleep, patient-reported outcomes (PROs play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of this study was to validate a new measure, the Post Sleep Questionnaire (PSQ, to assess sleep dysfunction in subjects with moderate-to-severe RLS symptoms. Methods Pooled data were analyzed from two 12-week, randomized, placebo-controlled trials of gabapentin enacarbil (N = 540. At baseline and Week 12, subjects completed the PSQ and other validated health surveys: IRLS Rating Scale, Clinical Global Impression of Improvement (CGI-I, Profile of Mood States (POMS, Medical Outcomes Study Scale-Sleep (MOS-Sleep, and RLS-Quality of Life (RLSQoL. Pooled data were used post hoc to examine the convergent, divergent, known-group validity and the responsiveness of the PSQ. Results Convergent validity was demonstrated by significant correlations between baseline PSQ items and total scores of IRLS, POMS, RLSQoL, and the MOS-Sleep Scale (p ≤ 0.007 each. Divergent validity was demonstrated through the lack of significant correlations between PSQ items and demographic characteristics. Correlations (p Conclusions Although these analyses were potentially limited by the use of clinical trial data and not prospective data from a study conducted solely for validation purposes, the PSQ demonstrated robust psychometric properties and is a valid instrument for assessing sleep and sleep improvements in subjects with moderate-to-severe RLS symptoms. Trial Registration This study analyzed data from two registered trials, NCT00298623 and NCT00365352.

  12. Effect of high and low glycemic index breakfast on postprandial metabolic parameters and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy: Controlled clinical trial.

    Science.gov (United States)

    Lobos, Daniela R; Vicuña, Isabella A; Novik, Victoria; Vega, Claudia A

    2017-08-01

    The results of studies evaluating the metabolic effects of glycemic index (GI) in subjects with type 2 diabetes mellitus (DM2) have been contradictory. Consequently, the benefits of its application are controversial and polarized opinions of international organizations have been disclosed. The above situation leads this study to evaluate the acute effect of low and high GI breakfast on the glycemic response and satiety in subjects with DM2 under intensive insulin therapy (IIT). A controlled, crossover and single-blind clinical trial was developed involving 10 obese subjects with DM2 under IIT, with a period of at least six months under IIT and with fast insulin prescription before breakfast. Subjects ingested on two different occasions a high or low GI breakfast. In both stages, glycemia was evaluated at 0 (basal), 30, 60 and 120 min, and satiety and satiation were evaluated through a visual analogue scale. In contrast to high GI breakfast, the low GI meal generated a significant decrease of 46% for the area under the curve of glucose (Δ 1940 mg/dL × 120 min, p = 0.022) and in mean glycemia evaluated at 30, 60 and 120 min. Moreover, in the low GI stage 8 of 10 patients achieved a 2 h postprandial glycemia lower than 180 mg/dL, without statistical significance. A nonsignificant increase of 12.7% (Δ 1.06 cm, p = 0.271) in satiety at 120 min in the low GI stage was observed. In contrast to high GI breakfast, the low GI breakfast generated a significantly lower glycemic response. This assay allowed for the contribution of more in depth nutritional recommendations for this group of patients. Registered under ClinicalTrials.gov Identifier no. NCT02881164. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

  13. A Poisson-like model of sub-clinical signs from the examination of healthy aging subjects.

    Science.gov (United States)

    Merrill, Stephen J; Myklebust, Barbara; Myklebust, Joel; Reynolds, Norman; Duthie, Edmund

    2008-08-01

    Our studies of the standard neurological examination on 66 middle-aged (50-64 yrs) and elderly subjects (65-84 yrs) demonstrate that healthy elders have neurological deficits (or "signs") that are not associated with specific known neurological disease. The purpose of the current study is to describe this loss of neurological function in healthy aging subjects as seen through accumulated subclinical neurological signs present. Logistic regression is applied to the data on each of six signs. Parameters determined are used to describe the distribution of first occurrence times for each sign. The results are then used to construct a Poisson-like model that describes the accumulation in the number of signs present over time on average. This model is also used to simulate a longitudinal population to explore the variability in the number of signs present over time in an aging population. As the rate of arrival of the signs is heterogeneous, as determined through logistic regression, and the number of signs detected is finite, the resulting distributions of the number of signs over time have a different nature than Poisson. Our results suggest that we can expect to see on average one neurological deficit in healthy people by the age of 62, and that the expected number of deficits increases linearly at the rate of 1 additional sign every 12 years over a wide age range (age 70-90). The distribution of the number of deficits over time is also described. The linearity in the average rate at which signs appear in this population is somewhat of a surprise, in that an increasing (accelerating) rate might be anticipated. In addition to characterizing the neurological exam results in this group, we demonstrate a methodology that allows the comparison of groups and defines a rate of neurological aging.

  14. Clinical interpretation of a masticatory normative indicator analysis of masticatory function in subjects with different occlusal and prosthodontic status.

    Science.gov (United States)

    Witter, Dick J; Woda, Alain; Bronkhorst, Ewald M; Creugers, Nico H J

    2013-05-01

    To analyse the masticatory function of subjects characterised by different occlusal and prosthodontic status. Using Optosil(®) as a test food, the masticatory normative indicator (MNIOPT) was used to differentiate between sufficient ('normal') and impaired masticatory function. Outcomes of occlusal force and masticatory tests were aggregated from three earlier studies dealing with four denture groups and three natural dentition groups. The four denture groups had a complete removable dental prosthesis in the upper jaw, and displayed one of the four following lower jaw prosthodontic rehabilitations: (i) complete removable dental prosthesis on a low mandible; (ii) complete removable dental prosthesis on a higher mandible; (iii) overdenture on natural roots; and (iv) overdenture on dental implants. The three natural dentition groups were: (i) shortened dental arch; (ii) complete dentition in older participants, and (iii) complete dentition in younger participants. All participants were women. They performed the same tests twice, and outcomes were averaged. A MNIOPT value of 3.68 mm was determined from the participants with complete natural dentitions. Applying the MNIOPT to the participants in the denture groups pointed at a considerable chance for impaired masticatory function, except for participants in the overdenture -implants group. The four denture groups compensated for reduced masticatory efficiency by increased number of masticatory cycles and prolonged mastication time until 'swallowing'. Nevertheless, they also 'swallowed' larger particles compared to the complete dentition group. For a given patient or for a group of subjects with specific dental conditions, MNI enables to discriminate between a sufficient ('normal') and an impaired masticatory function. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Multicenter, Prospective Clinical Evaluation of Respiratory Samples from Subjects at Risk for Pneumocystis jirovecii Infection by Use of a Commercial Real-Time PCR Assay▿†

    Science.gov (United States)

    Hauser, Philippe M.; Bille, Jacques; Lass-Flörl, Cornelia; Geltner, Christian; Feldmesser, Marta; Levi, Michael; Patel, Hitesh; Muggia, Victoria; Alexander, Barbara; Hughes, Martin; Follett, Sarah A.; Cui, Xiaohui; Leung, Flora; Morgan, Gillian; Moody, Adrian; Perlin, David S.; Denning, David W.

    2011-01-01

    Pneumocystis jirovecii pneumonia (PCP) is a common opportunistic infection. Microscopic diagnosis, including diagnosis using the Merifluor-Pneumocystis direct fluorescent antigen (MP-DFA) test, has limitations. Real-time PCR may assist in diagnosis, but no commercially validated real-time PCR assay has been available to date. MycAssay Pneumocystis is a commercial assay that targets the P. jirovecii mitochondrial large subunit (analytical detection limit, ≤3.5 copies/μl of sample). A multicenter trial recruited 110 subjects: 54 with transplants (40 with lung transplants), 32 with nonmalignant conditions, 13 with leukemia, and 11 with solid tumors; 9 were HIV positive. A total of 110 respiratory samples (92% of which were bronchoalveolar lavage [BAL] specimens) were analyzed by PCR. Performance was characterized relative to investigator-determined clinical diagnosis of PCP (including local diagnostic tests), and PCR results were compared with MP-DFA test results for 83 subjects. Thirteen of 14 subjects with PCP and 9/96 without PCP (including 5 undergoing BAL surveillance after lung transplantation) had positive PCR results; sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively) were 93%, 91%, 59%, and 99%, respectively. Fourteen of 83 subjects for whom PCR and MP-DFA test results were available had PCP; PCR sensitivity, specificity, PPV, and NPV were 93%, 90%, 65%, and 98%, respectively, and MP-DFA test sensitivity, specificity, PPV, and NPV were 93%, 100%, 100%, and 98%. Of the 9 PCR-positive subjects without PCP, 1 later developed PCP. The PCR diagnostic assay compares well with clinical diagnosis using nonmolecular methods. Additional positive results compared with the MP-DFA test may reflect low-level infection or colonization. PMID:21367988

  16. Intertester reliability of clinical shoulder instability and laxity tests in subjects with and without self-reported shoulder problems.

    Science.gov (United States)

    Eshoj, Henrik; Ingwersen, Kim Gordon; Larsen, Camilla Marie; Kjaer, Birgitte Hougs; Juul-Kristensen, Birgit

    2018-03-03

    First, to investigate the intertester reliability of clinical shoulder instability and laxity tests, and second, to describe the mutual dependency of each test evaluated by each tester for identifying self-reported shoulder instability and laxity. A standardised protocol for conducting reliability studies was used to test the intertester reliability of the six clinical shoulder instability and laxity tests: apprehension, relocation, surprise, load-and-shift, sulcus sign and Gagey. Cohen's kappa (κ) with 95% CIs besides prevalence-adjusted and bias-adjusted kappa (PABAK), accounting for insufficient prevalence and bias, were computed to establish the intertester reliability and mutual dependency. Forty individuals (13 with self-reported shoulder instability and laxity-related shoulder problems and 27 normal shoulder individuals) aged 18-60 were included. Fair (relocation), moderate (load-and-shift, sulcus sign) and substantial (apprehension, surprise, Gagey) intertester reliability were observed across tests (κ 0.39-0.73; 95% CI 0.00 to 1.00). PABAK improved reliability across tests, resulting in substantial to almost perfect intertester reliability for the apprehension, surprise, load-and-shift and Gagey tests (κ 0.65-0.90). Mutual dependencies between each test and self-reported shoulder problem showed apprehension, relocation and surprise to be the most often used tests to characterise self-reported shoulder instability and laxity conditions. Four tests (apprehension, surprise, load-and-shift and Gagey) out of six were considered intertester reliable for clinical use, while relocation and sulcus sign tests need further standardisation before acceptable evidence. Furthermore, the validity of the tests for shoulder instability and laxity needs to be studied. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Effects of an adapted physical activity program in a group of elderly subjects with flexed posture: clinical and instrumental assessment

    Directory of Open Access Journals (Sweden)

    Frizziero Antonio

    2008-11-01

    Full Text Available Abstract Background Flexed posture commonly increases with age and is related to musculoskeletal impairment and reduced physical performance. The purpose of this clinical study was to systematically compare the effects of a physical activity program that specifically address the flexed posture that marks a certain percentage of elderly individuals with a non specific exercise program for 3 months. Methods Participants were randomly divided into two groups: one followed an Adapted Physical Activity program for flexed posture and the other one completed a non-specific physical activity protocol for the elderly. A multidimensional clinical assessment was performed at baseline and at 3 months including anthropometric data, clinical profile, measures of musculoskeletal impairment and disability. The instrumental assessment of posture was realized using a stereophotogrammetric system and a specific biomechanical model designed to describe the reciprocal position of the body segments on the sagittal plane in a upright posture. Results The Adapted Physical Activity program determined a significant improvement in several key parameters of the multidimensional assessment in comparison to the non-specific protocol: decreased occiput-to-wall distance, greater lower limb range of motion, better flexibility of pectoralis, hamstrings and hip flexor muscles, increased spine extensor muscles strength. Stereophotogrammetric analysis confirmed a reduced protrusion of the head and revealed a reduction in compensative postural adaptations to flexed posture characterized by knee flexion and ankle dorsiflexion in the participants of the specific program. Conclusion The Adapted Physical Activity program for flexed posture significantly improved postural alignment and musculoskeletal impairment of the elderly. The stereophotogrammetric evaluation of posture was useful to measure the global postural alignment and especially to analyse the possible compensatory strategies

  18. Assessment of subjective and motor fatigue in Polio survivors, attending a Postpolio clinic, comparison with healthy controls and an exploration of clinical correlates.

    Science.gov (United States)

    Murray, Deirdre; Hardiman, Orla; Meldrum, Dara

    2014-05-01

    Polio survivors experience declining mobility, pain and fatigue. The extent of motor fatigue and its impact on mobility and quality of life, in addition to other commonly reported impairments requires evaluation. An observational, case-control, cross-sectional design was used to assess 30 Polio survivors and 30 age- and sex-matched controls. Muscle strength and motor fatigue were assessed using fixed dynamometry. Fatigue, pain and quality of life were assessed using the Piper Fatigue Scale, the Fatigue Severity Scale, visual analogue scales and the RAND Short Form-36, respectively. An 8-min walking test, including physiological cost index (PCI), evaluated mobility. A significant difference in motor fatigue was identified only in hand grip (p = 0.03). Polio survivors were significantly weaker (p < 0.001) and more fatigued (p < 0.001) than controls. Motor fatigue was not related to subjective fatigue, mobility or quality of life. Muscle strength predicted mobility. Pain and fatigue were associated with lower mental quality of life, while PCI was associated with physical quality of life. Motor fatigue has been identified in Polio survivors but was only significantly different in hand grip, using this approach. Pain, fatigue and elevated energy cost of walking negatively influenced quality of life. Motor fatigue was unrelated to subjective fatigue, mobility or quality of life.

  19. [Clinical-demographic factors associated with fear-avoidance in subjects with non-specific chronic low back pain in Primary Care: secondary analysis of intervention study].

    Science.gov (United States)

    Díaz-Cerrillo, Juan Luis; Rondón-Ramos, Antonio; Clavero-Cano, Susana; Pérez-González, Rita; Martinez-Calderon, Javier; Luque-Suarez, Alejandro

    2018-01-30

    To describe some sociodemographics and clinical characteristics of subjects with Non-specific Chronic Low Back Pain (NCLBP) in Primary Care, as well as to investigate their association with Fear-Avoidance (FA). Cross-sectional. Secondary analysis of an intervention study. Basic Health Areas in Costa del Sol Health District (Málaga, Spain). An analysis was performed on 147 subjects with NCLBP from a previous intervention study database in Primary Care Physiotherapy (PCP). Characteristics: age 18-65; understanding of the Spanish language; absence of cognitive disorders, fibromyalgia or dorsolumbar surgery, and to be able to perform physical exercise. The main variable was FA level (FABQ and the FABQ-PA and FABQ-W) sub-scales. Clinical variables included: pain (NRPS-11), disability (RMQ), evolution, previous treatments and diagnostic imaging. The sociodemographic variables included: gender, age, educational level, and employment status. Just over half (51.7%) of the subjects had high FA on the FABQ-PA sub-scale. Sick leave (SL) [β=24.45 (P=.009 * ); β=13.03 (P=.016 * ); β=14.04 (P=.011 * ) for FABQ, FABQ-PA and FABQ-W, respectively]; primary studies level [β=15.09 (P=.01 * ); β=9.73 (P=.01 * ) for FABQ and FABQ-PA], and disability [β=1.45 (P<.001); β=0.61 (P<.001); β=0.68 (P<.001) for FABQ, FABQ-PA and FABQ-W, respectively] were associated with FA when they were modeled by multivariate regression. Some sociodemographic and clinical features of the NCLBP population are presented. Imaging tests (81.63%) and previous passive treatments (55.78%) could reflect problems of adherence to recommendations of CPGs. Sick leave, primary studies level, and disability were associated with FA. The findings should be interpreted in the light of possible limitations. Some suggestions for clinical practice are provided. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  20. Early clinical development of artemether-lumefantrine dispersible tablet: palatability of three flavours and bioavailability in healthy subjects

    Directory of Open Access Journals (Sweden)

    Abdulla Salim

    2010-09-01

    Full Text Available Abstract Background Efforts to ease administration and enhance acceptability of the oral anti-malarial artemether-lumefantrine (A-L crushed tablet to infants and children triggered the development of a novel dispersible tablet of A-L. During early development of this new formulation, two studies were performed in healthy subjects, one to evaluate the palatability of three flavours of A-L, and a second one to compare the bioavailability of active principles between the dispersible tablet and the tablet (administered crushed and intact. Methods Study 1 was performed in 48 healthy schoolchildren in Tanzania. Within 1 day, all subjects tasted a strawberry-, orange- and cherry-flavoured oral A-L suspension for 10 seconds (without swallowing in a randomized, single-blind, crossover fashion. The palatability of each formulation was rated using a visual analogue scale (VAS. Study 2 was an open, randomized crossover trial in 48 healthy adults given single doses of A-L (80 mg artemether + 480 mg lumefantrine with food. The objectives were to compare the bioavailability of artemether, dihydroartemisinin (DHA and lumefantrine between the dispersible tablet and the tablet administered crushed (primary objective and intact (secondary objective. Results Study 1 showed no statistically significant difference in VAS scores between the three flavours but cherry had the highest score in several ratings (particularly for overall liking. Study 2 demonstrated that the dispersible and crushed tablets delivered bioequivalent artemether, DHA and lumefantrine systemic exposure (area under the curve [AUC]; mean ± SD AUC0-tlast were 208 ± 113 vs 195 ± 93 h.ng/ml for artemether, 206 ± 81 vs 199 ± 84 h.ng/ml for DHA and 262 ± 107 vs 291 ± 106 h.μg/ml for lumefantrine. Bioequivalence was also shown for peak plasma concentrations (Cmax of DHA and lumefantrine. Compared with the intact tablet, the dispersible tablet resulted in bioequivalent lumefantrine exposure, but

  1. High human herpesvirus 8 (HHV-8 prevalence, clinical correlates and high incidence among recently HIV-1-infected subjects in Sao Paulo, Brazil.

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    Mariana Dias Batista

    Full Text Available BACKGROUND: Human herpesvirus 8 (HHV-8 is the etiological agent for Kaposi Sarcoma, which occurs especially in HIV-infected subjects. HHV-8 infection and its clinical correlates have not been well characterized in recently HIV-1-infected subjects, especially men who have sex with men (MSM. METHODOLOGY/ PRINCIPAL FINDINGS: We assessed the HHV-8 seroprevalence, clinical correlates, and incidence after one year of follow-up in a cohort of 228 recently HIV-1-infected individuals, of whom 83.6% were MSM, using indirect immunofluorescence assay. The prevalence of HHV-8 infection at the time of cohort enrollment was 25.9% (59/228. In the univariate model, there were significant associations with male gender, black ethnicity, MSM practice, and previous hepatitis B virus and syphilis infections. In the multivariate model we could still demonstrate association with MSM, hepatitis B, and black ethnicity. No differences in mean CD4+ cell counts or HIV viral load according to HHV-8 status were found. In terms of incidence, there were 23/127 (18.1% seroconversions in the cohort after 1 year. CONCLUSIONS: HHV-8 is highly prevalent among recently HIV-1-infected subjects. Correlations with other sexually transmitted infections suggest common transmission routes.

  2. Serum and macular response to carotenoid-enriched egg supplementation in human subjects: the Egg Xanthophyll Intervention clinical Trial (EXIT).

    Science.gov (United States)

    Kelly, David; Nolan, John M; Howard, Alan N; Stack, Jim; Akuffo, Kwadwo O; Moran, Rachel; Thurnham, David I; Dennison, Jessica; Meagher, Katherine A; Beatty, Stephen

    2017-01-01

    The macular carotenoids lutein (L), zeaxanthin (Z) and meso-zeaxanthin (MZ) accumulate at the macula, where they are collectively referred to as macular pigment (MP). Augmentation of this pigment, typically achieved through diet and supplementation, enhances visual function and protects against progression of age-related macular degeneration. However, it is known that eggs are a rich dietary source of L and Z, in a highly bioavailable matrix. In this single-blind placebo-controlled study, L- and MZ-enriched eggs and control non-enriched eggs were fed to human subjects (mean age 41 and 35 years, respectively) over an 8-week period, and outcome measures included MP, visual function and serum concentrations of carotenoids and cholesterol. Serum carotenoid concentrations increased significantly in control and enriched egg groups, but to a significantly greater extent in the enriched egg group (Peggs may represent an effective dietary source of L, Z and MZ, reflected in significantly raised serum concentrations of these carotenoids, and consequentially improved bioavailability for capture by target tissues. However, benefits in terms of MP augmentation and /or improved visual performance were not realised over the 8-week study period, and a study of greater duration will be required to address these questions.

  3. Clinical and Laboratory Features of Acute Porphyria: A Study of 36 Subjects in a Chinese Tertiary Referral Center

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    Jing Yang

    2016-01-01

    Full Text Available Porphyria is a group of eight metabolic disorders characterized by defects in heme biosynthesis. The presentation of porphyria is highly variable, and the symptoms are nonspecific, which accounts in part for delays in establishing a diagnosis. In this study, we report the characteristics of 36 Chinese acute porphyria patients. Most of them were female (33/36, and the median age was 25.3 years (range 18–45 years. The most frequent presenting symptom was abdominal pain (32/36. Hyponatremia was the most common electrolyte abnormality (29/36, and the serum sodium concentration was significantly negatively correlated with convulsion (p=0.00. Genetic testing provided a precise diagnosis of the patients. Genetic analysis of the porphobilinogen deaminase (PBGD gene was performed for 10 subjects. Of them, 9 were found to harbor a mutation in the PBGD gene, proving a diagnosis of acute intermittent porphyria, and, in 1 case, a novel Cys209Term mutation was found.

  4. Clinical research, comparison of the subjective visual function in patients with epiphora and patients with second-eye cataract.

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    Kafil-Hussain, Namir; Khooshebah, Ramona

    2005-03-01

    To assess the subjective visual disability of patients with epiphora and to compare the results with that of patients waiting for second eye cataract surgery. A prospective, randomised, questionnaire-based study. Forty-six patients with epiphora listed for dacryocystorhinostomy and 50 patients having second eye cataract extraction were enrolled. A questionnaire focusing on functional visual disability in daily life and based on VF-14 was completed for each participant. Eighty-six percent of patients with epiphora and 41% of second-eye cataracts had difficulty reading small print (P vs. 42%) (P watching television (63.1% vs. 19%) (P vs. 10%) (P reading signs (39.1% vs. 4%) (P < 0.05), respectively. There is widespread recognition of the effect of cataract on visual function. This has resulted in substantial government funding to improve access to cataract surgery. In comparison, epiphora is rarely considered as a significant cause of visual disability. This study suggests that patients with epiphora suffer the same if not more of a visual handicap than patients awaiting second eye cataract surgery.

  5. Testicular microlithiasis and leydig cell proliferation in wistar rats underwent fowler-stephens procedure

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    E. Gougoudi

    2012-08-01

    Full Text Available Objectives: The present study investigates the outcome of Fowler-Stephens operation in prepubertal Wistar rats focused on microlithiasis and Leydig cell hyperplasia development. Methods: Thirty-eight (38 animals underwent laparoscopic Fowler-Stephens operation on the right testis (8 of them formed the control group and 6 of them additional contra-lateral orchectomy. The testes were examined histological 9,30,70 and 90 days later, while ultrasound study was perfomed a day earlier. Results: Initially, atrophic signs were visible as early as 9 days after the operation. Signs of intratubular calcification were obvious 30 days after the operation, in severe atrophic testes. Another important point was that in the animals that underwent orchectomy, testicular microlithiasis co-existed with lesions of Leydig cell hyperplasia. Conclusions: Microlithiasis and Leydig cell hyperplasia seem to have causative relation in operated undescended testis and present serious postoperative complications, with a review in the literature.

  6. PROPHYLAXIS OF SURGICAL SITE INFECTION WITH VANCOMYCIN IN 513 PATIENTS THAT UNDERWENT TO LUMBAR FUSION

    OpenAIRE

    Scheverin, Nicolas; Steverlynck, Alejandro; Castelli, Roberto; Sobrero, Diego; Kopp, Nicolas Videla; Dinelli, Dino; Sarotto, Anibal; Falavigna, Asdrubal

    2015-01-01

    Objective:To assess the prophylactic effects of local vancomycin on an infection of the surgical site in patients undergoing lumbar instrumented fusion.Methods:Retrospective study from January 2011 to June 2014 in patients with symptomatic and refractory lumbar spine stenosis and listhesis who underwent instrumented pedicle screw spinal fusion. Two groups of patient were analyzed, one using vancomycin on the surgical site, vancomycin group (VG) and the control group (CG) without topical vanco...

  7. Complex and Simple Clinical Reaction Times Are Associated with Gait, Balance, and Major Fall Injury in Older Subjects with Diabetic Peripheral Neuropathy.

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    Richardson, James K; Eckner, James T; Allet, Lara; Kim, Hogene; Ashton-Miller, James A

    2017-01-01

    The aim of this work was to identify relationships between complex and simple clinical measures of reaction time (RTclin) and indicators of balance in older subjects with and without diabetic peripheral neuropathy (DPN). Prospective cohort design. Complex RTclin accuracy, simple RTclin latency, and their ratio were determined using a novel device in 42 subjects (mean ± SD age, 69.1 ± 8.3 yrs), 26 with DPN and 16 without. Dependent variables included unipedal stance time (UST), step width variability and range on an uneven surface, and major fall-related injury over 12 months. In the DPN subjects, the ratio of complex RTclin accuracy to simple RTclin latency was strongly associated with longer UST (R/P = 0.653/0.004), and decreased step width variability and range (R/P = -0.696/0.001 and -0.782/injuries had lower complex RTclin accuracy:simple RTclin latency than those without. The ratio of complex RTclin accuracy:simple RTclin latency is a potent predictor of UST and frontal plane gait variability in response to perturbations and may predict major fall injury in older subjects with DPN. These short latency neurocognitive measures may compensate for lower limb neuromuscular impairments and provide a more comprehensive understanding of balance and fall risk.

  8. Risk Factors for Metachronous Gastric Neoplasms in Patients Who Underwent Endoscopic Resection of a Gastric Neoplasm.

    Science.gov (United States)

    Yoon, Hyuk; Kim, Nayoung; Shin, Cheol Min; Lee, Hye Seung; Kim, Bo Kyoung; Kang, Gyeong Hoon; Kim, Jung Mogg; Kim, Joo Sung; Lee, Dong Ho; Jung, Hyun Chae

    2016-03-01

    To identify the risk factors for metachronous gastric neoplasms in patients who underwent an endoscopic resection of a gastric neoplasm. We prospectively collected clinicopathologic data and measured the methylation levels of HAND1, THBD, APC, and MOS in the gastric mucosa by methylation-specific real-time polymerase chain reaction in patients who underwent endoscopic resection of gastric neoplasms. A total of 257 patients with gastric neoplasms (113 low-grade dysplasias, 25 highgrade dysplasias, and 119 early gastric cancers) were enrolled. Metachronous gastric neoplasm developed in 7.4% of patients during a mean follow-up of 52 months. The 5-year cumulative incidence of metachronous gastric neoplasm was 4.8%. Multivariate analysis showed that moderate/severe corpus intestinal metaplasia and family history of gastric cancer were independent risk factors for metachronous gastric neoplasm development; the hazard ratios were 4.12 (95% confidence interval [CI], 1.23 to 13.87; p=0.022) and 3.52 (95% CI, 1.09 to 11.40; p=0.036), respectively. The methylation level of MOS was significantly elevated in patients with metachronous gastric neoplasms compared age- and sex-matched patients without metachronous gastric neoplasms (p=0.020). In patients who underwent endoscopic resection of gastric neoplasms, moderate/severe corpus intestinal metaplasia and a family history of gastric cancer were independent risk factors for metachronous gastric neoplasm, and MOS was significantly hypermethylated in patients with metachronous gastric neoplasms.

  9. Acute myocardial infarctation in patients with critical ischemia underwent lower limb revascularization

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    Esdras Marques Lins

    2013-12-01

    Full Text Available BACKGROUND: Atherosclerosis is the main cause of peripheral artery occlusive disease (PAOD of the lower limbs. Patients with PAOD often also have obstructive atherosclerosis in other arterial sites, mainly the coronary arteries. This means that patients who undergo infrainguinal bypass to treat critical ischemia have a higher risk of AMI. There are, however, few reports in the literature that have assessed this risk properly. OBJECTIVE: The aim of this study was to determine the incidence of acute myocardial infarction in patients who underwent infrainguinal bypass to treat critical ischemia of the lower limbs caused by PAOD. MATERIAL AND METHODS: A total of 64 patients who underwent 82 infrainguinal bypass operations, from February 2011 to July 2012 were studied. All patients had electrocardiograms and troponin I blood assays during the postoperative period (within 72 hours. RESULTS: There were abnormal ECG findings and elevated blood troponin I levels suggestive of AMI in five (6% of the 82 operations performed. All five had conventional surgery. The incidence of AMI as a proportion of the 52 conventional surgery cases was 9.6%. Two patients died. CONCLUSION: There was a 6% AMI incidence among patients who underwent infrainguinal bypass due to PAOD. Considering only cases operated using conventional surgery, the incidence of AMI was 9.6%.

  10. Efficacy and safety of abciximab in diabetic patients who underwent percutaneous coronary intervention with thienopyridines loading: a meta-analysis.

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    Yihua Wu

    Full Text Available BACKGROUND: It has been controversial whether abciximab offered additional benefits for diabetic patients who underwent percutaneous coronary intervention (PCI with thienopyridines loading. METHODS: MEDLINE, EMBASE, the Cochrane library clinical trials registry, ISI Science Citation Index, ISI Web of Knowledge and China National Knowledge Infrastructure (CNKI were searched, supplemented with manual-screening for relevant publications. Quantitative meta-analyses were performed to assess differences between abciximab groups and controls with respect to post-PCI risk of major cardiac events (MACEs, angiographic restenosis and bleeding complications. RESULTS: 9 trials were identified, involving 2,607 diabetic patients receiving PCI for coronary artery diseases. Among those patients who underwent elective PCI or primary PCI, pooling results showed that abciximab did not significantly reduce risks of MACEs (for elective-PCI patients: RR(1-month: 0.93, 95% CI: 0.60-1.44; RR(1-year: 0.95, 95% CI: 0.81-1.11; for primary-PCI patients: RR(1-month: 1.05, 95% CI: 0.70-1.57; RR(1-year: 0.98, 95% CI: 0.80-1.21, nor all-cause mortality, re-infarction and angiographic restenosis in either group. The only beneficial effect by abciximab appeared to be a decrease 1-year TLR (target lesion revascularization risk in elective-PCI patients (RR1-year: 0.83, 95% CI: 0.70-0.99. Moreover, occurrence of minor bleeding complications increased in elective-PCI patients treated with abciximab (RR: 2.94, 95% CI: 1.68-5.13, P<0.001, whereas major bleedings rate was similar (RR: 0.83, 95% CI: 0.27-2.57. CONCLUSIONS: Concomitant dosing of abciximab and thienopyridines provides no additional benefit among diabetic patients who underwent PCI; this conclusion, though, needs further confirmation in larger studies.

  11. Effects of cervical headgear and pendulum appliance on vertical dimension in growing subjects: a retrospective controlled clinical trial.

    Science.gov (United States)

    Lione, Roberta; Franchi, Lorenzo; Laganà, Giuseppina; Cozza, Paola

    2015-06-01

    To analyze the effects on vertical dentoskeletal dimension produced by cervical headgear (CHG) or Pendulum (P) both followed by full fixed appliances in growing patients with Class II malocclusion. The CHG group (CHGG) consisted of 40 patients (25 females, 15 males) with a mean age of 11.5 years. The P group (PG) comprised 40 patients (21 females, 19 males) with a mean age of 11.6 years. Mean treatment duration with the CHG and P appliances were 1.5 years and 8.2 months, respectively. Lateral cephalograms were available before treatment (T1) and at the end of fixed therapy (T2) with a mean interval of 3.5 years. The effects of the 2 protocols were compared with a matched control group (CG) of 25 untreated Class II subjects (13 females, 12 males). The ANOVA with Tukey's post hoc tests was used to evaluate between-group differences at T1 and during the T1-T2 interval (P < 0.05). CHGG showed significantly greater decreases in both Sella-Nasion to A point angle and A-Nasion-B point anglel when compared with both PG (-1.2 and -0.9 degrees, respectively) and CG (-1.9 and -1.5 degrees, respectively). No significant between-group differences were recorded for any of the vertical skeletal measurements. Both CHGG and PG showed significantly greater improvement in molar relationships with respect to CG (+2.5mm). Both distalizing protocols were effective in the correction of Class II malocclusion without increasing the vertical dimension at the end of comprehensive treatment. © The Author 2014. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  12. Clinical measurement of the thoracic kyphosis. A study of the intra-rater reliability in subjects with and without shoulder pain

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    Lewis Jeremy S

    2010-03-01

    Full Text Available Abstract Background Clinical sagittal plane assessment of the thoracic kyphosis angle is considered an essential component of the postural examination of patients presenting with upper body pain syndromes. Cervical headaches and conditions involving the shoulder, such as subacromial pain syndrome, have all been associated with an increase in the thoracic kyphosis. Concomitantly a decrease in the thoracic kyphosis as a result of a stretching and strengthening rehabilitation programme is believed to be associated with a reduction in symptoms and pain and improvement in function. Clinicians generally measure the sagittal plane kyphosis angle visually. There is no certainty that this method is reliable or is capable of measuring angular changes over time or in response to intervention. As such a simple and reliable clinical method of measuring the thoracic kyphosis would enable clinicians to record this information. The aim of this investigation was to determine the intra-tester reliability of measuring the thoracic kyphosis angle using a clinical method Methods Measurements were made in 45 subjects with and 45 subjects without upper body symptoms. Measurements were made with the subjects in relaxed standing. Two gravity dependent inclinometers were used to measure the kyphosis. The first was placed over the region of the 1st and 2nd thoracic spinous processes. The other, over the region of the 12th thoracic and 1st lumbar spinous processes. The angle produced by each inclinometer was measured 3 times in succession. Each set of 3 measurements was made on two occasions (separated by a minimum of 30 minutes and additional data collection involving 46 further measurements of posture and movement on the same and an additional subject before the thoracic kyphosis measurements were re-measured by one rater. The reliability of the measurements was analyzed using 2-way ANOVA intraclass correlation coefficients (ICC, 95% confidence intervals (CI and standard

  13. THE KARDIOKANON STUDY: A WAY TO SETTLE THE SUBJECT OF CLINICAL EQUIVALENCE OF GENERIC AND ORIGINAL DRUGS

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    S. Yu. Martsevich

    2012-01-01

    Full Text Available Aim. To compare two therapies based on the use of original or generic drugs in patients with stable ischemic heart disease (IHD. Material and methods. Patients (n=120, aged 40–72 (58.7±7.7 years, 93 men and 27 women, with stable angina, functional class (FC II (n=117, 97.5% and III (n=3, 2.5%, were included in the multi-center open randomized study with parallel groups. Patients were randomized into 2 groups: group 1 (n=59 received therapy with original drugs only , and group 2 (n=61 — with generics ones only. Efficacy of the therapies was evaluated by the rate of achievement of target blood pressure (BP<130/80 mm Hg, heart rate (HR=55–60 beat per minute and cholesterol of low density lipoprotein (LDL<70 mg% or 1.8 mmol/l, as well as by the degree of reduction in the angina attacks rate, the need in short-acting nitrates, and the angina FC. Treatment duration was 12 weeks. Results. After randomization both groups of patients were comparable by the main clinical indicators. The rates of target levels achievement were the following in group 1 vs group 2, respectively: for BP - 54 vs 44%, p=0.08; for HR - 51 vs 53%, р=0.66; LDL cholesterol - 27.7 vs 9.9% of patients, p=0.002. There were no significant differences between original and generic drugs effects on the angina pectoris symptoms dynamics, as well as their influence on glucose, bilirubin, creatinine, alanine and asparagine transaminases, and creatine phosphokinase blood levels dynamics. The original and generic drugs prescription rates, a total number of prescribed drugs and prescribed doses were comparable in both groups at the end of the study. Three patients dropped out of the trial, the frequency of adverse events was 3.4% in group 1 and 11.5% — in group 2 (p=0.09. Conclusion. Generic drugs with proven bioequivalence, used in the KARDIOKANON study , demonstrated their clinical equivalence to original drugs. The use of these drugs in patients with stable IHD may provide efficacy

  14. Assessment of the accuracy of portable monitors for halitosis evaluation in subjects without malodor complaint. Are they reliable for clinical practice?

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    Denise Pinheiro Falcão

    Full Text Available Abstract Halitosis is defined as a foul odor emanated from the oral cavity, with great impact in quality of life and social restraints. Recently, the use of Breath Alert™ in research increased significantly. Halimeter™, another portable device, is often used in clinical practice. Nevertheless, not many studies have verified the accuracy and compared the results of both devices simultaneously. Objective: To verify the accuracy of Breath Alert™ and Halimeter™ in patients without chief complaint of halitosis, using the organoleptic test (OT as "gold standard." The second aim was to verify whether their concomitant use could enhance the diagnostic accuracy of halitosis. Material and Methods: A cross-sectional analytical study was performed. The quality of expired air of 34 subjects without chief complaint of halitosis was assessed. Two experienced examiners carried out the OT. Afterward, a third blinded examiner performed Halimeter™ (HT and Breath Alert™ (BA tests. Results: The OT identified halitosis in 21 subjects (62%. The area under the ROC curve (95% confidence interval was 0.67 (0.48-0.85 and 0.54 (0.34-0.75 for HT and BA, respectively. The accuracy for HT and BA was 59% and 47%, respectively. The combined usage of HT and BA provided 11 positive results, being 9 subjects (43% out of the total of 21 positive cases. Conclusions: Halimeter™ and Breath Alert™ were not able to diagnose halitosis in non-complainer subjects at the same level as the organoleptic examination, since their accuracy were low. Our results suggest that such portable devices are not reliable tools to assess halitosis and may neglect or misdiagnose a considerable number of patients in clinical practice.

  15. [Prophylaxis of urinary tract infections in subjects with spinal cord injury and bladder function disorders - current clinical practice].

    Science.gov (United States)

    Pannek, J

    2012-01-01

    The aim of this study was to investigate current clinical practice in the prevention of urinary tract infections (UTI) in persons with spinal cord injury in German-speaking spinal cord injury centres. A standardised questionnaire was mailed to 16 German-speaking spinal cord injury rehabilitation centres. Of the 16 centres, 13 responded. The most common strategies for prevention of UTI were antibiotics, urine acidification and cranberry products, although a recent meta-analysis demonstrated that there is no evidence for the usefulness of any of these substances; on the contrary, the use of antibiotics leads to the induction of resistant bacterial strains. Even in specialised centers, prevention of UTI in patients with spinal cord injuries is based rather on the personal experience of the treating physicians than on published evidence. This may at least partly be due to the paucity of evidence-based data. The widespread use of antibiotics carries substantial future risks. Therefore in future, evidence-based studies evaluating the success of the preventive strategies currently in use are urgently needed. © Georg Thieme Verlag KG Stuttgart · New York.

  16. The effects of motor rehabilitation training on clinical symptoms and serum BDNF levels in Parkinson's disease subjects.

    Science.gov (United States)

    Angelucci, Francesco; Piermaria, Jacopo; Gelfo, Francesca; Shofany, Jacob; Tramontano, Marco; Fiore, Marco; Caltagirone, Carlo; Peppe, Antonella

    2016-04-01

    Increasing evidence suggests that motor rehabilitation may delay Parkinson's disease (PD) progression. Moreover, parallel treatments in animals up-regulate brain-derived neurotrophic factor (BDNF). Thus, we investigated the effect of a motor rehabilitation protocol on PD symptoms and BDNF serum levels. Motor rehabilitation training consisted of a cycle of 20 days/month of physiotherapy divided in 3 daily sessions. Clinical data were collected at the beginning, at the end, and at 90 days follow-up. BDNF serum levels were detected by ELISA at 0, 7, 14, 21, 30, and 90 days. The follow-up period had a duration of 60 days (T30-T90). The results showed that at the end of the treatment (day 30), an improvement in extrapyramidal signs (UPDRS III; UPDRS III - Gait and Balance items), motor (6 Minute Walking Test), and daily living activities (UPDRS II; PDQ-39) was observed. BDNF levels were increased at day 7 as compared with baseline. After that, no changes in BDNF were observed during the treatment and in the successive follow-up. This study demonstrates that motor rehabilitation training is able to ameliorate PD symptoms and to increase temporarily BDNF serum levels. The latter effect may potentially contribute to the therapeutic action.

  17. Single and multiple cardiovascular biomarkers in subjects without a previous cardiovascular event

    DEFF Research Database (Denmark)

    Pareek, Manan; Bhatt, Deepak L; Vaduganathan, Muthiah

    2017-01-01

    population-based cohort study of 1324 subjects without a previous cardiovascular event, who underwent baseline echocardiography and biomarker assessment between 2002 and 2006. The clinical endpoint was the composite of myocardial infarction, invasively treated stable/unstable ischemic heart disease, heart...

  18. The Mid-Term Results of Patients who Underwent Radiofrequency Atrial Fibrillation Ablation Together with Mitral Valve Surgery

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    Abdurrahim Çolak

    Full Text Available Abstract Objetive: Saline-irrigated radiofrequency ablation, which has been widely used for surgical treatment of atrial fibrillation in recent years, is 80-90% successful in achieving sinus rhythm. In our study, our surgical experience and mid-term results in patients who underwent mitral valve surgery and left atrial radiofrequency ablation were analyzed. Methods: Forty patients (15 males, 25 females; mean age 52.05±9.9 years; range 32-74 underwent surgery for atrial fibrillation associated with mitral valvular disease. All patients manifested atrial fibrillation, which started at least six months before the surgical intervention. The majority of patients (36 patients, 90% were in NYHA class III; 34 (85% patients had rheumatic heart disease. In addition to mitral valve surgery and radiofrequency ablation, coronary artery bypass, DeVega tricuspid annuloplasty, left ventricular aneurysm repair, and left atrial thrombus excision were performed. Following discharge from the hospital, patients' follow-up was performed as outpatient clinic examinations and the average follow-up period of patients was 18±3 months. Results: While the incidence of sinus rhythm was 85.3% on the first postoperative day, it was 80% during discharge and 71% in the 1st year follow-up examination. Conclusion: Radiofrequency ablation is an effective method when it is performed by appropriate surgical technique. Its rate for returning to sinus rhythm is as high as the rate of conventional surgical procedure.

  19. [Subgroup analysis results of platelet inhibition trial in acute coronary syndrome patients (PLATO) who underwent intervention or medical treatment].

    Science.gov (United States)

    Aksakal, Enbiya

    2013-04-01

    Antiplatelet agents are among the most important drug classes in reducing mortality in patients with acute coronary syndromes (ACS). Ticagrelor is the first reversible and direct acting P2Y(12) receptor inhibitor with an earlier onset of action compared to clopidogrel. The PLATO study (Platelet Inhibition and Patient Outcomes) with ticagrelor was conducted with a design providing consistency with the current clinical practice, including all forms of ACS and a wide spectrum of treatment options in 18624 patients from 862 centers in 43 countries. Of these patients, 13408 underwent interventional procedures (ticagrelor/clopidogrel; 6732/6676) (PLATO-INVASIVE). As reported by the investigator, non-invasive treatment strategy was planned for 5216 patients (ticagrelor/clopidogrel; 2601/2615). However, 2040 patients in this group received interventional treatment during the follow-up (PLATO-NON-INVASIVE/MEDICAL TREATMENT). 1261 patients requiring surgical treatment underwent coronary artery bypass grafting (CABG) within 7 days after the discontinuation of study treatment (ticagrelor/clopidogrel; 632/629) (PLATO-CABG). The results of these three subgroups were consistent with the main PLATO study results, demonstrating that ticagrelor reduced the primary (cardiovascular death, myocardial Infarction and stroke) and secondary composite endpoints without increasing bleeding compared with clopidogrel. Ticagrelor fulfills an important unmet need regarding antiplatelet effectiveness in patients with ACS. This review evaluates the INVASIVE and MEDICAL subgroup studies of the PLATO study.

  20. Subjective Cognitive Decline Correlates With Depression Symptoms and Not With Concurrent Objective Cognition in a Clinic-Based Sample of Older Adults.

    Science.gov (United States)

    Zlatar, Zvinka Z; Muniz, Martha; Galasko, Douglas; Salmon, David P

    2017-01-19

    Subjective cognitive decline (SCD) is common in older adults; however, its utility in clinic-based samples remains controversial given its strong associations with mood symptoms. Five hundred nineteen individuals aged 60-95 with a wide range of cognitive performance scores were referred by community health clinics for brief screening of cognitive complaints. Linear regression models examined the cross-sectional associations between SCD (5-item self-reported questions), symptoms of depression (Beck Depression Inventory [BDI]), and concurrent objective cognitive performance (Cognitive Composite) adjusting for demographics. There was not a significant association between SCD and concurrent objective cognition after adjusting for demographics and depression. In contrast, there was a significant association between SCD and depression after adjusting for demographics and objective cognition. There was also a consistent association between SCD and depression, but not between SCD and objective cognition, in those with high and low levels of SCD reporting, in all ranges of cognitive performance, and in those with mild to moderate depression. Results are consistent with previous findings and suggest that SCD does not accurately reflect concurrent cognitive performance in a clinic-based sample of older adults. Clinical interpretation of SCD should account for the role of depression.

  1. The Incidence of Concomitant Precancerous Lesions in Cases Who Underwent Hysterectomy for Prolapse

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    Serdar Aydin

    2016-09-01

    Full Text Available Aim: The aim of the study was is to assess the incidence of unexpected gynecological cancers and pre-cancerous lesions following hysterectomy for pelvic organ prolapse to better understand the risks of uterine sparing surgery. Material and Method: This was a retrospective analysis of histopathology findings after hysterectomy for uterine prolapse surgery who underwent preoperative diagnostic work including cervical cytology, transvaginal ultrasonography and endometrial histopathological examination for a high risk group (Postmenopausal women with an endometrial thickness of %u22655 mm and premenopausal women with abnormal bleeding. Patients with a history of endometrial, cervical and/or adnexal precancerous or cancerous pathological conditions and with incomplete medical records were excluded.Results: Results were taken from 106 women who underwent hysterectomy. The abdominal route was used in 22 cases (21.7 %, the vaginal route in 82 patients (77.4 % and laparoscopic-assisted vaginal route in two (1.9 % women. Oophorectomy was performed in 35 (33 % cases. None of the patients had malignant histopathology specimens from hysterectomy. Total premalignant pathology incidence was 7.5 % (8/106. Six (5.7% patients had simple endometrial hyperplasia and 2 patients (1.9 % had cervical intraepithelial neoplasia. Discussion: The incidence of unexpected endometrial, cervical or ovarian malignancy among women who underwent hysterectomy after preoperative diagnostic workup including transvaginal ultrasonograhy, endometrial pathological examination to high risk cases was negligible. The inclusion of low risk endometrial and cervical precancerous lesions increased the incidences. Our results could provide precious data to extrapolate to similar populations with uterine prolapse who desire surgical correction sparing uterus.

  2. Usefulness of the CHA2DS2-VASc Score to Predict Outcome in Patients Who Underwent Transcatheter Aortic Valve Implantation.

    Science.gov (United States)

    Orvin, Katia; Levi, Amos; Landes, Uri; Bental, Tamir; Sagie, Alexander; Shapira, Yaron; Vaknin-Assa, Hana; Assali, Abid; Kornowski, Ran

    2017-10-19

    Risk assessment for transcatheter aortic valve implantation (TAVI) patients remains challenging, especially in elderly and high-risk candidates. Although several risk factors contribute to increased morbidity and mortality after TAVI, simple risk scores for routine use are lacking. Applying the CHA2DS2-VASC (congestive heart failure, hypertension, age ≥ 75 years, diabetes, prior stroke, vascular disease, age 65-74 years, sex [female] category) score as a novel risk stratification tool for conditions other than atrial fibrillation and stroke prevention has been previously examined; however, its usefulness in a population of patients with aortic stenosis after TAVI has not been established. Thus, we investigated 633 consecutive patients who underwent TAVI between November 2008 and May 2017, and calculated the CHA2DS2-VASC score. Patients were stratified according to their CHA2DS2-VASC score into 3 categories (0 to 3, 4 to 6, 7 to 9), and the association between CHA2DS2-VASC score and 1-year clinical outcomes (stroke, all-cause mortality, and combined outcome of stroke or mortality) was evaluated. We found that both stroke and mortality at 1 year were significantly more frequent with increasing CHA2DS2-VASC score (p = 0.012 and p = 0.025, respectively). Each single-point rise in CHA2DS2-VASC score was associated with a 38% increase in the 1-year combined outcome of mortality or stroke (p = 0.022; C index 0.615). In conclusion, CHA2DS2-VASC score can be used as a simple and effective tool to predict 1-year clinical outcomes including death and stroke in patients who underwent TAVI. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Comparison of Outcomes in Patients Who Underwent Deep Anterior Lamellar Keratoplasty and Those Converted to Penetrating Keratoplasty

    Directory of Open Access Journals (Sweden)

    Yusuf Koçluk

    2017-03-01

    Full Text Available Objectives: To compare clinical outcomes of cases who underwent deep anterior lamellar keratoplasty (DALK and cases who were converted to penetrating keratoplasty (PKP from DALK surgery. Materials and Methods: The records of 54 patients for whom DALK surgery was planned and were operated for different diagnoses between March 2013 and June 2015 were retrospectively analyzed. Patients were divided into two groups: group 1 (PKP group consisted of 23 cases who were converted to PKP due to Descemet’s membrane perforation at any stage of surgery; group 2 (DALK group consisted of 31 patients whose surgery could be completed as DALK. Preoperative and postoperative follow-up results were evaluated in each group. Results: Corrected distance visual acuity (CDVA increased in the postoperative period according to baseline in both groups. However, there was no statistically significant difference in the rates of CDVA increase between the groups (p=0.142. The mean astigmatism measured by corneal topography at final examination was 5.8±2.3 diopters in group 1 and 5.4±1.8 diopters in group 2. The difference between groups was not statistically significant (p=0.430. The groups were not statistically different regarding postoperative pachymetry (p=0.453. The grafts in all 54 patients (100% were clear at final postoperative examination. There were no statistically significant differences between the groups in terms of postoperative complications. Conclusion: Similar clinical outcomes were obtained in our study for patients who underwent DALK and those whose procedure was converted from DALK to PKP.

  4. Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial.

    Science.gov (United States)

    Zenico, T; Cicero, A F G; Valmorri, L; Mercuriali, M; Bercovich, E

    2009-04-01

    Lepidium meyenii (Maca) is a cultivated root belonging to the brassica family used in the Andean region for its supposed aphrodisiac properties. We carried out a double-blind clinical trial on 50 Caucasian men affected by mild erectile dysfunction (ED), randomised to treatment with Maca dry extract, 2400 mg, or placebo. The treatment effect on ED and subjective well-being was tested administrating before and after 12 weeks the International Index of Erectile Function (IIEF-5) and the Satisfaction Profile (SAT-P). After 12 weeks of treatment, both Maca- and placebo-treated patients experienced a significant increase in IIEF-5 score (P Maca experienced a more significant increase than those taking placebo (1.6 +/- 1.1 versus 0.5 +/- 0.6, P Maca- and placebo-treated subjects experienced a significant improvement in psychological performance-related SAT-P score, but the Maca group higher than that of placebo group (+9 +/- 6 versus +6 +/- 5, P Maca-treated patients experienced a significant improvement in physical and social performance-related SAT-P score compared with the baseline (+7 +/- 6 and +7 +/- 6, both P Maca supplementation on subjective perception of general and sexual well-being in adult patients with mild ED.

  5. Effects of Kinesio® Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects.

    Science.gov (United States)

    Álvarez-Álvarez, S; José, F García-Muro San; Rodríguez-Fernández, A L; Güeita-Rodríguez, J; Waller, B J

    2014-01-01

    Muscle fatigue of the trunk extensor musculature plays a considerable role in chronic low back pain (LBP). The underlying physiology of fatigue is complex and not fully understood. The Kinesio® Taping (KT) supports damaged structures while allowing mobility and at the same time may influence some of the mechanisms associated with muscle fatigue such as blood flow and proprioception. The aim of this study is to determine the influence of KT on the resistance to fatigue of the lumbar extensor musculature in a sample of young healthy subjects. A randomized, controlled, doubled-blinded clinical trial was conducted. Ninety nine healthy subjects were randomized in to the three arms of the study Kinesio® Tape (KT), placebo (P) and control (C). Directly after application of KT we measured lumbar extensor musculature endurance with the Biering-Sorensen test. Subjects and researchers were blinded to the intervention. Time achieved (seconds) was compared between groups with one-way ANOVA with confidence intervals of 95%. There were significant differences between the time achieved in the KT group versus the control group (p < 0.05). The placebo group performed better than the control group but worse than the KT group, these were not significant in either case. KT appears to improve the time to failure of the extensor muscle of the trunk obtained using the Biering-Sorensen test. These findings suggest that KT influences processes that lead to muscle fatigue and that KT could be effective in the management of LBP.

  6. Clinical and prognostic significance of human papillomavirus DNA in the sperm or exfoliated cells of infertile patients and subjects with risk factors.

    Science.gov (United States)

    Foresta, Carlo; Pizzol, Damiano; Moretti, Afra; Barzon, Luisa; Palù, Giorgio; Garolla, Andrea

    2010-10-01

    To evaluate human papillomavirus (HPV) sperm infection and its correlation with sperm parameters in infertile patients and subjects with risk factors. Cross-sectional clinical study. Andrology and microbiology sections at a university hospital. A cohort of 290 subjects: 26 with genital warts, 66 with HPV positive partners, 108 infertile patients, and 90 fertile controls. Semen analysis, sperm culture, polymerase chain reaction, and fluorescence in situ hybridization (FISH) for HPV detection. Statistical analysis was performed with a two-tailed Student's t-test. The prevalence of HPV semen infection found in all groups was as follows: patients with genital warts, 53.8%; infected partners, 40.9%; infertile patients, 10.2%, fertile controls, 2.2%. Infertile patients had a higher HPV DNA prevalence in sperm cells than the other groups. The results of HPV investigation were compared with sperm parameters and the results of FISH analysis. Sperm motility was more frequently reduced in infected samples and in particular when the infection was present in the sperm. This study demonstrated a very high prevalence of infection in the semen of patients with risk factors for HPV. In each group of subjects, HPV seems to be preferentially located in sperm or exfoliated cells, with different effects on sperm motility. Copyright © 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  7. Motor Performance Assessment in Parkinson’s Disease: Association between Objective In-Clinic, Objective In-Home, and Subjective/Semi-Objective Measures

    Science.gov (United States)

    Toosizadeh, Nima; Mohler, Jane; Lei, Hong; Parvaneh, Saman; Sherman, Scott; Najafi, Bijan

    2015-01-01

    Advances in wearable technology allow for the objective assessment of motor performance in both in-home and in-clinic environments and were used to explore motor impairments in Parkinson’s disease (PD). The aims of this study were to: 1) assess differences between in-clinic and in-home gait speed, and sit-to-stand and stand-to-sit duration in PD patients (in comparison with healthy controls); and 2) determine the objective physical activity measures, including gait, postural balance, instrumented Timed-up-and-go (iTUG), and in-home spontaneous physical activity (SPA), with the highest correlation with subjective/semi-objective measures, including health survey, fall history (fallers vs. non-fallers), fear of falling, pain, Unified Parkinson's Disease Rating Scale, and PD stage (Hoehn and Yahr). Objective assessments of motor performance were made by measuring physical activities in the same sample of PD patients (n = 15, Age: 71.2±6.3 years) and age-matched healthy controls (n = 35, Age: 71.9±3.8 years). The association between in-clinic and in-home parameters, and between objective parameters and subjective/semi-objective evaluations in the PD group was assessed using linear regression-analysis of variance models and reported as Pearson correlations (R). Both in-home SPA and in-clinic assessments demonstrated strong discriminatory power in detecting impaired motor function in PD. However, mean effect size (0.94±0.37) for in-home measures was smaller compared to in-clinic assessments (1.30±0.34) for parameters that were significantly different between PD and healthy groups. No significant correlation was observed between identical in-clinic and in-home parameters in the PD group (R = 0.10–0.25; p>0.40), while the healthy showed stronger correlation in gait speed, sit-to-stand duration, and stand-to-sit duration (R = 0.36–0.56; p<0.03). This suggests a better correlation between supervised and unsupervised motor function assessments in healthy controls

  8. Association between Seminal Vesicle Invasion and Prostate Cancer Detection Location after Transrectal Systemic Biopsy among Men Who Underwent Radical Prostatectomy.

    Science.gov (United States)

    Lee, Young Ik; Lee, Hak Min; Jo, Jung Ki; Lee, Sangchul; Hong, Sung Kyu; Byun, Seok-Soo; Lee, Sang Eun; Oh, Jong Jin

    2016-01-01

    Our hypothesis is that the location of the seminal vesicles near the base of the prostate, the more positive cores are detected in the base, the greater the risk of seminal vesicle invasion. Therefore we investigate the clinical outcomes of base dominant prostate cancer (BDPC) in transrectal ultrasound (TRUS) -guided biopsies compared with anteromiddle dominant prostate cancer (AMPC). From November 2003 to June 2014, a total of 990 intermediate and high risk prostate cancer (PCa) patients who underwent radical prostatectomy (RP) were enrolled and stratified into two groups according to proportion of positive cores-BDPC group had ≥ 33.3% ratio of positive cores from the prostate base among all positive cores and AMPC group regression model to confirm the significance of BDPC to seminal vesicle invasion (SVI) and Cox proportional hazard analysis to BCR. Among these 990 PCa patients, the 487 patients in BDPC group had more advanced clinical stage (pextension (ECE), SVI and BCR (all pCox proportional analysis (hazard ratio: 1.466, p = 0.004). BDPC in TRUS-guided prostate biopsies was significantly associated with SVI and BCR after adjusting for other clinical factors. Therefore, BDPC should be considered to be a more aggressive tumor despite an otherwise similar cancer profile.

  9. Socio-demographic and clinical differences in subjects with tuberculosis with and without diabetes mellitus in Brazil--a multivariate analysis.

    Science.gov (United States)

    Reis-Santos, Barbara; Locatelli, Rodrigo; Horta, Bernardo L; Faerstein, Eduardo; Sanchez, Mauro N; Riley, Lee W; Maciel, Ethel Leonor

    2013-01-01

    Several studies have evaluated the relationship between diabetes mellitus (DM) and tuberculosis (TB), but the nature of this relationship is not fully understood. TB incidence may be influenced by immunosuppression from DM, but this association may be confounded by other clinical and socioeconomic factors. We aimed to assess socio-demographic and clinical differences in TB patients with and without DM. Using the Brazilian national surveillance system (SINAN), we compared 1,797 subjects with TB and DM with 29,275 subjects diagnosed with TB only in 2009. We performed multivariate analysis to identify factors associated with the presence of DM among TB patients. Subjects with TB - DM were older; have initial positive sputum smear test (OR = 1.42, 95% CI 1.26-1.60), and were more likely to die from TB (OR = 1.44, 95% CI 1.03-2.01). They were less likely to have been institutionalized [in prison, shelter, orphanage, psychiatric hospital (OR = 0.74, 95% CI 0.60-0.93)]; developed extra pulmonary TB (OR = 0.62, 95% CI 0.51-0.75) and to return to TB treatment after abandonment (OR = 0.66, 95% CI 0.51-0.86). Prevalence of NCD continues to rise in developing countries, especially with the rise of elderly population, the prevention and treatment of infectious diseases will be urgent. DM and TB represent a critical intersection between communicable and non-communicable diseases in these countries and the effect of DM on TB incidence and outcomes provide numerous opportunities for collaboration and management of these complex diseases in the national public health programs.

  10. Association between total serum cholesterol and suicide attempts in subjects with major depressive disorder: Exploring the role of clinical and biochemical confounding factors.

    Science.gov (United States)

    Bartoli, Francesco; Crocamo, Cristina; Dakanalis, Antonios; Riboldi, Ilaria; Miotto, Alessio; Brosio, Enrico; Clerici, Massimo; Carrà, Giuseppe

    2017-04-01

    We tested whether serum total cholesterol levels might be associated with recent suicide attempts in subjects with major depressive disorder, after controlling for relevant individual characteristics. We conducted a comparative cross-sectional study including consecutive inpatients with major depressive disorder. We differentiated subjects admitted for a recent serious (violent or non-violent) suicide attempt and those without such recent history. Total cholesterol was measured from fasting blood tests. At univariate analyses, suicide attempters had levels of total cholesterol (174.0±45.7mg/dL) lower than non-attempters (193.9±42.6mg/dL) (p=0.004). This was confirmed among both violent (174.1±46.2mg/dL) and non-violent (173.8±46.1mg/dL) suicide attempters (p=0.035 and 0.016, respectively). However, logistic regression analyses, sequentially including demographic, clinical (comorbid alcohol and personality disorders), and biochemical factors, did not show any association between serum cholesterol and recent suicide attempts (p=0.172). Similar findings were observed in multinomial logistic regression analyses, for both violent (p=0.512) and non-violent (p=0.157) suicide attempts. Our findings do not support the hypothesis that serum cholesterol and suicide attempts are associated among subjects with major depressive disorder. The identification of valid and accessible biological markers of suicidal behaviors still represents a challenge for future research. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  11. IgE, IgG1 and IgG4 response to specific allergens in sensitized subjects showing different clinical reactivity to Anisakis simplex.

    Science.gov (United States)

    Ventura, M T; Rodriguez-Perez, R; Caballero, M L; Garcia-Alonso, M; Antonicelli, L; Asero, R

    2017-03-01

    Background. Anisakis simplex hypersensitive subjects may be sensitized without clinical allergy, or experience acute symptoms or chronic urticaria induced by raw fish. We studied whether the 3 subgroups differ in IgE, IgG1 or IgG4 reactivity to specific Anisakis simplex allergens. Methods. 28 Anisakis simplex-hypersensitive adults, 11 with acute symptoms, 9 with chronic urticaria, and 8 sensitized were studied. IgE, IgG1 and IgG4 to rAni s 1, 5, 9 and 10 were sought by ELISA. IgE and IgG4 to nAni s 4 were determined by WB. Results. IgE to Ani s 1, 4, 5, 9, and 10 were found in 8, 3, 2, 5, and 9 sera, respectively. Nine sera did not react to any allergen. IgG1 to Ani s 1, 5, 9, and 10 were detected in 5, 16, 14, and 4 sera, respectively. Four sera did not react to any of the 4 allergens. IgG4 to Ani s 1, 4, 5, 9, and 10 were detected in 10, 0, 2, 6 and 1 sera, respectively. Fifteen subjects did not react to any of the 5 allergens. On ELISA sensitized subjects showed lower IgE and IgG1 levels than patients. IgG4 levels were highest in the sensitized group. The prevalence of IgE, IgG1 or IgG4 reactivity to any of the studied allergens did not differ between the 3 subgroups. Conclusion. The clinical expression of Anisakis simplex sensitization does not seem to depend on IgE reactivity to a specific allergen of the parasite, nor on the presence of IgG antibodies possibly related with blocking activity.

  12. Voiding patterns of adult patients who underwent hypospadias repair in childhood.

    Science.gov (United States)

    Jaber, Jawdat; Kocherov, Stanislav; Chertin, Leonid; Farkas, Amicur; Chertin, Boris

    2017-02-01

    This study aimed at evaluating the voiding patterns of adult patients who underwent hypospadias repair in childhood. Following IRB approval 103 (22.7%) of 449 adult patients who underwent hypospadias repair between 1978 and 1993 responded to the following questionnaires: International Prostate Symptom Score (I-PSS) and Short Form 12 questionnaire (SF-12). Uroflowmetry (UF) was performed for all patients. The patients were divided into three groups according to the primary meatus localization. Group I had 63 patients (61.5%) treated for glanular hypospadias, group II had 19 patients (18.4%) treated for distal hypospadias, and group III comprised the remaining 21 patients (20.4%) treated for proximal hypospadias. The mean ± SD I-PSS score for all patients who responded to the questionnaire was 2.3 ± 2.4, and UF was 21.1 ± 4.3 mL/s. The patients from groups I and III had fewer urinary symptoms compared with those of the group II: 1.3 ± 1.5, 5.5 ± 2.4, and 1.6 ± 1.4, respectively (p hypospadias repair in childhood had normal or mild voiding disturbance, with no effects on their physical or mental status. Copyright © 2016 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

  13. Circulating S100B and Adiponectin in Children Who Underwent Open Heart Surgery and Cardiopulmonary Bypass

    Directory of Open Access Journals (Sweden)

    Alessandro Varrica

    2015-01-01

    Full Text Available Background. S100B protein, previously proposed as a consolidated marker of brain damage in congenital heart disease (CHD newborns who underwent cardiac surgery and cardiopulmonary bypass (CPB, has been progressively abandoned due to S100B CNS extra-source such as adipose tissue. The present study investigated CHD newborns, if adipose tissue contributes significantly to S100B serum levels. Methods. We conducted a prospective study in 26 CHD infants, without preexisting neurological disorders, who underwent cardiac surgery and CPB in whom blood samples for S100B and adiponectin (ADN measurement were drawn at five perioperative time-points. Results. S100B showed a significant increase from hospital admission up to 24 h after procedure reaching its maximum peak (P0.05 have been found all along perioperative monitoring. ADN/S100B ratio pattern was identical to S100B alone with the higher peak at the end of CPB and remained higher up to 24 h from surgery. Conclusions. The present study provides evidence that, in CHD infants, S100B protein is not affected by an extra-source adipose tissue release as suggested by no changes in circulating ADN concentrations.

  14. Efficacy and Safety of IncobotulinumtoxinA in Asian Subjects: A Pooled Analysis of Clinical Trials in the Treatment of Glabellar Frown Lines.

    Science.gov (United States)

    Seo, Kyle; Tsai, Tsen-Fang; Chao, Yates Yen-Yu; Goodman, Greg J

    2016-09-01

    Owing to differences in facial anatomy and cultural beauty ideals, dose adaptations are often necessary when administering botulinum toxin type A to Asians and non-Asians. To assess potential differences in the efficacy and safety of incobotulinumtoxinA in Asian and non-Asians. Efficacy data were pooled from several Phase II/III trials that used 20 U incobotulinumtoxinA to treat glabellar frown lines in Asian subjects. The variable of interest was investigator-assessed improvement in scores on the 4-point Facial Wrinkle Scale from baseline to days 30, 60, 90, and 120. Subjects with a 1-point improvement were considered 'responders'. Data were also assessed for treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest among a pool of incobotulinumtoxinA safety studies. Four trials were pooled, comprising 19 Asian and 563 non-Asian subjects. At maximum frown on day 30, 100% of Asians and 87% of non-Asians were responders; by day 120, values were 37% and 40%, respectively. At rest on day 30, 63% of Asians and 56% of non-Asians were responders. Corresponding values for day 120 were 11% and 25%. The mean change in score on the Facial Wrinkle Scale from baseline over time was similar in both groups. Very few adverse events occurred. Overall, treatment-emergent adverse events were lower amongst Asians than non-Asians. Compared with non-Asians, a trend towards slightly higher responses was observed in Asians at maximum frown. There were no clinically relevant differences in the safety of incobotulinumtoxinA when administered to Asian and non-Asian subjects. J Drugs Dermatol. 2016;15(9):1084-1087.

  15. Automated 3D mapping of hippocampal atrophy and its clinical correlates in 400 subjects with Alzheimer's disease, mild cognitive impairment, and elderly controls.

    Science.gov (United States)

    Morra, Jonathan H; Tu, Zhuowen; Apostolova, Liana G; Green, Amity E; Avedissian, Christina; Madsen, Sarah K; Parikshak, Neelroop; Hua, Xue; Toga, Arthur W; Jack, Clifford R; Schuff, Norbert; Weiner, Michael W; Thompson, Paul M

    2009-09-01

    We used a new method we developed for automated hippocampal segmentation, called the auto context model, to analyze brain MRI scans of 400 subjects from the Alzheimer's disease neuroimaging initiative. After training the classifier on 21 hand-labeled expert segmentations, we created binary maps of the hippocampus for three age- and sex-matched groups: 100 subjects with Alzheimer's disease (AD), 200 with mild cognitive impairment (MCI) and 100 elderly controls (mean age: 75.84; SD: 6.64). Hippocampal traces were converted to parametric surface meshes and a radial atrophy mapping technique was used to compute average surface models and local statistics of atrophy. Surface-based statistical maps visualized links between regional atrophy and diagnosis (MCI versus controls: P = 0.008; MCI versus AD: P = 0.001), mini-mental state exam (MMSE) scores, and global and sum-of-boxes clinical dementia rating scores (CDR; all P < 0.0001, corrected). Right but not left hippocampal atrophy was associated with geriatric depression scores (P = 0.004, corrected); hippocampal atrophy was not associated with subsequent decline in MMSE and CDR scores, educational level, ApoE genotype, systolic or diastolic blood pressure measures, or homocysteine. We gradually reduced sample sizes and used false discovery rate curves to examine the method's power to detect associations with diagnosis and cognition in smaller samples. Forty subjects were sufficient to discriminate AD from normal and correlate atrophy with CDR scores; 104, 200, and 304 subjects, respectively, were required to correlate MMSE with atrophy, to distinguish MCI from normal, and MCI from AD. 2009 Wiley-Liss, Inc.

  16. Outcome of Patients Underwent Emergency Department Thoracotomy and Its Predictive Factors

    Directory of Open Access Journals (Sweden)

    Shahram Paydar

    2014-08-01

    Full Text Available Introduction: Emergency department thoracotomy (EDT may serve as the last survival chance for patients who arrive at hospital in extremis. It is considered as an effective tool for improvement of traumatic patients’ outcome. The present study was done with the goal of assessing the outcome of patients who underwent EDT and its predictive factors. Methods: In the present study, medical charts of 50 retrospective and 8 prospective cases underwent emergency department thoracotomy (EDT were reviewed during November 2011 to June 2013. Comparisons between survived and died patients were performed by Mann-Whitney U test and the predictive factors of EDT outcome were measured using multivariate logistic regression analysis. P < 0.05 considered statistically significant. Results: Fifty eight cases of EDT were enrolled (86.2% male. The mean age of patients was 43.27±19.85 years with the range of 18-85. The mean time duration of CPR was recorded as 37.12±12.49 minutes. Eleven cases (19% were alive to be transported to OR (defined as ED survived. The mean time of survival in ED survived patients was 223.5±450.8 hours. More than 24 hours survival rate (late survived was 6.9% (4 cases. Only one case (1.7% survived to discharge from hospital (mortality rate=98.3%. There were only a significant relation between ED survival and SBP, GCS, CPR duration, and chest trauma (p=0.04. The results demonstrated that initial SBP lower than 80 mmHg (OR=1.03, 95% CI: 1.001-1.05, p=0.04 and presence of chest trauma (OR=2.6, 95% CI: 1.75-3.16, p=0.02 were independent predictive factors of EDT mortality. Conclusion: The findings of the present study showed that the survival rate of trauma patients underwent EDT was 1.7%. In addition, it was defined that falling systolic blood pressure below 80 mmHg and blunt trauma of chest are independent factors that along with poor outcome.

  17. Complementarity of Subjective Global Assessment (SGA) and Nutritional Risk Screening 2002 (NRS 2002) for predicting poor clinical outcomes in hospitalized patients.

    Science.gov (United States)

    Raslan, Mariana; Gonzalez, Maria Cristina; Torrinhas, Raquel Suzana M M; Ravacci, Graziela Rosa; Pereira, Julio C R; Waitzberg, Dan L

    2011-02-01

    We evaluated the ability of Nutritional Risk Screening 2002 (NRS 2002) and Subjective Global Assessment (SGA) to predict malnutrition related to poor clinical outcomes. We assessed 705 patients at a public university hospital within 48 h of admission. Logistic regression and number needed to screen (NNS) were calculated to test the complementarity between the tools and their ability to predict very long length of hospital stay (VLLOS), complications, and death. Of the patients screened, 27.9% were at nutritional risk (NRS+) and 38.9% were malnourished (SGA B or C). Compared to those patients not at nutritional risk, NRS+, SGA B or C patients were at increased risk for complications (p=0.03, 0.02, and 0.003, respectively). NRS+ patients had an increased risk of death (p=0.03), and SGA B and C patients had an increased likelihood of VLLOS (p=0.008 and pSGA C had lower estimates of NNS than patients who were NRS+ or SGA C only, though their confidence intervals did overlap. The concurrent application of SGA in NRS+ patients might enhance the ability to predict poor clinical outcomes in hospitalized patients in Brazil. Copyright © 2010 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  18. Saline-filled breast implant contamination with Curvularia species among women who underwent cosmetic breast augmentation.

    Science.gov (United States)

    Kainer, Marion A; Keshavarz, Homa; Jensen, Bette J; Arduino, Matthew J; Brandt, Mary E; Padhye, Arvind A; Jarvis, William R; Archibald, Lennox K

    2005-07-01

    During December 2000-July 2001, black sediment was noted in saline-filled silicone breast implants of women who had undergone revision surgery at facility A. Curvularia fungus was isolated from implant saline. To identify risk factors for contamination with Curvularia species, we performed case-control, retrospective cohort, and laboratory studies and conducted procedural reviews. A case patient was defined as any woman who underwent revision surgery at facility A between January 2000 and June 2001 and had black sediment in her implants. Five patients met the case definition. Contamination was associated with having had surgery performed in operating room (OR) 2 (4/88 vs. 1/140; P=.07) and a longer duration of surgery (PSurgery center infection control measures must include moisture control and balanced ventilation systems.

  19. A Pregnant Woman Who Underwent Laparoscopic Adrenalectomy due to Cushing’s Syndrome

    Directory of Open Access Journals (Sweden)

    Halit Diri

    2014-01-01

    Full Text Available Cushing’s syndrome (CS may lead to severe maternal and fetal morbidities and even mortalities in pregnancy. However, pregnancy complicates the diagnosis and treatment of CS. This study describes a 26-year-old pregnant woman admitted with hypertension-induced headache. Hormonal analyses performed due to her cushingoid phenotype revealed a diagnosis of adrenocorticotropic hormone- (ACTH- independent CS. MRI showed a 3.5 cm adenoma in her right adrenal gland. After preoperative metyrapone therapy, she underwent a successful unilateral laparoscopic adrenalectomy at 14-week gestation. Although she had a temporary postoperative adrenal insufficiency, hormonal analyses showed that she has been in remission since delivery. Findings in this patient, as well as those in previous patients, indicate that pregnancy is not an absolute contraindication for laparoscopic adrenalectomy. Rather, such surgery should be considered a safe and efficient treatment method for pregnant women with cortisol-secreting adrenal adenomas.

  20. Correlation between location of transposed ovary and function in cervical cancer patients who underwent radical hysterectomy.

    Science.gov (United States)

    Yoon, Aera; Lee, Yoo-Young; Park, Won; Huh, Seung Jae; Choi, Chel Hun; Kim, Tae-Joong; Lee, Jeong-Won; Kim, Byoung-Gie; Bae, Duk-Soo

    2015-05-01

    The study investigated the association between the location of transposed ovaries and posttreatment ovarian function in patients with early cervical cancer (IB1-IIA) who underwent radical hysterectomy and ovarian transposition with or without adjuvant therapies. Retrospective medical records were reviewed to enroll the patients with early cervical cancer who underwent ovarian transposition during radical hysterectomy at Samsung Medical Center between July 1995 and July 2012. Serum follicle-stimulating hormone (FSH) level was used as a surrogate marker for ovarian function. Twenty-one patients were enrolled. The median age and body mass index (BMI) were 31 years (range, 24-39 years) and 21.3 kg/m² (range, 17.7-31.2 kg/m²), respectively. The median serum FSH level after treatment was 7.9 mIU/mL (range, 2.4-143.4 mIU/mL). The median distance from the iliac crest to transposed ovaries on erect plain abdominal x-ray was 0.5 cm (range, -2.7 to 5.2 cm). In multivariate analysis, posttreatment serum FSH levels were significantly associated with the location of transposed ovaries (β = -8.1, P = 0.032), concurrent chemoradiation (CCRT) as an adjuvant therapy (β = 71.08, P = 0.006), and BMI before treatment (underweight: β = -59.93, P = 0.05; overweight: β = -40.62, P = 0.041). Location of transposed ovaries, adjuvant CCRT, and BMI before treatment may be associated with ovarian function after treatment. We suggest that ovaries should be transposed as highly as possible during radical hysterectomy to preserve ovarian function in young patients with early cervical cancer who might be a candidate for adjuvant CCRT and who have low BMI before treatment.

  1. Abdominal acupuncture reduces laser-evoked potentials in healthy subjects

    DEFF Research Database (Denmark)

    Pazzaglia, C.; Liguori, S.; Minciotti, I.

    2015-01-01

    Objective: Acupuncture is known to reduce clinical pain, although the exact mechanism is unknown. The aim of the current study was to investigate the effect of acupuncture on laser-evoked potential amplitudes and laser pain perception. Methods: In order to evaluate whether abdominal acupuncture...... is able to modify pain perception, 10 healthy subjects underwent a protocol in which laser-evoked potentials (LEPs) and laser pain perception were collected before the test (baseline), during abdominal acupuncture, and 15. min after needle removal. The same subjects also underwent a similar protocol...... in which, however, sham acupuncture without any needle penetration was used. Results: During real acupuncture, both N1 and N2/P2 amplitudes were reduced, as compared to baseline (p . < 0.01). The reduction lasted up to 15. min after needle removal. Furthermore, laser pain perception was reduced during...

  2. Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

    Directory of Open Access Journals (Sweden)

    Pérula-de-Torres LuisÁ

    2012-10-01

    Full Text Available Abstract Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group. As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group. Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis. Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob

  3. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

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    Arce Roger M

    2011-02-01

    Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

  4. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Science.gov (United States)

    2011-01-01

    Background Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen) after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group) or supragingival plaque removal only (control group). A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating

  5. Survey of users of TOPS, an internet-based system to prevent healthy subjects from over-volunteering for clinical trials.

    Science.gov (United States)

    Boyce, M; Walther, M; Kirk, J; Smith, S; Warrington, S

    2013-10-01

    To analyse users' experience of TOPS, an internet-based system that helps UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or starting a second trial too soon after the first. We sent to all units that currently use TOPS an anonymous questionnaire comprising 18 questions about the effectiveness and ease of use of the system. Of 35 units that currently use TOPS, 31 (85.7 %) returned questionnaires. Most users find TOPS easy to use, had increased their detection rate of over-volunteering, and had rejected subjects as a result of using TOPS. A GP reply alone is not enough to prevent over-volunteering. Ethics committees, the MHRA and sponsors know about TOPS and support its use. The results confirm that TOPS does prevent healthy subjects from over-volunteering. Consequently, the Health Research Authority has agreed to take over the management of TOPS. Ethics committee approval of a phase 1 trial and MHRA accreditation of the unit will henceforth be conditional on consistent and proper use of TOPS. That should enhance its effectiveness and improve the safety of volunteers in non-therapeutic trials in the UK.

  6. A toolkit for clinical statisticians to fix problems based on biomarker measurements subject to instrumental limitations: from repeated measurement techniques to a hybrid pooled-unpooled design.

    Science.gov (United States)

    Vexler, Albert; Tao, Ge; Chen, Xiwei

    2015-01-01

    The aim of this chapter is to review and examine different methods in order to display correct and efficient statistical techniques based on complete/incomplete data subject to different sorts of measurement error (ME) problems. Instrument inaccuracies, biological variations, and/or errors in questionnaire-based self-report data can lead to significant MEs in various clinical experiments. Ignoring MEs can cause bias or inconsistency of statistical inferences. The biostatistical literature well addresses two categories of MEs: errors related to additive models and errors caused by the limit of detection (LOD). Several statistical approaches have been developed to analyze data affected by MEs, including the parametric/nonparametric likelihood methodologies, Bayesian methods, the single and multiple imputation techniques, and the repeated measurement design of experiment. We present a novel hybrid pooled-unpooled design as one of the strategies to provide correct statistical inferences when data is subject to MEs. This hybrid design and the classical techniques are compared to show the advantages and disadvantages of the considered methods.

  7. Comparative Study Between the Effect of Myofascial Release Using M2T Blade and Kinesiotape on Recreational Badminton Shoulder Pain Subjects: A Randomised Clinical Trial

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    Varun Naik

    2017-05-01

    Full Text Available Background: Shoulder pain is one of the most common conditions seen in recreational badminton players. It is caused due to repeated movements at the shoulder joint which further limits the range of motion and hence hampers the activities of daily living. M2T helps to release the myofascial tightness which causes the pain. Kinesiotape also helps in increasing the range of motion. Patients and Methods: Thirty recreational shoulder pain subjects were assessed and treated between the age group of 18-30 years at the KLE University’s Indoor Stadium, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India. Methods: The recreational shoulder pain subjects were divided into Group “A” and Group “B” by Randomized clinical trial. Outcome measures used were the visual analogue scale (VAS for pain and the Disability of Arm, Hand, and Shoulder (DASH. VAS and DASH were assessed pre-treatment and post-treatment. Results: Inter-group comparison for both the groups had differences but showed no statistical significance. Hence based on results it can be concluded that both the treatment techniques are effective in reducing pain and increasing ability at the shoulder joint.

  8. Efficacy of a novel herbal composition licorice flavonoid oil in subject with metabolic syndrome: a randomized double-blind placebo-controlled clinical study

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    Kaku Nakagawa

    2017-03-01

    Full Text Available Background:In order toevaluate the effects of licorice flavonoid oil (LFOon abdominalwaist circumference, blood pressure, body weight, body mass index (BMI, lipid profile, body fat composition,and fasting blood glucose in patients with metabolic syndrome, a 12 week randomized double-blind placebo-controlledstudywas conducted. Methods: Fiftypatientswith metabolic syndrome agedbetween 18-75 years were assigned toeither the LFO or placebo group. Abdominal waist circumference, blood pressure, body weight,and BMI were assessed atbaseline, week 4, week 8,and week 12. Clinical laboratory examinations, fat composition,andfasting blood glucose level wereassessed at baseline (week 0 and final visit(week 12.Results: Atotal of 50 subjects (25 subjects in each groupcompleted the 12-weekstudy. Significant difference inchangesfrom the baseline wasobserved in body weight, waist circumference,and BMI in the LFOgroup compared to the placebo group from week 4or week 8 onwards. No adverse events were noted throughout the study. Conclusion: The present study suggeststhat LFOisa promising dietary nutrient forimproving metabolic syndrome, particularlythroughits beneficial effect of normalizingbody weight, BMI,and possibly the amount of visceral fatand HDL cholesterol.

  9. Fundus fluorescein angiographic findings in patients who underwent ventricular assist device implantation.

    Science.gov (United States)

    Ozturk, Taylan; Nalcaci, Serhad; Ozturk, Pelin; Engin, Cagatay; Yagdi, Tahir; Akkin, Cezmi; Ozbaran, Mustafa

    2013-09-01

    Disruption of microcirculation in various tissues as a result of deformed blood rheology due to ventricular assist device (VAD) implantation causes novel arteriovenous malformations. Capillary disturbances and related vascular leakage in the retina and choroidea may also be seen in patients supported by VADs. We aimed to evaluate retinal vasculature deteriorations after VAD implantation. The charts of 17 patients who underwent VAD implantation surgery for the treatment of end-stage heart failure were retrospectively reviewed. Eight cases (47.1%) underwent pulsatile pump implantation (Berlin Heart EXCOR, Berlin Heart Mediprodukt GmbH, Berlin, Germany); however, nine cases (52.9%) had continuous-flow pump using centrifugal design (HeartWare, HeartWare Inc., Miramar, FL, USA). Study participants were selected among the patients who had survived with a VAD for at least 6 months, and results of detailed ophthalmologic examinations including optic coherence tomography (OCT) and fundus fluorescein angiography (FA) were documented. All of the 17 patients were male, with a mean age of 48.5 ± 14.8 years (15-67 years). Detailed ophthalmologic examinations including the evaluation of retinal vascular deteriorations via FA were performed at a mean of 11.8 ± 3.7 months of follow-up (6-18 months). Mean best-corrected visual acuity and intraocular pressure were found as logMAR 0.02 ± 0.08 and 14.6 ± 1.9 mm Hg, respectively in the study population. Dilated fundoscopy revealed severe focal arteriolar narrowing in two patients (11.8%), and arteriovenous crossing changes in four patients (23.5%); however, no pathological alteration was present in macular OCT scans. In patients with continuous-flow blood pumps, mean arm-retina circulation time (ARCT) and arteriovenous transit time (AVTT) were found to be 16.8 ± 3.0 and 12.4 ± 6.2 s, respectively; whereas those with pulsatile-flow blood pumps were found to be 17.4 ± 3.6 and 14.0 ± 2.1 s in patients (P=0.526 and P=0

  10. Transcranial doppler sonography in two patients who underwent decompressive craniectomy for traumatic brain swelling: report of two cases

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    Bor-Seng-Shu Edson

    2004-01-01

    Full Text Available The role of decompressive craniectomy in the treatment of severe posttraumatic cerebral swelling remains quite a controversial issue. To the best of our knowledge, there is no study demonstrating the effect of decompressive craniectomy on cerebral blood flow (CBF velocity by means of transcranial Doppler sonography (TCD. We present two patients who developed traumatic brain swelling and uncontrollable intracranial hypertension with coma and signs of transtentorial herniation. One patient underwent bifrontal, while the second, unilateral, frontotemporoparietal decompressive craniectomy with dural expansion. In both patients, TCD examinations were performed immediately before and after surgery to study the cerebral hemodynamic changes related to the operations. Pre and postoperative TCD examinations demonstrated a significant increase in blood flow velocity in the intracranial arteries in both subjects. In conclusion, our cases suggest that decompressive craniectomy with dural expansion may result in elevation of CBF velocity in patients with massive brain swelling. The increase in CBF velocity appears to occur not only in the decompressed hemisphere, but also on the opposite side.

  11. The Effects of Functional Knee Brace on Postural Control in Patients Who Underwent Anterior Cruciate Ligament Reconstruction

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    Salehi

    2016-09-01

    Full Text Available Background The current study aimed to evaluate the postural control in patients underwent anterior cruciate ligament reconstruction pre and post wearing functional knee brace. Methods Eighteen athletes undergone unilateral anterior cruciate ligament reconstruction included in the study. They had unilateral anterior cruciate ligament reconstruction at least six months before session test. Postural control was assessed pre and post wearing custom-fit functional knee brace using a posturographic platform prokin 254. The balance tests included: 1 standing on prokin platform with eyes open/closed on anterior cruciate ligament reconstruction limb, 2 standing on prokin platform with eyes open/closed on both limbs. The standard deviation (SD of body sway along the anteroposterior (AP and mediolateral (ML axis, mean velocity of center of pressure (COP along AP/ ML axis and the area ellipse (measured in 2 mm were calculated. Results Results of the paired T-test revealed a significant effect on selected postural control variables for the brace conditions especially in low challengeable conditions (double leg, eyes open test situations (P < 0.05. But in high challengeable conditions this effect was not significant. Conclusions Functional knee brace improved postural control in the simple balancing task in the subjects with anterior cruciate ligament reconstruction. But this improvement in more difficult balancing task was limited.

  12. Anticholinergic drugs and functional, cognitive impairment and behavioral disturbances in patients from a memory clinic with subjective cognitive decline or neurocognitive disorders.

    Science.gov (United States)

    Dauphinot, Virginie; Mouchoux, Christelle; Veillard, Sébastien; Delphin-Combe, Floriane; Krolak-Salmon, Pierre

    2017-08-01

    Drugs with anticholinergic properties may be associated with various adverse clinical effects. The relationship between the anticholinergic (AC) burden and functional, global cognitive performance and behavior disturbances was assessed among elderly patients. A cross-sectional study was conducted between January 2012 and June 2014 in a memory clinic among outpatients living at home and with subjective cognitive decline (SCD) or neurocognitive disorders (NCD). The AC burden was measured using the Anticholinergic Drug Scale (ADS), the Anticholinergic Risk Scale (ARS), the Anticholinergic Cognitive Burden (ACB), Chew's score, Han's score, and the number of drugs with AC activity. Functional, cognitive performance and behavior disturbances were assessed using the Instrumental Activities of Daily Living (IADL) scale (IADL), the Mini Mental State Examination (MMSE), and the Neuropsychiatric Inventory (NPI). Among 473 included patients, 46.3% were at major NCD. Patients took on average 5.3 ± 2.6 drugs. MMSE was lower when Han's score (p = 0.04) and number of AC drugs were higher (p drugs were higher. After adjustment, all AC scores remained associated with IADL, while Han's score and number of drugs with AC remained associated with the MMSE. In patients with SCD or NCD, AC burden is associated with lower functional score, whereas the cross-sectional association between AC burden and cognitive performance or behavioral disturbance varies according to AC scores. Particular attention should be paid when prescribing drugs with AC properties, especially among patients with memory complaints.

  13. Impact of clinical, psychological, and social factors on decreased Tinetti test score in community-living elderly subjects: a prospective study with two-year follow-up.

    Science.gov (United States)

    Manckoundia, Patrick; Thomas, Frédérique; Buatois, Séverine; Guize, Louis; Jégo, Bertrand; Aquino, Jean-Pierre; Benetos, Athanase

    2008-06-01

    Balance and gait are essential to maintain physical autonomy, particularly in elderly people. Thus the detection of risk factors of balance and gait impairment appears necessary in order to prevent falls and dependency. The objective of this study was to analyze the impact of demographic, social, clinical, psychological, and biological parameters on the decline in balance and gait assessed by the Tinetti test (TT) after a two-year follow-up. This prospective study was conducted among community-living, young elderly volunteers in the centre "Investigations Preventives et Cliniques" and "Observatoire De l'Age" (Paris, France). Three hundred and forty-four participants aged 63.5 on average were enrolled and performed the TT twice, once at inclusion and again two years later. After the two-year follow-up, two groups were constituted according to whether or not there was a decrease in the TT score: the "TT no-deterioration" group comprised subjects with a decrease of less than two points and the "TT deterioration" group comprised those with a decrease of two points or more. Selected demographic, social, clinical, psychological, and biological parameters for the two groups were then compared. Statistical analysis showed that female sex, advanced age, high body mass index, osteoarticular pain, and a high level of anxiety all have a negative impact on TT score. Knowledge of predictive factors of the onset or worsening of balance and gait disorders could allow clinicians to detect young elderly people who should benefit from a specific prevention program.

  14. Subjective Cognitive Impairment Is a Predominantly Benign Condition in Memory Clinic Patients Followed for 6 Years: The Gothenburg-Oslo MCI Study

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    Erik Hessen

    2017-02-01

    Full Text Available Background/Aims: In the quest for prevention or treatment, there is a need to find early markers for preclinical dementia. This study observed memory clinic patients with subjective cognitive impairment (SCI and normal cognitive function at baseline. The primary aim was to address SCI as a potential risk factor for cognitive decline. The secondary aim was to address a potential relation between (1 baseline cerebrospinal fluid biomarkers and (2 a decline in memory performance over the first 2 years of follow-up, with a possible cognitive decline after 6 years. Methods: Eighty-one patients (mean age 61 years were recruited from university memory clinics and followed up for 6 years. Results: Eighty-six percent of the cohort remained cognitively stable or improved, 9% developed mild cognitive impairment, and only 5% (n = 4 developed dementia. Regression analysis revealed that low levels of Aβ42 at baseline and memory decline during the first 2 years predicted dementia. When combined, these variables were associated with a 50% risk of developing dementia. Conclusions: Cognitive stability for 86% of the cohort suggests that SCI is predominantly a benign condition with regard to neuropathology. The low number of individuals who developed dementia limits the generalizability of the results and discussion of progression factors.

  15. Association between Seminal Vesicle Invasion and Prostate Cancer Detection Location after Transrectal Systemic Biopsy among Men Who Underwent Radical Prostatectomy.

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    Young Ik Lee

    Full Text Available Our hypothesis is that the location of the seminal vesicles near the base of the prostate, the more positive cores are detected in the base, the greater the risk of seminal vesicle invasion. Therefore we investigate the clinical outcomes of base dominant prostate cancer (BDPC in transrectal ultrasound (TRUS -guided biopsies compared with anteromiddle dominant prostate cancer (AMPC.From November 2003 to June 2014, a total of 990 intermediate and high risk prostate cancer (PCa patients who underwent radical prostatectomy (RP were enrolled and stratified into two groups according to proportion of positive cores-BDPC group had ≥ 33.3% ratio of positive cores from the prostate base among all positive cores and AMPC group < 33.3% in systemic biopsy. Between two groups, we compared the rate of pathologic outcomes and biochemical recurrence (BCR. We performed multivariate logistic regression model to confirm the significance of BDPC to seminal vesicle invasion (SVI and Cox proportional hazard analysis to BCR.Among these 990 PCa patients, the 487 patients in BDPC group had more advanced clinical stage (p<0.001, a higher biopsy GS (p = 0.002, and a higher rate of extracapsular extension (ECE, SVI and BCR (all p<0.001 than AMPC group. The patients in BDPC group had poor BCR free survival rate via Kaplan-meier analysis (p<0.001. The ratio of the base positive cores was a significant predictor to SVI in multivariate analysis (p < 0.001 and significant predictor of BCR in multivariate Cox proportional analysis (hazard ratio: 1.466, p = 0.004.BDPC in TRUS-guided prostate biopsies was significantly associated with SVI and BCR after adjusting for other clinical factors. Therefore, BDPC should be considered to be a more aggressive tumor despite an otherwise similar cancer profile.

  16. Intraocular lens power estimation by accurate ray tracing for eyes underwent previous refractive surgeries

    Science.gov (United States)

    Yang, Que; Wang, Shanshan; Wang, Kai; Zhang, Chunyu; Zhang, Lu; Meng, Qingyu; Zhu, Qiudong

    2015-08-01

    For normal eyes without history of any ocular surgery, traditional equations for calculating intraocular lens (IOL) power, such as SRK-T, Holladay, Higis, SRK-II, et al., all were relativley accurate. However, for eyes underwent refractive surgeries, such as LASIK, or eyes diagnosed as keratoconus, these equations may cause significant postoperative refractive error, which may cause poor satisfaction after cataract surgery. Although some methods have been carried out to solve this problem, such as Hagis-L equation[1], or using preoperative data (data before LASIK) to estimate K value[2], no precise equations were available for these eyes. Here, we introduced a novel intraocular lens power estimation method by accurate ray tracing with optical design software ZEMAX. Instead of using traditional regression formula, we adopted the exact measured corneal elevation distribution, central corneal thickness, anterior chamber depth, axial length, and estimated effective lens plane as the input parameters. The calculation of intraocular lens power for a patient with keratoconus and another LASIK postoperative patient met very well with their visual capacity after cataract surgery.

  17. Incidence of venous thromboembolism among patients who underwent major surgery in a public hospital in Singapore

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    Anindya P. Susanto

    2014-03-01

    Full Text Available Background: Venous thromboembolism (VTE is a fatal yet potentially preventable complication of surgery. Routine thromboprophylaxis is still unequivocal prescription is problematic due to perception of low VTE incidence among Asian population. This study aims to investigate the incidence of VTE and thromboprophylaxis prescription among patients undergoing major surgery in a Singapore hospital.Methods: This was a cross-sectional study. Data were obtained from medical record of 1,103 patients who had underwent major orthopaedic or abdominal surgery in 2011-2012 at Khoo Teck Puat Hospital, Singapore. Incidence of VTE events either in the same admission or re-admission in less than one month time were noted as study parameters.Results: Incidence of VTE was 2.1% (95% CI: 1.67 - 2.53 of which 1.3% and 0.8% were DVT and PE cases respectively. Age, gender, history of VTE, ischemic heart disease, and mechanical prophylaxis were associated with VTE incidence based on bivariate analysis. The prescription of pharmacological thromboprophylaxis was associated with prior anticoagulant medication, type of surgery, and incidence of new bleeding. Conclusion: Subsequent to major surgeries, VTE is as common in Asian patients as published data in other populations. Pharmacologic thromboprophylaxis should be considered as recommended in non-Asian guidelines.Keywords: thromboprophylaxis, venous thromboembolism

  18. Influence of perioperative administration of amino acids on thermoregulation response in patients underwent colorectal surgical procedures

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    Zeba Snježana

    2007-01-01

    Full Text Available Background. Hypothermia in the surgical patients can be the consequence of long duration of surgical intervention, general anesthesia and low temperature in operating room. Postoperative hypothermia contributes to a number of postoperative complications such as arrhythmia, myocardial ischemia, hypertension, bleeding, wound infection, coagulopathy, prolonged effect of muscle relaxants. External heating procedures are used to prevent this condition, but some investigations reported that infusion of aminoacids during surgery can induce thermogenesis and prevent postoperative hypothermia. Case report. We reported two males who underwent major colorectal surgery for rectal carcinoma. One patient received Aminosol 15% solution, 125 ml/h, while the other did not. The esophageal temperatures in both cases were measured every 30 minutes during the operation and 60 minutes after in Intensive Care Unit. We were monitoring blood pressure, heart rate, ECG, and shivering. Patient who received aminoacids showed ameliorated postoperative hypothermia without hypertension, arrhythmia, or shivering, while the other showed all symptoms mentioned above. Conclusion. According to literature data, as well as our findings, we can conclude that intraoperative intravenous treatment with amino acid solution ameliorates postoperative hypothermia along with its complications. .

  19. The X-43A hypersonic research aircraft and its modified Pegasus booster rocket recently underwent c

    Science.gov (United States)

    2001-01-01

    The first of three X-43A hypersonic research aircraft and its modified Pegasus booster rocket recently underwent combined systems testing while mounted to NASA's NB-52B carrier aircraft at the Dryden Flight Research Center, Edwards, Calif. The combined systems test was one of the last major milestones in the Hyper-X research program before the first X-43A flight. The X-43A flights will be the first actual flight tests of an aircraft powered by a revolutionary supersonic-combustion ramjet ('scramjet') engine capable of operating at hypersonic speeds (above Mach 5, or five times the speed of sound). The 12-foot, unpiloted research vehicle was developed and built by MicroCraft Inc., Tullahoma, Tenn., under NASA contract. The booster was built by Orbital Sciences Corp., Dulles, Va.,After being air-launched from NASA's venerable NB-52 mothership, the booster will accelerate the X-43A to test speed and altitude. The X-43A will then separate from the rocket and fly a pre-programmed trajectory, conducting aerodynamic and propulsion experiments until it descends into the Pacific Ocean. Three research flights are planned, two at Mach 7 and one at Mach 10.

  20. AB103. Overexpression of RNF2 is an independent predictor of outcome in patients with urothelial carcinoma of the bladder underwent radical cystectomy

    OpenAIRE

    Liu, Zhuowei; Li, Xiangdong

    2016-01-01

    Objective RNF2 is frequently overexpressed in several types of human cancer, but the status of RNF2 amplification and expression in urothelial carcinoma of the bladder (UCB) and its clinical/prognostic significance is unclear. Methods In this study, the methods of immunohistochemistry and fluorescence in situ hybridization (FISH) were utilized to examine the protein expression and amplification of RNF2 in 184 patients of with UCBs who underwent radical cystectomy. Results Overexpression of RN...

  1. THE EXPERIENCE OF TREGALOZA BASED LUBRICANT USAGE FOR PATIENTS WHO UNDERWENT EXCIMER LASER SURGERY

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    E. Eskina

    2016-01-01

    Full Text Available Purpose: to evaluate the tregalose based eye drops effectiveness in patients who underwent PRK or TransPRK surgery. patients and methods: 50 patients with moderate myopia were examined before, 7 days and 1 month after PRK or TransPRK surgery made by SCHWIND Amaris excimer laser by the same surgeon. In addition to conventional diagnostics, Schirmer test and tear break up time were performed as well as ODSI questionare and Oxford index of ocular surface disorders were investigated. Patients were divided in two groups, Study group — “Thealos” group and “Control” group. In both groups patients have started using non preservative eye drops based on tregalosa and hyaluronic acid 4-th day after surgery respectively. results: The tear film breakup time was significantly better in “Thealos” group (7,22±3,61 sec 7 days postop and 9,36±3,68 sec 1 month postop in comparison to «Control” group 5,21±0,25 (р<0,01 sec and 7,21±2,85 sec respectively (р<0,05 as well as ocular surface index score in “Thealos” group post surgery was less (0,26±0,38 и 0,85±0,31 marks 7 days postop (р<0,05 and 0,09±0,19 and 0,21±0,4 (р<0,05 1 month postop respectively. There were no other statistically significant differences found in analysed data. Conclusion: Using of “Thealoz” non-preservative eye drops leads to faster recovery after surface excimer laser ablations in terms of dry eye manifestation, those as tearfilm stability and ocular surface index score, measured using “Oxford” scale. Moistening properties of tregaloze solution could be compared with those of hyaluronic acid solution.

  2. Retention of laparoscopic skills in naive medical students who underwent short training.

    Science.gov (United States)

    Sant'Ana, Guilherme M; Cavalini, Worens; Negrello, Bruce; Bonin, Eduardo A; Dimbarre, Daniellson; Claus, Christiano; Loureiro, Marcelo P; Salvalaggio, Paolo R

    2017-02-01

    Simulators are useful tools in the development of laparoscopic skills. However, little is known about the effectiveness of short laparoscopic training sessions and how retention of skills occurs in surgical trainees who are naïve to laparoscopy. This study analyses the retention of laparoscopic surgical skills in medical students without prior surgical training. A group of first- and second-year medical students (n = 68), without prior experience in surgery or laparoscopy, answered a demographic questionnaire and had their laparoscopic skills assessed by the Fundamentals of Laparoscopic Surgery (FLS) training protocol. Subsequently, they underwent a 150-minute training course after which they were re-tested. One year after the training, the medical students' performance in the simulator was re-evaluated in order to analyse retention. Of the initial 68 students, a total of 36 participated throughout the entire study, giving a final participation rate of 52 %. Thirty-six medical students with no gender predominance and an average age of 20 years were evaluated. One year after the short training programme, retention was 69.3 % in the peg transfer (p training evaluation. There was no significant difference in suturing. The average sample score in the baseline test was 8.3, in the post-training test it was 89.7, and in the retention test it was 84.2, which corresponded to a skill retention equivalence of 93 %. There was a significant retention of the laparoscopic surgical skills developed. Even 1 year after a short training session, medical students without previous surgical experience showed that they have retained a great part of the skills acquired through training.

  3. Impact of seizure frequency reduction on health-related quality of life among clinical trial subjects with refractory partial-onset seizures: A pooled analysis of phase III clinical trials of eslicarbazepine acetate.

    Science.gov (United States)

    Velez, Fulton F; Bond, T Christopher; Anastassopoulos, Kathryn P; Wang, Xuezhe; Sousa, Rui; Blum, David; Cramer, Joyce A

    2017-03-01

    Subjects who received eslicarbazepine acetate (ESL) as adjunctive therapy experienced significantly greater seizure frequency reduction (SFR) than placebo in three phase III, randomized, double-blind trials. This analysis compared changes in health-related quality of life (HRQOL) between treatment responders and non-responders across the pooled, per-protocol population (N=842) using the validated Quality of Life in Epilepsy Inventory-31 (QOLIE-31). QOLIE-31 scores were calculated for Total Score (TS) and seven subscales; higher scores indicate better HRQOL. Mean changes from baseline were calculated. Analysis of covariance examined least square mean (LSM) differences in final scores between responders (≥50% and ≥75% SFR) and non-responders. Clinical significance was based on established minimal clinically important differences (MCIDs). Mean changes were greater among responders for TS (5.2 versus 1.4 for ≥50% SFR; 7.5 versus 1.9 for ≥75% SFR) and all subscales. Additionally, the percentage of subjects with changes meeting or exceeding MCIDs was higher among responders for TS (48.4% versus 33.9% for ≥50% SFR; 56.9% versus 35.8% for ≥75% SFR) and all subscales. Responders had significantly higher final scores for TS (LSM difference=4.0 for ≥50% SFR; LSM difference=5.7 for ≥75% SFR) and all subscales except emotional well-being at ≥50% SFR. LSM differences exceeded MCIDs at ≥75% SFR for TS and five of seven subscales, and two subscales at ≥50% SFR. In a subgroup analysis with placebo removed, LSM differences were larger overall. In clinical trials of adjunctive ESL, higher levels of SFR were associated with greater improvements in HRQOL. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. The influence of expectation on spinal manipulation induced hypoalgesia: an experimental study in normal subjects.

    Science.gov (United States)

    Bialosky, Joel E; Bishop, Mark D; Robinson, Michael E; Barabas, Josh A; George, Steven Z

    2008-02-11

    The mechanisms thorough which spinal manipulative therapy (SMT) exerts clinical effects are not established. A prior study has suggested a dorsal horn modulated effect; however, the role of subject expectation was not considered. The purpose of the current study was to determine the effect of subject expectation on hypoalgesia associated with SMT. Sixty healthy subjects agreed to participate and underwent quantitative sensory testing (QST) to their leg and low back. Next, participants were randomly assigned to receive a positive, negative, or neutral expectation instructional set regarding the effects of a specific SMT technique on pain perception. Following the instructional set, all subjects received SMT and underwent repeat QST. No interaction (p = 0.38) between group assignment and pain response was present in the lower extremity following SMT; however, a main effect (p influence of expectation on SMT induced hypoalgesia in the body area to which the expectation is directed.

  5. Short-term efficacy of calcium fructoborate on subjects with knee discomfort: a comparative, double-blind, placebo-controlled clinical study

    Directory of Open Access Journals (Sweden)

    Pietrzkowski Z

    2014-06-01

    Full Text Available Zbigniew Pietrzkowski,1 Michael J Phelan,2 Robert Keller,3 Cynthia Shu,1 Ruby Argumedo,1 Tania Reyes-Izquierdo11FutureCeuticals, Inc., Applied BioClinical Laboratory; 2Department of Statistics, School of Information and Computer Science, University of California at Irvine; 3NutraClinical Inc., Irvine, CA, USAAbstract: Calcium fructoborate (CFB at a dose of 110 mg twice per day was previously reported to improve knee discomfort during the first 14 days of treatment. In this study, 60 participants with self-reported knee discomfort were randomized into two groups receiving CFB or placebo. Initial levels of knee discomfort were evaluated by Western Ontario and McMaster Universities Arthritis Index (WOMAC and McGill Pain Questionnaire (MPQ scores at the beginning of the study and also at 7 and 14 days after treatment. Results showed that supplementation with CFB significantly improved knee discomfort in the study subjects; significant reductions of mean within-subject change in WOMAC and MPQ scores were observed for the CFB group compared to the placebo group at both 7 and 14 days after treatment. Estimated treatment differences for the MPQ score were -5.8 (P=0.0009 and -8.9 (P<0.0001 at Day 7 and 14, respectively. Estimated differences for the WOMAC score were -5.3 (P=0.06 and -13.73 (P<0.0001 at Day 7 and 14, respectively. Negative values indicate greater reductions in reported discomfort. On both Day 7 and Day 14, the trend was toward greater improvement in the CFB group. The placebo group did not exhibit any change in the WOMAC and MPQ scores. In conclusion, supplementation with 110 mg CFB twice per day was associated with improving knee discomfort during the 2 weeks of intake.Keywords: CFB, joint discomfort, WOMAC score, McGill pain score

  6. A clinical study to examine the potential effect of lansoprazole on the pharmacokinetics of bosutinib when administered concomitantly to healthy subjects.

    Science.gov (United States)

    Abbas, Richat; Leister, Cathie; Sonnichsen, Daryl

    2013-08-01

    characterized by diarrhea (33 %), headache (21 %), and nausea (13 %). One subject experienced serious adverse events of diverticulitis, gastritis, and duodenitis after co-administration; however, no participant withdrew because of toxicity. This study demonstrated that bosutinib absorption may be reduced when co-administered with lansoprazole or other proton pump inhibitors. Caution should be used with such drug combinations, as subtherapeutic exposure of bosutinib may limit its clinical antitumor activity; short-acting antacids are recommended instead.

  7. Regular consumption of vitamin D-fortified yogurt drink (Doogh improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Shab-Bidar Sakineh

    2011-11-01

    Full Text Available Abstract Background Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease, the major cause of death in diabetes. We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes (T2D. In this study, the effects of improvement of vitamin D status on glycemic status, lipid profile and endothelial biomarkers in T2D subjects were investigated. Methods Subjects with T2D were randomly allocated to one of the two groups to receive either plain yogurt drink (PYD; containing 170 mg calcium and no vitamin D/250 mL, n1 = 50 or vitamin D3-fortified yogurt drink (FYD; containing 170 mg calcium and 500 IU/250 mL, n2 = 50 twice a day for 12 weeks. Anthropometric measures, glycemic status, lipid profile, body fat mass (FM and endothelial biomarkers including serum endothelin-1, E-selectin and matrix metalloproteinase (MMP-9 were evaluated at the beginning and after the 12-week intervention period. Results The intervention resulted in a significant improvement in fasting glucose, the Quantitative Insulin Check Index (QUICKI, glycated hemoglobin (HbA1c, triacylglycerols, high-density lipoprotein cholesterol (HDL-C, endothelin-1, E-selectin and MMP-9 in FYD compared to PYD (P P = 0.028; -3.8 ± 7.3 versus 0.95 ± 8.3, P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL, respectively, P P = 0.009 and P = 0.005, respectively but disappeared for E-selectin (P = 0.092. On the contrary, after controlling for serum 25(OHD, the differences disappeared for endothelin-1(P = 0.066 and MMP-9 (P = 0.277 but still remained significant for E-selectin (P = 0.011. Conclusions Ameliorated vitamin D status was accompanied by improved glycemic status, lipid profile and endothelial biomarkers in T2D subjects. Our findings suggest both direct and indirect ameliorating effects of vitamin D on the endothelial biomarkers. Trial registration

  8. Regular consumption of vitamin D-fortified yogurt drink (Doogh) improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial.

    Science.gov (United States)

    Shab-Bidar, Sakineh; Neyestani, Tirang R; Djazayery, Abolghassem; Eshraghian, Mohammad-Reza; Houshiarrad, Anahita; Gharavi, A'azam; Kalayi, Ali; Shariatzadeh, Nastaran; Zahedirad, Malihe; Khalaji, Niloufar; Haidari, Homa

    2011-11-24

    .011). Ameliorated vitamin D status was accompanied by improved glycemic status, lipid profile and endothelial biomarkers in T2D subjects. Our findings suggest both direct and indirect ameliorating effects of vitamin D on the endothelial biomarkers. ClinicalTrials.gov: NCT01236846.

  9. Repetitive Intermittent Hypoxia and Locomotor Training Enhances Walking Function in Incomplete Spinal Cord Injury Subjects: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Navarrete-Opazo, Angela; Alcayaga, Julio; Sepúlveda, Oscar; Rojas, Enrique; Astudillo, Carolina

    2017-05-01

    Incomplete spinal cord injuries (iSCI) leave spared synaptic pathways below the level of injury. Intermittent hypoxia (IH) elicits plasticity in the spinal cord and strengthens spared synaptic pathways, expressed as respiratory and somatic functional recovery in experimental animals and humans with iSCI. This study is a randomized, triple-blind, two-arm parallel clinical trial performed in Santiago, Chile. We compared the effects of a 4-week protocol of IH combined with body weight-supported treadmill training (BWSTT), with continuous normoxia (Nx) and BWSTT on 10-meter walk test (10MWT), 6-minute walk test (6MWT), and timed up and go (TUG) test in American Spinal Injury Association C and D individuals with iSCI. Subjects received daily IH (cycling 9%/21% O 2 every 1.5 min, 15 cycles/day) or continuous Nx (21% O 2 ) combined with 45 min BWSTT for 5 consecutive days, followed by IH/Nx 3 × per week (3 × wIH/Nx) for 3 additional weeks. Subjects were assessed at day 5, weekly from weeks 2-4, and at a 2-week follow-up. Daily IH plus BWSTT enhanced walking speed, expressed as decreased 10MWT time at day 5 versus baseline (IH: -10.2 ± 3.0 vs. Nx: -1.7 ± 1.7 sec, p = 0.006), and walking endurance expressed as increased 6MWT distance at day 5 versus baseline (IH: 43.0 ± 10.7 vs. Nx: 6.1 ± 3.4 m, p = 0.012), but not TUG time. Further, 3 × wIH maintained the daily IH-induced walking speed, and enhanced the daily IH-induced walking endurance, which is maintained up to the 2-week follow-up. We conclude that daily IH enhances walking recovery in subjects with iSCI, confirming previous findings. Moreover, 3 × wIH prolonged or enhanced daily IH-induced walking speed and endurance improvements, respectively, up to 5 weeks post-daily IH. Repetitive IH may be a safe and effective therapeutic alternative for persons with iSCI.

  10. The Effect of Cumin cyminum L. Plus Lime Administration on Weight Loss and Metabolic Status in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Abedi, Fatemeh; Sharifi, Nasrin; Karamali, Fatemeh; Fakhrieh Kashan, Zohreh; Asemi, Zatollah

    2016-08-01

    Limited data are available regarding the effects of combined administration of Cumin cyminum L. and lime on weight loss and metabolic profiles among subjects with overweight subjects. The current study aimed to assess the effects of combined administration of Cumin cyminum L. and lime on weight loss and metabolic profiles among subjects with overweight. This randomized double-blind placebo-controlled clinical trial was conducted on 72 subjects with overweight, aged 18 - 50 years old. Participants were randomly divided into three groups: Group A received high-dose Cumin cyminum L. and lime capsules (75 mg each, n = 24), group B low-dose Cumin cyminum L. and lime capsules (25 mg each, n = 24) and group C placebos (n = 24) twice daily for eight weeks. After eight weeks of intervention, compared with low-dose C. cyminum L. plus lime and placebo, taking high-dose C. cyminum L. plus lime resulted in significant weight loss (in the high-dose group: -2.1 ± 1.7 vs. in the low-dose group: -1.2 ± 1.5 and in the placebo group: + 0.2 ± 1.3 kg, respectively; P < 0.001) and body mass index (-0.8 ± 0.6 vs. -0.5 ± 0.5 and +0.1 ± 0.5 kg/m(2), respectively; P < 0.001). In addition, administration of high-dose C. cyminum L. plus lime compared with low-dose C. cyminum L. plus lime and placebo, led to a significant reduction in fasting plasma glucose (FPG) (P < 0.001) and a significant rise in quantitative insulin sensitivity check index (QUICKI) (+ 0.02 ± 0.02 vs. + 0.01 ± 0.02 and 0.01 ± 0.01, respectively; P = 0.01). Moreover, a significant decrease in serum triglycerides (-14.1 ± 56.2 vs. +13.9 ± 36.8 and + 10.6 ± 25.1 mg/dL; respectively; P = 0.03), total-cholesterol (-18.4 ± 28.6 vs. +8.6 ± 28.5 and -1.0 ± 24.8 mg/dL; respectively; P = 0.004) and low density lipoproteins- (LDL)-cholesterol levels (-11.8 ± 20.7 vs. +6.5 ± 23.2 and -2.9 ± 20.4 mg/dL, respectively; P = 0.01) was observed following the consumption of high-dose C. cyminum L. plus lime compared with

  11. FUNCTIONAL OUTCOME IN PATIENTS WHO UNDERWENT LUMBAR MICRODISCECTOMY FOR INTERVERTEBRAL DISC PROLAPSE (IVDP

    Directory of Open Access Journals (Sweden)

    Sudheer Urampath

    2016-11-01

    Full Text Available BACKGROUND Intervertebral Disc Prolapse (IVDP is a very common cause for low backache in younger population. When conservative treatment fails or when patient develops complications like neurological deficit, then the treatment is surgical discectomy. Open laminectomy and microdiscectomy are the modes of surgical interventions for such patients. There is a lot of morbidity for open laminectomy when compared to microdiscectomy to assess the functional outcome of patients underwent lumbar microdiscectomy. METHODS A prospective study was done among 30 patients with Intervertebral Disc Prolapse (IVDP who did not respond to conservative treatment were undergone the surgical procedure microdiscectomy. The patients were re-evaluated for pre and postoperative neurological deficit and postoperative pain relief at 1 week, 6 weeks, 6 months, 12 months and 24 months after surgery. RESULTS Out of 30 patients in 15 (50% patients, microdiscectomy was done in hip flexion and in the remaining half (15 patients it was done without hip flexion. There were 18 men and 12 women with a mean age of 39.4. All patients 30 (100% is presented with preoperative neurological impairment had a positive Lasegue sign, 20 (66.67% had motor deficits and 18 (60% had sensory deficits. In this study group, the vertebral levels mainly affected were L4-L5 in 18 (60% patients and L5-S1 in 12 (40% patients. After microdiscectomy, motor deficit was reduced from 66.67% to 20% out of 30 patients by the end of one year. Similarly, a reduction in sensory deficit was also seen from 60% to 20%. Pain relief was also found to be excellent in 86.6% patients at the end of 24 months. CONCLUSION Early postoperative mobilisation and earlier pain relief are the most important advantages of this novel technique. Lesser blood loss, low surgical time, least destabilisation of spine are other merits of this procedure and can be recommended as the gold standard surgical method for patients with IVDP who

  12. Expanding subjectivities

    DEFF Research Database (Denmark)

    Lundgaard Andersen, Linda; Soldz, Stephen

    2012-01-01

    A major theme in recent psychoanalytic thinking concerns the use of therapist subjectivity, especially “countertransference,” in understanding patients. This thinking converges with and expands developments in qualitative research regarding the use of researcher subjectivity as a tool to understa...

  13. Effects of a Combined Nutraceutical on Lipid Pattern, Glucose Metabolism and Inflammatory Parameters in Moderately Hypercholesterolemic Subjects: A Double-blind, Cross-over, Randomized Clinical Trial.

    Science.gov (United States)

    Cicero, Arrigo Francesco Giuseppe; Colletti, Alessandro; Fogacci, Federica; Bove, Marilisa; Rosticci, Martina; Borghi, Claudio

    2017-03-01

    There is an increasing interest for combined nutraceuticals that can act on several points of lipid and glucose metabolism with preventive purposes. However, the simple assemblage of nutraceuticals with potentially additive mechanism of action need to be clinically tested. To assess the effects of a combination of nutraceuticals based on artichoke, red yeast rice, banaba, and coenzyme Q10, we performed a double bind, cross-over designed trial versus placebo in 30 adults with LDL cholesterol suboptimal in primary prevention of cardiovascular disease. After a period of 3 weeks of dietary habits correction, patients began a period of 6 weeks of treatment with nutraceutical or placebo, followed by 2 weeks of washout and finally 6 weeks in cross-over. Data related to lipid pattern, insulin resistance, renal function, liver and CPK have been obtained at each visit. In particular, the after the nutraceutical treatment the enrolled patients experienced a significant improvement in total cholesterol (-13.6 %), LDL-C (-18.2 %), non-HDL-C (-15 %), glutamic oxaloacetic transaminase (-10 %), glutamate-pyruvate transaminase (-30.9 %), and hs-CRP (-18.2 %) versus placebo. No changes have been observed in the other investigated parameters in both groups. The tested combination of nutraceuticals has shown clinical efficacy in the reduction of total cholesterol, non-HDL, LDL and triglycerides, while improving the level of liver transaminases and high sensitivity C-reactive protein. Further confirmation are needed to verify these observations on the middle and long term with a larger number of subjects.

  14. Safety and effects of two mistletoe preparations on production of Interleukin-6 and other immune parameters - a placebo controlled clinical trial in healthy subjects

    Directory of Open Access Journals (Sweden)

    Huber Roman

    2011-11-01

    Full Text Available Abstract Background In Germany, Iscucin® Populi (IP, a preparation from mistletoe growing on the poplar tree, is used in cancer therapy while Viscum Mali e planta tota (VM, a preparation from mistletoe growing on the apple tree, is used in patients with osteoarthritis. Since mistletoe preparations are suspected to induce production of potentially tumor promoting cytokines like interleukin (IL-6, further studies on the immunological effects are of interest. Methods In this 3-armed randomized, double blind clinical trial healthy volunteers received increasing doses of either IP (strength F, 0.0125%, G, 0.25% and H, 5%, each for 4 weeks, or VM (1:1000 [D3], 1:100 [D2] and 2% each for 4 weeks or placebo (isotonic solution subcutaneously twice per week over a period of 12 weeks. Physical examination was performed weekly. Routine laboratory parameters and immunological parameters (C-reactive protein (CRP, differential blood count, lymphocyte subsets, immunoglobulins, IL-6 and tumor necrosis factor (TNF-α were analysed every 4 weeks. Results 71 subjects were included in the study (IP = 30, VM = 21, placebo = 20 of whom 69 concluded it according to protocol. Application of IP strengths G and H caused strong local reactions at the site of injection. In parallel, a distinct eosinophilia (p Conclusion Treatment with IP results in eosinophilia and an increase of CD4 cells but not in an increase of IL-6 or CRP. No safety concerns regarding the two mistletoe preparations have been raised by this study. EudraCT-Number 2007-002166-35. Trial registration ClinicalTrials.gov: NCT01378702

  15. Implants with an Oxidized Surface Placed Predominately in Soft Bone Quality and Subjected to Immediate Occlusal Loading: Results from an 11-Year Clinical Follow-Up.

    Science.gov (United States)

    Glauser, Roland

    2016-06-01

    The purpose of this clinical follow-up was to document the 11-year outcome of implants with a moderately rough oxidized surface subjected to immediate occlusal loading. Twenty-six of 38 patients enrolled in a 5-year prospective study were available for this follow-up analysis, with 33 restorations supported by 66 slightly tapered implants (Brånemark System MkIV, Nobel Biocare, Gothenburg, Sweden). The majority of implants were placed in posterior regions (88%) and into soft bone (76%). Parameters included cumulative survival rate (CSR), radiographic marginal bone level, bleeding on probing (BOP), intrasulcular counts of perio-pathogenic markers (DNA probes), and total bacterial load (TBL). The CSR was 97.1% at 11.2 years mean follow-up. Mean marginal bone remodeling was 0.47 mm (SD 1.09, n = 65) from 1 year postplacement to 11-year follow-up. BOP was absent at most sites (63.6%). No statistically significant differences in TBL or perio-pathogenic marker species were observed at implants and teeth. The results of the present follow-up show high long-term survival, stable marginal bone levels, and soft tissue outcomes of oxidized surface implants placed predominately in posterior regions and soft bone. The quantity and quality of intrasulcular microbiota were comparable at implants and teeth. © 2015 Wiley Periodicals, Inc.

  16. Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate/ethinyl estradiol in HCV-uninfected female subjects.

    Science.gov (United States)

    German, P; Moorehead, L; Pang, Phillip; Vimal, M; Mathias, A

    2014-11-01

    This study evaluated the potential for a drug-drug interaction between HCV direct-acting antivirals sofosbuvir or ledipasvir and oral hormonal contraceptive (OC) norgestimate/ethinyl estradiol (norgestimate 0.18/0.215/0.25 mg with ethinyl estradiol 25 μg). This was a 112-day, open-label, fixed-sequence pharmacokinetic (PK) study in healthy female subjects that included a lead-in cycle (OC only; N = 21), cycle 1 (OC only; N = 15), cycle 2 (OC + sofosbuvir; N = 15), and cycle 3 (OC + ledipasvir; N = 15). Administration of sofosbuvir with OC did not alter PK of norelgestromin (primary norgestimate metabolite) or ethinyl estradiol. Small increases in norgestrel (secondary norgestimate metabolite) AUC(tau) (19%) and C(tau) (23%) with sofosbuvir were noted. Ledipasvir did not impact PK of norelgestromin or norgestrel but modestly increased ethinyl estradiol C(max) (40%). Sofosbuvir, GS- 331007 (predominant circulating metabolite of SOF), and ledipasvir PK were similar to historical data. Pharmacodynamic markers luteinizing hormone, follicle-stimulating hormone, and progesterone values were generally comparable in all cycles. No loss in contraceptive efficacy is expected upon administration of sofosbuvir or ledipasvir/sofosbuvir with oral contraceptives containing norgestimate and ethinyl estradiol. The use of sofosbuvir or ledipasvir/sofosbuvir FDC with oral contraceptives is permitted. © 2014, The American College of Clinical Pharmacology.

  17. The effect of nano-curcumin on HbA1c, fasting blood glucose, and lipid profile in diabetic subjects: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hamid Reza Rahimi

    2016-08-01

    Full Text Available Objective: Diabetes mellitus is defined as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both or insulin resistance. Curcumin inhibits NF-κB signaling pathway. The aim of this study is evaluation of the effect of Nano-curcumin on HbA1C, fast blood glucose and lipid profile in diabetic patients. Materials and Methods: Seventy type-2 diabetic patients (fasting blood glucose (FBG ≥ 126 mg/dL or 2-hr postprandial blood glucose ≥200 mg/dl randomly receivedeither Curcumin (as nano-micelle 80 mg/day or placebo for 3 months in a double blind randomized clinical trial. Fasting blood glucose, HbA1C, and lipids profile were checked before and after the intervention. Data analyses, including parametric and nonparametric tests were done using the SPSS 11.5 software. A p value < 0.05 was regarded as statistically significant. (RCT registration code: IRCT2013081114330N1 Results: Mean age, BMI, FBG, total cholesterol (TC, triglyceride (TG, LDL, HDL, HbA1c , and  sex and had no significant difference at the baseline between the groups. In Nano-curcumin group, a significant decrease was found in HbA1C, FBG, TG, and BMI comparing results of each subject before and after the treatment (p

  18. The Bt-DUX: development of a subjective measure of health-related quality of life in patients who underwent surgery for lower extremity malignant bone tumor.

    NARCIS (Netherlands)

    Bekkering, W.P.; Vlieland, T.P.; Koopman, H.M.; Schaap, G.R.; Schreuder, H.W.B.; Beishuizen, A.; Tissing, W.J.; Hoogerbrugge, P.M.; Anninga, J.K.; Taminiau, A.H.M.

    2009-01-01

    BACKGROUND: To examine the practical applicability, internal consistency, and validity of the Bt-DUX, a disease-specific Health Related Quality of Life (HRQoL) instrument. The Bt-Dux was developed to examine patients' individual values of their life after a malignant bone tumor of the lower

  19. The Bt-DUX : Development of a Subjective Measure of Health-Related Quality of Life in Patients Who Underwent Surgery for Lower Extremity Malignant Bone Tumor

    NARCIS (Netherlands)

    Bekkering, W. Peter; Vlieland, Theodora P. M. Vliet; Koopman, Hendrik M.; Schaap, Gerard R.; Schreuder, H. W. Bart; Beishuizen, Auke; Tissing, Wim J. E.; Hoogerbrugge, Peter M.; Anninga, Jacob K.; Taminiau, Antonie H. M.

    Background To examine the practical applicability, internal consistency, and validity of the Bt-DUX, a disease-specific Health Related Quality of Life (HRQoL) instrument. The Bt-Dux was developed to examine patients' individual values of their life after a malignant bone tumor of the lower extremity

  20. Skeletal pattern in subjects with temporomandibular joint disorders.

    Science.gov (United States)

    Almăşan, Oana Cristina; Băciuţ, Mihaela; Almăşan, Horea Artimoniu; Bran, Simion; Lascu, Liana; Iancu, Mihaela; Băciuţ, Grigore

    2013-02-21

    To establish the skeletal pattern in subjects with malocclusions and temporomandibular disorders (TMD); to assess the relationship between craniofacial skeletal structures and TMD in subjects with malocclusions. Sixty-four subjects with malocclusions, over 18 years of age, were included in the study. Temporomandibular disorders were clinically assessed according to the Helkimo Anamnestic Index. Subjects underwent a lateral cephalogram. Subjects were grouped according to the sagittal skeletal pattern (ANB angle) into class I, II and III. Parametric Student tests with equal or unequal variations were used (variations were previously tested with Levene test). Twenty-four patients with TMD (experimental sample); 40 patients without TMD (control group); interincisal angle was higher in class I and II (p < 0.05) experimental subjects; overjet was larger in experimental subjects; midline shift and Wits appraisal were broader in the experimental group in all three classes. In class III subjects, the SNB angle was higher in the experimental group (p = 0.01). Joint noises followed by reduced mandible mobility, muscular pain and temporomandibular joint (TMJ) pain were the most frequent symptoms in subjects with TMD and malocclusions. Temporomandibular joint status is an important factor to consider when planning orthodontic treatment in patients with severe malocclusions; midline shift, large overjet and deep overbite have been associated with signs and symptoms of TMD.

  1. Factors associated with bone mineral density in women who underwent bariatric surgery

    Directory of Open Access Journals (Sweden)

    Luzia Jaeger Hintze

    2014-03-01

    To analyze factors associated with bone mineral density (BMD of candidates and patients admitted to Bariatric Surgery (BS. This study included 61 women who had done or were waiting for BS. Anthropometric variables, body composition and BMD from the femur, femoral neck, lumbar spine and the whole body were measured. The factors associated with changes in BMD, such as smoking, alcohol ingestion, sedentary lifestyle, BS, nutritional supplementation and age were evaluated. The statistical significance was set at 5%. Age and BS were associated with changes in BMD. Among the individuals who had  BS done, the rates of osteopenia/osteoporosis were greater in the femur (OR 3.34; CI [1.52 - 1.83] and femoral neck (OR 3.69; CI [1.34 – 2.08]. Subjects older than 50 years also had greater rates of BMD in the lumbar spine (OR 4.12; CI [2.09 – 22.33], the whole body (OR 4.77; CI [1.34 – 28.14], femur (OR 16.94; CI [2.16 - 124.32] and femoral neck (OR 14.95; CI [1.86 - 110.66]. Patients who have had BS and are over 50 years of age showed higher rates of osteopenia/osteoporosis, which demonstrate the necessity of further studies exploring the effects of BS and its impact on bone metabolism.

  2. Preoperative hepatitis B virus DNA level is a risk factor for postoperative liver failure in patients who underwent partial hepatectomy for hepatitis B-related hepatocellular carcinoma.

    Science.gov (United States)

    Huang, Gang; Lau, Wan Yee; Shen, Feng; Pan, Ze-Ya; Fu, Si-Yuan; Yang, Yun; Zhou, Wei-Ping; Wu, Meng-Chao

    2014-09-01

    Our objective was to explore the short-term effects of preoperative serum hepatitis B virus DNA level (HBV DNA) on postoperative hepatic function in patients who underwent partial hepatectomy for hepatitis B-related hepatocellular carcinoma (HCC). The clinical data of 1,602 patients with hepatitis B-related HCC who underwent partial hepatectomy in our department were retrospectively studied. The patients were divided into three groups according to their preoperative HBV DNA levels: group A 20,000 IU/mL. The rates of postoperative complications, especially the rate of postoperative liver failure, were compared. There were significant differences among the three groups in the rates of postoperative liver failure. On multivariate logistic regression analysis, a high preoperative HBV DNA level was an independent risk factor for postoperative liver failure. Preoperative HBV DNA level was a significant risk factor for postoperative hepatic dysfunction.

  3. A systematic review of methods for quantifying serum testosterone in patients with prostate cancer who underwent castration.

    Science.gov (United States)

    Comas, I; Ferrer, R; Planas, J; Celma, A; Regis, L; Morote, J

    2017-03-02

    The clinical practice guidelines recommend measuring serum testosterone in patients with prostate cancer (PC) who undergo castration. The serum testosterone concentration should be <50ng/dL, a level established by using a radioimmunoassay method. The use of chemiluminescent immunoassays (IA) has become widespread, although their metrological characteristics do not seem appropriate for quantifying low testosterone concentrations. The objective of this review is to analyse the methods for quantifying testosterone and to establish whether there is scientific evidence that justifies measuring it in patients with PC who undergo castration, through liquid chromatography attached to a mass spectrometry in tandem (LC-MSMS). We performed a search in PubMed with the following MeSH terms: measurement, testosterone, androgen suppression and prostate cancer. We selected 12 studies that compared the metrological characteristics of various methods for quantifying serum testosterone compared with MS detection methods. IAs are standard tools for measuring testosterone levels; however, there is evidence that IAs lack accuracy and precision for quantifying low concentrations. Most chemiluminescent IAs overestimate their concentration, especially below 100ng/dL. The procedures that use LC-MSMS have an adequate lower quantification limit and proper accuracy and precision. We found no specific evidence in patients with PC who underwent castration. LC-MSMS is the appropriate method for quantifying low serum testosterone concentrations. We need to define the level of castration with this method and the optimal level related to better progression of the disease. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  4. Usefulness of Inferior Vena Cava Filters in Unstable Patients With Acute Pulmonary Embolism and Patients Who Underwent Pulmonary Embolectomy.

    Science.gov (United States)

    Stein, Paul D; Matta, Fadi; Lawrence, Frank R; Hughes, Mary J

    2018-02-15

    Administrative data were analyzed from the Premier Healthcare Database, 2010 to 2014, to assess whether inferior vena cava (IVC) filters reduce mortality in unstable patients (in shock or on ventilator support) with acute pulmonary embolism and in stable patients who undergo surgical pulmonary embolectomy. Mortality was assumed to be due to pulmonary embolism in patients who had none of the co-morbid conditions listed in the Charlson Comorbidity Index. Data were determined on the basis of International Classification of Disease-9th Clinical Modification (ICD-9-CM) codes. All-cause mortality in unstable patients was lower with IVC filters in-hospital, 288 of 1,972 (23%) versus 1339 of 3002 (45%) (p <0.0001), and at 3 months, all-cause mortality was 316 of 1,272 (25%) versus 1,428 of 3,002 (48%) (p <0.0001). Pulmonary embolism mortality was lower with IVC filters in unstable patients in-hospital, 191 of 926 (21%) versus 913 of 2,138 (43%) (p <0.0001) and at 3 months, 215 of 926 (23%) versus 971 of 2,138 (45%) (p <0.0001). A lower in-hospital and 3-month all-cause mortality and pulmonary embolism mortality was also shown with IVC filters in stable patients who underwent pulmonary embolectomy. These data, in concert with previous retrospective data, suggest that unstable patients with pulmonary embolism and stable patients who undergo pulmonary embolectomy may benefit from an IVC filter. Further investigations would be useful. Copyright © 2017. Published by Elsevier Inc.

  5. [Usefulness of the residual SYNTAX score to predict long term outcome in acute coronary syndrome patients underwent percutaneous coronary intervention].

    Science.gov (United States)

    Song, Y; Xu, J J; Tang, X F; Ma, Y L; Yao, Y; He, C; Wang, H H; Liu, R; Xu, N; Jiang, P; Jiang, L; Zhao, X Y; Gao, Z; Gao, R L; Qiao, S B; Yang, Y J; Xu, B; Yuan, J Q

    2017-02-21

    Objective: To quantify the extent and complexity of residual coronary stenosis following PCI by the residual SYNTAX score, and to evaluate its impact on adverse ischemic outcomes in acute coronary syndrome(ACS) patients. Methods: From January 2013 to December 2013, a total of 1 414 consecutive moderate- and high-risk ACS patients who underwent any PCI with multi-vessel coronary artery disease were evaluated.Patients were stratified by rSS quartiles and their outcomes were compared. Results: The rSS was 4.8±6.7. 591 patients (41.8%) had rSS=0(CR), 233 patients (16.5%) had rSS>0 but ≤ 3, 296 patients (20.9%) had rSS>3 but ≤8 and 294 patients (20.8%) had rSS>8.Clinical risk factors were more frequent in patients with incomplete revascularization(IR) compared with complete revascularization(CR). The 2-year rates of all-caused death(1.2% vs 0.4%, 2.0%, 4.4%, P=0.003), cardiac death, revascularization and MACCE were significantly higher in high rSS group, compared to other groups.By multivariable analysis, rSS was a strong independent predictor of ischemic outcomes at 2-year, including all-cause mortality (HR=1.05, 95%CI 1.01-1.09, P=0.019), cardiac death, revascularization and MACCE. Conclusions: The rSS is a strong independent predictor of all-caused death, cardiac death, revascularization and MACCE and has moderated predictive ability for those ischemic outcomes.

  6. Emergency peripartum hysterectomy in Isfahan; maternal mortality and morbidity rates among the women who underwent peripartum hysterectomy

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    Fatemeh Mostajeran Gurtani

    2013-01-01

    Conclusion : This study indicated the high rate of mortality among patients underwent peripartum hysterectomy. Evaluation of management during referring the patients and designing more studies to evaluate the mortality and morbidities are warranted.

  7. Evaluation of the utility of subjective clinical parameters for estimating fecal egg counts and packed cell volume in Canadian sheep flocks.

    Science.gov (United States)

    Mederos, A; Kelton, D; Peregrine, A S; VanLeeuwen, J; Fernández, S; LeBoeuf, A; Menzies, P; Martin, R

    2014-10-15

    A study was conducted in sheep on Canadian farms to describe the relationship between packed cell volume (PCV) or fecal egg counts (FEC) and subjective clinical parameters that may indicate the severity of parasitic gastroenteritis. Twenty-one farms in Ontario (ON) and 8 farms in Quebec (QC) were purposively selected and visited during April-May (spring) and August (summer) 2007. At each farm visit, blood and fecal samples were collected from 10 ewes and 10 female lambs; body condition score (BCS), dag score (DS), fecal consistency score (FCS) and FAMACHA score were recorded for all sampled sheep. Packed cell volume was determined for all blood samples, and FEC were performed for all fecal samples. Summary statistics and simple correlations were performed for the parameters recorded. Two mixed models with random effects at the farm level were developed; one using PCV as the response variable and another using the natural log of eggs per gram of feces (lnEPG). Finally, the residuals from both models were correlated to the covariates in the models. The mean PCV values during the spring were 29.7% and 36.7% for lambs, and 28.8% and 31.1% for ewes, in ON and QC, respectively. During the summer, the mean PCV was 32.0% and 32.8% for lambs, and 30.1% and 29.9% for ewes, in ON and QC, respectively. The arithmetic mean FEC per gram of feces (EPG) during the spring was 3 and 2 for lambs, and 1266 and 789 for ewes, in ON and QC, respectively, whereas during summer the arithmetic mean EPG was 907 and 237 for lambs, and 458 and 246 for ewes, in ON and QC, respectively. Results from simple correlations indicated that PCV was negatively correlated with lnEPG (r = -0.255; r(2) = 6.5%) and FAMACHA (r = -0.312; r(2) = 9.7%), and positively correlated with BCS (r = 0.317; r(2) = 10%). LnEPG was negatively correlated with BCS (r = -0.232; r(2) = 5.4%) and PCV (r = -0.255; r(2) = 6.5%), but positively correlated with FAMACHA (r = 0.178; r(2) = 3.2%) and DS (r = 0.086; r(2) = 0

  8. N-acetyl cysteine in ovulation induction of PCOS women underwent intrauterine insemination: An RCT

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    Tahereh Behrouzi Lak

    2017-08-01

    Full Text Available Background: N-acetyl cysteine (NAC was proposed as an adjuvant to clomiphene citratefor ovulation induction in patients with polycystic ovary syndrome (PCOS without clomiphene citrate resistance. Objective: To evaluate the effect of NAC on pregnancy rate in PCOS patients who were candidates for intrauterine insemination. Materials and Methods: In this randomized clinical trial 97 PCOS women aged 18-38 years were enrolled in two groups, randomly. For the case group (n=49, NAC (1.2 gr+ clomiphene citrate (100 mg + letrozole (5mg were prescribed Daily from the third day of menstruation cycle for five days. The control group (n=48 had the same drug regimen without NAC. In order to follicular development, GONALF was injected on days of 7-11 menstrual cycles in all participants. When the follicle size was 18mm or more, HCG (10000 IU was injected intramuscular and the intrauterine insemination was performed after 34-36 hr. Results: There were not significant differences between study groups regarding mean endometrial thickness (p=0.14, mean number of mature follicles (p=0.20 and the pregnancy rate (p=0.09. Conclusion: NAC is ineffective in inducing or augmenting ovulation in PCOS patients who were candidates for intrauterine insemination and cannot be recommended as an adjuvant to CC in such patients.

  9. Evaluation of polyomavirus BK reactivation in lupus patients who underwent kidney transplantation

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    Cristina Costa

    2012-06-01

    Full Text Available Background. A pathogenic role for polyomavirus BK in systemic lupus erythematosus (SLE has been proposed, however no study evaluated the occurrence of BK replication in renal transplant recipients according to the underlying disease leading to transplantation and its potential impact. Methods. The occurrence of BK reactivation was serially evaluated in 468 renal transplant recipients, including 11 patients with SLE as underlying disease (overall, 2370 serum and 2370 urine specimens; 65 from SLE patients. Results. Considering the overall occurrence of viral reactivation (viremia and/or viruria, 26/65 (40% specimens were positive in four SLE patients (36.3% versus 331/2143 (15.4% in 130/227 (57.3% non-SLE patients. A patient transplanted for class III lupus nephritis evidenced sustained BK viremia and viruria (with viremia values potentially indicative of polyomavirus-associated nephropathy in the absence of clinical features of renal dysfunction or recurrence of lupus nephritis. Conclusions. Further studies on larger populations and for a longer follow-up should be required to evaluate the impact of BKV reactivation in renal transplant patients with SLE as underlying disease, as well as the potential therapeutic implications.

  10. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus

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    Jastreboff Pawel J

    2011-01-01

    Full Text Available Abstract Background Neramexane is a new substance that exhibits antagonistic properties at α9α10 cholinergic nicotinic receptors and N-methyl-D-aspartate receptors, suggesting potential efficacy in the treatment of tinnitus. Methods A total of 431 outpatients with moderate to severe subjective tinnitus (onset 3-18 months before screening were assigned randomly to receive either placebo or neramexane mesylate (25 mg/day, 50 mg/day and 75 mg/day for 16 weeks, with assessment at 4-week intervals. The primary (intention-to-treat efficacy analysis was based on the change from baseline in Week 16 in the total score of the adapted German short version of the validated Tinnitus Handicap Inventory questionnaire (THI-12. Results Compared with placebo, the largest improvement was achieved in the 50 mg/d neramexane group, followed by the 75 mg/d neramexane group. This treatment difference did not reach statistical significance at the pre-defined endpoint in Week 16 (p = 0.098 for 50 mg/d; p = 0.289 for 75 mg/d neramexane, but consistent numerical superiority of both neramexane groups compared with placebo was observed. Four weeks after the end of treatment, THI-12 scores in the 50 mg/d group were significantly better than those of the controls. Secondary efficacy variables supported this trend, with p values of Conclusions This study demonstrated the safety and tolerability of neramexane treatment in patients with moderate to severe tinnitus. The primary efficacy variable showed a trend towards improvement of tinnitus suffering in the medium- and high-dose neramexane groups. This finding is in line with consistent beneficial effects observed in secondary assessment variables. These results allow appropriate dose selection for further studies. Trial Registration ClinicalTrials.gov NCT00405886

  11. Comparison of propofol effect with Ketamine for sedation induction in pediatric patients who underwent cardiol catheterization

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    Houshang Shahryari

    2010-04-01

    Full Text Available Background: The goals for sedation in pediatric patients scheduled to undergo cardiac catheterization include immobility, analgesia, cardiovascular and respiratory stability. We investigated the effects of Propofol and Ketamine on hemodynamic, respiratory status, sedation level, pain score and recovery period in pediatric patients undergoing cardiac catheterization. Methods: We preformed a randomized clinical trial study on 40 pediatric patients. The patients were randomly assigned to two groups, so that 20 patients received Ketamine and 20 patients received Propofol. In all patients, sedation was started with Midazolam (0.03mg/kg, then followed by Propofol in the first group and Ketamine in the second one. The hemodynamic responses, respiratory parameters, recovery characteristics (Ramsey scale, pain score VAS and relevant adverse effects of the two groups were recorded. Data was analyzed using Paired T Test, ANOVA and Stearman correlation coefficient. Results: Five patients in the Propofol group andon patients in the Ketamine group experienced a transient decrease in mean systolic blood pressure greater than 10% of baseline(p=0.034. Time to full recovery (mean ± SD was not significantly different in the Propofol group and Ketamine group (1.8 min vs. 2.9 min, P > 0.05. Pain scores were significantly different in both groups (P= 0.010. Patients’ heart rates were significantly higher in Ketamine group(P=0.029. No significant difference in respiratory rate was recorded in both groups(p›0.05. Conclusion: Both Ketamine and Propofol are useful and safe in pediatric patients undergoing cardiac catheterization but it seems that it is better to use Propofol in stable hemodynamic pediatric patients under continuous blood pressure monitoring.

  12. Correlation of radiographic and functional measurements in patients who underwent primary scoliosis surgery in adult age.

    Science.gov (United States)

    Sánchez-Mariscal, Felisa; Gomez-Rice, Alejandro; Izquierdo, Enrique; Pizones, Javier; Zúñiga, Lorenzo; Alvarez-González, Patricia

    2012-04-01

    Prospective radiographic and clinical analysis. To evaluate whether radiographic spinopelvic parameters correlate with health-related quality of life (HRQOL) measures, in the long run, in patients operated on scoliosis in adult age. There are papers that correlate sagittal radiographic parameters with HRQOL scores for healthy spine as well as for some spinal disorders. However, there are limited studies evaluating correlations between HRQOL measures, radiographic spinopelvic parameters, and age in patients operated on scoliosis in adult age. Fifty-nine patients, older than 21 years at surgery time (median: 50.2 years), were operated upon at a single center. All of them suffered mainly frontal deformity, idiopathic or degenerative curves, and long fusions, with more than a 2-year follow-up (median:8.5 years). Full-length freestanding radiographs, including the spine and pelvis, and SRS22 and SF36 instruments, were available for every patient at final follow-up. Sagittal and frontal radiographic parameters and age were analyzed for correlation with HRQOL. A multivariate analysis was performed. No significant correlation was found between frontal parameters and HRQOL measures. Spearman rank order test showed correlation (P Scoliosis Research Society (SRS) activity and sagittal vertical axis (SVA) (r = -0.44), pelvic tilt (PT) (r = -0.49), and age (r = -0.5). SRS total was correlated (P scoliosis, frontal radiographic parameters did not correlate with HRQOL measures. In univariate analysis, patient age, SVA, and PT correlated with activity scores, although the correlation coefficients did not reach high values. After multivariate analysis, SVA was not a predictor of function.

  13. Changes in Quality of Life and Anxiety of Lung Cancer Patients Underwent 
Chemotherapy

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    Shufang LI

    2012-08-01

    Full Text Available Background and objective This study aims to observe the changes in quality of life as well as the anxiety among lung cancer patients before and after chemotherapy. This work also aims to explore the effect of chemotherapy on quality of life and anxiety. Methods Fifty-eight lung cancer patients were evaluated based on clinical outcomes, EORTC QLQ-C30, and on SAS questionnaires before chemotherapy, one week after two courses of chemotherapy, and one week after four courses of chemotherapy. Results Before chemotherapy, functioning scale, fatigue, and dyspnoea scores were high, the rate of anxiety was 56%, while the SAS score was 49.54±5.64. Anxiety was found to be positively correlated with insomnia (P<0.05. After two courses of chemotherapy, dyspnoea scores decreased, while insomnia and appetite loss scores increased. The difference was statistically significant (P<0.05. The rate of anxiety was 80%, and the SAS score was 52.48±6.10. The difference was statistically significant compared with that before chemotherapy (P<0.05. The SAS scores of patients with disease history were higher than those of patients without disease history (P<0.05. SAS score was found to be positively correlated with fatigue and dyspnoea (P<0.05. After four courses of chemotherapy, the physical, role, emotional, and social function scores decreased, while the nausea and vomiting, appetite loss, constipation, and financial impact scores increased. The difference was statistically significant (P<0.05. The anxiety rate was 72%, and the SAS score was 54.82±6.55. The difference was statistically significant (P<0.05. The SAS score was negatively correlated with KPS (P<0.05, significantly positively correlated with fatigue and insomnia (P<0.01, and positively correlated with constipation (P<0.05. Conclusion A number of patients have experienced symptom relief, but during chemotherapy, the patients had significant anxiety. Thus, quality of life decreased. The quality of life and

  14. SUBJECT INDEX

    Indian Academy of Sciences (India)

    Subject Index. Variation of surface electric field during geomagnetic disturbed period at Maitri, Antarctica. 1721. Geomorphology. A simple depression-filling method for raster and irregular elevation datasets. 1653. Decision Support System integrated with Geographic. Information System to target restoration actions in water-.

  15. Patients' expectations of deep brain stimulation, and subjective perceived outcome related to clinical measures in Parkinson's disease: a mixed-method approach.

    Science.gov (United States)

    Maier, Franziska; Lewis, Catharine J; Horstkoetter, Nina; Eggers, Carsten; Kalbe, Elke; Maarouf, Mohammad; Kuhn, Jens; Zurowski, Mateusz; Moro, Elena; Woopen, Christiane; Timmermann, Lars

    2013-11-01

    To study patients' expectations of subthalamic deep brain stimulation (STN-DBS) and their subjective perceived outcome, by using qualitative and quantitative methods in Parkinson's disease (PD). PD patients were prospectively examined before and 3 months after surgery. Semistructured interviews regarding preoperative expectations and postsurgical subjective perceived outcome were conducted. These were analysed using content analysis. For statistical analyses, patients were classified according to their subjective perceived outcome, resulting in three different subjective outcome groups (negative, mixed, positive outcome). The groups were used for multiple comparisons between and within each group regarding motor impairment, quality of life (QoL), neuropsychiatric status and cognitive functioning, using standard instruments. A logistic regression analysis was conducted to find predictors of subjective negative outcome. Receiver operating characteristic curves were used to analyse cut-off scores for predictive tests. Of the 30 PD patients participating, 8 had a subjective negative outcome, 8 a mixed and 14 a positive outcome. All groups significantly improved in motor functioning. Patients with subjective negative outcome were characterised by preoperative unrealistic expectations, no postsurgical improvement in QoL, and significantly higher presurgical and postsurgical apathy and depression scores. Higher preoperative apathy and depression scores were significant predictors of negative subjective outcome. Cut-off scores for apathy and depression were identified. The mixed-method approach proved useful in examining a patient's subjective perception of STN-DBS outcome. Our results show that significant motor improvement does not necessarily lead to a positive subjective outcome. Moreover, PD patients should be screened carefully before surgery regarding apathy and depression. (DRKS-ID: DRKS00003221).

  16. Development and Validation of Risk Matrices for Crohn's Disease Outcomes in Patients Who Underwent Early Therapeutic Interventions.

    Science.gov (United States)

    Dias, Cláudia Camila; Rodrigues, Pedro Pereira; Coelho, Rosa; Santos, Paula Moura; Fernandes, Samuel; Lago, Paula; Caetano, Cidalina; Rodrigues, Ângela; Portela, Francisco; Oliveira, Ana; Ministro, Paula; Cancela, Eugénia; Vieira, Ana Isabel; Barosa, Rita; Cotter, José; Carvalho, Pedro; Cremers, Isabelle; Trabulo, Daniel; Caldeira, Paulo; Antunes, Artur; Rosa, Isadora; Moleiro, Joana; Peixe, Paula; Herculano, Rita; Gonçalves, Raquel; Gonçalves, Bruno; Sousa, Helena Tavares; Contente, Luís; Morna, Henrique; Lopes, Susana; Magro, Fernando

    2017-04-01

    The establishment of prognostic models for Crohn's disease [CD] is highly desirable, as they have the potential to guide physicians in the decision-making process concerning therapeutic choices, thus improving patients' health and quality of life. Our aim was to derive models for disabling CD and reoperation based solely on clinical/demographic data. A multicentric and retrospectively enrolled cohort of CD patients, subject to early surgery or immunosuppression, was analysed in order to build Bayesian network models and risk matrices. The final results were validated internally and with a multicentric and prospectively enrolled cohort. The derivation cohort included a total of 489 CD patients [64% with disabling disease and 18% who needed reoperation], while the validation cohort included 129 CD patients with similar outcome proportions. The Bayesian models achieved an area under the curve of 78% for disabling disease and 86% for reoperation. Age at diagnosis, perianal disease, disease aggressiveness and early therapeutic decisions were found to be significant factors, and were used to construct user-friendly matrices depicting the probability of each outcome in patients with various combinations of these factors. The matrices exhibit good performance for the most important criteria: disabling disease positive post-test odds = 8.00 [2.72-23.44] and reoperation negative post-test odds = 0.02 [0.00-0.11]. Clinical and demographical risk factors for disabling CD and reoperation were determined and their impact was quantified by means of risk matrices, which are applicable as bedside clinical tools that can help physicians during therapeutic decisions in early disease management.

  17. Perfil de sujeitos de pesquisa clínica em um centro ambulatorial independente Profile of clinical research subjects in an independent outpatient center

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    Paulo Gustavo Sampaio Lacativa

    2008-06-01

    Full Text Available Este artigo tem como objetivos avaliar a qualidade de atendimento de um centro de pesquisa clínica e o entendimento do termo de consentimento informado (TCLE; determinar os motivos da participação e detalhar níveis socioeconômicos. Foi feito um estudo transversal em centro de pesquisa ambulatorial, através de questionário auto-explicativo. Dos cem questionários avaliados, todos os sujeitos de pesquisa consideraram o centro como ótimo (86% ou bom (9%. A quase totalidade foi bem informada do conteúdo do TCLE e o conhecimento do direito "confidencialidade", comum a todos os TCLEs, foi seis vezes maior que " acesso aos dados", que não faz parte. Os principais motivos para participarem foram para "saber mais sobre a sua saúde" (59% e para "beneficiar outras pessoas no futuro" (47%. A principal faixa de renda salarial dos participantes foi entre dois e cinco salários mínimos (48% e a maioria (66% concluiu pelo menos até a 4º série do ensino fundamental. A população possui o mesmo perfil econômico do Rio de Janeiro, nível de escolaridade suficiente para assinar e compreender o que está assinando, conhecendo não só a existência do TCLE, mas demonstrando conhecer seu conteúdo. O motivo principal para participação é para autobenefício e por atitude altruísta.This paper assesses the quality of assistance in a clinical trial outpatient center as well as the patients´understanding of the informed consent (IC; determine the reasons why they participate and detail socio-economic levels. A cross-sectional study was adopted in a clinical trial outpatient center using a self-explanatory questionnaire. All 100 respondents considered the assistance at the center excellent (86% or good (9%. Almost all of them were well informed about the content of the IC. Their knowledge about the right to "confidentiality", present in all ICs, was 6 times higher than their knowledge about their right to "access the results", generally not included

  18. Accuracy of a Staging System for Prognosis of 5-Year Survival of Patients With Nasopharyngeal Carcinoma Who Underwent Chemoradiotherapy.

    Science.gov (United States)

    Huang, Chung-I; Chen, Li-Fu; Chang, Shih-Lun; Wu, Hung-Chang; Ting, Wei-Chen; Yang, Ching-Chieh

    2017-11-01

    Concurrent chemoradiotherapy delivers a high level of tumor control and survival benefits for patients with nasopharyngeal carcinoma (NPC). However, many uncertainties still exist regarding the outcomes of chemoradiotherapy, making a more precise survival prognostic system necessary. To introduce a new staging system that combines tumor and clinical characteristics to improve the accuracy of prognosis for patients with NPC. This cohort study enrolled 207 patients with newly diagnosed NPC who underwent concurrent chemoradiotherapy between January 1, 2007, and December 31, 2014, at Chi-Mei Medical Center in Tainan, Taiwan. Data on these patients were collected from the cancer registry database of the Chi-Mei Medical Center. Patients who had a history of cancer or were unable to complete a full course of radiotherapy were excluded. Follow-up was completed on September 30, 2016, and the data analysis was performed from January 1, 2017, to February 28, 2017. The risk factors associated with 5-year disease-specific survival were incorporated into the American Joint Committee on Cancer (AJCC) and the International Union Against Cancer TNM staging system to construct a new prognostic staging system. The χ2 test for linear trend, the Akaike information criterion, and the C statistic were used to evaluate the monotonicity and discriminatory ability of the new prognostic staging system and the AJCC TNM staging system. Of the 207 patients enrolled in the study, 157 (75.8%) were men, and the mean (SD) age was 48 (11) years. Multivariate analysis identified advanced clinical T stage (adjusted hazard ratio [aHR], 3.20; 95% CI, 1.58-6.48), poor performance status (aHR, 2.62; 95% CI, 1.30-5.28), and cumulative cisplatin dose lower than 100 mg/m2 (aHR, 2.28; 95% CI, 1.10-4.74) as independent prognostic factors. The β coefficients from the Cox proportional hazards regression model were used to develop an integer-based, weighted point system; advanced clinical T stage, poor

  19. Cell culture replication of a genotype 1b hepatitis C virus isolate cloned from a patient who underwent liver transplantation.

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    George Koutsoudakis

    Full Text Available The introduction of the genotype 2a isolate JFH1 was a major breakthrough in the field of hepatitis C virus (HCV, allowing researchers to study the complete life cycle of the virus in cell culture. However, fully competent culture systems encompassing the most therapeutically relevant HCV genotypes are still lacking, especially for the highly drug-resistant genotype 1b. For most isolated HCV clones, efficient replication in cultured hepatoma cells requires the introduction of replication-enhancing mutations. However, such mutations may interfere with viral assembly, as occurs in the case of the genotype 1b isolate Con1. In this study, we show that a clinical serum carrying a genotype 1b virus with an exceptionally high viral load was able to infect Huh7.5 cells. Similar to previous reports, inoculation of Huh7.5 cells by natural virus is very inefficient compared to infection by cell culture HCV. A consensus sequence of a new genotype 1b HCV isolate was cloned from the clinical serum (designated Barcelona HCV1, and then subjected to replication studies. This virus replicated poorly in a transient fashion in Huh7.5 cells after electroporation with in vitro transcribed RNA. Nonetheless, approximately 3 weeks post electroporation and thereafter, core protein-positive cells were detected by immunofluorescence. Surprisingly, small amounts of core protein were also measurable in the supernatant of electroporated cells, suggesting that HCV particles might be assembled and released. Our findings not only enhance the current method of cloning in vitro HCV replication-competent isolates, but also offer valuable insights for the realization of fully competent culture systems for HCV.

  20. Cortical hypermetabolism in MCI subjects: a compensatory mechanism?

    Energy Technology Data Exchange (ETDEWEB)

    Ashraf, A.; Fan, Z.; Brooks, D.J.; Edison, P. [Imperial College London, Neurology Imaging Unit, Division of Brain Sciences, London (United Kingdom)

    2014-09-30

    Alzheimer's disease (AD) is associated with amyloid accumulation that takes place decades before symptoms appear. Cognitive impairment in AD is associated with reduced glucose metabolism. However, neuronal plasticity/compensatory mechanisms might come into play before the onset of dementia. The aim of this study was to determine whether there is evidence of cortical hypermetabolism as a compensatory mechanism before amyloid deposition takes place in subjects with amnestic mild cognitive impairment (aMCI). Nine AD subjects and ten aMCI subjects had both [{sup 11}C]PIB and [{sup 18}F]FDG PET scans with arterial input in order to quantify the amyloid deposition and glucose metabolism in vivo in comparison with healthy control subjects who underwent either [{sup 11}C]PIB or [{sup 18}F]FDG PET scans. The [{sup 11}C]PIB PET scans were quantified using [{sup 11}C]PIB target region to cerebellum uptake ratio images created by integrating the activity collected from 60 to 90 min, and regional cerebral glucose metabolism was quantified using spectral analysis. In MCI subjects, cortical hypermetabolism was observed in four amyloid-negative subjects and one amyloid-positive subject, while hypometabolism was seen in five other MCI subjects with high amyloid load. Subjects with hypermetabolism and low amyloid did not convert to AD during clinical follow-up for 18 months in contrast to four amyloid-positive hypometabolic subjects who did convert to AD. This preliminary study suggests that compensatory hypermetabolism can occur in aMCI subjects, particularly in those who are amyloid-negative. The increase in metabolic rate in different cortical regions with predominance in the occipital cortex may be a compensatory response to the neuronal damage occurring early in the disease process. It may also reflect recruitment of relatively minimally affected cortical regions to compensate for reduced function in the temporoparietal cortical association areas. (orig.)

  1. Outcome and preferences in male–to–female subjects with gender dysphoria: Experience from Eastern India

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    Anirban Majumder

    2017-01-01

    Full Text Available Context: Gender dysphoria (GD is an increasingly recognized medical condition in India, and little scientific data on treatment outcomes are available. Aims: Our objective is to study the therapeutic options including psychotherapy, hormone, and surgical treatments used for alleviating GD in male–to–female (MTF transgender subjects in Eastern India. Subjects and Methods: This is a retrospective study of treatment preferences and outcome in 55 MTF transgender subjects who were presented to the endocrine clinic. Statistical Analysis Used: Descriptive statistical analysis is carried out in the present study, and Microsoft Word and Excel are used to generate graphs and tables. Results: The mean follow-up was 1.9 years and 14 subjects (25.5% were lost to follow-up after a single or 2–3 contact sessions. Rest 41 subjects (74.5% desiring treatment had regular counseling and medical monitoring. All 41 subjects were dressing to present herself as female and all of them were receiving cross-sex hormone therapy either estrogen only (68%, or drospirenone in combination with estrogen (12% or gonadotropin-releasing hormone agonist (GnRH in combination with estrogens (19.5%. Most of the subjects preferred estrogen therapy as it was most affordable and only a small number of subjects preferred drospirenone or GnRH agonist because of cost and availability. 23.6% subjects underwent esthetic breast augmentation surgery and 25.5% underwent orchiectomy and/or vaginoplasty. Three subjects presented with prior breast augmentation surgery and nine subjects presented with prior orchiectomy without vaginoplasty, depicting a high prevalence of poorly supervised surgeries. Conclusions: Standards of care documents provide clinical guidance for health professionals about the optimal management of transsexual people. The lack of information among health professionals about proper and protocolwise management leads to suboptimal physical, social, and sexual results.

  2. Evaluation of a Topical Anti-inflammatory/Antifungal Combination Cream in Mild-to-moderate Facial Seborrheic Dermatitis: An Intra-subject Controlled Trial Examining Treated vs. Untreated Skin Utilizing Clinical Features and Erythema-directed Digital Photography.

    Science.gov (United States)

    Dall'Oglio, Federica; Tedeschi, Aurora; Guardabasso, Vincenzo; Micali, Giuseppe

    2015-09-01

    To evaluate if nonprescription topical agents may provide positive outcomes in the management of mild-to-moderate facial seborrheic dermatitis by reducing inflammation and scale production through clinical evaluation and erythema-directed digital photography. Open-label, prospective, not-blinded, intra-patient, controlled, clinical trial (target area). Twenty adult subjects affected by mild-to-moderate facial seborrheic dermatitis were enrolled and instructed to apply the study cream two times daily, initially on a selected target area only for seven days. If the subject developed visible improvement, it was advised to extend the application to all facial affected area for 21 additional days. Efficacy was evaluated by measuring the grade of erythema (by clinical examination and by erythema-directed digital photography), desquamation (by clinical examination), and pruritus (by subject-completed visual analog scale). Additionally, at the end of the protocol, a Physician Global Assessment was carried out. Eighteen subjects completed the study, whereas two subjects were lost to follow-up for nonadherence and personal reasons, respectively. Day 7 data from target areas showed a significant reduction in erythema. At the end of study, a significant improvement was recorded for erythema, desquamation, and pruritus compared to baseline. Physician Global Assessment showed improvement in 89 percent of patients, with a complete response in 56 percent of cases. These preliminary results indicate that the study cream may be a viable nonprescription therapeutic option for patients affected by facial seborrheic dermatitis able to determine early and significant improvement. This study also emphasizes the advantages of using an erythema-directed digital photography system for assisting in a simple, more accurate erythema severity grading and therapeutic monitoring in patients affected by seborrheic dermatitis.

  3. The effects of alcohol mixed with energy drink (AMED) on subjective intoxication and alertness : results from a double-blind placebo-controlled clinical trial

    NARCIS (Netherlands)

    van de Loo, Aurora J A E; van Andel, Nienke; van Gelder, Charlotte A G H; Janssen, Boris S G; Titulaer, Joep; Jansen, Jimmy; Verster, Joris C

    2016-01-01

    OBJECTIVE: The purpose of this double blind placebo controlled study was to examine if specific effects on subjective intoxication and alertness-sleepiness ratings could be demonstrated after consuming alcohol mixed with energy drink (AMED) when compared to consuming alcohol only (AO). METHODS: 56

  4. Acute subjective effects after smoking joints containing up to 69 mg Δ9-tetrahydrocannabinol in recreational users : a randomized, crossover clinical trial

    NARCIS (Netherlands)

    Hunault, Claudine C.; Böcker, Koen B E; Stellato, R. K.; Kenemans, J. Leon; de Vries, Irma; Meulenbelt, Jan

    2014-01-01

    Rationale An increase in the potency of the cannabis cigarettes has been observed over the past three decades. Objectives In this study, we aimed to establish the impact of Δ9-tetrahydrocannabinol (THC) on the rating of subjective effects (intensity and duration of the effects), up to 23 % THC

  5. Clinical implications of gait analysis in the rehabilitation of adult patients with "Prader-Willi" Syndrome: a cross-sectional comparative study ("Prader-Willi" Syndrome vs matched obese patients and healthy subjects

    Directory of Open Access Journals (Sweden)

    Baccalaro Gabriele

    2007-05-01

    Full Text Available Abstract Background Being severely overweight is a distinctive clinical feature of Prader-Willi Syndrome (PWS. PWS is a complex multisystem disorder, representing the most common form of genetic obesity. The aim of this study was the analysis of the gait pattern of adult subjects with PWS by using three-Dimensional Gait Analysis. The results were compared with those obtained in a group of obese patients and in a group of healthy subjects. Methods Cross-sectional, comparative study: 19 patients with PWS (11 males and 8 females, age: 18–40 years, BMI: 29.3–50.3 kg/m2; 14 obese matched patients (5 males and 9 females, age: 18–40 years, BMI: 34.3–45.2 kg/m2; 20 healthy subjects (10 males and 10 females, age: 21–41 years, BMI: 19.3–25.4 kg/m2. Kinematic and kinetic parameters during walking were assessed by an optoelectronic system and two force platforms. Results PWS adult patients walked slower, had a shorter stride length, a lower cadence and a longer stance phase compared with both matched obese, and healthy subjects. Obese matched patients showed spatio-temporal parameters significantly different from healthy subjects. Furthermore, Range Of Motion (ROM at knee and ankle, and plantaflexor activity of PWS patients were significantly different between obese and healthy subjects. Obese subjects revealed kinematic and kinetic data similar to healthy subjects. Conclusion PWS subjects had a gait pattern significantly different from obese patients. Despite that, both groups had a similar BMI. We suggest that PWS gait abnormalities may be related to abnormalities in the development of motor skills in childhood, due to precocious obesity. A tailored rehabilitation program in early childhood of PWS patients could prevent gait pattern changes.

  6. Effects of acute exercise on pancreatic endocrine function in subjects with type 2 diabetes

    DEFF Research Database (Denmark)

    Knudsen, Sine H; Karstoft, Kristian; Winding, Kamilla

    2015-01-01

    We determined the effects of exercise on pancreatic endocrine responses to metabolic stimuli in type 2 diabetic (T2D) subjects and examined the influence of the diabetic status. Fourteen subjects underwent a hyperglycaemic clamp with GLP-1 infusion and arginine injection, the morning after a one...... drug naïve subjects. Exercise-induced increases in insulin secretion are blunted in T2D subjects with high hyperglycaemia and in those using anti-diabetic drugs. Clinical Trials Registration Number: NCT01812590.......-hour walk or no exercise. Subjects were stratified by high and low quantiles of fasting plasma glucose (FPG) and HbA1c as well as current use/non-use of anti-diabetic medication. In the entire cohort, exercise did not alter insulin secretion, while glucagon levels were increased in all clamp phases (P 

  7. Development of a minimum protocol for assessment in the paediatric voice clinic. Part 2: subjective measurement of symptoms of voice disorder.

    Science.gov (United States)

    Cohen, Wendy; Wardrop, Amanda; Wynne, David McGregor; Kubba, Haytham; McCartney, Elspeth

    2012-04-01

    The European Laryngological Society (ELS) recommend that functional assessment of voice disorder in adults requires evaluation of a number of different parameters. These include perceptual evaluation of voice, videostroboscopic imaging of vocal fold movement, acoustic analysis of specific voicing aspects, aerodynamic support for voicing, and a subjective rating of voice impact. No specific guidelines are available for children, but a similar range of parameters is needed to guide intervention and measure outcomes. The development of subjective voice measures for adults and their adaptations for the paediatric population are reviewed and compared to the research comparing these to evaluation of vocal function. The need for further refinement of child assessment measures, and a proposal of how these might be developed, is discussed.

  8. Pilot clinical study of the effects of ginger root extract on eicosanoids in colonic mucosa of subjects at increased risk for colorectal cancer.

    Science.gov (United States)

    Zick, Suzanna M; Turgeon, D Kim; Ren, Jianwei; Ruffin, Mack T; Wright, Benjamin D; Sen, Ananda; Djuric, Zora; Brenner, Dean E

    2015-09-01

    Colorectal cancer (CRC) remains a significant cause of mortality. Inhibitors of cyclooxygenase (COX) and thus prostaglandin E2, are promising CRC preventives, but have significant toxicities. Ginger has been shown to inhibit COX, to decrease the incidence and multiplicity of adenomas, and decrease PGE2 concentrations in subjects at normal risk for CRC. This study was conducted to determine the effects of 2.0 g/d of ginger given orally on the levels of PGE2, leukotriene B4 (LTB4), 13-hydroxy-octadecadienoic acids, and 5-, 12-, & 15-hydroxyeicosatetraenoic acid, in the colonic mucosa of subjects at increased risk for CRC. We randomized 20 subjects to 2.0 g/d ginger or placebo for 28 d. At baseline and Day 28, a flexible sigmoidoscopy was used to obtain colon biopsies. A liquid chromatography mass spectrometry method was used to determine eicosanoid levels in the biopsies, and levels were expressed per amount of protein or free arachidonic acid (AA). There was a significant decrease in AA between baseline and Day 28 (P = 0.05) and significant increase in LTB4 (P = 0.04) when normalized to protein, in subjects treated with ginger versus placebo. No other changes in eicosanoids were observed. There was no difference between the groups in total adverse events (AE; P = 0.06). Ginger lacks the ability to decrease eicosanoid levels in people at increased risk for CRC. Ginger did appear to be both tolerable and safe; and could have chemopreventive effects through other mechanisms. Further investigation should focus on other markers of CRC risk in those at increased CRC risk. © 2014 Wiley Periodicals, Inc.

  9. Effects of 8-Week Hatha Yoga Training on Metabolic and Inflammatory Markers in Healthy, Female Chinese Subjects: A Randomized Clinical Trial

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    Neng Chen

    2016-01-01

    Full Text Available We aimed to determine the effects of an 8 wk Hatha yoga training on blood glucose, insulin, lipid profiles, endothelial microparticles (EMPs, and inflammatory status in healthy, lean, and female Chinese subjects. A total of 30 healthy, female Chinese subjects were recruited and randomized into control or yoga practice group. The yoga practice included 8 wks of yoga practice (2 times/wk for a total of 16 times. Fasting blood samples were collected before and after yoga training. Plasma was isolated for the measurement of lipid profiles, glucose, insulin, EMPs, and inflammatory cytokines. Whole blood was cultured ex vivo and stimulated with lipopolysaccharide (LPS and Pam3Cys-SK4. Peripheral blood mononuclear cells (PBMCs were isolated for the measurement of TLR2 and TLR4 protein expression. Yoga practice significantly reduced plasma cholesterol, LDL-cholesterol, insulin levels, and CD31+/CD42b− EMPs. Cultured whole blood from the yoga group has reduced proinflammatory cytokines secretion both at unstimulated condition and when stimulated with Pam3Cys-SK4; this might be associated with reduced TLR2 protein expression in PBMCs after yoga training. Hatha yoga practice in healthy Chinese female subjects could improve hallmarks related to MetS; thus it can be considered as an ancillary intervention in the primary MetS prevention for the healthy population. This trial is registered with ChiCTR-IOR-14005747.

  10. Association of Subjective and Objective Sleep Duration as well as Sleep Quality with Non-Invasive Markers of Sub-Clinical Cardiovascular Disease (CVD): A Systematic Review

    Science.gov (United States)

    Aziz, Muhammad; Ali, Shozab S.; Das, Sankalp; Younus, Adnan; Malik, Rehan; Latif, Muhammad A.; Humayun, Choudhry; Anugula, Dixitha; Abbas, Ghulam; Salami, Joseph; Elizondo, Javier Valero; Veledar, Emir

    2017-01-01

    Aim: Abnormal daily sleep duration and quality have been linked to hypertension, diabetes, stroke, and overall cardiovascular disease (CVD) morbidity & mortality. However, the relationship between daily sleep duration and quality with subclinical measures of CVD remain less well studied. This systematic review evaluated how daily sleep duration and quality affect burden of subclinical CVD in subjects free of symptomatic CVD. Methods: Literature search was done via MEDLINE, EMBASE, Web of Science until June 2016 and 32 studies met the inclusion criteria. Sleep duration and quality were measured either via subjective methods, as self-reported questionnaires or Pittsburg Sleep Quality Index (PSQI) or via objective methods, as actigraphy or polysomnography or by both. Among subclinical CVD measures, coronary artery calcium (CAC) was measured by electron beam computed tomography, Carotid intima-media thickness (CIMT) measured by high-resolution B-mode ultrasound on carotid arteries, endothelial/microvascular function measured by flow mediated dilation (FMD) or peripheral arterial tone (PAT) or iontophoresis or nailfold capillaroscopy, and arterial stiffness measured by pulse wave velocity (PWV) or ankle brachial index (ABI). Results: Subjective short sleep duration was associated with CAC and CIMT, but variably associated with endothelial dysfunction (ED) and arterial stiffness; however, subjective long sleep duration was associated with CAC, CIMT and arterial stiffness, but variably associated with ED. Objective short sleep duration was positively associated with CIMT and variably with CAC but not associated with ED. Objective long sleep duration was variably associated with CAC and CIMT but not associated with ED. Poor subjective sleep quality was significantly associated with ED and arterial stiffness but variably associated with CAC and CIMT. Poor objective sleep quality was significantly associated with CIMT, and ED but variably associated with CAC. Conclusions

  11. Association of Subjective and Objective Sleep Duration as well as Sleep Quality with Non-Invasive Markers of Sub-Clinical Cardiovascular Disease (CVD): A Systematic Review.

    Science.gov (United States)

    Aziz, Muhammad; Ali, Shozab S; Das, Sankalp; Younus, Adnan; Malik, Rehan; Latif, Muhammad A; Humayun, Choudhry; Anugula, Dixitha; Abbas, Ghulam; Salami, Joseph; Elizondo, Javier Valero; Veledar, Emir; Nasir, Khurram

    2017-03-01

    Abnormal daily sleep duration and quality have been linked to hypertension, diabetes, stroke, and overall cardiovascular disease (CVD) morbidity& mortality. However, the relationship between daily sleep duration and quality with subclinical measures of CVD remains less well studied. This systematic review evaluated how daily sleep duration and quality affect burden of subclinical CVD in subjects free of symptomatic CVD. Literature search was done via MEDLINE, EMBASE, Web of Science until June 2016 and 32 studies met the inclusion criteria. Sleep duration and quality were measured either via subjective methods, as self-reported questionnaires or Pittsburg Sleep Quality Index (PSQI) or via objective methods, as actigraphy or polysomnography or by both. Among subclinical CVD measures, coronary artery calcium (CAC) was measured by electron beam computed tomography, Carotid intima-media thickness (CIMT) measured by high-resolution B-mode ultrasound on carotid arteries, endothelial/microvascular function measured by flow mediated dilation (FMD) or peripheral arterial tone (PAT) or iontophoresis or nailfold capillaroscopy, and arterial stiffness measured by pulse wave velocity (PWV) or ankle brachial index (ABI). Subjective short sleep duration was associated with CAC and CIMT, but variably associated with endothelial dysfunction (ED) and arterial stiffness; however, subjective long sleep duration was associated with CAC, CIMT and arterial stiffness, but variably associated with ED. Objective short sleep duration was positively associated with CIMT and variably with CAC but not associated with ED. Objective long sleep duration was variably associated with CAC and CIMT but not associated with ED. Poor subjective sleep quality was significantly associated with ED and arterial stiffness but variably associated with CAC and CIMT. Poor objective sleep quality was significantly associated with CIMT, and ED but variably associated with CAC. Overall, our review provided mixed

  12. Metabolic Effects of Replacing Sugar-Sweetened Beverages with Artificially-Sweetened Beverages in Overweight Subjects with or without Hepatic Steatosis: A Randomized Control Clinical Trial

    Directory of Open Access Journals (Sweden)

    Vanessa Campos

    2017-02-01

    Full Text Available Objective: Addition of fructose to the diet of normal weight and overweight subjects can increase postprandial plasma triglyceride and uric acid concentration. We, therefore, assessed whether replacing sugar-sweetened beverages (SSB with artificially-sweetened beverages (ASB in the diet of overweight and obese subjects would decrease these parameters. Methods: Twenty-six participants of the REDUCS study, which assessed the effects of replacing SSB by ASB over 12 weeks on intra-hepatocellular lipid concentration, were included in this sub-analysis. All were studied after a four-week run-in period during which they consumed their usual diet and SSBs, and after a 12-week intervention in which they were randomly assigned to replace their SSBs with ASBs (ASB arm or to continue their usual diet and SSBs (control arm, CTRL. At the end of run-in (week 4 and again at the end of intervention (week 16, they took part in an 8.5 h metabolic investigation during which their plasma glucose, insulin, glucagon, lactate, triglyceride (TG, non-esterified fatty acids (NEFA, and uric acid concentrations were measured over a 30 min fasting period (−30–0 min, then every 2 h over 480 min. with ingestion of standard breakfast at time 0 min and a standard lunch at time 240 min. Breakfast and lunch were consumed together with a 3.3 dL SSB at week 4 and with either an ASB (ASB arm or a SSB (CTRL arm at week 16. After analyzing the whole group, a secondary analysis was performed on 14 subjects with hepatic steatosis (seven randomized to ASB, seven to CTRL and 12 subjects without hepatic steatosis (six randomized to ASB and six to CTRL. Results: Ingestion of meals increased plasma glucose, insulin, glucagon, lactate, and TG concentrations and decreased NEFA concentrations, but with no significant difference of integrated postprandial responses between week 4 and week 16 in both ASB and CTRL, except for a slightly decreased glucagon response in ASB. There was, however, no

  13. The importance of superficial basal cell carcinoma in a retrospective study of 139 patients who underwent Mohs micrographic surgery in a Brazilian university hospital.

    Science.gov (United States)

    Takata Pontes, Luciana; Fantelli Stelini, Rafael; Cintra, Maria Leticia; Magalhães, Renata Ferreira; Velho, Paulo Eduardo N F; Moraes, Aparecida Machado

    2015-11-01

    Mohs micrographic surgery is a specialized surgical procedure used to treat skin cancer. The purpose of this study was to better understand the profile of the patients who underwent the procedure and to determine how histology might be related to complications and the number of stages required for complete removal. The records of patients who underwent Mohs micrographic surgery from October 2008 to November 2013 at the Dermatology Division of the Hospital of the Campinas University were assessed. The variables included were gender, age, anatomical location, histology, number of stages required and complications. Contingency tables were used to compare the number of stages with the histological diagnosis. The analysis showed that patients with superficial basal cell carcinoma were 9.03 times more likely to require more than one stage. A comparison between complications and histological diagnosis showed that patients with superficial basal cell carcinoma were 6.5 times more likely to experience complications. Although superficial basal cell carcinoma is typically thought to represent a less-aggressive variant of these tumors, its propensity for demonstrating "skip areas" and clinically indistinct borders make it a challenge to treat. Its particular nature may result in the higher number of surgery stages required, which may, as a consequence, result in more complications, including recurrence. Recurrence likely occurs due to the inadequate excision of the tumors despite their clear margins. Further research on this subtype of basal cell carcinoma is needed to optimize treatments and decrease morbidity.

  14. Effects of Cactus Fiber on the Excretion of Dietary Fat in Healthy Subjects: A Double Blind, Randomized, Placebo-Controlled, Crossover Clinical Investigation

    Directory of Open Access Journals (Sweden)

    Ralf Uebelhack, MD, PhD

    2014-12-01

    Conclusions: Cactus fiber has been shown to significantly promote fecal fat excretion in healthy adults. The results of our study support the hypothesis that cactus fiber helps in reducing body weight by binding to dietary fat and increasing its excretion, thus reducing dietary fat available for absorption. ClinicalTrials.gov identifier: NCT01590667.

  15. Benefits of Repetitive Transcranial Magnetic Stimulation (rTMS for Spastic Subjects: Clinical, Functional, and Biomechanical Parameters for Lower Limb and Walking in Five Hemiparetic Patients

    Directory of Open Access Journals (Sweden)

    Luc Terreaux

    2014-01-01

    Full Text Available Introduction. Spasticity is a disabling symptom resulting from reorganization of spinal reflexes no longer inhibited by supraspinal control. Several studies have demonstrated interest in repetitive transcranial magnetic stimulation in spastic patients. We conducted a prospective, randomized, double-blind crossover study on five spastic hemiparetic patients to determine whether this type of stimulation of the premotor cortex can provide a clinical benefit. Material and Methods. Two stimulation frequencies (1 Hz and 10 Hz were tested versus placebo. Patients were assessed clinically, by quantitative analysis of walking and measurement of neuromechanical parameters (H and T reflexes, musculoarticular stiffness of the ankle. Results. No change was observed after placebo and 10 Hz protocols. Clinical parameters were not significantly modified after 1 Hz stimulation, apart from a tendency towards improved recruitment of antagonist muscles on the Fügl-Meyer scale. Only cadence and recurvatum were significantly modified on quantitative analysis of walking. Neuromechanical parameters were modified with significant decreases in Hmax⁡ /Mmax⁡ and T/Mmax⁡ ratios and stiffness indices 9 days or 31 days after initiation of TMS. Conclusion. This preliminary study supports the efficacy of low-frequency TMS to reduce reflex excitability and stiffness of ankle plantar flexors, while clinical signs of spasticity were not significantly modified.

  16. Evaluation of the effect of the specific CCR1 antagonist CP-481715 on the clinical and cellular responses observed following epicutaneous nickel challenge in human subjects

    DEFF Research Database (Denmark)

    Borregaard, Jeanett; Skov, Lone; Wang, Lisy

    2008-01-01

    BACKGROUND: The CC-chemokine receptor-1 (CCR1) is thought to be involved in recruitment of inflammatory cells in allergic contact dermatitis (ACD). CP-481715 is a specific antagonist of CCR1. OBJECTIVES: To determine the inhibitory effects of CP-418 715 in ACD by evaluating the clinical signs...

  17. The effect of two different hand exercises on grip strength, forearm circumference, and vascular maturation in patients who underwent arteriovenous fistula surgery.

    Science.gov (United States)

    Kong, Sangwon; Lee, Kyung Soo; Kim, Junho; Jang, Seong Ho

    2014-10-01

    To compare the effect of two different hand exercises on hand strength and vascular maturation in patients who underwent arteriovenous fistula surgery. We recruited 18 patients who had chronic kidney disease and had undergone arteriovenous fistula surgery for hemodialysis. After the surgery, 10 subjects performed hand-squeezing exercise with GD Grip, and other 8 subjects used Soft Ball. The subjects continued the exercises for 4 weeks. The hand grip strength, pinch strength (tip, palmar and lateral pinch), and forearm circumference of the subjects were assessed before and after the hand-squeezing exercise. The cephalic vein size, blood flow velocity and volume were also measured by ultrasonography in the operated limb. All of the 3 types of pinch strengths, grip strength, and forearm circumference were significantly increased in the group using GD Grip. Cephalic vein size and blood flow volume were also significantly increased. However, blood flow velocity showed no difference after the exercise. The group using Soft Ball showed a significant increase in the tip and lateral pinch strength and forearm circumference. The cephalic vein size and blood flow volume were also significantly increased. On comparing the effect of the two different hand exercises, hand-squeezing exercise with GD Grip had a significantly better effect on the tip and palmar pinch strength than hand-squeezing exercise with Soft Ball. The effect on cephalic vein size was not significantly different between the two groups. The results showed that hand squeezing exercise with GD Grip was more effective in increasing the tip and palmar pinch strength compared to hand squeezing exercise with soft ball.

  18. Clinical efficacy of probiotic Bifidobacterium longum for the treatment of symptoms of Japanese cedar pollen allergy in subjects evaluated in an environmental exposure unit.

    Science.gov (United States)

    Xiao, Jin-zhong; Kondo, Shizuki; Yanagisawa, Naotake; Miyaji, Kazuhiro; Enomoto, Keisuke; Sakoda, Takema; Iwatsuki, Keiji; Enomoto, Tadao

    2007-03-01

    Japanese cedar pollinosis (JCPsis) affects nearly one in six Japanese. Oral administration of Bifidobacterium longum BB536 has been shown to be effective in relieving JCPsis symptoms during the pollen season. This double- two-way crossover study was designed to evaluate the efficacy of BB536 on reducing symptoms in JCPsis patients exposed to Japanese cedar pollen (JCP) in an environmental exposure unit (EEU) outside of the normal JCP season. After a 1-week run-in period, subjects (n=24) were randomly allocated to receive BB536 powder (approximately 5x1010) or placebo twice a day for 4 weeks. After a 2-week washout period, subjects were crossed over to another 4 weeks of intake. At the end of each intake period, subjects received controlled JCP exposure for 4 hours in the EEU. Symptoms were self-rated 30 minutes before and every 30 minutes during the exposures. From the first day of exposure through the next 5 successive days, participants self-rated their delayed symptoms and medication uses. Blood samples were taken before the exposures. The mean JCP levels for exposures were 6500 to 7000 grains/m3 air. In comparison with placebo, BB536 intake significantly reduced the ocular symptom scores during JCP exposures. Evaluating delayed symptoms after exposures indicated that scores for disruption of normal activities were significantly lower in the BB536 group compared with the placebo group. Prevalence of medication use was markedly reduced by BB536 intake. These results suggest the potential beneficial effect of BB536 in relieving symptoms of JCP allergy.

  19. Clinical evaluation of iterative reconstruction (ordered-subset expectation maximization) in dynamic positron emission tomography: quantitative effects on kinetic modeling with N-13 ammonia in healthy subjects

    DEFF Research Database (Denmark)

    Hove, Jens D; Rasmussen, Rune; Freiberg, Jacob

    2008-01-01

    BACKGROUND: The purpose of this study was to investigate the quantitative properties of ordered-subset expectation maximization (OSEM) on kinetic modeling with nitrogen 13 ammonia compared with filtered backprojection (FBP) in healthy subjects. METHODS AND RESULTS: Cardiac N-13 ammonia positron...... and OSEM flow values were observed with a flow underestimation of 45% (rest/dipyridamole) in the septum and of 5% (rest) and 15% (dipyridamole) in the lateral myocardial wall. CONCLUSIONS: OSEM reconstruction of myocardial perfusion images with N-13 ammonia and PET produces high-quality images for visual...

  20. Atopic asthmatic subjects but not atopic subjects without ...

    Science.gov (United States)

    BACKGROUND: Asthma is a known risk factor for acute ozone-associated respiratory disease. Ozone causes an immediate decrease in lung function and increased airway inflammation. The role of atopy and asthma in modulation of ozone-induced inflammation has not been determined. OBJECTIVE: We sought to determine whether atopic status modulates ozone response phenotypes in human subjects. METHODS: Fifty volunteers (25 healthy volunteers, 14 atopic nonasthmatic subjects, and 11 atopic asthmatic subjects not requiring maintenance therapy) underwent a 0.4-ppm ozone exposure protocol. Ozone response was determined based on changes in lung function and induced sputum composition, including airway inflammatory cell concentration, cell-surface markers, and cytokine and hyaluronic acid concentrations. RESULTS: All cohorts experienced similar decreases in lung function after ozone. Atopic and atopic asthmatic subjects had increased sputum neutrophil numbers and IL-8 levels after ozone exposure; values did not significantly change in healthy volunteers. After ozone exposure, atopic asthmatic subjects had significantly increased sputum IL-6 and IL-1beta levels and airway macrophage Toll-like receptor 4, Fc(epsilon)RI, and CD23 expression; values in healthy volunteers and atopic nonasthmatic subjects showed no significant change. Atopic asthmatic subjects had significantly decreased IL-10 levels at baseline compared with healthy volunteers; IL-10 levels did not significa

  1. Evaluation of a teaching strategy based on integration of clinical subjects, virtual autopsy, pathology museum, and digital microscopy for medical students**

    OpenAIRE

    Diaz-Perez,Julio A.; Sharat Raju; Echeverri, Jorge H.

    2014-01-01

    Background: Learning pathology is fundamental for a successful medical practice. In recent years, medical education has undergone a profound transformation toward the development of an integrated curriculum incorporating both basic science and clinical material. Simultaneously, there has been a shift from a magisterial teaching approach to one centered around problem-based learning. Now-a-days, informatics tools are expected to help better implement these strategies. Aim: We applied and evalu...

  2. Systematic review with network meta-analysis: comparative efficacy of different enteral immunonutrition formulas in patients underwent gastrectomy.

    Science.gov (United States)

    Song, Guo-Min; Liu, Xiao-Ling; Bian, Wei; Wu, Jing; Deng, Yong-Hong; Zhang, Hui; Tian, Xu

    2017-04-04

    Optimal enteral immunonutrition (EIN) regime for gastric cancer (GC) patients underwent gastrectomy remains uncertainty. To assess comparative efficacy of different EIN formulas in GC patients underwent gastrectomy, we performed network meta-analysis. We included 11 RCTs enrolling 840 patients. Pairwise meta-analysis indicated that EIN (RR 0.56, 95% CI 0.36-0.86; MD -0.42, 95% CI -0.74-0.10), Arg+RNA+ω-3-FAs (RR 0.37, 95% CI 0.22-0.63; MD -0.42, 95% CI -0.75-0.07), Arg+Gln+ω-3-FAs (RR 0.22, 95% CI 0.05-0.94; MD -0.69, 95% CI -1.22-1.07) reduced ICs and LOS. Network meta-analysis confirmed the potential of Arg+RNA+ω-3-FAs for ICs (OR 0.27, 95% Crl 0.12-0.49) and Arg+Gln+ω-3-FAs for CIs (OR 0.22, 95% Crl 0.02-0.84) and LOS (SMD -0.63, 95% Crl -1.07-0.13), and indicated that Arg+RNA+ω-3-FAs was superior to Arg+RNA and Arg+Gln for ICs as well. We performed direct and network meta-analyses for randomized controlled trials comparing EIN formulas with each other or standard enteral nutrition (SEN) in reducing infectious complications (ICs), noninfectious complications (NICs) and length of hospital stay (LOS), through January 2016. The surface under the cumulative ranking curve (SCURA) and Grading of Recommendations Assessment, Development and Evaluation (GRADE) were used to rank regimes and rate qualities of evidences respectively. As for GC patients underwent gastrectomy, Arg+RNA+ω-3-FAs and Arg+Gln+ω-3-FAs are the optimal regimes of reducing ICs and LOS.

  3. Evaluation of a teaching strategy based on integration of clinical subjects, virtual autopsy, pathology museum, and digital microscopy for medical students.

    Science.gov (United States)

    Diaz-Perez, Julio A; Raju, Sharat; Echeverri, Jorge H

    2014-01-01

    Learning pathology is fundamental for a successful medical practice. In recent years, medical education has undergone a profound transformation toward the development of an integrated curriculum incorporating both basic science and clinical material. Simultaneously, there has been a shift from a magisterial teaching approach to one centered around problem-based learning. Now-a-days, informatics tools are expected to help better implement these strategies. We applied and evaluated a new teaching method based on an active combination of clinical problems, gross pathology, histopathology, and autopsy pathology, all given through informatics tools, to teach a group of medical students at the Universidad de Santander, Colombia. Ninety-four medical students were followed in two consecutive semesters. Students were randomized to receive teaching either through traditional methodology or through the new integrated approach. There was no significant difference between the intervention group and the control group at baseline. At the end of the study, the scores in the intervention group were significantly higher compared to the control group (3.91/5.0 vs. 3.33/5.0, P = 0.0008). Students and tutors endorsed the benefits of the integrated approach. Participants were very satisfied with this training approach and rated the program an 8.7 out of 10, on average. This study confirms that an integrated curriculum utilizing informatics systems provides an excellent opportunity to associate pathology with clinical medicine early in training of medical students. This can be possible with the use of virtual microscopy and digital imaging.

  4. Political and clinical developments in analytical psychology, 1972-2014: subjectivity, equality and diversity-inside and outside the consulting room.

    Science.gov (United States)

    Samuels, Andrew

    2014-11-01

    Utilizing Jung's idea of theory as a 'personal confession', the author charts his own development as a theorist, establishing links between his personal history and his ideas. Such links include his relationship with both parents, his sexuality, his cultural heritage, and his fascination with Tricksters and with Hermes. There follows a substantial critical interrogation of what the author discerns as the two main lines of clinical theorizing in contemporary analytical psychotherapy: interpretation of transference-countertransference, and the relational approach. His conclusion is that neither is superior to the other and neither is in fact adequate as a basis for clinical work. The focus then shifts to explore a range of political and social aspects of the clinical project of analytical psychology: economic inequality, diversity within the professional field, and Jung's controversial ideas about Jews and Africans. The author calls for an apology from the 'Jungian community' for remarks about Africans analogous to the apology already issued for remarks about Jews. The paper is dedicated to the author's friend Fred Plaut (1913-2009). © 2014, The Society of Analytical Psychology.

  5. Analysis of 175 Cases Underwent Surgical Treatment in Our Hospital After Having Abdominal Wounding by Firearm in the War at Syria

    Directory of Open Access Journals (Sweden)

    Yusuf Yucel

    2016-04-01

    Full Text Available Aim: We aimed at analysing the patients, who underwent surgical treatment in our hospital after having abdominal wounding by firearm in the war at Syria, retrospectively. Material and Method: The files of Syrian patients, who applied to Emergency Service of Harran University Medical Faculty because of gunshot wounds and had operation after being hospitalized in General Surgery Clinic due to abdominal injuries between the years of 2011 and 2014, were analysed retrospectively. Results: 175 Syrian patients, who had abdominal injuries by firearms, underwent operation in our general surgery clinic. 99.4% (n=174 of the patients were male, and 0.6% (n=1 were female. Trauma-admission to hospital times of all cases were %u2265 6 hours. 62.8% (n=110 of the patients had isolated abdominal injuries, and 37.1% (n=65 had two or more system injuries. The frequency of more than one organ injuries in abdominal region was 44.5% (n=78 and the most frequent complication was wound infection (10%. Negative laparoscopy was 2.8% (n=5, support for intensive care was 38.2% (n=67, average duration of intensive care unit stay was 5.57 days and mortality was 9.7% (n=17. Discussion: In our study, it was seen that infectious morbidity and mortality increased for the patients, who applied to our hospital because of abdominal injuries by firearm, particularly the ones with gastrointestinal perforation, if trauma-admission to hospital times were %u2265 6 hours. And this shows us that the early intervention to injuries that perforate gastrointestinal tract was an important factor for decreasing morbidity and mortality.

  6. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial.

    Science.gov (United States)

    Cicero, Arrigo F G; Fogacci, Federica; Rosticci, Martina; Parini, Angelo; Giovannini, Marina; Veronesi, Maddalena; D'Addato, Sergio; Borghi, Claudio

    2017-01-01

    Phytosterols and red yeast rice are largely studied cholesterol-lowering nutraceuticals, respectively inhibiting the bowel absorption and liver synthesis of cholesterol. Our aim was to test the effect on lipid profile of phytosterols, red yeast rice and their association. We performed a three parallel arms, double blind, clinical trial randomizing 90 moderately hypercholesterolemic subjects to treatment with phytosterols 800 mg (group 1), red yeast rice standardized to contain 5 mg monacolins from Monascus purpureus (group 2), or both combined nutraceuticals (group 3). After 8 weeks of treatment, in group 1 no significant variation of lipid parameters has been detected. In group 2 a significant reduction (p red yeast rice seems to have additive cholesterol lowering effect, reaching a clinically significant LDL-Cholesterol reduction in mildly hypercholesterolemic patients. ClinicalTrial.gov ID: NCT02603276, Registered 27/08/2015.

  7. Clinical evaluation of iterative reconstruction (ordered-subset expectation maximization) in dynamic positron emission tomography: quantitative effects on kinetic modeling with N-13 ammonia in healthy subjects

    DEFF Research Database (Denmark)

    Hove, Jens Dahlgaard; Rasmussen, R.; Freiberg, J.

    2008-01-01

    BACKGROUND: The purpose of this study was to investigate the quantitative properties of ordered-subset expectation maximization (OSEM) on kinetic modeling with nitrogen 13 ammonia compared with filtered backprojection (FBP) in healthy subjects. METHODS AND RESULTS: Cardiac N-13 ammonia positron...... emission tomography (PET) studies from 20 normal volunteers at rest and during dipyridamole stimulation were analyzed. Image data were reconstructed with either FBP or OSEM. FBP- and OSEM-derived input functions and tissue curves were compared together with the myocardial blood flow and spillover values...... and OSEM flow values were observed with a flow underestimation of 45% (rest/dipyridamole) in the septum and of 5% (rest) and 15% (dipyridamole) in the lateral myocardial wall. CONCLUSIONS: OSEM reconstruction of myocardial perfusion images with N-13 ammonia and PET produces high-quality images for visual...

  8. An investigation of objective and subjective types of binge eating episodes in a clinical sample of people with co-morbid obesity.

    Science.gov (United States)

    Palavras, Marly Amorim; Morgan, Christina Marcondes; Borges, Ferrari Maria Beatriz; Claudino, Angélica Medeiros; Hay, Phillipa J

    2013-01-01

    Objective binge eating episodes (OBEs) refer to binge eating on an unusually large amount of food and are the core symptom in current definitions of bulimia nervosa (BN) and binge eating disorder (BED). Subjective binge eating episodes (SBEs) refer to eating on a small or moderate amount of food (that is perceived as large) and like OBEs are associated with loss of control (LOC). Reaching consensus on what is considered a large amount of food can however be problematic and it remains unclear if the size of a binge is an essential component for defining a binge eating episode. The aim of this study was to compare the eating disorder features and general psychopathology of subjects reporting OBEs with those reporting only SBEs. This is a retrospective secondary analysis of data from 70 obese participants at the recruitment phase of a multicentre trial for BED. Individuals who answered positively to the presence of binge eating and LOC over eating had their binge eating episodes further explored by interview and self-report. Two groups, those who reported current OBEs (with or without SBEs) and those who reported current SBEs only were compared for age, gender, marital status, body mass index (BMI), indicators of LOC over eating, severity of binge-eating and associated psychopathology. The majority of participants in both the OBE and SBE groups endorsed the experience of at least four indicators of LOC. There were no significant differences between the groups. Both groups had high levels of binge-eating severity, moderate severity of associated depressive symptoms and frequent psychiatric co-morbidity. Treatment seeking participants with obesity who reported SBEs alone were similar to those who reported OBEs in terms of eating disorder features and general psychopathology. These findings suggest that classificatory systems of mental illnesses should consider introducing SBEs as a feature of the diagnostic criteria for binge eating and, thus, facilitate the inclusion

  9. Outcome and preferences in female-to-male subjects with gender dysphoria: Experience from Eastern India

    Directory of Open Access Journals (Sweden)

    Anirban Majumder

    2016-01-01

    Full Text Available Context: Awareness of gender dysphoria (GD and its treatment is increasing. There is paucity of scientific data from India regarding the therapeutic options being used for alleviating GD, which includes psychotherapy, hormone, and surgical treatments. Aim: To study the therapeutic options including psychotherapy, hormone, and surgical treatments used for alleviating GD. Settings and Design: This is a retrospective study of treatment preferences and outcome in 18 female-to-male (FTM transgender subjects who presented to the endocrine clinic. Results: The mean follow-up was 1.6 years and only one subject was lost to follow-up after a single visit. All subjects desiring treatment had regular counseling and medical monitoring. All FTM subjects were cross-dressing. Seventeen (94.4% FTM subjects were receiving cross-sex hormone therapy, in the form of testosterone only (61.1% or gonadotropin-releasing hormone (GnRH agonist in combination with testosterone (11.1% or medroxyprogesterone acetate (MPA depot in combination with testosterone (22.2%. FTM subjects preferred testosterone or testosterone plus MPA; very few could afford GnRH therapy. Testosterone esters injection was preferred by most (72.2% subjects as it was most affordable while 22.2% chose 3 monthly injections of testosterone undecanoate for convenience and better symptomatic improvement, but it was more expensive. None preferred testosterone gels because of cost and availability concerns. About 33.3% of our subjects underwent mastectomy, 38.9% had hysterectomy with bilateral salpingo-oophorectomy, and only one subject underwent phalloplasty. About 16.7% of FTM subjects presented with prior mastectomy depicting a high prevalence of unsupervised or poorly supervised surgeries not following protocol wise approach. Conclusion: Notwithstanding of advances in Standards of Care in the Western world, there is lack of awareness and acceptance in the FTM subjects, about proper and timely protocol

  10. Evaluation of a teaching strategy based on integration of clinical subjects, virtual autopsy, pathology museum, and digital microscopy for medical students**

    Science.gov (United States)

    Diaz-Perez, Julio A.; Raju, Sharat; Echeverri, Jorge H.

    2014-01-01

    Background: Learning pathology is fundamental for a successful medical practice. In recent years, medical education has undergone a profound transformation toward the development of an integrated curriculum incorporating both basic science and clinical material. Simultaneously, there has been a shift from a magisterial teaching approach to one centered around problem-based learning. Now-a-days, informatics tools are expected to help better implement these strategies. Aim: We applied and evaluated a new teaching method based on an active combination of clinical problems, gross pathology, histopathology, and autopsy pathology, all given through informatics tools, to teach a group of medical students at the Universidad de Santander, Colombia. Design: Ninety-four medical students were followed in two consecutive semesters. Students were randomized to receive teaching either through traditional methodology or through the new integrated approach. Results: There was no significant difference between the intervention group and the control group at baseline. At the end of the study, the scores in the intervention group were significantly higher compared to the control group (3.91/5.0 vs. 3.33/5.0, P = 0.0008). Students and tutors endorsed the benefits of the integrated approach. Participants were very satisfied with this training approach and rated the program an 8.7 out of 10, on average. Conclusion: This study confirms that an integrated curriculum utilizing informatics systems provides an excellent opportunity to associate pathology with clinical medicine early in training of medical students. This can be possible with the use of virtual microscopy and digital imaging. PMID:25191624

  11. Evaluation of a teaching strategy based on integration of clinical subjects, virtual autopsy, pathology museum, and digital microscopy for medical students

    Directory of Open Access Journals (Sweden)

    Julio A Diaz-Perez

    2014-01-01

    Full Text Available Background: Learning pathology is fundamental for a successful medical practice. In recent years, medical education has undergone a profound transformation toward the development of an integrated curriculum incorporating both basic science and clinical material. Simultaneously, there has been a shift from a magisterial teaching approach to one centered around problem-based learning. Now-a-days, informatics tools are expected to help better implement these strategies. Aim: We applied and evaluated a new teaching method based on an active combination of clinical problems, gross pathology, histopathology, and autopsy pathology, all given through informatics tools, to teach a group of medical students at the Universidad de Santander, Colombia. Design: Ninety-four medical students were followed in two consecutive semesters. Students were randomized to receive teaching either through traditional methodology or through the new integrated approach. Results: There was no significant difference between the intervention group and the control group at baseline. At the end of the study, the scores in the intervention group were significantly higher compared to the control group (3.91/5.0 vs. 3.33/5.0, P = 0.0008. Students and tutors endorsed the benefits of the integrated approach. Participants were very satisfied with this training approach and rated the program an 8.7 out of 10, on average. Conclusion: This study confirms that an integrated curriculum utilizing informatics systems provides an excellent opportunity to associate pathology with clinical medicine early in training of medical students. This can be possible with the use of virtual microscopy and digital imaging.

  12. Citrus aurantium Naringenin Prevents Osteosarcoma Progression and Recurrence in the Patients Who Underwent Osteosarcoma Surgery by Improving Antioxidant Capability

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    Lirong Zhang

    2018-01-01

    Full Text Available Citrus aurantium is rich in flavonoids, which may prevent osteosarcoma progression, but its related molecular mechanism remains unclear. Flavonoids were extracted from C. aurantium and purified by reparative HPLC. Each fraction was identified by using electrospray ionisation mass spectrometry (ESI-MS. Three main components (naringin, naringenin, and hesperetin were isolated from C. aurantium. Naringenin inhibited the growth of MG-63 cells, whereas naringin and hesperetin had no inhibitory function on cell growth. ROS production was increased in naringin- and hesperetin-treated groups after one day of culture while the level was always lowest in the naringenin-treated group after three days of culture. 95 osteosarcoma patients who underwent surgery were assigned into two groups: naringenin group (NG, received 20 mg naringenin daily, n=47 and control group (CG, received 20 mg placebo daily, n=48. After an average of two-year follow-up, osteosarcoma volumes were smaller in the NG group than in the CG group (P>0.01. The rate of osteosarcoma recurrence was also lower in the NG group than in CG group. ROS levels were lower in the NG group than in the CG group. Thus, naringenin from Citrus aurantium inhibits osteosarcoma progression and local recurrence in the patients who underwent osteosarcoma surgery by improving antioxidant capability.

  13. The Role of Speech Therapy in Patients Who Underwent Laryngeal Microsurgery due to Phonotraumatic Lesions and Lesions Unrelated to Phonotrauma

    Science.gov (United States)

    Macedo, Claudia de Assis Corrêa de; Macedo, Evaldo Dacheux de; Malafaia, Osvaldo; Catani, Guilherme Simas do Amaral; Ido, Jorge Massaki; Stahlke, Henrique Jorge

    2014-01-01

    Introduction The role of the speech-language pathology in the multiprofessional team dealing with laryngology and the voice has been recognized for a long time. Scientific studies in this field recommend therapies for laryngeal microsurgeries; few of the studies, however, effectively evaluate the result of postoperative speech therapy. Objective To compare speech therapy evaluation and treatment among patients with phonotraumatic lesions and patients with lesions unrelated to phonotrauma who underwent laryngeal microsurgery. Methods This study was performed at IPO Hospital (Paranaense Institute of Otorhinolaryngology, Curitiba, Paraná, Brazil) between February 2010 and February 2011. Of 254 patients who underwent laryngeal microsurgery, 208 patients were included in the study and divided in two groups: group A with phonotraumatic lesions (n = 131) and group B with lesions unrelated to phonotrauma (n = 77). The number of sessions and the functional result after speech therapy were evaluated. Results The number of postoperative phonotherapy sessions after microsurgery was up to 10 sessions in 89.31% and 87.71% for groups A and B, respectively. Phonotherapy treatment showed a better functional evolution in group A (92.37%). Conclusion A significant difference was observed only in functional evolution, which was better in the group with phonotraumatic lesions (p < 0.0001). PMID:25992078

  14. Aspectos clínicos e funcionais do equilíbrio corporal em idosos com vertigem posicional paroxística benigna Clinical and functional aspects of body balance in elderly subjects with benign paroxysmal positional vertigo

    Directory of Open Access Journals (Sweden)

    Daniela Patricia Vaz

    2013-04-01

    Full Text Available Vertigem Posicional Paroxística Benigna (VPPB pode alterar o equilíbrio corporal em pacientes idosos. OBJETIVO: Observar os efeitos da manobra de Epley em idosos com VPPB, avaliando os aspectos clínicos e funcionais do equilíbrio corporal. Forma de estudo: clínico e prospectivo. MÉTODO: Após o diagnóstico da doença (teste de DixHallpike, os testes Time Up and Go (TUGT, Clinical test of Sensory Interaction and Balance (CTSIB e o teste de membros inferiores (MMI foram realizados antes e após a manobra de reposicionamento de Epley modificada. RESULTADOS: O gênero feminino foi o mais prevalente e a média etária foi de 70,10 anos (DP = 7,00. Todos os pacientes apresentaram ductolitíase de canal posterior. Os seguintes sintomas melhoraram após a manobra: a instabilidade postural (p = 0,006, náusea e vômito (p = 0,021 e zumbido (p = 0,003. Em relação ao TUGT e o escore do teste de MMII, observou-se diminuição significante do tempo pós-manobra de Epley (p Benign paroxysmal positional vertigo (BPPV may compromise the balance of elderly subjects. OBJECTIVE: To observe the effects of the Epley maneuver in elderly subjects with BPPV and assess clinical and functional aspects of body balance. METHOD: This is a prospective clinical study. Patients diagnosed with BPPV (Dix-Hallpike test were submitted to the Timed Up & Go (TUG test, the Clinical Test of Sensory Interaction and Balance (CTSIB, and lower limb testing before and after they were repositioned using the modified Epley maneuver. RESULTS: Most subjects were females, and the group's mean age was 70.10 years (SD = 7.00. All patients had canalithiasis of the posterior canal. The following symptoms improved after the maneuver: postural instability (p = 0.006, nausea and vomiting (p = 0.021, and tinnitus (p = 0.003. Subjects improved their times significantly in the TUG and lower limb tests after the Epley maneuver (p < 0.001. Patients performed better on the CTSIB after the Epley

  15. Cardiovascular Safety of Oral p-Synephrine (Bitter Orange) in Healthy Subjects: A Randomized Placebo-Controlled Cross-over Clinical Trial.

    Science.gov (United States)

    Shara, Mohd; Stohs, Sidney J; Mukattash, Tareq L

    2016-05-01

    Bitter orange (Citrus aurantium) extract and its primary protoalkaloid p-synephrine are widely consumed in combination with multiple herbal ingredients for weight management and sports performance. p-Synephrine is also present in juices and foods derived from a variety of Citrus species. Questions exist regarding the safety of p-synephrine because of structural similarities with other biogenic amines. This study assessed the cardiovascular (stimulatory) effects of bitter orange extract (49-mg p-synephrine) given to 18 healthy subjects (nine men and nine women) in a double-blinded, placebo-controlled cross-over study. Heart rates, blood pressures, and electrocardiograms were determined at baseline, 30, 60, 90 min, 2, 4 , 6, and 8 h. Blood samples were drawn at baseline, 2 h and 8 h for serum chemistries, blood cell counts, and p-synephrine and caffeine levels. No significant changes occurred in electrocardiograms, heart rates, systolic blood pressure, blood chemistries, or blood cell counts at any time point in either control or p-synephrine treated group. A small (4.5 mmHg) decrease in diastolic blood pressure occurred in the p-synephrine treated group at 60 min. No adverse effects were reported. Caffeine ingestion varied markedly among the participants. p-Synephrine does not act as a stimulant at the dose used. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  16. Long-term follow-up of hepatic ultrasound findings in subjects with magnetic resonance imaging defined hepatic steatosis following clinical islet transplantation: a case-control study.

    Science.gov (United States)

    Jackson, Stephanie; Mager, Diana R; Bhargava, Ravi; Ackerman, Thomas; Imes, Sharleen; Hubert, Grace; Koh, Angela; Shapiro, A M James; Senior, Peter A

    2013-01-01

    Hepatic steatosis is one complication patients may experience following clinical islet transplantation (CIT), yet the cause and consequences of this are poorly understood. The purpose of this case-control study was to examine the relationship between hepatic steatosis, metabolic parameters and graft function in an Albertan cohort of CIT recipients. Hepatic steatosis was detected by magnetic resonance imaging (MRI) in n = 10 cases age-matched with n=10 MRI-negative controls. Progression/regression of steatosis was determined by ultrasound (US) in cases. Hepatic steatosis first appeared 2.8 ± 2.2 (mean ± SD) years post-CIT, and lasted approximately 4.6 ± 2.0 years. In five cases steatosis resolved, with recurrence in two cases during the follow-up period (8.5 ± 3.2 years). No evidence of CIT causing deleterious effects on long-term liver function or graft outcome was observed.

  17. Long-term follow-up of hepatic ultrasound findings in subjects with magnetic resonance imaging defined hepatic steatosis following clinical islet transplantation

    Science.gov (United States)

    Jackson, Stephanie; Mager, Diana R.; Bhargava, Ravi; Ackerman, Thomas; Imes, Sharleen; Hubert, Grace; Koh, Angela; Shapiro, A.M. James; Senior, Peter A.

    2013-01-01

    Hepatic steatosis is one complication patients may experience following clinical islet transplantation (CIT), yet the cause and consequences of this are poorly understood. The purpose of this case-control study was to examine the relationship between hepatic steatosis, metabolic parameters and graft function in an Albertan cohort of CIT recipients. Hepatic steatosis was detected by magnetic resonance imaging (MRI) in n = 10 cases age-matched with n=10 MRI-negative controls. Progression/regression of steatosis was determined by ultrasound (US) in cases. Hepatic steatosis first appeared 2.8 ± 2.2 (mean ± SD) years post-CIT, and lasted approximately 4.6 ± 2.0 years. In five cases steatosis resolved, with recurrence in two cases during the follow-up period (8.5 ± 3.2 years). No evidence of CIT causing deleterious effects on long-term liver function or graft outcome was observed. PMID:23514958

  18. Using tablet computers compared to interactive voice response to improve subject recruitment in osteoporosis pragmatic clinical trials: feasibility, satisfaction, and sample size

    Directory of Open Access Journals (Sweden)

    Mudano AS

    2013-06-01

    Full Text Available Amy S Mudano,1,2,3 Lisa C Gary,1,2,3 Ana L Oliveira,1,2,3 Mary Melton,1,2,3 Nicole C Wright,1,2,3 Jeffrey R Curtis,1,2,3 Elizabeth Delzell,1,2,3 T Michael Harrington,1,2,3 Meredith L Kilgore,1,2,3 Cora Elizabeth Lewis,1,2,3 Jasvinder A Singh,1,2,3,4 Amy H Warriner,1,2,3 Wilson D Pace,5 Kenneth G Saag1,2,31Center for Education and Research on Therapeutics (CERTs, 2Center for Outcomes Effectiveness Research and Education (COERE, and 3Center for Clinical and Translational Sciences (CCTS, (University of Alabama at Birmingham, Birmingham, AL, USA; 4Veterans Affairs Medical Center, Birmingham, AL, USA; 5Distributed Ambulatory Research in Therapeutics Network (DARTNet, American Academy of Family Physicians (AAFP, University of Colorado, Denver, CO, USAIntroduction: Pragmatic clinical trials (PCTs provide large sample sizes and enhanced generalizability to assess therapeutic effectiveness, but efficient patient enrollment procedures are a challenge, especially for community physicians. Advances in technology may improve methods of patient recruitment and screening in PCTs. Our study looked at a tablet computer versus an integrated voice response system (IVRS for patient recruitment and screening for an osteoporosis PCT in community physician offices.Materials and methods: We recruited women ≥ 65 years of age from community physician offices to answer screening questions for a hypothetical osteoporosis active comparator PCT using a tablet computer or IVRS. We assessed the feasibility of these technologies for patient recruitment as well as for patient, physician, and office staff satisfaction with the process. We also evaluated the implications of these novel recruitment processes in determining the number of primary care practices and screened patients needed to conduct the proposed trial.Results: A total of 160 women (80% of those approached agreed to complete the osteoporosis screening questions in ten family physicians’ offices. Women using the

  19. [Readaptation time after photo-stress in normal subjects and glaucoma patients].

    Science.gov (United States)

    Kamppeter, B; Degenring, R F; Jonas, J B

    2003-12-01

    A photo-stress test was conducted at the subjective contrast threshold to evaluate whether psychophysical differences could be detected between chronic open-angle glaucoma patients and normal subjects. The prospective, comparative, clinical observational study included 20 patients (29 eyes) with chronic open-angle glaucoma and 20 control subjects (29 eyes). The study groups did not vary significantly in age and refractive error, but visual acuity showed a difference of 0.16. All participants underwent photo-stress using the Kontrastometer BA4. In the glaucoma group compared with the control group, the mean contrast threshold was significantly higher and the readaptation time significantly longer. The latter correlated significantly with the papillo-morphological glaucoma stage. In patients with chronic open-angle glaucoma, the foveal recovery time after a photo-stress test is significantly prolonged compared with normal subjects. It may suggest involvement of the fovea in glaucoma even if the visual acuity is 20/20.

  20. A Clinical Prediction Rule for Functional Outcomes in Patients Undergoing Surgery for Degenerative Cervical Myelopathy: Analysis of an International Prospective Multicenter Data Set of 757 Subjects.

    Science.gov (United States)

    Tetreault, Lindsay; Kopjar, Branko; Côté, Pierre; Arnold, Paul; Fehlings, Michael G

    2015-12-16

    Cervical spondylotic myelopathy (CSM) is a progressive spinal condition that is often managed surgically. Knowledge of important predictors of surgical outcome can provide decision support to surgeons and enable them to effectively manage their patients' expectations. The purpose of this study was to identify the most important clinical predictors of surgical outcome in patients with CSM using data from two multinational prospective studies. A total of 757 patients treated surgically for CSM participated in either the CSM-North America or the CSM-International study. The model was designed to distinguish between patients who achieved a modified Japanese Orthopaedic Association (mJOA) score of ≥16 at the one-year follow-up and those who did not (mJOA myelopathy, and older age. The final model consisted of six significant and clinically relevant predictors: baseline severity score (relative risk [RR], 1.11; 95% confidence interval [CI], 1.07 to 1.15), impaired gait (RR, 0.76 [ref. = absence]; 95% CI, 0.66 to 0.88), age (RR, 0.91 per decade; 95% CI, 0.85 to 0.96), comorbidity score (RR, 0.93; 95% CI, 0.88 to 0.98), smoking status (RR, 0.78 [ref. = non-smoking]; 95% CI, 0.65 to 0.93), and duration of symptoms (RR, 0.95; 95% CI, 0.90 to 0.99). Patients were more likely to achieve a score of ≥16 (indicating minimal impairment) if they were younger, had milder preoperative myelopathy, did not smoke, had fewer and less severe comorbidities, did not present with impaired gait, and had shorter symptom duration. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

  1. Four-fold increase in foot ulcers in type 2 diabetic subjects without an increase in major amputations by a multidisciplinary setting

    DEFF Research Database (Denmark)

    Hedetoft, Christoffer; Rasmussen, Anne; Fabrin, Jesper

    2008-01-01

    AIMS: We observed a large increase in type 2 diabetic subjects with foot ulcers in our diabetic outpatient foot clinic and wanted to identify the amputations rate and individuals at risk of amputations by comparing those who had had a regular control in the multidisciplinary foot clinic prior...... to the amputations and those who had not. METHODS: We examined all clinical records from the orthopaedic surgery department and the diabetic outpatient foot clinic of diabetic patients who underwent amputations for 6 years. RESULTS: Eighty-eight patients with type 2 diabetes underwent 142 amputations; 42 major...... and 100 minor amputations. There was no increase in the number of major amputations in this period. In the group not followed in the foot clinic prior to amputations we showed a greater major amputations rate (pdiabetes and less retinopathy...

  2. Clinical use of ultrashort-lived radionuclide krypton-81m for noninvasive analysis of right ventricular performance in normal subjects and patients with right ventricular dysfunction

    Energy Technology Data Exchange (ETDEWEB)

    Nienaber, C.A.; Spielmann, R.P.; Wasmus, G.; Mathey, D.G.; Montz, R.; Bleifeld, W.H.

    1985-03-01

    The ultrashort-lived radionuclide krypton-81m, eluted in 5% dextrose from a bedside rubidium-81m generator, was intravenously infused for rapid imaging of the right-sided heart chambers in the right anterior oblique projection adjusted for optimal right atrioventricular separation. Left-sided heart and lung background was minimized by rapid decay and efficient exhalation of krypton-81m, requiring no algorithm for background correction. A double region of interest method decreased the variability in the assessment of ejection fraction to 5%. In 10 normal subjects, 11 patients with pulmonary hypertension, 4 patients with right ventricular outflow tract obstruction and 4 patients with right ventricular infarction, right ventricular ejection fraction determined by krypton-81m equilibrium blood pool imaging ranged from 14 to 76%. The correlation between these values and those determined by cineangiography according to Simpson's rule was close: r . 0.93 for all data points, r . 0.92 for studies at rest and r . 0.93 for exercise studies. Exercise-related changes in right ventricular function revealed a disturbed functional reserve with pulmonary hypertension and right ventricular infarction, whereas in compensated right ventricular outflow tract obstruction there was a physiologic increase in ejection fraction with exercise. Thus, equilibrium-gated right ventricular imaging using ultrashort-lived krypton-81m is a simple, accurate and reproducible method with potential for serial assessment of right ventricular ejection fraction in a variety of right ventricular anatomic and functional abnormalities, both at rest and during exercise. Advantages of this method include an extremely low radiation dose to patients and clear right atrioventricular separation without the need to correct for background activity.

  3. Influence of Blood Pressure and Other Clinical Variables on Long-Term Mortality in a Cohort of Elderly Subjects with Type 2 Diabetes.

    Science.gov (United States)

    Tessier, Daniel M; Meneilly, Graydon S; Moleski, Luc; Trottier, Lise; Lanthier, Luc

    2016-02-01

    Diabetes mellitus and high blood pressure (HBP) are commonly associated conditions in the elderly population. An effect of treatments, biologic and anthropometric variables on long-term mortality is unknown in this population. To determine the prevalence of HBP control in a sample of elderly patients with type 2 diabetes with office blood pressure (BP) readings and ambulatory blood pressure monitoring (ABPM) and evaluate the influence of BP, anthropometric and laboratory variables on long term mortality. Cohort study in patients living at home in the area of Sherbrooke, ≥65 years old, receiving reimbursement for antidiabetic medication. The study included medical history, 2 sets of BP measurements, 2 24-hour urinary collections for microalbuminuria, 1 24-hour ABPM, blood level of creatinine and glycosylated hemoglobin. Charts were reanalyzed 8 years later for analysis of cardiovascular and total mortality cases. 198 patients were initially recruited. By history, 83% of the subjects had diagnoses and treatments for high blood pressure. In multivariate analysis, factors associated with an 8-year increased risk for cardiovascular mortality were creatinine ≥84 µmol/L, office seated systolic blood pressure ≤130 and diastolic BP ≤67.6 over 24 hours. Factors associated with total mortality were lower waist circumference, serum creatinine ≥84 and diastolic BP ≤67.6 over 24 hours. Lower systolic and diastolic BP (office and ABPM), lower waist circumference and higher creatinine values are associated with an increased mortality risk. This suggests that a lower BP, declining kidney function and frailty are factors associated with this observation. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

  4. The association between orthostatic hypotension and cognitive state among adults 65 years and older who underwent a comprehensive geriatric assessment

    Science.gov (United States)

    Punchick, Boris; Freud, Tamar; Press, Yan

    2016-01-01

    Abstract The prevalence of cognitive impairment and orthostatic hypotension (OH) increases with age, but the results of studies that assessed possible associations between them are inconsistent. The aim of this study is to assess possible associations between cognitive impairment and OH in patients ≥65 years of age who underwent a comprehensive geriatric assessment. A retrospective analysis was conducted of the computerized medical records of the study population from 2005 to 2013. Data collected included blood pressure measurements that enabled the calculation of OH, results of the mini-mental state examination (MMSE), results of the Montreal cognitive assessment (MoCA) test, and cognitive diagnoses that were determined over the course of the assessment. The rate of OH in the study population of 571 adults was 32.1%. The mean MMSE score was 22.5 ± 5.2 among participants with OH and 21.6 ± 5.8 among those without OH (P = 0.09). The absence of a significant association between OH and MMSE remained after adjusting the MMSE score for age and education level. The mean MoCA score was 16.4 ± 5.0 among participants with OH and 16.4 ± 4.8 among those without (P = 0.33). The prevalence of OH was 39% among participants without cognitive impairment, 28.9% among those with mild cognitive impairment (MCI), and 30.6% among those with dementia (P = 0.13). There was no association between OH and cognitive impairment in adults who underwent a comprehensive geriatric assessment. PMID:27442658

  5. Autotransplantation of spleen tissue in children with mansonic schistosomiasis who underwent splenectomy: Evaluation of splenic residual functions

    Directory of Open Access Journals (Sweden)

    Brandt Carlos Teixeira

    1998-01-01

    Full Text Available Autotransplantation of spleen tissue is an attempt for maintenance of splenic functions when splenectomy is indicated in children. It minimizes the risks of overwhelming postsplenectomy infection and it has been done in children with severe portal hypertension due to hepatosplenic mansonic schistosomiasis that underwent splenectomy. The purposes of this investigation were to study the morphology of the residual splenic tissue; to evaluate the residual filtration function of this splenosis; and to assess the immune response to polyvalent pneumococcal vaccine of these patients. Twenty-three children with portal hypertension from mansonic schistosomiasis who underwent splenectomy, ligature of the left gastric vein, autotransplantation of spleen tissue into an omental pouch were evaluated for residual splenic parenchyma and functions. Tc-99m sulfur colloid liver-spleen scans were used for detection of splenic nodules. The search for Howell Jolly bodies were used for assessing the filtration function and Enzyme-linked immunosorbent assay was used for measuring the relative rise in titter of specific pneumococcal antibodies. Splenosis was evident in all children; however, in two there were less than five splenic nodules in the greater omentum, which was considered insufficient. Howell-Jolly bodies were found in the peripheral blood only in these two patients with less evident splenosis. The immune response was adequate in 15 patients; it was intermediate in 4 patients and inadequate in 4 patients. Autotransplantation of spleen tissue into an omental pouch is efficient in maintaining the filtration splenic function in more than 90% of the cases and the immune response to pneumococcal vaccination in approximately 65% of the children.

  6. Risk Factors for Pedicle Flap Complications in 251 Elderly Chinese Patients Who Underwent Oral and Maxillofacial Reconstruction.

    Science.gov (United States)

    Fang, Zao; Tian, Zhuowei; Zhang, Chenping; Sun, Jian; Hu, Jingzhou; He, Yue

    2016-10-01

    To determine risk factors for pedicle flap complications in elderly patients undergoing oral and maxillofacial reconstruction. The authors designed and implemented a retrospective cohort study and enrolled a sample of patients at least 75 years old who underwent resection of oral and maxillofacial tumors and pedicle flap reconstruction from January 2004 through December 2013. The primary predictor variable was reconstructive technique grouped into 5 types of pedicle flap. The difference among groups was tested with the χ(2) test and t test. The primary outcome variable was the presence of flap complication, which was divided into minor and major groups. Other variables were grouped into the following sets: demographic, operative, and adjuvant treatments. Univariate, bivariate, and regression statistics were computed and statistical significance was set at a P value less than .05. The study sample was composed of 251 patients with a mean age of 78 years and 62.95% were men. Of these, 68.13% had various preoperative systemic diseases. With regard to flap type, 120 underwent reconstruction with a pectoralis major myocutaneous flap, 5 with a submental island flap, 4 with a submandibular gland flap, 13 with a platysma myocutaneous flap, and 109 with a sternocleidomastoid flap. TNM stage (negative correlation) and smoking (positive correlation) correlated with flap type. There were 48 complications, of which 32 were minor and 16 were major; flap failure was observed in only 1 patient. Risk factors associated with complications were types of pedicle flap, age, heart score, hypertension, diabetes, postoperative hypoproteinemia, and drug-induced liver injury. The pedicle flap is suitable and safe for the reconstruction of defects caused by the ablation of oral and maxillofacial tumors in elderly patients. Preoperative evaluation of positive risk factors, including type of surgery and systemic conditions, is very important for the selection of an appropriate flap for such

  7. [Evaluation of the antithrombotic strategy in low thrombotic risk patients who underwent aortic valve replacement with a bioprosthesis].

    Science.gov (United States)

    Aceves-Velázquez, Eduardo; Vieyra-Herrera, Gerardo; Rodríguez-Chávez, Laura; Herrera-Alarcón, Valentín

    2017-07-16

    According to current guidelines, in patients without additional risk factors who have undergone aortic valve replacement with a bioprosthesis, anticoagulation in the first 3 months after surgery is still a matter of debate. According to current evidence, aspirin in low doses is a reasonable alternative to vitamin K antagonists (VKA). A comparison is made between the incidence of thrombotic and haemorrhagic complications in patients with low thrombotic risk who underwent aortic valve replacement with a bioprosthesis in the National Institute of Cardiology of Ignacio Chávez of Mexico. The hypothesis: aspirin as monotherapy has a beneficial effect compared to VKA. The studied patients were the low thrombotic risk patients who underwent aortic valve replacement with a bioprosthesis in the National Institute of Cardiology of Ignacio Chávez of Mexico from 2011 to 2015. The groups studied were: aspirin only, VKA only, and the combination of VKA plus aspirin. The patients were retrospectively followed-up for 12 months, and the thrombotic and haemorrhagic complications were documented. Of the 231 patients included in the study, only one patient in the VKA only group presented with a haemorrhagic complication. No thrombotic complications were observed. In the present study no thrombotic complications were observed in patients who did not receive anticoagulation in the first 3 months after an aortic valve replacement with a bioprosthesis after a follow up period of 12 months. This suggests that the use of aspirin only is safe during this period. Copyright © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

  8. Potential human neurotoxicity of MDMA ('Ecstasy'): subjective self-reports, evidence from an Italian drug addiction centre and clinical case studies.

    Science.gov (United States)

    Schifano, F

    2000-01-01

    The present paper attempts to give an updated overview of the magnitude of the phenomenon of ecstasy abuse in Italy and other European countries. It gives an account of some clinical case studies and of a larger-scale report on polydrug (including MDMA) consumers attending our Public Health Addiction Treatment Unit in recent years, with a view to clarifying the characteristics and psychopathological consequences (mainly depression, psychotic disorders, cognitive disturbances, bulimic episodes, impulse control disorders, panic disorders, social phobia) of MDMA consumption. Longer-term, larger-dose (acute or cumulative) MDMA consumers were found to be at high risk of developing these psychopathological disturbances. A tentative description of certain personological dimensions of ecstasy consumers is also given (the novelty-seeking dimension was characteristic of those who occasionally experimented with the drug) while those who ingested larger quantities revealed low harm avoidance scores). Results are discussed in the light of the complex and different methodological issues arising from this kind of study, in which MDMA is far from being the only drug of abuse. Copyright 2000 S. Karger AG, Basel

  9. Supplementation of the diet with the functional fiber PolyGlycoplex® is well tolerated by healthy subjects in a clinical trial

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    Wood Simon

    2009-02-01

    Full Text Available Abstract Background The relationship of dietary fiber to overall health is of great importance, as beneficial effects have been demonstrated with the use of fiber from diverse sources, some traditional, other novel. PolyGlycopleX® (PGX® is a unique proprietary product composed of three water-soluble polysaccharides, that when processed using novel technology give rise to a final product – a soluble, highly viscous functional fiber. Methods Because of its potential use in food and dietary supplements, a randomized, double-blind, placebo controlled clinical study was conducted to evaluate the tolerance to PGX ingestion for 21 days, to a maximum dose level of 10 g per day, in healthy male and female volunteers. The main objective of the study was to evaluate the overall gastrointestinal (GI tolerance, while secondary objectives were to evaluate possible changes in hematological, biochemical, urinary and fecal parameters. Results Results show that PGX is well tolerated as part of a regular diet with only mild to moderate adverse effects, similar to those seen with a moderate intake of dietary fiber in general, and fruits and vegetables. Because PGX is a highly viscous, functional fiber, it also demonstrates several physiological responses including, but not limited to maintaining healthy total and LDL cholesterol and uric acid levels.

  10. Supplementation of the diet with the functional fiber PolyGlycoplex is well tolerated by healthy subjects in a clinical trial.

    Science.gov (United States)

    Carabin, Ioana G; Lyon, Michael R; Wood, Simon; Pelletier, Xavier; Donazzolo, Yves; Burdock, George A

    2009-02-05

    The relationship of dietary fiber to overall health is of great importance, as beneficial effects have been demonstrated with the use of fiber from diverse sources, some traditional, other novel. PolyGlycopleX (PGX) is a unique proprietary product composed of three water-soluble polysaccharides, that when processed using novel technology give rise to a final product - a soluble, highly viscous functional fiber. Because of its potential use in food and dietary supplements, a randomized, double-blind, placebo controlled clinical study was conducted to evaluate the tolerance to PGX ingestion for 21 days, to a maximum dose level of 10 g per day, in healthy male and female volunteers. The main objective of the study was to evaluate the overall gastrointestinal (GI) tolerance, while secondary objectives were to evaluate possible changes in hematological, biochemical, urinary and fecal parameters. Results show that PGX is well tolerated as part of a regular diet with only mild to moderate adverse effects, similar to those seen with a moderate intake of dietary fiber in general, and fruits and vegetables. Because PGX is a highly viscous, functional fiber, it also demonstrates several physiological responses including, but not limited to maintaining healthy total and LDL cholesterol and uric acid levels.

  11. A NEW APPROACH IN THE CLINICAL DECISION-MAKING FOR CEREBRAL PALSY USING THREE-DIMENSIONAL SUBJECT-SPECIFIC MUSCULOSKELETAL RECONSTRUCTIONS.

    Science.gov (United States)

    Massaad, Abir; Assi, Ayman; Bakouny, Ziad; Skalli, Wafa; Ghanem, Ismat

    2016-01-01

    Cerebral palsy (CP) is a neurological disorder which can cause muscular spasticity. Children with this condition suffer from a combination of gait deviations, skeletal deformities and muscular abnormalities. Precise evaluation of each of these three components is crucial for management planning in children with CP. The aim of this study is to review the latest innovative methods used for three-dimensional (3D) gait analysis and musculoskeletal modeling in children with cerebral palsy. 3D gait analysis is a quantitative objective method based on the use of infrared cameras. It allows the evaluation of dynamic joint angles, forces and moments applied on joints and is usually coupled with dynamic electromyography. Skeletal evaluation is usually based on two-dimensional X-rays and physical examination in clinical practice. However, a novel method based on stereoradiographic 3D reconstruction of biplanar low dose X-rays allows a more thorough evaluation of skeletal deformities, and in particular torsional anomalies. Muscular evaluation of children with CP is most commonly based on magnetic resonance imaging, whereby delimitation of lower limb muscles on axial slices allows 3D reconstruction of these muscles. Novel innovative techniques allow similar reconstructions by extrapolation, thus limiting the necessary quantity of axial slices that need to be manually delimitated.

  12. Evidence for altered metabolic pathways during environmental stress: (1)H-NMR spectroscopy based metabolomics and clinical studies on subjects of sea-voyage and Antarctic-stay.

    Science.gov (United States)

    Yadav, Anand Prakash; Chaturvedi, Shubhra; Mishra, Kamla Prasad; Pal, Sunil; Ganju, Lilly; Singh, Shashi Bala

    2014-08-01

    The Antarctic context is an analogue of space travel, with close similarity in ambience of extreme climate, isolation, constrained living spaces, disrupted sleep cycles, and environmental stress. The present study examined the impact of the harsh habitat of Antarctica on human physiology and its metabolic pathways, by analyzing human serum samples, using (1)H-NMR spectroscopy for identification of metabolites; and quantifying other physiological and clinical parameters for correlation between expression data and metabolite data. Sera from seven adult males (of median age 36years) who participated in this study, from the 28th Indian Expeditionary group to the Antarctica station Maitri, were collected in chronological sequence. These included: i) baseline control; ii) during ship journey; iii) at Antarctica, in the months of March, May, August and November; to enable study of temporal evolution of monitored physiological states. 29 metabolites in serum were identified from the 400MHz (1)H-NMR spectra. Out of these, 19 metabolites showed significant variations in levels, during the ship journey and the stay at Maitri, compared to the base-line levels. Further biochemical analysis also supported these results, indicating that the ship journey, and the long-term Antarctic exposure, affected kidney and liver functioning. Our metabolite data highlights for the first time the effect of environmental stress on the patho-physiology of the human system. Multivariate analysis tools were employed for this metabonomics study, using (1)H-NMR spectroscopy. Copyright © 2014. Published by Elsevier Inc.

  13. Single and Multiple Dose Pharmacokinetics, Pharmacodynamics and Safety of the Novel Lipoprotein-Associated Phospholipase A2 Enzyme Inhibitor Darapladib in Healthy Chinese Subjects: An Open Label Phase-1 Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Chaoying Hu

    Full Text Available Darapladib is a lipoprotein-associated phospholipase A2 (Lp-PLA2 inhibitor. This study evaluated the pharmacokinetics, pharmacodynamics and safety of darapladib in healthy Chinese subjects.Twenty-four subjects received darapladib 160 mg orally, approximately 1 hour after a standard breakfast, as a single dose and once daily for 28 days. Non-compartmental methods were used to determine the single and multiple dose pharmacokinetics of darapladib and its metabolite SB-553253. Repeat dose Lp-PLA2 activity and safety were evaluated.Systemic exposure (AUC(0-T, Cmax geometric mean (CVb% of darapladib was higher after multiple-dosing (519 ng.h/mL (33.3%, 34.4 ng/mL (49.9% compared to single-dose administration (153 ng.h/mL (69.0%, 17.9 ng/mL (55.2%. The steady-state accumulation ratio was less than unity (Rs = 0.80, indicating time-dependent pharmacokinetics of darapladib. Darapladib steady-state was reached by Day 14 of once daily dosing. Systemic exposure to SB-553253 was lower than darapladib with median (SB-553253: darapladib ratios for AUC(0-τ of 0.0786 for single dose and 0.0532 for multiple dose administration. On Day 28, pre-dose and maximum inhibition of Lp-PLA2 activity was approximately 70% and 75% relative to the baseline value, respectively and was dependent of darapladib concentration. The most common adverse events (≥ 21% subjects were abnormal faeces, abnormal urine odour, diarrhoea and nasopharyngitis.Darapladib 160 mg single and repeat doses were profiled in healthy Chinese subjects. Single dose systemic exposure to darapladib in healthy Chinese subjects was consistent with that observed previously in Western subjects whereas steady-state systemic exposure was approximately 65% higher in Chinese than Western subjects. The Lp-PLA2 activity and adverse event profile were similar in healthy Chinese and previous reports in Western subjects. Ethnic-specific dose adjustment of darapladib is not considered necessary for the Chinese

  14. Acute myocardial infarction in progressively elderly patients. A comparative analysis of immediate results in patients who underwent primary percutaneous coronary intervention

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    Mattos Luiz Alberto

    2001-01-01

    Full Text Available OBJECTIVE: Analysis of the in-hospital results, in progressively elderly patients who undergo primary percutaneous coronary intervention (PCI in the first 24 hours of AMI. METHODS: The patients were divided into three different age groups (60/69, 70/79, and > or = 80 years and were treated from 7/95 until 12/99. The primary success rate and the occurrence of major clinical events were analyzed at the end of the in-hospital phase. Coronary stent implantation and abciximab use were employed at the intervencionist discretion. RESULTS: We analyzed 201 patients with age ranging from 60 to 93 years, who underwent primary PCI. Patients with ages above 70 were more often female (p=.015. Those with ages above 80 were treated later with PCI (p=.054, and all of them presented with total occlusion of the infarct-related artery. Coronary stents were implanted in 30% of the patients. Procedural success was lower in > or = 80 year old patients (p=.022, and the death rate was higher in > or = 70 years olds (p=.019. Reinfarction and coronary bypass surgery were uncommon events. A trend occurred toward a higher combined incidence of major in-hospital events according to increased age (p=.064. CONCLUSION: Elderly patients ( > or = 70 years presented with adverse clinical and angiographic profiles and patients > or = 80 years of age obtained reduced TIMI 3 flow success rates after primary PTCA, and those > or = 70 years had a higher death rate.

  15. Acute myocardial infarction in progressively elderly patients. A comparative analysis of immediate results in patients who underwent primary percutaneous coronary intervention.

    Science.gov (United States)

    Mattos, L A; Zago, A; Chaves, A; Pinto, I; Tanajura, L; Staico, R; Centemero, M; Feres, F; Maldonado, G; Cano, M; Abizaid, A; Abizaid, A; Sousa, A G; Sousa, J E

    2001-01-01

    Analysis of the in-hospital results, in progressively elderly patients who undergo primary percutaneous coronary intervention (PCI) in the first 24 hours of AMI. The patients were divided into three different age groups (60/69, 70/79, and > or =80 years) and were treated from 7/95 until 12/99. The primary success rate and the occurrence of major clinical events were analyzed at the end of the in-hospital phase. Coronary stent implantation and abciximab use were employed at the interventionist discretion. We analyzed 201 patients with age ranging from 60 to 93 years, who underwent primary PCI. Patients with ages above 70 were more often female (p=.015). Those with ages above 80 were treated later with PCI (p=.054), and all of them presented with total occlusion of the infarct-related artery. Coronary stents were implanted in 30% of the patients. Procedural success was lower in > or =80 year old patients (p=.022), and the death rate was higher in > or =70 years olds (p=.019). Reinfarction and coronary bypass surgery were uncommon events. A trend occurred toward a higher combined incidence of major in-hospital events according to increased age (p=.064). Elderly patients (> or =70 years) presented with adverse clinical and angiographic profiles and patients > or =80 years of age obtained reduced TIMI 3 flow success rates after primary PTCA, and those > or =70 years had a higher death rate.

  16. Paying Hypertension Research Subjects

    Science.gov (United States)

    Casarett, David; Karlawish, Jason; Asch, David A

    2002-01-01

    CONTEXT Cash payments are often used to compensate subjects who participate in research. However, ethicists have argued that these payments might constitute an undue inducement. OBJECTIVES To determine whether potential subjects agree with theoretical arguments that a payment could be an undue inducement. DESIGN/SETTING/PARTICIPANTS Survey of 350 prospective jurors. MAIN OUTCOME MEASURES Belief that a $500 payment for research participation would impair their own, and others' ability to think carefully about the risks and benefits of a clinical trial. RESULTS Two hundred sixty-one jurors (74.6%) believed that a $500 payment would impair subjects' ability to think carefully about the risks and benefits of research. Ninety-six of 120 (80%) expressed this concern about subjects with a low income ($50,000). In contrast, only 69 (19.7%) of jurors believed that a $500 payment would influence them. Jurors who believed that this payment would influence them reported lower incomes and less education. CONCLUSION Members of the general public share ethical concerns about the influence of payments for research, although they believe that these concerns are more applicable to others than to themselves.

  17. Production of high specific activity (195m) Pt-cisplatinum at South African Nuclear Energy Corporation for Phase 0 clinical trials in healthy individual subjects.

    Science.gov (United States)

    Zeevaart, Jan Rijn; Wagener, Judith; Marjanovic-Painter, Biljana; Sathekge, Mike; Soni, Nischal; Zinn, Christa; Perkins, Gary; Smith, Suzanne V

    2013-01-01

    Platinum agents continue to be the main chemotherapeutic agents used in the first-line and second-line treatments of cancer patients. It is important to fully understand the biological profile of these compounds in order to optimize the dose given to each patient. In a joint project with the Australian Nuclear Science and Technology Organisation and the Nuclear Medicine Department at Steve Biko Academic Hospital, South African Nuclear Energy Corporation synthesized and supplied (195m) Pt-cisplatinum (commonly referred to as cisplatin) for a clinical pilot study on healthy volunteers. Enriched (194) PtCl2 was prepared by digestion of enriched (194) Pt metal (>95%) followed by thermal decomposition over a 3 h period. The (194) PtCl2 was then placed in a quartz ampoule, was irradiated in SAFARI-1 up to 200 h, then decay cooled for a minimum of 34 h prior to synthesis of final product. (195m) Pt(NH3 )2 I2 , formed with the addition of KI and NH4 OH, was converted to the diaqua species [(195m) Pt(NH3 )2 (H2 O)2 ](2+) by reaction with AgNO3 . The conversion to (195m) Pt-cisplatinum was completed by the addition of concentrated HCl. The final product yield was 51.7% ± 5.2% (n = 5). The chemical and radionuclidic purity in each case was >95%. The use of a high flux reactor position affords a higher specific activity product (15.9 ± 2.5 MBq/mg at end of synthesis) than previously found (5 MBq/mg). Volunteers received between 108 and 126 MBq of radioactivity, which is equivalent to 6.8-10.0 mg of carrier cisplatinum. Such high specific activities afforded a significant reduction (~50%) in the chemical dose of a carrier cisplatinum, which represents less than 10% of a typical chemotherapeutic dose given to patients. A good manufacturing practice GMP compliant product was produced and was administered to 10 healthy volunteers as part of an ethically approved Phase 0 clinical trial. The majority of the injected activity 27.5% ± 5.8% was excreted

  18. Effect of pulsed short-wave diathermy on pain and function of subjects with osteoarthritis of the knee: a placebo-controlled double-blind clinical trial.

    Science.gov (United States)

    Laufer, Y; Zilberman, R; Porat, R; Nahir, A M

    2005-05-01

    To examine the effects of pulsed short-wave diathermy (PSWD), delivered at an intensity sufficient to induce a thermal sensation and at an athermal intensity, in comparison with a placebo short-wave diathermy treatment, on reported pain, stiffness and functional ability and on mobility performance of patients with osteoarthritis of the knee. A placebo-controlled double-blind trial with sequential allocation of patients to different treatment groups. Outpatient physiotherapy department. One hundred and three consecutive patients, mean age 73.7 (+/-6.6) years with osteoarthritis of one or both knees for at least three months. All participants received three 20-min-long treatments per week for three weeks. One group received PSWD with mean power of 18 W (thermal effect), one group received PSWD with mean power of 1.8 W (athermal effect), and one group received sham short-wave diathermy treatment. Patients were assessed before the initial treatment, immediately following the last treatment, and at a three-month follow-up. Outcome measures included the WOMAC Osteoarthritis Index, which assessed reported pain, stiffness, and functional ability, and four measures of mobility performance: Timed Get Up and Go test (TGUG), stair-climbing, stair, descending and a 3-min walk. A difference across time was observed for the pain and stiffness categories of the WOMAC Osteoarthritis Index (p = 0.033 and p = 0.008, respectively), with no differences between groups. No other significant differences across time or between groups were observed in any of the other measures. The findings do not demonstrate pulsed short-wave diathermy, as it is utilized in clinical settings, to be effective in the treatment of osteoarthritis of the knee.

  19. Characterization of renal biomarkers for use in clinical trials: effect of preanalytical processing and qualification using samples from subjects with diabetes

    Directory of Open Access Journals (Sweden)

    Brott DA

    2015-06-01

    Full Text Available David A Brott,1 Stephen T Furlong,1 Scott H Adler,1 James W Hainer,2 Ramin B Arani,2 Mark Pinches,3 Peter Rossing,4–6 Nish Chaturvedi7 On behalf of the DIRECT Programme Steering Committee1Enabling Safety Sciences, 2AstraZeneca Pharmaceuticals, Wilmington, DE, USA; 3Drug Safety and Metabolism, AstraZeneca Pharmaceuticals, Alderley Park, UK; 4Steno Diabetes Center, Gentofte, Denmark; 5Aarhus University, Aarhus, Denmark, 6University of Copenhagen, Denmark; 7Institute of Cardiovascular Sciences, University College London, London, UK Background: Identifying the potential for drug-induced kidney injury is essential for the successful research and development of new drugs. Newer and more sensitive preclinical drug-induced kidney injury biomarkers are now qualified for use in rat toxicology studies, but biomarkers for clinical studies are still undergoing qualification. The current studies investigated biomarkers in healthy volunteer (HV urine samples with and without the addition of stabilizer as well as in urine from patients with normoalbuminuric diabetes mellitus (P-DM.Methods: Urine samples from 20 male HV with stabilizer, 69 male HV without stabilizer, and 95 male DM without stabilizer (39 type 1 and 56 type 2 were analyzed for the following biomarkers using multiplex assays: α-1-microglobulin (A1M, β-2-microglobulin, calbindin, clusterin, connective tissue growth factor (CTGF, creatinine, cystatin-C, glutathione s-transferase α (GSTα, kidney injury marker-1 (KIM-1, microalbumin, neutrophil gelatinase-associated lipocalin, osteopontin, Tamm–Horsfall urinary glycoprotein (THP, tissue inhibitor of metalloproteinase 1, trefoil factor 3 (TFF3, and vascular endothelial growth factor.Results: CTGF and GSTα assays on nonstabilized urine were deemed nonoptimal (>50% of values below assay lower limits of quantification. “Expected values” were determined for HV with stabilizer, HV without stabilizer, and P-DM without stabilizer. There was a

  20. Characterization of renal biomarkers for use in clinical trials: effect of preanalytical processing and qualification using samples from subjects with diabetes

    Science.gov (United States)

    Brott, David A; Furlong, Stephen T; Adler, Scott H; Hainer, James W; Arani, Ramin B; Pinches, Mark; Rossing, Peter; Chaturvedi, Nish

    2015-01-01

    Background Identifying the potential for drug-induced kidney injury is essential for the successful research and development of new drugs. Newer and more sensitive preclinical drug-induced kidney injury biomarkers are now qualified for use in rat toxicology studies, but biomarkers for clinical studies are still undergoing qualification. The current studies investigated biomarkers in healthy volunteer (HV) urine samples with and without the addition of stabilizer as well as in urine from patients with normoalbuminuric diabetes mellitus (P-DM). Methods Urine samples from 20 male HV with stabilizer, 69 male HV without stabilizer, and 95 male DM without stabilizer (39 type 1 and 56 type 2) were analyzed for the following bio-markers using multiplex assays: α-1-microglobulin (A1M), β-2-microglobulin, calbindin, clus-terin, connective tissue growth factor (CTGF), creatinine, cystatin-C, glutathione S-transferase α (GSTα), kidney injury marker-1 (KIM-1), microalbumin, neutrophil gelatinase-associated lipocalin, osteopontin, Tamm–Horsfall urinary glycoprotein (THP), tissue inhibitor of metalloproteinase 1, trefoil factor 3 (TFF3), and vascular endothelial growth factor. Results CTGF and GSTα assays on nonstabilized urine were deemed nonoptimal (>50% of values below assay lower limits of quantification). “Expected values” were determined for HV with stabilizer, HV without stabilizer, and P-DM without stabilizer. There was a statistically significant difference between HV with stabilizer compared to HV without stabilizer for A1M, CTGF, GSTα, and THP. DM urine samples differed from HV (without stabilizer) for A1M CTGF, GSTα, KIM-1, microalbumin, osteopontin, and TFF3. A1M also correctly identified HV and DM with an accuracy of 89.0%. Summary These studies: 1) determined that nonstabilized urine can be used for assays under qualification; and 2) documented that A1M, CTGF, GSTα, KIM-1, microalbumin, osteopontin, and TFF3 were significantly increased in urine from

  1. A Phase 1, Single-center, Double-blind, Placebo-controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Clinical Effects, and Pharmacokinetics-Pharmacodynamics of Intravenous Cyclopropyl-methoxycarbonylmetomidate (ABP-700) after a Single Ascending Bolus Dose.

    Science.gov (United States)

    Struys, Michel M R F; Valk, Beatrijs I; Eleveld, Douglas J; Absalom, Anthony R; Meyer, Peter; Meier, Sascha; den Daas, Izaak; Chou, Thomas; van Amsterdam, Kai; Campagna, Jason A; Sweeney, Steven P

    2017-07-01

    Cyclopropyl-methoxycarbonylmetomidate (ABP-700) is a new "soft" etomidate analog. The primary objectives of this first-in-human study were to describe the safety and efficacy of ABP-700 and to determine its maximum tolerated dose. Secondary objectives were to characterize the pharmacokinetics of ABP-700 and its primary metabolite (cyclopropyl-methoxycarbonyl acid), to assess the clinical effects of ABP-700, and to investigate the dose-response and pharmacokinetic/pharmacodynamic relationships. Sixty subjects were divided into 10 cohorts and received an increasing, single bolus of either ABP-700 or placebo. Safety was assessed by clinical laboratory evaluations, infusion-site reactions, continuous monitoring of vital signs, physical examination, adverse event monitoring, and adrenocorticotropic hormone stimulation testing. Clinical effects were assessed with modified observer's assessment of alertness/sedation and Bispectral Index monitoring. Pharmacokinetic parameters were calculated. Stopping criteria were met at 1.00 mg/kg dose. No serious adverse events were reported. Adverse events were dose-dependent and comprised involuntary muscle movement, tachycardia, and ventilatory effects. Adrenocorticotropic hormone stimulation evoked a physiologic cortisol response in all subjects, no different from placebo. Pharmacokinetics were dose-proportional. A three-compartment pharmacokinetic model described the data well. A rapid onset of anesthesia/sedation after bolus administration and also a rapid recovery were observed. A quantitative concentration-effect relationship was described for the modified observer's assessment of alertness/sedation and Bispectral Index. This first-in-human study of ABP-700 shows that ABP-700 was safe and well tolerated after single-bolus injections up to 1.00 mg/kg. Bolus doses of 0.25 and 0.35 mg/kg were found to provide the most beneficial clinical effect versus side-effect profile.

  2. Preoperative and Postoperative (1st and 3rd Month Metabolic Data of Patients Who Underwent Bariatric Surgery

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    Nilüfer Özdemir Kutbay

    2015-03-01

    Full Text Available Purpose: The growing prevalence of obesity has become a major concern. The efficacy of medical treatment, diet and behavior therapy in morbidly obese patients is limited. Obesity surgery is a treatment option for selected morbidly obese patients. Material and Method: Data of 47 patients (n=39 women, 8 men who underwent bariatric surgery were investigated. Results: Out of 47 patients, 20 underwent Roux-en-Y gastric bypass (RYGB (43% and 27 had sleeve gastrectomy (SG (57%. The mean age of the patients was 37±9.5 (19-59 years. 17% of patients were men and 83% were women. In the analysis of data on weight that could be found for 31 out of 47 patients, we detected preoperative and postoperative (1st and 3rd month mean weight values as 125.4±15.9 kg, 112.7±13.2 kg (p<0.001 and 100.9±17.5 kg (p<0.001, respectively. In addition, the analysis of the data on mean fasting plasma glucose (FPG levels which could be found for 23 out of 47 patients, showed us that preoperative and postoperative (1st and 3rd month FPG levels were 100.9±17.5 mg/dL, 91.6±10.9 mg/dL (p=0.03 and 87.3±2.0 mg/dL, respectively. Only 1 patient had diabetes before the surgery. In the RYGB group, the mean change in weight was 12.4±5.5 kg in the 1st month and 22.2±8.6 kg in the 3rd month (compared to the weights in the preoperative period. Moreover, in the SG group, the mean change in weight was 13.7±4.5 kg in the 1st month and 23.4±5.8 kg in the 3rd month. No statistically significant difference was found between the weight changes in the 1st and the 3rd month as for surgery types. Discussion: After bariatric surgery, significant loss in weight and reduction in FPG occurred in short-term.

  3. In vitro study of trematodicidal action of Dicranopteris linearis (Burm.f.) Underw. extracts against Gastrothylax crumenifer.

    Science.gov (United States)

    Rajesh, Kalpana Devi; Subramani, Vasantha; Annamalai, Panneerselvam; Nakulan V, Rajesh; Narayanaperumal, Jeyathilakan; Solomon, Jeeva

    2016-12-01

    The anthelmintic activity of column fractioned Dicranopteris linearis (Burm.f.) Underw. extracts was used for in vitro incubation study against adult Gastrothylax crumenifer. The qualitative analysis showed ethanol extract performed well to express 12 secondary metabolites studied except anthocyanin. Quantitative phytochemical analysis of terpenoids, phenols, flavonoids and tannins showed predominant amount of terpenoids (97.0±1.15)mg/g and tannins (30.8±0.44)mg tannic acid equivalents/gram. GC-MS analysis of fraction separated under column (Fraction V-79.5%) showed presence of QUERCETIN 7,3',4' TRIMETHOXY, a flavonoids (polyphenol derivative), PHYTOL, a diterpenoids, feren-8-ene, a triterpenoids, hexdecanoic acid, a fatty acid derivative shown to have potent anthelmintic property. 25ml of Hedon-Fleig (H-F) salt solution containing various concentrations (1, 2, 3, 4 and 5mg/ml) respectively as test extracts, Standard control Oxyclozanide @1(*)% (0.25g/25ml) and negative control H-F salt solution, distributed to 7-Petri plates in an incubator with 5% CO2 at 37°C. Twenty five amphistomes were incubated and the motility of control and drug treated flukes was observed under dissection microscope at a regular time interval of 0, 10, 15, 30min and 1hr respectively. The motility response of the parasites was categorized with specific score 3, 2, 1, 0 respectively. Relative Motility (RM) value based on mean mortality and drug concentration for analysis of Lethal Concentration (LC50) and were determined by Probit regression analysis. In vitro incubation study revealed death of all trematodes, lethal at 10min incubation time at 5mg/ml concentration, indicated RM value is 0, equivalent effective to Standard control Oxyclozanide, where RM value is 0 at 10min. Confirmative study on gross morphology, histopathology, and ultra-structural changes showed considerable effect on suckers, teguments and internal organs and were dose dependent. It is indicative that presence of

  4. The Biological Activity of Propolis-Containing Toothpaste on Oral Health Environment in Patients Who Underwent Implant-Supported Prosthodontic Rehabilitation

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    Tadeusz Morawiec

    2013-01-01

    Full Text Available The soft and periodontal tissues surrounding dental implants are particularly susceptible to bacteria invasion and inflammatory reactions due to complex histological structures. This study was carried out to investigate the influence of a propolis-containing hygienic agent on selected oral health parameters, oral microflora, and the condition of periodontal health. Sixteen subjects who underwent an oral rehabilitation with dental implants were selected and randomly assigned into two groups, which received a newly formulated propolis-containing toothpaste (3% (CA or a negative control without an active ingredient (CC. Approximal plaque index (API, oral hygiene index (OHI, debris component, and sulcus bleeding index (SBI were assessed in three subsequent stages. During the first and last examinations, the swabs were employed for microbiological inoculation. Propolis-containing toothpaste was found to be distinctively effective in improving oral health and the occurrence of gingivitis triggered by dental plaque. The qualitative and quantitative changes in oral bacteria spectrum were observed. Antibacterial measures containing propolis might be used as a natural adjuvant to other active substances in individuals with a high risk of periodontal problems against pathogenic oral microflora.

  5. The biological activity of propolis-containing toothpaste on oral health environment in patients who underwent implant-supported prosthodontic rehabilitation.

    Science.gov (United States)

    Morawiec, Tadeusz; Dziedzic, Arkadiusz; Niedzielska, Iwona; Mertas, Anna; Tanasiewicz, Marta; Skaba, Dariusz; Kasperski, Jacek; Machorowska-Pieniążek, Agnieszka; Kucharzewski, Marek; Szaniawska, Karolina; Więckiewicz, Włodzimierz; Więckiewicz, Mieszko

    2013-01-01

    The soft and periodontal tissues surrounding dental implants are particularly susceptible to bacteria invasion and inflammatory reactions due to complex histological structures. This study was carried out to investigate the influence of a propolis-containing hygienic agent on selected oral health parameters, oral microflora, and the condition of periodontal health. Sixteen subjects who underwent an oral rehabilitation with dental implants were selected and randomly assigned into two groups, which received a newly formulated propolis-containing toothpaste (3% (CA)) or a negative control without an active ingredient (CC). Approximal plaque index (API), oral hygiene index (OHI, debris component), and sulcus bleeding index (SBI) were assessed in three subsequent stages. During the first and last examinations, the swabs were employed for microbiological inoculation. Propolis-containing toothpaste was found to be distinctively effective in improving oral health and the occurrence of gingivitis triggered by dental plaque. The qualitative and quantitative changes in oral bacteria spectrum were observed. Antibacterial measures containing propolis might be used as a natural adjuvant to other active substances in individuals with a high risk of periodontal problems against pathogenic oral microflora.

  6. The Effect of Prazosin and Oxybutynin on the Symptoms Due to Using Double J Catheter in Patients Underwent TUL

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    K. Tavakkoli Tabassi

    2014-01-01

    Full Text Available Background & Aims: Double J catheter has been used for years as an independent practice or a part of other urological practices. Although these catheters have solved many patients’ problems but those can cause symptoms and problems for patients. The aim of this study was the investigation the effect of prazosin and oxybutynin on the degree of symptoms due to using Double J catheter. Methods: In this interventional study, patients who underwent TUL from July 2008 to march 2008 in the lithotripsy ward of Imam Reza hospital were entered to the study and randomly divided in 3 groups randomly. In the first group, placebo, in the second group, oxybutynin, in the third group prazosin were prescribed. Three weeks later standard questionnaire Ureteric Stent Symptom Questionnaire (USSQ was completed. After collecting data, was analyzed using SPSS software. Results: A total of 113 patients (70 men 43 women were included to the study. The mean age was 39 years. There were no significance difference among urinary symptoms score pain of body and physical activity problems in three groups (P>0.05, but there was a significant difference in general health and work problems among them (P<0.05. Conclusion: Oxybutynin caused a low effect on improvement of general health and work problems in patients who were studied. It might Prazosin does not has a sufficient time to affect on urinary symptoms, because of shortness of usage.

  7. The effect of anxiety and depression scores of couples who underwent assisted reproductive techniques on the pregnancy outcomes.

    Science.gov (United States)

    Terzioglu, Fusun; Turk, Rukiye; Yucel, Cigdem; Dilbaz, Serdar; Cinar, Ozgur; Karahalil, Bensu

    2016-06-01

    The aim of this study was to determine the effect of anxiety and depression scores of couples who underwent Assisted Reproductive Techniques (ART) on pregnancy outcomes. This study was conducted as a prospective and comparative study with 217 couples. The study data was collected by using a semi-structured questionnaire and the Turkish version of the State-Trait Anxiety Inventory (STAI), and Beck Depression Inventory (BDI). The questionnaire, STAI and BDI were applied to couples who initiated ART treatment. Couples' state anxiety scores were re-evaluated after embryo transfer (ET). A significant relationship was found between the depression score of women and pregnancy outcome (p 0.05) and lower depression scores (p <0.05) than spouses of women with a positive pregnancy outcome. Study results indicated that the anxiety and depression scores of couples who had achieved a positive pregnancy result were lower than for couples with a negative result. The results of this study will contribute to the health professionals especially to the nurses who spend the most time with couples in providing consulting services and supporting psychological status of couples during ART process in Turkey.

  8. Comparison of TIMI and Gensini score in patients admitted to the emergency department with chest pain, who underwent coronary angiography.

    Science.gov (United States)

    İşcanlı, Murat Doğan; Metin Aksu, Nalan; Evranos, Banu; Aytemir, Kudret; Özmen, Mehmet Mahir

    2014-03-01

    In patients admitted to the emergency department with complaints of chest pain and unstable angina pectoris, ST-elevation MI scoring is done according to risk factors used to calculate risks of urgent revascularization, MI, and death within 14 days. For this calculation, the most widely used scoring system is TIMI risk score. In this prospective, cross-sectional descriptive study, we evaluated and compared the effectiveness of TIMI and Gensini scores of patients with chest pain who were admitted to Hacettepe University Hospitals Emergency Department between March 2011 and September 2011 and who underwent coronary angiography. The mean (range) age of 165 patients was 62 (31-88) years. Moderate correlation between TIMI and Gensini scores was detected (mean values of Gensini score for TIMI 1 is 53.50, for TIMI 2 it is 52.09, for TIMI 3 it is 102.77, for TIMI 4 it is 113.70, and for TIMI 5 it is 115.43). There was also a positive correlation between TIMI score and the results. TIMI risk stratification score is safe and easy to use for rapid assessment of mortality and MI risk, despite its low possibility of predicting the outcome.

  9. Assessment of quality of life of patients who underwent anterior cruciate ligament reconstruction and a rehabilitation program

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    Moises Cohen

    2004-12-01

    Full Text Available Introduction: Quality of life can be defined as the expression of aconceptual model that tries to represent patient’s perspectivesand his/her level of satisfaction expressed by numbers. Theobjective of this study is to evaluate the parameters of quality oflife of 23 patients who underwent surgery for anterior cruciateligament reconstruction. Methods: We adopted SF-36, a generichealth-related evaluation questionnaire, to obtain informationregarding several aspects of patients’ health conditions, and theLysholm questionnaire, specific to evaluate the symptoms andfunction of the knee. The questionnaires were applied at two stagesof the treatment: pre- and postoperatively (after the rehabilitationprogram. Results: Before surgery, the Lysholm questionnairepresented the following results: excellent in 4% of the cases, goodin 22%, fair in 22%, and poor in 52%. After surgery (Lysholm e SF-36 the correlation level was approximately 44% (p = 0.041.Discussion: The correlation between the Lysholm and the SF-36questionnaires showed the following: the lower the level of pain,the higher the Lysholm score. The high scores presented by theLysholm questionnaire are directly proportional to physical andemotional aspects, and to functional capacity. Conclusion:Analysis of both questionnaires, as well as of their correlation,showed some improvement in patients´ quality of life. We werealso able to demonstrate the importance and usefulness of applyingthe two questionnaires at three different moments: before, duringand after physiotherapeutic intervention.

  10. Neurocognitive performance, subjective well-being, and psychosocial functioning after benzodiazepine withdrawal in patients with schizophrenia or bipolar disorder: a randomized clinical trial of add-on melatonin versus placebo.

    Science.gov (United States)

    Baandrup, Lone; Fagerlund, Birgitte; Glenthoj, Birte

    2017-03-01

    Chronic benzodiazepine use is common in patients with mental illness and is associated with cognitive impairment. It is unclear whether benzodiazepine-induced cognitive impairment is reversible. Amelioration of cognitive dysfunction may be facilitated during benzodiazepine tapering by add-on melatonin due to its anti-inflammatory and neuroprotective properties. We examined how melatonin and benzodiazepine withdrawal affect cognition, subjective well-being, and psychosocial functioning. Eighty patients with schizophrenia or bipolar disorder were randomized to add-on treatment once daily with either prolonged-release melatonin or placebo in a 24-week, double-blind clinical trial. All participants gradually tapered usual benzodiazepine dosage in a closely monitored treatment setting. We used the Brief Assessment of Cognition in Schizophrenia (BACS) to assess neurocognitive performance with additional assessments of subjective well-being and psychosocial functioning. BACS composite and subscale scores (except motor speed) significantly improved in parallel with benzodiazepine dose reduction, but there was no additional effect of melatonin. Cognitive performance was still markedly impaired post-tapering compared with normative data. Neither benzodiazepine withdrawal nor treatment group affected subjective well-being or psychosocial functioning. In conclusion, add-on melatonin does not seem to affect cognition, well-being, or psychosocial functioning in patients with severe mental illness. The observed improvement in cognitive performance could not be distinguished from retest effects, which may in turn have been facilitated by the benzodiazepine tapering.

  11. Três obstáculos epistemológicos para o reconhecimento da subjetividade na psicologia clínica Three epistemological obstacles to the recognizing of subjectivity in clinical psychology

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    Maurício S. Neubern

    2001-01-01

    Full Text Available No presente artigo, obstáculos epistemológicos são concebidos como formas de construção do pensamento presentes na psicologia clínica que não integram a complexidade e as diversas condições dos processos subjetivos. Parte-se de uma breve contextualização do percurso do tema da subjetividade na ciência e na psicologia: de um espaço marginal, quando é vista como oposição à objetividade, a uma posição privilegiada em que é discutida como momento integrante da construção do saber. Contudo, neste momento a psicologia clínica se depara com grandes dificuldades, pois as influências recebidas do paradigma dominante são pouco condizentes com a abordagem da subjetividade. Os obstáculos epistemológicos - como o conhecimento geral e totalitário, as tendências patologizantes e as conclusões apressadas -- são momentos de tais influências que descaracterizam a subjetividade como objeto de estudo e, em conseqüência, opõem-se às exigências necessárias para a abordagem das mesmas. Sendo assim, buscam-se destacar suas principais características e possibilidades de superação de modo que sua retificação aponte novos caminhos para a implantação de uma forma de pensar e investigar coerentes com as condições da subjetividade.In this article, epistemological obstacles are understood as a kind of though construction that does not integrate the complexity and the different conditions of the subjective process. The text begins with an introduction about the trajectory of subjectivity in both science and psychology. First, the subjectivity occupied a marginal place and it was seen as the oposite of objectivity; afterwards it became a central question, when it was reconized as an important moment to the construction of the knowledge. However, nowadays, clinical psychology faces huge difficulties, caused by the influences received from the dominant paradigm that are not coherent with the approach from the subjectivity. The

  12. Size, number, and distribution of thyroid nodules and the risk of malignancy in radiation-exposed patients who underwent surgery.

    Science.gov (United States)

    Mihailescu, Dan V; Schneider, Arthur B

    2008-06-01

    The chance that a thyroid nodule is malignant is higher when there is a history of childhood radiation exposure. The objective of the study was to determine how the size of a thyroid nodule, the number of nodules, and the distribution of nodules influence the risk of cancer in irradiated patients. From a cohort of 4296 radiation-exposed people, we studied the 1059 that underwent thyroid surgery. DESIGN AND OUTCOMES: We studied the association between the size, number, distribution, and rank order of thyroid nodules and the chance of malignancy. There were 612 malignant nodules in 358 patients and 2037 benign ones in 930 patients. There was no change in the risk that a nodule was malignant with increasing size (odds ratio 0.91/cm, P = 0.11) among the 1709 nodules that were 0.5 cm or greater. A solitary nodule had a similar likelihood of being malignant as a nodule that was one of several (18.8 vs. 17.3%), whereas patients with multiple nodules were more likely to have thyroid cancer than those with solitary nodules [30.7 vs. 18.7%; risk ratio 1.64 (1.27-2.13)]. Aspirating only the largest nodule would have missed 111 of the cancers (42%), whereas aspirating the two largest nodules would have missed 45 of the cases (17%), although none would have been 10 mm or greater. In radiation-exposed patients, the following conclusions were made: 1) the likelihood that a nodule is malignant is independent of nodule number and size; 2) the likelihood of cancer is increased if more than one nodule is present; 3) evaluating the two largest nodules by fine-needle aspiration would have resulted in a significant number of cases being missed but none with large cancers; and 4) more than half of the patients with thyroid cancer had multifocal tumors.

  13. Efficacy of Prothrombin Complex Concentrate Treatment in Patients with Liver Coagulopathy Who Underwent Various Invasive Hepatobiliary and Gastrointestinal Procedures

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    Cosmas Rinaldi A. Lesmana

    2016-06-01

    Full Text Available Background: Prothrombin complex concentrates (PCCs containing prothrombin, factors VII, IX, and X, as well as the inhibitors protein C and S have been used as an emergent reversal for oral anticoagulation therapy. The use of PCCs in hepatobiliary disorder patients or patients with liver coagulopathy who need to undergo invasive procedures has not been well studied. Objective: To evaluate the efficacy of PCC treatment in order to control or prevent bleeding complications in patients with liver coagulopathy who undergo various invasive procedures. Methods: This was a prospective, open-label, non-randomized, before-and-after study in patients with hepatobiliary disorders who underwent invasive procedures accompanied by liver impairment and received PCC injection (Cofact®, Sanquin, The Netherlands. Patients with coagulopathy from various causes were recruited consecutively. Data collected were the episodes of bleeding, liver function test and the international normalized ratio (INR before and after PCC therapy. The primary endpoint was INR change after treatment, while secondary endpoints included bleeding control and bleeding event after treatment. Results: Thirty patients (17 men, 13 women were enrolled. Patients’ mean age was 57.0 + 15.5 years. Liver cirrhosis was found in 14 patients (46.7%. The procedures consisted of liver biopsy, liver abscess aspiration, abdominal paracentesis, therapeutic upper gastrointestinal endoscopy, abdominal surgery, endoscopic retrograde cholangiopancreatography and percutaneous transhepatic biliary drainage. After treatment, 25 patients (83.3% showed a decreased median INR (from 1.6 to 1.3 (p < 0.001, Wilcoxon’s signed-rank test. Five patients failed to show INR reduction. No new bleeding event related to the invasive procedures was observed. Conclusion: PCC treatment is effective to control and prevent bleeding complications in patients with liver coagulopathy who undergo invasive procedures.

  14. Effectiveness of informational and emotional consultation on the psychological impact on women with breast cancer who underwent modified radical mastectomy.

    Science.gov (United States)

    Hsu, Su-Chin; Wang, Hsiu-Hung; Chu, Shu-Yuan; Yen, Hsiu-Fang

    2010-09-01

    Female breast cancer has been ranked as the leading cause of cancer death in Taiwan. Women who undergo a mastectomy are at risk of suffering emotional disturbance because of deteriorating body image. A nursing intervention designed to restore body image perceptions and to reduce anxiety and emotional distress in this vulnerable group should be developed and administered. This study was developed to evaluate the effectiveness of informational and emotional consultation on body image, anxiety, and emotional distress in women with breast cancer who underwent modified radical mastectomy. A quasi-experimental design with convenience sampling was used. Two hospitals within the same hospital system in southern Taiwan provided the research setting. Sixty-three women diagnosed with breast cancer completed the interviews (experimental group = 32, control group = 31). The experimental group participants received a two-session informational and emotional consultation, whereas those in the control group received routine nursing care only. All participants completed a series of three face-to-face interviews, including one pretest (Time 1, before surgery), a first posttest (Time 2, the day of discharge), and a second (follow-up) test (Time 3, 2 months after surgery). The intervention had an immediate positive effect (i.e., on the day of hospital discharge) on anxiety and a delayed positive effect (i.e., 2 months after surgery) on body image, anxiety, and emotional distress. The experimental group participants indicated a high level of satisfaction with the intervention. Our findings suggest the ability of this nursing informational and emotional consultation intervention to reduce patient anxiety at both short- and long-term stages. However, improved perception of body image and emotional distress only over the longer term indicates that these dimensions take time to be internalized and improved. This nursing informational and emotional consultation intervention may provide a

  15. Long-term follow-up of children who underwent severe hypospadias repair using an online survey with validated questionnaires.

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    Fraumann, Sarah A; Stephany, Heidi A; Clayton, Douglass B; Thomas, John C; Pope, John C; Adams, Mark C; Brock, John W; Tanaka, Stacy T

    2014-06-01

    Few studies of hypospadias repair in childhood have used validated questionnaires to investigate outcomes of cosmesis, urinary function, and sexual function in adulthood. We sought to investigate long-term outcomes in adult patients who had undergone severe hypospadias repair as children using an existing web-based application available to multiple institutions in order to develop an online patient survey of previously validated questionnaires. Patients aged 18 years or older who underwent severe hypospadias repair between 1992 and 1997 at our institution were contacted to complete an online survey. Through medical chart reviews, we analyzed the location of meatus, type of repair, and complications. The online survey included questions about penile appearance, and validated questionnaires to assess urinary and sexual function. Of 58 patients who met the inclusion criteria, we contacted 19, and 13 completed the survey. Fifty-nine percent had complications, with an average of 2.2 procedures per patient. Most (85.0%) were satisfied with penile appearance, although 38.0% had residual penile curvature. Hypospadias patients had mean lower orgasmic function than normal controls. Mean scores for urinary function and other domains of sexual function were similar to normal controls. Although the majority of adult patients were satisfied with the outcomes of penile appearance, urinary function, and sexual function, our online survey suggests decreased lower orgasmic function as measured by validated questionnaire. An online survey accessible to multiple institutions with validated questionnaires may facilitate assessment of long-term hypospadias results. Copyright © 2014 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

  16. Clinical outcomes for T1-2N0-1 oral tongue cancer patients underwent surgery with and without postoperative radiotherapy

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    Choi Eun

    2010-05-01

    Full Text Available Abstract Background The aim of this study was to assess the results of curative surgery with and without radiotherapy in patients with T1-2N0-1 oral tongue squamous cell carcinoma (OSCC and to evaluate survival and prognostic factors. Methods Retrospective analysis of 86 patients with T1-2N0-1 OSCC who received surgery between January 2000 and December 2006. Fourteen patients (16.3% received postoperative radiotherapy (PORT. Patient characteristics, tumor characteristics, treatment modality, failure patterns, and survival rates were analyzed. Results The median follow-up was 45 months. The five-year overall survival (OS and disease-free survival (DFS rates were 80.8% and 80.2%, respectively. Higher tumor grade and invasion depth ≥ 0.5 cm were the significant prognostic factors affecting five-year OS and DFS (OS rate; 65% vs. 91%, p = 0.001 for grade; 66% vs. 92%, p = 0.01 for invasion depth: DFS rate; 69% vs. 88%, p = 0.005 for grade; 66% vs. 92%, p = 0.013 for invasion depth. In the risk group, there was no local failure in patients with postoperative radiotherapy. Conclusions In T1-2N0-1 OSCC, factors that affected prognosis after primary surgery were higher tumor grade and deep invasion depth over 0.5 cm. Postoperative radiotherapy should be considered in early oral tongue cancer patients with these high-risk pathologic features.

  17. [Subjective cognition in schizophrenia].

    Science.gov (United States)

    Potvin, S; Aubin, G; Stip, E

    2017-02-01

    Given the extent, magnitude and functional significance of the neurocognitive deficits of schizophrenia, growing attention has been paid recently to patients' self-awareness of their own deficits. Thus far, the literature has shown either that patients fail to recognize their cognitive deficits or that the association between subjective and objective cognition is weak in schizophrenia. The reasons for this lack of consistency remain unexplained but may have to do, among others, with the influence of potential confounding clinical variables and the choice of the scale used to measure self-awareness of cognitive deficits. In the current study, we sought to examine the relationships between subjective and objective cognitive performance in schizophrenia, while controlling for the influence of sociodemographic and psychiatric variables. Eighty-two patients with a schizophrenia-spectrum disorder (DSM-IV criteria) were recruited. Patients' subjective cognitive complaints were evaluated with the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS), the most frequently used scale to measure self-awareness of cognitive deficits in schizophrenia. Neurocognition was evaluated with working memory, planning and visual learning tasks taken from Cambridge Neuropsychological Tests Automated Battery. The Stroop Color-Word test was also administered. Psychiatric symptoms were evaluated with the Positive and Negative Syndrome Scale and the Calgary Depression Scale for Schizophrenia. The relationships between subjective and objective cognition were evaluated with multivariate hierarchic linear regression analyses, taking into consideration potential confounders such as sociodemographic and psychiatric variables. Finally, a factor analysis of the SSTICS was performed. For the SSTICS total score, the regression analysis produced a model including two predictors, namely visual learning and Stoop interference performance, explaining a moderate portion of the variance

  18. Body composition changes over 9 years in healthy elderly subjects and impact of physical activity.

    Science.gov (United States)

    Genton, Laurence; Karsegard, Véronique L; Chevalley, Thierry; Kossovsky, Michel P; Darmon, Patrice; Pichard, Claude

    2011-08-01

    Age-related changes of body composition affect health status. This study aims at clarifying body composition changes in healthy elderly subjects, and evaluating the impact of physical activity on these changes. In 1999, 213 subjects ≥ 65 years recruited through advertisements underwent assessment of health state, energy expenditure by physical activity, body composition by bioimpedance analysis and body cell mass by total body potassium. In 2008, 112 of them repeated these assessments with additional determination of Barthel index, Mini Mental State Examination and Geriatric Depression Score. Lean tissues decreased in both genders (p physical activity limited lean tissue loss in men but not in women. Loss of lean tissues occurs exponentially with aging. Further research should confirm these changes in subjects over 80 years. Increasing physical activity limits fat-free mass loss in men but not women. Copyright © 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  19. Switching between ticagrelor and clopidogrel in patients who underwent percutaneous coronary intervention: insight into contemporary practice in Chinese patients

    OpenAIRE

    Wang, Xuyun; Xi, Shaozhi; Liu, Jia; Qin, Liuan; Jing, Jing; Yin, Tong; Chen, Yundai

    2016-01-01

    Ticagrelor has been proved to be more effective than clopidogrel; however, little is known about the switching between ticagrelor and clopidogrel in real-world clinical practice. We assessed the prevalence, related factors, dose bridging, compliance, and short-term outcomes of in-hospital switching between ticagrelor and clopidogrel in consecutively recruited patients treated by ticagrelor after percutaneous coronary intervention (PCI). A total of 417 eligible patients administrated with tica...

  20. Association between Seminal Vesicle Invasion and Prostate Cancer Detection Location after Transrectal Systemic Biopsy among Men Who Underwent Radical Prostatectomy

    OpenAIRE

    Young Ik Lee; Hak Min Lee; Jung Ki Jo; Sangchul Lee; Sung Kyu Hong; Seok-Soo Byun; Sang Eun Lee; Jong Jin Oh

    2016-01-01

    Background Our hypothesis is that the location of the seminal vesicles near the base of the prostate, the more positive cores are detected in the base, the greater the risk of seminal vesicle invasion. Therefore we investigate the clinical outcomes of base dominant prostate cancer (BDPC) in transrectal ultrasound (TRUS) -guided biopsies compared with anteromiddle dominant prostate cancer (AMPC). Methods From November 2003 to June 2014, a total of 990 intermediate and high risk prostate cancer...

  1. Short- and Long-Term Mortality Rates of Elderly Acute Kidney Injury Patients Who Underwent Continuous Renal Replacement Therapy.

    Directory of Open Access Journals (Sweden)

    Harin Rhee

    Full Text Available The world's population is aging faster and the incidence of acute kidney injury (AKI needing continuous renal replacement therapy (CRRT is increasing in elderly population. The outcome of AKI needing CRRT in elderly patients is known to be poor. However, the definitions of elderly used in the previous literatures were diverse and, there were few data that compared the long-term mortality rates of these patients with middle aged patients. This study was aimed to evaluate this issue.This study was a single-center, retrospective cohort study of patients who underwent CRRT from January 2013 to December 2015. The patients were divided into the following four age cohorts: middle-aged (55-64, young-old (65-74, middle-old (75-84, and old-old (≥85. The short- and long-term mortality rates for each age cohort were compared.A total of 562 patients met the inclusion criteria. The short-term mortality rate was 57.3% in the entire cohort. Compared with the middle-aged cohort, the middle-old cohort (HR 1.48 (1.09-2.02, p = 0.012 and the old-old cohort (HR 2.33 (1.30-4.19, p = 0.005 showed an increased short-term mortality rate along with an increased SOFA score, acidemia and a prolonged prothrombin time. When we analyzed the long-term mortality rate of the 238 survived patients, the middle-old cohort (HR 3.76 (1.84-7.68, p<0.001, the old-old cohort (HR 4.40(1.20-16.10, p = 0.025, a lower BMI, the presence of liver cirrhosis, the presence of congestive heart failure and a history of sepsis were independent risk factors for the prediction of long-term mortality.Compared with the middle-aged cohort, the middle-old and the old-old cohort showed an increased short-term and long-term mortality rate. However, in the young-old cohort, neither the short-term nor the long-term mortality rate was increased.

  2. Comparison of Standard Catheters Versus Radial Artery-Specific Catheter in Patients Who Underwent Coronary Angiography Through Transradial Access.

    Science.gov (United States)

    Chen, On; Goel, Sunny; Acholonu, Michael; Kulbak, Guy; Verma, Shivani; Travlos, Efstratios; Casazza, Richard; Borgen, Elliot; Malik, Bilal; Friedman, Michael; Moskovits, Norbert; Frankel, Robert; Shani, Jacob; Ayzenberg, Sergey

    2016-08-01

    In this prospective, randomized controlled study, we aim to compare the performance outcomes of standard catheters with the radial artery-specific catheter. Over the past decade, transradial cardiac catheterization has gained widespread popularity because of its low complication rates compared with transfemoral access. Operators have the choice of using either standard catheters (used for both transfemoral and transradial approach, with need for separate catheter use for either right or left coronary artery engagement) or a dedicated radial artery catheter, which is specifically designed to engage both coronary arteries through radial artery access. A total of 110 consecutive patients who underwent coronary angiography at our institution from March 2015 to April 2015 were prospectively randomized to either radial artery-specific Tiger catheter (5Fr; Terumo Interventional Systems, Somerset, New Jersey) versus standard Judkins left and right catheters (5Fr R4, L4; Cordis Corporation, Miami, Florida). The end points of the study included fluoroscopy time, dose-area product, contrast volume used, and total procedure time for the coronary angiography. A total of 57 patients (52%) were randomized to radial artery-specific catheter and 53 (48%) to the standard catheter. Tiger catheter was associated with significantly lower fluoroscopy time (184 ± 91 vs 238 ± 131 seconds, p = 0.015), which was statistically significant. Other outcome measures such as dose-area product (2,882.4 ± 1,471.2 vs 3,524.6 ± 2,111.7 Gy·cm(2), p = 0.07), total contrast volume (48.1 ± 16.1 vs 53.4 ± 18.5 ml, p = 0.114), and total procedure time (337 ± 382 vs 434 ± 137 seconds, p = 0.085) were also lower in single-catheter group, but it did not reach statistical significance. A total of 8 patients (14%) were crossed over from radial-specific catheter arm to standard catheter arm because of substandard image quality and difficulty in coronary engagement. Six patients had to be

  3. Retrospective analysis of prognostic factors in 205 patients with laryngeal squamous cell carcinoma who underwent surgical treatment.

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    Si-Yi Zhang

    Full Text Available OBJECTIVES: To investigate the most important factors affecting the prognosis of the patients with squamous cell carcinoma (SCC of the larynx. METHODS: Based on the clinical and follow-up data, 205 patients with SCC of the larynx receiving total laryngectomy, partial laryngectomy, or CO2 laser surgery in GuangDong General Hospital were retrospectively analyzed. A survival analysis was performed by the Kaplan-Meier method and a multivariable analysis of prognostic factors was carried out using the Cox proportional hazard model. RESULTS: Subtypes of carcinoma included 69.8% glottic and 30.2% supraglottic. Most patients were in N0 stage (77.6%, and 22.4% patients were in N1∼N3 stage. Over half of the patients were in T1∼T2 stage (55.1%, 20.0% in T3, and 24.9% in T4. Mean follow-up duration was 49.2 months. The survival rates 1, 2, and 3 years after the surgery were 99.0%, 91.7%, and 81.5%, respectively. The survival rate for those patients with clinical stage IV was significantly lower than for those with clinical stage I and II (p<0.001 and p = 0.013, respectively. The disease-free progression rates 1, 2, and 3 years after the surgery were 83.9%, 74.6%, and 71.2%, respectively. Futhermore, those patients with a Charlson score of 1 to 2 and ≥3 had higher risk of mortality than those with a Charlson score of 0 (hazard ratios of 1.8 and 2.41 p = 0.042 and p = 0.008. Multivariable analysis revealed that clinical stage, surgical margin, and comorbidity were significantly associated with both mortality and disease-free progression. CONCLUSION: The surgical resection margin, clinical stage, and comorbidity were independent factors affecting the laryngeal cancer prognosis. The survival rates were lower for patients with advanced laryngeal cancer, positive surgical margins, or severe comorbidity, suggesting the importance of early diagnosis, early treatment, negative surgical margins, and conditions of comorbidity.

  4. The Subject in Cognitive Psychotherapy

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    Isabel Caro-Gabalda

    2015-05-01

    Full Text Available This paper discusses the various subjects embedded in cognitive psychotherapy. The cognitive model developed by Beck, considered as a rationalist and modernist model, will exemplify these subjects. Cognitive therapy should be placed in the modernist historical context and related to a subject characterized as having rationality and the ability to observe and detect cognitions, emotions and behaviors. The paper develops this background introducing three main subject types. The first is the introspective and conscious subject, who is able to observe what is within oneself, has free access, and is conscious of one's cognitive world. The second is the cognitive miser that describes the subject who enters into therapy. The final subject identified, is the trained scientist who is able to develop a more objective knowledge, changing faulty schemas and cognitive distortions. This subject is the one most looked for in cognitive therapy. We could connect these subjects to some of the main elements of cognitive therapy such as the concept of ABC, assessment procedures, cognitive techniques or the relevance of schemas. Finally, the paper suggests some issues for study that could contribute to the theoretical and clinical evolution of cognitive psychotherapy.

  5. Incidence of Y-chromosome microdeletions in children whose fathers underwent vasectomy reversal or in vitro fertilization with epididymal sperm aspiration: a case-control study.

    Science.gov (United States)

    Ghirelli-Filho, Milton; Marchi, Patricia Leme de; Mafra, Fernanda Abani; Cavalcanti, Viviane; Christofolini, Denise Maria; Barbosa, Caio Parente; Bianco, Bianca; Glina, Sidney

    2016-01-01

    To evaluate the incidence of Y-chromosome microdeletions in individuals born from vasectomized fathers who underwent vasectomy reversal or in vitro fertilization with sperm retrieval by epididymal aspiration (percutaneous epididymal sperm aspiration). A case-control study comprising male children of couples in which the man had been previously vasectomized and chose vasectomy reversal (n=31) or in vitro fertilization with sperm retrieval by percutaneous epididymal sperm aspiration (n=30) to conceive new children, and a Control Group of male children of fertile men who had programmed vasectomies (n=60). Y-chromosome microdeletions research was performed by polymerase chain reaction on fathers and children, evaluating 20 regions of the chromosome. The results showed no Y-chromosome microdeletions in any of the studied subjects. The incidence of Y-chromosome microdeletions in individuals born from vasectomized fathers who underwent vasectomy reversal or in vitro fertilization with spermatozoa recovered by percutaneous epididymal sperm aspiration did not differ between the groups, and there was no difference between control subjects born from natural pregnancies or population incidence in fertile men. We found no association considering microdeletions in the azoospermia factor region of the Y chromosome and assisted reproduction. We also found no correlation between these Y-chromosome microdeletions and vasectomies, which suggests that the assisted reproduction techniques do not increase the incidence of Y-chromosome microdeletions. Avaliar a incidência de microdeleções do cromossomo Y em indivíduos nascidos de pais vasectomizados submetidos à reversão de vasectomia ou fertilização in vitro com recuperação de espermatozoides por aspiração do epidídimo (aspiração percutânea de espermatozoides do epidídimo). Estudo caso-controle que compreende crianças do sexo masculino de casais em que o homem havia sido previamente vasectomizado e escolheu revers

  6. The influence of expectation on spinal manipulation induced hypoalgesia: An experimental study in normal subjects

    Directory of Open Access Journals (Sweden)

    Barabas Josh A

    2008-02-01

    Full Text Available Abstract Background The mechanisms thorough which spinal manipulative therapy (SMT exerts clinical effects are not established. A prior study has suggested a dorsal horn modulated effect; however, the role of subject expectation was not considered. The purpose of the current study was to determine the effect of subject expectation on hypoalgesia associated with SMT. Methods Sixty healthy subjects agreed to participate and underwent quantitative sensory testing (QST to their leg and low back. Next, participants were randomly assigned to receive a positive, negative, or neutral expectation instructional set regarding the effects of a specific SMT technique on pain perception. Following the instructional set, all subjects received SMT and underwent repeat QST. Results No interaction (p = 0.38 between group assignment and pain response was present in the lower extremity following SMT; however, a main effect (p Conclusion The current study replicates prior findings of c- fiber mediated hypoalgesia in the lower extremity following SMT and this occurred regardless of expectation. A significant increase in pain perception occurred following SMT in the low back of participants receiving negative expectation suggesting a potential influence of expectation on SMT induced hypoalgesia in the body area to which the expectation is directed.

  7. Hipnose, dor e subjetividade: considerações teóricas e clínicas Hipnosis, dolor y subjetividad: consideraciones teóricas y clínicas Hypnosis, pain and subjectivity: theoretical and clinical considerations

    Directory of Open Access Journals (Sweden)

    Maurício da Silva Neubern

    2009-06-01

    subjetividad y sujeto en el ámbito de las complejas relaciones entre dolor e hipnosis dentro del contexto clínico.The present article aims to propose a qualitative and clinical approach to the comprehension of the relationship between hypnosis and pain, taking as a reference the notion of subjectivity. Having a criticism of the statistical methodologies as a starting-point, three other points are discussed in that sense. Firstly, the pain is conceived as a subjective process, organized in terms of configurations, senses, emotions and meanings that are built in the actions of the subject in his or her respective social insertion sceneries. Secondly, the relationship between hypnosis and pain is emphasized, giving a highlight to the intersubjective processes that exist in the communication and relationship between therapist and subject. The third point accentuates the importance of the singularity that should range the comprehension of pain, as well as the construction of hypnotic interventions. The article is concluded by emphasizing the relevance of subjectivity and subject notions in what regards the complex relationships between pain and hypnosis in the clinical context.

  8. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials.

    Science.gov (United States)

    García-Gea, Consuelo; Martínez, Joan; Ballester, Maria Rosa; Gich, Ignasi; Valiente, Román; Antonijoan, Rosa Maria

    2014-03-01

    The aim of this study was to compare the effects of concomitant administration of alcohol and bilastine versus alcohol alone on the central nervous system. Twenty-four healthy young volunteers of both sexes participated in a randomized, double-blind, double-dummy, crossover, and positive-controlled and placebo-controlled clinical trials. At 1-week intervals, subjects received six different treatments: (i) placebo; (ii) alcohol 0.8 g/kg alone (ALC); (iii) ALC in combination with: bilastine 20 mg (B20 + A); (iv) bilastine 80 mg (B80 + A); (v) cetirizine 10 mg (CET + A); and (vi) hydroxyzine 25 mg (HYD + A). Psychomotor performance tests (fine motor, finger tapping, nystagmus, critical flicker-fusion frequency, temporal estimation, 'd2' cancellation, and simple reaction time) and subjective self-reports (drunkenness, drowsiness, mental slowness, clumsiness, anger, attentiveness, competence, happiness, hostility, interest, and extroversion) were carried out at baseline and multiple points thereafter. All active treatments induced a significant psychomotor impairment. The greatest and most lasting impairment was observed with HYD + A followed by B80 + A and CET + A. In contrast, objective measures showed less impairment with B20 + A and ALC, both with a similar magnitude. Self-reports showed a subjective perception of performance impairment in all active treatments. Concomitant administration of bilastine (at therapeutic dose) and alcohol does not produce greater central nervous system depressant effects than ACL alone. Copyright © 2014 John Wiley & Sons, Ltd.

  9. Subjective quality of life and emotional pain among subjects with ...

    African Journals Online (AJOL)

    Objective: Heart failure (HF) is a common pathology worldwide. Associated emotional pain is an important risk factor of increased morbidity and secondary psychopathology. Methods: Subjects in stable state of HF attending the cardiology clinic of Lagos University Teaching Hospital (LUTH) were recruited into the study.

  10. A randomized, double blind, cross-over, placebo-controlled clinical trial to assess the effects of Candesartan on the insulin sensitivity on non diabetic, non hypertense subjects with dysglyce mia and abdominal obesity. "ARAMIA"

    Directory of Open Access Journals (Sweden)

    Rueda-Clausen Christian F

    2006-09-01

    Full Text Available Abstract Background The raising prevalence of type-2 diabetes mellitus and obesity has been recognized as a major problem for public health, affecting both developed and developing countries. Impaired fasting plasma glucose has been previously associated with endothelial dysfunction, higher levels of inflammatory markers and increased risk of developing insulin resistance and cardiovascular events. Besides life-style changes, the blockade of the renin-angiotensin system has been proposed as a useful alternative intervention to improve insulin resistance and decrease the number of new type-2 diabetes cases. The aim of this clinical trial is to study the effect of the treatment with Candesartan, an angiotensin II receptor antagonist, on the insulin resistance, the plasma levels of adipoquines, oxidative stress and prothrombotic markers, in a group of non diabetic, non hypertensive, dysglycemic and obese subjects. Methods and design A randomized, double blind, cross-over, placebo-controlled, clinical trial was designed to assess the effects of Candesartan (up to 32 mg/day during 6 months on the Homeostasis Model Assessment (HOMA index, lipid profile, protrombotic state, oxidative stress and plasma levels of inflammatory markers. The participants will be recruited in the "Fundación Cardiovascular de Colombia". Subjects who fullfil selection criteria will receive permanent educational, nutritional and exercise support during their participation in the study. After a 15 days-run-in period with placebo and life-style recommendations, the patients who have a treatment compliance equal or greater than 80% will be randomlly assigned to one of the treatment groups. Group A will receive Candesartan during 6 months and placebo during 6 months. Group B will receive placebo during the first 6 months, and then, Candesartan during the last 6 months. Control visits will be programed monthly and all parameters of interest will be evaluated every 6 months

  11. Physiotherapy in brest cancer: life quality and function clinical evolution Fisioterapia em oncologia mamária: qualidade de vida e evolução clínico funcional

    OpenAIRE

    Verônica Baptista Frison; Felipe Pereira Zerwes; Caroline Helena Lazzarotto de Lima; Mara Regina Knorst; Gabriela Tomedi Leites

    2010-01-01

    Purpose: to assess physiotherapy intervention impact on quality of life and functional evolution of women who underwent clinical treatment of breast cancer. Methods: almost-experimental study of the type before and after, carried out from March to June of 2009. We have included 10 patients subjected to surgical treatment of breast cancer and who underwent adjuvant treatment. We performed functional evaluation and a quality life questionnaire application, and a intervention protocol proposal w...

  12. Do subjects with minimal motor features have prodromal PD?

    Science.gov (United States)

    Chu, Yaping; Buchman, Aron S; Olanow, C W; Kordower, Jeffrey H

    2018-02-08

    Understanding the pathological changes underlying mild motor features of the eldery and defining a patient population with prodromal Parkinson's disease (PD) are of great clinical importance. It remains unclear, however, how to accurately and specifically diagnose prodromal PD. We examined whether older adults with minimal parkinsonian motor features have nigrostriatal degeneration and α-synuclein pathology consistent with prodromal PD. Brain sections were obtained from older adults with a clinical diagnosis of PD (N=21) and without a clinical diagnosis of PD (N=27) who underwent motor examination proximate to death. Cases without PD were further dichotomized into no motor deficit (n=9) or minimal motor features (n-18) groups using a modified Unified Parkinson's Disease Rating Scale. We performed quantitative unbiased stereological analyses of dopaminergic neurons/terminals and α-synuclein accumulation in the nigrostriatal system. In all subjects with minimal motor features, there were significant reductions in dopaminergic neurons and terminals in the substantia nigra and putamen that was intermediate between subjects with no motor deficit and PD. Phosphorylated α-synuclein inclusions were observed in the substantia nigra that were of similar density to what was seen in PD. Furthermore, there was greater Lewy neuritic pathology in the putamen relative to PD patients. Lastly, neurons with α-synuclein inclusions displayed reductions in tyrosine hydroxylase expression that was comparable in subjects with both minimal motor features and PD. Minimal motor features in older adults may represent prodromal PD and identify at risk individuals for testing putative neuroprotective interventions that could slow or prevent PD progression. This article is protected by copyright. All rights reserved. © 2018 American Neurological Association.

  13. Physical activity reduces the risk of dementia in mild cognitive impairment subjects: a cohort study.

    Science.gov (United States)

    Grande, Giulia; Vanacore, Nicola; Maggiore, Laura; Cucumo, Valentina; Ghiretti, Roberta; Galimberti, Daniela; Scarpini, Elio; Mariani, Claudio; Clerici, Francesca

    2014-01-01

    Leisure activities, particularly exercise, play a protective role against dementia in healthy people, but it is unknown if this protective effect could be generalized to subjects with mild cognitive impairment (MCI). To investigate the influence of leisure activities on the risk of progression of MCI to dementia. 176 MCI subjects attending a memory clinic underwent a standardized lifestyle questionnaire between October 2007 and May 2010. Social, cognitive, and physical scores were derived based on the assiduity of interpersonal contacts and on the frequency of participation in individual leisure activities. Subjects were requested to return every 12 months for dementia surveillance. The outcome measure was the risk of dementia associated with social, cognitive, and physical scores. Over a median follow-up time of 2.59 year, 92 (52.2%) MCI subjects developed dementia. Subjects with physical scores in the highest third had a lower risk (HR 0.44; 95% CI 0.23-0.85) of dementia compared with those in the lowest third. No association was found between cognitive or social scores and the risk of dementia. To our knowledge, this is the first prospective clinical study which demonstrates that high levels of participation in physical leisure activities are associated with reduced risk of dementia in subjects with MCI. In line with findings coming from community-based studies on healthy elderly, our finding suggests that the protective role of exercise against the development of dementia can be generalized to MCI subjects seen in clinical practice. Clinicians should encourage MCI subjects to participate in physical leisure activities.

  14. AB103. Overexpression of RNF2 is an independent predictor of outcome in patients with urothelial carcinoma of the bladder underwent radical cystectomy

    Science.gov (United States)

    Liu, Zhuowei; Li, Xiangdong

    2016-01-01

    Objective RNF2 is frequently overexpressed in several types of human cancer, but the status of RNF2 amplification and expression in urothelial carcinoma of the bladder (UCB) and its clinical/prognostic significance is unclear. Methods In this study, the methods of immunohistochemistry and fluorescence in situ hybridization (FISH) were utilized to examine the protein expression and amplification of RNF2 in 184 patients of with UCBs who underwent radical cystectomy. Results Overexpression of RNF2 was found in 44.0% of UCBs. A highly significant association between overexpression of RNF2 with shortened patient overall and cancer specific survival (P<0.001, logrank test) was demonstrated. In different subsets of UCB patients, overexpression of RNF2 was also a prognostic indicator in patients with pT1, pT2, pN(-) and/or negative surgical margins (P<0.05). Importantly, RNF2 expression together with pT status and surgical margins status provided significant independent prognostic parameters in multivariate analysis (P<0.05). Additionally, a significant correlation (P=0.003) of overexpression of RNF2 with an increased UCB labeling index of Ki-67 was observed in this UCB cohort. FISH results showed that the amplification of RNF2 was examined in 8/79 (10.1%) of informative UCB cases; in each of the 7 cases with RNF2 amplification, overexpression of RNF2 was observed. In the remaining 71 informative cancers without RNF2 amplification, 25 (35.2%) cases showed overexpression of RNF2. Conclusions our findings suggested that overexpression of RNF2, as examined by immunohistochemistry, might serve as a novel prognostic biomarker and potential therapeutic target for UCB patients treated with radical cystectomy.

  15. Experiences of Women Who Underwent Predictive BRCA 1/2 Mutation Testing Before the Age of 30.

    Science.gov (United States)

    Brunstrom, Kate; Murray, Alexandra; McAllister, Marion

    2016-02-01

    This qualitative interview study focuses on the experiences of a sample of British female BRCA 1/2 carriers who had predictive testing before the age of 30, which is the minimum age for breast screening in the UK. Following appropriate informed consent procedures participants were recruited through the Cancer Genetics Service for Wales. Semi-structured interviews were conducted face-to-face with seven participants, transcribed in full and analyzed using thematic analysis. The motives for testing and perceived advantages described by participants were similar to those identified in previous studies with older participants, such as increased awareness and knowledge and feeling more in control. However some of the perceived disadvantages were specific to younger women, including feeling pressured to make important life decisions earlier than they would have liked, such as about family planning and risk reducing surgery. Participants also reported feeling abandoned or forgotten because of lack of ongoing clinical contact, or feeling "stuck waiting" for screening to begin. However, none felt that these disadvantages were a reason to regret having testing. Findings in this small study suggest that having BRCA 1/2 predictive testing can have positive outcomes for young women even though they may be unable to access interventions such as breast screening. However it may be helpful to encourage young women during pre-test counseling to explore the decisions and choices they may face. These young women could benefit from ongoing support and follow up and increased interaction with healthcare professionals.

  16. Micromorphology of the dental pulp is highly preserved in cancer patients who underwent head and neck radiotherapy.

    Science.gov (United States)

    Faria, Karina Morais; Brandão, Thais Bianca; Ribeiro, Ana Carolina Prado; Vasconcellos, Adriele Ferreira Gouvêa; de Carvalho, Icaro Thiago; de Arruda, Fernando Freire; Castro Junior, Gilberto; Gross, Vanessa Cristina; Almeida, Oslei Paes; Lopes, Marcio Ajudarte; Santos-Silva, Alan Roger

    2014-10-01

    Teeth are often included in the radiation field during head and neck radiotherapy, and recent clinical evidence suggests that dental pulp is negatively affected by the direct effects of radiation, leading to impaired sensitivity of the dental pulp. Therefore, this study aimed to investigate the direct effects of radiation on the microvasculature, innervation, and extracellular matrix of the dental pulp of patients who have undergone head and neck radiotherapy. Twenty-three samples of dental pulp from patients who finished head and neck radiotherapy were analyzed. Samples were histologically processed and stained with hematoxylin-eosin for morphologic evaluation of the microvasculature, innervation, and extracellular matrix. Subsequently, immunohistochemical analysis of proteins related to vascularization (CD34 and smooth muscle actin), innervation (S-100, NCAM/CD56, and neurofilament), and extracellular matrix (vimentin) of the dental pulp was performed. The morphologic study identified preservation of the microvasculature, nerve bundles, and components of the extracellular matrix in all studied samples. The immunohistochemical analysis confirmed the morphologic findings and showed a normal pattern of expression for the studied proteins in all samples. Direct effects of radiotherapy are not able to generate morphologic changes in the microvasculature, innervation, and extracellular matrix components of the dental pulp in head and neck cancer patients. Copyright © 2014. Published by Elsevier Inc.

  17. Sensibility and Subjectivity: Levinas’ Traumatic Subject

    Directory of Open Access Journals (Sweden)

    Rashmika Pandya

    2011-02-01

    Full Text Available The importance of Levinas’ notions of sensibility and subjectivity are evident in the revision of phenomenological method by current phenomenologists such as Jean-Luc Marion and Michel Henry. The criticisms of key tenants of classical phenomenology, intentionality and reduction, are of a particular note. However, there are problems with Levinas’ characterization of subjectivity as essentially sensible. In “Totality and Infinity” and “Otherwise than Being”, Levinas criticizes and recasts a traditional notion of subjectivity, particularly the notion of the subject as the first and foremost rational subject. The subject in Levinas’ works is characterized more by its sensibility and affectedness than by its capacity to reason or affect its world. Levinas ties rationality to economy and suggests an alternative notion of reason that leads to his analysis of the ethical relation as the face-to-face encounter. The ‘origin’ of the social relation is located not in our capacity to know but rather in a sensibility that is diametrically opposed to the reason understood as economy. I argue that the opposition in Levinas’ thought between reason and sensibility is problematic and essentially leads to a self-conflicted subject. In fact, it would seem that violence characterizes the subject’s self-relation and, thus, is also inscribed at the base of the social relation. Rather than overcoming a problematic tendency to dualistic thought in philosophy Levinas merely reverses traditional hierarchies of reason/emotion, subject/object and self/other. 

  18. Neuropsychological Test Performance to Enhance Identification of Subjects at Clinical High Risk for Psychosis and to Be Most Promising for Predictive Algorithms for Conversion to Psychosis: A Meta-Analysis.

    Science.gov (United States)

    Hauser, Marta; Zhang, Jian-Ping; Sheridan, Eva M; Burdick, Katherine E; Mogil, Rachel; Kane, John M; Auther, Andrea; Carrión, Ricardo E; Cornblatt, Barbara A; Correll, Christoph U

    2017-01-01

    To compare neuropsychological performance in people at clinical high risk for psychosis (CHR), healthy controls (HCs), or subjects with first-episode psychosis (FEP). Systematic PubMed/MEDLINE search through January 2014, without language restrictions, using search terms prodrome OR clinical high-risk OR ultra-high risk AND cognition OR individual test names. Studies reporting neuropsychological data in CHR versus a HC or FEP groups or comparing CHR subjects who converted to psychosis (CHR-P) with CHR subjects who did not convert to psychosis (CHR-NP). Two authors independently extracted and compared neurocognitive test data. A meta-analysis was performed on 60 neuropsychological tests from 9 domains in 32 studies with 21 nonoverlapping samples (CHR = 1,684 patients, HC = 986, FEP = 405). Compared to HCs, people with CHR performed significantly worse in 7 of 9 domains (Hedges g effect size [95% confidence limit] = -0.17 [-0.30, -0.04] [attention/vigilance] to -0.42 [-0.64, -0.20] [verbal learning, speed of processing] and -0.43 [-0.68, -0.18] [social cognition]), except reasoning/problem solving and working memory (which separated in longitudinal studies). California Verbal Learning Test (-0.65 [-0.84, -0.46]) and Digit Symbol Test (-0.63 [-0.86, -0.40]) separated groups the most. Compared to FEP subjects, people with CHR performed significantly better in 5 of 6 domains (from 0.29 [0.03, 0.56] [speed of processing] to 0.39 [0.17, 0.62] [attention/vigilance, verbal learning] and -0.40 [0.18, 0.64] [working memory]), except reasoning/problem solving. CHR-P and CHR-NP performed significantly worse than HC (except visual learning, working memory in CHR-NP). Compared to CHR-NP, CHR-P performed significantly worse in 6 of 8 domains (from -0.24 [-0.44, -0.03] [attention/vigilance] to -0.49 [-0.76, -0.22] [verbal learning] and -0.54 [-0.80, -0.27] [visual learning]), without differences in reasoning/problem solving and working memory. Three individual tests (Rey

  19. Impact of Virgin Olive Oil and Phenol-Enriched Virgin Olive Oils on the HDL Proteome in Hypercholesterolemic Subjects: A Double Blind, Randomized, Controlled, Cross-Over Clinical Trial (VOHF Study.

    Directory of Open Access Journals (Sweden)

    Anna Pedret

    Full Text Available The effects of olive oil phenolic compounds (PCs on HDL proteome, with respect to new aspects of cardioprotective properties, are still unknown. The aim of this study was to assess the impact on the HDL protein cargo of the intake of virgin olive oil (VOO and two functional VOOs, enriched with their own PCs (FVOO or complemented with thyme PCs (FVOOT, in hypercholesterolemic subjects. Eligible volunteers were recruited from the IMIM-Hospital del Mar Medical Research Institute (Spain from April 2012 to September 2012. Thirty-three hypercholesterolemic participants (total cholesterol >200 mg/dL; 19 men and 14 women; aged 35 to 80 years were randomized in the double-blind, controlled, cross-over VOHF clinical trial. The subjects received for 3 weeks 25 mL/day of: VOO, FVOO, or FVOOT. Using a quantitative proteomics approach, 127 HDL-associated proteins were identified. Among these, 15 were commonly differently expressed after the three VOO interventions compared to baseline, with specific changes observed for each intervention. The 15 common proteins were mainly involved in the following pathways: LXR/RXR activation, acute phase response, and atherosclerosis. The three VOOs were well tolerated by all participants. Consumption of VOO, or phenol-enriched VOOs, has an impact on the HDL proteome in a cardioprotective mode by up-regulating proteins related to cholesterol homeostasis, protection against oxidation and blood coagulation while down-regulating proteins implicated in acute-phase response, lipid transport, and immune response. The common observed protein expression modifications after the three VOOs indicate a major matrix effect.International Standard Randomized Controlled Trials ISRCTN77500181.

  20. Multiple biomarkers including cardiac troponins T and I measured by high-sensitivity assays, as predictors of long-term mortality in patients with chronic renal failure who underwent dialysis.

    Science.gov (United States)

    Hickman, Peter E; McGill, Darryl; Potter, Julia M; Koerbin, Gus; Apple, Fred S; Talaulikar, Girish

    2015-06-01

    There is a high cardiac mortality in patients on long-term renal dialysis. No studies have reported long-term outcomes relating to both high-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) in these patients. Patients who underwent long-term dialysis at the Canberra Hospital had blood samples collected for both cardiac and other biomarkers. Samples were stored at -80°C until analysis. Mortality data were collected at 5 years, and univariate and multivariate analyses were performed to identify which biomarkers were predictive of mortality at 5 years. After multivariate analysis, albumin, C-reactive protein (CRP), and hs-cTnT remained independently predictive of all-cause mortality, with hs-cTnT having the highest hazard ratio. If hs-cTnT was excluded from the analysis, then hs-cTnI was independently predictive of mortality. For hs-cTnT, for both genders, the ninety-ninth percentile, derived from a population with subjects with subclinical disease excluded, served as an excellent partition between survivors and nonsurvivors. Receiver-operating characteristic curve analysis for hs-cTnT had area under the curve of 0.798 and for hs-cTnI of 0.774. Kaplan-Meier curves for the aggregation of albumin, CRP, and hs-cTnT showed a stronger predictive power with receiver-operating characteristic area under the curve of 0.805. The addition of echocardiographic data in an analysis of all patients who had an echocardiogram for clinical reasons (n = 105) did not alter the final observations in this subgroup. In conclusion, hs-cTnT retains a superior predictive power in a dialysis-dependent population for identifying those at risk for death and when aggregated with albumin and CRP also has substantial additive value for identifying mortality risk in a renal-dialysis population. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Switching between ticagrelor and clopidogrel in patients who underwent percutaneous coronary intervention: insight into contemporary practice in Chinese patients

    Science.gov (United States)

    Wang, Xuyun; Xi, Shaozhi; Liu, Jia; Qin, Liuan; Jing, Jing; Yin, Tong; Chen, Yundai

    2016-01-01

    Ticagrelor has been proved to be more effective than clopidogrel; however, little is known about the switching between ticagrelor and clopidogrel in real-world clinical practice. We assessed the prevalence, related factors, dose bridging, compliance, and short-term outcomes of in-hospital switching between ticagrelor and clopidogrel in consecutively recruited patients treated by ticagrelor after percutaneous coronary intervention (PCI). A total of 417 eligible patients administrated with ticagrelor in-hospital after PCI were recruited. Switching between ticagrelor and clopidogrel occurred in 362 (86.8%) patients, with 318 (76.3%) from clopidogrel to ticagrelor occurring mainly after PCI and 44 (10.6%) from ticagrelor to clopidogrel primarily at discharge. History of cerebrovascular disease, final diagnosis of acute coronary syndrome, left main disease, ostial lesion, co-administration with warfarin, CYP2C19 loss-of-function alleles’ carriage status, and ticagrelor-related dyspnoea emerged as related factors for the switching between clopidogrel and ticagrelor. Dose bridging between clopidogrel loading dose and ticagrelor maintenance dose (MD) was more frequent in patients switching from clopidogrel to ticagrelor, while the bridging between ticagrelor MD and clopidogrel MD was more likely to occur in patients switched from ticagrelor to clopidogrel. At 6 month follow-up, poor compliance was observed in patients from clopidogrel to ticagrelor (64.8%) or treated only by ticagrelor (50.9%), but perfect compliance in patients from ticagrelor to clopidogrel (100%). After excluding the cases with incompliance, patients switching from ticagrelor to clopidogrel had a relatively lower bleeding risk in comparison with patients with constant ticagrelor treatment and those switching from clopidogrel to ticagrelor (29.5% vs. 50.0% vs. 46.6%, adjusted P = 0.02). In-hospital switching between ticagrelor and clopidogrel is frequent in patients undergoing PCI. In comparison with

  2. Effect of the cumin cyminum L. Intake on Weight Loss, Metabolic Profiles and Biomarkers of Oxidative Stress in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah; Esmaillzadeh, Ahmad

    2015-01-01

    The current study was performed to determine the effects of cumin cyminum L. intake on weight loss and metabolic profiles among overweight subjects. This randomized double-blind placebo-controlled clinical trial was conducted among 78 overweight subjects (male, n = 18; female, n = 60) aged 18-60 years old. Participants were randomly assigned into three groups to receive: (1) cumin cyminum L. capsule (n = 26); (2) orlistat120 capsule (n = 26) and (3) placebo (n = 26) three times a day for 8 weeks. Anthropometric measures and fasting blood samples were taken at baseline and after 8 weeks of intervention. Consumption of the Cuminum cyminum L. and orlistat120 resulted in a similar significant decrease in weight (-1.1 ± 1.2 and -0.9 ± 1.5 vs. 0.2 ± 1.5 kg, respectively, p = 0.002) and BMI (-0.4 ± 0.5 and -0.4 ± 0.6 vs. 0.1 ± 0.6 kg/m(2), respectively, p = 0.003) compared with placebo. In addition, taking Cuminum cyminum L., compared with orlistat and placebo, led to a significant reduction in serum insulin levels (-1.4 ± 4.5 vs. 1.3 ± 3.3 and 0.3 ± 2.2 µIU/ml, respectively, p = 0.02), HOMA-B (-5.4 ± 18.9 vs. 5.8 ± 13.3 and 1.0 ± 11.0, respectively, p = 0.02) and a significant rise in QUICKI (0.01 ± 0.01 vs. -0.005 ± 0.01 and -0.004 ± 0.01, respectively, p = 0.02). Taking cumin cyminum L. for eight weeks among overweight subjects had the same effects of orlistat120 on weight and BMI and beneficial effects on insulin metabolism compared with orlistat120 and placebo. © 2015 S. Karger AG, Basel.

  3. The role of clinical pharmacology in molecular genetics

    Science.gov (United States)

    Robertson, D.

    1997-01-01

    PROBLEM: Discovering the causes of unusual phenotypes in human subjects is an important aspect of patient-oriented research. MATERIAL: The tools of clinical pharmacology are uniquely useful in addressing these problems. PATIENTS, SUBJECTS, OR CASE HISTORIES: We evaluated a 42-year-old patient with lifelong orthostatic hypotension and ptosis of the eyelids. He underwent a series of biochemical, physiological, and pharmacological tests outlined in this article. RESULTS: These studies indicated that sympathetic innervation was intact but that the sympathetic neurotransmitter was dopamine rather than norepinephrine. These results demonstrated that dopamine-beta-hydroxylase deficiency underlies the clinical abnormalities of this patient. CONCLUSION: In selected individuals with unusual phenotypes, the techniques of clinical chemistry and clinical pharmacology can define the nature of the defect at almost the resolution of the human genome.

  4. Braille character discrimination in blindfolded human subjects.

    Science.gov (United States)

    Kauffman, Thomas; Théoret, Hugo; Pascual-Leone, Alvaro

    2002-04-16

    Visual deprivation may lead to enhanced performance in other sensory modalities. Whether this is the case in the tactile modality is controversial and may depend upon specific training and experience. We compared the performance of sighted subjects on a Braille character discrimination task to that of normal individuals blindfolded for a period of five days. Some participants in each group (blindfolded and sighted) received intensive Braille training to offset the effects of experience. Blindfolded subjects performed better than sighted subjects in the Braille discrimination task, irrespective of tactile training. For the left index finger, which had not been used in the formal Braille classes, blindfolding had no effect on performance while subjects who underwent tactile training outperformed non-stimulated participants. These results suggest that visual deprivation speeds up Braille learning and may be associated with behaviorally relevant neuroplastic changes.

  5. Accuracy of ultrasound imaging technique for assessing lipoatrophy in HIV-infected subjects.

    Science.gov (United States)

    Ferraioli, Giovanna; Tinelli, Carmine; Scudeller, Luigia; Filice, Gaetano; Filice, Carlo

    2011-07-01

    To compare the accuracy of ultrasound imaging technique to that of clinical diagnosis in evaluating subcutaneous fat changes in HIV-infected subjects. HIV-uninfected control subjects (Group A), HIV-infected subjects with clinically assessed lipoatrophy (Group B), and HIV-infected subjects without clinical lipoatrophy (Group C) underwent ultrasound measurements of subcutaneous fat thickness at facial, brachial and thigh regions. ROC curve analyses were used to estimate ultrasound prediction accuracy and cut-off values of subcutaneous fat thickness. 228 subjects were enrolled: 78 in Group A, 73 in Group B, and 77 in Group C. Facial lipoatrophy: ROC curve analysis identified optimal cut-off value of 13.3 mm [sensitivity, 96.0%; specificity, 76.9% AUC 0.92], 5.0 mm [sensitivity, 71.4%; specificity, 92.3%; AUC 0.90] and 11.2 mm [sensitivity, 95.8%; specificity, 89.7%; AUC 0.97] for females and 12.05 mm [sensitivity, 51.2%; specificity, 87.2%; AUC 0.74], 4.1 mm [sensitivity, 76.2%; specificity, 89.7%; AUC 0.85] and 4.35 mm [sensitivity, 60.0%; specificity, 89.7%; AUC 0.82] for males in assessing facial, brachial and crural lipoatrophy respectively. Using this cut-off values, 12/25 (48%) females and 17/49 (34.7%) males, 12/28 (42.9%) females and 23/49 (46.9%) males, 19/28 (67.9%) females and 12/49 (24.5%) males in Group C would be classified as "sub-clinical" facial, brachial and crural lipoatrophy respectively. The results of our study show that in the assessment of subtle subcutaneous fat changes ultrasound is more accurate than clinical evaluation and confirm the usefulness of ultrasound imaging technique in identifying lipoatrophy at an early stage.

  6. Infarct Artery Distribution and Clinical Outcomes in Occluded Artery Trial Subjects Presenting with Non ST elevation Myocardial Infarction (From the Long Term Follow-up of the Occluded Artery Trial)

    Science.gov (United States)

    Menon, Venu; Ruzyllo, Witold; Carvalho, Antonio C.; Marconi, Jose; de Sousa, Almeida; Forman, Sandra A.; Jaworska, Krystyna; Lamas, Gervasio A.; Roik, Marek; Thuaire, Christophe; Turgeman, Yoav; Hochman, Judith S.

    2013-01-01

    We hypothesized that the insensitivity of the electrocardiogram (ECG) in identifying acute circumflex occlusion would result in differences in the distribution of the infarct related artery (IRA) between patients with non ST elevation myocardial infarction (NSTEMI) and ST elevation myocardial infarction (STEMI) enrolled in the Occluded Artery Trial. We also sought to evaluate the impact of percutaneous intervention to the IRA on clinical outcomes for patients with NSTEMI. Overall NSTEMI subjects comprised 13% (n=283) of the trial population. The circumflex IRA was overrepresented in the NSTEMI group compared to patients enrolled with STEMI (42.5 vs. 11.2%; pCHF) (22.3 vs. 20.23%, p=0.51, HR 1.20; 0.59-2.43); as well as the individual endpoints of Death (13.8 vs. 17.0%, p=0.51, HR 0.81;0.36-1.85); MI (6.1 vs. 5.1%, p=0.84, HR=1.11; 0.28-4.41); Class IV CHF (6.7 vs. 6.0%, p=0.45, HR 1.50;0.37-6.02). There was no interaction between MI type by ECG and treatment effect (p= NS). In conclusion the occluded circumflex IRA is overrepresented in the NSTEMI population. Consistent with the overall trial results, stable patients with NSTEMI and a totally occluded IRA did not benefit from randomization to PCI. PMID:23351464

  7. A randomized, double-blind, placebo-, and positive-controlled clinical pilot study to evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica in subjects with hyperuricemia

    Directory of Open Access Journals (Sweden)

    Usharani P

    2016-06-01

    Full Text Available Pingali Usharani,1 Chandrasekhar Nutalapati,1 Venkata Kishan Pokuri,1 Chiranjeevi Uday Kumar,1 Gangadhar Taduri,21Department of Clinical Pharmacology and Therapeutics, 2Department of Nephrology, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad, India Objectives: To evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica versus febuxostat and placebo on reduction in serum uric acid levels in subjects with hyperuricemia. Materials and methods: A total of 110 eligible subjects with hyperuricemia were enrolled and randomized to either of the five treatment groups – T. chebula 500 mg twice a day (BID, T. bellerica 250 mg BID, T. bellerica 500 mg BID, placebo BID, and febuxostat 40 mg once daily plus an identical placebo – for a duration of 24 weeks. Serum uric acid levels were measured at baseline and at the end of 4, 8, 12, 16, 20, and 24 weeks. Statistical analysis was done using GraphPad Prism Software 4. Results and interpretation: All active treatment groups showed a reduction in serum uric acid levels compared to baseline and placebo. Significant reduction in mean serum uric acid levels started as early as 4 weeks following treatment, compared to baseline, with T. bellerica (500 and 250 mg, febuxostat (P<0.001, and T. chebula 500 mg (P<0.01; an increase in serum uric acid levels was seen with placebo (P<0.05. The serum uric acid levels became steady after 16 weeks of treatment and remained the same until the end of 24 weeks. The reduction of serum uric acid levels in the T. bellerica 500 mg group was nearly twice that of the T. chebula 500 mg group as well as T. bellerica 250 mg group at all time points. T. bellerica 500 mg reduced serum uric acid levels from 8.07±0.87 to 5.78±0.25 compared to febuxostat, which reduced serum uric acid levels from 8.53±0.97 to 4.28±0.67 (P<0.001 at the end of 24 weeks. The efficacy of T. bellerica appeared to be dose dependent

  8. Aspirin challenge/desensitisation before coronary stenting in subjects with history of hypersensitivity. A pragmatic approach.

    Science.gov (United States)

    Cortellini, G; Testi, S; Severino, M; Chechi, T; Iorno, M L; Santucci, A; Corvetta, A; Piovaccari, G; Santarelli, A; Franco, N; Canonica, G W; Passalacqua, G

    2012-08-01

    Aspirin hypersensitivity may represent a major problem in patients with ischemic coronary disease who need a stenting procedure. In those patients, clinically unsettled reasonably quick desensitisation procedures are needed. In our study we attempted to select the most suitable procedure on the basis of characteristics and severity of ASA hypersensitivity. Thirty patients with a history of mild reactions to anti-inflammatory doses of aspirin (> 325 mg) were considered at low risk and underwent a tolerance test in 5 steps. Thirty-one patients, with a history of severe reactions to anti-platelet doses of aspirin 0 mg) underwent a slow desensitisation in 12 steps, reaching a cumulative dose of 150 mg ASA in 220 minutes. In the first group, 29 patients tolerated the challenge. One developed urticaria, thus underwent challenge/desensitisation and achieved tolerance. In the second group, 3 patients did not tolerate the procedure and had to discontinue. CONCLUSION. Our approach to aspirin hypersensitivity in patients needing coronary stenting, based on a severity stratification, allowed to achieve an effective tolerance to aspirin in the majority of subject in a reasonable short time.

  9. A subjective scheduler for subjective dedicated networks

    Science.gov (United States)

    Suherman; Fakhrizal, Said Reza; Al-Akaidi, Marwan

    2017-09-01

    Multiple access technique is one of important techniques within medium access layer in TCP/IP protocol stack. Each network technology implements the selected access method. Priority can be implemented in those methods to differentiate services. Some internet networks are dedicated for specific purpose. Education browsing or tutorial video accesses are preferred in a library hotspot, while entertainment and sport contents could be subjects of limitation. Current solution may use IP address filter or access list. This paper proposes subjective properties of users or applications are used for priority determination in multiple access techniques. The NS-2 simulator is employed to evaluate the method. A video surveillance network using WiMAX is chosen as the object. Subjective priority is implemented on WiMAX scheduler based on traffic properties. Three different traffic sources from monitoring video: palace, park, and market are evaluated. The proposed subjective scheduler prioritizes palace monitoring video that results better quality, xx dB than the later monitoring spots.

  10. Nutrient-rich dairy proteins improve appendicular skeletal muscle mass and physical performance, and attenuate the loss of muscle strength in older men and women subjects: a single-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Alemán-Mateo H

    2014-09-01

    Full Text Available Heliodoro Alemán-Mateo,1 Virginia Ramírez Carreón,1 Liliana Macías,1 Humberto Astiazaran-García,1 Ana Cristina Gallegos-Aguilar,1 José Rogelio Ramos Enríquez2 1Coordinación de Nutrición, Centro de Investigación en Alimentación y Desarrollo, A.C., 2Laboratorio de Análisis Clínicos e Investigación, Departamento de Ciencias Químico Biológicas, Universidad de Sonora, Hermosillo, Mexico Background: At present, it is unknown whether the use of nutrient-rich dairy proteins improves the markers of sarcopenia syndrome. Therefore, our proposal was to investigate whether ­adding 210 g of ricotta cheese daily would improve skeletal muscle mass, handgrip strength, and ­physical performance in non-sarcopenic older subjects.Subjects and methods: This was a single-blind randomized clinical trial that included two homogeneous, randomized groups of men and women over 60 years of age. Participants in the intervention group were asked to consume their habitual diet but add 210 g of ricotta cheese (IG/HD + RCH, while the control group was instructed to consume only their habitual diet (CG/HD. Basal and 12-week follow-up measurements included appendicular skeletal muscle mass (ASMM by dual-energy X-ray absorptiometry, handgrip strength by a handheld dynamometer, and physical performance using the short physical performance battery (SPPB and the stair-climb power test (SCPT. The main outcomes were relative changes in ASMM, strength, SPPB, and SCPT.Results: ASMM increased in the IG/HD + RCH (0.6±3.5 kg, but decreased in the CG/HD (–1.0±2.6. The relative change between groups was statistically significant (P=0.009. The relative change in strength in both groups was negative, but the loss of muscle strength was more pronounced in CG/HD, though in this regard statistical analysis found only a tendency (P=0.07. The relative change in the balance-test scores was positive for the IG/HD + RCH, while in the CG/HD it was negative, as those individuals had

  11. Comparison of Successful Myocardial Reperfusion and Adverse Events in Patients With ST-Elevation Myocardial Infarction Who Underwent Rescue Percutaneous Coronary Intervention After Failed Fibrinolytic Therapy With Versus Without Manual Coronary Thrombus Aspiration.

    Science.gov (United States)

    Boghdady, Ahmed; Elbadry, Mahmoud I

    2015-10-15

    It has been unclear the impact of manual thrombus aspiration (TA) on procedural outcomes in patients with ST-elevation myocardial infarction (STEMI) who underwent rescue percutaneous coronary intervention (PCI) after failed fibrinolytic therapy in comparison with primary PCI. Our aim was to test the hypothesis that manual TA may improve myocardial reperfusion and clinical outcomes in patients with STEMI who underwent rescue PCI after failed fibrinolytic therapy. From March 2011 to March 2014, 70 patients with STEMI after unsuccessful fibrinolysis were randomized to either rescue PCI with TA (TA group) or without TA (NTA group). Primary end points were rate of myocardial blush grade ≥2 and ST-segment resolution ≥70%. The secondary end point included 30 days follow-up for major adverse cardiac events (MACEs). Baseline clinical and angiographic characteristics were similar in the 2 groups. The TA and NTA groups were compared as follows: myocardial blush grade ≥2, 71% versus 46% (p manual TA leads to better myocardial reperfusion and significant reduction of MACE. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Preventing parastomal hernia with modified stapled mesh stoma reinforcement technique (SMART) in patients who underwent surgery for rectal cancer: a case-control study.

    Science.gov (United States)

    Canda, A E; Terzi, C; Agalar, C; Egeli, T; Arslan, C; Altay, C; Obuz, F

    2018-01-05

    Parastomal hernia is a frequent complication of an abdominal wall stoma. Surgical repairs have high complication and recurrence rates. Several different techniques have been suggested to prevent parastomal hernia during stoma creation. The aim of the present case-control study was to evaluate the efficacy of modified Stapled Mesh stomA Reinforcement Technique (SMART) for prevention of parastomal hernia compared with conventional colostomy formation in patients who underwent open or laparoscopic rectal resection and end colostomy for cancer. Between January 2014 and May 2016, all consecutive patients who underwent open or laparoscopic resection and end colostomy for primary or recurrent rectal cancer were identified from a prospectively collected database. Since January 2014, one surgeon in our team has routinely offered modified SMART procedure to all patients who are candidates for permanent terminal colostomy. In the SMART group patients, while creating an end colostomy, we placed a standard polypropylene mesh in the retromuscular position, fixed and cut the mesh by firing a 31- or 33-mm-diameter circular stapler and constructed the stoma. In the control group, a stoma was created conventionally by a longitudinal or transverse incision of the rectus abdominis sheath sufficiently large for the colon to pass through. Twenty-nine patients underwent parastomal hernia prophylaxis with modified SMART and 38 patients underwent end-colostomy formation without prophylaxis (control group). Groups were similar in terms of age, sex and underlying conditions predisposing to herniation. Median follow-up time is 27 (range 12-41) months. Nineteen patients (28.4%) developed parastomal herniation. In the SMART group, 4 patients (13.8%) developed parastomal herniation which is significantly lower than the control group in which 15 patients (39.5%) developed parastomal herniation (p = 0.029). We did not observe mesh infection, stenosis, erosion or fistulation in the SMART group

  13. Management of the Axilla in T1-2 Breast Cancer Patients with Macrometastatic Sentinel Node Involvement Who Underwent Breast-Conserving Therapy.

    Science.gov (United States)

    Kuru, Bekir; Yuruker, Savas; Sullu, Yurdanur; Gursel, Bilge; Ozen, Necati

    2017-09-25

    The aims of our study were to determine the incidence of axillary recurrence and arm morbidity in T1-2 invasive breast cancer patients with macrometastases on the sentinel lymph node (SLN) who underwent breast-conserving therapy (BCT), with or without axillary lymph node dissection (ALND). One hundred and nine T1-2 invasive breast cancer patients with macrometastases on the SLN who underwent BCT in our institution were included in the study. Patients with 1-2 positive SLN and without extra nodal extension (ENE) on the SLN did not undergo ALND (SLN-only group) and patients with ENE or patients who had >2 metastatic nodes underwent level I, II ALND (ALND group). The SLN-only group received radiotherapy to three axillary levels, the supraclavicular fossa, and ± mammaria interna. ALND group received radiotherapy to axillary level III, the supraclavicular fossa, and ± mammaria interna. The incidence of axillary recurrence and arm morbidity were investigated. Of the 109 patients, 18 patients with >2 metastatic SLNs and 10 with ENE on the SLN underwent ALND and 81 patients underwent SLN only. Median follow-up time was 37 months (3-77). There was no axillary recurrence in SLN-only group. However, in the ALND group 1 patient had developed axillary metastasis. There were 2 objective lymphoedema and 3 arm-shoulder restriction cases in the SLN-only group, and 2 and 3 in the ALND group, respectively. Axillary dissection could safely be omitted in patients with 1-2 macrometastatic SLN and without ENE who undergo BCT and axillary radiotherapy.

  14. Subjective memory complaints in preclinical autosomal dominant Alzheimer disease.

    Science.gov (United States)

    Norton, Daniel J; Amariglio, Rebecca; Protas, Hillary; Chen, Kewei; Aguirre-Acevedo, Daniel C; Pulsifer, Brendan; Castrillon, Gabriel; Tirado, Victoria; Munoz, Claudia; Tariot, Pierre; Langbaum, Jessica B; Reiman, Eric M; Lopera, Francisco; Sperling, Reisa A; Quiroz, Yakeel T

    2017-10-03

    To cross-sectionally study subjective memory complaints (SMC) in autosomal dominant Alzheimer disease (ADAD). We examined self-reported and study partner-based SMC in 52 young, cognitively unimpaired individuals from a Colombian kindred with early-onset ADAD. Twenty-six carried the PSEN-1 E280A mutation, averaging 7 years of age younger than the kindred's expected clinical onset. Twenty-six were age-matched noncarriers. Participants also underwent structural MRI and cognitive testing. Self-reported SMC were greater in carriers than noncarriers ( p = 0.02). Study partner-based SMC did not differ between groups ( p = 0.21), but in carriers increased with age ( r = 0.66, p < 0.001) and decreased with hippocampal volume ( r = -0.35, p = 0.08). Cognitively unimpaired PSEN-1 carriers have elevated SMC. Self-reported SMC may be a relatively early indicator of preclinical AD, while partner- reported SMC increases later in preclinical AD, closer to clinical onset. © 2017 American Academy of Neurology.

  15. Seroreversion in subjects receiving antiretroviral therapy during acute/early HIV infection.

    Science.gov (United States)

    Hare, C Bradley; Pappalardo, Brandee L; Busch, Michael P; Karlsson, Annika C; Phelps, Bruce H; Alexander, Steven S; Bentsen, Christopher; Ramstead, Clarissa A; Nixon, Douglas F; Levy, Jay A; Hecht, Frederick M

    2006-03-01

    We assessed human immunodeficiency virus (HIV) antibody seroreversion among individuals initiating antiretroviral therapy (ART) during acute/early HIV infection and determined whether seroreversion was associated with loss of cytotoxic T lymphocyte responses. Subjects in a cohort with acute/early HIV infection (HIV type 1 ribonucleic acid levels of 24 weeks were selected. Two clinically available second-generation enzyme immunoassays (EIAs) and a confirmatory Western blot were used to screen subjects for antibody reversion. Those with negative screening test results underwent additional antibody testing, including a third-generation EIA, and were assessed for cytotoxic T lymphocyte responses. Of 87 subjects identified, 12 (14%) had negative antibody test results at the start of ART; all 12 had seroconversion, although 1 had seroconversion only on a third-generation EIA. Of the 87 subjects, 6 (7%) had seroreversion on at least 1 EIA antibody assay while receiving ART during a median follow-up of 90 weeks. The only clinical predictor of seroreversion was a low baseline "detuned" (less sensitive) antibody. Cytotoxic T lymphocyte responses to HIV Gag peptides were detected in 4 of 5 subjects with seroreversion who could be tested. All 5 who had seroreversion who stopped ART experienced virologic rebound and antibody evolution. HIV antibody seroconversion on second-generation EIA antibody tests may fail to occur when ART is initiated early. Seroreversion was not uncommon among subjects treated early, although cytotoxic T lymphocyte responses to HIV antigens remained detectable in most subjects. Antibody seroreversion did not indicate viral eradication. A third-generation EIA was the most sensitive test for HIV antibodies.

  16. Clinical verification of a unilateral otolith test

    Science.gov (United States)

    Wetzig, J.; Hofstetter-Degen, K.; Maurer, J.; von Baumgarten, R. J.

    In a previous study 13 we reported promising results for a new test to differentiate in vivo unilateral otolith functions. That study pointed to a need for further validation on known pathological cases. In this presentation we will detail the results gathered on a group of clinically verified vestibular defectives (verum) and a normal (control) group. The subjects in the verum group were former patients of the ENT clinic of the university hospital. These subjects had usually suffered from neurinoma of the VIIth cranial nerve or inner ear infections. All had required surgical intervention including removal of the vestibular system. The patients were contacted usually two or more years postoperatively. A group of students from the pre- and clinical phase of medical training served as control. Both groups were subjected to standardized clinical tests. These tests served to reconfirm the intra- or postoperative diagnosis of unilateral vestibular loss in the verum group. In the control group they had to establish the normalcy of the responses of the vestibular system. Both groups then underwent testing on our exccentric rotary chair in the manner described before 13. Preliminary results of the trials indicate that this test may indeed for the first time offer a chance to look at isolated otolith apparati in vivo.

  17. Effects of pregabalin on subjective sleep disturbance symptoms during withdrawal from long-term benzodiazepine use.

    Science.gov (United States)

    Rubio, Gabriel; Bobes, Julio; Cervera, Gaspar; Terán, Antonio; Pérez, María; López-Gómez, Vanessa; Rejas, Javier

    2011-01-01

    To evaluate the effectiveness of pregabalin as a tapering therapy on the subjective sleep quality of patients who underwent a benzodiazepine withdrawal program in routine medical practice. Secondary analysis of a 12-week prospective, open noncontrolled study carried out in patients who met DSM-IV-TR criteria for benzodiazepine dependence. Sleep was evaluated with the Medical Outcomes Study Sleep Scale (MOS Sleep Scale). 282 patients were included in the analysis. Mean (±SD) pregabalin dose was 315 ± 166 mg/day at the end of the trial. We observed a significant and clinically relevant improvement in sleep outcomes at the endpoint, with a total score reduction from 55.8 ± 18.9 to 25.1 ± 18.0 at week 12 (i.e. a 55% reduction). Similar findings were apparent using the six dimensions of the MOS Sleep Scale. Moderate correlations were observed between the MOS Sleep summary index and sleep domains, and there were improvements in anxiety symptoms and disease severity. These findings suggest that pregabalin may improve subjective sleep quality in patients who underwent a benzodiazepine withdrawal program. This effect appears to be partly independent of improvements in symptoms of anxiety or withdrawal. However, controlled studies are needed to establish the magnitude of the effect of pregabalin. Copyright © 2011 S. Karger AG, Basel.

  18. King's Health Questionnaire to assess subjective outcomes after surgical treatment for urinary incontinence: can it be useful?

    Science.gov (United States)

    Luz, Rita; Pereira, Inês; Henriques, Alexandra; Ribeirinho, Ana Luísa; Valentim-Lourenço, Alexandre

    2017-01-01

    Midurethral slings (MUS) are the mainstay of treatment for stress urinary incontinence, but the definition of success varies widely amongst studies. The King's Health Questionnaire (KHQ) was designed to evaluate the impact of urinary incontinence on the quality of life. We hypothesised that the KHQ could be useful for postoperative quantitative assessment of subjective outcomes. This is a retrospective analysis of 204 patients who underwent incontinence surgery with transobturator MUS between 2004 and 2013. Follow-up was planned at 6, 12 and 24 months and success was evaluated using the cough stress test (objective cure) and the KHQ global score (subjective outcomes). Statistical analysis included receiver operating characteristic (ROC) curves to calculate a cut-off value for the KHQ global score to define subjective cure. The minimal clinically important difference was calculated with a distribution-based method (effect size) to estimate subjective improvement. Objective cure rates were 97 % and 95 % at 6 and 24 months respectively. ROC curves established the cut-off score at ≤ 31 for subjective cure, with sensitivity of 63-100 % and specificity of 82-88 %. Subjective cure rates were 80 % and 85 % at 6 and 24 months respectively. The minimal clinically important difference was set at 10 and an improvement of ≥ 10 points was defined as subjective improvement. Rates varied between 10 and 13 %. This study showed the value of the KHQ as an evaluation tool after UI surgery and determined clinically relevant threshold scores to define subjective outcomes.

  19. Simplified Chinese version of the Forgotten Joint Score (FJS) for patients who underwent joint arthroplasty: cross-cultural adaptation and validation

    OpenAIRE

    Cao, Shiqi; Liu, Ning; Han, Wuxiang; Zi, Yunpeng; Peng,Fan; Li, Lexiang; Fu, Qiwei; Chen, Yi; Zheng, Weijie; Qian, Qirong

    2017-01-01

    Background The Forgotten Joint Score (FJS) is a newly developed health-related quality of life (HRQoL) questionnaire designed to evaluate the awareness after total knee arthroplasty (TKA). This study cross-culturally adapted and psychometrically validated a simplified Chinese version of the FJS (SC-FJS). Methods Cross-cultural adaptation was performed according to the internationally recognized guidelines. One-hundred and fifty participants who underwent primary TKA were recruited in this stu...

  20. Efficacy of auditory training in elderly subjects

    Directory of Open Access Journals (Sweden)

    Aline Albuquerque Morais

    2015-05-01

    Full Text Available Auditory training (AT  has been used for auditory rehabilitation in elderly individuals and is an effective tool for optimizing speech processing in this population. However, it is necessary to distinguish training-related improvements from placebo and test-retest effects. Thus, we investigated the efficacy of short-term auditory training (acoustically controlled auditory training - ACAT in elderly subjects through behavioral measures and P300. Sixteen elderly individuals with APD received an initial evaluation (evaluation 1 - E1 consisting of behavioral and electrophysiological tests (P300 evoked by tone burst and speech sounds to evaluate their auditory processing. The individuals were divided into two groups. The Active Control Group [ACG (n=8] underwent placebo training. The Passive Control Group [PCG (n=8] did not receive any intervention. After 12 weeks, the subjects were  revaluated (evaluation 2 - E2. Then, all of the subjects underwent ACAT. Following another 12 weeks (8 training sessions, they underwent the final evaluation (evaluation 3 – E3. There was no significant difference between E1 and E2 in the behavioral test [F(9.6=0,.6 p=0.92, λ de Wilks=0.65] or P300 [F(8.7=2.11, p=0.17, λ de Wilks=0.29] (discarding the presence of placebo effects and test-retest. A significant improvement was observed between the pre- and post-ACAT conditions (E2 and E3 for all auditory skills according to the behavioral methods [F(4.27=0.18, p=0.94, λ de Wilks=0.97]. However, the same result was not observed for P300 in any condition. There was no significant difference between P300 stimuli. The ACAT improved the behavioral performance of the elderly for all auditory skills and was an effective method for hearing rehabilitation.